Protecting Research Participants: Finding the Right Balance

The teaching of ethical principles is included in many courses that train researchers on  “responsible conduct of research”. The IRB 101sm preconference program at the 2018 Advancing Ethical Research Conference (AER18), however, was unique in describing the history of the development of modern research ethics, and then providing practical application in real research practice.

The teaching of ethics is not easy, as the boundaries between right and wrong may not always be obvious or clear-cut. Elucidating the ethical path can be a complex and challenging process.

During the course, first I identified vulnerable populations, at risk of being misused in the name of research. This could occur either by coercion or a lack of knowledge or understanding (or ability to obtain and understand that knowledge). Although I do understand the fundamental tension in the conduct of research i.e. “greater good” vs “best interest” of the participants, I recognized that any harm which is scientifically unnecessary is ethically unacceptable.

In this session, there was an increased emphasis on the ethical principle of respect for autonomy. Additionally, following key components of research ethics were highlighted.

  • Clinical research with human subjects must be clinically justified and scientifically sound
  • Informed consent is required
  • Oversight of research is required

Adequate oversight is essential—even in the worst examples of research gone wrong, sometimes the researchers had the best of intentions. This course demonstrated how various research incidents and atrocities have led to tighter oversight of human-subjects research. After describing widely publicized cases of research abuse, the presenters showed the relationship between each regulation and how each is traced back to these cases. This helped make the ethical framework on which current federal regulations for the protection of human participants in research are based more approachable and understandable.

The presentation also showed how federal agencies adopted the core of these regulations in a common Federal Policy for the Protection of Human Subjects which is now known colloquially as the “Common Rule“. Presenters also discussed how Common Rule application may be different among various regulatory authorities such as FDA and HHS. Examples include institutional assurance, definitions and applicability, exemptions and waiver of consent. This is particularly important and more relevant with the revised Rule that just went into effect.

Attending this session provided me with insight into how to truly protect the health and welfare of research participants. I believe such discussion sessions can be helpful the researchers and IRB professionals alike when making ethically appropriate decisions, in the conduct of medical research.

Hence, researchers should be made aware of the range of ethical problems to help them learn how to avoid them. The ultimate goal should be to ensure that human research is conducted ethically, with a sound scientific rationale, to maximize benefits and minimize the risks. As this is achieved, all will benefit significantly.

Muhammad Waseem, MD, MS, CIP, CPI, CCRP, is currently Professor of Emergency Medicine in Clinical Pediatrics at Weill Cornell Medical College, New York. He completed a residency in Pediatrics and a fellowship in Pediatric Emergency Medicine. He also holds Master’s degrees in Clinical Investigation and Epidemiology & Health Services Research from Cornell University, New York. He serves as the Research Director for the Department of Emergency Medicine and Vice chair for the IRB at Lincoln Medical Center Bronx, New York.

His special interests are ethical issues involving children and protection of vulnerable populations. He addresses these interests via his work in the pediatric emergency department as an investigator and educator. He has been serving an under-represented population in an urban community for over 20 years.

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