[T. L. Beauchamp, "Why Our Conceptions of Research and Practice May Not Serve the Best Interest of Patients and Subjects, Journal of Internal Medicine 269, no. 4, (April 2011): 383-387, doi: 10.1111/j.1365-2796.2011.02350_1.x]
As a staffer of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, Beauchamp played a key role in the development of the Belmont Report. Yet in this essay, he disparages one of the National Commission's most enduring legacies: the definition of research encoded in today's federal regulations.
Beauchamp writes,
In the Code of Federal Regulations in the United States, the term 'research' means 'a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge'. This conception still today is the received view. However, there are many problems with this definition. First, it uses the notion of research to define the term 'research,' creating problems of circular definition. Second, it does not define any of the several important terms (the key conceptual conditions) used in the definition, such as 'systematic investigation,' 'testing' and 'generalizable knowledge,' and these terms can be understood in several ways. Third, the definition is vague and overly broad because it is not clearly confined to biomedical research, clinical research and behavioural research – or even to scientific research, more generally. Its scope is left unclear. Fourth, and perhaps most importantly, it does not preclude 'research' from having a very close tie to 'practice.'
Because the definition is so nonspecific, regulatory requirements that use the definition may judge that some activities that are questionably research involving human subjects nonetheless must be treated as such. Government requirements are today commonly applied even if 'human subjects' may not need to be protected by the rules of human-subjects research. A sweeping – that is, all-inclusive conception – of 'human-subjects research' can have immediate and unjustifiable practical impact on attempts to upgrade medical care . . ."
Beauchamp goes on to relate the experience of Peter Pronovost's study of infection-control, that was temporarily halted by OHRP on the grounds that the Johns Hopkins University had incorrectly interpreted federal regulations. Beauchamp argues that "There were no new interventions with patients. There were not even subjects in any meaningful sense. In my view, such work should not need an institutional review board approval even as expedited review." Like Whitney and Schneider, he warns that human subjects regulations can kill.
Beauchamp does not expand on his third point, that the federal definition of research is not confined to the "biomedical and behavioral research" specified by the National Research Act and embedded in the National Commission's title. Nor does he mention that the commission offered two competing definitions of research, one in the Belmont Report and another in its IRB Report. Still, it is nice to have so prominent a bioethicist admit that the definition of research at the center of the Common Rule is so poorly worded.
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2 comments:
As someone who has to apply the regulations I would agree that the wording, lack of examples examples, and lack of guidance is very problematic.
Some of the better discussion of 'research' and 'non-research', at least as it applies to public health, is to be found on the CDC's site. See http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf
And it's not just the definition of research. There needs to be much clearly guidance on the application of exempt categories, as identified by SACHRP (http://www.hhs.gov/ohrp/archive/sachrp/mtgings/mtg10-07/present/SubpartAEXEMPTIONS.doc), to mention one other area that causes lots of headaches. Read the literature and it becomes clear that even the 'experts' don't agree on the interpretation of the exemptions. E.g. some people apply b1 independently of b2 and Subpart D limitations and some don't.
Thanks for these comments. I quite agree that clarity would require not only better definitions of research and the various exemptions, but also realistic examples and continuing guidance from OHRP. See http://www.institutionalreviewblog.com/2010/12/menikoff-passes-buck.html
The SACHRP document offers some helpful suggestions. But I can't agree with its recommendation that "research conducted under the exempt categories be determined to be no greater than minimal risk"; I do not think that appropriate for the public-official exemption in particular. And it is telling that SACHRP did not offer specific recommendations on "focus groups; ethnography; oral history," choosing instead only to call for guidance from OHRP. The fact is that both SACHRP and OHRP lack sufficient expertise to offer meaningful guidance and should seek the input of the National Science Foundation, other agencies that sponsor such research, and disciplinary bodies such as the American Historical Association.
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