Bioethics Caribe Newsletter - February 2022 by bioethicscaribebsec

Secretariat: St George’s University (SGU) Grenada. www.bioethicscaribe.com

Newsletter of the Bioethics Society of the English-Speaking Caribbean (BSEC) February 2022 Issue

INSIDE THIS ISSUE Editor’s Note………….. ………………………………………………….2 President’s Message……………………………..........................3 Members’ Articles………………………………………………………4-35 Justice in Covering Healthcare Costs Allegedly Brought About by People's Own Earlier Health-Adverse Behavior: Suzanne Andrews ....................................................................4 Ethical Considerations During a Pandemic: Derrick Aarons……….…………………………….9 Ethical Ambivalence On The Use Of Placebo-Controlled Versus Standard Therapy For Trials In Low Middle-Income Countries (Lmic): Shereen Cox……………………..15 Essay in Clinical Ethics: "Ethical Issues in the care of Covid-19 infected patients": Sherry Ephraim-Le Compte ……………………………………………………………………..…26 Report On The Work Of The Central And South America Bioethics Network Of Unesco: Derrick Aarons…………………………………………….………….………………..32 Advancing Research Ethics in the Caribbean Region: Kareem Coomansingh………………….35

Members’ Accomplishments………………………………………...37-41

EDITOR’S NOTE In spite of the challenges presented by COVID-19 during the year the mid-year Newsletter was successfully published in June .However the December issue was delayed due to late submissions despite reminders of the deadline, and will now be issued at the end of February. This may have been to COVID_19 fatigue or time-off to celebrate during the Holiday Season. Or it may have been that the date for submission of articles coincided with the date of the highly successful Webinar which was held at the end of November (See President’s message).

G. Sirju-Charran Editor

I urge you to read these articles and more importantly to click on the link provided to share your views with all members so that not only do we begin a conversation with the authors and among ourselves, but we would all gain further insights on these issues.

Nevertheless, four insightful articles were received. Susan Andrews’ piece compares the coverage of healthcare costs from the ideologies of Libertarians and Libertarian-Egalitarians with reference to Trinidad and Tobago, The United States of America, Norway and Cuba. Derrick Aarons explores the construct of “Ethics Consideration” and identifies a number of ethical guiding principles that can be applied in managing a pandemic. Sherry Ephraim in her extensive discussion of ethical issues in the care of COVID-19 patients concludes with a recommendation for the “Jonsen’s four-approach framework as an objective and structured training tool to help health professionals navigate their way in ethical deliberations”. Shereen Cox undertakes an expansive review of the ethical ambivalence presented in the use of placebos in standard therapy clinical trials, using the AZT trials conducted in countries belonging to the Lower- and Middle-Class Income. You are urged to post your thoughts and comments on these papers using the link provided, so that we can have robust discussions on the ideas presented in each. Also included in this issue is a compilation of several excellent reviews of Derrick Aarons book entitled: “Vital Communications in Medicine.” This publication is reasonably priced and is very timely given the significance the pandemic revealed, of the need for accurate and timely communication.

Derrick has also submitted a Report on the Bioethics Network for Latin America and the Caribbean (Redbioetica UNESCO) which was founded in 2003 and to which Dr. Aarons has been making a valuable contribution since 2009. Of particular note is the further strengthening of ties with BSEC through the election by 100% of the vote in Nov. 2021, of President Shereen Cox to serve on the Executive Council of RedBioetica. The programme coordinator of CREEi, Kareem Coomansingh has submitted an article containing information on the programme and inviting application for entry into the 3rd cohort, due on February 23rd, 2022.

Accomplishments of BSEC Members is a recurring feature in the newsletter and although this is included in the call for papers, only one member made an appropriate submission. Happy Reading everyone and let this New Year resolution be: To contribute individually and collectively, to make 2022 a much better year than the past two years.

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PRESIDENT’S MESSAGE

Shereen Dawkins Cox JP, MA, Bpharm, Dip Pharm President, BSEC

Happy New Year to the Executive and members of the Bioethics Society of the English-Speaking Caribbean. It is 2022, and we are still discussing the end of the COVID-19 pandemic. The discussions have changed from the inequity of vaccine access between high and low-income countries to how many boosters will make a real difference. Vaccine passports are no longer a debate but have been enforced in many countries. In the region, countries' leaders are adamant that we need to improve the percentage of vaccinated compared to unvaccinated. As such, discussions on mandatory vaccinations continue. The world has become so COVIDfocused that we can rarely turn on the news or go on our favourite social media pages without receiving information on COVID. The Executive of BSEC decided to join in the conversation but differently. We focused on our health care workers and policymakers across the region. Those on the frontline. Those who have to face the challenges daily that we as academicians can only debate and publish articles. They know the stress of deciding who should receive treatment and who should be sent home. This was the motivation for the theme of our annual forum: Moral Distress on the frontline: COVID-19 in the Caribbean. This was held virtually on November 28, 2021. We had a historical turnout of over 100 doctors, pharmacists, nurses, psychologists, and ethicists. It was a very moving seminar. The Chief Medical Officer of St. Lucia, Dr Belmar George, reflected on how difficult it was for her to make decisions to keep schools closed on realizing that school was a safe haven for many children; protecting them from unwanted pregnancies, crime, and providing many with a daily meal. The social impact of lockdowns was very real to her. Yet, she had to create a balance between public health and social needs as a policymaker. Dr. Jennifer Solomon of Grenada shared a story of a nurse who felt remorse for not giving the standard of care that she knows should be given to her patients, simply because of the limited resources available. She shared pictures of the faces of nurses who had the imprint of the facemasks that they had to wear all the time while delivering care. A pharmacist from Jamaica shared her struggle with losing a patient because she hesitated to recommend a product off-label that she thought might have made a difference. The moral residue of that situation left her with sleepless nights. Moral distress and moral residue are challenges frontline workers have to overcome. Executive member and psychologist Dr. Mike Campbell of Barbados gave some handy tips on managing these challenges to avoid depression and burnout. He emphasized relaxation techniques, religious/spiritual practices, adequate sleep, regular exercise, healthy eating, allowing emotional expression regularly, taking breaks, counseling, and selfcare practices. As we journey into 2022, let us take the tips from this webinar and practice more self -care. Take a break, breathe deeply, laugh a little or a lot, and rest. Going forward at the end of each day, reflect on the day, take a moment to inhale and exhale, do it now, and appreciate that breath. COVID-19 is one part of our lives. We cannot allow it to consume us to forget the beautiful things still happening around us. I wish you a year of self-care. Shereen Dawkins Cox President

MEMBERS’ ARTICLES Justice in Covering Healthcare Costs Allegedly Brought About by People's Own Earlier Health-Adverse Behavior: Libertarians vs. Liberal-Egalitarians By: Suzanne Andrews, MEng., MSc. In a 2020 University of Oxford Study which evaluated how nations performed as they emerged

out of COVID-19 lockdowns Trinidad and Tobago (T&T), a small island developing nation ranked number one.1 On the contrary, the very large developed state, the United States (US), Suzanne Andrews MEng., MSc. Member of the Executive Council of RedBioetica UNESCO

ranked number 84 in this same study of over 150 countries. 2 The US performed dismally in this study because, unlike T&T, the US during those earlier months of the COVID-19 pandemic was led by an anti-lockdown libertarian-inclined president.3 In fact, the Stanford Encyclopedia of Philosophy describes libertarians as, “strongly valuing individual freedom and justifying strong protections for individual freedom.”4 Yet, apart from the pandemic, and in the realm of healthcare overall, the US most recently ranked last, in which only the high-income countries of the world and their overall health systems were considered.5 US News (2021) wrote that, “The US is the

worst-performing nation for healthcare among a group of 11 high-income countries, according to a new study by the health policy think tank, The Commonwealth Fund .”6 With Norway taking the top spot in this study, it is therefore not surprising that a pair of Norwegian authors, Cappelen and Norheim (2005) had hoped to offer the US a helping hand, about two decades ago, in terms of how to devise a universal healthcare taxation system that could assist the US in remedying its chronic and constant poor performance in world health rankings, as well as reduce some of the US’s healthcare costs. Given the above multi-country view of healthcare systems, from Trinidad and Tobago, the United States and Norway, Kawachi (2005) who is

originally from another top health performing country, New Zealand, had fervently hoped to assist the US in the area of universal healthcare coverage policy, decades ago, as well, but also without success. Regrettably, therefore, the same US News (2021) notes that a key reason why the US will never have universal health care coverage is because Americans, and American conservatives, in particular, have a strong belief in libertarianism and the idea that the government should play a limited role in society.7 Since universal healthcare coverage clashes with the libertarian belief in individualism and limited government, it is also not surprising that universal healthcare coverage has never been enacted in the United States even as it has been enacted elsewhere around the world.8 Therefore, on the matter of “Justice in Covering Healthcare Costs Allegedly Brought About by (American) People's Own Earlier Health-Adverse Behavior”, this paper considers this decades-old Norwegian-authored liberal-egalitarian offer to American libertarian-designed healthcare policymakers. It explores what arguments can be made both for and against the liberalegalitarian and the libertarian positions, respectively. It then aspires to find a middle ground between these two positions. Finally, this paper points out possible unaddressed issues, and concludes with a rational overall assessment

of the matter. Indeed, wanton freedom in choice

of lifestyle, especially in the earlier stages of American life, eventually has its health consequences and healthcare costs later in life.

5 Justice in Covering Healthcare …..cont’d As such, two key age-old questions that face American healthcare policymakers are: 1) who ought to pay for such consequences, and 2) if all choices made by Americans, by default, are freely made choices, when Americans get sick, in light of these freely made choices, how should the cost of treatment for such choice-related illnesses be distributed? This is where the issue of the healthcare costs of treating preventable diseases which are caused by American individual freedoms, such as the free choice to smoke, to drink and to have unsafe sex, becomes a significant bioethical issue, specifically in the realm of distributive justice, with which libertarians are most concerned. 9 This means that on the one hand, if “libertarians affirm their right to personal responsibility”10, then according to the work of Cappelen and Norheim (2005), libertarians would be worried that if universal healthcare coverage is guaranteed in the United States (US), then the US government will “a) be super -intrusive into people’s lives, and b) burden people unfairly with the costs of other people’s [freely made choices].11 On the other hand, Kawachi (2005) notes that, “as staunch as libertarians may be about personal responsibility, even they can concede that in the case of smoking, since 80% of the adult smokers in the US were deliberately targeted to smoke by tobacco companies, since they were under-age minors, these adults should not be held personally responsible for their tobacco-derived

health illnesses later on in their lives.”12 Instead, that responsibility ought to be placed on tobacco companies.13 How tobacco companies can play a role in healthcare policy that is designed by a liberal-egalitarian approach forms the basis of the proposal put forward by Cappelen and Norheim (2005). In their proposal, they embrace the principle of personal responsibility, just as libertarians would. They then offer that individuals who “make the same choices should also have the same outcomes” – what they call the principle of equalization.14 In the context of healthcare, “the principle of equalization implies that all individuals who make the same choices should be treated as if they were identical with respect to all factors outside their own control – that is, as if they had the same disposition to become sick and faced the same health risks.”15 Cappelen and Norheim (2005) envision both libertarians and liberal-egalitarians finding a middle ground where the equality of individuals is concerned. Where they differ is that the libertarian would be more concerned about “how the costs of treating equal individuals would be calculated”.16 Using the case of tobacco again, Cappelen and Norheim (2005) ask libertarians to “consider the scenario whereby a particular disease is proportionally related to the consumption of tobacco, and that tobacco can be taxed.”17 According to liberal-egalitarians, “in the absence of an efficient insurance market, tobacco would be taxed in order to finance the costs of treatment rather than to require that patients pay for their own treatment. A tax policy could be to set the per-unit taxes on tobacco so that the total

tax revenues are equal to the added cost of treatment associated with smoking. Another implication of the theory is that all smokers should pay the same tax rate independent of their genetic disposition and the expected cost of their treatment.”18 By following these policies, the libertarian would not have to worry about the state being super-intrusive in people’s lives, because the tax policies will not give the state (and physicians) any controlling role which might easily intrude on patients’ privacy.

