Creating and enhancing TRUSTworthy responsible and equitable partnerships in international research eNewsletter 2016, Issue 2
Why animals must matter globally. What TRUST can do for animals in research. Can animals trust humans? Prof. David Morton “The question is not, can they reason? Nor can they talk? But can they suffer?” Jeremy Bentham (1724-1832) “He who is cruel to animals becomes hard also in his dealings with men.” Immanuel Kant (1724-1804) People’s concern with sentient animals commonly stems from their close relationship with them as companions, when farmed for food and clothing, or seeing them in the wild, on TV, or even in zoos. In other instances animals may be seen as
objects of aesthetic appreciation, as athletes, as pests, or as scientific tools. In whatever way they are viewed, and wherever they are in the world, it is difficult to deny, in the light of current scientific evidence, that they have similar, if not identical feelings to ourselves in their abilities to suffer, reason, and communicate. The subtleties are in understanding how they feel emotionally, and how they carry out these mental challenges in environments that are alien to our human experiences. Continued on page 06
David Morton Professor Emeritus of Biomedical Science and Ethics at the University of Birmingham, UK
The Importance of Equitable Research Relationships in
Horizon 2020 Dorian Karatzas
International cooperation in research is fundamental in order to tackle current scientific, societal and environmental challenges. Promoting such cooperation is a key priority of Horizon 2020, which is currently the world's largest multinational funding programme for research and innovation. Launched by the European Union, Horizon 2020 aims to create smart, sustainable and inclusive growth and jobs, and places particular emphasis on excellent science, industrial leadership and tackling societal challenges [1].
promote innovation and access to scientific knowledge and technology is encouraged by Horizon 2020, which is open to participants from across the world. International cooperation in research is of particular value when it comes to global issues such as infectious diseases, food security and the protection of the environment [2]. Given that, in principle, these problems affect low and middle income countries (LMICs) most severely, cooperation between high income countries and LMICs and the adoption of a common approach in research is particularly important [2].
International cooperation in research as a means to Continued on page 02
The TRUST project
Dorian Karatzas Head of the Ethics Sector, European Commission, DG Research & Innovation
The TRUST Project is an EU funded project which aims to catalyse a global collaborative effort to improve adherence to high ethical standards around the world. In an interdisciplinary collaboration between multi-level ethics bodies, policy advisors, policy makers, civil society organisations, funding organisations, industry, and academic scholars from a range of disciplines, this project combines long-standing, highly respected efforts to build international governance structures with new exciting network opportunities in Europe, India, Sub-Saharan Africa, China and Russia. Read more at www.trust-project.eu/
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eNewsletter 2016, Issue 2
The Importance of Equitable Research Relationships in
Horizon 2020 Dorian Karatzas continued from Page 1
Research standards may vary widely across countries. Taking into account that LMICs may suffer from higher rates of poverty, illiteracy and disease, as well as a lack of infrastructure, special attention is required in order to avoid exploitation of research participants and natural resources and ensure equitable distribution of the benefits of research [3]. In order to address potential ethical issues arising from research taking place in or in cooperation with LMICs, Horizon 2020 sets specific ethical standards: First of all, research projects funded by this programme must comply with the relevant European and national legislation as well as international standards. Secondly, such projects must be beneficial for all stakeholders, especially when it comes to the research participants and their communities. Hence, if research is undertaken in an LMIC, a clear match with local research needs is necessary. Thirdly, local communities should receive adequate compensation in cases where local resources are used. In addition, specific emphasis is placed on the need to obtain genuine informed consent from vulnerable populations taking part in research. Such informed consent processes should take into account potential cultural differences, economic and linguistic barriers and levels of education [3]. In this way, Horizon 2020 aims to promote both equity and benefit sharing, and to address basic needs such as education, training, institutional capacity building, and transfer of knowledge and technology. A particularly important contribution towards the realisation of this objective is provided by TRUST, a global collaborative project that aims to improve adherence to high ethical standards in research across the world.
