SAJBL Vol 7, No 1 (2014) by HMPG

ISSN 1999-7639

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW May 2014 Vol. 7 No. 1

SAJBL is published by the Health and Medical Publishing Group.

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW May 2014 Vol. 7 No. 1

CONTENTS 2 4 5

EDITORIAL Limiting donor conceptions to six: Time for change A Dhai LETTER TO THE EDITOR The ethics of claiming a 60% reduction in HIV acquisition from voluntary medical male circumcision G Masukume FORUM The Global Forum for Bioethics in Research: Past, present and future K Littler, J Millum, D R Wassenaar, for the GFBR Interim Steering Committee

ARTICLES Is there a foundation in South African legislation to require 9 students to disclose their academic status to patients when involved in their care? M van Niekerk, A Dhai, Y Guidozzi 14

Language, cultural brokerage and informed consent – will technological terms impede telemedicine use? C Jack, Y Singh, B Hlombe, M Mars

Current role of research ethics committees in health research in three geopolitical zones in Nigeria: A qualitative study A M Agunloye, A T Salami, A Lawan

Auditing the process of ethics approval for Master’s degrees at a South African university D L Clarke

Reporting sexual offences involving child patients: What is the current law following the Constitutional Court judgment? P Mahery

Ethical issues in public health promotion J Gardner

Questioning South Africa’s ‘genetic link’ requirement for surrogacy T Metz

CPD

EDITOR Ames Dhai CO-EDITOR David Mcquoid-Mason EDITORIAL BOARD Kevin Behrens Alexandra Capron Peter Cleaton-Jones Liz Gwyther Mariana Kruger Willem Landman Leslie London Nhlanhla Mkhize Charles Ngwenya J P de V van Niekerk Daniel Wikler HMPG EDITOR Janet Seggie EDITOR EMERITUS Daniel J Ncayiyana CONSULTING EDITOR J P de V van Niekerk DEPUTY EDITOR Bridget Farham EDITORIAL SYSTEMS MANAGER Melissa Raemaekers SCIENTIFIC EDITOR Ingrid Nye TECHNICAL EDITORS Emma Buchanan Paula van der Bijl HEAD OF PUBLISHING Robert Arendse PRODUCTION ASSISTANT Neesha Hassan ART DIRECTOR Brent Meder DTP & DESIGN Anelia du Plessis Carl Sampson HMPG BOARD OF DIRECTORS M Veller M Lukhele M Mbokota A A Stulting M R Abbas G Wolvaardt ISSN 1999-7639

Plagiarism is defined as the use of another’s work, words or ideas without attribution or permission, and representation of them as one’s own original work. Manuscripts containing plagiarism will not be considered for publication in the SAJBL. For more information on our plagiarism policy, please visit http://www.sajbl.org.za/ index.php/sajbl/about/editorialPolicies

SAJBL is published by the Health and Medical Publishing Group (Pty) Ltd, Co registration 2004/0220 32/07, a subsidiary of SAMA. 28 Main Road (Cnr Devonshire Hill Road), Rondebosch, 7700 All letters and articles for publication must be submitted online at www.sajbl.org.za Tel. (021) 681-7200. E-mail: publishing@hmpg.co.za

SAJBL is published by the Health and Medical Publishing Group.

EDITORIAL

Limiting donor conceptions to six: Time for change

Ames Dhai Editor amaboo.dhai@wits.ac.za In terms of the Regulations Relating to the Artificial Fertilisation of Persons (R.175) of the National Health Act,[1] when gametes are removed or withdrawn from the body of a gamete donor, this is done for the purpose of artificial fertilisation. In the Regulations, artificial fertilisation is defined as â&#x20AC;&#x2DC;... the introduction by other than natural means of a male gamete or gametes into the internal reproductive organs of a female person for the purpose of human reproduction ...â&#x20AC;&#x2122;. All information regarding the donated gametes is to be stored in an electronic central databank. No further gametes can be removed or withdrawn from the body of a donor once six children have been conceived through artificial fertilisation using the gametes of that donor. If a competent person involved in this aspect of reproductive medicine is informed or suspects that the maximum number of conceptions have occurred, s/he must make the donor aware of this and in addition must inform the donor that s/he may not make any further donation of gametes. This information must also be relayed to the central databank. A competent person is defined very broadly as a medical practitioner specialising in gynaecology with training in reproductive medicine, or a medical scientist, medical technologist or clinical technologist with training in reproductive biology and related laboratory procedures.[1] Currently there is no information on what informed the limitation to six live births in the Regulations or how this figure was arrived at. In addition, there appears to be no information from valid population genetics in the country indicating that if the number of donor offspring was not limited to fewer than six, the possibility of inbreeding would increase. What the Regulations have also not taken into consideration is that a conception is not the same as a live birth. The facts that pregnancy losses do occur, and that there is a definite attrition rate during pregnancies from conception to birth, have been ignored. In addition, the Regulations are silent on donor siblings and leave very little room for consideration of family desires. An appraisal of the international situation reveals that in order to decrease the chance of offspring intermarrying, donor gametes will not normally be used once the number of children believed to have been born from them has reached a certain number. The number

May 2014, Vol. 7, No. 1 SAJBL

varies between different countries: for example, it is 10 in the UK, and 25 in Holland.[2] In the UK, the limit is set as families and not number of children,[3] which makes it possible for parents to choose the same donor for a second or third sibling without being told that the donor has reached his limit. This is not the situation in South Africa (SA), unfortunately, with the blanket limit of six stemming from the outdated and repealed Human Tissue Act No. 65 of 1983. The limit is not only restrictive but also lags far behind the required legal and ethical changes that are necessary in any country striving towards an enabling environment to accommodate the rapid global advances in science and technology. Furthermore, it does not take into consideration the changed political climate in SA. It is possible that the 1983 Act was restrictive because the pool of donors and recipients was limited to the small minority of advantaged individuals in the country at that time, when the possibility of consanguinity could have been a real fear. The question is: Is it a compelling and defensible argument today? In The Netherlands, a limit of 25 children is used based on the principle that children from sperm donors may have, at most, a similar risk to children in the general population of having a relationship with a naturally conceived unknown half-sibling.[4] This calculation was based on specific population data in the country and included figures on the chance of having an unknown half-sibling, the average number of children parents have, the chance of donor-conceived children having children themselves, age and geographical factors determining the likelihood of meeting a partner in the district of a donor bank, and the size of the population being served by a donor bank. The American Society of Reproductive Medicine recommends that the limit should be based on the population from which a donor is selected and the catchment area that may be served by a particular donor.[5] Using this recommendation, it came up with a figure of not more than 25 pregnancies for a population of 800Â 000 to avoid the risk of unintentional relationships between two genetically linked individuals. The limit, while being set to minimise the possibility of two children from the same donor having a consanguineous relationship without knowing that they are genetically related, should ideally apply to sperm donations only, as sperm cells can be donated more easily and in larger quantities than eggs, and donation of eggs involves a complex medical intervention that could give rise to complications. Section 8(2)(iii) of the SA Regulations states that once six conceptions have occurred, all gametes donated by the gamete donor and in storage must be destroyed unless the Minister of Health consents to the practitioner keeping those gametes.[1] This section does not stipulate the purpose of keeping the gametes and is open-ended and ambiguous. One can therefore only speculate as to the reasons for keeping the gametes. Could it be that those who drew up the Regulations did foresee the possibility of requests that would necessitate more than six conceptions per donor being allowed, e.g. in situations of donor siblings? Perhaps this should be a common sense approach to use when interpreting this aspect of the Regulations, which needs to be read together with section 3(1),

EDITORIAL specifying that the purpose of removal or withdrawal of the gamete from the body of a gamete donor is that of artificial fertilisation. The Regulations, as part of chapter 8 of the National Health Act, were promulgated in March 2012, at the same time as several other regulations to the same chapter were passed. A number of authors have criticised these regulations as being problematic and have underscored the difficulties that have arisen in practice because of the resulting legal limbo and confusion.[6] This editorial is another such critique, but is specific to Regulation 175, which also needs review and amendment so that ambiguities are removed and it is brought in line with current developments, the international situation and the SA local context. Amendments to the Regulations should include a move away from conceptions to children in families, and include a realistic limit on the number based on research and appropriate consultation.

References 1. Regulations Relating to Artificial Fertilisation of Persons. http://www.greengazette. co.za/notices/national-health-act-no-61-of-2003-regulations-artificial-fertilisationof-persons_20120302-GGR-35099-00175 (accessed 11 April 2014). 2. Want to fall pregnant? http://www.ivf-infertility.com/donation/sperm/sperm4.php (accessed 10 April 2014). 3. The Human Fertilization and Embryology Authority. http://www.hfea.gov.uk/6192. html (accessed 10 April 2014). 4. Janssens PMW. No reason for a reduction in the number of offspring per sperm donor because of possible transmission of autosomal dominant disease. Journal of Human Reproduction 2003;18(4):669-671. [http://dx.doi.org/10.1093/humrep/ deg137] 5. Mayo Clinic. Sperm donations. http://www.mayoclinic.org/tests-procedures/ sperm-donation/basics/definition/prc-20009520 (accessed 10 April 2014). 6. Mahomed S, Nothling-Slabbert M, Pepper M. The legal position on the classification of human tissue in South Africa: Can tissues be owned? South African Journal of Bioethics and Law 2013;6(1):16-20. [http://dx.doi.org/10.7196/SAJBL.258]

S Afr J BL 2014;7(1):2-3. DOI:10.7196/SAJBL.322

May 2014, Vol. 7, No. 1 SAJBL

LETTER

The ethics of claiming a 60% reduction in HIV acquisition from voluntary medical male circumcision To the Editor: Is telling people that voluntary medical male circumcision (VMMC) reduces the risk of HIV acquisition (female to male) by 60% ethically defensible? It is commonly stated that VMMC reduces the risk of HIV acquisition by (about) 60%, and this statement is even repeated during the process of obtaining consent for the circumcision procedure, often without the clarification that this statement applies to female-to-male HIV transmission.[1,2] Say a person’s salary will be increased by 60% – the intuitive thing is to ask ‘60% of what?’ Knowing the baseline salary is vital for fuller understanding of the situation. Can one then give informed consent to undergo VMMC on the basis of just a percentage? (During the consenting process for VMMC other issues are discussed;[3,4] however, the focus of this letter is on the 60% issue.) Others state that VMMC can reduce by two-thirds (~66%) the rate of male acquisition of HIV.[5] Although this statement is technically true, it represents the upper margin of the 95% confidence interval relative risk reduction (40 - 67%) in favour of VMMC.[6,7] A two-thirds reduction therefore paints a more optimistic picture of VMMC. Medical authors have been known to use spin – as the media do – in scientific writing to achieve personal agendas.[8] I am of the opinion that it is unethical to just say to people that male circumcision will reduce HIV acquisition by approximately 60%, especially when alternatives exist that may be clearer and more easily understood. In more practical terms, the approximately 60% reduction translates to: ‘[On average] 72 circumcisions will have to be conducted over a 2-year period to prevent a new [HIV] infection.’[6] Mathematical modelling suggests ‘one HIV infection being averted for every five to 15 male circumcisions performed …’ in lowcircumcision, high HIV prevalence settings.[9] Risk compensation – where individuals engage in risky behaviour such as having multiple concurrent sexual partners because they think they are protected from acquiring HIV by VMMC – has been of concern in the HIV field.[10] The Orange Farm trial did ‘find a slight increase in risky behaviour in the circumcised men’.[11] In my opinion, the 60% (or higher) reduction story can create a false sense of security, because the fuller picture is not revealed. It is not inconceivable for someone to think that 60% is closer to 100% (full protection from

May 2014, Vol. 7, No. 1 SAJBL

HIV acquisition) than to 0% (no protection). Telling people about the number of men who have to be circumcised to prevent one HIV infection, rather than a percentage reduction, could make them more cautious (reduce risk compensation) about behaviours that could lead to HIV acquisition.

Gwinyai Masukume Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa parturitions@gmail.com References 1. Goldstuck ND. Adult circumcision in the prevention of HIV/AIDS. S Afr Med J 2013;104(1):17. [http://dx.doi.org/10.7196/SAMJ.7216] 2. Banerjee J, Klausner JD, Halperin DT, et al. Circumcision denialism unfounded and unscientific. Am J Prev Med 2011;40(3):e11-e12. [http://dx.doi.org/10.1016/j. amepre.2010.12.005] 3. Tobian AA, Gray RH. The medical benefits of male circumcision. JAMA 2011;306(13):1479-1480. [http://dx.doi.org/10.1001/jama.2011.1431] 4. KwaZulu-Natal Department of Health. Get circumcised. Know the facts. 2014. http://www.kznhealth.gov.za/comms/circumcision.pdf (accessed 12 March 2014). 5. Fauci AS, Marston HD. Ending AIDS – is an HIV vaccine necessary? N Engl J Med 2014;370(6):495-498. [http://dx.doi.org/10.1056/NEJMp1313771] 6. Mills E, Cooper C, Anema A, Guyatt G. Male circumcision for the prevention of heterosexually acquired HIV infection: A meta-analysis of randomized trials involving 11,050 men. HIV Med 2008;9(6):332-335. [http://dx.doi.org/10.1111/ j.1468-1293.2008.00596.x] 7. Siegfried N, Muller M, Deeks JJ, Volmink J. Male circumcision for prevention of heterosexual acquisition of HIV in men. Cochrane Database Syst Rev 2009;2:CD003362. [http://dx.doi.org/10.1002/14651858.CD003362.pub2] 8. Fletcher RH, Black B. ‘Spin’ in scientific writing: Scientific mischief and legal jeopardy. Med Law 2007;26(3):511-525. 9. UNAIDS/WHO/SACEMA Expert Group on Modelling the Impact and Cost of Male Circumcision for HIV Prevention. Male circumcision for HIV prevention in high HIV prevalence settings: What can mathematical modelling contribute to informed decision making? PLoS Med 2009;6(9):e1000109. [http://dx.doi.org/10.1371/ journal.pmed.1000109] 10. Wilson NL, Xiong W, Mattson CL. Is sex like driving? HIV prevention and risk compensation. J Dev Econ 2014;106:78-91. [http://dx.doi.org/10.1016/j. jdeveco.2013.08.012] 11. Kesinger M, Millard PS. Voluntary male medical circumcision. S Afr Med J 2012;102(3):123-124.

S Afr J BL 2014;7(1):4. DOI:10.7196/SAJBL.313

FORUM

The Global Forum for Bioethics in Research: Past, present and future K Littler, J Millum, D R Wassenaar, for the GFBR Interim Steering Committee Katherine Littler is a senior policy adviser at the Wellcome Trust, UK; Joseph Millum is a bioethicist at the Clinical Center Department of Bioethics and Fogarty International Center, National Institutes of Health, USA; and Douglas Wassenaar is director of the South African Research Ethics Training Initiative at the University of KwaZulu-Natal, South Africa. Corresponding author: D Wassenaar (wassenaar@ukzn.ac.za)

The Global Forum on Bioethics in Research (GFBR) served as a global platform for debate on ethical issues in international health research between 1999 and 2008, bringing together research ethics experts, researchers, policy makers and community members from developing and developed countries. In total, nine GFBR meetings were held on six continents. Work is currently underway to revive the GFBR. This paper describes the purpose and history of the GFBR and presents key elements for its reinstatement, future functioning and sustainability. Potential participants and sponsors are encouraged to contribute actively to the future of this unique international research ethics event. S Afr J BL 2014;7(1):5-8. DOI:10.7196/SAJBL.312

The Global Forum for Bioethics in Research (GFBR) was established following the controversy in the 1990s over perinatal trials of ‘short-course’ zidovudine (AZT) for the prevention of HIV transmission. The use of placebocontrolled trials in countries in sub-Saharan Africa and Southeast Asia was criticised as unethical in the New England Journal of Medicine[1] for providing participants with less than the global best standard of care. But the debate over these trials largely lacked voices from the countries most affected by the HIV/AIDS epidemic – countries whose citizens were participants in the trials and whose patients eventually benefited significantly from them.[2] A forum was needed in which representatives of all the stakeholders from developed and developing countries could freely discuss pressing issues in research ethics and work together towards solutions. The GFBR’s originally stated purpose was therefore to provide an open and transparent dialogue between delegates from the global north and south about the ethical challenges they faced.[3-5] Each meeting focused on one or two current ethical challenges in the field of health research, ranging from post-trial obligations to the ethics of mental health research. Meetings prioritised casebased discussion, diversity of attendees, and the intersection of academic and practical perspectives. A special effort was made to include voices from resource-poor or vulnerable settings. Over 70% of participants at the nine meetings held between 1999 and 2008 were from low- and middle-income countries (LMICs). By the seventh meeting, in Lithuania, over 1 000 delegates from over 40 countries had attended.[4] Funding support and in-kind contributions were made by Aga Khan University (AKU), the Council on Health Research for Development (COHRED), Facultad Latinoamericana de Ciencias Sociales (FLACSO), the Fogarty International Center and other institutes of the US National Institutes of Health, Institut National de la Santé et de la Recherche Médicale (INSERM), the Medical Research Council

(MRC) (UK), the MRC (South Africa), the Rockefeller Foundation, the Wellcome Trust, and the World Health Organization (listed alphabetically). Country hosts of particular events also contributed to funding and supporting specific events – such support was often, but not always, from host country government sources. The format of the GFBR positioned it uniquely on the international research ethics calendar, and it became a forum for open international dialogue on pressing or topical ethical issues affecting international health research. An informal steering committee managed the competitive selection of future hosts, based on the relevance of the topics proposed and applicants’ general track record in health research ethics. Hosts were requested to maintain the generic format of GFBR meetings and bring opportunities for dialogue and debate to the foreground rather than formal presentations of papers. The GFBR was designed and formatted to facilitate open and active engagement between delegates on specified topics of relevance to ethical issues in international health research. It created an environ ment ‘where conflicting and unresolved ethical issues can be debated and explored without expectation of immediate resolution’.[5] In some ways it is easier to describe what the GFBR was not than to describe what it was: it was not a bioethics conference with formal papers and presenter-initiated workshops; it was not an ethics guideline drafting exercise; it was not a research ethics training event. Instead, each GFBR meeting focused on one or two linked themes, which were explored through short, focused case presentations from selected experts or stakeholders, followed by extensive small-group discussion of case studies, commentaries, and report-backs to facilitated plenary sessions. Topics covered included partnerships between sponsors and investigators in clinical trials in developing countries; ethical issues in public health research; the ethics of cluster-randomised trials; capacity building needs and governance of research ethics committees; the ethics of genomics research; benefit sharing; research involving indigenous and vulnerable populations; post-trial access to drugs; and

May 2014, Vol. 7, No. 1 SAJBL

FORUM mental health research. Proceedings of each meeting were recorded by each host country, and were posted on an open access website hosted by AKU (http://gfbronline.com/). In 2009, the funders of the GFBR put future meetings on hold in order to review its role, format, funding and governance. This has allowed a period of consultation through discussions with other funders and stakeholders, round-table consultations at the 2012 Global Forum for Health Research and the 2012 World Congress of Bioethics, a survey of past participants, and a questionnaire to experts in the field. As a result of this consultative process, an Interim Steering Committee (ISC) facilitated by an informal coalition of funders (the Fogarty International Center, the MRC (UK) and the Wellcome Trust) has concluded that there is strong stakeholder support for the continuation of the GFBR as an event to promote and facilitate highquality and inclusive international discussion of major emerging research ethics issues of global significance. Such a forum, in line with original GFBR objectives, will provide a platform for international dialogue to shape policies and practices that affect researchers, funders, government and societies. The GFBR would help ensure that the voices of all the relevant communities are heard – including those from developing and developed countries.

Future of the GFBR The ISC has conducted several teleconferences to date. Work in progress is described below. The sustainability of the GFBR requires a wider funding base than existed during 1999 - 2008 for several principled and pragmatic reasons. It is advisable to have funding from a broad range of funders to reduce vulnerability to withdrawal (or undue influence) of a single major sponsor. Breadth of sponsorship would also strengthen the perceived independence of the GFBR from specific political or ideological positions as they arise from time to time. Breadth of sponsorship from a range of developed and developing country sources would also reinforce joint ownership and participation in a sustainable global event. The ISC has, for the present, decided to maintain the GFBR’s independence from industry sponsorship but this issue could itself be the subject of future GFBR debate.

Key recommendations • The GFBR should be funded for an initial period of 5 years with a review at the end of the third year. • The funding base of the GFBR should be expanded to achieve optimal core funding of up to US$450 000 per annum. • The GFBR should build on its core aims and objectives and be more proactive and strategic than previously. • The basic aims and mission of the GFBR are sound and should be preserved. • A steering committee should be selected, based on a transparent selection process. • A small part-time secretariat, stable for 5-year cycles, should be established to ensure that the GFBR is run efficiently and that institutional knowledge is maintained between meetings. • The website for the GFBR should be expanded to provide a discussion forum and a clearing house for disseminating research ethics information and contacts internationally. • Meetings should continue to be annual, but reports and outcomes of each GFBR must be published. Prior agreements with a journal

May 2014, Vol. 7, No. 1 SAJBL

publisher might be a criterion that the steering committee uses when selecting future GFBR event hosts competitively. • Clear, stable, transparent governance policies and structures should be established.

Mission The previous mission of the GFBR was: ‘To bring together key stakeholders from developing and developed countries to debate the ethics, social, legal and public policy issues related to health research in international settings.’[6] The GFBR’s aims were: • to maintain and strengthen the protection of human participants in health research • to provide a forum for developing country perspectives on ethical issues in research • to explore opportunities to enhance capacity for ethical review of research • to create a context for research involving human participants in which scientists, ethicists, community representatives, policymakers, industry, and other relevant stakeholders in developing and developed countries can address ethical issues in ways that allow expeditious long-term joint management of research protocols.[7] An implicit aim of the GFBR, ‘to promote high ethical standards in research’, should be included as an explicit future aim.

