Before we get too far into the new year, I wanted to take an opportunity to sneak in a few last reflections on the recent Advancing Ethical Research conference. As I prepared to leave Tennessee for Boston and AER15, I projected two goals: first and most basically, a renewal of knowledge; and second, the more lofty aspiration, to gain insight into the pragmatic relationships formed during the research process. Given the amorphous nature of both, I could argue I either achieved everything I could have hoped for, or, that I still have much work and learning left to do. The latter is probably more accurate—and also sets up a good rationale to attend next year’s conference in Anaheim!
The cacophony raised by the Department of Health and Human Services’ Notice of Proposed Rulemaking (NPRM) almost made any other conversation at AER impossible. This is certainly understandable at one level; the first wholesale set of changes to the rules governing human research in decades was inevitably going to get people talking—and worrying. Just mentioning the subject often swallowed all the oxygen in the room. The proposed changes are just that contentious.
Before going further, let me admit I’m the type of person who never saw a rule I didn’t want to bend, stretch, or modify in some way. It’s not that I’m anti-governance (how could I even remain at the IRB table if I was?), but that I worry constantly about what happens when our rules become norms. Once norms, they become normative, then normal, our new "natural"—and then we pay them no mind at all, because hey, who worries about what’s normal?
It always behooves us to remain conscious about what rules govern us, and to consider if these rules continue to do, or if they do at all, what we hoped they would. Albert Jonsen, a principal voice in the creation of one of human research protection’s guiding documents, The Belmont Report, even stated that it should serve as a "road map," not a fixed set of directions. Taken from this perspective, then, the NPRM serves as a necessary exercise in consciously considering what laws, rules, and guidelines have accreted into the formidable structure of administratively correct research review. Out of this process, we then ask ourselves: what about this makes sense? What could we change to better serve our goals of ethical oversight and human protection? What fails those goals and should be jettisoned?
However, the NPRM is not just an exercise. It proposed changes, many of which very well may come to pass—and gauging by the tone of the officials present during the conference’s "town hall" meeting on the subject—sooner rather than later. And while Jonsen may have expressed latitude in his "road map" descriptor, he also defended the document as getting a number of things right that should probably remain the same, or at least maintain their centrality to any discussion of human subjects protections: justice, beneficence, respect for persons. Even those who find principlism1 of limited appeal will find such categories useful, and rich, starting points.
The NPRM, though, tries to shoehorn the value of "efficiency" into the mix. We see this particularly in the push to create single IRBs of record for multi-site studies. In so doing, the proposal looks to eliminate squeaky wheels of difference—this IRB wants this; that IRB says that—so that the process might be streamlined, and our progress hurried along. Considering this, I’m reminded of the French philosopher and theologian Jacques Ellul’s concern that our quest for innovation, for new technology, has become "the defining force of a new social order in which efficiency is no longer an option but a necessity imposed on all human activity." When we feel overwhelmed when hearing from a diverse range of voices, perhaps a better place to start is our own-self management in the face of them, rather than trying to make other silent (read here as "made more efficient").
My son, a child on the autism spectrum, has a bit of difficulty in noisy environments. For a long time, he wouldn’t go into the gym, or music class, or the cafeteria. Then, his mom got him some basic muffling headphones; nothing fancy, just the type you might wear blowing leaves. Wearing them, he feels ready to handle all the different voices and activity. Because he wants to be part of those noisy environments—now that he’s got the headphones, he goes through the lunch line! Note that we didn’t ask his peers to stop doing what they were doing –basically, being noisy. We adjusted our son’s ability to navigate within the noisy environment. Asking his peers to quiet down might have helped our son, but it wouldn’t say much about our consideration of others—nor is it a practical, long-term solution to help him navigate all the noisy environments he may face. And this is where the NPRM loses track of the foundational goals it is meant to help us attain. It silences and makes powerless processes by which we work to engender justice and a respect for persons, substituting a rather hazily defined, yet still insistent, pursuit of some promise of "efficiency."
None of this is to say that there aren’t changes that we can and should make to help our efforts to act ethically and more efficiently with regards to all parties in the research process—participants, researchers, and all the rest. It is to say that we shouldn’t do so by simply shutting some of those parties up.
1 Principlism is a system of ethics based on four moral principles: autonomy (free-will or agency), beneficence (doing good), non-maleficence (doing no harm), and justice (social distribution of benefits and burdens). Three of these principles are closely mirrored in the three principles outlined in the Belmont Report as noted above.
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Thank you for this thoughtful article. I do understand it much better with the parallel about your son.