This week, we sat down with Elisa Hurley, PRIM&R’s education director and presenter of last week’s Research Ethics Beyond Respect, Beneficence, and Justice webinar. We discussed what it takes to do research ethics well, ways to become involved in human subjects protections, and key resources in the field.
Alexandra Shlimovich (AS): What does someone need to understand to do research ethics well?
Elisa Hurley (EH): I come at this question from the perspective of someone who teaches research ethics, and not as a human research protections professional. From my perspective, to do research ethics well, it’s important to first and foremost understand that it goes beyond compliance. As I mentioned during the webinar, compliance is about following the rules; it’s about dotting the I’s and crossing the T’s. Ethics goes beyond compliance. Ethics is about making judgments about what is right, based on reflection and reasoning. And to reflect and reason well, it is imperative to understand some of the key concepts of research ethics—not just respect, beneficence, and justice, but also concepts such as undue influence, coercion, vulnerability, reasonable risk-benefit ratio, and informed consent. We also have to understand that what makes influence undue, or what constitutes a reasonable risk-benefit ratio, or what counts as sufficiently informed consent is itself a matter for argument and reasoning. In fact, I think it’s pretty clear that our regulations are precisely set up so that we can’t just follow them; rather, the regulations call for the judgment, the deliberation, of a group—namely, the institutional review board (IRB).
AS: What are some ways people can obtain the experience necessary to enter this field?
EH: This is an interesting question, because there really isn’t a clearly defined path into the research ethics professions. My own view is that a master’s degree in bioethics that includes courses or a specialization in research ethics can never hurt for those interested in the theoretical foundations of the ethics of research with human subjects (as of course I am).
However, an advanced degree isn’t necessary. Probably one of the best ways to gain useful experience for anyone interested in entering the human research protections field is to serve on an IRB as an unaffiliated/community member. Most IRB offices have publicly accessible websites that include contact information for the administrator/manager and other staff. Searching online for local IRBs and making calls to administrators about their needs for unaffiliated members might be a way to get a foot in the door. Once there, don’t be shy about talking to the IRB staff about their roles, how they got there, etc.
I also think meeting people in the field who can not only share their stories but provide contacts is key. Joining a professional organization, such as PRIM&R, can provide those invaluable networking opportunities. In fact, PRIM&R’s mentoring program matches mentees and mentors based on needs and interests and is a wonderful resource for our members.
AS: What follow up readings or resources would you suggest to the attendees of this webinar?
EH: If people are interested in becoming more familiar with the concepts that are at the heart of research ethics, the best resource I can recommend is The Oxford Textbook of Clinical Research Ethics, published in 2008 and edited by Zeke Emanuel et al. It’s an unparalleled collection of original articles on just about every aspect of ethical research with human subjects, from the history of the field and its seminal documents, to issues in research design, subject selection, informed consent, risk-benefit analysis, to ethical issues unique to social science and behavioral research, and much more. I also can’t say enough about the value of reading and re-reading The Belmont Report. Every time I go back to it, I am surprised to find some new nuance or point that I hadn’t noticed before. It’s by no means perfect—for instance, it seems to universally advocate protecting research subjects, including the vulnerable, rather than empowering them in the research enterprise. Nevertheless, it remains such an impressive document—elegant, clear, insightful, and instructive, and all the more powerful for its brevity.
If you’re interested in learning more about the fundamentals of research ethics and did not have a chance to participate in last week’s webinar, the archive is available for purchase. PRIM&R members can also access additional research ethics readings on our Knowledge Center.
Dr. Hurley — a few reactions to your webinar…
Informed consent: disclosure — The example you described on-air during the "empirical evidence of persistence of therapeutic misconception" slide sounded like a paraphrase of "Case example #3" in Appelbaum, Roth and Lidz's 1982 paper originally describing therapeutic misconception (p327). I think it's important to note that expectations for informed consent process and documentation have changed signficantly since then.