Participants GFBR meetings should remain relatively small in size. Between 70 and 100 participants allows for discussion between participants and preservation of the case study format and is sufficient to ensure a diversity of standpoints and regional and global representation. The GFBR must continue to attract a mix of participants from an appropriate range of fields and experience levels from within their respective professions and fields of activity. Participants will be selected on a competitive basis, based on structured submissions requiring a motivated account of each applicant’s engagement with the topics being focused on at a particular meeting. One of the main reasons the GFBR had influence and was so widely supported was the fact that many delegates were senior and actively engaged in their field; they could effectively spread and apply the ideas generated. It is also important to continue to support the more junior participants and ensure that their viewpoints are heard in these debates.

Frequency Annual meetings would allow the GFBR to be responsive to the needs of the global community, enable participation from a range of people for greater sharing of knowledge and ideas, and ensure a process that develops momentum and memory.

Topics The future GFBR should be strategic in its choice of topics. Having the GFBR pre-empt or respond promptly to emerging issues and policy developments was identified as important and as adding value during the consultation period. The steering committee and secretariat could be tasked to identify these current issues and support ancillary activities between meetings (funds permitting), such as an open call for topics by email. The steering committee and the secretariat could

FORUM then provide opportunities for stakeholders to give feedback on the ethical issues they find pressing, either by pro-active consultation or through an interactive electronic facility on a revised GFBR website.

Outputs and dissemination The secretariat (discussed below) could play a crucial role in disseminating published GFBR discussion papers and interfacing with other national and international bioethics groups and committees. The GFBR website should become a key element of dissemination. A moderated discussion forum would help to stimulate and sustain discussion on GFBR topics and maintain links between forum participants and the wider community. It could also serve as a clearing house to connect forum participants and allow them to find local experts, share their ideas and solutions, and disseminate educational resources and opportunities.

Governance Robust governance is essential for any future GFBR. There is a clear need for written terms of reference and governance processes, including criteria for deciding on host countries and choosing forum participants. The ISC would work with the first GFBR secretariat to develop standard operating procedures, to be agreed by the steering committee, so that each set of meeting organisers can build on the experiences of past hosts to deliver an effective and energetic meeting with appropriate attendees selected through a transparent competitive process. As part of the goal of ensuring inclusivity, the steering committee should have significant representation from LMICs, periodically rotated so that different regional voices are heard. In all respects, the GFBR should seek to be a model of global partnership. Identifying suitable models of partnership is a current ISC priority.

Secretariat Most previous GFBRs were organised by different partner institutions with an annual change of secretariat. This resulted in continuity problems between meetings. As a result, in 2006/7, the funders established a ‘permanent’ co-ordinating secretariat, hosted by COHRED in Geneva, with funding from the European Commission. A 2009 evaluation of the secretariat showed strong support for it,[8] as did a stakeholder engagement survey, despite some divergent views on its exact scope and role. The ISC favours the establishment of a small, efficient, part-time GFBR secretariat that should be funded as a core component of the GFBR. This secretariat would maintain the infrastructure necessary to run the GFBR, retain institutional memory, and ensure continuity of debates that are started but not completed during meetings. The secretariat would be competitively selected, using predetermined criteria, for a 5-year period, subject to competitive renewal, funding permitting. The core activities of the secretariat should include: • Support the steering committee. • Administer the selection of successive GFBR hosts. • Work with the successful local hosts to organise meetings and produce reports and publications. • Conduct evaluations of the meetings and disseminate materials. • Maintain the GFBR website. • Facilitate the transition from one meeting to the next. • Preserve the ethos of the GFBR; preserve institutional memory.

Ideally the secretariat should be continuously hosted in a single location to ensure staffing, financial and operational stability. Options under consideration are: • Host in one of the funding organisations. This is a cost-effective model but could create perceived conflicts of interest. However, such conflicts have not been an issue in the Wellcome Trust’s experience with hosting the secretariat for the UK Biobank Ethics and Governance Council. • Host at an institution in an LMIC. This would have the benefit of helping to build local capacity. • Host in a neutral health research or policy organisation. A benefit is that such organisations have established contacts and infrastructure. However, this could be a more expensive option.

Monitoring and evaluation The GFBR should be regularly monitored and evaluated. One of the first tasks of the steering committee, together with the ISC, will be to formulate a list of progress aims and operationalise them as concretely as possible. Annual monitoring with full review and evaluation after the third meeting, is strongly recommended. The ISC has already developed a provisional monitoring and evaluation plan.

Budget To reinforce a sustainable GFBR for at least a further 5 years, core funding committed for a period of 5 years would be required. There are several main components of the budget that require funding: • annual travel and accommodation for 70 - 100 delegates • part-time secretariat • occasional face-to-face meetings of the steering committee (most could be tele- or videoconferences; the balance could coincide with the annual forum). The total estimated cost per annum would be in the region of US$250 000 - 420 000, depending on the location of the secretariat and the annual forum itself. Ideally, the support would cover the maximum number of delegates and enable some meetings to be held in less accessible but important locations. Not all funders are likely to be able to contribute equally, so a tiered funding model is recommended by the ISC. This will ensure that all partners contributing up to or over a specified threshold have an equal voice. Ensuring a balanced composition and rotation of funders on any future steering committee will help to secure this. The ISC is currently generating a list of international funders who will be formally approached to pledge a contribution.

Launch event Planning is underway to re-launch the GFBR at a satellite meeting of the International Association of Bioethics (IAB) World Congress of Bioethics in Mexico in June 2014. At this meeting the GFBR will host a one-day forum on a current controversial topic, host a launch event at which the permanent secretariat will be announced, and invite expressions of interest to host the next full GFBR in 2015.

Conclusions The GFBR played a unique and important role in advancing inter national debate on current issues in research ethics. Lessons learned

May 2014, Vol. 7, No. 1 SAJBL

FORUM during 1999 - 2009 suggest that a stable secretariat implementing a specified, popular vision, mission and operating principles will best serve this purpose for the next 5 - 10 years. A wider and more globally diverse pool of funders should broaden the funding base, which in turn will ensure better representation, stability and sustainability. The GFBR launch event that will take place at the IAB in Mexico in June 2014 is intended to draw on a broader, more globally inclusive pool of funders and set a renewed GFBR on course for at least a further 5 years of critical debate and discussion to promote high ethical standards in health research globally. Acknowledgements. Interim financial support of the ISC from the Wellcome Trust is acknowledged. Disclaimer (JM). The views expressed are the authorâ&#x20AC;&#x2122;s own. They do not represent the position or policy of the National Institutes of Health, the US Public Health Service, or the US Department of Health and Human Services. Members of the GFBR ISC. Elizabeth Bukusi, Kenya; Anant Bhan, India; Yali Cong, China; Catherine Elliott, UK; Patricia Garcia, Peru; Katherine

May 2014, Vol. 7, No. 1 SAJBL

Littler, UK; Florencia Luna, Argentina; Joseph Millum, USA; Michael Parker, UK; Barbara Sina, USA; Douglas Wassenaar, South Africa.

References 1. Editorial. The ethics of clinical research in the third world. N Engl J Med 1997;337(12):847-849. 2. Chi BH, Stringer JSA, Moodley D. Antiretroviral drug regimens to prevent motherto-child transmission of HIV: A review of scientific, program, and policy advances for sub-Saharan Africa. Curr HIV/AIDS Rep 2013;10(2):124-133. [http://dx.doi. org/10.1007/s 11904-013-0154-z] 3. Loff B. Africans discuss ethics of biomedical research. Lancet 2002;359(9310):956. [http://dx.doi.org/10.1016/S0140-6736(02)08059-5] 4. Realpe S, IJsselmuiden C. Global Forum on Bioethics in Research. Presentation at 8th Global Forum for Bioethics in Research, 2007. http://gfbronline.com/ presentations.htm (accessed 7 February 2014). 5. Realpe S, Wang X, Jiminez-Santos E, IJsselmuiden, C. Global Forum on Bioethics in Research: Nearing 10 years of dialogue. Presentation at 9th Global Forum for Bioethics in Research, 2008. http://gfbronline.com/presentations.htm (accessed 7 February 2014). 6. http://www.gfbronline.com/mission.htm (accessed 7 February 2014). 7. http://www.gfbronline.com/amis.htm (accessed 7 February 2014). 8. http://www.gfbronline.com/PDFs/Evaluation_Report_Feb09.pdf.p.5 (accessed 7 February 2014).

ARTICLE

Is there a foundation in South African legislation to require students to disclose their academic status to patients when involved in their care? M van Niekerk,1 MSc Med (Bioethics and Health Law), BOccTher, BProc; A Dhai,2 MB BCh, FCOG (SA), LLM; Y Guidozzi,2 BSc (Nurs), LLB, MBA Department of Occupational Therapy, School of Therapeutic Sciences, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 2 Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 1

Corresponding author: M van Niekerk (matty.vanniekerk@wits.ac.za)

Student involvement in patient care has been debated for many decades. There is an increasing body of literature calling for greater respect for patients’ rights in a teaching environment. South African legislation already gives patients certain rights, including the right to non-medical information such as the costs of procedures. This paper analyses pertinent international guidelines and South African legislation to ascertain whether the existing rights of patients extend to the teaching environment. It is concluded that patients have a right to informed consent in every aspect of healthcare, including student involvement. S Afr J BL 2014;7(1):9-13. DOI:10.7196/SAJBL.276

Using patients in the training of healthcare students is a deep-rooted practice,[1-3] and contact with patients is one of the requirements for medical training of accrediting/regulatory bodies such as the World Fed eration for Medical Education (WFME).[4] Nevertheless, the WFME has no guidelines for student conduct related to patient care. There are no South African (SA) guidelines that are specific to healthcare students. The Health Professions Council of South Africa (HPCSA), while registering students in all healthcare professions except nursing and pharmacology/pharmacy, does not have a codified set of ethical rules of conduct for students who interact with patients for educational purposes (e.g. taking the patient’s history, drawing blood or other fluids, and performing or assisting with procedures). There are some international guidelines, such as those of the American Medical Association (AMA) and the Health and Care Professions Council of the United Kingdom (HCPC), but even internationally, regulation of students’ conduct in terms of patient management is inconsistent. In this paper, we review and analyse the current situation regarding patient autonomy and student training. We recommend that students should disclose their academic status when interacting with patients for educational purposes.

Patient autonomy: Ethics and the law An important ethical concern related to student involvement in patient care that is frequently raised in the literature centres around respecting patients’ autonomy and obtaining informed consent.[5-7] It is a wellestablished principle in biomedical ethics that patients’ autonomy should be respected.[8] Such respect requires healthcare practitioners to give the patient information regarding the medical condition with which he/she has been diagnosed, to inform him/her of all possible

treatment options available together with their inherent risks, and to respect his/her right to refuse treatment.[8,9] Although few studies on students’ admission of their academic status to patients have been conducted, the international literature has highlighted the need for ethical guidelines when students are involved in patient management. Studies conducted in Turkey[10] and Jamaica[11] showed that patients often do not know the academic status of the people involved in their care, and that they would want to be informed of student involvement. In fact, the Turkish study indicates that some patients would even allow students to perform procedures on them when they were doing so for the first time, if the students would only ask.[10] Alarmingly, Beatty and Lewis[12] reported that all the medical students who participated in their 1992 study at the University of Connecticut had been introduced to patients as ‘doctor’ at some point in their academic career, and 5% of the participants had introduced themselves to patients as ‘doctor’. Beatty and Lewis suggest that one reason for this misrepresentation is that students are afraid patients would not consent to their involvement in patient management if they knew the students’ academic status. [12] A study by McLean and Naidoo[13] revealed that SA medical students have a similar fear. Interestingly, patients also have fears related to student practice – that refusal to allow student involvement will result in ill-treatment.[10] Patient autonomy, and specifically the right to make an informed decision, which is impossible if a patient is misled or not given all the necessary information, has been affirmed by the SA courts on a number of occasions, such as in the cases of Richter and Another v Estate Hammann[14] and Castell v de Greef.[15] More recent cases, such as Castell v de Greef,[15] advocated the use of the ‘prudent patient’ standard, a higher standard than the previously used ‘prudent doctor’

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE standard, which means that the patient needs to fully comprehend the extent of the risks involved in the procedure to which he/she is consenting (i.e. needs to be informed of the material risks involved in the treatment/procedure) in order to give informed consent. In this case (at 426) it was held that material risk is what a reasonable person in the plaintiff’s position would have considered significant (and therefore necessary to declare), or what the physician ought reasonably to have known that the specific patient upon whom he/she was about to perform a surgical procedure would have considered noteworthy enough to necessitate disclosure,[15] hence the term prudent patient standard. Although the prudent patient standard is now considered to be the more appropriate test to apply, because of its recognition of patient autonomy, the courts have been inconsistent in its application. This is evidenced by the more recent case of Louwrens v Oldwage,[16] where the court again applied the prudent doctor standard (a standard widely criticised for denying a patient’s right to self-determination[9]). This has caused confusion. It is important to note that both the standards applied by the courts when deciding about informed consent relate to the provision of medical information.[14-16] However, patients increasingly require and are entitled to non-medical information such as the costs related to procedures (in terms of section 6(1)(c) of the National Health Act (NHA)[17] and item 2.8 of the National Patients’ Rights Charter[18]). Provision of healthcare services in SA is regulated by legislation, including the Constitution of the Republic of South Africa,[19] the NHA,[17] the Mental Health Care Act (MHCA),[20] the Health Professions Act (HPA)[21] as amended, and the regulations and policies of the HPCSA. Unfortunately the definitions in the NHA[17] and the MHCA[20] provide no enlightenment on the role of healthcare students in healthcare service provision. This paper therefore analyses the relevant legislation to examine how much protection it provides patients, to establish whether this protection creates a duty for students to disclose their academic status to patients when involved in their care, and to formulate guidelines for student involvement in patient care. Although some psychiatric hospitals, e.g. Weskoppies and Sterkfontein hospitals, are teaching hospitals, the MHCA[20] does not address service provision by practitioners in training at all. Importantly, the MHCA,[20] which specifically regulates mental healthcare service provision, does not have similar provisions regarding disclosure to those of the NHA[17] and will therefore not be included in the analysis and discussion.

International best-practice guidelines Internationally, there has been a wide call for ethical guidelines regarding patient involvement in student training.[10,11] Despite this, few international regulatory bodies have taken up the task of formulating such guidelines. For the purposes of this paper, the guidelines published by the AMA[22] and the HCPC,[23] and the set of policy guidelines developed by St Bartholomew’s and the Royal London School of Medicine and Dentistry in 1996, available on the British Medical Journal website (BMJ guidelines),[24] were analysed. Although these are not the only existing international guidelines, others were not considered because they were too fragmented (e.g. the guidelines proposed by the General Medical Council), applied to practice situations too dissimilar to SA, or applied to populations

May 2014, Vol. 7, No. 1 SAJBL

that in SA already have specific rules pertaining to them (e.g. the Canadian Paediatric Society’s position statement on the participation of children in medical education). The guidelines that were considered are not uniform. The AMA guidelines[22] consist of three items, whereas the HCPC guidelines[23] contain 13 guidelines with sub-items. The BMJ policy[24] consists of seven points. The AMA and BMJ guidelines emphasise that supervisors and students are responsible for ensuring that students practise ethically,[22,24] whereas the HCPC places the onus on the student.[23] The AMA appears to approach its guidelines from a patients’ rights perspective,[22] whereas the HCPC guidelines are presented from a student conduct perspective.[23] The BMJ policy further differs from the AMA and HCPC guidelines in that it is aimed at regulating situations where patients participate in clinical training purely for educational purposes that are not aligned with their treatment.[24] The provisions of these guidelines/policies can be grouped under five ethical and professional principles, i.e. informed consent, benefiting the patient, acting in the patient’s best interests, confidentiality and honesty.

Informed consent The AMA guidelines require that patients are informed of the identity and educational status of everyone who is involved in their care.[22] The BMJ guidelines state that patients should know that participation in clinical education is voluntary and that they can refuse to participate.[24] All three sets of guidelines indicate that patients have the right to choose their service provider and therefore to choose to be treated by a qualified practitioner.[22-24] The BMJ guidelines prescribe that verbal consent is sufficient to allow student participation, except in those instances where students would perform actions while the patient is anaesthetised. In those cases, written consent should be obtained and kept in the patient’s file. Where verbal consent was obtained, the fact that the consent was obtained must be recorded in the file.[24]

Benefiting the patient The BMJ and AMA guidelines differ as to whether student involvement per se benefits the patient. Where the BMJ policy views student participation as purely educational,[24] the AMA guidelines indicate that student involvement results in ‘integrated care’[25] which benefits the patient. Importantly, the BMJ guidelines emphasise that patients should clearly understand that non-participation in clinical education will not compromise their care.[24]

Acting in the best interests of the patient Students should act in the best interests of their patients by: • Respecting a patient’s right not to participate in clinical training.[24] • Treating everyone equally and not abusing or exploiting their relationships with patients.[23] • Protecting patients’ dignity by not performing potentially embarrassing examinations (embarrassing either because of the nature of the examination or the number of students involved) without patients’ express (verbal) consent.[24] • Acting within the limits of their education and training:[23] • Students should ask for help from their supervisor or someone from the clinical placement.[23]

ARTICLE • Students should only perform unsupervised tasks if they believe they have adequate skills to do so,[23] or if there is ‘recorded evidence of competence’ (which is not defined).[24] • Not exposing patients to danger:[23] • Students should deal safely with the potential of infection.[23] • When students have serious health-related difficulties they should limit or cease their studies, especially when impairments in judgement may result, as this could pose a risk to patients.[23] • Keeping patients’ records up to date and ensuring that the infor mation they add to a patient’s file is correct and clear.[23]

Confidentiality All the patient’s information is confidential.[23,24] Information obtained from patients should only be used for the purposes for which it was obtained. However, patients should be informed that students may be required to disclose information obtained from a patient to a responsible clinical supervisor, especially when others may be at risk. [23,24]

Honesty The AMA and the HCPC emphasise that students (and supervisors) should be clear about the educational status of students and not inflate students’ skills.[22,23] Students should be referred to by their correct titles,[22,24] and confusing[22] or misleading titles such as ‘young doctors’, ‘my colleagues’ or ‘assistants’ may not be used.[24] Because the HCPC guidelines are student-centred, aspects related to plagiarism and academic honesty are included in its document. [23] These are beyond the purview of this article and will not be dis cussed. Whether a student-centred or a patient-centred approach is followed, the international instruments appear to agree that students should disclose their academic status to patients when involved in their care. An analysis of the SA position is necessary to establish whether the SA context may also require disclosure of academic status to patients.

SA ethical and legal instruments

The Constitution of the Republic of South Africa[19] In terms of the Constitution,[19] the following rights pertaining to autonomy and self-determination in the healthcare context are enshrined in the Bill of Rights: • The right to inherent dignity and the right to the protection and respect of dignity (section 10) • The right to freedom and security of the person, including the rights to be free from any form of violence from either public or private sources (section 12(1)(c)) and not to undergo any form of torture (section 12(1)(d)) • The right to bodily and psychological integrity, which means among other things that people should have control over their own bodies (section 12(2)(b)) and not be subject to medical or other experimentation without their informed consent (section 12(2)(d)) • The right to privacy (section 14) • The right to access healthcare services and reproductive healthcare (section 27(1)(a)).

The importance of these sections of the Constitution[19] for the health sector is that patients’ autonomy is constitutionally entrenched. Regardless of their benevolence, healthcare practitioners may therefore not undermine patients’ autonomy and right to give informed consent to (or refuse) healthcare services.[9] Because patients have an expectation to be treated in accordance with these constitutional rights, it follows that the conduct of student practitioners should reflect their respect for patients’ rights.

The NHA[17] Sections 6(1) and 6(2) of the NHA[17] provide that healthcare providers must inform patients, in a language and manner that they understand, of: • their health status • the range of procedures available to them • the benefits, risks and costs thereof • the right to refuse treatment and the implications of refusal of treatment. In terms of section 7 of the NHA,[17] health services may not be provided without the patient’s informed consent. In addition, section 8(1) of the NHA[17] gives a patient ‘the right to participate in any decision affecting his/her personal health and treatment’.

The HPA[21] and the HPCSA and its ethical rules and guidelines One of the purposes of the HPA[21] was to create the HPCSA. The function of the HPCSA is to ‘protect the public and guide the professions’, which it achieves through the ethical regulations (published as a schedule to the HPA[21]) and guidelines (contained in booklets 1, 3 - 14 and 16) it publishes in terms of section 49 read with sections 61(2) and 61A(2) of the HPA.[21] The HPA[21] further controls the education, training and registration of health professions and all related matters. While some of the more general ethical rules such as the rules about professional confidentiality (rule 13) and the reporting of a colleague’s (or one’s own) impairment, or unprofessional, illegal or unethical conduct (rule 25)[26] can easily also apply to student practice, most of the rules are targeted at qualified practitioners and do not apply to issues specific to students at all. The HPCSA’s documents refer to students in two places. The first is in the annexures to the ethical rules, published by all the professional boards to cover profession-specific concerns not covered in the rules. Most of these documents are relatively similar and require qualified practitioners, student practitioners, assistants and technologists to adhere to rules 2 - 27 contained in the main document, in addition to the board-specific rules contained in the relevant annexure. Each of the professional boards further requires students to perform acts under supervision only (a concept that is not defined), and to perform only those acts directly in keeping with their level of training, which is presumed to relate to skill. Medical and dental students, in addition, may not work in private practice or act as locum tenens.[26] The Professional Board for Psychology published a comprehensive appendix that follows a different format to the other documents. Psychology students, when obtaining consent from patients, are required to:

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE ‘… as early as is feasible in the therapeutic relationship, provide the client concerned with appropriate information … and when the psychologist is a trainee and the legal responsibility for the treatment provided resides with the supervisor, the client shall, as part of the informed consent procedure, be informed that the therapist is in training and is being supervised and the client shall be given the name of the supervisor.’[26] Although psychology students must disclose the fact that they are in training, the emphasis in this rule appears to be less on the fact that a patient should be able to make an autonomous decision about participating in the training of the psychology student and more on the fact that the patient should know who the supervisor is. While not stated overtly, it is presumed to be implied here that the patient should be aware that information shared may be disclosed to the named supervisor, so the patient must in effect consent to a breach of confidentiality. In addition to the schedules, booklet 9[27] in guideline 3.1.3 gives examples of information that patients may need for purposes of informed consent, including ‘… whether students will be involved, and the extent to which students may be involved in an investigation or treatment’.[27] This guideline is not specific about the process of obtaining informed consent for student involvement, or who must disclose information about student involvement. It is important to note that patients have the right to refuse treatment, not only in terms of section 6(1)(d) of the NHA, but also in terms of item 2.9 of the National Patients’ Rights Charter.[18] Further, patients may not be prevented from seeking a second opinion or being treated by another healthcare practitioner (rule 11).[26] Nondisclosure of academic status is likely to unfairly limit this right.

