Monday 27 September 2021

Exploring Ethics in Clinical Research

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If there are any positives to be discovered in the wake of the devastating COVID-19 pandemic, they may be found in the way that the outbreak has illuminated the clinical research process. The urgent search for life-saving therapeutics and vaccines has shed new light on the process of developing, testing, and disseminating medical treatments.

By Indiana Lee

Additionally, it has brought public attention to the all-important issue of ethics in clinical research. The reality is that the ethical implications of clinical research run deep, presenting a host of moral questions which provide few clear or easy answers. Clinical research has been and always will be necessary and urgent work, as with the case of COVID-19. Yet it is attended by a myriad of ethical dilemmas which may never be entirely resolved.

The Risk/Benefit Analysis

Clinical research, by definition, is seldom fully free of risk, and this means that it is incumbent upon researchers and stakeholders alike to accurately assess whether prospective benefits do, in fact, outweigh potential risks. This, however, can be a formidable challenge, particularly in the early stages of the process, when the unknowns may significantly outnumber the certainties.


In the presence of so much ambiguity, undertaking pharmacological or other forms of clinical research necessarily puts some persons at risk in the hope of achieving a significant benefit for the many. And this is, inherently, a fraught process, one deeply embedded in systems of power, equity, and social justice.


For all its lofty ambitions and ostensibly principled motivations, the history of clinical research is replete with examples of breathtaking abuse and exploitation, from the infamous “twin experiments” of Dr. Menghele to the notorious Tuskegee trials. Further, throughout the history of clinical research, it has been the powerless and the marginalized who have typically borne the greatest risk and, all too often, who have paid the price to serve the needs and interests of the powerful.

Research Ethics and Power Inequities

The rampant ethical abuses of past decades have been largely eradicated, or at least curtailed, by intensive international regulations designed to prevent the recurrence of past horrors. However, that by no means suggests that power inequities have been wholly erased, as can be seen perhaps most starkly in the rise of the so-called “professional patient.”


Professional patients are ones who habitually enroll in clinical trials, often including multiple simultaneous trials, despite regulations forbidding this. In addition to undermining the validity of the trials in which professional patients are enrolled, the professional patient must also be understood to reflect deeper, more systemic ethical challenges in clinical research.


For example, professional patients may use clinical trials as a primary source of income or even of medical care. And this means that clinical researchers may be exploiting vulnerable persons, those who may have been denied access to stable employment and quality healthcare by an inequitable social structure. And, thus, the powerful continue to benefit through the suffering of the weak.

The Issue of Informed Consent

Ethical clinical research, whatever form it may take and for whatever purposes it may be intended, must be grounded in the fundamental principles of beneficence, justice, and respect for individuals. The concept of informed consent derives from and is motivated by these three pillars of ethical clinical research and practice.


Informed consent, above all, is predicated upon the presumption that no individual should be made the subject of clinical research against their will. Further, the concept holds that consent cannot be given unless and until the individual, or the person(s) designated to act in the person’s best interest, is fully aware of the purposes, processes, and potential and known risks of the research, as well as their own right to refuse or to withdraw consent at any time.


In theory, of course, informed consent would seem to provide the ultimate safeguard against unethical research practices. In reality, however, informed consent is rarely if ever what the name suggests. For informed consent to function as intended, then it would have to be assumed that all study populations in all clinical research studies are not only in possession of their full mental, physical, and emotional faculties, but that they also possess full and unblemished understanding of the study and its risks.


While this is an admirable goal to aspire to, it is hardly ever achieved, if at all, “on the ground,” particularly in the study of some of humanity’s most devastating illnesses, such as Alzheimer’s, pediatric cancers, or mental illness. In cases such as these, researchers are often tasked to draw from a population of vulnerable subjects, including children, seniors with cognitive impairments, and persons with mental illness. All are groups that are unlikely to be able to provide informed consent.


To be sure, a constellation of internal and external safeguards exists to protect these populations. This includes not only the requirement that designated guardians provide informed consent by proxy but also that regulatory agencies and institutional review boards (IRB) oversee all phases of clinical research, from concept to execution to reporting. The goal in doing so is not only to ensure that all subjects and stakeholders are treated ethically, but also that the study is necessary and relevant, serving a purpose for which the potential benefits outweigh prospective risks.


An important example of this is the recent research into the use of antidepressant medications to treat patients with anxiety. Without observational studies of the reported benefits of these medications helping anxious patients, clinical trials might never have been pursued and, without research evidence to support treating some patients who have generalized anxiety disorder (GAD) with antidepressants, then these patients would have been denied access to the most effective treatment.

The Takeaway

Clinical research is a necessary and life-saving endeavor. But it is also one fraught with ethical challenges, including power inequities, social in/justice, and individual rights. Nevertheless, through mechanisms such as informed consent and institutional review, it is to be hoped that ethics in clinical research will continue to be prioritized and pursued.

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