Medical Ethics, Human Rights and the Potential Covid-19 Vaccination

Ethics, human rights and justice had not always gone hand in hand. Our collective history and ever-changing consensus on moral duties necessitated the definition of certain civil liberties and human rights such as the right to life, freedom from torture and inhuman and degrading treatment, and personal liberty. Human rights do not only dictate that we, as the humankind, must collectively recognise the worth, dignity and interests of one another but must do so under all circumstances. However, although we theoretically possess certain fundamental rights, we still encounter various dilemmas as our rights and liberties must, at times, be balanced with other conflicting interests. This is not an easy hurdle to confront, and the law cannot, with certainty, provide an answer to all moral and ethical problems.

Currently, in the day and age of the novel corona disease outbreak, there is much to examine with respect to personal rights and interests. Although states are vested with the positive obligation to protect and preserve their citizens’ rights to life, the primary means to do so are currently unavailable. As we hope for the creation of a vaccine that would immunize the general public and relieve us from the adverse effects of the outbreak, the manner under which virologists enable us to defend ourselves from contagious and serious diseases and the moral and ethical issues involved in the creation and development of such products should be pondered upon.

The primary tool for the prevention of wide-spread disease outbreaks is a vaccine. It is a product which contains a small amount of weak or dead viruses, bacteria or germs, and which, generally, immunizes a person against a specific type of disease. The creation of such a product requires virologists to conduct extensive research whereby they aim to generate new scientific knowledge through testing various hypothesises. Henceforth, they ultimately inject human subjects with a candidate product with uncertain effects and unproven effectiveness in the hopes of acquiring previously unknown information. The terms unknown information, uncertain effects and unproven effectiveness highlight the importance and significance of the research conducted.

Virologists and research teams cannot freely initiate and undertake their research as they see fit. They are conferred with numerous obligations and duties under national, regional laws and international guidelines and standards. Most importantly, they are vested with the obligation to justify the contents and structure of the clinical development programme they have devised for the purposes of conducting research on their candidate vaccine. This ensures that the four ethical principles that govern all medical practices, namely respect for personal autonomy, beneficence, nonmaleficence and justice, are present. Accordingly, researchers are under the obligation to acquire approvals from national and/or regional formal regulatory authorities and ethics committees before they begin testing on human subjects. Moreover, they are under the obligation to continuously monitor and evaluate practical and ethical problems on a case by case basis and determine a reasonable and appropriate course of action concerning all complications that may arise during their research.

Vaccination development research is divided into two stages, pre-clinical and clinical development, whereby virologists test and examine the safety, efficacy, efficiency and suitability of their candidate vaccine. The pre-clinical development stage concerns the use of in vitro techniques and, when necessary, the use of in vivo techniques on animals in line with good laboratory practice guidelines and national guidelines on animal experimentation. This stage aims to identify the characteristics, risks and the suitability of the candidate vaccine and acts as a prerequisite for clinical trials. In the event pre-clinical trials produce satisfactory results which justify subsequent clinical studies on human subjects, the clinical development stage is embarked upon. This stage is built on rigorous ethical principles with emphasis on safety, efficacy and quality as it concerns studies on human test subjects. It is divided into four trials which are pursued over several years. Briefly, Phase 1 studies consist of small scale studies on healthy human subjects, Phase 2 studies consist of a larger trial whereby the candidate vaccine is injected to a group of people suffering from the condition, Phase 3 studies concern a larger group of subjects who are vaccinated and monitored for an extended period, and Phase 4 studies are dedicated to examining the vaccines’ general use by the wider public, particularly on persons who were initially excluded from clinical trials.

When particular attention is given to the extraordinary times we are encountering, there are differing views on how these clinical trials should be conducted. Whilst some organisations are adopting accelerated clinical trial procedures, others are voluntarily infusing healthy patients with the virus or a milder type of the virus. There are also debates on whether persons who are categorised as vulnerable to the virus should be included in clinical trials or whether the acceleration of such clinical trials is in the best interest of our society considering the unknown short or long-term effects of a candidate vaccine. These differing views are based on the fact that our moral reasonings differ from one another and what seems fit and reasonable to some may not align with the views of another. As the notion of ethics stems from our understanding of what is right and wrong, these differing perspectives are a reflection of our priorities and views on conflicting interests, which may also influence the way clinical researches are currently conducted and regulated.

Two differing approaches that are primarily adopted with respect to ethics. One view is the utilitarian approach centred around the idea that the most ethical choice is the one that will produce the grates good for the greatest numbers. Hence, it justifies cutting corners and seeking faster ways to gain an effective end-product, although it may pose significant risks to the health of test subjects. This approach was adopted by Edward Jenner, the person who discovered the smallpox vaccine by deliberately injecting an eight-year-old with cowpox following the injection of smallpox, potentially endangering his life. The second approach is the deontological or Kantian approach centred on the well-being of a person. It can be categorised as a more humanitarian approach which adopts the principle that an action cannot be justified because of its favourable outcomes. Philosopher Immanuel Kant, who is often associated with this approach, has emphasised that one cannot and should not be treated as a means to an end. Whilst it is acknowledged that these approaches are opposite extremes, the reality of the pandemic demonstrates the adoption of the utilitarian approach by many states and health services. Examples include state policies not to mandate strong physical distancing policies aimed to create wide-spread immunity although it puts the elderly and those with chronic conditions under significant risk. Meanwhile, other contrary examples include countries which have acted in a bold manner (arguably deontologically) in slowing down the spread of the disease among the public within weeks.