Non-medical legislation The Consumer Protection Act[28] provides two further important rights to consumers that are likely to impact on students rendering healthcare services, i.e. the right to select suppliers (section 13) and the right to be provided with information in a plain and understandable way so as to be able to make an informed choice (section 22).[28] However, if patients are not informed that a person involved in their care is a student, they are unable to refuse treatment or to choose another service provider. Furthermore, section 41 requires fair and honest dealing.[28] ‘False, misleading or deceptive representations’ are impermissible in terms of this section, so it could be extrapolated that patients are entitled to know the academic status of persons involved in their care, and information provided to patients should be unambiguous. Information must be provided in such a way that it can reasonably be understood by the class of people for whom the notice, documentation or visual representation is intended, or those with average literacy skills and minimal experience as a consumer (section 22(2)).[28] This section does not require information to be available in all official languages.[29] The question that arises is whether people with minimal experience as consumers of healthcare services at teaching hospitals understand what it means to seek healthcare services at a teaching or academic hospital. It can be argued that the presence of signboards designating a hospital as a teaching hospital is not sufficient to absolve a student or healthcare practitioner from disclosing the academic status of persons involved in a patient’s care.

May 2014, Vol. 7, No. 1 SAJBL

Discussion and recommendations In the SA context, patients have rights that, while clear with respect to qualified practitioners, are not well defined in relation to student involvement in the rendering of healthcare services. One such right is that to informed consent. When patients are not provided with all the relevant information needed to give an informed consent to treatment, including knowledge of the academic status of persons involved in their care, healthcare practitioners and students fail to empower them to make informed decisions about their healthcare. This contravenes the autonomy of patients and the right they have to informed consent in terms of section 7 of the NHA.[17] In this regard, clear guidelines regarding student involvement in patient care are necessary. From the prudent patient standard, applied to test whether a patient has given informed consent, it can be argued that lack of skill of the person performing a procedure could constitute a material risk regarding the success of a procedure. It can therefore be extrapolated that a prudent patient would want to be informed that a student will be involved in his/her care, as well as the extent of such involvement. This could also be extended to simple procedures such as history taking, because an unskilled person is likely to take longer to take the history, to ask unnecessary questions or to leave out pertinent information, which could result in discomfort for the patient at the least, and may be to his/her detriment should serious aspects such as possible adverse drug interaction be missed. Nowhere does the NHA[17] explicitly require disclosure of the academic status of a healthcare provider. It could be argued that disclosure of academic status is part of stating the risks and consequences when obtaining informed consent from a patient, as required by section 6(1)(c) of the NHA.[17] Additionally, the fact that the NHA[17] gives patients the right to participate in decisions about their treatment could indicate that patients have a right to informed consent regarding student participation in their treatment. Furthermore, it could be argued that because of the inclusion of the right to know the costs of healthcare services, which relates to nonmedical information, it can be extrapolated that the NHA[17] allows for the disclosure of other pertinent non-medical information, such as academic status. It is reasonable to assume that patients entering healthcare facilities such as hospitals expect to receive care of the standard that would be provided by a qualified healthcare practitioner. However, students cannot measure up to this standard owing to their limited training, and patients should know when a person in training is involved in their care. There appears to be a need for guidelines on student involvement in patient care. Such guidelines should address patients’ right to informed consent and the disclosure of academic status of persons involved in their care. Patients’ right to refuse student involvement in their care should be included, as should their right not to be coerced or deceived in this regard. Students and their educators/supervisors should respect patients’ rights. References 1. Jagsi R, Lehmann LS. The ethics of medical education. BMJ 2004;329(7461):332-334. [http://dx.doi.org/10.1136/bmj.329.7461.332] 2. Blindless L. The use of patients in health care education: The need for ethical justification. J Med Ethics 1998;24:314-319. [http://dx.doi.org/10.1136/jme.24.5.314]

ARTICLE 3. Salter RH. Learning from patients – unfashionable but effective. Postgrad Med J 1996;72:385. [http://dx.doi.org/10.1136/pgmj.72.849.385] 4. World Federation for Medical Education. Basic Medical Education: WFME Global Standards for Quality Improvement. 2003. http://www.wfme.org/standards/bme (accessed 25 January 2012). 5. Waterbury JT. Refuting patients’ obligations to clinical training: A critical analysis of the arguments for an obligation of patients to participate in the clinical education of medical students. Med Educ 2001;35(3):286-294. [http://dx.doi.org/10.1111/j.13652923.2001.00865.x] 6. Lowe M, Kerridge I, McPhee J, Hart C. Do patients have an obligation to participate in student teaching? Med Educ 2008;42(3):237-241. [http://dx.doi.org/10.1111/j.13652923.2007.02948.x] 7. Yentis SM. The use of patients for learning and maintaining practical skills. J R Soc Med 2005;98(7):299-302. [http://dx.doi.org/10.1258/jrsm.98.7.299] 8. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. Oxford: Oxford University Press, 2001. 9. Claassen NJB, Verschoor T. Medical negligence in South Africa. Pretoria: Digma, 1992. 10. Basagaoglu I, Sari N. Patient attitude about ethical issues confronted during the clinical education of medical students with emphasis on informed consent. 2005. http://www.ishim.net/ishimj/jishim4_7_8/Vol4No7/ibrahim_sari.doc (accessed 22 March 2011). 11. Barnett AT, Cawich SO, Crandon IW, et al. Informed consent from patient participating in medical education: A survey from a university hospital in Jamaica. BMC Res Notes 2009;2(1):252-256. [http://dx.doi.org/10.1186/1756-0500-2-252] 12. Beatty ME, Lewis J. When students introduce themselves as doctors to patients. Acad Med 1995;70(3):175-176. [http://dx.doi.org/10.1097/00001888-199503000-00002] 13. McLean M, Naidoo SS. Medical students’ views on the white coat: A South African perspective on ethical issues. Ethics and Behaviour 2007;17(4):387-402. [http:// dx.doi.org/10.1080//10508420701519536] 14. Richter and Another v Estate Hammann 1976 (3) SA 226 (C). 15. Castell v De Greef 1994 (4) SA 408 (C). 16. Louwrens v Oldwage 2006 (2) SA 161 (SCA). 17. Republic of South Africa. National Health Act, No. 61. Government Gazette 2003;26595.

18. Health Professions Council of South Africa. National Patients’ Rights Charter. May 2008. http://www.hpcsa.co.za/downloads/conduct_ethics/rules/generic_ethical_ rules/booklet_3_patients_rights_charter.pdf (accessed 1 April 2010). 19. Republic of South Africa. Constitution of the Republic of South Africa. Government Gazette 1996;17678. 20. Republic of South Africa. Mental Health Care Act, No. 17. Government Gazette 2002;24024. 21. Republic of South Africa. Health Professions Act, No. 56. Government Gazette 1974. http://www.hpcsa.co.za/downloads/health_act/health_act_56_1974.pdf (accessed 12 March 2014). 22. American Medical Association. AMA Code of Medical Ethics: Opinion 8.087 – Medical student involvement in patient care. 2000. https://www.ama-assn.org/ama/pub/ physician-resources/medical-ethics/code-medical-ethics/opinion8087.page? (accessed 20 November 2012). 23. Health and Care Professions Council. Guidance on conduct and ethics for students. 2012. http://www.hpc-uk.org/assets/documents/10002C16Guidanceonconductand ethicsforstudents.pdf (accessed 21 November 2012). 24. St Bartholomew’s and the Royal London School of Medicine and Dentistry. Policy on the rights of patients in medical education. http://www.ncbi.nlm.nih.gov/ pmc/articles/PMC1119888/bin/bmj_322_7288_685__index.html (accessed 27 November 2012). 25. Council on Ethical and Judicial Affairs of the American Medical Association. Medical student involvement in patient care. J Clin Ethics 2000;12:111-115. 26. Republic of South Africa. Ethical rules of conduct for practitioners registered under the Health Professions Act, 1974. Government notice R717. Government Gazette 2006;29079. 27. Health Professions Council of South Africa. Seeking patients’ informed consent: The ethical considerations. 2008. http://www.hpcsa.co.za/downloads/conduct_ethics/ rules/generic_ethical_rules/booklet_9_informed_consent.pdf (accessed 1 April 2010). 28. Republic of South Africa. Consumer Protection Act, No. 68. Government Gazette 2008;32186. 29. Jacobs W, Stoop P, Van Niekerk R. Fundamental consumer rights under the Consumer Protection Act 68 of 2008: A critical overview and analysis. Potchefstroom Electronic Law Journal 2010;13(3):302-406. [http://dx.doi.org/10.4314/pelj.v13i3.63675]

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE

Language, cultural brokerage and informed consent – will technological terms impede telemedicine use? C Jack, BMedSci (Hons), LLM; Y Singh, PhD; B Hlombe; M Mars, MB ChB, MD Department of TeleHealth, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa Corresponding author: C Jack (jackc1@ukzn.ac.za)

Background. Telemedicine provides a solution to treatment of economically and geographically compromised patients and enhances the level of care. However, a problem has arisen in safeguarding patients’ rights to informed consent. Objective. To determine the impact of language, translation and interpretation barriers on gaining legally valid informed consent in telemedicine. Methods. Forty-one key words relevant to computer terminology and concepts required to gain informed consent for a telemedicine encounter were selected and sent for translation into isiZulu, the local indigenous language of KwaZulu-Natal, South Africa. A questionnaire with the list of words was developed with three domains covering information communication technology (ICT) use, ICT terms and ethics terms. This was administered to patients at four outpatient departments in rural KwaZulu-Natal hospitals. Results. Of the 54 participants, 50 (92.6%) did not know or understand the term ‘telemedicine’, 49 (90.7%) the term ‘video conference’ and 49 (90.7%) the term ‘electronic records’. Words such as ‘consent’ and ‘autonomy’ were understood by less than a third of the participants. Only 19 individuals (35.2%) understood the word ‘consent’, and only 4 (7.4%) understood both the words ‘consent’ and ‘telemedicine’. Conclusions. Obtaining informed consent for a telemedicine consultation is problematic. Alternative ways of doing so need to be investigated. S Afr J BL 2014;7(1):14-18. DOI:10.7196/SAJBL.291

South Africa (SA) has recently developed an eHealth strategy in which telemedicine is highlighted as a means of supporting the delivery of healthcare to rural areas.[1] In 2007, the Health Professions Council of South Africa (HPCSA) drafted proposed Guidelines for the Practice of Telemedicine in South Africa, with the requirement of written informed consent before commencement of a telemedicine encounter.[2] For consent to be legally valid, the patient must fully comprehend the procedures and acts to which they consent. The language of information communication technology (ICT) is replete with complex technical terms, some of which are used in informed consent documents and may be difficult to understand. In medicine, and by inference in telemedicine, patients prefer information in their own language, but in Africa development of technical terminology in most of the 2 000 indigenous languages has been neglected.[3] This lack of words in the lexicons of African languages may be a barrier to obtaining proper informed consent for either store-and-forward or synchronous telemedicine. In KwaZulu-Natal, SA, the majority of the population and users of the public health system speak isiZulu with English as a second language, but proficiency in English is low.[4] The SA Constitution grants equal and official status to 11 different languages, and the majority of SA citizens speak an indigenous language. The Constitution also requires that the state takes ‘practical and positive measures to elevate and advance the use of these languages’.[5] The dominant language of business and government is English, but only 35% of working-age South Africans are considered proficient

May 2014, Vol. 7, No. 1 SAJBL

in English.[6] English is also the primary language of the Internet, and Internet use in Africa is low. Only 16.3% of people in Africa access the Internet,[7] and in SA, Internet penetration is 21%.[8] Although telemedicine provides a solution to treatment of and can enhance the level of care to economically and geographically compromised patients, it also poses a challenge in safeguarding patients’ rights. Practitioners and regulators in the developing world have also expressed concern about the ethical and legal implications of diagnosing and managing patients by telemedicine.[9] The World Health Assembly resolution of 2005 (WHA 58.28), calling on member nations to advocate telemedicine, acknowledges the need to respect the principle of equality and differences in culture, education, language, physical and mental ability and geographical location.[10] It does not address specific ethical issues related to telemedicine, such as the lack of direct contact between patient and practitioner, confidentiality, safety, data security and informed consent, or the legal implications of cross-border, international practice of telemedicine. While the vulnerability of people in developing countries has been the focus of recent debate around ethical issues relating to the standard of care and research,[11] the debate on vulnerability has not extended to the practice and use of telemedicine. Worthington[12] states that the ‘main requirement to seek valid consent from patients before an intervention is to uphold and reinforce the concept of patients’ autonomy’. This allows the patient to refuse participation and seek alternative therapies if they so choose. A central issue in informed consent is that of understanding and comprehension. This can be an elusive concept that is extremely

ARTICLE difficult to gauge, especially when language and translation become additional factors.[13] In SA, with 11 different official languages and a population that can be defined as having limited English proficiency, interpreters are often used in clinical interviews.[14] Studies have shown that ad hoc interpreting procedures in a clinical setting have an up to 40% rate of translation errors,[15] and where language barriers exist there is a greater chance of patient dissatisfaction and non-compliance with care.[16,17] Pachter et al.[18] describe a system of culturally sensitive healthcare that respects ethnic and cultural values along with linguistic considerations to enhance the quality of the interaction between the patient and the healthcare system. In the pluralistic society of SA, the impact of language and culture on telemedicine and the use of complex computer terminology in the informed consent process has not been addressed. In SA, nurses are traditionally used to translate and in addition, advocate, mediate and negotiate on behalf of their patients. This is ‘cultural brokerage’, which may be defined as ‘the act of bridging, linking, or mediating between groups or persons of differing cultural backgrounds, for the purpose of reducing conflict or producing change’.[19] It is assumed that the cultural broker has a suitable level of linguistic competence, which is the capacity to communicate effectively and convey information in a manner that is easily understood by a diverse audience. In the developing world, it is therefore essential to ensure that culturally competent nurses help their patients receive culturally competent care.[20] The aims of this study were to determine whether language is a barrier to obtaining informed consent for a telemedicine encounter, by translating or transcripting (i.e. mapping the sounds of one language to the best matching script of another language) common and uncommon computing and technical terms and words into isiZulu and then assessing whether these words are readily understood by patients in rural settings.

Methods Telemedicine informed consent documents from several countries were studied. Thirty-eight words about computer terminology and concepts relevant to telemedicine and three relevant to consent were selected. The 41 words were sent for translation into isiZulu by an IT technician, a surgeon, an isiZulu linguist and translator, and a teacher of isiZulu, all of whom are isiZulu first-language speakers, and by an Englishspeaking doctor who is fluent in isiZulu. Some words were not directly translatable and were transcripted or left in English if transcription was not possible. Words were then translated back into English by the IT expert to ensure reliability. A questionnaire with the list of words was developed with three domains covering ICT use, ICT terms and ethics terms. These were further grouped into words that could be translated or transcribed into isiZulu and those that were not translatable. The study was conducted in the outpatient departments of the four rural hospitals that regularly participate in the regional telemedicine programme, as patients attending these hospitals may potentially be involved in a telemedicine consultation. Convenience sampling was used to select participants from those waiting to be seen. Subjects were engaged in conversation in isiZulu and asked if they would consent to participate. They were then asked, in isiZulu, if they understood the meaning of each word or phrase in isiZulu and of the untranslatable words in English. If they said they understood the word, they were asked to give their understanding of the meaning of

the word. Understanding of the words and terminology was reported with ‘yes’ or ‘no’ answers. Permission to conduct the research was obtained from the KwaZulu-Natal Department of Health and the Biomedical Research Ethics Committee of the University of KwaZulu-Natal. No personal details or identifying information were collected from participants. All data were entered into an Excel spreadsheet. SPSS version 21 was used for statistical analysis using Fisher’s exact test, with a significance level of p<0.05.

Results Fifty-four patients (39 female) were interviewed in four rural hospital outpatient departments. Their ages ranged from 18 to 65 years (mean 42). Most lived in rural areas, with only 8 resident in the local town. Forty-five individuals (83.3%) used a cellular phone and only 4 (7.4%) used a computer. Eight words could not be translated into isiZulu, and 45 people (83.3%) did not understand or could not explain the meaning of these English words. The two words that were transcribed were email and monitor, which were not understood by 40 (74.1%) of the participants. Most respondents did not know or understand the terms ‘telemedicine’ (50; 92.6%), ‘video conference’ (49; 90.7%) or ‘electronic records’ (49; 90.7%), words that are commonly used in informed consent documents internationally and locally. Many also did not understand words that are not unique to telemedicine, such as ‘confidentiality’ 38 (70.4%), ‘consent’ (35; 64.8%) and ‘autonomy’ (46; 85.2%). Only 3 (5.6%) of the participants, all of whom were computer users, understood uncommon, complex computer terminology such as ‘encryption’, ‘firewall’ and ‘synchronous’. The words and terminology understood by more than half of the participants are those also used when describing mobile or cellular phone technology and home entertainment systems, such as ‘television’ (51; 94.4%), ‘video’ (35; 64.8%), ‘speakers’ (30; 55.6%), ‘network’ (30; 55.6%) and ‘microphone’ (29; 53.7%) (Table 1). The 19 people (35.2%) who understood the word ‘consent’ were significantly more likely to understand the other words than those who did not understand its meaning (Table 2).

Discussion The National Health Act of South Africa states that ‘all users of the healthcare system have the right to be informed by a healthcare provider, in a language and manner that they understand’.[21] The concept of informed consent in Western medicine is firmly grounded in recognising that patients are autonomous agents. Consent is the primary means of ensuring that the patient’s right to control their own treatment is protected. Ideally consent is provided on an informed basis. In SA the requirements for legally valid consent have been set out in Castell v De Greeff:[22] The consenting party ‘must have had knowledge and been aware of the nature and extent of harm or risk’, ‘must have appreciated and understood the nature and extent of the harm or risk’, and ‘must have consented to the harm or assumed risk’. Consent ‘must be comprehensive, which extends to the entire transaction, inclusive of its consequences’. Our study highlights the problems that are faced when attempting to obtain informed consent from patients for a telemedicine consultation using standard consent forms that contain ICT terminology. A cornerstone of true informed consent is the full

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE Table 1. Subjects in the sample (N=54) who understood the isiZulu words and phrases used in telemedicine consent documents Term

Understood term n (%)

Telemedicine

4 (7.4)

Video conference

5 (9.3)

Autonomy

8 (14.8)

13 (24.1)

17 (31.5)

Security

21 (38.9)

Microphone

29 (53.7)

Network

30 (55.6)

Electronic records

5 (9.3)

Store and forward

6 (11.1)

Digital photograph

12 (22.2)

Confidentiality

16 (29.6)

Consent

19 (35.2)

Computer

21 (38.9)

Speakers

30 (55.6)

Video

35 (64.8)

GPRS

10 (18.5)

Internet

18 (33.3)

Intranet

9 (16.7)

Telediagnosis

5 (9.3)

Digital signature

7 (13.0)

Firewall

2 (3.7)

Encryption

4 (7.4)

Decryption

4 (7.4)

Latency

4 (7.4)

Synchronous

4 (7.4)

Antivirus

5 (9.3)

Trusted third party

6 (11.1)

Wireless

10 (18.5)

WWW

10 (18.5)

Television

51 (94.4)

Realtime

5 (9.3)

Non-realtime

5 (9.3)

Hacker

5 (9.3)

e-prescription

5 (9.3)

Authentication

6 (11.1)

Storage

8 (14.8)

Broadcasting

10 (18.5)

Monitor

12 (22.2)

Wi-fi

40 (74.1)

disclosure of all relevant information by the healthcare provider and understanding of this information by the patient. It also implies an understanding of the meaning of consent. Of concern is that 65% of patients did not understand the meaning of the word ‘consent’ and 70% the word ‘confidentiality’. Whether this is due to a cultural issue or ignorance is not known. While the study sample was relatively small, the participants were all potential users of a telemedicine service. Whether the same problems exist in other indigenous African languages is not known and needs further study.

May 2014, Vol. 7, No. 1 SAJBL

Table 2. Understanding of the remaining words among subjects who understood the word ‘consent’ (N=19)

Telemedicine

Understood term n (%)

p-value*

4 (21.1)

0.012 0.004

Video conference

5 (26.3)

Autonomy

7 (36.8)

0.002

11 (57.9)

0.0001

13 (68.4)

<0.0001

Security

16 (84.2)

<0.0001

Microphone

18 (94.7)

<0.001

Network

16 (84.2)

0.004

Electronic records

5 (26.3)

0.004

Store and forward

6 (31.6)

0.001

Digital photography

11 (57.9)

<0.0001

Confidentiality

15 (78.9)

<0.0001

Computer

17 (89.5)

<0.0001

Speakers

18 (94.7)

<0.0001

Video

18 (94.7)

0.001

GPRS

8 (42.1)

0.002

Internet

14 (73.7)

<0.0001

Intranet

9 (47.4)

<0.0001

Telediagnosis

5 (26.3)

0.004

Digital signature

7 (36.8)

<0.0001

Firewall

1 (5.3)

N/S

Encryption

4 (21.1)

0.012

Decryption

4 (21.1)

0.012

Latency

4 (21.1)

0.012

Synchronous

4 (21.1)

0.012

Antivirus

5 (26.3)

0.004 0.0001

Trusted third party

6 (31.6)

Wireless

8 (42.1)

0.001

WWW

10 (52.6)

0.0001

Television

19 (100.0)

N/S

Realtime

5 (26.3)

0.004

Non-realtime

5 (26.3)

0.004

e-prescription

5 (26.3)

0.012

Authentication

6 (31.6)

0.001 <0.0001

Storage

8 (41.2)

Broadcasting

10 (52.6)

<0.0001

Monitor

10 (52.6)

<0.0001

Wi-fi

5 (26.3)

0.004

Hacker

5 (26.3)

0.004

N/S = not significant. *Fisher’s exact test.

