At the PRIM&R conference in Washington last week I moderated a panel with Michael Carome and Julie Kaneshiro from OHRP on "When is it Human Subjects Research?" In his presentation, Dr. Carome finally clarified OHRP's position on oral history. As many of you know, in 2003 Dr. Carome wrote a letter stating that OHRP concurred with the position that oral history activities in general do not involve research as defined by the HHS regulations. Many oral historians took that to say that oral history was excluded from IRB review, including the Oral History Association. In his presentation at PRIM&R Dr. Carome clarified that this was meant in the same sense that drawing blood "in general" was not research.
Two points worth noting:
1. Dr. Carome chose to announce his latest views on historical research not to a group of historians, but to a group called Public Responsibility in Medicine and Research, a body dominated by professionals involved in biomedical research.
2. To understand the ethics of historical research, he sought an analogy in medical research: drawing blood.
In both these actions, he shows his deep grounding in biomedical research and his discomfort and unfamiliarity with other fields.
Dr. Cohen himself continues:
It is not the methodology that determines whether an activity is human subjects research, but whether it meets the regulatory definition of research - a systematic investigation designed to develop or contribute to generalizable knowledge. . . . The problem is that the regulations don't define "systematic investigation" or "generalizable knowledge" and they don't say who is to make that determination.
It is unfortunately true that the regulations, 45 CFR 46, fail to define "generalizable knowledge." But Cohen could have considered the two places where the regulations use the term, other than to define what is research. Section 46.406 twice refers to "generalizable knowledge about the subjects' disorder or condition." In a medical setting this makes sense; it distinguishes between knowledge about an individual's prognosis and knowledge about the disease itself. But the distinction is meaningless when disease is not the issue.
Thomas Kuhn writes, "in science . . . novelty emerges only with difficulty, manifested by resistance, against a background provided by expectation." (The Structure of Scientific Revolutions, 2d edition, p. 64). Both Carome and Cohen expect to see research that fits into their expectations for medical research. Faced with cases that don't fit, they try to shoehorn them into their preconceived models, ignoring contrary evidence. We need a revolution.