6 Justice in Covering Healthcare …..cont’d Also, libertarians need not worry that they will be unfairly burdened with the costs of other peoples’ choices. This is because “everyone who becomes sick is treated and taxes on tobacco will not restrict the set of health- related opportunities.”19 Unaddressed issues, though, of the liberal-egalitarian approach, include how would it be determined which factors are under a person’s control, and which are not? Perhaps the use of modern genetic sequencing as well as the increased use of mathematical, computer and statistical methods could help in this regard.20 Other

questions include, who should be taxed – a smoker or a sex-worker? Finally, in a libertarian society, is it right or moral to judge individuals’ free choices? Overall, I believe that in certain circumstances beyond one’s control, individuals in a society should feel free to turn to the government for help, in their individual circumstances, and in circumstances that involve their communities. What in the end, though, is the difference between a country that provides universal health care coverage to its citizens, and one that offers state-controlled healthcare as is the case in Cuba? Many of the Caribbean Community (CARICOM) nation-states, like Trinidad and Tobago, turned to its neighboring island of Cuba,

during the early months of the COVID-19 pandemic.21, 22 In Cuba, health care is considered a human right for all citizens; health care is also a national priority. 23 Admirably, too, healthcare is also an international priority for Cuba. In fact, when COVID-19 started to get out of hand, not only in CARICOM nation-states, but also in European Union countries (including with the passengers of a British COVID-19 hit cruise ship, prior to Brexit)24, 25, as well as in several countries in Africa, South America, Latin America and the Middle East,26-28 these countries also turned to Cuba for COVID-19 help. In fact, the intellectual Noam Chomsky has said that, “[Cuba] is the only country to have shown genuine internationalism during the [COVID-19] crisis.”29

Admittedly, Cuba cannot be said to fall within the category of countries that values and protects individual freedoms. This means that Cuba can neither be described as a libertarian nor as a liberal -egalitarian society. Nevertheless, top health-performing countries such as Norway and New Zealand can. In fact, perhaps more than in the area of universal healthcare coverage, the secret to a top-performing country in all of its sectors is the value and protection of universal human rights? According to US News (2021), the top performing country in that area is Canada, even if only by perception.30

References: 1.

Hunte, S., Pierre, K., St. Rose, R. and Simeon, D. (2020). Health Systems’ Resilience: COVID -19 Response in Trinidad and Tobago. Am J Trop Med Hyg. 103(2):590-592. Retrieved on December

19,

#__ffn_sectitle. 2. Ibid

2021,

from

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7410471/

7 Justice in Covering Healthcare …references..cont’d 3. Vieira, H. (2017). The contradiction of classical liberalism and libertarianism. London School of Economics Blog Post. Retrieved on December 19, 2021 from https://blogs.lse.ac.uk/ businessreview/2017/02/01/the-contradiction-of-classical-liberalism-and-libertarianism/. 4. Stanford Encyclopedia of Philosophy. (2021). Libertarianism. Retrieved on December 19, 2021, from https://plato.stanford.edu/entries/libertarianism/.

5. US News. (2021). US Ranks Last Among 11 Wealthy Nations for Healthcare, Study Says. Retrieved on December 19, 2021 from https://www.usnews.com/news/best-countries/articles/2021 -08-09/us-ranks-last-among-11-wealthy-nations-for-health-care-study-says. 6. Ibid. 7.US News. (2021). 3 Reasons the U.S. Doesn’t Have Universal Health Coverage. Retrieved on December 19, 2021 from https://www.usnews.com/news/national-news/articles/2016-10-26/3reasons-the-us-doesnt-have-universal-health-coverage. 8. Ibid. 9. Stanford Encyclopedia of Philosophy. 10. Preiss, J. (2017). Libertarianism personal responsibility: On the ethics, practice, and American politics of personal responsibility. Philosophy and Social Criticism 43(6):621-645. Retrieved on December 19, 2021, from https://philpapers.org/rec/PRELPR-2. 11. Dr. Arthur Kuflik's Final Paper Question, Columbia University Master’s Program in Bioethics. Retrieved on December 19, 2021. 12. Kawachi, I. (2005). Why the United States is not Number One in Health. Healthy, Wealthy and Fair: Healthcare and the Good Society, edited by Morone and Jacobs, 222-230. 13. Ibid. 14. Cappelen, A. and Norheim, O. (2005). Responsibility in health care: a liberal-egalitarian approach. J Med Ethics. 31:476-480. 15.. Ibid.

16. Ibid. 17. Ibid. 18. Ibid. 19. Ibid.

8 References cont’d….. 20. Ibid. 21. The Global Americans. (2020). A Cuban lifeline for CARICOM. Retrieved on January 8, 2022, from https://theglobalamericans.org/2020/05/a-cuban-lifeline-to-caricom/. 22. Hunte et al. (2020). 23. Iatridis, D. (1990). Cuba’s healthcare policy, prevention and active community participation. Soc Work. Jan 35(1), 29-35. Retrieved on December 19, 2021, from https:// pubmed.ncbi.nlm.nih.gov/2315760/. 24. Escobedo, A., Auza-Santiváñez, C., Rumbaut, R. et al. (2021). Cuba: Solidarity, Ebola and COVID-19. BMJ Paediatr Open. 5(1):e001089. Retrieved on January 8, 2022, from https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC8136810/. 25. Reuters. (2020). Passengers of British coronavirus-hit cruise ship evacuate in Cuba. Retrieved on January 8, 2022, from https://www.reuters.com/article/us-health-coronavirus-cubaidUSKBN215130.

26. Voice of America News. (2020). Cuban Doctors Arrive to Help South Africa Fight Coronavirus. Retrieved on January 8, 2022 from https://www.voanews.com/a/covid-19pandemic_cuban-doctors-arrive-help-south-africa-fight-coronavirus/6188249.html. 27. The Nation. (2020). Cuba Has Sent 2,000 Doctors and Nurses Overseas to Fight COVID-19. Retrieved on January 8, 2022, from https://www.thenation.com/article/world/cuba-doctorscovid-19/.

28. Ibid.

29. Ibid. 30. US News. (2021). The 10 Countries That Care The Most About Human Rights According to Perception. Retrieved on January 8, 2022 from https://www.usnews.com/news/best-countries/ articles/the-10-countries-that-care-the-most-about-human-rights-according-to-perception.

*About the author: Suzanne Andrews attended the Johns Hopkins Berman Institute of Bioethics for Summer 2021. She is currently pursuing a Master of Science degree in Bioethics at Columbia University.

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Ethical Considerations During a Pandemic Dr. Derrick Aarons Introduction Any consideration of ethical issues that occur during a pandemic must begin with a clear idea of what ‘ethical considerations’ mean. The consideration first begins with the individual, and then

moves on to others affected in the human-to-human interaction or transaction. Dr. Derrick Aarons MB.BS.(UWI); M.Sc. (Bioethics); PhD (McGill) Consultant Bioethicist and Family Physician Member of the Executive Council of RedBioetica UNESCO

The matter thus begins with morality, and what an individual personally believes is right or wrong. Morality reflects the personal value system that we developed during childhood through adolescence into adulthood. Since this exposure and development varies from person to person, as adults – people sometimes do not see ‘eye to eye’ on what they consider to be right or wrong. Therefore, the term used is ‘personal morality.’ This dichotomy in various persons’ perceptions and values has become even more stark during the current pandemic. Once we move outside of our own considerations and individual perspectives, however, the matter of ‘ethics’ kicks in! Ethics is involved once a person begins to interact with other persons. It is the domain of inter-personal interactions. Simply stated – ethics asks the question ‘How should I conduct myself in the presence of others?’ (Aarons, 1996). Ethical principles and guidelines seek to answer that question. Standards are therefore written to inform on how persons should conduct themselves, what they should do, and how they should behave (what is known as public morality). This article looks at some of the ethical principles that become pre-eminent during a pandemic and provides guidance and recommendations to health professionals as well as the lay public that are critical to minimize harm during this crisis.

Infectious Diseases and the matter of ethics Many of the ethical issues raised by infectious diseases are related to their powerful ability to engender fear in individuals and panic in populations (Aarons, 2020). The association of some infectious diseases with high morbidity and mortality rates, the acute onset and rapid course of many infectious diseases, and the communicability of infectious diseases all have undercurrent ethical issues. The individual fear and community panic associated with some infectious diseases often leads to rapid, emotionally driven decision-making about treatment and public health policies that are needed to protect the community. However, some bioethical principles regarding the care of individual patients may sometimes be at odds with some of these decisions and

policies (Aarons, 2020). The ethical approach requires us to consider the infected patient as both a victim with individual rights and needs as well as a potential vector of disease that is of concern to the community. While infected individuals can threaten the health of other individuals and the society as a whole, public health care measures such as surveillance, isolation, and quarantine can infringe on widely accepted basic human rights and liberties. So, a difficult ethical question is how to strike a balance between the utilitarian aim of promoting public health, and libertarian aims of protecting

10 Ethical Considerations during…...cont’d privacy and freedom of movement in situations that involve diseases that are contagious, deadly, or otherwise dangerous (Aarons, 2020). Healthcare providers are always on the front line of confronting infectious diseases, and often are advisors to the policy-makers in regard to balancing individual freedoms against the common good, fear for personal safety against the duty to treat sick people, and possible economic losses against

the need to contain the spread of a deadly disease. Such decisions have to be guided by both scientific knowledge and ethical considerations.

Ethics and individual health care Health professionals involved in medicine and health care are generally guided by ‘Principlism’ – the 4 basic ethical principles. The ethical principles they normally consider are: 

Beneficence – This basic ethical principle dictates that we not only treat persons autonomously and refrain from harming them, but also that we contribute to their welfare (Aarons, 1993);



Non-maleficence – This ethical principle, whose origins trace back to the Hippocratic Oath,

asserts an obligation not to inflict harm intentionally, and further - to act to minimize harm; 

Autonomy - This ethical principle is rooted in western philosophy and values, and requires a respect for persons and their right to make decisions for themselves based on their values and preferences (Aarons, 1993); and



Justice - This principle is linked to the concept of fairness. Social justice

dictates

that

treat persons fairly; that a fair distribution of access to health care exists; and further, that persons have a right to a decent minimum of health care (Aarons, 2003). These are principles and values that are sacrosanct when health professionals are taking care of

individual patients. They profess the ethical standards health practitioners should meet in individual health care, and the moral norms that should guide the one-to-one interaction between the health professional and his or her patient.

Health care during a Pandemic Many of the ethical issues that arise in infectious disease outbreaks are the same as those that arise in individual health care as well as areas of public health, but the decisions during an outbreak need to be made on an urgent basis, often in the context of scientific uncertainty, social and institutional disruption, and an overall climate of fear and distrust (Aarons, 2020). Within such contexts, it is not possible to satisfy all urgent needs simultaneously, forcing decisionmakers to weigh and prioritize potentially competing ethical values. Setting up decision-making systems and procedures in advance is the best way to ensure that ethically appropriate decisions will be made if an outbreak occurs. Most importantly however in a pandemic, the guiding ethical principles change from those pre-eminent in individual health care to those that exist within the field of public health ethics

11 Ethical Considerations during…...cont’d (Aarons, 2021[a]). Further, the interests of the general public take precedence over the interests of the individual patient or person. The focus thus shifts from considerations of the individual to considerations of the ‘collective’ and the ‘common good’ (Aarons, 2021[a]).