* From the Discussion in Appelbaum's article: “[I]t may be necessary to assault the beliefs that underlie the therapeutic distortions. Subjects may have to be told explicitly … that various aspects of the study may turn out not to be in their best interests at all…. [I]t is questionable whether investigators would be willing to be quite so brutal about shattering subjects’ therapeutic misconceptions. The perception of potential benefit, after all, is one of the most powerful incentives for subjects to agree to take part in research projects.”
* Howbeit potential subjects' understanding of research intent and potential benefit is still a research ethics issue, recent articles like Jansen et al.'s Unrealistic Optimism in Early-Phase Oncology Trials suggest the current issue is more subtle: “Unrealistic optimism need not result from cognitive mistakes about the risks and benefits associated with an event…. [U]nrealistic expectations of benefit among patient-subjects in early-phase oncology trials have been shown to persist even after the therapeutic misconception has been dispelled.”
Coercion v. undue influence —
* I agree with you that there is a distinction between these terms which is often lost in IRB meeteings. Boards may indeed characterize high payment as 'potentially coercive.'
* However, I disagree with your emphasis that the distinction is "very important." The working definition of 'coercive' in Board debates is often, basically, 'unfairly inducing potential subjects to underestimate risks or negative consequences.' So they're having the correct debate as per the Dickert and Grady chapter you cite (Chapter 36 in Oxford Textbook of Clinical Research Ethics). That they’re using incorrect vocabulary may not be ethically significant.
* You’re right that the example vulnerable populations in 45CFR46.111b are potentially vulnerable for different reasons, but “vulnerability to coercion and undue influence” is not just one of those reasons. In the plain language of the regulation, vulnerability to coercion or undue influence is exactly the vulnerability that triggers additional protections.
* I can see an argument that it may not completely make sense to say that pregnant women and their fetuses are vulnerable to undue influence as a result of their unique health situation, but that is the assumption the regulations as currently written seem to encourage.
Thanks for encouraging us all to think more deeply about the interpretive work of IRBs! As you mention in this post, the regulations are intended to function with human judgment.
Thank you so much for your thoughtful and thought-provoking comments in response to the webinar. I have a few of thoughts to share in return. First, I think you are absolutely right that norms and expectations around informed consent have changed quite a bit since Appelbaum first recognized the “therapeutic misconception” as a cognitive error, and that the distortions or overly optimistic beliefs that subjects of the sort you mention are now more likely to hold are of a subtler variety. I think that these more subtle distortions are still, though, failures of understanding about the fundamental purpose, structure, or outcomes of research– so it may just be a difference in degree, and not kind.
Second, your point that IRBs may just be using the word “coercion” incorrectly to refer to what we mean by “undue influence,” and may not therefore be making a deep conceptual mistake, is well taken. Nevertheless, I would reiterate my point that the distinctions between two distinct ways of getting anther to comply—either by threatening to make her worse off is she doesn’t, or promising to reward her if she does—are ethically important. I worry that if we start to call offers “coercive,” we lose sight of the fact that the types of interactions that comprise, the circumstances that make one vulnerable to, and the means for guarding against or addressing, these two types of interaction are importantly different.
Finally, I agree with you that the regulations as written seem to suggest that it is vulnerability to undue influence and coercion that trigger additional protections, and so, from a compliance standpoint, IRBs need to be particularly vigilant on those fronts. I suppose my point—and perhaps I could have been clearer about this—was that the taxonomy of vulnerability in the regulations incomplete, and incomplete given the very sorts of vulnerable groups the regulations name. I just think it’s a mistake to think that what makes children vulnerable is that they are particularly vulnerable to coercion or undue influence. From a broader perspective of thinking about research ethics, then, vulnerability to coercion or undue influence are just two types of vulnerability. And in fact, I think that the way we, as a research ethics “culture,” talk about vulnerability, or vulnerable populations, reflects that recognition.
In any case, I so appreciate you sharing your thoughts, and would love to hear from others on these topics!