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POST TIME: 30 May, 2018 00:00 00 AM
Ethical issues regarding medical research
Research ethics entails the wider notion of scientific integrity but is best known and most developed in relation to medical research involving human subjects
Mohammed Abul Kalam

Ethical issues regarding medical research

More and more research is conducted in developing countries where populations suffer from a high burden of diseases. Various factors affect the conditions under which the research is conducted, such as differences in cultures, in sanitation, in standards of care (that vary by sponsors and participants in studies), and differences manifested in political, legal and social contexts specific to these countries. Under these circumstances, it is not surprising that ethical issues emerge. They are generally viewed from two perspectives: by the universality or the relatively of the standards used, and through the perspective of the local ethics committees in the countries where the research is being conducted. One can only be delighted by the increasing number of initiatives aimed at dealing with these major issues. However, in so far in ethical regulation of research in developing countries is concerned, a larger variety of actors and institutions needs to become involved.

These actors should include sponsors of research, the investigators who conduct it, the national and international institutions that draw up codes of good practices, ethical review committees, legal practitioners and public authorities who draft the laws, academics or researchers who thoroughly analyse the issues, journal editors, and scientific reviewers who require compliance with ethical rules as a condition of publication, the mainstream media who may denounce certain practices, or non-governmental organizations who may represent and translate the expectations of study subjects.

These different actors, who are subject to multiple and contradictory rationales, have the responsibility of supporting innovation in therapy or prevention, and ensuring the best possible protection of study subjects against abuses.

What are the challenges faced by each actor in this process? What are practical solutions? What dialogue occurs between those actors? To what degree, and how is greater interaction between these various actors possible? Is ethics really interdisciplinary, inter-institutional and international? Basing examples, I will try to relate the fundamental questions of the ethics of research in this write-up.

Research ethics entails the wider notion of scientific integrity but is best known and most developed in relation to medical research involving human subjects. The development of human subjects’ research ethics guidelines can neither be divorced from breaches of ethical conduct in human subjects’ research nor wholly reduced to a reaction to these events. But beginning with the Nuremberg Code (1947), balancing risks and benefits to research subjects and getting their informed consent have been cornerstones of international research ethics guidelines. Far more influential than the Nuremberg Code, the Declaration of Helsinki from the World Medical Association (WMA) is a fundamental document in international human subjects’ research ethics guidelines. Its initial 1964 version included provisions for proxy consent for those with diminished autonomy. Its 1975 revision called for review of research by an independent committee, now known as an ethics review committee. The use of such committees began spreading under the aegis of WHO and then in response to the HIV/AIDS pandemic, as the number of large-scale vaccine and drug trials grew in developing countries. In the United States, research regulations set forth in the Common Rule govern ethics review committees as well as all human subjects’ research that receives U.S. government funding. In the United States, a standing ethics review committee generally functions within a specific governmental or university institution and therefore is referred to as an institutional review board (IRB). Beginning in 1982, the Council for International Organizations of Medical Sciences (CIOMS), in collaboration with WHO, proposed international ethical guidelines for biomedical research involving human subjects.

CIOMS’s most recent research guidelines 2002, for example, contain more than 60 pages of text, explanation, and commentary. But ensuring ethical conduct and scientific integrity in research requires more than the oversight function of ethical review committees. It also requires extensive training not only in research ethics but also in a number of related areas. Training and guidelines should cover, among other things, mentoring of junior researchers, authorship and publications policy, conflicts of interest that arise in partnerships and collaborative science, and data acquisition, management, sharing and ownership. Ethics training can help develop moral judgment. The hope is that training and application will enable practitioners to reason about new, difficult, or ambiguous cases in morally discerning ways.

Clinical ethics address the ethical issues that arise in clinical practice. Until the advent of bioethics, medical professionalism emphasized the health care provider’s obligation to prioritize the patient’s welfare, the health care provider’s professional judgment about what would most benefit the patient, and the importance of establishing patient trust. The traditional model of clinical ethics was frankly paternalistic. Under the influence of bioethics, many health care providers began embracing a more patient-cantered model of care that emphasized patient autonomy and informed consent. This patient-cantered model conceives care as a contract between patient and provider. The emphasis on contracts strikes some as an inappropriate consumerist model that undervalues professional judgment and undermines patient trust in the medical profession. Tensions between these two models have led to a compromise that reasserts the importance of medical professionalism and clinical judgment, while acknowledging the importance of respecting patient autonomy.

