(Parenthetical citations indicate the approximate time on the recording posted on the Commission website)
First, Emanuel emphasized his wish for a "risk-based review process" (6:00) and "a learning process that would be constant and dynamic to reflect actual risk" (8:55) rather than what he termed "gut reactions . . . which is worthless." (10:20)
This was a bit of a surprise, since it seems more ambitious than the proposals in the ANPRM itself. For example, the ANPRM imagines that "all data on adverse events and unanticipated problems collected in a central database accessible by all pertinent Federal agencies," (Question 69), but it does not explain how that database would filter down to individual IRBs. True, the ANPRM proposes a permanent federal body to update the criteria for expedited review, but that is just one element of determining what research methods impose risks.
Second, Emanuel noted that "written consent would be required for all use of biospecimens." (7:40) He did not mention such a requirement for datasets. Does this represent a backing away from ANPRM Question 46, which imagines requiring written consent for "unanticipated future analysis of data"?
Third, Emanuel noted that covering all research nationwide would require an act of Congress, and that is unlikely to happen. (9:20) But, he claimed, HHS could impose the Common Rule on all research conducted by institutions that receive federal funding. He described this as "a regulatory way of trying to achieve the goal incrementally." (9:45).
I am puzzled by Emanuel's simultaneous deference and indifference to the limits of statutory authority. The 26 January 1981 Federal Register notice announcing the revised 45 CFR 46 stated:
HHS has carefully considered its proposed policy regarding the regulation of non HHS-funded research in light of the comments received and the statutory basis for the more expansive interpretation. The public comment, including that of the President’s Commission, revealed a broad based and significant amount of objection to the extension. Further, the HHS General Counsel has advised that there is no clear statutory mandate in the National Research Act to support a requirement for IRB review of other than Public Health Service-funded research. Therefore, the Secretary of HHS, after considering a number of possible options, has decided not to extend the requirements for prior IRB review and approval to non HHS-funded research.
The statute has not changed. Why does Emanuel think that HHS now has statutory authority to require IRB review of research not directly funded by the federal government?
Finally, I was heartened by the commissioners' reaction to Emanuel's presentation. While the commissioners asked tough, detailed questions, none of them displayed any knee-jerk defensiveness on behalf of the status quo. This is a relief, because the ANPRM is a bold document, and it may need the high-level support that the Presidential Commission can provide.
Note. Emanuel pronounced "ANPRM" as "ay-en-pee-ar-em." It strikes me that a community used to EN-back, NUR-pack, and SACK-harp could save time by saying "AN-perm."