Public Health Ethics Principles Public health ethics involves a systematic process to clarify, prioritize and justify possible courses of public health action based on ethical principles, values and beliefs of stakeholders, and scientific and other information (CDC, 2017). Consequently, public health professionals should be

familiar with some methods of moral reasoning.

Moral reasoning involves

deliberating about ethical questions and problems, and coming to a decision with the help of good judgement and rational analysis (Aarons, 2016).

In such deliberations, we sometimes

seek to justify particular decisions and actions by applying moral rules and principles, which are in turn justified by ethical theory. Several ethical principles exist to guide public health officials in carrying out their normal duties, conduct public health operations, and interact with large groups of people. They include: •

Health necessity

At the individual level, health necessity refers to the health care services that a doctor, exercising prudent clinical judgement, would provide to a patient. However, at the community or national level, health necessity refers to the achievement of a very important public health goal as identified by a legitimate public health authority. •

Effectiveness and safety

This includes a consideration of expected benefits, which sometimes comes at a cost and so must be computed as a cost-effectiveness analysis (Aarons, 2016). In this analysis, risks, and contributions to quality of life and to length of life are important considerations, since the aim would be maximization, that is, choosing what would give more ‘bang for the buck’! •

Transparency / public participation

Transparency is necessary to foster and develop public trust. It involves not only providing all relevant information, but also doing so in a way that is helpful to the general public. Members of the public should be able to understand what is being communicated, and the information

should be provided in a timely manner (Aarons, 2021[b]). The information should also be made readily accessible and be easy to find (e.g., on websites, and so on).

12 Ethical Considerations during…...cont’d •

Proportionality

Simply put, this principle requires that any burden being imposed on persons should be accompanied by some commensurate benefit to offset the burden being imposed. This principle therefore seeks to provide a balance, whereby if a public health goal can be achieved using less coercive or less intrusive policy interventions, then this would yield a more favourable risk-benefit ratio (WHO, 2021). •

The Least Possible Burden

In the balancing of an individual’s personal freedom and liberty, public health operations and ventures should seek to impose the least possible burdens on persons. So, public health containment measures such as quarantine and isolation should only be implemented if less coercive or restrictive alternative means are not available or are not viable options to procure the outcome desired (Aarons, 2016). •

Equity and Justice

The notion of justice, or fairness, encompasses two different concepts: The first is equity, which refers to fairness in the distribution of resources, opportunities and outcomes. Key elements of equity include treating like cases alike, avoiding discrimination and exploitation, and being sensitive to persons who are especially vulnerable to harm or injustice. The second aspect of justice is procedural justice, which refers to a fair process for making important decisions. Elements of procedural justice include due process (providing notice to interested persons and an opportunity to be heard), transparency (providing clear and accurate information about the basis for decisions and the process by which they are made), inclusiveness/ community engagement (ensuring all relevant stakeholders are able to participate in decisions), accountability (allocating and enforcing responsibility for decisions), and oversight (ensuring appropriate •

mechanisms for monitoring and review). (Aarons, 2016).

Solidarity

Solidarity reflects, at the basic foundational level, a commitment to ‘stand up in support.’

involves, in fact, a public action in the face of common threats. It is an identification with others and their position or plight, driven by sympathy as well as understanding (Dawes and Jennings, 2012). It is directed towards correcting or improving some disadvantage or injustice and joining in a collective commitment to assist others. •

The Harm principle

First proposed by the English philosopher, John Stuart Mill during the 19 th Century, the Harm principle in essence says that people should be free to act as they wish unless their actions cause harm to somebody else (Mill, 1989). With this principle, intervention by the state to protect the health and welfare of other persons is justified.

13 Ethical Considerations during…...cont’d •

The Trust & Reciprocity principle

In this principle, during public health operations, public health departments have an obligation to assist individuals and communities in the discharge of their duties, while on the other hand - persons should comply with public health requests. Such an undertaking would foster trust in the general population and minimize disparities in the distribution of the benefits and burdens of the epidemic response efforts. During a pandemic, the pre-eminent ethical principles in public health are: Health Necessity; Transparency; Proportionality; Solidarity; and the Harm Principle.

The health professional’s role, Research, and protection in a Pandemic: First, all health professionals have a duty of care. Professional ethics requires that all health professionals give paramountcy to their duty to care for the sick. This comes with the ethical duty to prescribe in keeping with scientific evidence, and to meet the statutory reporting requirements to

their Ministry of Health. Health professionals are also required to protect ourselves while seeking to benefit our patients. During the current pandemic, the world is trying to cope with an infectious disease involving a virus that is undergoing periodic mutation, and so empiric health research during a pandemic is critical (Aarons, 2018; Aarons, 2017). Further, most health care workers are having direct contact with populations at high risk of SARS-Cov-2 infection or severe illness or death resulting from Covid-19 disease. Since they have an ethical obligation not to harm their patients, Covid-19 vaccination might appear to be particularly plausible for health care workers since vaccination of this group could be seen as necessary to protect the capacity of the health care system. The latter as-

sumes even greater significance when only a small cadre of health professionals exist to provide services within health care institutions (Aarons, 2021[a]). Depending on the local context (which should be investigated empirically before mandating), various forms of mandatory vaccination may be implemented, including the requirement to ‘stay at home’ for those refusing to be vaccinated, or policies in which vaccination is required as a condition of employment, or that unvaccinated health workers be transferred to settings where the risk is significantly lower. However, it might be difficult to distinguish ‘high-risk’ and ‘low-risk’ settings when there is widespread community transmission of the SARS-Cov-2 virus (Aarons, 2021 [a]). Finally, wearing a mask is likely to be a requirement in health care settings for the foreseeable future, and can be scientifically and ethically justified – given the importance of personal protective equipment for individual as well as institutional infection prevention and control measures. Since no vaccine is 100% effective, masks and other standard infection prevention and control precautions should always be used to minimize risk – in keeping with the Hippocratic requirement of doing no harm.

14 Ethical Considerations during…...cont’d

References: Aarons, Derrick E. (1996). Medical Ethics: A Sensitization to some important Issues. West Indian Medical Journal: 45(3): 74-77. Aarons, D.E. (2020). Ethical Issues in Infectious Diseases (Oral Presentation). Infectious Diseases

Symposium, Antigua, West Indies. Aarons DE. (1993). What is Bioethics? Caribbean College of Family Physicians Bulletin; Vol.5(1): 8-9. Aarons DE. (2003). Issues in Bioethics: Ethics and Professional Responsibilities. WIMJ; 52(1): 49. Aarons, D.E. (2021[a]). Ethical Considerations During a Pandemic (Oral Presentation). Conference of the Antigua & Barbuda Medical Council, virtually via Zoom. CDC (2017). Public Health Ethics. Centers for Disease Control and Prevention, Office of Science,

CDC 24/7; Saving lives, protecting people: https://www.cdc.gov/os/integrity/phethics/index.htm Aarons. D.E. (2016). Ethics in Public Health (Oral Presentation to Masters students in Public Health). University of the West Indies, St. Augustine, Trinidad. WHO (2021). Covid-19 and mandatory vaccination: Ethical considerations and caveats. World Health Organization, Switzerland: WHO/2019-nCoV/Policy brief/Mandatory vaccination/2021.1 Aarons, Derrick E. (2021[b]). Vital Communications in Medicine. Litho Press, Jamaica. Dawson, A., Jennings, B. The Place of Solidarity in Public Health Ethics. Public Health Reviews; 34(1): 65-79. Mill, J.S. On Liberty. Cambridge University Press, United Kingdom; 1989. Aarons D.E. (2018). Addressing the challenge for expedient ethical review of research in disasters and disease outbreaks. Bioethics; 00:1-4. https://doi.org/10.1111/bioe.12543 Aarons D.E. (2017). Research in epidemic and emergency situations: A model for collaboration and expediting ethics review in two Caribbean countries. Developing World Bioethics Journal; 00:1-10. https://doi.org/10.1111/dewb.12157.

….

Ethical Ambivalence On The Use Of Placebo-Controlled Versus Standard Therapy For Trials In Low Middle-Income Countries (Lmic): A Review Of The Literature Two Decades After The Azt (Zidovudine) Trials By: Shereen Cox Introduction In October 1997, Sidney Wolfe and Peter Lurie wrote the Secretary of the United States (USA) Department of Health and Human Services requesting intervention in what they Masters (Healthcare Law & Ethics), Bpharm (Hons) Doctoral Research Fellow, University of Oslo President, Bioethics Society of the English-Speaking Caribbean

outlined as unethical research in developing countries that were funded by the US Government (Public Citizen, 1997). The request was for her to: immediately order the researchers to stop any arm of their studies in which women are denied access to antiretroviral drugs and to provide at least short-term AZT for all women now getting a placebo or other unproven treatments (Public Citizen, 1997). The letter outlined that it was unethical for HIV positive pregnant women to be placed in the placebo arm of a clinical trial and cited examples where other US researchers chose not to use

placebo control in similar studies because of ethical considerations (Public Citizen, 1997). The letter sparked an international debate, bringing to the fore the convoluted balancing of science and ethics in research. The debates took place in the late 1990s to mid-2000s and influenced many publications in journals by ethicists across the globe as well as reviews of several international ethical guidelines (Landes, 2005; Lie, Emanuel, Grady, & Wendler, 2004; Schüklenk, 2004). The studies were to explore the efficacy of a new dosing regimen for the drug Zidovudine (AZT also labeled 076) in the prevention of mother to child transmission (MTCT) of HIV in developing countries in parts of Africa, Thailand, and the Caribbean (CDC, 1997; Landes, 2005; Public Citizen, 1997). HIV positive pregnant women in the respective

countries received AZT, and the requisite ethical approvals were done. The controversy was the drug was approved for use in the USA and France. It was the accepted standard of care in those countries. The trial design was scientifically sound but ethically questionable (CDC, 1997; Public Citizen, 1997). This paper will review some of the literature arguing for or against the use of placebo in clinical trials, the impact of the AZT studies on ethical discourse particularly related to the interpretation of the article on placebo use in the Declaration of Helsinki, and finally to give an anecdotal snapshot of what is happening in terms of the current situation with placebo-controlled trials globally.