Funded through Horizon 2020, TRUST is an interdisciplinary collaboration among multi-level ethics bodies, policy advisors/makers, civil society organisations, funding organisations, industry, and academic scholars from various disciplines [4,5]. By developing a global code of conduct for funders, a fair research contracting on-line tool, and a compliance and ethics follow-up tool which takes limited resources into account, TRUST provides a major contribution to equity in international research by promoting high ethical standards globally. As part of the funding agency for TRUST, the Ethics Unit wishes TRUST every success.
Isidoros (Dorian) Karatzas is the Head of the Ethics Sector, European Commission, DG Research & Innovation. He is a biochemist by training and set up the first European system on ethics follow-up and audit.
TRUST has a new video! In our second documentary Protecting San Indigenous Knowledge – From A Research Contract To A San Code Of Ethics San members from different communities talk about their experience with researchers in the past and explain the necessity for a San Code of Ethics as well as the need for a certain procedure to be followed by every researcher in order to avoid ‘ethics dumping’ and protect indigenous knowledge. The video is available on the TRUST website and the following link TRUST Project-YouTube.
We will have a third TRUST video coming in 2017!
Notes [1]https://ec.europa.eu/programmes/ho rizon2020/en/what-horizon-2020 [2]https://www.oecd.org/sti/scitech/47737209.pdf [3]http://ec.europa.eu/research/participa nts/data/ref/fp7/89888/ethics-forresearchers_en.pdf [4]http://trust-project.eu/wpcontent/uploads/2016/03/TRUST664771-Paradigmatic-Case-Studies-WP1Final.pdf [5]http://trust-project.eu/theproject/about/
TRUST on Twitter
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TRUST YouTube channel
TRUST Brochure out now Aims, vision and the consortium details all in one: the TRUST brochure is now.
Follow us on Twitter: @TRUST_Project is tweeting about the project news, events and outcomes, while keeping up to date with actors and projects around the world addressing the global challenges of our times.
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eNewsletter 2016, Issue 2
TRUST MEETINGS TRUST in Kimberley
On November 15-16, 2016, SASI organised the third workshop in Kimberley with 24 participants. This time the participating San representatives finalised the San Code of Research Ethics that was drafted during the previous workshop.
Hennie Swart, SASI Director
Based on the principles Respect, Honesty, Justice & Fairness, Care, and Process, the San compiled an expanded Code of Ethics, identifying the most important ethical principles. The workshop report will soon be available on our website and the San Code of Research Ethics will be launched at the next TRUST meeting in February after further consultation with TRUST partners.
!Xun delegate Martha Mangumbu
Coming up…
Launch event: San Code of Research Ethics
On March 02, 2017, TRUST is planning a media event at Kirstenbosch Botanical Gardens in Cape Town to launch the San Code of Research Ethics. More information about this important event will be available in the new year. SASI workshop, Roger Chennells
‡Khomani delegate Petrus Vaalbooi Group work
SASI workshop
TRUST on National South African News (SABC) On November 15, 2016, the SABC News (South African Broadcasting Corporation) reported on the 3rd Kimberley Workshop to finalise the San Code of Research Ethics. After consent was given by the attending delegates, the reporters interviewed Petrus Vaalbooi (‡Khomani community member), Hennie Swart (director SASI) and Leana Snyders (South African San Council) to report about the San Communities’ past experience of exploitation and the necessity of a San Code of Research Ethics, achieved through the TRUST project. The full article is available here. 3
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eNewsletter 2016, Issue 2
Vulnerable Populations in North-South Collaborative Research: TRUST in Nairobi. On May 23-24 2016, representatives of the thirteen TRUST partners together with project advisors met with representatives from Kenyan ethics committees, as well peer educators for sex workers in Nairobi. This was a unique opportunity to receive feedback directly from two of the most vulnerable and frequently researched populations in low and middle-income countries; sex workers and indigenous peoples. The concerns shared by the two groups were; consideration of cultural sensitivity, community engagement, power imbalances, and particularly for the sex workers: stigma and lack of organizational structures. Furthermore, the particular case of vulnerable populations in emergency research was presented by Action against Hunger. Representatives from Kenyan ethics committees shared the challenges and concerns from their points of view when approving North-South collaborations. The overall considerations that apply to all research projects in LMICs were pointed out, and the most pressing concerns were discussed. It was highlighted that research has to be needs driven, that weak systems should not be taken advantage of, and that language provisions have to be made.