The lack of comprehension of the words ‘telemedicine’, ‘video conference’, ‘Internet’ and ‘email’ by patients is a problem, as using ICT to transmit health information does carry an element of risk.[23] This lack of comprehension suggests that the formalistic requirement of informed consent set out in regulations will be impossible to meet in many instances. Another issue is the extent to which a cultural broker or interpreter helps in the patient’s understanding of a telemedicine consultation, or worsens the problem through their own lack of understanding of

ARTICLE the words and terminology. If the consent form is written in isiZulu, we can assume that the patient reads it or the form is read to them. The cultural broker’s role changes from that of an interpreter to being a source of information to clarify issues that are not understood by the patient. A limitation of this study is that the local nurses’ understanding of the terminology and words used was not assessed. This will be addressed in a future study of health service providers. The potential effects of language barriers in SA hospitals have been explored previously, with medicolegal dilemmas of informed consent and confidentiality highlighted when using interpreters and complex medical terminology.[24] Lindegger and Richter[25] looked at similar problems when debating critical issues of informed consent in HIV vaccine trials. The consent processes used fulfilled the legal requirements of information disclosure, but may not have addressed the ethical considerations of understanding and ability to make decisions that are in one’s best interests. The same applies to telemedicine terminology. When a sentence was taken from the consent form currently used in KwaZulu-Natal for teledermatology consultations, ‘I hereby give my informed consent for the use of telemedicine in my medical care’, 65% of the participants did not understand the term or the translation of the word ‘consent’ and 91% the word ‘telemedicine’. Of all 54 subjects, only 4 (7.4%) understood both words. This exemplifies the challenge of gaining legally valid and truly informed and understood consent for a telemedicine consultation. Does this mean that patients in our rural setting should be deprived of a telemedicine consultation with a specialist because the stringent consent standards set in the developed world cannot be met? The issue of written informed consent for telemedicine remains a controversial one. The Canadian National Initiative for Telehealth Framework of Guidelines identifies differing opinions relating to informed consent for video consultation. Some say that informed consent is not required, as there is implied or tacit consent to participate in a consultation. They argue that there is no distinction between a face-to-face consultation, for which informed consent is not required, and a video-conferenced telemedicine consultation, in which video conferencing is merely ‘a tool for health care delivery’.[26] Others submit that implied consent should not be extended to telemedicine and contend that written informed consent should be a prerequisite, as telemedicine is not yet a routine service incorporated into health services.[27] It is of interest that when telemedicine becomes fully integrated into routine clinical service, the expectation of written informed consent decreases. Most radiology services in the developed world now use digital imaging with images moved electronically for reporting and storage. This is teleradiology, and written informed consent is not seen as a requirement for standard X-ray imaging. The HPCSA guards against over-reliance on implied consent in the routine clinical face-to-face context, going as far as to state that healthcare practitioners should not take the action of a patient lying down on an examination table as permission to be examined.[28] Written informed consent is a requirement of the draft Guidelines for the Practice of Telemedicine in South Africa for all aspects of a telemedicine encounter. The World Medical Association takes a more practical approach, saying that ‘consent for telehealth should follow similar principles and processes as those used for other health services’ and that ‘To the extent possible, informed consent

shall be obtained by the physician before starting any service or intervention.’[29] Does ‘to the extent possible’ cover the patient’s lack of comprehension, on the basis that an attempt was made to gain informed consent? The lack of a lexicon of technological and computing terms in isiZulu makes it impossible to ensure that the full legal requirement of a valid informed consent, as proposed by the HPCSA, will be met in most cases. It is in the interests of patients and practitioners that obstacles around the requirement for written informed consent for the practice of telemedicine in SA be resolved in a pragmatic way that is appropriate to local circumstances and in the best interests of the majority of the population. This is needed to realise the vision set out in the eHealth Strategy for South Africa, which is ‘eHealth: Enabling a long and healthy life for all.’[1]

Conclusion This study identifies the need to develop new methods for gaining informed consent for telemedicine-related activities in the SA setting. Patients do not understand technological terms in their mother tongue. While they may give ‘informed consent’, its validity must be questioned because of lack of comprehension of what is being consented to. With over 2 000 languages in Africa, the problem is not confined to SA or to isiZulu. Africa needs telemedicine, and pragmatic solutions are required.

Author contributions. CJ conducted and designed the study, performed the primary analysis, collected the data and drafted the manuscript. MM was involved in conceptualising the study, interpretation of the data, statistical analysis and reviewing the manuscript. YS assisted in questionnaire design, statistical analysis and reviewing the manuscript. BH assisted in data collection and reviewing the manuscript. Acknowledgements. We acknowledge Mr Cunden Chetty and Ms Shikara Rambali for their administrative and logistical assistance.

References 1. Department of Health, Republic of South Africa. eHealth Strategy South Africa 2012-2016. Pretoria: Government Printer, 2012. http://www.hst.org.za/ publications/e-health-strategy-south-africa-2012-2016 (accessed 5 May 2013). 2. Kekana M, Noe P, Mkhize B. The practice of telemedicine and challenges for the regulatory authorities. South African Journal of Bioethics and Law 2010;3(1):33-37. 3. Madzimbamuto F. Developing anatomical terms in an African language. S Afr Med J 2012;102(3):132-135. 4. Kamper GD, Mahlobo EB, Lemmer EM. The relationship between standardised test performance and language learning in English second language: A case study. Journal of Language Teaching 2003;37(2):164-178. [http://dx.doi. org/10.4314/jlt.v37i2.6013] 5. Republic of South Africa. Constitution of the Republic of South Africa 1996. Pretoria: Government Printer, 1996. http://www.gov.za/documents/ constitution/1996/a108-96.pdf (accessed 5 May 2013). 6. Casale D, Posel D. English language proficiency and earnings in a developing country: The case of South Africa. Journal of Socio-Economics 2011;40(4):385393. [http://dx.doi.org/10.1016%2Fj.socec.2011.04.009] 7. International Telecommunications Union. Free statistics. http://www.itu.int/ ITU-D/ict/ (accessed 25 May 2013). 8. International Telecommunications Union. Percentage of individuals using the Internet. http://www.itu.int/ITU-D/ict/statistics/ (accessed 25 May 2013). 9. Hogenbirk JC, Brockway PD, Finley J, et al. Framework for Canadian telehealth guidelines: Summary of the environmental scan. J Telemed Telecare 2006;12(2):64-70. [http://dx.doi.org/10.1258%2F135763306776084338]

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE 10. World Health Assembly. World Health Assembly eHealth Resolution (WHA58.28). 25 May 2005. http://apps.who.int/iris/bitstream/10665/20378/1/WHA58_28-en. pdf (accessed 14 March 2014). 11. Rice N, Smith PC. Ethics and geographical equity in health care. J Med Ethics 2001;27(4):256-261. [http://dx.doi.org/10.1136%2Fjme.27.4.256] 12. Worthington R. Clinical issues on consent: Some philosophical concerns. J Med Ethics 2002;28(6):377-379. [http://dx.doi.org/10.1136%2Fjme.28.6.377] 13. Levin M. The importance of language and culture in pediatric asthma care: Communication problems between doctors and Xhosa speaking parents of children at a paediatric teaching hospital. Current Allergy and Clinical Immunology 2005;18(1):8-12. 14. Wu AC, Leventhal JM, Ortiz J, et al. The interpreter as cultural educator of residents. Archives of Pediatric and Adolescent Medicine 2006;160(11):11501154. [http://dx.doi.org/10.1001%2Farchpedi.160.11.1145] 15. Penn C. Factors affecting the success of mediated medical interviews in South Africa. Current Allergy and Clinical Immunology 2007;20(2):66-72. 16. Woloshin S, Bickell NA, Schwartz LM, et al. Language barriers in medicine in the United States. JAMA 1995;273(9):724-728. [http://dx.doi. org/10.1001%2Fjama.273.9.724] 17. Deumert A. It would be nice if they could give us more language – serving South Africa’s multilingual patient base. Social Science and Medicine 2012;71(1):53-61. [http://dx.doi.org/10.1016%2Fj.socscimed.2010.03.036] 18. Pachter LM, Sheehan J, Cloutier MM. Factor and subscale structure of a parental health locus of control instrument for use in a mainland United States Puerto Rican community. Social Science and Medicine 2000;50(5):715-721. [http:// dx.doi.org/10.1016%2FS0277-9536%2899%2900323-8]

May 2014, Vol. 7, No. 1 SAJBL

19. Jezewski MA. Cultural brokering in migrant farm workers health care. West J Nurs Res 1990;12(4):497-513. 20. Shaibu S. Ethical and cultural considerations in informed consent in Botswana. Nurs Ethics 2007;14(4)503-509.[ http://dx.doi.org/10.1177%2F0969733007077884] 21. Republic of South Africa. National Health Act No. 61 of 2003. Pretoria: Government Printer, 2003. http://www.gov.za/documents/index.php?term=national+health+a ct&dfrom=&dto=&yr=0&tps%5B%5D=1&subjs%5B%5D=0 (accessed 5 May 2013). 22. Castell v De Greef 1994 (4) SA 408 (C) at 425. 23. Stanberry B. Legal and ethical aspects of telemedicine. J Telemed Telecare 2006;12(4):166-175. [http://dx.doi.org/10.1258%2F135763306777488825] 24. Schlemmer A, Mash B. The effects of a language barrier in a South African district hospital. S Afr Med J 2006;96(10):1084-1088. 25. Lindegger G, Richter LM. HIV vaccine trials: Critical issues in informed consent. S Afr J Sci 2000;96:313-317. 26. National Initiative for Telehealth. Framework of guidelines. http://www.cstsct.org/resources/frameworkofGuidelines2003eng.pdf (accessed 25 May 2013). 27. Internet Health Coalition. Guidelines for disclosure, patient privacy and quality content. http://www.ihealthcoaltion.org/ethics/cod (accessed 25 May 2013). 28. Health Professions Council of South Africa. Guidelines for good practice in the health care professions: Seeking patients’ informed consent: The ethical considerations. http://www.hpcsa.co.za/downloads/conduct_ethics/rules/ generic_ethical_rules/booklet_9_informed_consent.pdf (accessed 25 May 2013). 29. World Medical Association. WMA Statement on guiding principles for the use of telehealth for the provision of health care. http://www.wma.net/ en/30publications/10policies/t5/ (accessed 10 August 2013).

ARTICLE

Current role of research ethics committees in health research in three geopolitical zones in Nigeria: A qualitative study A M Agunloye,1 MBBS, FWACS; A T Salami,2 MSc, PhD; A Lawan,3 MBBS, FWACS Department of Radiology, University of Ibadan, Ibadan, Nigeria Institute of Ecology and Environmental Studies, Obafemi Awolowo University, Ile-Ife, Nigeria 3 Department of Ophthalmology, Bayero University, Kano, Nigeria 1 2

Corresponding author: A M Agunloye (tinuagunloye@yahoo.com)

Background. Ethics are rules or standards governing the conduct of a person or members of a profession. Medical research must be regulated to ensure that fundamental human rights are not breached in the quest for knowledge. Nigeria had no laws or specific guidelines to regulate health research until 2007, when a national regulatory body, the National Health Research Ethics Committee (NHREC), was established. Its function is to ensure ethical conduct in research and to accredit institutional and state health research ethics committees (HRECs). Objective. To document the current role of HRECs in the ethical practice of health research in Nigeria, 4 years after the establishment of the NHREC. Methods. Functioning of the HRECs was evaluated via interviews of 14 members of state and institutional HRECs chosen from selected geopolitical zones of the country. Results. The HRECs surveyed had between nine and 15 members, with more males than females. Review meetings were held only occasionally owing to the competing interests of members, who receive no incentives for participation, and poor funding. Scientific and ethical reviews are conducted together by the same committee, but few members of the HRECs are trained in research ethics. Monitoring of research after approval is poor. Conclusion. Nigeria now has about 30 institutional HRECs, but their functioning is hampered by a shortage of both money and qualified individuals to serve on them. S Afr J BL 2014;7(1):19-22. DOI:10.7196/SAJBL.309

There have been several reports of non-ethical conduct of health research in developing countries. In some cases research does not conform to international standards, and researchers do not always respond to the health needs and priorities identified. Most of these cases have been in sub-Saharan Africa.[1,2] The more vulnerable groups in such populations have been most exploited. Poor sanitation, lack of adequate healthcare services and illiteracy, among other factors, mean that citizens of developing countries are often plagued with a range of diseases. These countries have therefore become a fertile ground for medical research, especially by pharmaceutical companies. In Nigeria it is easy to find volunteers for trials because of widespread disease, poverty, and the large population. There was no means of enforcing ethical practices in health research in Nigeria until recent developments following the negative publicity that resulted from testing of the drug trovafloxacin (Trovan) by the drug company Pfizer during a bacterial (meningococcal) meningitis epidemic in Tudun Wada, Kano, Northern Nigeria, in 1996.[3] At least 11 children died during the course of the trial, and several others suffered brain damage and paralysis. Subsequent to this incident, the National Health Research Ethics Committee (NHREC) was established in October 2005. The National Code of Health Research Ethics of August 2007,[4] produced by

theÂ NHREC, regulates all processes concerning research in Nigeria. The code also contains criteria for the registration and functioning of institutional or regional health research ethics committees (HRECs).

Objective To document the current role of HRECs in ensuring ethical practices in health research in Nigeria, and to identify the strengths and weaknesses of their process of ethical review.

Methods Nigeria has six geopolitical zones. The country was divided into northern and southern regions along tribal, cultural and religious lines, and further subdivision into six zones ensured that all minority and majority tribes are represented. Three HRECs from three geopolitical zones (North-Eastern (Maiduguri), South-Western (Ibadan) and South-South (Calabar)) were selected, and 14 members in total were recruited after a process of simple random sampling. Two of the HRECs were institutional and based in universities, while the third was a regional state government HREC. The study was carried out between June and August 2011. The invitation to be interviewed was made via telephone or email. The date, time and place chosen for the interview were designed to be convenient to the participant. After written and signed consent

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE had been obtained, semi-structured interviews (Appendix 1) were conducted with individual participants using an interview schedule that had been validated using pre-tests. All interviews were audiotaped and then transcribed to respect the participants’ speaking style, and each lasted 30 - 60 minutes. Consent was obtained before the use of the audio tape recording, and if consent to tape the interview was not given, secretarial staff recorded the response in written form. Ethical approval was obtained from the National Health Research Ethics Committee of Nigeria (NHREC) (ref. no. NHREC/01/01/200704/05/2011). Data were analysed using N6 qualitative software (QSR Inter national). Analysis aimed to describe the functioning of the HREC, focusing on the membership of the committees, their representativeness, their independence from research sponsors, and the institutions in which they were based.

Results A total of 14 HREC members were interviewed, only two of whom were females, giving a male:female ratio of 7:1. The membership of the HRECs studied ranged from nine to 15. People often became members because of positions they held in the government or an institution, and membership was sometimes based on experience in ethics as a subject. Tenure of membership was therefore frequently related to tenure of the position held. However, only a few (<30%) of the HREC members had formal training in research ethics. All the HRECs had legal advisers. All researchers who submitted proposals for ethical review paid a fee of between 2 000 and 20 000 Nigerian naira (US$1 = ~N150), the fee being higher for sponsored projects. It was the applicants’ responsibility to submit enough hard copies of their proposals for all members of the HREC. The frequency of HREC meetings to review submitted proposals ranged from fortnightly to quarterly. Scientific and ethical reviews were conducted together by the same committee. All the HRECs followed the guidelines of the NHREC, which is the national and supervising body. After approval, two of the HRECs did not monitor approved projects and the only HREC that monitored approved proposals relied solely on funding by the researcher to do so. Two of the three HRECs relied solely on the processing fees paid by the researchers to fund the committees, while committee functioning in the third was funded by the institution in which it was based. The HRECs ensured that participants with an excessive risk of harm were excluded from studies if possible. These included children, pregnant women, and members of socially, culturally, economically, politically, educationally, physically and psychologically disadvantaged groups. Specific safeguards were used to protect vulnerable subjects involved, appropriate to the degree of risk. Social and cultural factors that sometimes limited application of international ethical norms to research proposals during ethical reviews in Nigeria included the low level of education of much of the population, religious beliefs, lack of understanding of the concept of research on the part of most Nigerians, and unco-operative attitudes among some research participants, who viewed the researchers as strangers in their community. Most HREC members understood the concepts of autonomy and consent in research. With regard to issues relating to beneficence and non-harm to participants in the review of research protocols,

May 2014, Vol. 7, No. 1 SAJBL

most committees were multidisciplinary in composition, and experts in relevant fields were frequently asked to evaluate the risks and benefits to research participants. Financial compensation to research participants was usually not made compulsory for researchers, but incentives such as transport and refreshment allowances were advised when there was no direct benefit to the research participant. Challenges faced by the HRECs included irregular meetings due to committee members’ busy schedules, haphazard selection of members, and lack of remuneration or incentives for members.

Discussion Ethics are the rules or standards governing the conduct of a person or the members of a profession. The medical profession deals with human life, and research is an integral part of medicine. However, medical research must be regulated in order to ensure that fundamental human rights are not breached in the quest for knowledge. Before the 1960s, researchers were thought to be responsible and they were quite free to conduct ‘good research’. However, from the 1960s, ethics became a concern in the world of health and biomedical research. Researchers in developed countries have realised that using developing countries for their trials incurs lower costs compared with traditional research areas. Furthermore, less strict (or lack of ) legislation means that research protocols are accepted more easily and sooner than in developed countries. If preparatory procedures are done quickly, the company will have more time to optimise profits within the patent period. Also, volunteers for trials are easy to find in developing countries because of widespread disease and abject poverty. Although various organisations have been promoting ethical health research in Africa in conformity with international ethical guidelines,[5] Nigeria, as a developing country with a large population, is prone to exploitation by researchers, a classic example of which is the Pfizer testing of trovafloxacin on children with meningitis in 1996.[3] Before 2005, only the National Agency for Food and Drug Administration and Control (NAFDAC) had jurisdiction over medical research in the country, especially research involving drug trials. However, the NAFDAC focused largely on food safety and drug control and paid little attention to ethics in medical research. Nigeria had no laws or specific guidelines to regulate health research until the NHREC was established in 2005 by the Minister of Health as the body responsible for ensuring the protection of human research participants. The National Code of Health Research Ethics was produced by the NHREC in August 2007 and regulates all processes concerning research in Nigeria, such as granting approval for research, research supervision, and processes for suspension, revision or termination of research. International codes served as guidelines for the production of this code, with adjustments to cater for Nigeria’s specific sociocultural environment. Kirigia et al.[6] recommended that African countries should adopt international guidelines on biomedical research, pass laws on standards and regulations to strengthen the ethical review framework, and develop governance mechanisms to make sure that their HRECs approve projects in accordance with the Council for the International Organizations of Medical Sciences (CIOMS) guidelines of 2002.[7] The national code is easily accessible by researchers, as it is available online (www.nhrec.net). The NHREC has published a list of accredited HRECs, also known as ethics review committees or institutional review boards or committees, in various parts of Nigeria. Although the country now has about

ARTICLE 30 institutional HRECs, our study and previous work show that their functioning is hampered by a shortage of qualified individuals to serve on them, together with an imprecise definition of mandates and a highly scientific membership.[8,9] Evaluation work done by committee members is voluntary, and ethical review is very limited. Under such circumstances, even if laws are in place it may be difficult to enforce and apply them. We found that financial shortages faced by the HRECs mean that there is also inadequate monitoring of approved research protocols to ensure strict compliance by researchers. A study published by Kass et al.[10] on the organisation and functioning of 12 ethical review committees in nine African countries identified two similar main issues: lack of training of ethical review committee members, and lack of funding. These same issues were discussed by African participants, and participants from other regions of the world, during the Third International Bioethics Meeting of French-speaking Countries held in Quebec in October 2008 on the topic ‘A new governance, diversity, and sharing space of Francophone countries’.

• To ensure relevance of research to the population, research findings should be submitted to the approving HREC. An agency may be set up by the government to collate all such research findings in the state or country to influence government policies.

