Report: Give investigators more authority to approve some protocols

Says certain protocols should be exempt from IRB approval

The American Association of University Professors (AAUP) released a report taking IRBs to task over what they call “inappropriate, indeed absurd, alterations in research protocols” and overly stringent guidelines for study submission and approval.

The AAUP calls for more researcher autonomy for deciding whether a federally funded study needs IRB review, rather than relying on IRB members who “have no special competence in assessing research projects in the wide range of disciplines they are called on to assess, whose approval is required for an only minimally restricted range of research projects ... who are only minimally restricted in the demands they may make on the researchers, and whose judgments about whether to permit the research to be carried out at all are, in most institutions, final.”1

The report comes in response to the U.S. Department of Health and Human Services’ (HHS) 2011 advance notice of proposed rulemaking (ANPRM) for potential changes to the Common Rule.

The AAUP analyzed 1,100 responses sent to HHS and found behavioral, social, and humanities researchers have what the report calls “horror stories” and many complaints about overly cumbersome and complicated approval requirements and too-short lists of exempt study types.

The report, titled Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board, proposes the following:

“Research on autonomous adults should be exempt from IRB approval (straightforwardly exempt, with no provisos and no requirement of IRB approval of the exemption) if its methodology either:

(a) imposes no more than minimal risk of harm on its subjects, or

(b) consists entirely in speech or writing, freely engaged in, between subject and researcher.”1

Under HHS regulations published in 1995, such studies are exempt from review under 45 CFR 46.101(b)(1)-(6), unless the subjects’ responses could lead to subject identification, and if disclosure of the subjects’ responses outside of research could be personally damaging or bring civil or criminal liability. It is left to IRBs to determine whether such studies are exempt. The Office for Protection from Research Risks (OPRR) “advises that investigators should not have the authority to make an independent determination that research involving human subjects is exempt and should be cautioned to check with the IRB or other designated authorities.”2

The AAUP produced two previous reports on the issue, in 1981 and 1996, in what one study author says was a response to “widespread unhappiness” researchers felt with IRB approval regulations. After HHS’s ANPRM in 2011, the AAUP decided to update its report in response. “It was timed as a response to the advance notice, even though the report itself came well after deadline,” says Zachary Schrag, PhD, co-author of the AAUP report and professor of history at George Mason University in Fairfax, VA.

While critical of IRBs, the report is not an indictment of the system. “Many people report favorable experiences with it. Many researchers have thanked IRBs for helping them think through the moral issues raised by their work, and many present and former IRB members report that their IRB contributed substantially to developing the research projects they assessed and to protecting the research subjects,” the report authors note.1

Schrag also points out that the report is mainly from a university research perspective rather than a hospital one, and that it does not call for the abolition of the IRB system for medical research. The recommendations, he says, apply only to “studies where adults are talking to adults — when the conversations are restricted, the challenge to academic freedom is the most obvious.”

While Mark Schreiner, MD, chairman of the committee for the protection of human subjects at Children’s Hospital of Philadelphia (CHOP), agrees that some IRBs do overstep their bounds, he says that approval issues do not lie in the regulations but in IRBs themselves. “Inexperienced IRBs are afraid to do the wrong thing, and it results in conservatism,” Schreiner explains. For example, an IRB may require investigators to use extra consent forms just to be on the safe side — which is a waste of time for everyone, Schreiner says.

“If they [IRBs] are overstepping the bounds of their authority and deciding a study needs to go to IRB for review, I can see the problem there,” Schreiner says.

By not “checking the box” to apply Federal-Wide Assurance to non-federally funded research, IRBs have greater flexibility and oversight. “There has been an increasing trend in unchecking the box, and a majority of IRBs are taking advantage of increased flexibility,” Schreiner says. “I would propose that everyone consider unchecking the box and not applying the same stringent standard to all research. By not checking the box, IRBs have lots of ways to increase flexibility.”

“Instead of relaxing the regulations, let’s educate the IRBs to use their flexibility,” he continues. “The AAUP presents the issues as problems with regulations, but over and over again they’re problems with the IRBs.”

For the AAUP, the issue of protocol approval doesn’t lie entirely with efficiency, but with academic freedom. “The AAUP is not interested in efficiency so much as freedom,” Schrag says. “It’s not a term that gets included so much in human subjects protection. Freedom is not one of the big issues and can often be forgotten as people discuss this issue. The unique or special function in this debate is to assert the value of freedom.”

For now, Schrag says, the big question among administrators and researchers is what the federal regulators will do. “Since the close of the comment period in October 2011, we have only the vaguest rumors on the progress of that reform effort,” he says.

The full AAUP report can be found at http://www.aaup.org/file/IRB-Final-Report.pdf.

References

  1. Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board. The American Association of University Professors, March 2013. http://www.aaup.org/file/IRB-Final-Report.pdf.
  2. Exempt Research and Research That May Undergo Expedited Review. Office of Protection from Research Risks, May 1995. http://www.hhs.gov/ohrp/policy/hsdc95-02.html.