Wednesday, June 12, 2013

Robert Levine: We Should Have Done a Careful Study of Social and Behavioral Research

The June issue of the Journal of Clinical Research Best Practices features an interview with Robert Levine about his service as consultant to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Levine concedes that the commission did not sufficiently explore "sociology, anthropology, education and other vast areas of research."

[Mark Barnes, "Bob Levine on the Making of the Belmont Report," Journal of Clinical Research Best Practices 9, no. 6 (June 2013). h/t Michelle Meyer]

As part of the interview, Levine explains why the Common Rule defines "research" in reference to design, rather than intent:

In my initial draft of the definition of research, I said research refers to a class of activities intended to do certain things, to develop knowledge. Joe Brady argued that there is no such thing as intent. One of the tenets of behavioral psychology is that the only things that count are what you can observe and measure; Joe insisted that one could not observe intent. He and I had a friendly and collegial, but very forceful argument. I argued that, before you write a protocol, you should know what people intend to do. At the next meeting, Joe brought in reinforcements — Israel Goldiamond, a psychologist from Chicago, to help explain why intent should not be used because you could never measure intent. We compromised on the term, "design." You can measure the design. You can look at it. It's written out in a protocol. I said the protocol represents intent, but I lost the argument. I was a pretty good loser. "Design" is not all that bad.

More significantly for this blog, Levine concedes that both the Commission and Congress erred in their treatment of social research:

In my opinion, we should have done a careful study of social and behavioral research. Congress caused this mistake when it told the Commission to distinguish research from the routine and accepted practice of medicine or behavioral therapy. You don't have to go very far to distinguish sociology from routine practice. Sociologists don't have "practices." Sociology, anthropology, education and other vast areas of research were left out. The Commission made some passing statements that have been interpreted as being relevant to social and behavioral research, but they did not look into it thoroughly.

This is similar to what he said in his 2004 interview by Bernard Schwetz.

What would really have been nice, however, would have been for Levine to have said these things in 1979, when federal regulations were being debated most forcefully. Instead, at that fall's PRIM&R conference, he claimed the opposite:

If one takes more than a superficial look, one will find that this Commission was quite concerned with problems of social and behavioral scientists. For example, the Appendices to the Belmont Report contain several important papers by distinguished social scientists about ethical issues in their fields. In addition, the presence of social scientists on the staff of the Commission—particularly Brad Gray—kept the attention of the Commission focused on their problems. As it considered each recommendation it was forced to think, "What would be the implications of this recommendation if it were to be applied to social research?" [PRIM&R through the years, 1974-2005, p. 33]

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