Tuesday, August 30, 2011

Emanuel: ANPRM Will End Reliance on Worthless Gut Reactions

I watched the webcast of this morning's appearance by Ezekiel Emanuel before the Presidential Commission for the Study of Bioethical Issues. There were no huge surprises in Emanuel's presentation; much of it repeated points he had made in the New England Journal of Medicine. But I found some of his remarks, and the Commission's response, noteworthy.

(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."


Roberto Veloso said...

"Why does Emanuel think that HHS now has statutory authority to require IRB review of research not directly funded by the federal government?"

Just a guess (observation really), but I think he is referring to the large number of institutions that have expanded the jurisdictional authority of IRBs through the creation of institutional policies. Call it IRB over-reach by institutional policy.

Zachary M. Schrag said...

No, the ANPRM goes further than that:

"We are considering . . . requiring domestic institutions that receive some Federal funding from a Common Rule agency for research with human subjects to extend the Common Rule protections to all research studies conducted at their institution."

Institutions would no longer have a box to uncheck.

The question is why Emanuel thinks that this would not require an act of Congress, given that in 1980 or 1981, the HHS general counsel determined that it would.

Roberto Veloso said...

I suspect Emmanuel and OHRP are after the elusive goal of "fostering a culture of the ethical conduct of research" at all institutions that receive federal funds. I think that's the same reason why many institutions impose IRB oversight over research that could clearly be considered exempt (depending on who is making that determination of course).

As to why Emmanuel thinks he wouldn't need Congress to act, I think it has to do with who is running the OGC at HHS and the current state of Congressional politics.

Quite honestly, I think it is going to be very difficult for all of the contemplated reforms to go through given the influence that various stake holders will be able to exert on HHS by placing some calls to Capital Hill.

Zachary M. Schrag said...

Other than DeGette, does anyone in Congress care about this?

Roberto Veloso said...

Although reforming the Common Rule doesn’t have the same political implications as reforming healthcare last year, there’s no reason to believe Pharma wouldn’t exercise the same amount of muscle here, on a pro-rated basis.

“The Pharmaceutical Research and Manufacturers of America spent $22 million and deployed an army of no fewer than 52 lobbyists” in 2010. http://money.cnn.com/2011/03/25/news/economy/health_care_lobbying/index.htm

Also Pharma has the ear of the White House (http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html) as Pharma is viewed as one of the parts of the economy that has the potential for creating new jobs.

Zachary M. Schrag said...

I would think the pharmaceutical industry would welcome such reforms as the streamlining of multi-site studies and the harmonization of federal guidance.

Roberto Veloso said...

"I would think the pharmaceutical industry would welcome such reforms as the streamlining of multi-site studies and the harmonization of federal guidance."

. . . and that's about it. No real improvements to protect human research subjects. At least that's my fear.