Whose protection is it anyway?

by Julie Fine, Legal Specialist, Pfizer Inc. (Please note: The views presented here are my own and do not reflect the positions or policies of Pfizer Inc.)

Greetings from not-so-sunny San Diego! I attended the pre-conference session Advanced Research Ethics, which was based on curriculum developed by the Department of Bioethics at the National Institute of Health (NIH), and delivered by their faculty. As a first time attendee, this day was certainly an immersion in research ethics for me.

Throughout the day, I found myself thinking about the presentation Protection, Over-Protection, and Pseudo-Protection by Alan Wertheimer, PhD. As a bioethics scholar, Wertheimer offered an intriguing perspective on the role of institutional review boards (IRBs) and the ways in which they may go beyond what is necessary to protect human subjects—to the point where their actions actually impede investigation and novel research.

Since the mid-60s, NIH has required independent review boards and written informed consent documentation for human research studies. It’s assumed that this expectation has protected the rights and welfare of participants. However, we don’t know how much influence they truly have had. What we do know is that an entire industry of institutional programs, and a profession to administer them, has evolved. The IRB role has morphed beyond that of legitimate protection to what Wertheimer refers to as protectionism, over-protection, and pseudo-protection.

According to Wertheimer, legitimate protection has two central aspects:

  1. Risks are reasonable in relation to expected benefit and the importance of the knowledge reasonably expected to result (paraphrased from 45CFR46); and
  2. Valid informed consent.

But IRBs often exert power over potential participants by deciding what protocols they may go into.Despite scientific validity and social value, they may place strict limitations on risk and fail to respect the autonomy of prospective subjects—i.e, overprotection. Regardless of the compensatory benefit perceived by subjects, the IRB is motivated to protect them from harm and prevent coercion and undo influence—particularly when payment is involved (i.e., pseudo-protection). IRBs are biased to protect, but perhaps not legitimately so.

This got me thinking about why subjects agree to participate in research studies and their own risk/benefit assessment. Is it because the study’s drug is their last resort in treatment of a life-threatening illness? Is it altruism for the good of research? Or is it because they’ll get paid? And does consent justify exposure to risk?

With these questions buzzing in my head, I envision a scale balancing the risk of harm with the benefits of participation, striving for a state of equilibrium. Over the next few days, I’ll have these questions in the back of my mind while I seek answers in the sessions I’ll attend, taking on the perspective of the subjects we wish to protect.