Conclusions and recommendations

1. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997;337(12):853-856. [http://dx.doi.org/10.1056/NEJM199709183371212] 2. Mkoka C, Scott C. Unauthorised HIV trial questions ethics processes. Science and Development Network, 29 January 2009. http://www.scidev.net/global/ health/news/unauthorised-hiv-trial-questions-ethics-processes.html (accessed 11 March 2014). 3. Jones F. Nigeria sues Pfizer over drug trial scandal. Science and Development Network, 6 June 2007. http://www.scidev.net/en/news/nigeria-sues-pfizer-overdrug-trial-scandal.html (accessed 24 June 2010). 4. National Code of Health Research Ethics of August 2007. http://www.nhrec.net (accessed 11 March 2014). 5. Pan African Bioethics Initiative (PABIN): Terms of reference. In: Workshop on Ethical Review Committees in Africa. http://rds.refer.sn/IMG/doc/ ETHICALREVIEWCOMM.doc (accessed 11 March 2014). 6. Kirigia JM, Wambebe C, Baba-Moussa A. Status of national research bioethics committees in the WHO African region. BMC Med Ethics 2005;6:10. [http://dx.doi. org/10.1186/1472-6939-6-10] 7. International Ethical Guidelines for Biomedical Research Involving Human Subjects Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm (accessed 11 March 2014). 8. Ajuwon AJ, Kass N. Outcome of a research ethics training workshop among clinicians and scientists in a Nigerian university. BMC Med Ethics 2008;9:1. [http:// dx.doi.org/10.1186/1472-6939-9-1] 9. Ogundiran TO. Enhancing the African bioethics initiative. BMC Med Educ 2004;4:21. [http://dx.doi.org/10.1186/1472-6920-4-21] 10. Kass NE, Hyder AA, Ajuwon A, et al. The structure and function of research ethics committees in Africa: A case study. PLoS Med 2007;4(1):3. [http://dx.doi. org/10.1371/journal.pmed.0040003]

In view of the scale of previous ethical breaches in some research projects in Africa, and in Nigeria specifically, compliance with national and international ethical standards is vital. Ethical issues in the Pfizer testing of trovafloxacin in 1996[3] provided the impetus for change in the conduct of health research in Nigeria. However, our study shows that the HRECs still face many challenges. Suggested recommendations for improvement are: • Allocation of more funding to the NHREC and HRECs for better functioning. • Provision of financial incentives to HREC members to motivate them and improve their commitment. • Proper monitoring and supervision of projects by the HRECs to ensure that researchers comply with approved project formats. • Training and re-training of HREC members to update them on ethical principles. • Training of researchers and undergraduate students in the health professions on research ethics. • An increase in research funding and promotion of autonomy of researchers from funders. • Establishment of a forum for all HRECs in the country to meet and share knowledge and exchange ideas. This may be co-ordinated by the NHREC.

Authorship. All authors met the criteria for authorship. Conflict of interest. Research project funded by the International Development Research Centre (ref. no. 105714 – 001). Acknowledgements. We acknowledge contributions to the conception and design of the study from Prof. Benjamin Fayomi and Marius Kedote, Director and Program Co-ordinator, respectively, of the Benin Institute of Applied Biomedical Sciences.

References

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE Appendix 1. Interview guide for Health Research Ethics Committee members a) Functioning of the HREC When was the committee formally established? What are the functioning modalities and the committee membership? What are the criteria for selecting members of the committee? How many members of the committee have been trained in research ethics? How frequently does the committee meet? What are the procedures of protocol or proposal approval? What are the normative regulations used? What are the specific regulations used? What are the special arrangements made for vulnerable populations such as women, elderly people, children, migrants? Are the ethical review and the scientific review conducted together or separately? Does the same committee conduct both the ethical and scientific review of the proposals? How is the committee funded? Do you have dedicated staff and office space for the committee? What are the relationships between the various committees in the country? What are the main challenges confronting the smooth operation of the committee? What suggestions would you make to address these challenges? b) Ethical principles and rules International regulations (Council for the International Organizations of Medical Sciences, Good Clinical Practice, Declaration of Helsinki, etc.) state that research ethical principles include respect for research subjects, beneficence (and non-harming), and justice. How do you think these principles could be applied, taking into account the situation of individuals in Nigeria? What sociocultural factors in Nigeria complicate the application of international ethics rules? How do you understand the concept of autonomy of research participants in the Nigerian context? How do you understand the concept of consent of research participants in the Nigerian context? What difficulties have researchers been confronted with in getting consent from research participants? How can illiterate participants be helped to truly understand the research objectives and the scientific terms? How do you understand the concept of beneficence in the review of research projects in the Nigerian context? How do you understand the concept of justice in the review of research projects in the Nigerian context? How do you assess the fairness of the financial compensation proposed by researchers to research participants? c) Ethical monitoring of the protocol Is there any ethical monitoring of the protocol after approval by your ethical review committee? If yes, who is in charge of the monitoring? How is the monitoring funded? Has ethical monitoring of the protocol taken into account vulnerable populations (children, adults with disabilities, dependent populations/care) and/or the level of risks? Does the researcher draft an annual monitoring report? Does the report include the number of subjects recruited, and the number who have withdrawn from the research? Is there any ethical monitoring of the protocol with regard to: • observation of the consent process? • control of how research documents and duly signed consent forms are kept? • notification of modifications to the protocol, the administrative modifications? • re-submission of application to the ethical committee in case of modifications to the protocol? d) Comments What do you see as the key challenges confronting researchers with regard to conforming to the standards of ethics? Do you have suggestions to improve the framework of ethical research?

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE

Auditing the process of ethics approval for Master’s degrees at a South African university D L Clarke, FCS (SA), MMedSci, MBA, MPhil Department of Surgery, Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa Corresponding author: D L Clarke (damianclar@gmail.com)

Objective. This study audited the process of ethics approval for Master’s research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa. Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master’s proposal for the year 2010 was reviewed. Results. A total of 53 proposals for Master’s degrees were available for review. All the proposals were for low-risk studies, and all were subjected to expedited review. It took an average of 15 weeks (range 3 - 32) for the institutional ethics review board (the Biomedical Research Ethics Committee (BREC)) to respond to each of the 53 proposals. Twenty-three studies (43.4%) received provisional approval on the first response, 2 proposals (3.8%) were rejected, and 28 proposals (52.8%) were sent back with major queries. For the 28 proposals that required major revisions, 11 responses had been submitted by the time the data were collected. The average length of time to receive a response from the applicants to BREC queries was 4 weeks. Conclusion. This study suggests that there is a potential cumulative delay of over 4 months before data collection for low-risk clinical audits can be commenced. Any system designed to improve this situation must ensure that high standards of vigilance are maintained, but must be flexible enough to allow for a faster review and approval process. S Afr J BL 2014;7(1):23-25. DOI:10.7196/SAJBL.301

The new requirement for a formal research component of specialist training in South Africa means that the workload for health research ethics committees (HRECs) will increase. This increased ethics review workload will be set against the backdrop of an already pressurised postgraduate curriculum and the need for medical schools to continue to produce high-quality specialists to meet the country’s ever-increasing health needs. I audited the process of ethics approval for Master’s level research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, to classify the type of research being undertaken and identify common reasons for delay in the process of ethics approval.

Methods The HREC at the University of KwaZulu-Natal is called the Biomedical Research Ethics Committee (BREC). After obtaining the appropriate ethical approval from the BREC (ref. no. BE 217/09) to perform this audit, all correspondence surrounding each Master’s proposal for the year 2010 was reviewed. The following information was retrieved: the BREC number, the date at which the BREC received the proposal, the date of the BREC’s first response, and the dates of all subsequent responses until full ethical approval was given. Low-risk studies are sent for expedited review, which is quicker than full review. Proposals that are appropriate for expedited review are sent by the chairperson to two reviewers and are not formally discussed at a full meeting of the BREC. Provided the reviewers are satisfied with the protocol,

their comments are documented and the decision to approve the study is recorded in the minutes of the next meeting. The nature of the response from the BREC was recorded – this could be provisional approval, full approval or declined. If a study was granted provisional approval but still required some changes, it was classified as requiring minor revision. If a proposal was returned with queries but was not granted provisional approval, it was classified as requiring major revision. Whether the study underwent expedited approval or had to undergo the full ethics process was also noted. Studies were classified as retrospective chart reviews, prospective clinical audits, crosssectional studies, questionnaire-based studies, cadaver-based studies or randomised interventional-type studies. Two separate taxonomies were used to classify the nature of the queries raised by the BREC (Tables 1 and 2).

Taxonomy 1 A simple taxonomy was used to divide the queries into four broad groups (Table 1). The ethical queries were divided into major and minor queries. Table 1. Taxonomy 1 Ethical queries Scientific queries Stylistic/grammatical queries Legal queries

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE Taxonomy 2 In this taxonomy I further categorised the reasons for the queries from the BREC under categories based on Emanuel et al.â&#x20AC;&#x2122;s criteria for ethical research[1] (Table 2).

Results

Type of study A total of 53 proposals for Masterâ&#x20AC;&#x2122;s degrees were available for review. All the proposals were subjected to expedited review. The types of studies are listed in Table 3. There were 43 audits, and the remaining methods consisted of 8 questionnaires, a single cross-sectional study, and a single cadaver-based study from the Department of Anatomy. There were no interventional studies.

Response times It took an average of 15 weeks (range 3 - 32) for the BREC to respond to each of the proposals. Twenty-three studies (43.3%) received provisional approval on the first review. Two proposals (3.8%)

Table 2. Taxonomy 2 Reason for query

Category[1]

Fairness

Ethics

Risk benefit

Ethics

Independent review

Ethics

Consent

Ethics

Funding issues

Ethics

Confidentiality

Ethics

Authorship

Ethics

Reimbursement

Ethics

Human tissue storage issues

Ethics

Validity

Scientific

Method

Scientific

Statistics

Scientific

Stylistic concerns

Stylistic/grammatical

References

Stylistic/grammatical

Legal

were rejected. One of these was rejected because of consent and confidentiality issues. It involved a study designed to audit patterns of sick leave use among staff at a hospital, and would have required consent from the nursing staff and the nursing unions as well as the hospital management. The reviewers felt that this study was a gross invasion of privacy and the potential benefit was too small to justify this. The other study that was rejected did not declare its source of funding, had confused methods, was badly written and was unclear as to how tissue samples were to be stored. It also had major statistical deficits. Twenty-eight proposals (52.8%) did not receive provisional approval, and were sent back with major queries. Eleven responses to the initial queries had been submitted by the time the current data were collected. The average length of time before a response to BREC queries was received from the applicants was 4 weeks. All these 11 studies received provisional approval at the second sitting. At the time of data collection 17 studies (32.1%) requiring major revisions were still outstanding. The average length of time for a response to BREC queries to be received from the applicants was 5 months (range 1 - 8). By June 2011, of the 53 proposals that were audited, 21 (39.6%) had completed the entire review process and had full approval. Table 4 compares the results of this study with the published literature. A total of 142 queries were raised by the BREC (Table 5). There were 84 scientific queries, 45 ethical queries, 13 stylistic/grammatical queries, and no legal queries.

Table 5. Queries raised by the Biomedical Research Ethics Committee (N=142) and their taxonomic classification Query

Table 3. Methods of the proposed studies reviewed n

n (%)

Taxonomic classification

Fairness

3 (2.1)

Ethics

Risk benefit

4 (2.8)

Ethics

Appropriate investigators

6 (4.2)

Ethics

Consent

13 (9.2)

Ethics

Human tissue

1 (0.7)

Ethics

Funding

3 (1.4)

Ethics

Authorship issues

7 (4.9)

Ethics

Confidentiality

6 (4.3)

Ethics

Reimbursement

2 (1.4)

Ethics

Statistics

14 (9.9)

Scientific

Retrospective chart audit

Validity

10 (7.0)

Scientific

Prospective clinical audit

Study design

31 (21.8)

Scientific

Questionnaire

Methodology

29 (20.4)

Scientific

Cross-sectional study

Stylistic issues

10 (7.0)

Stylistic/grammatical

Randomised interventional study

References

4 (2.8)

Stylistic/grammatical

Cadaver-based anatomical study

Table 4. Approval rates (%) â&#x20AC;&#x201C; Cleaton-Jones[2] v. Angell et al.[5] v. the present study Cleaton-Jones, 2003[2]

Cleaton-Jones, 2007[2]

Cleaton-Jones, 2010[2]

Angell et al., 2005/6[3-5]

Present study, 2011

Approved at first sitting

Minor revision

Major revision

Not approved

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE Discussion The process of ethical approval of Master’s projects at our institution seems to be a prolonged one. It takes 3 months on average for a first review to be completed, and only 43% of studies receive provisional approval at this first review. Student response to the queries raised by the BREC is poor, and by the end of this study only 40% of the proposals had completed the entire review process. This delay is especially problematic in the context of a defined 4-year period for registrar training. This finding is not unusual, and there is an increasing body of literature documenting the bureaucratic delay associated with ethics review.[2-9] Cleaton-Jones[2] reported that in 2003 and 2007, out of 1 180 ethics applications at his institution, 27% were approved at the first sitting, 69% required revision, and 5% were rejected. He looked at this again in 2010, and found that 37% of proposals were accepted at the initial sitting, 59% required revision, and 4% were rejected.[2] Angell et al. in the UK[3-5] had similar rates. They reported that over the period July 2005 - April 2006, 15% of proposals were approved at the initial review, 64% required revision, and 8% were rejected. Table 4 compares the approval rates for these authors and the current study. Both CleatonJones[2] and Angell et al.[3-5] were reporting on all the studies reviewed by their respective HRECs and did not provide any assessment of the level of the proposals they were reviewing. The proposals in the present audit were all for low-risk studies. There appears to be a difference in the nature of the queries between this study and the reported literature. In the study by Cleaton-Jones,[2] ethical, stylistic and grammatical concerns predominated, whereas in this series the majority of queries were of a scientific nature. This difference is difficult to explain, but may reflect lack of appropriate supervision of the protocol writing process.[2] Cleaton-Jones[2] was concerned about the high rate of nonresponse, i.e. papers sent back for major revision that were never resubmitted for review. He found that in 2008 this had increased to 28% from 19% in 2003 and 16% in 2007. A similar tendency was documented in the present study. Cleaton-Jones[2] thought that the most likely reasons for failure to respond were either that the

applicants could not secure financial support to continue, or that they were intimidated by the bureaucracy involved and abandoned their projects. The reasons for these delays need to be studied further.

Conclusion This study suggests that there is a potential cumulative delay of at least 4 months prior to ethical approval for low-risk research projects. The compulsory research project creates a number of challenges around both the drawing up of research protocols and the ethical and scientific review of these protocols. A balance needs to be struck between the need to protect participants and the need to undertake research as part of the 4-year training programme. Attention must be given to improving the scientific quality of the submissions. Acknowledgement. Prof. S R Thomson.

References 1. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283(20):2701-2711. [http://dx.doi.org/10.1001/jama.283.20.2701] 2. Cleaton-Jones P. Process error rates in general research applications to the Human Research Ethics Committee (Medical) at the University of the Witwatersrand: A secondary data analysis. South African Journal of Bioethics and Law 2010;3(1):20-24. 3. Angell E, Bryman A, Ashcroft RE, Dixon-Woods M. An analysis of decision letters by research ethics committees: The ethics/scientific quality boundary examined. Qual Saf Health Care 2008;17(2):131-136. [http://dx.doi.org/10.1136/ qshc.2007.022756] 4. Angell E, Dixon-Woods M. Do research ethics committees identify process errors in applications for ethical approval? Med Ethics 2009;35(2):130-132. [http:// dx.doi.org/10.1136/jme.2008.025940] 5. Angell E, Sutton AJ, Windridge K, Dixon-Woods M. Consistency in decision making by research ethics committees: A controlled comparison. J Med Ethics 2006;32(11):662-664. [http://dx.doi.org/10.1136/jme.2005.014159] 6. Jamrozik K. Research ethics paperwork: What is the plot we seem to have lost? BMJ 2004;329(7460):286-287. [http://dx.doi.org/10.1136/bmj.329.7460.286] 7. Schwenzer KJ. Practical tips for working effectively with your institutional review board. Respir Care 2008;53(10):1354-1361. 8. Wald D. Bureaucracy of ethics applications. BMJ 2004;329(7460):282-284. [http:// dx.doi.org/10.1136/bmj.329.7460.282] 9. Warlow C. Clinical research under the cosh again. BMJ 2004;329(7460):241-242. [http://dx.doi.org/10.1136/bmj.329.7460.241]

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE

Reporting sexual offences involving child patients: What is the current law following the Constitutional Court judgment? P Mahery, LLB, LLM Oliver Schreiner School of Law, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: P Mahery (prinslean.mahery@wits.ac.za)

The Constitutional Court of South Africa has recently invalidated certain sexual offences involving adolescents and placed a moratorium on reporting adolescents who engage in ‘lawful’ sexual activity. In evaluating the constitutionality of the law that criminalises sexual activity between adolescents, the Court recognised how the reporting obligations could exacerbate the violation of children’s constitutional rights. However, in light of the Court’s narrow focus, its judgment only slightly amends the reporting obligations of healthcare providers in terms of adolescent patients, and for the most part the current law remains intact. Despite this judgment, adolescent patients can still be exposed to the negative effects of the reporting obligations placed on healthcare providers, and healthcare providers are still faced with the challenges created by their duty to report sexual offences involving young patients. This article explores the judgment in order to clarify the current law on reporting sexual conduct involving adolescents, and also provides some analysis to assess the implications of the judgment for healthcare providers. S Afr J BL 2014;7(1):26-29. DOI:10.7196/SAJBL.303

In South Africa a child is able to engage in sexual activity legally from the age of 16 years. The Criminal Law (Sexual Offences and Related Matters) Amendment Act[1] (hereinafter called the Sexual Offences Act) makes it an offence for anyone to engage in sexual conduct with children aged 12 - 15 years (hereinafter referred to as adolescents, following the Constitutional Court’s approach of categorising children aged 12 - 15 as adolescents), even if this is done consensually (sections 15 and 16 of the Sexual Offences Act read with the definition of a child in section 1). Also, anyone who engages in sexual activity with a child under the age of 12 years commits an offence. The Act further obligates everyone, including healthcare providers, to report such incidents of sexual behaviour involving adolescents to the police should they have knowledge of them. Failure to report is an offence, and according to section 54(1) (b) of the Act, perpetrators face a penalty of a fine or imprisonment upon conviction. What this means, for example, is that if a 13-year-old boy approaches a clinic nurse for treatment of a sexually transmitted infection, or a 14-year-old girl goes to a clinic for prenatal care or for an abortion, in terms of the law the attending nurse or other healthcare provider would have knowledge of a sexual offence and would be obliged to report the incident to the police or risk penalties for failure to report. In creating these reporting obligations, the lawmakers effectively force healthcare providers to disclose confidential information probably obtained during consultation. While such reporting would be in direct conflict with laws such as the Choice on Termination of Pregnancy Act 92 of 1996,[2] which require strict confidentiality, or the objectives of the healthcare provisions in the Children’s Act,[3] other laws such as the National Health Act[4]

May 2014, Vol. 7, No. 1 SAJBL

(section 14(2)(b)) and the Ethical Rules of Conduct for practitioners registered in terms of the Health Professions Act 56 of 1974[5] (section 13(1)(a)) actually authorise healthcare providers to disclose patient information when a law requires such disclosure. The ethical duty of maintaining patient confidentiality can therefore be limited by any law that legally requires a breach of such confidentiality, such as mandatory reporting provisions. Although the Constitutional Court had the final say on the constitutionality of sexual offences involving adolescents, both the High Court and the Constitutional Court explored the effects of the reporting obligations attached to the sexual offences laws. This article therefore considers both court decisions in order to establish the current law on sexual offences involving adolescents and the consequent impact of the judgments on the reporting obligations set out in the Sexual Offences Act.

The High Court case[6] In April 2012 two non-profit organisations providing child protection services approached the North Gauteng High Court seeking orders to decriminalise consensual sexual conduct between adolescents. The matter was heard on 23 and 24 April by J Rabie, and in January 2013 he delivered his judgment. The judgment highlighted the negative implications of sections 15 and 16 of the Sexual Offences Act generally, and also the negative effects of the reporting obligations triggered when persons such as healthcare providers become aware of sexual conduct between adolescents. The Court found in paragraph 53 that: ‘The impugned provisions will furthermore in all probability prevent the vast majority of adolescents from seeking help because they would fear that they would be charged with a crime. After all, any councillor or other person in authority would be placed in an

ARTICLE invidious position for the simple reason that in order to properly conduct his or her duties, or assist the adolescent and to build a trust relationship with the adolescent, they have to solicit the required information in order to do so. However, once they have received this information they would be required to report the child for the behaviour which has been elicited. This will isolate adolescents from potentially supportive resources and systems.’ The Court ultimately found the relevant provisions to be unconsti tutional. Following the declaration of invalidity, Rabie took the route of deleting words from and reading words into the Act to rectify its defects and refused to grant Parliament an opportunity to amend the Act. The Constitutional Court took a different approach, as is discussed below. The High Court judgment created much debate on its effects on the reporting obligations of healthcare providers. The issue was discussed by McQuoid-Mason[7] and Strode et al.[8] in two articles published in the SAJBL. I believe that Strode et al. describe the effects of the case more accurately, and some of their arguments still apply after the Constitutional Court judgment.

The Constitutional Court case[9] The Constitutional Court heard the matter on 30 May 2013. The applicants argued again before this court that the relevant provisions of the Sexual Offences Act were unconstitutional because it was irrational, caused harm, violated various rights of children including their right to dignity and privacy, and failed to serve the best interests of children. Judgment was handed down on 3 October 2013. In its judgment the Court emphasised the narrow scope of the case before it, which concerned the prohibition of sex between adolescents. The case was not about the law that prohibits sexual acts with a child below the age of 12. It was also not about unlawful sexual conduct between adults and adolescents, or between 16- and 17-year-olds and children aged 12 - 15. After analysing the law this court too was convinced that the offences created by the Act breached the constitutional rights of adolescents. The Court had this to say about the reporting obligations set out in the Act (paragraph 60): ‘The offences allow police officers, prosecutors and judicial officers to scrutinise and assume control of the intimate relationships of adolescents, thereby intruding into a deeply personal realm of their lives. This intrusion is exacerbated by the reporting provisions: trusted third parties are obliged by section 54 of the Sexual Offences Act to disclose information which may have been shared with them in the strictest confidence, on pain of prosecution.’ It was held further (paragraph 72): ‘… that the existence and enforcement of the offences created by … the Sexual Offences Act exacerbate harm and risk to adolescents by undermining support structures, preventing adolescents from seeking help and potentially driving adolescent sexual behaviour underground.’ and that (paragraph 73): ‘… the expert report indicates that the reporting provisions are likely to create an atmosphere in which adolescents will not freely communicate about sexual relations with parents and counsellors.’

