Infectious disease group calls for lessening of regulatory burden
Society recommends removing research from HIPAA
Another voice has been added t o the chorus of those blaming excessive regulatory oversight for a slowdown in vital research.
The Infectious Diseases Society of America (IDSA) recently published a paper listing several recommendations aimed at lessening the burden on researchers, from removing research from activities covered by the HIPAA Privacy Rule to encouraging the use of central IRBs and funding OHRP to provide more guidance to local boards.
William Burman, MD, an associate professor in the Division of Infectious Diseases at the University of Colorado at Denver and Health Sciences Center, was the IDSA's lead author of the article, which ran in a recent issue of the journal Clinical Infectious Diseases.
Burman, who serves on the IDSA's research committee, says the issue has been percolating within the society for several years, as infectious disease investigators have reported difficulty getting research approved.
"It became clear to us that this was one of the major factors affecting research that we think needs to be addressed to save lives of people with serious infections," he says. "It wasn't a single event (that prompted the paper); it was the cumulative effect of increasing burden as we perceive it."
Burman says the paper is a call for restoring balance between the need for research and the need for research oversight. He says that balance has been tilted in favor of oversight in the last decade.
"Both parts are absolutely necessary, there's no question, but we need to restore balance between them," he says.
HIPAA's burden
Burman says it was important to the group not to enter into the discussion blaming IRBs, who he says have been put into an increasingly impossible situation, particularly since the advent of the Health Insurance Portability and Accountability Act (HIPAA).
"HIPAA was a tremendous increase in the workload of local IRBs, not just to review authorization forms themselves," Burman says. "HIPAA in essence defined a whole lot of data gathering and review activities as something that should be reviewed by an IRB that hadn't been before.
"It markedly increased the types of activities that IRBs review and I think to no benefit – to no benefit to IRBs, to no benefit to researchers, to no benefit to participants and patients."
Burman praises a recent Institute of Medicine report, which also recommends removing research from HIPAA oversight. The IOM report recommends that interventional research would be handled under the Common Rule. Informational research, which uses medical records or stored biological samples, would have a separate oversight system, with federal certification of organizations collecting and analyzing personally identifiable health information for clearly defined purposes, without individual consent.
"I think the IOM report is a wonderful document that fleshed out the negative effects of HIPAA," Burman says. "I think they very convincingly document the negative effects of the application of HIPAA to research. And then I think they have an interesting proposal for a resolution to this problem."
He says the report came out just as his group was finishing the IDSA statement.
"In fact, we were on one of the final drafts and somebody sent me the link and so I read it really quickly and thought, 'Great — it's always wonderful to have a body with the prestige and respect that is given to the Institute of Medicine agree with you.'"
In addition to the HIPAA recommendation, the IDSA also took on other issues that members felt were stymieing research:
Duplicative review of multicenter studies. Having local IRB review at every site in a multicenter study unnecessarily delays and complicates such studies, the IDSA report asserts. In particular, it often introduces language to consent forms that makes them longer and less readable.
"It's very clear that duplicative local review delays the initiation and completion of federally sponsored research," Burman says. "In some cases it can be severe, with months and even more than a year's delay in starting studies at some local sites."
To alleviate the problem, the IDSA report makes two suggestions: Expand the availability of central review panels for federally sponsored research and have NIH and other federal agencies create an incentive for the use of those panels by giving institutions that agree to use a central IRB points toward the peer-reviewed score of a grant application.
"My sense is that the level of concern (about using central IRBs) is not necessarily at the IRB level but that it may be at other levels of the administration of academic health centers in particular," Burman says. "It may revolve around concerns about legal liability, for example. I think the incentive isn't designed so much for the chair or director of the local IRB itself but rather for the larger institution."
Burman says the IDSA already has made some progress in this area, having corresponded with the National Institute of Allergy and Infectious Diseases to request creation of central IRBs for adult and pediatric studies. He says his group will work with other professional societies to urge similar conversations with their corresponding sections at NIH.
"I think there's a good chance that we'll get creation of additional central review panels."
Centralize AERs
Redundant review of adverse event reports. The IDSA report states that sending reports of serious adverse events to IRBs at all local sites of a multicenter study drains IRB resources, while often not providing enough information to the IRBs to be useful.
"You jam up the works with a bunch of reports which the local IRB cannot interpret because they're not provided with the key parameters that would allow them to do anything with them," Burman says. "How many received the drug for what period of time, what happened in the control group? IRBs have no knowledge of any of that."
He says data centers for multicenter trials have the means to conduct sophisticated analysis of adverse events, making local reviews unnecessary.
Burman says OHRP has published guidance stating that local IRBs shouldn't be involved in the review of off-site adverse event reports.
"I think it's an excellent document — anyone who says that the federal government can't produce clear guidance should read it," he says.
But he says a Food and Drug Administration (FDA) guidance on the subject is much less clear, which can be confusing to IRBs. IDSA recommends harmonization between the two guidelines, and a refocusing of local IRB efforts on adverse event reports from single-site studies.
Clearer OHRP guidance — in such areas as risk assessment in pediatric research and criteria for IRB review of quality improvement activities.
Increased funding for OHRP — Burman says it's disingenuous to ask more of OHRP when it's already underfunded.
"What we proposed is an increase in funding and coupled with a clear mandate to produce results," he says.
Asked which of these issues he considers most pressing, Burman barely hesitates: "HIPAA. I think HIPAA has been destructive."
But he says he's optimistic that the time may be right for progress on that front. He says if a change is going to occur, the research community needs the support of patient and disease advocacy groups, who have so much at stake in getting research moving faster.
"I think we need to work with disease advocacy groups to make clear to them that HIPAA is delaying valuable research, that it's stopping valuable research, that it's increasing the costs of research, all of which has now been very clearly documented.
"We'll get action when it isn't me testifying to a committee of Congress, it's patient and disease advocacy groups saying, 'Why is the government requiring this when it demonstrably slows down, prevents and delays research which is needed to help my condition?'
"That's when we'll get action and that's why we're working a lot with disease advocacy groups at the start of this effort."
Reference
- Infectious Diseases Society of America. "Grinding to a halt: The effects of the increasing regulatory burden on research and quality improvement efforts." Clin Infect Dis 2009;49(3):328-335.
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