The placebo- a historical overview The use of placebo in clinical settings has been in existence since the late 1700s (Finniss, 2018). Earlier documentation noted that physicians gave medications to their patients with incurable ailments or for conditions they expected to resolve naturally (Blander, 1991; Finniss, 2018). The word placebo has a root meaning “to please,” which explains its usage in these medical scenarios (Price, Finniss, & Benedetti, 2007). The idea behind this concept was to give the patient the psychological reassurance that there was an intervention, although this

16 Ethical Ambivalence On The Use …… cont’d

intervention had no or very minimal real physiological impact on the patient (Finniss, 2018; Kaptchuk & Miller, 2015; Price et al., 2007). Early use of placebo in clinical practice involved fake surgical interventions, administering sub-standard doses of medications of no therapeutic relevance, and over time evolved into inert substances such as sugar-coated pills (Finniss, 2018). In modern medicine, the placebo is predominantly used in clinical research and has become a gold standard for

how clinical trials are conducted (Vickers & De Craen, 2000). The concept of the placebo effect was documented clinically by Henry Beecher in the 1950s and has been discussed extensively in psychology (Kienle & Kiene, 1997). The placebo effect is defined as improvements in patients' symptoms that are attributable to their participation in the therapeutic encounter, with its rituals, symbols, and interactions (Kaptchuk & Miller, 2015, p. 8) The placebo effect plays a significant role in medical conditions where there is a psychosomatic component (Harvard Health Publishing, 2017; Kienle & Kiene, 1997). It is for this reason; scientists have maintained their position that the study design using placebo-control in interventional research is the best method for conducting clinical research (Vickers & De Craen, 2000). The placebo effect creates bias and interferes with the ability to know the real effects of new medical interventions (Vickers & De Craen, 2000). Vickers et al. summarized arguments for the use of placebo in clinical trials into five explicit arguments: (1) “a placebo group controls for the placebo effect, (2) placebos facilitate outcome blinding, (3) promote similarity of clinician and patient compliance in comparison groups, (4) controls for natural remission and non-trial interventions and (5) have advantages over active controls” (Vickers & De Craen, 2000, p. 158). They also summarized reasons to avoid the use of placebo; “(1) placebo trials may interfere with an accurate estimation of effect size, (2) interfere with nonspecific aspects of treatment, and (3) do not inform real decisions” (Vickers & De Craen, 2000, p. 159). They concluded that placebo-controlled trials are useful in determining whether an intervention has a specific effect. However, trials without placebo controls may be required to provide information of clinical value…medicine-based evidence (Vickers & De Craen, 2000, p. 160) The reason highlighting that placebo-controlled trials do not inform real decisions in clinical practice is perhaps the most relevant point for examination. They noted, Clinical practice does not normally involve a decision between giving a treatment or a placebo. Typically, the decision that needs to be made is which of several treatments should be given or whether any treatment is preferable to no intervention. It is this second set of choices that should determine the control groups in clinical trials. For instance, knowing that antidepressant A is better than placebo and that antidepressant B is also better than placebo may be useful but does not help a psychiatrist choose which drug to prescribe (Vickers & De Craen, 2000, p. 160).

17 Ethical Ambivalence On The Use …… cont’d

Placebo in Clinical trials The argument for the use of placebo controls in clinical trials was centered around the concept of equipoise rather than as a method for aiding clinical decision making. Clinical equipoise is when all of the available evidence about a new intervention/treatment does not show that it is more beneficial than an alternative and, equally, does not show that it is less beneficial than the

alternative (Turner, 2013) It is this uncertainty that presented one of the most persuasive arguments for the use of placebo (Ovosi, Ibrahim, & Bello-Ovosi, 2017). As stated earlier, a placebo-controlled design “controls” biases that would exist if the intervention group was compared to the general population who had no intervention (Vickers & De Craen, 2000). Placebo-controlled orthodoxy refers to the scientifically superior way of doing clinical research (Emanuel & Miller, 2001; Skierka & Michels, 2018). However, active control advocates support the position that once there is available therapy, equipoise no longer exists. The research would not be ethically acceptable or clinically useful, albeit scientifically justified (Emanuel & Miller, 2001; Skierka & Michels, 2018; Vickers & De Craen, 2000). Emanuel et al. sought to find a middle ground between the two positions because “both positions are absolute and indefensible.” The paper argued placebo-controlled trials are permitted, but only when the methodologic reasons for their use are compelling, a strict ethical evaluation has made it clear that patients who receive placebo will not be subject to serious harm, and provisions have been made to minimize the risks associated with the receipt of placebo (Emanuel & Miller, 2001, p. 919). In the AZT study, the researchers could not claim clinical equipoise as they already had proof of the drug’s efficacy (CDC, 1997). They justified conducting the study based on 1) existing standard of care in the country, 2) affordability, 3) new dosing regimen, and 4) tailoring the study to meet the public health

needs of the country (CDC, 1997). The justification created what is considered a double standard in ethics, and ethicists across the globe shared various perspectives (Emanuel & Miller, 2001; Landes, 2005; Schüklenk, 2004). Researchers, policymakers, and regulators were divided on the acceptability of the research on vulnerable populations in a low-resource setting/country (Landes, 2005; Lie et al., 2004; Schüklenk, 2004). Some were of the view that research should be encouraged in Low and Middle-Income Countries (LMIC) and the standard of care applied to the research should be what ordinarily obtains in those countries once the following criteria were met: “1) valid scientific reason, 2) social benefits to community, and 3) favourable risk/benefit to individual” (Lie et al., 2004, p. 191). Others argued that it is a double standard and a form of exploitation (Landes, 2005; Schüklenk, 2004) while the Center for

Disease Control defended its methodology by highlighting the long-term public health benefits of a more affordable regimen (CDC, 1997).

Ethical considerations regarding the use of placebo The early ethical discourse on the use of placebo was concentrated on clinical practice, and the main ethical issues were deception, trust, respecting patient’s right to self-determination, and justice (Bishop, Aizlewood, & Adams, 2014). The issue of deception has been discussed from both consequentialist and

18 Ethical Ambivalence On The Use …… cont’d deontological perspectives (Blander, 1991). The consequentialist perspective was; if the patient benefits from the deception and there is no harm (good consequences), the deception may be ethically acceptable (Bishop et al., 2014; Blander, 1991). The deontological view is that the doctor-patient relationship is based on trust, and there is a duty owed to the patient to be open and honest (Bishop et al., 2014; Blander, 1991). It is essentially respecting the patients’ right to self-determination. The perspectives of clinicians, as well as patients, have been

investigated (Bishop et al., 2014). The consequentialist perspec-

tive seems acceptable to both clinicians and patients within specific parameters that is; there must be a balancing of benefit and harm (Bishop et al., 2014). In the limited clinical setting, this may be addressed on a case-by-case basis. However, in the research context, the discourse regarding the use of placebo is much more significant as it challenges major ethical guidelines outlining the need for informed consent in research and avoiding exploitation of the vulnerable (Landes, 2005). Some researchers have tested the concept of what is called “open placebo,” where research participants are informed that they are getting a placebo, and at times the product is labelled placebo (Colloca & Howick, 2018). The results revealed that even when patients knew the drug should be ineffective, they still reported improvements in how they felt. The improvements may be attributable to the attention and

care of a health practitioner. With this perspective in mind, maybe there is no need for a disguising placebo to resemble test products when openness and honesty could still yield the placebo effect (Colloca & Howick, 2018). The use of open-label placebo could address the deontological expectation of respecting patients’ autonomy. Having summarized the use of placebo in a historical context, I will now reflect on what took place after the AZT trials and the impact it had on clinical research.

The World Medical Association (WMA)’s position on the use of placebo in clinical trials Following the AZT trials scandal, the World Medical Association revised the Declaration of Helsinki

(DoH) to require the standard of therapy instead of placebo as much as possible. Article 29 of the 2000 version of the DoH states: The benefits, risks, burdens, and effectiveness of a new method should be assessed against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic, or therapeutic method exists (WMA, 2001). The WMA further clarified this requirement to be independent of the utilitarian and economic (affordable/availability) contexts, which were used to justify the studies. The WMA noted that it

opposes the notion that the non-availability of drugs should be used as a justification to conduct placebo-controlled trials…. “this would lead to poor countries of the world being used as the laboratory of research institutions of the developed world.” He added: “The WMA and its policies are always focused on what is in the best interest of the individual patients involved in research, and this case, persons could easily be exploited (WMA, 2001).”

19 Ethical Ambivalence On The Use …… cont’d Over the past 20 years, the Declaration has been revised, and the position on placebo remained with minor amendments seeking to clarify areas of ambiguity.

Global interpretation and application of the DoH’s position on the use of placebo To test the interpretation and application of WMA’s position on the use of placebo by the regulatory authorities in different countries, a study published in 2018, revealed that the interpretation of the WMA’s position on the use of placebo is still “ambivalent”(Skierka & Michels, 2018). The study acknowledged that the Declaration is widely accepted as a guidance document for clinical research. However, some countries noted that placebo is only acceptable under certain conditions such as (a)“in the case of the disease not being life-threatening”, (b)“if the only burden on the patient is transient discomfort,”

available”(Skierka & Michels, 2018). It was interesting to note that four countries accepted placebo-controlled trials if the standard therapy is not available locally, the very reason that sparked the fire in the first instance and indicates the ethical double standard remains regardless

of revisions and clarifications (Skierka & Michels, 2018). The stipulation of certain parameters for the use of placebo, such as not in life-threatening situations or where the burden on the patient is transient discomfort could be an indication of a general acceptance that there may be a leaning internationally from the scientific arguments for the use of placebo to what is in the best interests of the patients. Additionally, those who allowed placebo only when no standard of therapy exists is also possibly a positive indication in support for the judicious use of placebo as required by the Declaration (Skierka & Michels, 2018). A flexible rather than strict interpretation of the DoH indicated prudent use of placebo rather than an absolute preference for active controls. The interpretation is contextual, in favour of the protection of research participants. It

did not seem to be an outright opposition to placebo when therapy exists except to those who chose to maintain a strict interpretation of the clause. The European Medicines Agency (EMA) opinion was published in 2001 and noted: Although the efficacy of some new medicinal products can be satisfactorily demonstrated without the use of placebo, for others, the judicious use of placebo remains essential to demonstrate their value(EMA, 2001). They agreed it was difficult to adopt a strict interpretation of the DoH and indicated that the use of placebo must be evaluated on a case by case basis for ethical issues and noted that placebo should not be used where there is “additional risk of irreversible harm to the patient”(EMA, 2001). Subsequently, the position of the EMA changed towards what they describe as a “universal standard of ethics; that is, clinical research conducted in LMICs should conform to the same standards of the country in marketing authorization is sought” (EMA, 2011a). The US Food and Drug Administration (FDA) historically complied with the versions of the Declaration that predate the 2000 review restricting the use of placebo. In 2008, the agency

20 Ethical Ambivalence On The Use …… cont’d outright distanced itself from the Declaration in favour of Good Clinical Practice guidelines for studies conducted outside of the USA (FDA, 2008). This position was criticized because of the implicit support for placebo-controlled trials in LMIC (Burgess & Pretorius, 2012). In 2019, the FDA published a position paper stating that the use of placebo in cancer clinical trials for which “there is known effective therapy” is ethically unacceptable (FDA, CDER, & CBER, 2019). The positions of both agencies regarding the use of placebo have become more scientifically and ethically contextual. The contextual viewpoint is important, but only if the context is in the best interests of the research participants regardless of location or economic disparities. Context can lean towards the double standard, which facilitates exploitation and the research methodology tailored as a form of justification in favour of science (Landes, 2005). It could be inferred from the middle point perspective stated earlier in the paper by Emanuel et al., placebo-controlled trials, regardless of where they are conducted, ought to be done with the welfare of the patient as paramount (Emanuel & Miller, 2001). The assessment of the welfare of the research subject should be based on the medical situation of the individual, that is, is there a possibility of irreversible harm, to what extent does reversible harm exists and who will assess the risk-benefit ratio on behalf of research participants (Emanuel & Miller, 2001)? It is a case-by-case scenario hence supporting

the critical role of Ethics Committees and Regulators. Without oversight and whistleblowers, researchers may follow the path of least resistance. After all the placebo-orthodoxy versus active control and the ethical double standard conundrum, if a universal standard ethics was agreed on, does this guarantee, in and of itself, ensure research is conducted ethically?