Bioethics has a range of meanings, the first of which applies to ethical issues brought about by advances in biomedicine and biotechnology. Ethical issues that arise from using life-sustaining technologies in end-of-life and beginning-of-life care epitomize this sense of bioethics. But bioethics also arose in response to medical paternalism and to the abuse of human subjects in medical research.

Bioethics has championed informed consent, patient autonomy in doctor-patient relationships and the safety of human subjects in research. However, many bioethicists think the focus on clinical ethics and on personal autonomy unduly restricts bioethics’ purview. They advocate a more holistic, social justice approach in bioethics, which has been referred to as “population-based bioethics” or “integrative bioethics”. It can be argued that this expansion of bioethics beyond clinical ethics into population issues moves bioethics into the arena of public health ethics.

Principlism came into being in a 1979 document called the Belmont Report. The report was the work of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, which convened in 1974 partly in response to the exposé of the U.S. Public Health Service Tuskegee Syphilis Study. The Belmont Report became the basis for revising 45 CFR 46, the so-called Common Rule, partof the legally binding U.S. Code of Federal Regulations, governing the protection of human subjects. The Belmont Report clearly explained the underlying ethical principles that informed existing regulations and provided an ethical framework for thinking about subsequent regulations. Principlism has remained the predominant ethical framework in biomedical ethics. Its explanatory groundwork accounts for much of its success, but its relevance to medicine and research, the prestige that attaches to these fields, and its compatibility with liberal individualism also have played a role.

Now several questions raised on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and commodification in research have shed light on the importance of transparency.

Beneficence (doing good) and nonmaleficence (doing no harm) date back to the Hippocratic Oath as medical principles. Collapsing them both into beneficence, as the Belmont Report does, underscores the practical consideration that biomedical decisions generally aim to optimize net benefit over harm, rather than to maximize only benefits or minimize only harms or risks. However, these principles are distinct, not mere opposites. Not doing harm has a certain priority (first, do no harm), because not benefitting someone seems a less serious offense than doing that person harm. That priority partly reflects the human tendency more readily to forgive overlooked benefits (errors of omission) than deliberate actions resulting in harm (errors of commission).

Justice has several meanings that include due process and fair deliberative procedure, properly assessing what people are owed or due, and equitable distribution of burdens and benefits. According to philosophic tradition, justice has always functioned dually, applying to individuals but more importantly serving as an overarching principle for adjudicating competing claims in relation to the group or to other members of society. The phrase, “social justice,” then, is redundant but in political contexts marked by individualism serves as a reminder of justice’s social dimension. In fact, this phrase came into vogue in public health circles to counter the ideology of “market justice,” which views the equal access of individuals to the free-market as a valid, reliable, and preferred means for sorting out issues of economic and social justice. The notion of health equity, which compares different groups, primarily refers to this social dimension of justice, although denial of access to health care, a contributing factor to health inequity, violates what the individual is owed.

Respect for persons emphasizes that individuals, as agents in charge of their own lives and bodies, have the right to make decisions and choices free from undue interference. Respect for people forms the basis of informed consent, namely, the right of patients and human research subjects to be informed of, and to assent to, medical or research procedures they might undergo, especially procedures that pose potential harm or risk. Conducting research on human subjects or performing medical procedures on patients without their prior knowledge or consent in most cases violates their personal autonomy. However, health professionals have a special (i.e., paternal) obligation to look out for the welfare of people with diminished decisional capacity—such as those in a coma or the very young—and to protect them from harm.

These four principles were originally conceived as prima facie principles, that is, each expressed a self-evident though not absolutely binding obligation and none had an inherent priority over another. However, in many Western countries and in the United States in particular, respect for persons has dominated discussion in bioethics, clinical ethics, and research ethics where it often takes precedence as a moral consideration over the other principles. This ascendancy most likely reflects the high value that these countries place on liberty and freedom.

At any rate, in public discourse generally and in public debate about public health interventions, respect for persons often amounts to an insistence on non-interference with individual free choice or with personal preferences. In part for this reason, the social justice movement has had to challenge the emphasis on respect for persons in order to promote the public good and health equity.

The writer is Former Head, Department of Medical Sociology, Institute of Epidemiology, Disease Control & Research (IEDCR), E-mail: med_sociology_iedcr@yahoo.com