Monday, July 25, 2011

New York Times Reports on ANPRM

Andrew Pollack, "Rule Changes Proposed for Research on Humans," New York Times, 24 July 2011.

Like the Washington Post story, this lacks any explanation of who wrote the ANPRM or why it came out now. But it does have some good quotations:

“It’s a terrible drag on getting good research done,” said Dr. Robert J. Levine, a professor of medicine and a bioethicist at Yale who headed the university’s institutional review board for 31 years. He said Sunday that while he had not thoroughly reviewed the government’s lengthy proposal, he was encouraged by what he had seen.


Carl Wieman, associate director for science at the White House Office of Science and Technology Policy, said it was now difficult to observe teachers and students in classrooms to help determine what makes a good teacher, given all the consent required. “You’re not doing anything here except watching people,” he said.


Anonymous said...

Our institution does a large amount of work on curriculum evaluation of the sort referenced in the Carl Wieman quote above. Practically all of it is determined to meet the criteria for exemption under §46.101(b)(1). Where just teachers are involved it usually meets the criteria for exemption under §46.101(b)(2) as well. We often make recommendations about appropriate consent procedures but don't formally review or approve consent procedures and forms for exempt studies.

The proposed revisions may in fact offer less than they appear with regard to social science research as most social science research can be treated as exempt under the current regulations but many institutions choose not to do so.

Zachary M. Schrag said...

Thanks for this comment.

I am glad to learn that the exemption process is working at your institution, but the ANPRM recognizes that not all institutions function so well. It addresses the problem of institutions' overregulating by seeking to "clarify that routine review by an IRB staff member or some other person of such minimal risk exempt studies is neither required nor even recommended." This is an important reversal of current guidance. Other potentially helpful measures considered in the ANPRM include the gathering of data, and the requirement that institutions distinguish between federal requirements and their own rules.

See "Menikoff Passes the Buck."

Anonymous said...

I haven't worked my way through the whole document but I think it is wishful thinking to assume that clarifications and some rule changes will get rid of institutional dysfunction.

They are proposing a one page exemption registration. But that still leaves the problem that some researchers are not going to apply the criteria appropriately. They try to address this with "require random retrospective audits of a sample of exempt studies to assess
whether the exemptions were being appropriately applied." I think this is potentially more burdensome on everyone, and certainly opens the door to more dysfunction. I'd prefer sticking with a simple, independent check up front that asks what type of data is being collected, how, from whom and where to ascertain that the project involves no greater than minimal risk and meets at least one of the exempt categories. I guess that could be one page, plus attached instruments in some cases.

Zachary M. Schrag said...

I think the idea is that the exemption (or excusal) criteria should be made clearer. Right now, no one knows what risk to reputation means, so researchers get in fights with IRB staff. The HIPAA criteria are clearer, so whether the review is done prospectively or retroactively, I would hope that the system would involve less guesswork.

I take your point that retrospective audits could be "potentially more burdensome" than prospective review. I wish the ANPRM included a mechanism by which new systems of oversight could be tested and refined through experience. Instead, it asks us to guess how an untried system might work.

Anonymous said...

I agree with you about new procedures and guesswork. It seems to me that there is a high risk of practice turning out to be something other than expected.