CIOMS The Council for International Organizations of Medical Sciences (CIOMS) is a partner agency of the World Health Organisation and UNESCO (CIOMS, 2016). The reviewed CIOMS guidelines sought to clarify some of the ambivalent areas of the Declaration of Helsinki by publishing a more cautiously worded guideline that would be reflective of the middle ground for both placebo and standard therapy. The first revision carefully identified that a “gold standard” was clinically confusing, as this is subjective (CIOMS, 2002). However, their outlined position was that the use of placebo should be the exception, not the norm. CIOMS guideline 11:

As a general rule, research subjects in the control group of a trial of a diagnostic, therapeutic, or preventive intervention should receive an established effective intervention. In some circumstances, it may be ethically acceptable to use an alternative comparator, such as pla-

cebo or "no treatment," Placebo may be used: •

when there is no established effective intervention;

•

when withholding an established effective intervention would expose subjects to, at most, temporary discomfort or delay in relief of symptoms;

•

when use of an established effective intervention as comparator would not yield scientifically reliable results and use of placebo (CIOMS, 2002)

21 Ethical Ambivalence On The Use …… cont’d The subsequent revisions of the CIOMS guidelines maintained the middle ground position noting that: the preferred option is to test potential new interventions against an established effective intervention. When researchers propose to deviate from this option, they must provide a compelling methodological justification and evidence that the risks from withholding or delaying the established intervention are no greater than a minor increase above minimal risk

(CIOMS, 2016). The CIOMS ethicists in both the 2000 and 2016 versions placed the onus of evaluating risks and monitoring on the Ethics Committees of the participating countries as well as the sponsor. It was recommended that Ethics Committees, which lacked the expertise to evaluate the scientific methodology justifying the use of placebo over standard therapy, should seek external support (CIOMS, 2002, 2016). While the Ethics Committees may be required to carefully review protocols to determine judicious use of placebo controls versus standard active controls, this does not in and of itself rule out the possibility of harm in comparator studies of the latter. An example of this was the SWEN (Six Week Extended dose Nevirapine) studies with HIV positive breastfeeding mothers in

Uganda, India, and Ethiopia (Bedri et al., 2008; Omer, 2011; SWEN Study Team, 2008). The final recommendation of the studies was for HIV positive mothers to breastfeed infants while on ARVs, and the infants should be given a course of Nevirapine for longer than six weeks to prevent MTCT of the virus (SWEN Study Team, 2008). The Indian investigators disagreed in the interpretation of the study results and published different opinions. They highlighted concerns about the long term effects of drug resistance due to unnecessary exposure to ARV in giving a single dose of Nevirapine to one group of infants as well as toxic side effects such as the risk of neutropenia to infants in the comparator group (Phadke, Bulakh, & Kshirsagar, 2008). The investigators suggested that avoidance of breastfeeding was a better standard of care, which was what obtained in developed countries (Phadke

et al., 2008). The Lancet published a statement on the disagreement indicating it sought guidance from the Committee on Publication Ethics on how to handle the situation (Pini & Kleinert, 2008). It would have been interesting to know if the Ethics Committees in the respective countries were aware of this disagreement or whether they were active participants in the monitoring and final evaluation of the study results. What is noteworthy also, this type of study would not have received ethical clearance in the USA, as it is against the standard of care to breastfeed babies born to HIV positive mothers due to resource disparities (CDC, 2018).

A persistent double standard and the need for regulatory oversight In 2014, Michael Carome of Public Citizen published an open letter highlighting what he calls a “persistent double standard (Carome, 2014)”. He cited the use of placebo in clinical trials in India on infants as a control arm for the rotavirus vaccine (Carome, 2014). In a blog on the webpage of the Journal of Medical Ethics, Jeremy Howick questioned the ethics of using placebo control for patients with advanced skin cancer instead of the accepted standard treatment of interferon-alpha (Howick, 2018). A search of clinical trials.gov with the search terms placebo, placebo-controlled trials,

22 Ethical Ambivalence On The Use …… cont’d produced 48303 studies, 24,129 studies were in North America, and 15,023 in Europe (US National Library of Medicine, n.d.). There were only 1847 trials in Africa, while over 6000 spreads across Asia. This search is a snapshot of the extent to which placebo-controlled trials are still practiced globally (US National Library of Medicine, n.d.). In order to ensure the ethically acceptable practice of placebo-controlled trials globally, there is a need for continuous monitoring. The need for oversight and not just universal ethics was the crux of the 2010 EMA’s international workshop in London. What is needed is a robust framework for the oversight and conduct of clinical trials, no matter where in the world the clinical investigator sites are located and patients recruited…” said the EMA’s Executive Director, Thomas Lönngren, concluding the meeting, “… The Agency is committed to build and extend its relationship with regulators in all parts of the world and with international organizations to work to standards agreed and recognized by all (EMA, 2011b). The four key points of the meeting were “(1) ethical principles are universal and should not be negotiable, 2) All countries play a role in the advancement of clinical research, drug development, and human health,

(3) The standards expected for the conduct of clinical trials conducted in non-EU countries should not be more stringent than those required within the EU, and the guidance should not restrict the conduct of good trials or use of data from well-conducted trials, wherever that takes place, (4) Ethics Committees play a key role in the verification that ethical standards are applied at the time that the trials are conducted” (EMA, 2011a). The meeting identified a major challenge with advancing universal standards of ethics: There are wide variations in the extent to which the regulation of clinical trials has developed or been implemented in practice. These differences reflect the stages of development of regulatory

frameworks and the degree to which adequate resource, capacity or expertise are available for the ethics review mechanism and regulatory framework for the supervision of clinical trials (EMA, 2011a) Monitoring of research is key, and self-reporting reviews by researchers may not be entirely reliable (Silva, Amato, Guilhem, & Novaes, 2016). The placebo-controlled versus active control arguments spanned over two decades and shifted from a double standard to a middle ground compromise and eventually to a conversation about capacity building for local Ethics and effective monitoring of global clinical trials. The arguments for and against placebo-controlled trials in LMIC both had salient points. However, to effectively balance science and ethics, they must shake hands not just on the global level but on the local

level. The conversation is not about what is good for the goose is also good for the gander or ruling out one in favour of another. Researchers, members of Ethics Committees, Drug regulators have roles to play in ensuring that clinical trials are conducted ethically, and research subjects are protected. The concept of a universal standard of ethics will always be challenged whenever there are vulnerabilities and loopholes. These vulnerabilities are not limited to economics, but due to a real need for stringent oversight for research. Vulnerabilities also exist in High-income countries. The comparison by Landes of the HIV pregnant mothers to the Tuskegee scandal lends support to this argument (Landes, 2005).

23 Ethical Ambivalence On The Use …… cont’d

International agencies and guidelines, such as the WMA, DoH and CIOMS, are very relevant for general guidance but may not adequately address individual countries’ health/research priorities. Capacity building in terms of stringent regulatory, establishment, and support of Ethics Committees to careful review and monitor research as well as holding researchers accountable may be the only way to achieve this goal. Health regulators of each country, as a hen gathers her chicks under her wings, must aspire to judiciously examine and monitor every research or health intervention within their borders with the singular aim to protect their people.

References Bedri, A., Gudetta, B., Isehak, A., Kumbi, S., Lulseged, S., Mengistu, Y., … Zwerski, S. (2008). Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: An analysis of three randomised controlled trials. The Lancet, 372(9635), 300–313. https://doi.org/10.1016/S0140-6736(08)61114-9

Bishop, F. L., Aizlewood, L., & Adams, A. E. M. (2014). When and Why Placebo-Prescribing Is Acceptable and Unacceptable: A Focus Group Study of Patients’ Views. PLOS ONE, 9(7). https:// doi.org/10.1371/journal.pone.0101822 Blander, G. (1991). Ethical conflicts in placebo treatment. Journal of Advanced Nursing, 16(8), 947– 951. https://doi.org/10.1111/j.1365-2648.1991.tb01799.x Burgess, L. J., & Pretorius, D. (2012). FDA abandons the Declaration of Helsinki: The effect on the ethical aspects of clinical trial conduct in South Africa and other developing countries. South African Journal of Bioethics and Law, 5(2). https://doi.org/10.7196/sajbl.222

CDC. (1997). CDC Studies of AZT to Prevent Mother-to-Child HIV Transmission in Developing Countries | News | AIDSinfo. Retrieved February 2, 2020, from AIDS Info website: https:// aidsinfo.nih.gov/news/363/cdc-studies-of-azt-to-prevent-mother-to-child-hiv-transmission-indeveloping-countries CDC. (2018). Human Immunodeficiency Virus (HIV) | Breastfeeding | CDC. Retrieved February 3, 2020, from https://www.cdc.gov/breastfeeding/breastfeeding-special-circumstances/maternal-orinfant-illnesses/hiv.html Colloca, L., & Howick, J. (2018). Placebos Without Deception: Outcomes, Mechanisms, and Ethics.

International Review of Neurobiology, 138, 219–240. https://doi.org/10.1016/bs.irn.2018.01.005 EMA. (2001). The European Agency for the Evaluation of Medicinal Products Pre-authorisation evaluation of medicines for human use EMEA/CPMP POSITION STATEMENT ON THE USE OF PLACEBO IN CLINICAL TRIALS WITH REGARD TO THE REVISED DECLARATION OF HELSINKI. Retrieved from http://www.emea.eu.int/London,

24 Ethical Ambivalence On The Use …… cont’d

EMA. (2011a). Patient Health Protection International workshop Meeting Report Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries

and

submitted

marketing-authorisation

applications

to.

Retrieved

from

www.ema.europa.eu EMA. (2011b). Patient Health Protection International workshop Meeting Report Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and

submitted in

marketing-authorisation

applications to

Retrieved

from

www.ema.europa.eu Emanuel, E. J., & Miller, F. G. (2001). The Ethics of Placebo-Controlled Trials — A Middle Ground. New England Journal of Medicine, 345(12), 915–919. https://doi.org/10.1056/NEJM200109203451211 FDA. (2008). Federal Register :: Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application. Retrieved February 1, 2020, from https:// www.federalregister.gov/documents/2008/04/28/E8-9200/human-subject-protection-foreign-clinical

-studies-not-conducted-under-an-investigational-new-drug FDA, CDER, & CBER. (2019). Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry. Retrieved from https://www.fda.gov/ drugs/guidance-compliance-regulatory-information/guidances-drugsand/or Finniss, D. G. (2018). Placebo Effects: Historical and Modern Evaluation. In International Review of Neurobiology (Vol. 139, pp. 1–27). https://doi.org/10.1016/bs.irn.2018.07.010 Harvard Health Publishing. (2017). The power of the placebo effect - Harvard Health. Retrieved January 30, 2020, from Harvard’s Men Health Watch website: https://www.health.harvard.edu/mental-

health/the-power-of-the-placebo-effect Kaptchuk, T. J., & Miller, F. G. (2015). Placebo Effects in Medicine. New England Journal of Medicine, 373(1), 8–9. https://doi.org/10.1056/NEJMp1504023 Kienle, G. S., & Kiene, H. (1997). The powerful placebo effect: Fact or fiction? Journal of Clinical Epidemiology, 50(12), 1311–1318. https://doi.org/10.1016/S0895-4356(97)00203-5 Landes, M. (2005). Can context justify an ethical double standard for clinical research in developing countries? Globalization and Health, 1. https://doi.org/10.1186/1744-8603-1-11 Lie, R. K., Emanuel, E., Grady, C., & Wendler, D. (2004). The standard of care debate: The declaration of Helsinki versus the international consensus opinion. Journal of Medical Ethics, 30(2), 190–193. https://doi.org/10.1136/jme.2003.006031 Omer, S. B. (2011). Twelve-month follow-up of Six Week Extended Dose Nevirapine randomized controlled trials: Differential impact of extended-dose nevirapine on mother-to-child transmission and infant death by maternal CD4 cell count. AIDS, 25(6), 767–776. https://doi.org/10.1097/ QAD.0b013e328344c12a

