23
Nov2011

by Elisa Hurley, PhD


Last  week, the Presidential Commission for the Study of Bioethical Issues held its seventh public meeting in Boston. This was the final meeting devoted to President Obama’s charge to assess how well current regulations protect human subjects in research. The President’s instruction came in response to the revelation last year that from 1946 to 1948 the US Public Health Service (PHS) supported research on sexually transmitted diseases in Guatemala involving the intentional exposure and infection of subjects. Much of the commission’s agenda was devoted to discussion of a draft of the report it will deliver to President Obama this December.

As I sat in the audience, I was particularly intrigued by a session launched by commissioner John Arras’ observation that John Cutler, the principal investigator of the US PHS Guatemala Study, viewed the norms of research ethics as onerous obstacles to conducting research. This led the commission to grapple with the question of how to help researchers see research ethics norms as professional standards. 

 

At first glance it might seem that there is a tension between approaches to protecting human subjects that focus on external sets of rules or regulations, and those that focus on the internalization of ethical norms. Certainly the previous generation of physician-researchers viewed things this way.  As Arras pointed out, Henry Beecher—the anesthesiologist who exposed unethical practices in research in a seminal 1966 New England Journal of Medicine—was against the imposition of external, law-like regulations on research ethics.  He believed that the intelligent, informed, conscientious, and  compassionate investigator—who Aristotle would have called the “virtuous” researcher— would make ethically sound decisions.

 
But Beecher’s view is as dubious as Cutler’s. The protection of human subjects should not be left solely to the discretion of the “benevolent” researcher. With research this complex, varied, and large-scale, we need a system of public rules that is transparent, enforceable, and practically applicable.  Yet there is a kernel of wisdom in Beecher’s view, one that seems to have been lost amid the layers of complex regulations and guidance around human subjects research: the idea that the norms of research ethics should be part of the researcher’s professional identity. In other words, such norms must be embodied in the very idea of what it means to be a good researcher
 

The key, according to the commission, is to promulgate a system of regulations that fosters an ongoing and lively engagement with ethical norms among those who are involved in research.  And with the release of the recent Advance Notice of Proposed Rulemaking (ANPRM)  regarding human subjects protections, we have an opportunity to transform the regulations to do just that—to, in the commission’s language, “prune” away the unnecessarily onerous aspects of the regulations and strive for harmonization.  If we mindfully pare down the regulations, we might end up with a set of rules that elicit greater respect from investigators.  Of course, as the commission suggested, and as PRIM&R and many others noted in their comments on the ANPRM, a revised “Common Rule” must first address investigator responsibilities and obligations directly, something the current “Common Rule” fails to do.

 

As the commission recognized last week, regulations that speak directly and palatably to investigators so they feel supported, as well as responsible, solve  only half the puzzle of how to help professionals internalize research ethics norms.

 

The missing pieces involve education. Here we probably need better data, but the commission seemed to be in agreement on three recommendations regarding research ethics education:

 
  1. It should begin long before people are research professionals, perhaps in high school and certainly at the undergraduate level;
  2. It needs to be interactive, case-based, and focused on details; and
  3. It must be ongoing, in the form of collegial mentoring and, once professionals are established, coaching and consulting.
 

In the words of one commissioner, “How do we institutionalize a lively culture of ethical thinking in our professional organizations?” 

 

What do you think?

 
 

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