Avert Your Eyes: Making Sausages, I Mean Policy
The new "Common Rule" for the protection of human research subjects is published and available. The Common Rule governed 15 federal departments and agencies, evolving from the early 1970s and 1980s as the National Research Act. The Department of Health and Human Services' 45 CFR 46 responded to the "Tuskegee Study of Untreated Syphilis in the Negro Male," initiated in 1932, that abused research subjects by neither educating them about the studies they were in, nor providing standard-of-care curative treatments as they became available. It entered the code in its most recent incarnation in 1991. A Notice of Proposed Rule Making was published for comment in September 2015, representing a "wish list" from 16 federal entities (excludingthe Food and Drug Administration). This first major revision was in response to deaths among contemporary research participants, perceived gaps in the local application of the rule and, critically to me, the changing nature of research, including the proliferation of multisite trials and logarithmic expansion of genomic studies. Among its goals was an extension of protections to subjects in all clinical trials at sites receivingANYfederal funding; an enhancement and streamlining of informed consent; and redefinition of even anonymized human biospecimens as "human subjects" to extend to them a requirement for informed consent and tracking.
The last, most controversial, provision was addressed in more than half of the thousands of comments on the rule. It was opposed in 80 percent of those comments. The rationales in its support were an autonomy assertion (vague to my mind) that folks have a right to know what their specimens are being used for, general distrust of the scientific/research enterprise, a desire to know results from testing on these specimens, and to allow subjects to profit from discoveries related to their use. Opposition, including that from ABC, was predicated on several considerations: the feasibility and costs of getting and tracking consent; the waste of valuable research materials; the probability that this requirement would inhibit research; and a paradoxical likelihood that requiring all biospecimens to be traceable would impose greater privacy risks than the current system. Most important to me was the lack of material risk associated with the use of anonymized specimens.
ABC centers have participated in countless studies for years providing anonymized (often left over) blood samples to companies developing and improving supplies we use daily. You may be glad to know, that in the final rule, the classification of biospecimens as "human subjects" and the consent requirement were rescinded. What remains is still controversial (you will have to read the document), but compromise is at the core of a functioning democracy. As such, we got an important part of what we asked. I am certain this will not be the last time rational policy is made in the next several years.
Louis Katz, MD; Chief Medical Officer