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Ovosi, J., Ibrahim, M., & Bello-Ovosi, B. (2017). Randomized controlled trials: Ethical and scientific issues in the choice of placebo or active control. Annals of African Medicine, 16(3), 97. https:// doi.org/10.4103/aam.aam_211_16 Phadke, M. A., Bulakh, P., & Kshirsagar, N. (2008). Nevirapine to prevent HIV transmission via breastfeeding. The Lancet, Vol. 372, p. 287. https://doi.org/10.1016/S0140-6736(08)61100-9

Pini, P., & Kleinert, S. (2008). SWEN-when authors disagree. The Lancet, Vol. 372, pp. 269–270. https://doi.org/10.1016/S0140-6736(08)61088-0 Price, D. D., Finniss, D. G., & Benedetti, F. (2007). A Comprehensive Review of the Placebo Effect: Recent

Advances

and

Current

Thought

Further.

https://doi.org/10.1146/

annurev.psych.59.113006.095941 Public Citizen. (1997). Letter Concerning Unethical Placebo-Controlled Studies on HIV-Positive Pregnant Women in Developing Countries - Public Citizen. Retrieved January 31, 2020, from Public Citizen website:

https://www.citizen.org/article/letter-concerning-unethical-placebo-controlled-

studies-on-hiv-positive-pregnant-women-in-developing-countries/ Schüklenk, U. (2004). The standard of care debate: Against the myth of an “international consensus opinion.” Journal of Medical Ethics, 30(2), 194–197. https://doi.org/10.1136/jme.2003.006981 Silva, R. E. da, Amato, A. A., Guilhem, D. B., & Novaes, M. R. C. G. (2016). Globalization of clinical trials: ethical and regulatory implications. International Journal of Clinical Trials, 3(1), 1–8. Retrieved from https://www.ijclinicaltrials.com/index.php/ijct/article/view/103/66 Skierka, A.-S., & Michels, K. B. (2018). Ethical principles and placebo-controlled trials – interpretation and implementation of the Declaration of Helsinki’s placebo paragraph in medical research. BMC

Medical Ethics, 19(1), 24. https://doi.org/10.1186/s12910-018-0262-9 SWEN Study Team. (2008). Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials. Lancet, 372, 300–313. Retrieved from https://www.thelancet.com/action/ showPdf?pii=S0140-6736%2808%2961114-9 Turner, J. R. (2013). Principle of Equipoise. In Encyclopedia of Behavioral Medicine (pp. 1537–1538). https://doi.org/10.1007/978-1-4419-1005-9_1052 Vickers, A. J., & De Craen, A. J. M. (2000). Why use placebos in clinical trials? A narrative review of

the methodological literature. Journal of Clinical Epidemiology, 53(2), 157–161. https:// doi.org/10.1016/S0895-4356(99)00139-0 WMA. (2001). When Are Placebo Controlled Trials Ethically Acceptable? – WMA – The World Medical Association. Retrieved from https://www.wma.net/news-post/when-are-placebo-controlled-trialsethically-acceptable/

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Essay in Clinical Ethics: "Ethical Issues in the care of Covid-19 infected patients" By: Sherry Ephraim-Le Compte DDS. Introduction The burden on healthcare professionals to make ethical decisions in their day-to-day practice for the well-being of their patients puts them in a continuous quandary. There are ethical issues such as “religious Sherry Ephraim-Le Compte, DDS.

and cultural diversity”, socioeconomic factors, “quality of life issues” that health professionals must consider. (Aarons, slide 6, 2021) With the advent of the COVID-19 global pandemic, health professionals

Vice President

were quickly thrust into making decisions on who lives or who dies, who gets to be put on ventilators as

MSc. Bioethics Student

opposed to who is removed. The increased volume of sick patients who presented themselves at the hospitals with severe complications, with resources being scarce, the clinical care and ethical decisions became entrapped with other influencing factors, making it particularly challenging for healthcare professionals. According to Toh et.al. (2018), “While physicians are competent in providing medical care, they are often ill-equipped to handle complex ethical dilemmas in the course of clinical work.”, which was particularly true during the COVID-19 pandemic. The basic ethical principles of beneficence, non-maleficence, justice, and patient autonomy could no longer be sufficient in the deliberative processes of clinical cases and needed consideration of other or sub-principles that would make them more applicable in the context of the COVID-19 pandemic. Fortunately, in spite of the myriad of influencing factors and issues that affect the decision-making power of healthcare professionals, there is a framework within which most of these ethical decisions can be considered by healthcare professionals. This framework is termed the Clinical Ethics Algorithm and has four main pillars that clearly delineate how healthcare professionals should make these day-to-day ethical decisions in their practice, reducing the subjectivity and conundrum that they find themselves in during the

decision-making processes. These four pillars according to Toh et.al. (2018) follow the AR “Jonsen’s four topic approach” that require health professionals to make such deliberations employing (1) the medical intervention to employ on a case-by-case basis whilst trying their best to (2) respect the autonomous decision-making capacity, and preferences of the patient under their care, (3) having a clear understanding of the situational context in which they currently provide care, because they are charged with making decisions as it relates to the “economics of healthcare”

(Aarons, slide 11, 2021), therefore health professionals should have knowledge of the resources that are available that would assist them in their provision of care. The final pillar or approach relates to quality-of

-life issues which healthcare professionals must critically consider as the issues can influence their judgment and practice in deciding what is best for their patients. This paper discusses the ethical issues in the care of the COVID-19 infected patients, the challenges faced by health care professionals and the functionality of the four-pillar approach of the clinical ethics algorithm designed to help them in their deliberations of clinical cases.

27 Essay in Clinical Ethics….cont’d

Discussion What is Clinical Ethics, one might ask? Nandi (2000) defines “Clinical Ethics” as the application of the science and understanding of morality in the field of medicine and health sciences, with the goal to improve the quality of patient care. She also quotes the definition of Dunstan et. al (1981) in her article, as "the obligations of moral nature which govern the practice of medicine." On any normal day, health professionals are faced with many issues that need ethical review and considerations.

During a pandemic, the level of scrutiny of these ethical issues increases due to the added circumstances that compound the situations. One of the overarching ethical issues, I believe that took the fore during this pandemic, is the “Duty to care” and the health professionals “Right to protection”.

Ethical issues-Duty to care versus right to protection The COVID-19 pandemic, a public health emergency due to its marked infectivity, highlighted the ethical conundrum between duty to care versus right to protection. Practically overnight, healthcare professionals were faced with taking care of patients affected by a highly infectious and deadly

disease. Ethical questions loom during the provision of care: “Do I take care of these patients without the proper protections”, “Should I neglect the care of this patient, who is helpless, dying and certainly in need of my care without first ensuring my protection?” “What if I get infected and end up like this patient or worse infect my family?”. It is widely known that large numbers of healthcare professionals died during the pandemic, having contracted the virus whilst caring for COVID-19 infected patients. According to Gopichandran (2020), “It takes years of training for healthcare providers to have the unique skills to provide specialized services to the public which they must put to maximum use during a pandemic” and though “they are obligated to provide care, they also have the right to be protected from harm. because only with good health can they continue to serve society. “Gopichandran (2020)

gives an example of the views of the General Medical Council (GMC), with the statement that “doctors must not refuse to treat patients because exposure will endanger their lives, and recommends that a “balance be struck between serving during the time of need and protecting the health and welfare of healthcare providers, at the local level by providing adequate PPE to protect their health to the maximum extent possible”. Globally, the consensus to guide this ethical conundrum is “that duty to care during pandemics and emergency situations must be voluntary and must be associated with reciprocity from the health system, the government and society to protect providers.” (Gopichandran 2020)

Photo taken from Google images: Ethics and COVID-19 by WHO.INT

28 Essay in Clinical Ethics….cont’d Gopichandran (2020) summarizes the ethical issues in the following table: Table 1: Ethical issues in the clinical care of patients with Covid-19

Clinical ethics algorithm- A Saint Lucian perspective

Indications of medical interventions Through my knowledge and experience in Saint Lucia, just as had been reported by countries around the globe, the ethical issues associated with the impact of the COVID-19 pandemic made management quite challenging. Deliberations on the medical interventions to use in the treatment of this virus were

continuous and the health professionals heavily relied on the position of international organizations such as the World Health Organization (WHO) and the Pan American Health Organization (PAHO). Physicians deliberated on questions such as “what medical interventions are we to use?” and “what drug combination will work best for the patient?” among others. Patients presented with varying degrees of complications and so each case had to be carefully assessed to decide which treatment or medical intervention is best for that patient, to ensure that the expected clinical “outcomes are accomplished and worth the effort, with minimal harm and maximum benefits”. (Aarons, slide 8 2021).

29 Essay in Clinical Ethics….cont’d Some patients were not in agreement with the established treatment protocols and insisted on other treatments such as Ivermectin which were yet to be authorized for use in this regard by the Ministry of Health nor by WHO or PAHO. In such situations, patients who were able to be part of the decisionmaking process for their treatment were fully engaged and given all the facts about the different medical interventions and those which the hospital could or could not legally administer. Religious and spiritual beliefs also played a significant role in influencing the deliberations of the

health professionals particularly in cases where blood transfusions were indicated, as some religious doctrines strictly preach against the use of blood and its products.

Respect for autonomy and preferences of the patients Based on information given form the Medical Director and other medical specialists of the Respiratory Hospital which was repurposed to take care of COVID-19 patients, patient autonomy is highly respected. This is evident by the obligation of the health professionals to give patients and their families the opportunity to be part of the discussions on the treatment of the patient. There is an internal

policy that makes provision for autonomous patients to allow their next of kin to provide a signed informed

consent for their agreed treatment plan. Those patients who were unable to be part of the

deliberations, for example ICU patients, their documented next of kin would be called in to discuss the way forward with the medical interventions and proffer their signed consent for the clinical management of their relative. (MOH, 2021)

Context Aarons (2021) lists confidentiality as an example of the context of patient care and management.

Confidentiality and privacy are taken very seriously in the management of COVID-10 patients at the Respiratory hospital. Patient information is securely guarded and where possible codes are used. The information in the patient notes can be accessed only by the immediate care providers and securely kept on the ward. Even if the documented next of kin is engaged in the patient clinical management, they are not given any personal health information other than the COVID-19 virus information. The patient information (other co-morbidities or diseases) is securely kept and not written on the death certificate so that the patient still maintains some level of dignity, even in death. Confidentiality is also maintained during ward rounds. Rounds are done in “clusters” (MOH 2021), whereby all relevant health personnel visit the patient as a team. Patient beds are kept at least six feet apart and curtains are drawn to provide a sound barrier. In terms of the economics of health care (Aarons, 2021), the “cluster” visits also help to conserve and ration the already limited personal protective equipment (PPE) as the team is pulled together for one multi-disciplinary team-visit, per patient. Pharmaceuticals are also managed by ensuring the hospital pharmacy is stocked with the current medications being used to treat the COVID-19 patients. An ethical quandary occurs when there is not enough medication and health professionals have to decide on who to treat with the scarce resources.