Prof. Elizabeth Bukusi
Dr Nandini Kumar
For a full workshop report, please see: http://trust-project.eu/category/meetings/ TRUST partner EDCTP also shared the major concerns from a funder’s point of view. Please visit our website for the full report. TRUST aims to address gaps and missing links in research ethics systems by the development and implementation of appropriate tools. The feedback received from all participants will feed into one of the main deliverables of the TRUST project: A Global Code of Conduct. Dr Joshua Kimani, Dr Vasantha Muthuswamy, Prof. Doris Schroeder,
Prof. Pamela Andanda, Prof Anastasia Guantai, Dr Lilian Omutoko 4
Andries Steenkamp, Catherine Njoki
Prof. Fatima Alvarez� Castillo, Dr Vasantha Muthuswamy
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eNewsletter 2016, Issue 2
National and International Compliance Tools - A TRUST Report The existence of varying ethics review practices across and between countries can lead to “ethics dumping”, the purposeful exploitation of third country research participants/resources, as well as exploitation based on insufficient ethics awareness or oversight. As a first step towards the Compliance and Ethics Follow‐ up Tool, TRUST undertook a mapping exercise to provide a resource of existing national and international compliance tools. This report lists the diverse legal instruments and ethics guidelines that are relevant to NorthSouth collaboration from the perspective of the Horizon 2020 ethics review. Furthermore, it contains an overview of self-regulatory mechanisms operated by 13 pharmaceutical companies, as well as an overview of existing compliance tools.Read the full report available on the TRUST website.
Ethics Dumping
TRUST’s Handbook on Paradigmatic Case Studies available now!
Publications Books
Drue H. Barrett et. al (2016): Public Health Ethics Analysis, Volume 3. Springer Open. [Open Access here] Parrington, John (2016) : Redesigning Life: How Genome Editing Will Transform the World. OUP Oxford. [Available here]
Articles
Kengne-Ouafo, Jonas et. al. (2015): Understanding of research, genetics and genetic research in a rapid ethical assessment in north west Cameroon. Oxford Journals, International Health, Volume 8, Issue 3, May 2016. [Open Access here] Cheah, Phaik Yeong et. al. (2016): Development of drugs for severe malaria in children. Oxford Journals, International Health, Volume 8, Issue 5, September 2016. [Open Access here] Caplan, Arthur L. & Ray, Amrit (2016): The Ethical Challenges of Compassionate Use. JAMA March 2016, Vol. 315, No. 10. [Available here]
We at TRUST are very proud to present our completed case study handbook listing “ethics dumping” cases for all sections of the Horizon 2020 ethics review table. The report involves authors from 12 countries and points to ongoing exploitation problems in North-South collaborations. The case studies were sourced from TRUST partner organisations and through a bottom-up case study competition which was launched to receive additional cases from low and middle-income countries. The authors present and analyse their cases, identifying risks of exploitation and lessons learned in order to individually draw recommendations to avoid ethics dumping.
Ravinetto R, Tinto H, Diro E, et al. (2016): It is time to revise the international Good Clinical Practices guidelines: recommendations from non- commercial North–South collaborative trials. BMJ Global Health 2016;1: e000122. doi:10.1136/ bmjgh-2016-000122. [Open Access here] Clayton, Janine Austin & Tannenbaum, Cara (2016): Reporting Sex, Gender or both in Clinical Research. JAMA November 2016, Vol. 316, No. 18. [Available here]
The whole report is available on the TRUST Website.
