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Possible OHRP guidance could come this year
HHS, other agencies must approve draft first
Does the Office of Human Research Protections (OHRP) plan to release guidelines this year clarifying what is and isn't research requiring IRB review?
Apparently, the answer is an unqualified "maybe."
In an interview in February with The New York Times, ORHP Director Bernard Schwetz, DVM, PhD, hinted that new guidance might be forthcoming this year.
The article discussed the continuing tensions between IRBs and researchers in disciplines such as anthropology and oral history. Researchers in these areas have long complained that IRBs have unnecessarily intruded into studies that were not true research, with burdensome and time-consuming requirements — a phenomenon they describe as "mission creep."
Schwetz acknowledged that guidelines for IRBs weren't clear enough. The Times reported that he said new guidelines would provide better examples to help IRBs determine whether a proposed study qualified as "research" under the Common Rule.
However, in an interview with IRB Advisor, Schwetz says a 2007 timeline for new guidance on this contentious issue is dependent on many factors, none of them a sure bet.
'Go' or 'no go'
Schwetz described a process with several "go" or "no go" steps, any of which could derail the planned guidance:
• Currently, the draft proposal is being discussed within the agencies of the U.S. Department of Health and Human Services, which includes OHRP.
"We're trying to determine if we're going to be able to reach agreement on what this guidance would look like within HHS," Schwetz says. "If, in fact, we find that there are some significant things that we have to work on before we could ever reach agreement on a guidance, then we would essentially retreat and work on those."
Schwetz says he hopes that decision — to retreat or go forward with a proposed guidance — could come in the next few months.
• If the guidance does pass this point, then it still would have to be reviewed by the other agencies bound by the Common Rule.
"That, again, is a process where we often get a fairly wide divergence of opinions," Schwetz says. "So, it likely would be several additional months before we would get some reading on what other agencies have told us to do and whether we can satisfactorily respond to their comments."
• If the proposed guidance continues to be a "go," Schwetz says it's possible that it could be available for public comment by the end of this year.
Part of the difficulty in shepherding this proposal along is the sheer number of agencies that must review it, Schwetz says. He says there are divergent views among this group as to whether a new guidance would even be advisable.
The studies in question occupy a gray area between research that clearly warrants IRB review and academic activities that obviously don't constitute research and so don't need the input of an IRB. Trying to clarify the research definition will inevitably cause some researchers to disagree with the results, Schwetz says.
"It isn't our intent to create a lot more burden," he says. "On the other hand, there are people who want this to be clarified because they don't like the feeling of possibly operating outside of compliance — or operating with compliance when they didn't need it."
The controversy over what constitutes research under the Common Rule isn't a new one, Schwetz says.
"I remember talking to some of the people who have been the leaders in the human subject protection community for decades saying this was an issue 20 to 30 years ago," he says. "Ever since the regulations have been out there, and even before, people have argued about whether something is research or not.
"In fact, we were advised by some of them, don't take this on because you'll never get an answer."
For his part, Schwetz isn't sure whether the issue will be resolved this year. But he's willing to take it slowly, noting that the studies involved don't represent a large degree of risk to participants.
"Because we hear fairly divergent views on it, we're going slowly to make sure we don't have to retreat and do something different," he says. "I don't want to do this twice. If we're going to do it, I want to do it once — right."