In addition to general principles found under human rights law, there is much to examine and consider when one deals with research on human subjects. While terms such as respect for individual autonomy, nonmaleficence and justice, found under all relevant national laws or international guidelines, are of paramount importance, they are also a reflection of human kinds continuous troubles with balancing conflicting interests. Likewise, although one may assume that these terms are self-evident, these principles have constantly been redefined to adapt to societal norms and complications encountered in the field of medical research. Similarly, whilst it is quite simple to provide notable examples of complications encountered during clinical researches (the TGN 1412 disaster being one of them), the real ethical issues that must be scrutinised are found in the manner subjects are recruited, the depth of the information they are provided, the way and manner their consents are acquired, and the emphasis put on their well-being versus the personal interests of research teams, stakeholders or sponsors. Recent examples of prominent doctors stating that clinical trials concerning the novel coronavirus disease should be undertaken in countries with limited access to masks and equipment once again highlight the importance of such debates on ethical principles.

Currently, almost all countries and territories are impacted by the outbreak, and almost half of the world’s population is confined in some manner. Lives, businesses have been put on hold, and the economic disruption the outbreak has caused is expected to be long-lasting and profound. Under these conditions, the dilemma we are faced with is how our normalcy expectancy should be reflected in the numerous clinical studies that are ongoing today. The answer lies with soft laws concerning medical ethics due to the lack of an internationally accepted legal framework governing clinical research. Whilst these soft laws lack enforcement and penalty capacities, they are important documents which must be used to guide national courts when dealing with ethical issues that may arise in light of the outbreak.

Historically, although Germany was the first country to proclaim national ethical criteria for human experimentation, the conducts of researchers and members of the medical profession in Germany during the Second World War were also the reason for the establishment of the first international code of research. The trials widely known as the Nuremberg Doctors’ Trials or the Medical Case resulted in the establishment of the Nuremberg Code, a framework aimed to govern the future conduct of medical research. Although all actions undertaken by German officials during the Second World War were in line with the law in Germany, the court found some of the most renowned physicians of the time had committed crimes against humanity and war crimes due to their grave unethical conduct. The Code highlighted ten ethical principles and completely changed the views around ethical conduct of medical research. It emphasised the importance of personal autonomy and highlighted the importance of the balance that must be stuck during medical experiments.

Thereafter, the Ethical Principles for Medical Research Involving Human Subjects, also known as the Helsinki Declaration, was drafted by the World Medical Association during 1954. This document focused on principles that must be followed in clinical trials involving human subjects and went further than just stating fundamental principles. It examines circumstances where research on human subjects could be held as legitimate. Some essential principles highlighted in the Helsinki Declaration include consent, privacy and confidentiality of the research subject, the right to withdraw from the research and the need for proportionality between potential benefits and risks.

With grave concerns that medical research in developing countries were conducted in a manner which were not ethical or based on moral grounds the World Health Organisation and the Council for International Organisations of Medical Sciences published the International Ethical Guidelines for Biomedical Research Involving Human Subjects during 1982. The text has been revised on a number of occasions and relates to ethical justifications, ethical reviews, informed consent, the vulnerability of certain types of persons or communities, equality regarding burdens and benefits and strengthening national and local capacity for ethical review. The first guideline explicitly highlights that the rights of test subjects must be upheld under all circumstances, by stating:

 “The ethical justification for undertaking health-related research involving humans is its scientific and social value: the prospect of generating the knowledge and the means necessary to protect and promote people’s health. Patients, health professionals, researchers, policy-makers, public health officials, pharmaceutical companies and others rely on the results of research for activities and decisions that impact individual and public health, welfare, and the use of limited resources. Therefore, researchers, sponsors, research ethics committees, and health authorities, must ensure that proposed studies are scientifically sound, build on an adequate prior knowledge base, and are likely to generate valuable information.

Although scientific and social value are the fundamental justification for undertaking research, researchers, sponsors, research ethics committees and health authorities have a moral obligation to ensure that all research is carried out in ways that uphold human rights, and respect, protect, and are fair to study participants and the communities in which the research is conducted. Scientific and social value cannot legitimate subjecting study participants or host communities to mistreatment, or injustice.”

These international ethical codes and declarations do not only act as pieces of important documents but also as reminders of our collective history and the manner in which the medical profession and its views have progressed. Although it is generally accepted that each research team undertaking the important task of creating a vaccine must calculate potential risks and benefits and ensure that interests such as self-interest or potential future funding do not trump a subjects’ rights (possibly more so during a global pandemic), the primary obligation to ensure that this balance is struck lies with national regulatory authorities and ethical committees’. The universality of human rights demands that fundamental liberties and human rights should prevail and should not be restrained under any circumstances, however dire they may be. Drastic circumstances certainly should not warrant drastic measures.

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Murat Erbilen
Murat ErbilenPartner
Alya Yamakoğlu
Alya YamakoğluAssociate