Waiting on the ANPRM, IRBs continue innovating
Waiting on the ANPRM, IRBs continue innovating
Some IRBs plan to reduce burden
More than a year after the Department of Health and Human Services released its proposed rewrite of the Common Rule, researchers and IRBs still are waiting for the other shoe to drop.
The advance notice of proposed rule-making (ANPRM) recommends sweeping changes to the ways in which IRBs and researchers protect human subjects — from risk assignment to protecting personal information to handling multisite review.
It prompted an avalanche of comments, more than 1,100 on virtually every aspect of the proposal. But since the comment period closed in late October, things have been quiet at HHS. There's no word on when — or if — the ANPRM will advance to its next step, a notice of proposed rule-making, let alone to an eventual final rule.
In the meantime, IRBs are left to wonder what they should do. Sit tight and wait to see what happens? Forge ahead with quality improvement efforts? Innovate, as many institutions already have, using the flexibility in the existing federal regulations?
Those who have been watching the process say institutions would be wise to proceed as though there is no ANPRM, since any final outcome of a Common Rule rewrite could be far off, and extremely uncertain.
"I generally advise people not to worry about the ANPRM," says Jeffrey Cooper, MD, MMM, of Huron Consulting Group in Arlington, VA. Cooper advises IRBs about ways to improve their operations.
"What eventually comes out could be nothing like what was suggested," he says. "I think predicting the ANPRM is harder than predicting the presidential election after this presidential election."
Inter-agency concerns and politics
HHS spokeswoman Ann Bradley says the department is still weighing how the public comments will be incorporated into any notice of proposed rule-making.
"We do not, to my knowledge, have a timetable for next steps," she says.
Cooper notes that the huge number of comments generated by this proposal will take a while to sort out. And Cooper says that the process going forward will have to involve a number of other federal agencies who abide by the Common Rule — everyone from the Department of Energy to Veterans Affairs and the Department of Defense.
"If you look at DOD regulations, for example, or you look at VA regulations, you would find a set of regulations that mirror the wording that's in 45 CFR 46, so their regulations would have to change as well," Cooper says.
Getting all of those different agencies to sign off on the changes is not an easy or speedy process, he says.
"There was an inaccurate footnote in the Common Rule when Subpart B was changed for pregnant women," Cooper says. "It was a footnote on the exemption rules and it took about five years to get that taken off."
Politics also may come into play, say Cooper and Moira Keane, MA, CIP, who retired this summer as director of the University of Minnesota's Human Research Protection Program in Minneapolis. A presidential election could change the playing field in Washington, as well as the direction in which HHS plans to go.
"It wouldn't surprise me if they decided to just let it sit until things are sorted out in terms of elections and a cabinet, and if there are changes at HHS, who knows?" Keane says. "I would actually be surprised if something happened between now and November."
Keane is also among those advising IRBs not to make any big plans based on what's in the ANPRM. At the same time, she says institutions that are planning their own improvements or innovations shouldn't table them to see what happens with the federal regulations.
Among those taking that advice is the University of Southern California in Los Angeles. Susan Rose, PhD, executive director of USC's Office for the Protection of Research Subjects, has been leading a group of institutions in what they call the Flexibility Coalition, searching for ways to use the flexibility in the existing federal regulations to alleviate burdens on IRBs and researchers while better protecting subjects.
One tool these organizations have used is "unchecking the box" on their Federalwide Assurance (FWA), so that they are not required to apply every aspect of the federal regulations to every study, regardless of funding source.
The unchecking advantage
For example, an organization that doesn't check the box would not be required to extend Subpart B to minimal risk surveys of pregnant women as long as the research isn't federally funded. Proponents of unchecking note that the federal regulations make it difficult to do even minimal-risk social and behavioral research with pregnant women because of Subpart B's requirement that the research either directly benefit the woman or fetus or contribute to the development of "important biomedical knowledge."
"Subpart B is essentially written to pretty much exclude the possibility of doing non-biomedical research with pregnant women," Cooper says. "So if you uncheck the box, and you have research that involves no more than minimal risk to the subject and the subject's pregnancy, don't apply Subpart B."
Rose says her group is continuing to pursue these types of initiatives, even though one ANPRM proposal would extend federal regulatory protections to all research, regardless of funding — essentially eliminating the unchecking advantage.
She and others want to retain this flexibility in the federal regulations, saying it allows institutions to better calibrate the level of review to the actual risks in studies. Rose says she hopes that the lack of an immediate notice of proposed rule-making is a sign that HHS is taking the objections raised by commenters seriously.
"Everybody is enjoying the silence, hoping that it means the feds are reflecting on how very thoughtful the comments were," Rose says. "If they had rushed out with something, it would be a sign that they weren't listening."
Another institution using unchecking is the Children's Hospital of Philadelphia. Mark Schreiner, MD, chairman of the Committee for the Protection of Human Subjects at CHOP, says officials at his institution actually unchecked the box after the ANPRM was released, in part to deal with expedited review categories that they found to be too constraining.
"We had several conversations with [the Office for Human Research Protections] and they said, 'We're working on a revision,'" Schreiner says. "So we didn't do anything. And when we saw the proposed rule, we said 'OK, we're just going to act.'"
And what happens if an eventual final rule removes this possibility?
Schreiner says he's not worrying about that now.
"We don't operate based on rumors; we operate based on what's real and here right now."
More than a year after the Department of Health and Human Services released its proposed rewrite of the Common Rule, researchers and IRBs still are waiting for the other shoe to drop.Subscribe Now for Access
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