The order The Court confirmed that the relevant provisions of the Sexual Offen ces Act were unconstitutional and declared it invalid. This meant that the provisions which criminalise consensual sexual behaviour between adolescents are no longer in force and that the requirement to report such consensual sexual behaviour also falls away. However, the Court suspended its order of invalidity and gave Parliament 18 months to amend the relevant provisions (paragraphs 110 and 117 of the judgment; see also section 172(1)(b)(ii) of the Constitution[10]). An order suspending the declaration of invalidity effectively keeps the invalidated law in operation.[11] The decision to suspend the order usually serves to ‘control the effects of invalidity’.[11] In this case the Court found that not suspending the order would have unintended consequences such as creating a gap in the law that proscribes sex between children and adults, which could not be allowed. Furthermore, the Court emphasised that Parliament as the lawmaking body was in a better position to improve the provisions (paragraphs 107 - 109 of the judgment). Given the negative impact of the reporting obligations, the Court decided to supplement its order of invalidity. It was held in paragraph 117 that: ‘From the date of this judgment, a moratorium is placed on all investigations into, arrests of, prosecutions of, and criminal and ancillary proceedings against children under the age of 16 years in relation to sections 15 and 16 of the Act, pending Parliament’s correction of the defects in the Act.’ The Court clarified this in the judgment (paragraph 111), stating that: ‘[t]his moratorium will put in abeyance any related reporting obligations which may otherwise have arisen from the operation of section 54 of the Act.’ To counter the consequence of suspending its order, the Court therefore expressly suspended the reporting obligations in respect of adolescents who engage in consensual sexual activity with other adolescents. This means that if a healthcare provider becomes aware of an adolescent patient voluntarily engaging in sexual conduct with another adolescent, in contrast to the previous situation they do not have to report the incident, and these children can now rely on confidentiality. However, the moratorium is limited in its reach and benefits. Firstly, it only suspends reporting of consensual sexual activities between adolescents for a period of 18 months from the date of the Constitutional Court order. Secondly, if the child patient is an adolescent and the sexual partner is 16 or 17 or an adult, the healthcare provider will still have to disclose the confidential information obtained from the adolescent in order to report the sexual partner. The sexual partner will have a right to defend any prosecution, and as noted by Strode et al.,[8] the adolescent could then still be exposed to ‘the same harmful consequences that were identified in the Teddy Bear case’. As part of the Constitutional Court order, the moratorium must be understood and implemented effectively. However, what happens if a healthcare provider is faced with a situation where an adolescent has engaged in consensual sexual conduct with someone but it is not totally clear whether the moratorium applies or not? No legal obligation exists to force a child patient to disclose private

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE intimate information to enable healthcare providers to determine whether or not the moratorium applies in a particular instance. To make a proper decision, certain questions could be asked during consultation. However, what if the adolescent does not want to disclose the age of the sexual partner, or refuses to say anything about the sexual partner at all? It is submitted that in such instances the healthcare provider has no knowledge of a sexual offence and so the duty to report the incident in terms of the Sexual Offences Act is not triggered. It is also important to note that neither the High Court nor the Constitutional Court considered the constitutionality of the reporting obligations as a separate issue. Both courts considered the duty to report only in relation to the criminal prohibitions that were under scrutiny. This means that reporting obligations are still open to constitutional challenge, as was conceded by the High Court and advocated by others (e.g. McQuoid-Mason[12]). The Teddy Bear Clinic case illustrates how the duty to report can be detrimental to children’s rights. In this case the sexual offence created by the Act had the effect that the reporting obligation could not serve the best interests of the children affected, but instead proved detrimental to their rights to privacy, dignity and physical integrity. By invalidating the offence, the Constitutional Court rendered the reporting obligation inoperative only to a certain extent and consequently minimised (but certainly did not erase) the negative effects that mandatory reporting could have for adolescents engaging in consensual sex. More needs to be done to ensure that the duty to report always serves the best interests of children. Healthcare providers are therefore urged to engage and attempt to persuade Parliament during its amendment process to reconsider the reporting obligations and align it more with the Constitution.

The effect of the Constitutional Court judgment is significant but narrow when considered in the broader scope of the reporting obligations of healthcare providers in relation to sexual conduct of children. The current reporting obligations of healthcare providers in terms of the Sexual Offences Act are set out in Table 1. It is quite clear from the above that in order to avoid confusion on the effect of the Constitutional Court judgment, an education campaign is needed to ensure that the law is properly understood and applied by healthcare providers. Healthcare providers must also remember that the Children’s Act also creates reporting obligations that have not been altered by this judgment. The Sexual Offences Act and the Children’s Act have different reporting approaches. These Acts differ with regard to what triggers the reporting obligation, the particular incidents that require reporting, and to whom the report needs to be made. Reporting in terms of the Children’s Act is triggered when a healthcare provider finds reasonable grounds to conclude that a child patient has been abused physically or sexually or that a child has been neglected deliberately. The report can be made to a child protection organisation, the Department of Social Development, or a police officer (section 110). In contrast, as noted above, the Sexual Offences Act requires reporting as soon as there is any knowledge of a sexual violation, and that report must be made to a police officer. In comparison with the Sexual Offences Act, the reporting provision in the Children’s Act is more protective because it generally limits unnecessary interference with the rights of adolescents.

Conclusion The Constitutional Court judgment has the effect of removing some barriers to allow adolescents and healthcare providers the freedom to engage in issues around sexual health without either fearing the

Table 1. The reporting obligations of health providers in relation to the Sexual Offences Act Sexual activity involving children, in terms of the Act

If a health provider becomes aware of such activity he/she should:

Anyone who commits a sexual act with a child of any age without their consent is committing an offence

Report the incident

Anyone who commits a sexual act with a child below the age of 12 years commits an offence (even if consensual)

Report the incident

Incidents of children aged 12 - 15 years engaging in consensual sexual activity with partners also in this age category

Not report the incident (following the moratorium)

If a 16- or 17-year-old engages in sexual activity (including sexual intercourse) with a child between the ages of 12 and 15 years, an offence is committed (even if consensual)

Report the incident Note: In these instances only the 16- and 17-year-olds can be prosecuted Note further: In the case of sexual acts not involving penetration it is a defence to claim that there is a less than 2-year age gap between the sexual partners; I submit that it is not the work of the health provider to investigate this defence before reporting the incident

If an adult (persons 18 years and older) engages in sexual activity with a child aged 12 - 15 years, then a sexual offence is committed (even if consensual)

Report the incident; only the adult will be prosecuted

Note: The legal age of consent to engage in sexual conduct remains 16, and if children of this age engage in consensual sexual activity with anyone 16 years or older no offence is committed

Not report the incident

Note: If in any of the abovementioned instances the child concerned is clearly incapable of consenting to sexual conduct, no matter what their age, for example if the child is mentally disabled, then it is an offence for anyone to engage in sexual conduct with such a child

Report the incident

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE consequences stemming from reporting obligations. However, much of the current law on reporting sexual offences involving adolescents remains intact, which could result in these children still being exposed to the negative effects of the mandatory reporting provisions. When issues of sexual conduct arise in the course of providing healthcare services to child patients, healthcare providers therefore have a responsibility to ensure that the law in general is applied properly and that sexual offences are still identified and reported accordingly.

References 1. South African National Government. Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007. http://www.gov.za/documents/index. php?term=Criminal+Law&dfrom=&dto=&yr=2007&tps%5B%5D=1&subjs%5B% 5D=0 (accessed 13 March 2014). 2. South African National Government. Choice on Termination of Pregnancy Act 92 of 1996. http://www.gov.za/documents/index.php?term=Choice+on&dfrom =&dto=&yr=1996&tps%5B%5D=1&subjs%5B%5D=0 (accessed 13 March 2014). 3. South African National Government. The Children’s Act No. 38 of 2005. http:// www.justice.gov.za/legislation/acts/2005-038%20childrensact.pdf (accessed 13 March 2014).

4. South African National Government. National Health Act No. 61 of 2003. http:// www.gov.za/documents/index.php?term=national+health&dfrom=&dto=&yr= 0&tps%5B%5D=1&subjs%5B%5D=0 (accessed 13 March 2014). 5. National Department of Health. Government Notice No. 717 of 2006. http:// www.gov.za/documents/index.php?term=health&dfrom=&dto=&yr=2006&tps %5B%5D=4&subjs%5B%5D=0 (accessed 13 March 2014). 6. The Teddy Bear Clinic for Abused Children v Minister of Justice and Constitutional Development 2013 JDR 0025 (GNP) (unreported). 7. McQuoid-Mason D. Decriminalisation of consensual sexual conduct between children: What should doctors do regarding the reporting of sexual offences under the Sexual Offences Act until the Constitutional Court confirms the judgment of the Teddy Bear Clinic case? South African Journal of Bioethics and Law 2013;6(1):10-12. [http://dx.doi.org/10.7196/SAJBL.257] 8. Strode A, Toohey J, Slack C, et al. Reporting underage consensual sex after the Teddy Bear case: A different perspective. South African Journal of Bioethics and Law 2013;6(2):45-57. [http://dx.doi.org/10.7196/SAJBL.289] 9. Teddy Bear Clinic for Abused Children and Another v Minister of Justice and Constitutional Development and Another 2014 (2) SA 168 (CC). 10. Constitution of the Republic of South Africa 1996. http://www.thehda.co.za/ uploads/images/unpan005172.pdf (accessed 13 March 2014). 11. Currie I, De Waal J. The New Constitutional and Administrative Law. Vol. 1. Cape Town: Juta & Co, 2001:287 and 295. 12. McQuoid-Mason D. Mandatory reporting of sexual abuse under the Sexual Offences Act and the ‘best interests of the child’. South African Journal of Bioethics and Law 2011;4(2):74-78.

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE

Ethical issues in public health promotion J Gardner, MScMed (Bioethics and Health Law) Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: J Gardner (jillian.gardner@wits.ac.za)

Health promotion is a key element of public health practice. Among strategies aiming to deal with public health problems, health promotion purports to help people achieve better health. Health promotion can significantly alter people’s lifestyles, and three main ethical issues relate to it: (i) what are the ultimate goals for public health practice, i.e. what ‘good’ should be achieved? (ii) how should this good be distributed in the population? and (iii) what means may we use to try to achieve and distribute this good? The last question is the subject of this article. Concerns raised about health promotion can be divided into two groups: (i) efficacy-based considerations – are they cost-effective or costineffective? and (ii) autonomy-based concerns – (to what extent) do they interfere with free choice, i.e. do they attempt to direct social values and lifestyles? Ways in which an individual’s autonomy may be compromised by means of influencing behaviour change are considered. S Afr J BL 2014;7(1):30-33. DOI:10.7196/SAJBL.268

Health promotion is a key element of public health practice, but understanding of the concept is controversial. The World Health Organization defines health promotion as the process of enabling people to increase control over, and to improve, their health. It moves beyond a focus on individual behaviour towards a wide range of social and environmental interventions.[1] Among strategies that aim to deal with public health problems, health promotion purports to help people achieve better health.[2] Health promotion has significant potential to alter people’s lifestyles. It aims to ‘make the healthy choice the easy choice and the unhealthy choice the more difficult choice’, and seeks to influence people to change their healthrelated behaviour, e.g. stop smoking, exercise more, eat healthy food, practise safe sex, wear helmets, etc.[3,4] Health promotion therefore aims to lead to better health by changing health-related behaviour or lifestyle. Health promotion has three main ethical issues: (i) what are the ultimate goals for public health practice, i.e. what ‘good’ should be achieved? (ii) how should this good be distributed in the population? and (iii) what means may be used in trying to achieve and distribute this good?[5] The last question is the subject of this article. I focus on health promotion approaches supported by government (financially or otherwise), since these are often paid for by taxpayers and aimed at the wider public. Arguably, private funders can determine for themselves what they will or will not fund, and their approaches need not be aimed at the general public.

Approaches to health promotion David Buchanan[3] mentions four kinds of more or less problematic strategies that health promotion uses to influence people to change their behaviour: (i) behaviourist conditioning, e.g. through rewards and punishment; (ii) communicative persuasion, e.g. through subliminal information or ‘scare’ campaigns; (iii) group pressure, e.g. through meeting strategies where people are influenced to abstain

May 2014, Vol. 7, No. 1 SAJBL

from certain kinds of behaviour; and (iv) direct instrumental power, e.g. through prohibitions or use of authority. Furthermore, different theories (or models) are used to underpin the various strategies to change behaviour or lifestyle.[3] To achieve their ends, many strategies use social psychological theory, e.g. the health belief model, the theory of reasoned action, or the social cognitive theory.[3] Other theories used are the trans-theoretical (stages of change) model, the diffusion of innovation theory, and the communication-behaviour change model.[6,7] These theories and models are used as tools for targeting specific kinds of behaviours to change them. They are therefore instrumental in influencing and changing the healthrelated behaviour of groups of people.[3,7] The primary aim is healthrelated behaviour change, but the immediate targets are typically psychological or cognitive factors, such as beliefs, attitudes and selfefficacy, and to an extent the social environment.[7]

Ethical issues raised by health promotion strategies Concerns raised about health promotion can be divided into two groups: (i) efficacy-based considerations – are they cost-effective or ineffective? and (ii) autonomy-based concerns – (to what extent) do they interfere with free choice, i.e. attempt to direct social values and lifestyles?[8] Health promotion raises many controversial ethical questions, including the question of the appropriate methods that might be used in seeking to promote health.[9] ‘Appropriate’ can be understood to mean the most (cost)-effective means of achieving the desired ends and/or the ethically acceptable means. Serious questions face the cost and effectiveness of health promotion, e.g. what should count as a successful strategy? What strategies count as health promotion for purposes of evaluation? What should be the criteria for measuring success? Should it be behaviour change or just attitude change? How much change must be achieved for the strategy to be called successful? Who can rightly claim success for the good outcome, or who can be blamed?

ARTICLE Many projects aiming to change people’s behaviour and lifestyle to enhance health have been tried. Coercive, top-down, legislative interventions, such as the requirement to wear seatbelts and crash helmets, have often succeeded,[10] as have some fiscal policies, such as taxing alcohol highly, as in the Nordic countries.[11] But the results of lifestyle projects are mixed; some have succeeded, or partly succeeded,[6] while others have failed.[12] Health promotion includes ‘a range of interventions, ranging from providing information through education, persuasion, the construction of new norms, the shaping of existing norms, the manipulation of preferences, or even coercion’.[9] Often behaviourchange approaches have narrow lifestyle goals, such as smoking cessation or increased physical activity, and use various means to influence the target group, sometimes informing, persuading, coercing, or manipulating the individuals or groups targeted, to reach these goals. Because health promotion involves significant potential to changes people’s lifestyles, it also raises questions about the values in health promotion. For example, suggesting that it is immoral and risky to have polygamous unions could lead to discrimination and stigmatisation of individuals who are, consensually, in such unions. It is also not clear why monogamy, despite its potential for good social consequences, should be the prized value. In the case of competent adults, does it make a difference if they voluntarily agree to the arrangement? Is it ethical to not separate the medical facts, i.e. that HIV is spread through unprotected sex with an infected person, from the underlying moral judgement that having multiple sexual partners is immoral? It is not obvious that the practice is harmful to or harms others. Health promotion involves a commitment to all kinds of activities to promote health, and this will inevitably touch on controversial political issues.[9] Health promotion also raises concerns about the legitimacy of state interference in influencing or shaping individuals’ choices. Liberal societies tend to think that lifestyle behaviour choices should be left to individuals. But it is also understood that a government is sometimes justified in infringing or limiting people’s autonomy. Accepting that a government has a legitimate role to play in health promotion, i.e. ‘making the healthy choice easier’ for people, what health promotion strategies or government efforts to change behaviour are ethical? Some health promotion strategies do not sufficiently respect the individual’s right to autonomy (self-determination) and liberty, i.e. the right to make decisions about one’s life, and about specific issues concerning that life. Others are less problematic and can be defended on other moral grounds. Some ways in which an individual’s autonomy may be compromised by different means to influence behaviour change are considered.

Persuasion Persuasion can be defined as the intentional and successful attempt to induce a person, through appeals to reason, to freely accept the beliefs, attitudes, values, intentions or actions advocated by the influencing agent.[8,13] A central feature of persuasion is that the reasons that compromise the persuasive appeal exist independent of the persuader and are conveyed by the use of structured argument or reasoning. In the words of Leroy Walters,[13] they simply ‘appeal to the rational capacities of the hearer’. In persuasion, the influencing agent

must therefore bring to the persuadee’s attention reasons, whether conveyed verbally, in writing or through non-verbal mediums, for acceptance of the desired perspective. Alistair Campbell[14] argues that persuasion can respect people’s autonomy if we make it clear that we are persuading, do not distort the facts, argue overtly rather than influence covertly, and remain independent of vested interests. If the influencing agent creates or controls the contingencies that the agent offers as ‘reasons’, the influence is not strictly persuasive, but rather manipulative or even coercive. Health education or information sharing are not usually regarded as intrusive and are generally considered to be effective. Informing about health threats or health benefits appears not to involve major ethical problems, because if the strategy is successful, it is because the individuals or groups found it useful or persuasive and chose to act on it. Information sharing can therefore be defended because it seeks to facilitate informed decision making. However, it may be problematic in that it constitutes a potential infringement of people’s right to autonomy if they receive information about lifestyle matters that they did not ask for, or if they are asked about their lifestyles, since such questions may cause embarrassment, shame or feelings of guilt.[3,4,15] Persuasion, especially the use of authority, is a problem that might appear in face-to-face encounters, especially when the agenda is set by a professional with authority. Authoritative persuasion here means that a person with real or perceived high status,[16] e.g. a doctor, tries to persuade someone to change behaviour. It becomes an ethical question when the issue or problem, and how it should be dealt with, is wholly determined by the professional without taking into account what the individual (or group) wants, and pressure is put on them to comply with the advice given. In these situations, there is a mixture of paternalism, i.e. an imposition of limitations on an individual by someone else for that person’s own good,[17] and that authority that puts the individual in a weak position. It therefore does not respect an individual’s right to autonomy, and risks making the person feel offended, vulnerable and powerless.[3,4]

Manipulation and deception Manipulation is a deliberate act that successfully influences people by non-persuasively altering their understanding of a situation, thereby modifying perceptions of the available options.[8] Manipulation of information compromises autonomy to the extent that it renders people ignorant, thereby causally constraining relevant aspects of their decisions. Informational manipulation affects what people believe. The influencing agent does not change the person’s actual options; the person’s perception is modified as a result of the manipulation. Deception includes such strategies as lying, withholding information, and misleading exaggeration where people are led to believe what is false. Other ways in which information can be manipulated and people deceived include:[8] • Intentionally overwhelming a person with excessive information to induce confusion and reduce understanding. • Intentionally provoking or taking advantage of fear, anxiety, pain or other negative affective or cognitive states known to compromise a person’s ability to process information effectively. • Intentionally presenting information in a way that leads the mani pulatee to draw predictable and misleading influences.

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE Questions concerning psychological and informational manipu lation have been raised more frequently about commercial cam paigns (advertising) than about social marketing campaigns. Social marketing is an intervention that uses commercial marketing tools to benefit the individual, group and society,[15] e.g. using gender and age stereotypes to ‘sell’ health behaviour.[18] In advertising the central issue seems to be deception. By contrast, health promotion is seldom seen as deceptive in any ordinary or straightforward, intentional sense. In practice, it is often difficult to distinguish between persuasion and other forms of psychological and informational manipulation. Arguably, many social influence or change attempts contain elements of both persuasion and manipulation. If there are any autonomyrelated problems with health promotion, they are likely to be more subtle than commercial advertising and to derive largely from the potential for skillful application of psychological theory.[8]

Coercion Coercion is commonly understood as using power to gain advantages over others (including self-protection), punishing non-compliance with demands, and imposing one’s will on the will of others.[19] Some kinds of coercion are morally unproblematic. It is generally accepted that public health strategies should use the least coercive means.[20] All governments act paternalistically, often for good reasons. Much of this is done by coercing people through legislation, e.g. to wear seatbelts and crash helmets. However, in liberal welfare societies there is a suspicion about too many restrictions.[4] For example, the use of sugar, or smoking (unless in public areas), is not prohibited, despite the fact that we know they are bad for people’s health. There is a tension between the government’s interest in intervening to protect the population from itself and people’s right to do what they themselves find best.[4] Using coercive means to change health-related behaviour is not always problematic. The less important, or the more trivial, the infringement and the greater the health gain, the less problematic the project, especially if it respects other important ethical principles, such as reciprocity, equality or social justice.[4,20] Another reason why coercion and manipulation are not always problematic relates to the idea that people voluntarily consent to coercion and/or manipulation. Sometimes individuals, or groups, targeted by health promotion accept being manipulated or coerced, e.g. in certain kinds of psychotherapy, where the therapist uses manipulative techniques that are (autonomously) accepted by the participant, such as accepting treatment with hypnosis for smoking cessation. Another example is where individuals ask to be committed to treatment, e.g. for drug abuse. This suggests that coercion and manipulation are acceptable strategies in such cases. Strategies that are persuasive, manipulative or coercive do not respect the individual’s right to autonomy. However, some strategies can be defended if they constitute minor rights infringements and the harms avoided are substantial, e.g. requiring people to wear seatbelts when driving. But what if a person is harmed in some other way? Are there behaviour change strategies that lead to situations that are worse than the problems they were designed to alleviate? Might improving a person’s future health through reducing his or her (immediate) quality of life be an example? Health promotion might

May 2014, Vol. 7, No. 1 SAJBL

persuade, manipulate or coerce people to adopt behaviours that they may dislike, e.g. exercising more or giving up smoking.[4] Could a more serious harm be that of reducing a person’s ability for autonomy, or similarly, that coercive interference might displace individual initiative? Manipulation risks leading to such a result. Marketing strategies are in general manipulative, because they try to induce people to do, or buy, things that they did not originally want, and that they would not have bought or done, had they had more information or sufficient time to deliberate. Employing manipulative techniques in social marketing appears to be counterproductive, as the risk is that the more people are manipulated, the less autonomous they will become. Reasons for this include that manipulation reduces knowledge (a prerequisite for autonomous choices) through false, skewed or partial information, and that it makes the individual less inclined to reflect critically on the options that are available.[21] Defenders of these strategies might claim that people are not very autonomous in the first place, since many forces in society influence us to want and do things,[22] and in this case we might as well ‘counter-manipulate’ individuals.[4] The ability for autonomy (selfdetermination) differs in the population. However, assuming that we are not fully determined by material or social structures, the answer to this problem should not be more paternalistic manipulation, but rather to strengthen or enhance the autonomy of those with less ability for it.