30 Essay in Clinical Ethics….cont’d Quality-of-life issues The clinical management of a patient needs to “enhance their life”. Healthcare professionals should consider that if a patient’s quality-of-life is “below minimal” despite the integrative care provided, asking the question “Is such a life worth living?” (Aarons, 2021) would help them put into context all the factors that relate to the patient’s health and continued care. Engaging the patient and their family in the discussion on the way forward in such cases, is also an activity conducted at the Respiratory

Hospital in Saint Lucia. One critical question discussed would be, “do we continue to try our best and use all necessary resources to keep the patient alive?” Sometimes, cancer patients or patients with multiple co-morbidities, indicate that prolonging life is more excruciating and so they would prefer the health professionals taper down the medications to manage the pain and do not resuscitate if their health deteriorates.

Conclusion The COVID-19 pandemic has made clinical care management particularly challenging. Many health professionals faced ethical issues which required a multidisciplinary approach. Prevalent issues

presented related to “Justice”, in particular resource allocation (PPE resources, medications, space, devices), respect of patient autonomy-informed consent and treatment plan, balancing duty to care and the right to protection, and doing no harm. This highlights the need for more training and public health policies to equip and prepare professionals to skillfully navigate the ethical quandaries that arise in their clinical practice. Employing the clinical ethics algorithm or the Jonsen’s four-approach framework is recommended as an objective and structured training tool to help health professionals navigate their way in ethical deliberations. Notwithstanding, governments need to support health professionals by providing the resources that they need to adequately manage patients

during pandemics so that they are not forced to make these life-determining or resource rationing decisions. Governments also need to provide the legislative backing to health professionals in the event such decisions need to be made. Regulations are also needed to detail the support to health care professionals who volunteer their services during pandemics as well as the state the incentives, insurance, concessions on vehicles (as implemented in Saint Lucia) Concurrently, patients will have more trust in the system knowing that their welfare is considered and that health professionals are guided by regulation during their care, so the conflict between duty of care and right to protection will not cause so much of an ethical quandary, that would significantly impact on either party.

References Aarons, D. (2021). Clinical Ethics Algorithm. [PowerPoint slides presented at Bioethics Society of the English-Speaking Caribbean (BSEC) Forum in 2015]. Week 10 Healthcare Ethics/Clinical Ethics. Masters Bioethics Programme at Clarkson University. Toh, H. J., Low, J. A., Lim, Z. Y., Lim, Y., Siddiqui, S., & Tan, L. (2018). Jonsen's Four Topics. Approach as a Framework for Clinical Ethics Consultation. Asian bioethics review, 10(1), 37–51. https://doi.org/10.1007/s41649-018-0047-y

31 Essay in Clinical Ethics….cont’d

Nandi PL. Ethical Aspects of Clinical Practice. Arch Surg. 2000;135(1):22–25. doi:10.1001/archsurg.135.1.22. https://jamanetwork.com/journals/jamasurgery/ fullarticle/390481

Dunstan, G. R., Duncan, A. S., Welbourn, R. B. (1981). Dictionary of Medical Ethics, pp.28-31. New York, NY. The Crossroad Publishing Co.

GOPICHANDRAN, Vijayaprasad (2020). Clinical ethics during the Covid-19 pandemic: Missing the trees for the forest. Indian Journal of Medical Ethics, [S.l.], v. V, n. 3, p. 182-187, Apr. 2020. ISSN 0975-5691. https://ijme.in/articles/clinical-ethicsduring-the-covid-19-pandemic-missing-the-trees-for-the-forest/>.

MOH (2021), Interview with the Medical Director of the Respiratory Hospital. Ministry of Health, Wellness and Elderly Affairs. Saint Lucia.

Dr. Sherry Ephraim-Le Compte is student at Clarkson University, pursuing the MSc. Bioethics. She is a dentist by profession, who has found a passion in ethics. Dr. Ephraim-Le Compte was selected to participate in the first Fogarty funded CREEi cohort for the Research Ethics programme offered at St. Georges University in Grenada, after having attained a post graduate diploma in Clinical Research from the University of Liverpool. She established the Research Ethics Committee as a committee of the Medical and Dental Council which she chaired for 10 years until 2019 and now continues to provide support as a member. Dr. Ephraim-Le Compte is the current vice president of BSEC and is a reviewer for Caribbean Medical Journal and Global Bioethics Editorial Manager system.

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Report On The Work Of The Central And South America Bioethics Network Of Unesco By: Derrick Aarons Introduction The Bioethics Network for Latin America and the Caribbean (Redbioetica) was founded at an international meeting in Cancun, Mexico, in May 2003. From the onset of the process,

UNESCO decided to decisively support the Network’s activities and actions, initially through Dr. Derrick Aarons M.D. PhD. Member of the Executive Council of RedBioetica UNESCO

its regional office in Mexico, and subsequently via its regional office for Latin America and the Caribbean, headquartered in Montevideo, Uruguay. Internal Medicine specialist with a Masters in Bioethics, Dra. Susana Vidal was eventually appointed to be the UNESCO Director for the network (RedBioetica UNESCO). The work of Redbioetica UNESCO subsequently established bioethics links across all the countries in South America, including Brazil, Chile, Argentina, Paraguay, Ecuador, Peru, Panama, Costa Rica, Honduras, Nicaragua, Mexico, Venezuela, and Colombia. It then began its bioethics reach into the Caribbean, developing bioethics ties with Cuba and the Dominican Republic.

BSEC enters the fold By 2006, the Bioethics Society of the English-speaking Caribbean (BSEC) had established itself as a strong regional bioethics entity, and so in 2009, its then President, Dr. Derrick Aarons, was nominated by Dra. Susana Vidal to serve as a member of the Scientific Committee for the RedBioetica UNESCO Journal. The next year, in 2010, Dr. Aarons was elected to serve on the Executive Council of Redbioetica UNESCO, a position in which he continues to serve eleven (11) years later. The leadership of the Network continuously assesses bioethical developments across South

America and the Caribbean, and issues pertinent guidelines, statements of advocacy, or positions of solidarity where bioethical values or principles are under threat or attack. It lobbies errant states and governments to conform and adhere to the international treaties that protect human rights and social justice, and its statements are promoted not only to the head office of UNESCO in Paris, France, but to all the member states throughout Latin America and the Caribbean.

Bioethics Conference Every two years, RedBioetica UNESCO also hosts a Bioethics Congress that rotates through the

several countries within its Network, and persons across all countries are invited to submit abstracts and make bioethical presentations on the vast array of topics within the field of bioethics! These presentations may then be expanded into academic papers for publication in the peer-reviewed Revista Redbioetica UNESCO (Journal of the Latin America Bioethics Network of UNESCO). The Journal accepts and publishes manuscripts written in three of the languages found within the region: Spanish, Portuguese, and English.

33 Report on the Work …..cont’d Over the years, representing BSEC, Dr. Aarons has been invited to present several topics in bioethics at the various Congress throughout the region, including: Nov. ’10:

Bioethics and the Environment in the English-speaking Caribbean – 3rd International Congress of the RedBioetica UNESCO – Bogota, Colombia

Nov. ’12:

Priorities in Bioethics for the English-speaking Caribbean – IV International

Congress of Red LatinoAmericana Y Del Caribe De Bioetica, Brasilia, Brazil Dec. ’14:

Bioethical Perspectives in the English-speaking Caribbean – 5th Congres of Latin America & the Caribbean of RedBioetica UNESCO, Lima, Peru

Nov.’16:

Risks/Benefits Balance and Exploitation in biomedical research – 6th International Congres of RedBioetica UNESCO, Costa Rica

Nov.’18:

Bioethics and the environment against the violation of human rights: Redefinition of agrarian and food sovereignty – VII Congres of the UNESCO Bioethics Network of Latin America & the Caribbean – Brasilia, Brazil

July ’20:

“Covid-19 Pandemic in Jamaica: Social and bioethical aspects” – Meeting of the Central America and Caribbean Chapter of RedBioetica UNESCO, virtually.

Sept.’21:

Will there be an improvement of ecosystems in the world post-pandemic? – 8th International Congres of RedBioetica UNESCO, Colombia

CARCEC and the Executive Council In 2018, on the initiative of the UNESCO Regional Director Dra. Susan Vidal, Dr. Aarons was

invited along with Prof. Miguel Suazo of the Dominican Republic, Dr. Gerald Lerebours of Haiti, and Prof. Jose ‘Pepe’ Acosta of Cuba, to discuss the possibility of forming a sub-chapter of the Network to serve the bioethics interests of Central America. After much planning, CARCEC (the Central American Chapter) was formed in 2019, with Miguel Suazo serving as Chair, and Gabriela Sibala F of Costa Rica serving as Secretary. Now, in 2021, BSEC has its ‘icing on the cake’ with its new President, Ms. Shereen Dawkins Cox, being co-nominated by Dra. Susan Vidal and Dr. Derrick Aarons to serve on the Executive Council of RedBioetica UNESCO, and then her subsequent election by 100% of the vote to make her the newest member of the Executive Council. The latter election was ratified at the meeting of the Executive Council at the biannual Congres of Redbioetica UNESCO, hosted in Columbia Sept. 24-26, 2021, where BSEC President Shereen was warmly congratulated (virtually) and welcomed into service at the executive level. The English-speaking Caribbean therefore now has two (2) members serving on the Executive Council of Redbioetica UNESCO, thereby better able to foster increased dialogue and bi-lateral work in bioethics, the dissemination of information about bioethical developments across our

34 Report on the Work …..cont’d region, and increased possibilities for intra-regional collaborative work and solidarity on social and bioethical issues, in addition to increased lobbying to mitigate social injustice and other bioethical issues and concerns pervading our Central and South America region. BSEC is also now very firmly linked and integrated into the pervading bioethical arena of the western hemisphere!

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Advancing Research Ethics in the Caribbean Region By: Mr. Kareem Coomansingh The renewal of the Caribbean Research Ethics Education initiative (CREEii) (NIH Fogarty International Center, Grant: #R25TW009731) is strengthening skills for research ethics and responsibly conducting and publishing research in the Caribbean Basin through an online Masters in Bioethics (MScB) program. CREEii is delivered through partnerships between the Windward Mr. Kareem Coomansingh, MScB, MPH,

CREEii Program Coordinator and alumnus

Islands Research and Education Foundation (WINDREF) and St. George’s University (SGU) in Grenada, Universidad Autónoma de Querétaro (UAQ) in Mexico, and Clarkson University (CU) in the USA. It is led by Principal Investigator and Program Director, Cheryl Macpherson and site PI’s Hilda Romero Zepeda and Paul J. Cummins respectively at UAQ and CU. CREEii has enrolled two cohorts of fellows in its two-year Master’s in Bioethics (MScB) and just released the call for applications for its third and final cohort. CREEii’s MScB builds on the previously funded iteration which graduated over 80 professionals from 17 different low- and middle-income countries (LMIC) of the Caribbean basin through a oneyear graduate-level certificate program. The alumni of the first iteration are using the skills

obtained to develop courses, policies, and research involving research ethics in their own institutions and countries. Several of them are now CREEii faculty or consultants. The goals of the CREEii program are: 1.

To provide a culturally relevant knowledge base and skill set in research ethics that will allow fellows from low- and middle-income countries (LMICs) in the Caribbean basin to function as independent research ethicists in their home countries and institutions.

To prepare fellows and faculty to act as research ethics educators in their home countries and institutions.

To prepare fellows to facilitate institutional change with regard to ethical practices in research.

To develop and maintain centers of excellence in bioethics and research ethics at St. George’s University and the Universidad Autónoma de Querétaro.

To further develop and sustain a research ethics network in the Caribbean.

