Understanding Institutional Review Boards: A Conversation with Jack Corman
Introduction
In the first part of our two-part series, Saaqshi Sharma and Gazal Vakili from Clinical Trials Canada magazine engage in a discussion with Jack Corman, President of the Institutional Review Board Services based in Aurora, Ontario. The focus of their conversation is centered on patient safety and research ethics.
The Role of Institutional Review Boards
SS: What is an Institutional Review Board (IRB) and why is it significant?
JC: Institutional Review Boards are responsible for reviewing the scientific and ethical aspects of research studies that involve human participants. The concept originated from the Declaration of Helsinki in the 1960s and was further solidified into U.S. law following the Tuskegee Syphilis Study scandal and the enactment of the National Research Act. Historical events have demonstrated that research sponsors and researchers, despite good intentions, require an independent review to ensure the protection of participants’ rights and welfare.
The primary objective of an IRB is to safeguard participants by ensuring research is scientifically valid and that measures are in place to minimize risks. Participants must be adequately informed to make autonomous decisions regarding their involvement, understanding the risks and benefits without coercion or undue influence. This is the fundamental mission of our organization: to uphold ethical standards in research.
The Meaning of Ethics in Research
SS: As President of IRB Services, what does ethics signify for you?
JC: While ethics is technically a branch of philosophy, its essence transcends mere philosophical discourse. For me, ethics is fundamentally about “doing the right thing.” Defining what constitutes the right action can be complex, but it is reflected in the respect we show to individuals. Ethics extends beyond research; it pervades our daily interactions with family, friends, and colleagues.
We bear a social responsibility to contribute positively, whether through social marketing or participation in advocacy groups promoting best practices. In the realm of research, ethics is about ensuring the well-being of the individual research participant, emphasizing that studies should be designed to benefit them while minimizing risks.
Motivations for Volunteering in Research
SS: Based on your experience, what motivates individuals to volunteer for research, and how does an IRB advocate for participant safety?
JC: Conducting trials or experiments on humans carries significant responsibilities that extend beyond the individual participants involved. One key responsibility is ensuring that public communications are truthful. In advertising, it can be tempting to over-promise benefits.
Individuals who consider participating in research often have two primary motivations. The first is self-interest; many believe that a new treatment may provide better outcomes, especially when they or their children are not achieving desired results. However, it is essential to recognize that clinical research involves uncertainties, and participants cannot be assured of positive outcomes. This principle is crucial for ethics boards, which must ensure that all communications are honest and do not promise benefits.
The second reason many volunteers participate, particularly in Phase 1 studies with healthy individuals, is financial compensation. While it is unethical to “buy” research subjects, offering payment can be a legitimate incentive, provided it is not excessive or coercive. Additionally, some individuals volunteer to access treatments that may be unaffordable or not covered by government programs, such as advanced anti-inflammatory or targeted cancer therapies.
Advertising and Communication in Research
It is also vital to consider how advertising messages are conveyed. The imagery utilized can significantly influence perceptions. For instance, beer advertisements often depict individuals enjoying themselves, which is not comparable to research participation. It is misleading to suggest that volunteering for an untested study will be a carefree experience; research can entail serious risks and responsibilities.
Conclusion and Upcoming Insights
Stay tuned for the winter edition of Clinical Trials Canada magazine, where Jack Corman shares insights from his interactions with concerned patients and emphasizes the necessity of the informed consent process in a supportive environment. Don’t miss it!