Conclusion This article highlights some ways in which health promotion strategies can be ethically problematic. Reasons for why behaviour change projects can be morally problematic include that they do not sufficiently respect, or further, the autonomy of the individuals involved. However, some people participate in behaviour change projects that they have chosen, and in which the goals and means are determined beforehand. Marketing tools are morally problematic if they influence the individual’s wants and beliefs, i.e. if they try to make people do something that they have not chosen, for reasons they are not fully aware of. This creates inauthentic wants and instills false beliefs, and thus disregards the right to autonomy (self-determination). Health promotion strategies are not typically thought of as paternalistic, but when they go beyond the provision of information and systematically seek to transform the desires and preferences of those to whom they are directed, they assume a fundamentally different character. Health promotion approaches that rely on manipulative or deceptive techniques to induce people to (i) come to hold certain beliefs, and as a result (ii) change their unhealthy behaviour, even in the service of a good end (e.g. a long and healthy life), are problematic. Although it would be a mistake to assume that respect for individual autonomy should always trump other considerations or values, e.g. general welfare, the violation of autonomy counts as a shortcoming in any approach to health promotion. Whether individual autonomy should be the deciding value in any particular case, however, depends upon what other values are at issue and the importance ascribed to them. Whether an approach is justified depends largely on the seriousness of the violation and the moral importance of the reason for conducting the approach. The questions can always be posed: Does the autonomy violation serve the approach well? Is it effective?

ARTICLE Acknowledgements. I would like to thank Prof. JP van Niekerk for valu able comments on an earlier draft of this article.

References 1. World Health Organization. Health promotion. http://www.who.int/topics/ health_promotion/en/ (accessed 30 April 2013). 2. Tengland P-A. Behavior change or empowerment: On the ethics of healthpromotion strategies. Public Health Ethics 2012;5(2):140-153. [http://dx.doi. org/10.1093/phe/phs022] 3. Buchanan D. An Ethic for Health Promotion. Oxford: Oxford University Press, 2000. 4. Holland S. Public Health Ethics. Cambridge: Polity, 2007. 5. Brülde B. Health, disease, and the goals of public health. In: Dawson A, eds. Public Health Ethics. Cambridge: Cambridge University Press, 2011:20-47. 6. Glanz K, Rimer BK, Viswanath K. Health Behavior and Health Education: Theory, Research, and Practice. 4th ed. San Francisco: Jossey-Bass, 2008. 7. Nutbeam D, Harris E, Wise M. Theory in a Nutshell: A Practical Guide to Health Promotion Theories. North Ryde: McGraw-Hill, 2010. 8. Faden RR. Ethical issues in government-sponsored public health campaigns. In: Gostin LO, ed. Public Health Law and Ethics: A Reader. California: University of California Press, 2002:346-353. 9. Dawson A, Grill K. Health promotion: Conceptual and ethical issues. Public Health Ethics 2012;5(2):101-103. [http://dx.doi.org/10.1093/phe/phs024] 10. Pellmer K, Wramner B. Grundläggande folkhälsovetenskap [Basic Public Health]. Stockholm: Liber, 2009. 11. Babor T, Caetano R, Casswell S, et al. Alcohol: No Ordinary Commodity – Research and Public Policy. Oxford: Oxford University Press, 2003.

12. SBU. Att förebygga sjukdom i hjärta och kärl genom befolkningsinriktade program – en systematisk litteraturöversikt [To prevent cardiovascular disease through public programs – a systematic literature review]. Stockholm: SBU (Statens beredning för utvärdering av medicinsk metodik [The government drafting committee for evaluations of methods in medicine]), 1997. http://www. sbu.se/upload/Publikationer/Content0/1/hjarta_karl_1997/Fulltext_foreb_ hjartakarl.pdf (accessed 30 April 2012). 13. Walters L. Ethical issues in the prevention and treatment of HIV infection and AIDS. Science 1988;239(4840):597-603. [http://dx.doi.org/10.1126/science.3340846] 14. Campbell A. Education or indoctrination: The issue of autonomy in health education. In: Doxiades SA, ed. Ethics in Health Education. Chichester: Wiley, 1990:15-28. 15. French J, Blair-Stevens C, McVey D, Merritt R. Social Marketing and Public Health: Theory and Practice. Oxford: Oxford University Press, 2009. 16. Wrong D. Power: Its Forms, Bases and Uses. New Brunswick: Transaction, 2004. 17. Bayer R, Gostin LO, Jennings B, Steinbock B. Public Health Ethics. Theory, Policy, and Practice. Oxford: Oxford University Press, 2007. 18. Naidoo J, Wills J. Public Health and Health Promotion. Developing Practice, 2nd ed. Edinburgh: Baillière Tindall, 2005. 19. Anderson S. Coercion. In: Zalta EN, ed. The Stanford Encyclopedia of Philosophy (Winter 2011). http://plato.stanford.edu/archives/win2011/entries/coercion/ (accessed 30 April 2012). 20. Upshur REG. Principles for the justification of public health intervention. Can J Public Health 2002;93(2):101-103. 21. Pollay RW. The distorted mirror: Reflections on the unintended consequences of advertising. J Mark 1986;50(2):18-36. [http://dx.doi.org/10.2307/1251597] 22. Michael Focault. In: Gordon, C, ed. Michael Foucault: Power/Knowledge. Brighton: Harvester Press, 1986.

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE

Questioning South Africa’s ‘genetic link’ requirement for surrogacy T Metz, BA, MA, PhD Department of Philosophy, University of Johannesburg, South Africa Corresponding author: T Metz (tmetz@uj.ac.za)

South African law currently forbids those seeking to arrange a surrogate motherhood agreement from creating a child that will not be genetically related to at least one of them. For a surrogacy contract to be legally valid, there must be a ‘genetic link’ between the child created through a surrogate and the parents who will raise it. This law is currently being challenged in the High Court of South Africa, and in this article I critically explore salient ethical facets of the dispute. I argue that the law is unjust and should be revised. S Afr J BL 2014;7(1):34-39. DOI:10.7196/SAJBL.314

South African (SA) law currently forbids those seeking to arrange a surrogate motherhood agreement from creating a child that will not be genetically related to at least one of them. For a surrogacy contract to be legally valid, there must be a ‘genetic link’ between the child created through a surrogate and the parents who will raise it. Specifically, the law says: ‘No surrogate motherhood agreement is valid unless the conception of the child contemplated in the agreement is to be effected by the use of the gametes of both commissioning parents or, if that is not possible due to biological, medical or other valid reasons, the gamete of at least one of the commissioning parents or, where the commissioning parent is a single person, the gamete of that person.’[1] This law implies that at least one of the commissioning parents must provide a gamete, i.e., either sperm or eggs, which will be used to form the embryo of the child that she or they intend to rear. Interest in this topic is heating up in SA, with a recent (brief ) ethical overview of the matter having been published[2] and a legal challenge currently being made against SA’s Minister of Social Development, who supports the current law.[3] To begin to appreciate some of the rationale for doubting the justice of the law, consider the following scenario. Imagine a couple that has tried for over a decade to get pregnant, but has been unable to do so. Suppose that he is sterile and she is now in her late 40s, without viable eggs and unable to gestate a fetus. And yet both still long to be involved with a child from the start, perhaps one that is likely to have features similar to theirs. The law, as it stands in SA, forbids them from using a surrogate mother who would carry an embryo fertilised by donor gametes that the couple has selected. In this article I appeal to moral-philosophical reasons to conclude that SA’s surrogacy law is unjust in respect of the above scenario and those similar to it. I rebut rationales, usefully divided into consequentialist and non-consequentialist moral arguments, for

May 2014, Vol. 7, No. 1 SAJBL

thinking that the law is justified. The consequentialist arguments maintain that the results of changing the law to permit surrogacy without a genetic link would be undesirable in some way, perhaps for causing harm to the child or starting a ‘slippery slope’ towards a society that systematically employs eugenics. The nonconsequentialist arguments contend that there is something immoral in itself, apart from the long-term consequences, about creating a child that will not be genetically related to the parents who care for it. After arguing against both attempts to ethically justify the status quo, I provide some positive reasons for thinking that the law is unjust. Note that in this article I do not address broader issues relating to the ethics of in vitro fertilisation (IVF), the destruction of embryos, embryo transfer and gestational surrogacy. I focus strictly on whether surrogacy is morally impermissible and should be legally forbidden for the specific reason that a genetic link would be missing between those commissioning the pregnancy and the created child. In addition, I do not wade into the thicket of ethical debates about related issues such as cloning and genetic enhancement, and where they are mentioned, it is only to put the present issue in context. Most of those who have written on surrogacy in the absence of a genetic link have been either religious conservatives, on the one hand, or radical transhumanists, on the other. They have either sought to preserve traditional mores or to completely upend them in favour of overhauling human nature towards something allegedly much better. Part of my aim in this article is to articulate a moderate position, in between these extremes and grounded on values consonant with SA’s Constitution, including contemporary understandings of the African ethic of ubuntu.

Consequentialist arguments for a genetic link A consequentialist argument for a certain law is a moral rationale according to which the long-term outcomes for society with the law would be better than without it. Frequently called ‘cost-benefit

ARTICLE analysis’ in the realm of public policy, the idea is that a norm is justified insofar as it is expected to produce more good and to reduce more bad than the feasible alternatives to it. Applied to the law requiring a genetic link between those who create a child and those who intend to rear it, the claim would be that more desirable net benefits are expected from the law than from some other law that could realistically be adopted. In the present context, two types of harm are most commonly discussed, namely psychological damage to the child who has been created, and the much more far-reaching prospects of opening the floodgates to a society that uses eugenics to enhance embryos.

Would the created child be harmed? One natural question to ask about a child who would be reared with parents genetically unrelated to him is whether he would badly off as a result. In particular, perhaps such a child would be confused about his identity or, as the moral philosopher J David Velleman has put it, suffer from a kind of blindness about who he is: ‘In coming to know and define themselves, most people rely on their acquaintance with people who are like them by virtue of being their biological relatives ... Knowing what I am like would be that much harder if I didn’t know other people like me. And if people bear me a literal family resemblance, then the respects in which they are like me will be especially relevant to my knowledge of what I am like ... Not knowing any biological relatives must be like wandering in a world without reflective surfaces, permanently self-blind.’[4] Based on one oft-cited study,[5] some psychologists have also indicated concern about those reared in families with whom they lack a genetic link in terms of feeling different and consequently lacking some self-esteem. Now, children who are adopted lack a genetic link with the parents looking after them, and virtually no one believes that adopting such a child is immoral and that staying in an orphanage would be preferable. So, one might wonder whether there is a genuine prima facie concern on this score. However, there is plausibly some morally relevant difference between adopting a child who already exists and who will lack a genetic link with its parents, on the one hand, and creating a child who does not yet exist and who will lack a genetic link with its parents, on the other. Perhaps it is impermissible to create a person whom one can foresee is likely to undergo some kind of psychological harm, but permissible to adopt an extant person who might suffer the same harm, when doing so would minimise the harm he would face overall, viz. if left in an orphanage. Velleman also makes this point eloquently: ‘Much as we love disadvantaged children, we rightly believe that people should not deliberately create children who they already know will be disadvantaged. In my view, people who create children by donor conception already know – or already should know – that their children will be disadvantaged by the lack of a basic good on which most people rely in their pursuit of self-knowledge and identity formation.’[4] And since the law in relation to children ought to serve their interests, it should forbid creating children who will foreseeably lack a genetic link to those who rear them, or so the argument goes.

I have two objections to make to this argument. First, I point to very recent and substantial counter-evidence, viz. based on large samples and longitudinal studies, indicating that psychological harm has not been suffered by the offspring of donated gametes in respect of a lack of a genetic link with their parents.[6-9] One of these concludes: ‘The findings of this study add to the growing body of research suggesting that biological relatedness between parents and children is not essential for positive child adjustment.’[6] My second point is that even if, for the sake of argument, there were some foreseeable harms to an adolescent or adult who lacks a genetic link to his parents, it would not necessarily be immoral to create him, since the alternative would be his non-existence, which is far from obviously preferable (for a different but related answer to this question, which emphasises the fact that the law seeks to remove children from parents only in the most extreme cases, see Meyerson[10]). Returning to a comparison between adopting a genetically unrelated child and creating one, the alternative to adoption is that a child remains alive in the care of a state orphanage or the like. The alternative to creating a child with donated gametes and a surrogate birth-mother is the non-existence of that child. Hence, for the present consideration of harm to the child to hold weight, it must be that never existing at all would be better for a child than being created and then living in a loving, supportive home with parents who are not genetically related to him. That claim is, if not absurd, then extraordinarily dubious and, still more, morally improper as a ground of law. Surely, the relevant test is whether the life of the created child would be worth living. And I submit that the overwhelming majority of those working in ethics would contend that your life could indeed be worth living even if you were not genetically related to parents who loved you and did all they could to help you flourish in the world. After all, virtually no one believes that it would be better for, say, an adopted child in an intimate, supportive household to die than to carry on living. However, the logic of the present argument entails that it would be, by virtue of the alleged harm occasioned by being reared by those not genetically related to him.

Would a eugenic rat-race ensue? Here is another version of a consequentialist argument for SA’s law requiring a genetic link between those who create a child and those who intend to rear it. It appeals not to the short- to medium-term harm to the child, but rather to long-term results for the broader society. Even if the specific offspring of donated gametes would not suffer in terms of their identities or otherwise, it could be that changing the law to allow people to create such children would have disastrous consequences down the road for others. In particular, it is natural to be concerned about opening the floodgates to a eugenic society in which embryos are routinely screened and engineered with regard to traits such as sex, height, intelligence, memory, patience, beauty and related traits that tend to confer competitive advantage. Perhaps in such a society children would be ‘reduced to’ their genetic potential and not given the freedom to act in accordance with their own desires. Maybe there would be even more systematic kinds of inequality, biologically engendered through genetic manipulation, beyond the social ones of race and class that are already so salient in SA society. It could even be the case that opening the door to severing any genetic

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE link between children and parents could encourage society to allow the converse of an identical genetic link in the form of reproductive cloning (famously argued by Leon Kass[11]). There might of course be some thinkers who maintain that these risks would be worth the benefits of much-improved health to the human race. However, I set that sort of transhumanist and fairly radical objection aside. Instead of welcoming the slippery slope, I provide reason to doubt that it would be likely to occur. Slippery slopes are often readily forestalled by putting laws and other rules in place. A few such laws already exist in SA. SA could continue its policy of forbidding commercial gamete distribution[12] and commercial surrogacy,[13] permitting these practices only for altruistic reasons, with compensation for time and other inconvenience being the only financial element involved. It could retain the requirement that only people who cannot give birth themselves may make use of surrogacy.[14] And it could of course continue to maintain a ban on human cloning.[15] I do not express any view in this article as to which of these kinds of ‘brakes’, if any, would be appropriate. My point is merely that something of the sort appears to be on hand, if one were keen to stop the slide towards a society in which, say, the rich seek out the choicest donated eggs and sperm, or the genetic engineering of their own, with the aim of creating what in the popular press are often called ‘designer babies’[16,17] who would eventually dominate the rest of society.

Non-consequentialist arguments for a genetic link Non-consequentialist arguments in favour of forbidding people from creating children they know will not be genetically related to themselves imply that there is something wrong with doing so ‘in itself’, setting aside consideration of the results of doing so. Too often such arguments either appeal to religious tracts about God’s will, which hardly command acceptance from a broad array of rational enquirers, on the one hand, or to vague and easily questioned rationales about such a practice being ‘unnatural’ (so is getting a tattoo) or a matter of ‘playing God’ (so is killing in self-defence), on the other. In this section, I instead focus on arguments that are prima facie stronger, some of which have been advanced by Kass, who acknowledges the weaknesses of the usual rationales. Kass, in my opinion, has two distinct arguments for a genetic link: according to one, lineage is good for its own sake, and according to another, sexual procreation, which implies a genetic link, is good for its own sake. As I will demonstrate, both arguments rest on the basic principle that human nature has a dignity that is not to be degraded, and I will bring out respects in which this principle is deeply flawed as a reason for concluding that a genetic link is morally required. I will also address an ubuntu-based argument for a genetic link that appeals to the moral value of kinship.

A requirement to respect the dignity of ‘human nature’ About the first uses of IVF, Kass, at least as of 2002,[18] says that he has no complaint, since they involved taking the sperm and eggs of a married couple to create an embryo that they would then rear. Speaking of this intramarital use of IVF, Kass remarks that ‘there could

May 2014, Vol. 7, No. 1 SAJBL

be no objection. Here indeed is the natural and proper home for the human embryo. Here indeed is the affirmation of transmission and the importance of lineage and connectedness.’[18] However, criticising the use of IVF and embryo transfer for the purposes of creating a child that will not have a genetic link to those who rear it, Kass says that such new techniques will serve: ‘... not to ensure and preserve lineage, but rather to confound and complicate it ... Properly understood, the largely universal taboo against incest, and also the prohibitions against adultery, defend the integrity of marriage, kinship, and especially the lines of origin and descent. These time-honored restraints implicitly teach ... clarity about who your parents are, clarity in the lines of generation, clarity about who is whose ... This means, concretely, no encouragement of embryo adoption or especially of surrogate pregnancy.’[18] Some of Kass’s rationale is consequentialist, to the effect that when origins and parentage become opaque, the prospects of what he calls ‘civilized community’ decline. However, another part of it, on which I focus here, is non-consequentialist and, specifically, a matter of respect for human dignity. Elsewhere Kass remarks, ‘Man is partly defined by his origins; to be bound up with parents, siblings, ancestors, is part of what we mean by “human”,’[19] so that when people are foreseeably created without a genetic link to those who will take care of them, then they are objectionably treated as inhuman. Not only are the embryo, fetus and child treated inhumanly or degraded by virtue of knowingly being created in ways that sever the genetic relationship between them and their caregivers, but the parents themselves, and perhaps the traditional family more generally, are treated disrespectfully. On this, Kass remarks in an early article: ‘There are more and less human ways of bringing a child into the world. I am arguing that the laboratory production of human beings is no longer human procreation, that making babies in laboratories – even ‘perfect’ babies – means a degradation of parenthood ... If the depersonalization of the process of reproduction and its separation from human sexuality dehumanize the activity which brings new life, and if the manufacture of human life threatens its humanness, both together add up to yet another assault on the existence of marriage and the human family.’[19] Kass also has this to say: ‘When it comes to human biotechnical engineering, only if there is something inherently good or dignified about, say, natural procreation, human finitude, the human life cycle (with its rhythm of rise and fall), and human erotic longing ... only then can we begin to see why those aspects of our nature need to be defended. (It is for this reason why a richer bioethics will always begin by trying to clarify the human good and aspects of our given humanity that are rightly dear to us, and that biotechnology may serve or threaten.) We must move from the hubristic attitude of the powerful designer to consider how the proposed improvements might impinge upon the nature of the one being improved.’[20] Notice the difference in argument here from the previous one. The logic of the present argument entails a much broader conclusion, to the effect that even using IVF in ways that preserve a genetic link is immoral for not being part of the characteristic process by which human beings procreate, viz. by sexual intercourse.