Reports
Very sad news: Andries Steenkamp passed away
Exeter Stakeholders Meeting Report: Ethical Issues and Best Practice in Clinically Based Genomic Research. [Open Access here]
The TRUST consortium is exceptionally sad to report the news of Andries Steenkamp’s death. Andries was only in his fifties and was heavily involved in TRUST, representing the South African San community. We will try to do our best to do justice to Andries’ wishes, as expressed in our video. “It is very important for the San to be involved in TRUST. The San have been researched a lot and that has made them careful and nervous. We want to protect ourselves, but we also want to work with people. On the TRUST project we can learn together.”
SciDevNet published a page remembering Andries’ last contributions to TRUST: http://www.scidev.net/global/ethics/multimedia/ethical-research-code-san-leader.html 5
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eNewsletter 2016, Issue 2
TRUST and global fairness for animals in research
Why animals must matter globally What TRUST can do for animals in research. Can animals trust humans? Professor David Morton continued from Page 1 We use animals in research to gain knowledge that has benefited humans to varying degrees. In the 21st century, we question more how we should use them, and what outcomes are considered adequate to justify the intensity and duration of any pain and distress we cause to them. It is important to remember that to an animal it does not matter where he or she resides in the world, or the purpose for which it is being used – the animal cannot appreciate the value that humans place on the consequences of using them. Animals can only know the pain, discomfort and distress they experience throughout their lives in the cages or environments in which they are confined 24 hours a day until they die. Sometimes their husbandry may cause more cumulative suffering than the experimental protocols. The attitude of their human keepers to their care is key to their treatment and can increase or decrease animals’ feelings of vulnerability. Whether this is true of all vertebrates covered by legislation is contestable, but it almost certainly applies to all mammals and birds, and to the higher primates in particular. When animals that are commonly seen as pests are used, (“It does not matter … it is only a rat/mouse/baboon/stray dog, etc”) a worrying attitude can develop, which is the more worrying as we find increasing links between human and animal abuses.
TRUST is trying to ensure that animals are considered equally, no matter where they live or are kept for research, and that they all receive equal care and consideration appropriate to their mental and physical needs and wants. If that means that some research will not be carried out, then unless it is of outstanding importance to humans, perhaps it should not be undertaken. Consequently, experimental procedures that cause intense adverse effects on animals that endure should not be condoned or undertaken. This is particularly important when, and if, research is carried out in low and middle income countries that would not be permitted ‘at home’.
The Council for International Organizations of Medical Sciences (CIOMS)[1] have drawn up some international considerations for the global use of animals in research: These principles, along with the Three Rs proposed by Russell and Burch[2], should be used by the international scientific community to guide the responsible use of vertebrate (and certain invertebrate) animals in scientific and/or
educational activities. They are a good starting point but could and will be further refined with time as non-animal alternatives to the use of animals in research are developed and internationally accepted. Meanwhile high income countries have an ethical responsibility to lead the way using some of the concepts embodied in “One Health”[3] which emphasises the problems, diseases and solutions common to both humans and animals. DBM November 2016 Notes [1]http://www.cioms.ch/images/stories/CI OMS/IGP2012.pdf [2]http://ec.europa.eu/environment/chemica ls/lab_animals/3r/alternative_en.htm [3]“One Health recognizes that the health of people is connected to the health of animals and the environment. The goal of One Health is to encourage the collaborative efforts of multiple disciplines-working locally, nationally, and globally-to achieve the best health for people, animals, and our environment. A One Health approach is important because 6 out of every 10 infectious diseases in humans are spread from animals.” https://www.cdc.gov/onehealth/.