To develop additional research ethics capacity in the Caribbean.

The first cohort had an enrolment of14 fellows with 3 being from English speaking countries of the region and 11 from Spanish speaking ones (Grenada, Guyana, Mexico and Honduras). The following cohort enrolled 16 fellows with 6 from English speaking countries and 10 Spanish speaking countries. In addition to those mentioned above, these include Jamaica, St. Lucia, Costa Rica, and Guatemala.

36 Advancing Research Ethics…..cont’d

It should be noted that previous CREEi alumni have gone on to become senior leaders in the Bioethics Society of the English-Speaking Caribbean (BSEC) which works to increase knowledge and understanding of bioethics through promoting and fostering deliberations across the region (http://www.bioethicscaribe.com). In turn, some senior members of BSEC have played an important part in developing and guiding the CREEii program through their work as members of the CREEii Advisory Board. Notable CREEii activities in 2021 include launching of its website and establishment of the Center for Global Bioethics (CGB) in WINDREF. The CGB will advance education and analytic research about the influences of social, physical, and other environments on health and health priorities in the Caribbean Basin by providing resources for research ethics with a regional focus. The CGB will also offer opportunities for education and research involving global bioethics. In 2022, the CGB will develop partnerships to provide access to research ethics and bioethics resources, investigate regional research ethics and broader but related areas like the dependence

of health on environment and ecosystems, and promote public understanding of science and medicine. In 2022, CREEii will continue to update and deliver its curriculum; provide research supervisors to support fellows doing their master’s research, thesis, and submission for publication; and provide faculty development and mentoring for fellows’ professional development.

Application to apply to the MScB program, and more information can be found on the CREEii website: https://creeii.org/ . Applications to cohort # 3 will be accepted until Feb 23, 2022.

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MEMBERS’ ACCOMPLISHMENTS DR. DERRICK AARONS

2021 -

Commissioner – The worldwide Anglican Communion Science Commission

2021 -

Faculty – Center for Global Bioethics, St. George’s University, Grenada, West Indies

2021 2020 – 2021:

Member – The IBC Bureau of UNESCO Co-Coordinator and Co-Editor – UNESCO International Bioethics Committee (IBC) Project on “The Principle of Protecting Future Generations” – Paris, France

2020 –

Tutor – Masters in Bioethics, St. George’s University, Grenada, Universidad Autonoma de Queretaro, Mexico, and Clarkson University,USA –Caribbean Research Ethics Education Initiative

2020 –

Chief Executive Officer – the Health Professions Authority, Turks & Caicos Islands

PEER REVIEWED JOURNAL PUBLICATIONS: Aarons Derrick. Covid-19 vaccines and Caribbean countries. The International Bioethics Committee of UNESCO (IBC) Newsletter, July 2021; Vol.2; 41-44. Aarons DE. The disability-rights perspective within the bioethics agenda. Nursing Ethics Journal. Mar.’2020 https://journals.sagepub.com/doi/10.1177/0969733020906599 Member – Editorial Board – Developing World Bioethics Journal. Manuscripts reviewed 2020. Member – Scientific Board – Revista RedBioetica/UNESCO Journal. Manuscripts reviewed 2020.

International Reviewer – Journal Nursing Ethics. Manuscripts reviewed – 2020; 2021.

BOOK PUBLICATION: Aarons Derrick E. Vital Communications in Medicine. Published by Litho Press, Jamaica, and Amazon – 2021. SPECIAL PUBLICATIONS: Author – Sections on ‘Clinical Ethics’ and ‘Research Ethics’ – in the Report of the International Bioeth-

ics Committee (IBC) of UNESCO on “The Ethics of Neuro-Technology” – Apr’2021 ACADEMIC PROJECTS: 1. External Examiner – PhD Thesis, Faculty of Health Sciences, University of Witwatersrand, South Africa – 2021. 2. Supervised students doing their Masters in Bioethics – Clarkson University, USA: 2020 – 2021.

38 Members Accomplishments cont’d

KEYNOTE ADDRESSES: Sept ’21:

“Report on the Principle of Protecting Future Generations” – 12th Session of the Intergovernmental Bioethics Committee (IGBC) of UNESCO

April ’21:

“Ethical principles in research with human participants: An Overview” - Virtual Ethics Symposium, InterHealth Canada, TCI

Oct. 2020:

“Where are the Caribbean Islands in terms of public health, ethics, and Covid-19?” – UNESCO – Haifa Mexico International Bioethics Conference – Queretero, Mexico

Jan. 2020:

“Ethical Issues in Infectious Diseases” – Infectious Diseases Symposium, Antigua, West Indies

INTERNATIONAL CONFERENCE PRESENTATIONS: Sept.’21:

Will there be an improvement of ecosystems in the world post-pandemic? – 8th

International Congres of RedBioetica UNESCO, Colombia REGIONAL PRESENTATIONS: May ’21:

“Patient Confidentiality: Data Protection in today’s world” – Surgery Grand Rounds, Dept. of Surgery, Spanish Town Hospital, Jamaica

May ’21:

“Ethics in Coaching and Team Management” – Technical & Coaches Commission, Jamaica

July ’20:

“Covid-19 Pandemic in Jamaica: Social and bioethical aspects” – Meeting of the Central America and Caribbean Chapter of RedBioetica UNESCO, virtually.

CONFERENCES: - Annual Bioethics Forum on the Bioethics Society of the English-speaking Caribbean (BSEC) – Moderator of “Covid-19 Bioethical Perspectives” – virtual Forum via Zoom, Oct’2020 - Ad hoc Expert Group Meeting on The Ethics of Artificial Intelligence – Sub-regional consultation on the draft recommendations for UNESCO – via Zoom, Aug’20 - Infectious Diseases: What’s New and Emerging! – Antigua and Barbuda Medical Council Sympo-

sium, Jan’20

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Reviews of the Book - Vital Communication in Medicine

“Vital Communications in Medicine” is now available on Amazon for ordering either as E-Book (US$9.99) or as paperback (US$19.99).

Authored by Dr. Derrick Aarons MD, PhD, a family

physician from Jamaica who specialized in Bioethics and Experimental Medicine, the book captures decades of literary scholarship involving medical anthropology, the social sciences, the life sciences,

medicine, nursing, and health care settings. It includes empiric research done within hospitals, as well as recent developments in e-health, telemedicine, and a Covid-19 epidemic that entrenched the world. This book is written for all health care providers, students, as well as patients and persons who may become patients in the future! All readers will go away not only much more informed, but also better equipped as health care providers, as patients, and as potential patients to communicate adequately and more effectively, resulting in better patient satisfaction as well as in improved health outcomes for all patients, much to the relief of their concerned relatives and friends!

To purchase through Amazon: https://www.amazon.com/dp/B09DMW6PL2/ref=mp_s_a_1_3? dchild=1&keywords=dr+derrick+aarons&qid=1630259803&sr=8-3 To purchase through website: https://caribbeanbioethicist.com/

READERS’ REVIEWS OF THE BOOK “VITAL COMMUNICATIONS IN MEDICINE” POSTED ON AMAZON: Vital communications: “Vital Communications in Medicine is written by Dr. Derrick Aarons, a Family Practice physician who is trained in bioethics and experimental medicine. The arrangement of the book is in parts and sections beginning with concepts of communication and then goes into different areas in which a doctor interacts with patients. These doctor-patient interactions occur in either an outpatient private practice setting, public health care facilities or inside a hospital. The importance of doctors and other health care workers’ knowledge of a patient’s culture and socio-economic status in communication, is highlighted and stressed. The book was written from a trans-cultural perspective and includes perspec-

tives of communication in health care from both the global North (industrialized, developed countries) and the global South (less industrialized, lower and middle-income countries). The book therefore can be useful as a resource for doctors and other health care workers all over the world. “The book should be on the “required reading list” for all health care trainees especially medical students. However, practicing doctors, nurses and allied health care workers would also benefit from reading this book. Five-star rating.” - Dr. Michael Gayle, USA.

40 Reviews of the Book ….Cont’d

Deserving of the most prestigious book awards! “The author, Dr. Derrick Aarons, has provided the world with a publication that is thoroughly researched, insightful, and expertly penned. Vital Communications in Medicine is an excellent read that addresses an area that not only concerns health care professionals but all persons. The presentation and layout of the book made for an easy read, and I thoroughly appreciated the summaries provided at the end of each

chapter. It does not matter if you are a health care professional or a layperson, once you have read this book you will embrace effective communication as a tool to achieve the best outcomes in health. A MUST READ!” - Andre Morgan, Turks & Caicos Islands. I have lived this book! “This book details the importance of engaging and building relationships with doctors and other care professionals in seeking the best path in your health journey. It is an easy read, and each chapter ends with a detailed synopsis capturing the essence of the researched articles. A great book to add to your collection and share with others, especially now when poor communication, misinformation, and disinformation are causing vaccine apprehension for many.” – Carolyn, USA. Excellent and well-researched! “The author gives the readers a heavy dose of reality as he explores and highlights the realities of human experiences as we interact with each other. Everyone in a caregiving occupation will benefit. He documents the undesirable outcomes in health care when there is deficiency in communicative skills. I found correlations to my over four decades in the nursing profession, with multiple examples of how various categories of health care personnel could have better served the population given training in structured communication techniques. As the author opines effective communication and understanding can change the outcome for the patient. The author connects well with the reader; the content is relevant,

practical and current. The author’s expository style of writing makes this book an incredible reference text on the booklist of all health care professions. Five-star rating!” ~ Lorraine (Jamaica). The value of good communication in medicine: “The length of the book allows for a comfortable read and I am especially impressed by the summary at the end of each chapter and the epilogue at the end, that allows the main points to be reviewed. The author should be commended for his recognition of a gap in medicine that needed to be filled and commended even more for the effective way he himself communicates the information to the readers. Well done!” Dr. Selbourne Goode, USA.

Required reading: “This text is well written and gives credence to the subject matter. While it is about communication between medical professionals and patients, this can apply to people relating to each other in everyday life. Life is about communication and understanding the nuisances that aid and can make life easier. Brilliantly done.” – Rev. Garfield Campbell, Jamaica.

41 Reviews of the Book ….Cont’d

Timely and enlightening read: “I was pleasantly surprised by the insight, advice, guidance and wealth of knowledge that was shared by Dr. Aarons with medical practitioners, lay persons and other professionals. I found the book to be insightful, transparent, analytical, educational and much more. I developed a greater understanding and appreciation for the role communication plays between doctors and patients. A must read for all, since: "Your health is your wealth." I will certainly recommend this book to my family and friends.” – Antoinette, Jamaica. Exceptional! “Vital Communications in Medicine is a treasure chest of knowledge, written in a clear and detailed manner.

It is evident that if these principles of effective communication are adhered to, the

doctor-patient relationship will succeed in achieving the highest level of care, dignity and possibly lifesaving interventions.” - Liane Ifill, Trinidad.

Timely publication: “Well written publication which could not have come at a more appropriate time. Highly recommended for medical students and all healthcare professionals yet simply penned the average layperson can understand and apply the tenets therein. A must read!” – Dr. Neveta, Jamaica. The perfect read for young budding medical professionals: “An amazing read for medical professionals and health care trainers. Perfect for physicians and nurses who work in critical care units and large hospitals. Every doctor who is serious about ensuring that the

patient understands them effectively should read this book as a guide. Good concise work and an easy read.” – Dr. Patrick Lindo, Guyana.

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Bioethics Caribe Newsletter - February 2022

Articles inside

Editor’s Note

Members’ Accomplishments

President’s Message