Want to do Research Ethics Well? Go Beyond Compliance

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.