Jeffrey Cohen on Generalizable Knowledge

Dr. Jeffrey Cohen, an important figure in the IRB world, has offered further comments on a post I wrote in December. I appreciate his attention to my writing, and lest his critique be lost in the comments section of such an old post, I present it here as well:

Cohen writes:

Whether the National Commission adequately considered non-biomedical research in its deliberations is a matter of historical interest, but not directly relevant to understanding the regulations. The regulations were not written by the National Commission, but by individuals within the then Department of Health and Human Services. The regulations, as they are written, do not relate "generalizable knowledge" to disease. When those regulations were written, in the late 1970s, they were always intended to cover non-biomedical research. I was at the PRIM&R meeting in the fall of 1979 when officials from the Office for the Protection from Research Risks (OPRR, the predecessor to OHRP) discussed how the "new" regulations would apply to the social and behavioral sciences. At that meeting they discussed how they were building into the regulations adequate flexibility for IRBs to effectively review social and behavioral research. The subsequent regulations had that flexibility built in and it works well. The interpretation of "generalizable knowledge" that I described in my comment works to help us differentiate between research that needs IRB review and that which does not.

Let me respond step by step:

1. Cohen writes: “Whether the National Commission adequately considered non-biomedical research in its deliberations is a matter of historical interest, but not directly relevant to understanding the regulations. The regulations were not written by the National Commission, but by individuals within the then Department of Health and Human Services.”

Schrag responds: When the regulations were revised in 1979, the Federal Register reported: “The Department of Health, Education, and Welfare (HEW or Department) is proposing regulations amending HEW policy for the protection of human research subjects and responding to the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Commission) concerning institutional review boards (IRBs or Boards). These proposed rules adopt, for the most part, the recommendations of the Commission . . .” Since the stated goal of the revision was to follow the National Commission, I would expect serious interpretation to include attention to that Commission. I also note that the term we are debating, “generalizable,” was introduced into the regulations as a result of its appearance in the Commission’s Belmont Report.

2. Cohen: “The regulations, as they are written, do not relate 'generalizable knowledge' to disease.”

Schrag: I repeat, Section 46.406 twice refers to "generalizable knowledge about the subjects' disorder or condition."

3. Cohen: “When those regulations were written, in the late 1970s, they were always intended to cover non-biomedical research. I was at the PRIM&R meeting in the fall of 1979 when officials from the Office for the Protection from Research Risks (OPRR, the predecessor to OHRP) discussed how the ‘new’ regulations would apply to the social and behavioral sciences. At that meeting they discussed how they were building into the regulations adequate flexibility for IRBs to effectively review social and behavioral research.”

Schrag: At the same PRIM&R meeting, psychologist E. L. Pattullo lamented, “what began as fifteen years ago as an afterthought about legitimate concern for the protection of biomedical subjects has become, at present, a classic example of counterproductive over-regulation.” Political scientist Ithiel de Sola Pool called the regulations “grossly improper and unconstitutional.” (PRIM&R Through the Years, pp. 37 and 42) In other words, for nearly three decades, federal officials have been trying to impose medical ethics on the social sciences, and social scientists have resisted. That some (not all) of the regulations’ authors intended this imposition does not make it proper.

4. Cohen: “The subsequent regulations had that flexibility built in and it works well. The interpretation of ‘generalizable knowledge’ that I described in my comment works to help us differentiate between research that needs IRB review and that which does not.”

Schrag: These are empirical claims that demand evidence. One of the purposes of this blog is to document cases where the current regulations do not work well, and I invite readers to read past posts and follow the links and references to choose their own examples. February's New York Times story and November's Chronicle of Higher Education story make a fine introduction.

On his blog, Dr. Cohen offered his own interpretation of the term “generalizable,” and here he claims that it “works to help us differentiate between research that needs IRB review and that which does not.” Who is "us"? What institutions have taken Cohen’s advice, and do the historians there feel they have been treated fairly?