ARTICLE As Kass himself seems to have changed his mind about that, as per the discussion above regarding intramarital use of IVF, one might be tempted to set the present rationale aside. However, both arguments are a straightforward product of a common moral foundation, and so I will continue to address them both. I suspect that they stand or fall together. Both of the previous arguments, when understood in nonconsequentialist terms, maintain that human nature has a dignity that it is wrong to degrade, that the use of reproductive technologies and surrogacy to create a child that will not be genetically related to its caregivers degrades human nature, and hence that they are wrong to use. Here, I argue that the claim that human nature has a dignity can be understood in one of two major ways, of which one begs the question and the other has extremely counterintuitive implications. To say that ‘human nature’ has a dignity is ambiguous, for it is not clear whether that phrase is associated with a ‘moralised’ concept or not. A moralised concept is one that is inherently evaluative or normative, and is the sort of notion that ethicists invoke for a living, with good examples being justice, virtue, well-being, meaningfulness and human excellence. Given the ways in which these concepts are normally invoked, one would be contradicting oneself to say that there is nothing desirable about virtue and that one has no reason to seek it out. In contrast, a non-moralised concept does not essentially include some kind of appraisal, and is instead the sort of notion that a scientist would employ to describe some facet of the world. Here, a very good example is the anthropological concept of Homo sapiens. My contention is that speaking of ‘human nature’ could mean either human excellence or Homo sapiens, and that Kass’s arguments fail to convince, regardless of which is meant. First, consider the differences in what the phrase ‘human nature’ might mean, depending on whether a moralised concept is intended or not. Sometimes when we speak of ‘human nature’, we have moralised ideals in mind, e.g. when we praise someone in Yiddish for being a mentsh, or in German for displaying Menschlichkeit, or in the Nguni languages for exhibiting ubuntu (literally, humanness for Zulu, Xhosa and Ndebele people). When we speak of ‘humanity’ in these contexts, we are referring to particular aspects of human nature that we find to be intrinsically valuable or good for their own sake. Other times when we speak of ‘human nature’ we have a much more neutral concept in mind. Here, we would be speaking of humanity as a species, comparable in connotation to the categories of Canis lupis familiaris (domestic dogs) or Felis catus (domestic cats). A scientific use of the term refers to a being with a particular sort of DNA, a natural kind distinct from others on earth. Here, now, is the rub. Kass must have one or the other sense of ‘human nature’ in mind, and it turns out that neither will do any justificatory work for him. Suppose, first, that Kass is using a moralised concept. In that case, it is quite plausible to assert that so-called ‘human nature’ has a dignity or otherwise deserves respect; for it is a priori designated as picking out features of us that are good for their own sake. However, if Kass now claims that conditions such as maintaining a genetic link and reproducing sexually are parts of ‘human nature’ that deserve respect, then he is begging the question against those who are inclined to deny these claims. If these conditions are facets of human nature in a moralised sense, then Kass is merely asserting that they are good for their own sake in calling them aspects of ‘human nature’. But he is

supposed to be contributing to a debate about whether they indeed deserve respect, and merely calling them ‘human nature’, and hence implicitly good for their own sake thereby, does not provide a reason to believe that they are. Suppose Kass is instead using a non-moralised concept of human nature. To say that maintaining a genetic link and reproducing sexually are parts of human nature in this sense does not beg the question and indeed is clearly true. Characteristically, human beings as a species do reproduce sexually and thereby maintain a genetic link with the children for whom they care. Of course, not all human beings do that. However, even though not all domestic cats meow and have four legs, it is true that the species Felis catus does. Now, making the descriptive point that members of Homo sapiens characteristically reproduce sexually and are genetically related to the offspring they look after carries with it no evaluation. And so it is quite open for one to question whether it is good for its own sake or otherwise deserves respect. After all, there are other facets of ‘human nature’ in the descriptive sense that are clearly bad and should instead be shunned, as well as some that are neither good nor bad. For instance, it is plausible to think that members of Homo sapiens have a disposition to see others who they perceive as different from themselves as pollution and to want to cleanse themselves of such others upon feeling threatened.[21] It is such an orientation that I believe best accounts for atrocities such as the Nazi Holocaust, the Rwandan genocide and many other large-scale crimes against humanity. Supposing for the sake of argument that this disposition were indeed part of our inherent biological make-up, it would nonetheless not deserve respect. Kass cannot plausibly claim that ‘human nature’ in the descriptive sense is completely valuable and worthy of protection. For an additional example, being born with four toes on each foot instead of five would be a deviation from ‘human nature’ in the descriptive sense, but would not carry with it anything of moral salience. Similar remarks, for all that has been said so far, might well go for conditions such as ensuring a genetic link between children and parents. In sum, when Kass says things such as ‘Man is partly defined by his origins’, he means either (i) that human beings are good for their own sake insofar as they have come from a certain source, which begs the question against people like me who doubt that; or (ii) that human beings characteristically come from a certain source, which is true but carries with it no normative appraisal and is therefore up for grabs in terms of whether it deserves respect or not. Parts of human nature are surely valuable and deserve respect, but not all of them, and Kass does not provide substantive reason to think that a genetic link is one of them. Indeed, he is well known for eschewing the idea that we can reason much about ethical matters, instead finding wisdom in people’s emotional reactions of repulsion, widely known among bioethicists as the ‘yuck factor’. Few contemporary professional ethicists and moral philosophers, however, think that people’s common disgust of, say, inter-racial romance in the 20th century was revealing of anything morally significant.

A requirement to exhibit human excellence As I have indicated above, ‘ubuntu’ means humanness or human excellence, in other words attitudes and behaviour that are morally upright and to be pursued in life. In an SA context, it is natural to want

May 2014, Vol. 7, No. 1 SAJBL

ARTICLE to know what an ubuntu-based ethic would entail for the present moral dilemma. In addition, one might have the strong suspicion that an indigenous African ethic would require there to be a genetic link between parents commissioning a surrogate and the resultant child, given how often kinship relationships are prized in sub-Saharan Africa. As Anthony Appiah remarks of a typically African approach to ethics: ‘This form of moral thought permits someone, the agent, to treat someone else, the patient, in a certain manner because the two are related, not because the patient has particular qualities or needs, for example, I might give shelter to someone “because she is my kinswoman”.’[22] The recurrent focus on kinship, which connotes blood ties and common descent, among traditional African peoples might lead one to think that it should be of utmost importance when creating children, i.e. that one would fail to exhibit ubuntu, and would rather be acting in a more animalistic manner, in knowingly creating a child that would not be related to one. Perhaps those who question SA’s law, such as myself, are simply Western liberals who prize autonomy above all. I cannot comment on what a given indigenous people in subSaharan Africa would say about the ethics of using IVF, embryo transfer and gestational surrogacy to create a child that would lack a genetic link to the commissioning parents. What I can speak to, however, are the values typically prized by post-war moral theorists who claim inspiration by mores associated with ubuntu. Conceptions of how to relate morally to others in recent southern (and more generally sub-Saharan) African analyses of ubuntu do not tend to include the idea of anything biological. What is instead recurrent in the literature about the proper relationships to have with others in order to exhibit human excellence are these social elements: sharing a way of life with others and caring for others’ quality of life. That is, it is characteristic of adherents to ubuntu to maintain that one displays virtue to the extent that one enjoys a sense of togetherness with others, participates with them on a co-operative basis, and helps them out of sympathy or otherwise for their sake.[23] Communal or harmonious relationships are what matter, not genetic ones. In support of my interpretation, consider the following representative remarks of SA thinkers on the nature of ubuntu. First, note that former SA Constitutional Court Justice Yvonne Mokgoro remarks of an ubuntu ethic, ‘Harmony is achieved through close and sympathetic social relations within the group.’[24] Prof. Muxe Nkondo, who has had positions of leadership on SA’s National Heritage Council, says: ‘If you asked ubuntu advocates and philosophers: What principles inform and organise your life? What do you live for? ... the answers would express commitment to the good of the community in which their identities were formed, and a need to experience their lives as bound up in that of their community.’[25] Dr Mluleki Mnyaka and author Mokgethi Motlhabi together say of ubuntu: ‘Individuals consider themselves integral parts of the whole community. A person is socialised to think of himself, or herself, as inextricably bound to others ... Ubuntu ethics can be termed antiegoistic as it discourages people from seeking their own good without regard for, or to the detriment of, others and the community.’[26] Dr Reuel Khoza, author of a well-regarded book on ubuntu and leadership, with introductions by Nelson Mandela and Thabo Mbeki, sums up the view this way: ‘Ubuntu is characterised by such values

May 2014, Vol. 7, No. 1 SAJBL

as caring, reciprocity, sharing, compassion, hospitality, cohabitation, cooperation and tolerance.’[27] Finally, renowned exponent of an ubuntu morality Archbishop Desmond Tutu says: ‘When we want to give high praise to someone we say, “Yu, u nobuntu”; “Hey, so-and-so has ubuntu.” This means they are generous, hospitable, friendly, caring and compassionate. They share what they have.’[28] I could easily add many more citations that indicate similar ideas. As should be clear, none of these kinds of relationships implies, or otherwise requires, a genetic link between those party to them. Among contemporary exponents of an ubuntu ethic, it is much more controversial to claim that a genetic link is central to morality than it is to maintain that loving, friendly, communal and generally positive social relationships are what are to be prized. In fact, it is more characteristic of an ubuntu perspective to maintain that ‘it takes a village to raise a child’, a natural interpretation of which is that those without a genetic link to the young can have a vital role to play in their healthy upbringing. Finally, recall that a quintessential feature of ubuntu is not a function of intimate, let alone biological, relationships, but is instead a matter of being hospitable to strangers, as Nelson Mandela[29] and others[26] have maintained. I have in mind the practice, widespread in pre-colonial Africa, of welcoming visitors to a village to the point of sharing one’s best food with him or her, at least for a time. Viewing everyone, regardless of whether or not they are related to oneself, as part of a human family and someone with whom to commune is also a core aspect of ubuntu and sub-Saharan ethics more generally.[30,31]

Severing the genetic link: Some positive reasons to permit it So far I have provided objections to the major ethical arguments in the literature for thinking that SA’s law is just insofar as it requires an embryo placed in a surrogate to be genetically related to the parents who will care for the newborn baby. I now supplement this negative strategy by concluding with some brief positive considerations for overturning this law. Appealing to values that resonate with SA’s Constitution, I contend that they entail that the law is unjust. The lack of overlapping consensus in SA society about the best form that the family should take provides strong reason to think that the government should remain neutral on the matter, letting residents decide for themselves. Just as it would be wrong in SA society for the state to intentionally promote a single religion in the face of religious diversity among residents, so it would be wrong for the state to intentionally promote a single type of family when there is a diversity of intelligent opinion about which sort of family is worthwhile. Where there is reasonable disagreement about a matter, as there is with respect to religion and family, respect for people’s judgement, privacy, autonomy and related factors normally entails that the state ought to let them decide for themselves, as others have also suggested previously, including in the context of surrogacy.[10] One need not be a staunch Western liberal fan of autonomy to appreciate the force of this argument. Consider that, in terms of ubuntu, part of what is valuable about communal relationships is that people come together and stay together of their own accord and are not corralled into living with certain people as opposed to others. From that ethical standpoint, too, the state should not dictate the nature of the family South Africans are permitted to enjoy.

ARTICLE Finally, even if there were, ex hypothesi, some substantial agreement among South Africans about which family is most desirable, it would not follow that it would necessarily be appropriate to base law on those views. One major ethical purpose of the SA Constitution is to protect those with minority viewpoints and ways of life, when these would not violate others’ abilities to take advantage of civil liberties, participation in democratic governance, socioeconomic goods and the like. Hence, even if a survey of South Africans indicated that a large majority favours a genetic link between parents and children, those with a different view morally should be afforded the space to live as they please, so long as they are not preventing others from choosing the kind of family they prefer or otherwise violating a right.

Conclusion In this article I have mostly argued against a variety of ethical rationales for SA’s current approach to surrogacy, which requires a genetic link between the commissioning parents and the created child. These rationales have appealed to: the prospect of harm to the child; a slippery slope towards systematic eugenics; a principle of respect for human nature; and a principle of developing one’s humanness. In each case I argued that these considerations fail to provide a sound defence for the law. Furthermore, I contended that in the absence of a strong, or even widely held, ethical rationale for it, the law should be revoked out of respect for people’s privacy and their ability to create loving and intimate relationships. Such a position, which would accord more liberty than a reli gious traditionalism, is not necessarily motivated by a radical trans humanism, and also need not lead to that in practice. Instead, SA’s Constitution and its attendant values can chart a safe course.

References 1. South African National Government. The Children’s Act No. 38 of 2005, section 294. http://www.justice.gov.za/legislation/acts/2005-038%20childrensact.pdf (accessed 11 March 2014). 2. Slabbert MN. Legal issues relating to the use of surrogate mothers in the practice of assisted conception. South African Journal of Bioethics and Law 2012;5(1):27-32. 3. AB and Surrogacy Advisory Group v Minister of Social Development, High Court of South Africa, Case No 40658/13. 4. Velleman JD. Family history. Philosophical Papers 2005;34(3):357-378. [http:// dx.doi.org/10.1080/05568640509485163] 5. Turner AJ, Coyle A. What does it mean to be a donor offspring? The identity experiences of adults conceived by donor insemination and the implications

for counselling and therapy. Hum Reprod 2000;15(9):2041-2051. [http://dx.doi. org/10.1093/humrep/15.9.2041] 6. Golombok S, Blake L, Casey P, Roman G, Jadva V. Children born through reproductive donation: A longitudinal study of psychological adjustment. J Child Psychol Psychiatry 2012;54(6):653-660. [http://dx.doi.org/10.1111/jcpp.12015] 7. Van Gelderen L, Bos H, Gartrell N, Hermanns J, Perrin E. Quality of life of adolescents raised from birth by lesbian mothers: The US national longitudinal family study. J Dev Behav Pediatr 2012;33(1):1-7. [http://dx.doi.org/10.1097/ DBP.0b013e31823b62af ] 8. Jadva V, Blake L, Casey P, Golombok S. Surrogacy families 10 years on: Relationship with the surrogate, decisions over disclosure and children’s understanding of their surrogacy origins. Hum Reprod 2012;27(10):3008-3014. [http://dx.doi. org/10.1093/humrep/des273] 9. Blake L, Casey P, Jadva V, Golombok S. ‘I was quite amazed’: Donor conception and parent-child relationships from the child’s perspective. Children and Society 2013;1-13. [http://dx.doi.org/10.1111/chso.12014] 10. Meyerson D. Surrogacy agreements. Acta Juridica 1994;27(3):121-145. 11. Kass LR. The wisdom of repugnance. The New Republic 1997;2 June:17-26. 12. National Health Act No. 61 of 2003. Regulations relating to the artificial fertilisation of persons. Government Notices No. 35099, 2012, section 4. 13. Children’s Act No. 38 of 2005, section 301. 14. Children’s Act No. 38 of 2005, section 295(a). 15. National Health Act No. 61 of 2003, section 57. 16. Brownlee S. Designer babies. Washington Monthly 2002; March. http://www. washingtonmonthly.com/features/2001/0203.brownlee.html (accessed 11 March 2014). 17. Baird S. Designer babies: Eugenics repacked or consumer options? The Technology Teacher 2007;66(7):12-16. 18. Kass LR. The meaning of life – in the laboratory. The Public Interest 2002; 146(Winter):38-73. 19. Kass LR. Making babies – the new biology and the ‘old’ morality. The Public Interest 1972;26(Winter):18-56. 20. Kass LR. Ageless bodies, happy souls. The New Atlantis 2003;1:9-28. 21. Koestler A. The Ghost in the Machine. New York: Macmillan, 1967. 22. Appiah A. Ethical systems, African. In: Craig E, ed. Routledge Encyclopaedia of Philosophy. London: Routledge, 1998. 23. Metz T. African and western moral theories in a bioethical context. Developing World Bioethics 2010;10(1):49-58. [http://dx.doi.org/10.1111/j.14718847.2009.00273.x] 24. Mokgoro Y. Ubuntu and the law in South Africa. Potchefstroom Electronic Law Journal 1998;1(1):15-26. [http://dx.doi.org/10.4314/pelj.v1i1.43567] 25. Nkondo GM. Ubuntu as a public policy in South Africa: A conceptual framework. International Journal of African Renaissance Studies 2007;2(1):88-100. 26. Mnyaka M, Motlhabi M. Ubuntu and its socio-moral significance. In: Murove FM, ed. African Ethics: An Anthology of Comparative and Applied Ethics. Pietermaritzburg: KwaZulu-Natal Press, 2009:63-84. 27. Khoza R. Let Africa Lead. Johannesburg: Vezubuntu, 2005:xxii. 28. Tutu D. No Future without Forgiveness. New York: Random House, 1999:34. 29. Mandela N. Experience ubuntu (excerpt from an interview with T Modise in 2006). http://www.youtube.com/watch?v=HED4h00xPPA (accessed 11 March 2014). 30. Shutte A. Ubuntu: An Ethic for the New South Africa. Cape Town: Cluster Publications, 2001:25-30. 31. Gyekye K. African ethics. In: Zalta E, ed. Stanford Encyclopedia of Philosophy. 2010. http://plato.stanford.edu/entries/african-ethics/ (accessed 11 March 2014).

May 2014, Vol. 7, No. 1 SAJBL

CPD

NOTIFICATION

Dear CPD client, We wish to take this opportunity to thank you for your continued support through the completion of our online CPD questionnaires as well as to share some exciting news with you. HMPG’s journal CPD questionnaires will be moving to the Medical Practice Consulting (MPC) CPD platform (www.mpconsulting.co.za) as part of a strategy to consolidate all South African Medical Association (SAMA) members’ CPD certificates and history. All SAMA CPD certificates (whether for annual conferences, branch meetings or workshops) are already available online on the MPC CPD platform and moving all active HMPG online CPD questionnaires to the same platform will mean that all SAMA member CPD certificates will be issued in one central, convenient location – resulting in less admin for our CPD clients. An additional benefit is that the MPC CPD manager can complete your IAR form on your behalf (no more countless hours of reconciling CPD records before a compliance audit) and submit your CPD history to the HPCSA once you have approved it and are happy with the results. All that is required of you, when you are ready, is to click a single button to submit your CPD Activity Record to the HPCSA. Nothing will, of course, ever be submitted without your prior approval and consent. The MPC system also adds additional functionality to the CPD questionnaires and the system has been set up to make the process as easy to follow as possible. The South African Medical Association (SAMA) board has concluded that the CPD services associated with the South African Medical Journal (incorporating Continuing Medical Education) and the South African Journal of Bioethics and Law will only be offered to registered and fully paid-up SAMA members, as per the SAMA member benefit schedule; therefore, you will be required to register a profile on the MPC CPD system (if you do not already have one – if you already have one, login as usual) and to supply your SAMA membership number. You will be required to do this only once. Your membership will be validated in real-time and you will be able to access the journal CPD questionnaires. This once-off registration should not take more than 2 minutes and you will be on your way to completing the CPD questionnaires. Below are some questions and answers that will assist you in getting started.

When will the CPD questionnaires move to MPC? All HMPG-issued journal CPD questionnaires will move to the MPC CPD platform from February 2014 onwards. This will include all prior CPD questionnaires that are still active.

What website do I access to complete the HMPG questionnaires? www.mpconsulting.co.za

Who is MPC? Medical Practice Consulting (MPC) is a group company of SAMA. MPC has historically hosted CPD at SAMA’s annual conferences, issued all SAMA member CPD certificates and has hosted SAMA’s online branch elections. By moving active HMPG journal CPD questionnaires to the MPC system, SAMA members will have all their CPD certificates in one central, convenient location. MPC has also been supplying the Foundation for Professional Development distance learning courses online for the last 2 years and has hosted some of the largest online training initiatives in the South African healthcare industry.

What do I need to register a profile on the MPC CPD system? MPC does not retain any confidential information on their database, so you will not be requested to share your telephone number, practice or home address. All that is required for registration is your name, surname, specialty, SAMA membership number and HPCSA number (which is included on your CPD certificate to comply with HPCSA CPD requirements).

How long will registration take? Completing registration should take no longer than 2 minutes – please remember to have your HPCSA (MP Number) and SAMA membership number at hand.

What about my historic CPD certificates on the www.cpdjournals.co.za website? If you register on the MPC CPD platform with the same email address as you were using on the www.cpdjournals.co.za website, MPC will import all your CPD certificates for the last 36 months into your MPC CPD manager for you. Alternatively you can still login to www.cpdjournals.co.za and save any CPD certificates that are still valid (remember that CEUs have a 24-month shelf life and expire after 24 months).

What happens if I run into technical difficulties? Simply complete an online contact form and MPC will assist you with your technical problem. If your SAMA number for some reason does not match that in the SAMA membership database, MPC will assist with rectifying the problem. MPC’s contact details are available online: www.mpconsulting.co.za/contact-us Sincerely, Gert Steyn CEO, Health and Medical Publishing Group (HMPG)

CPD QUESTIONNAIRE

May 2014 True (A) or false (B): Regarding the Global Forum for Bioethics in Research: 1. Placebo-controlled trials conducted in the developing world in the 1990s were criticised as unethical for providing participants with less than the global best standard of care. 2. Ethics are rules or standards governing the conduct of a person or members of a profession. Regarding students’ disclosure of their academic status to patients: 3. The Health Professions Council of South Africa (HPCSA) does not have a codified set of ethical rules of conduct for students who interact with patients for educational purposes. 4. In terms of the prudent doctor standard, material risk is what a reasonable person in the patient’s position will consider significant. 5. Information to be given to the patient during the informed consent process includes the costs associated with management. 6. The right to inherent dignity does not pertain to autonomy and self-determination in the healthcare context. Regarding language barriers to informed consent in telemedicine: 7. The Constitution of South Africa grants official but unequal status to 11 different languages, and not many South African citizens speak an indigenous language. 8. Telemedicine enhances the level of care to economically and geographically compromised patients, and does not pose a challenge in safeguarding patients’ rights. 9. The World Health Assembly Resolution of 2005 does not address specific ethical issues related to telemedicine. Regarding the role of research ethics committees in health research: 10. In the past decade, the number of clinical trials being conducted in developing countries has increased tremendously.

11. P opulations in which literacy is low can be exploited into allow ing themselves to participate in clinical trials without fully understanding the risks involved. Regarding the reporting of sexual offences involving child patients: 12. In South Africa, a child is able to legally engage in sexual activity from the age of 10. 13. The Sexual Offences Act makes it an offence for anyone to engage in sexual conduct with adolescents (children aged 12 - 15). 14. The Sexual Offences Act obligates everyone, including health prov iders, to report incidents of sexual behaviour involving adolescents to the police. 15. It is not an offence for a 16- or 17-year-old to engage in sexual activity (including sexual intercourse) with a child between the ages of 12 and 15. Regarding ethical issues in public health promotion: 16. Health promotion moves beyond a focus on individual behaviour towards a wide range of social and environmental interventions. 17. Direct instrumental power is not a strategy used in health prom otion to try to influence individuals to change their behaviour. Regarding surrogacy in South Africa: 18. South African law allows those seeking to arrange a surrogate motherhood agreement to create a child that will not be genetically related to at least one of them. 19. A consequentialist argument for a certain law is a moral rationale according to which the long-term outcomes for society with the law would be better than without it. 20. The word‘ubuntu’means humanness or human excellence, i.e. attitudes and behaviour that are morally upright and to be pursued in life.

AAmaximum maximumof of35CEUs CEUswill willbe beawarded awardedper percorrectly correctlycompleted completedtest. test.

Effective in 2014, the CPD programme for SAJBL will be administered by Medical Practice Consulting: CPD questionnaires must be completed online at www.mpconsulting.co.za After submission you can check the answers and print your certificate. Questions may be answered up to 6 months after publication of each issue. Accreditation number: MDB001/019/01/2014 (Ethics)

May 2014, Vol. 7, No. 1 SAJBL