David Morton is Professor Emeritus of Biomedical Science and Ethics at the University of Birmingham, UK. He is a veterinary surgeon whose research interests concern the recognition, assessment and alleviation of pain and distress in animals. He was (retired July 2012) a member of the EU’s (EFSA (FDA equivalent)) scientific panel on animal health and animal welfare. He was a government adviser for the UK’s legislation controlling the use of animals in research (Animals (Scientific Procedures) Act 1986). He has sat on working groups at the Nuffield Institute in the UK, at the Hastings Centre and the Kennedy Institute in the USA, reporting on animal experimentation. He was the prime author of the OECD’s Guidance Document on the Recognition, Assessment, and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. He received the Commander of the Most Excellent Order of the British Empire (CBE) on Animal Welfare and Animal Ethics. David Morton advises TRUST. 6
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eNewsletter 2016, Issue 2
News from around the world Opening up clinical data on new medicines As of 20 October 2016, the European Medicines Agency (EMA) gives open access to clinical reports for new medicines for human use authorized in the European Union (EU). Independent experts to advise Commission on impact of EU research funding The European Commission will set up a High Level Group of experts who will advise on how to maximize the impact of the EU's investment into research and innovation. Experimental treatments aim to prevent brain damage in babies. Neuroscientists and physicians have embarked on what they hope will be a revolution in treatments to prevent brain damage in newborn babies. Researchers develop novel woundhealing technology A Washington State University research team has successfully used a mild electric current to take on and beat drug-resistant
bacterial infections, a technology that may eventually be used to treat chronic wound infections. Request for Proposals – Grand Challenges Africa – Innovation Seed Grants – Round 1 The African Academy of Sciences - Alliance for Accelerating Excellence in Science in Africa (AAS-AESA) is launching two new Grand Challenges. Call Release Date: 17. November 2016 Call Closure Date: 17. February 2017 Global Health Bioethics, Research Ethics & Review: Course Provider A list of interesting free research ethics training courses. Almost Half of Medical Trials Are Never Published – And It’s Hurting Patients A new website has found that 8.7 million patients in the last decade have taken part in clinical trials that have never seen the light of day – and says this failure to publish stops doctors making good decisions about medicines.
UPCOMING EVENTS Barcelona, Spain, 26–27 May 2017 ICSMRE: 19th International Conference on Scientific Method and Research Ethics Oxford, UK, 29 June – 01 July 2017 2017 International Health Conference St Hugh’s College Oxford Farmington, USA, 5-7 June 2017 The 4th ELSI Congress: Genomics and Society: Expanding the ELSI Universe Deerfield, USA, 22-24 June 2017 Genetic & Reproductive TechnologiesThe Center for Bioethics & Human Dignity’s 24th Annual Conference Singapore, 25 -27 May 2017 13th International Conference on Clinical Ethics Consultation (ICCEC) 2017 Atlanta, USA, 8-10 June 2017 2017 Health Law Professors Conference
TRUST PROJECT CO-ORDINATOR Centre for Professional Ethics, University of Central Lancashire, UCLan PARTNERS Partners for Health and Development in Africa, PHDA ACF, Action Contre la Faim, Council on Health Research for Development, COHRED UCT, University of Cape Town, Department of Environmental and Forum for Ethics Review Committees in India, FERCI Geographical Sciences United Nations Educational, Scientific and Cultural Organization, SIGNOSIS, Signosis SPRL UNESCO FGVA, Stiftung Globale Werte Allianz The South African San Institute Trust, SASI EDCTP, European & Developing Countries Clinical Trials Partnership Institut National de la Sante et de la Recherche Medicale, INSERM WITS, University of the Witwatersrand Johannesburg, School of Law
TRUST is funded by the H2020 Programme of the European Commission, Programme Science with and for Society, Developing Governance For The Advancement Of Responsible Research And Innovation (GARRI 2014-2015). Coordination and Support Action/CSA. Grant Agreement n 664771