Common Rule makeover denotes research reform

Proposals include streamlining process, expanding federal oversight to more studies

In its proposed revision of the Common Rule, the U.S. Department of Health and Human Services is considering the most extensive changes to human subjects protection regulations in decades.

If approved, the new regulations would affect nearly every aspect of research review, including data collection and security, biobanking, informed consent and the assessment of research risk levels.

The changes had been long rumored, and in many quarters, long hoped for, because of concerns that the original Common Rule, written in 1991, is ill-suited to the changing research landscape of genomics, Internet research, multisite trials and increased social and behavioral studies.

Social and behavioral researchers in particular had complained that the current regulations force a biomedical template onto their work, subjecting it to informed consent requirements and risk assessments intended for clinical trials, rather than the minimal risk research that they typically conduct.

They argued that the regulations lead IRBs to spend too much time and energy on these low-risk studies, rather than higher-risk biomedical research that could benefit from more IRB attention.

The revisions under consideration, included in an advance notice of proposed rulemaking (ANPRM) released in late July, address many of those concerns:

• Revising existing review categories to better match the risk levels of different types of research. These changes, detailed in Section II of the ANPRM, have potentially the most significant effect on social and behavioral researchers and IRBs.

• Establishing mandatory data collection and protection standards for all studies that involve potentially identifiable information. At the same time, IRBs would no longer be required to review the risk of possible harms that could come from the inappropriate disclosure of study information.

• Extension of federal regulatory protections to all research, regardless of whether it is federally funded, at any institution that receives funding for human subjects research from a Common Rule agency.

• Improvement of consent forms and the consent process to make forms shorter and clearer, to remove boilerplate language that doesn't protect subjects and to clarify rules for waiving consent and consent documentation.

• Requiring a mechanism for allowing researchers to appeal an IRB's decisions.

Other provisions of the revised federal regulations include requiring a single IRB review of record for domestic multisite trials; improving the collection and analysis of data about unanticipated problems and adverse events; clarifying rules for use of biospecimens and identifiable data; and improving harmonization of regulations and guidance across federal agencies.

Very positive in tone'

C.K. Gunsalus, JD, director of the National Center for Professional and Research Ethics at the University of Illinois at Urbana-Champaign, has for years been advocating changes to IRB oversight of social and behavioral research.

Gunsalus says she is pleased with the proposed changes to the handling of social and behavioral studies in the ANPRM.

"There are many proposals that I'm pleased and excited to see," she says. "The presumptions about what shouldn't be included, talking about appeal, talking about removing IRB duties, talking about why it's important to streamline and to focus on things. I think it's very positive in its tone, its direction and its contents."

And Gunsalus says she's happy to see an emphasis on improving informed consent documents. "It takes into account a lot of the research that shows that regular human beings simply don't read 15- or 30- or 100-page consent forms."

Simon Craddock Lee, PhD, MPH, a medical anthropologist at the University of Texas Southwestern Medical Center in Dallas, also serves on the institution's IRB. While he personally has not had problems getting his research approved by the IRB, he thinks the idea of an appeals process is a good one, especially for investigators in disciplines unfamiliar to their IRBs.

"If, for example, an anthropologist has tried to do their due diligence with an IRB and there continues to be resistance, than you can go to the vice president for researcher services and have a conversation," Lee says. "And maybe what that requires is that they make phone calls to their peers at other institutions of repute and say, How does your institution handle this? Is there a learning process that needs to happen here?' And maybe that needs to come from above."

One question in the ANPRM asks whether certain types of activities, including history, languages, literature and journalism, should be covered by the Common Rule at all. This issue has long been a sore point between IRBs and researchers in those disciplines.

Zachary M. Schrag, PhD, an associate professor of history at George Mason University in Fairfax, VA, who blogs about IRB issues at www.institutionalreviewblog.com, says this change is long overdue.

"Congress has never said we want you to regulate journalism or oral history or folklore," he says. "No one sat down and said, That kind of research should be covered by the Common Rule,' and it's only sloppy drafting and a failure of regulatory interpretation that ever got it covered in the first place."

Concerns about extension

One provision in the ANPRM that Gunsalus and Schrag do have concerns about is the proposed extension of the Common Rule to all research at an institution that conducts any human subjects research funded by a Common Rule agency.

They're worried that the extension will jeopardize some universities' attempts to streamline review by following a limited assurance, rather than an institution-wide federal assurance.

"It could impact some of the more innovative research institutions, where people have thought more carefully about alternative systems of oversight," Schrag says. "I'm concerned that it could stifle some innovation."

The proposed expansion could have an impact on audits of institutions as well, says Paul Reitemeier, PhD, who chairs the Human Research Review Committee at Grand Valley State University in Grand Rapids, MI.

Currently, he says, when an institution is audited by the Office for Human Research Protections (OHRP) or the Office of Research Integrity, the agency can only look at files of federally funded research — unless the institution has checked the box on its FWA form agreeing to apply HHS regulations to all research regardless of funding.

He says studies themselves are reviewed in the same way, regardless of funding source.

"It's just a question of which research files do you open to the feds — the ones they pay for, or everything? And if they didn't pay for the research, then where does their authorization to snoop around in those files come from?

"I think there's going to be strong resistance to that one."

Her concerns aside, Gunsalus says she's happy with the ANPRM, particularly its emphasis on seeking comment from those affected by the rule.

"The intent of the ANPRM is to put these changes out for public comment, and let investigators and others speak out about whether these changes are good," says OHRP director Jerry Menikoff, MD, JD.

Menikoff says feedback will be analyzed at the conclusion of the comment period.

"You couldn't ask for a more open, clear, inviting, collaborative approach," Gunsalus says. "There is invitation for a lot of response and I think we need to sharpen our pencils and start putting together considered responses that show as much effort and thought as has gone into this document."

Those interested in commenting on the plan have until 5 p.m. Sept. 26 to do so. It's a fast turnaround, particularly at a time of year when many academics are out of the office, Gunsalus says.

"But we've been talking and thinking about this for so long," she says. "I think those of us who have spent a long time thinking about this out to be able to pull things together."

View the advance notice of proposed rulemaking at www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18792.pdf