By the end of the post, I may call into question my own particular existence. In the meantime, though, let’s talk about research ethics (the two are related, I assure you).
As the 2015 Advancing Ethical Research (AER) Conference wound through its days, a theme of sorts began to emerge. It found its clearest statement in the conference’s final session, a discussion of the various reports and inquires that have come forth regarding the state of research ethics oversight at the University of Minnesota. The recent headlines about this—"Why the U. of Minnesota Research Scandal Threatens Us All" in Forbes, for example—pick up the message that Carl Elliot has been trying to get across for years.
During this session, the panelists avoided use of such heightened rhetoric as was used by Forbes, though the multiple issues of concern were no less seriously discussed: the ethical culture of institutions; the willingness of individuals and groups to receive critique from both within and without; and the pragmatic, critical caution that “we shouldn’t confuse aspirations with enforceable standards," a point voiced by the always thoughtful Steven Joffe.
But what about that theme I mentioned? Bluntly, it is this: Who watches whom? While the presence of University of Minnesota’s vice president for research on the panel was welcome and appropriate, even his best answers couldn’t shake the question of how institutions can best oversee themselves when the culture is not amenable to change—or even willing to recognize that it needs to. This issue becomes all the more important in light of the changes suggested by the Notice of Proposed Rulemaking (NPRM) for Revisions to the Common Rule, in which some research oversight is handed over to the researchers themselves (via a to-be-provided web-based “decision tool"). The University of Minnesota vice president for research as much as admitted that his institution had not done enough to foster an ethical culture; I hate to be cynical enough to say that his is probably not the only institution so problematically inclined. Yet it is the members of these less- and more- ethical environments to which we are considering handing oversight?
I understand that many who have long critiqued the IRB system generally are rejoicing at these potential changes. For these folks, the proposed recommendations help address long-standing issues with a system of ethical oversight geared towards medical research, but to which many other types of investigation have been forced to comply. Thus, in part, Schrag’s charge of closed-door imperialism (a concern with which Laura Stark’s Behind Closed Doors shares some similarities). But the conversation—for it to even be a conversation—about ethical research requires engaging with the multiple parties involved in the research process, and adequately addressing their various concerns and priorities. Notice, though, how multiple this dynamic is; while reducing the number of parties might certainly make for a more efficient process, that doesn’t necessarily make it a more ethical one.
And by parties, I mean the variety of voices represented at the table and involved in research review. Thus, if the NPRM reduces that range to one (or, one-plus-website-questionnaire), this is no longer a conversation, but a single person’s decision. Likewise, if review is consolidated into a single IRB, we have lost a diversity of ethical perspectives that help attune the specifics of a project to the needs and understandings of a given research site or area. To return to where we started, this issue can also occur—has occurred and still does—on the institutional level. When the University of Minnesotas of the world work to shut out critique, or more banally, just don’t leave space for voices outside of its own culture, then the elements for adequate ethical review are lacking.
As a non-scientist and community member on an IRB (ours treats those two categories distinctly), one might expect such an argument from me. However, I’ll say this: I take seriously the implications of my own logic. That is, I believe that there may be a time when I can no longer claim myself to be sufficiently removed from the institutional structure to serve as an appropriate representative of any community outside it. In other words, the reason for my particular existence on the IRB should, if I’m being honest, expire. Now, hopefully, that will create an opening for the introduction of a new, distinct voice to enter into our process for ethical review. That is, it should create that opening—but only for the studies that aren’t being decided upon by isolated individuals, or reviewed by remote IRBs of record, or caught up in institutional systems that brook no perspectives outside their own. Who, indeed, will be watching whom then?
Dahron Johnson, BA, chaplain at the Tennessee Valley Healthcare System, is a member of the PRIM&R Blog Squad for the 2015 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who blogged here, on Ampersand, to give our readers an inside peek of what happened at the conference in Boston, MA.