Seeking genetic review common ground

Survey: Researchers and IRBs agree on what the issues are — now if we could only solve them

In response to concerns raised about IRB review of genetic research, a group of investigators, ethicists and other stakeholders has surveyed genetic researchers and IRB professionals to discern what issues are complicating review.

The results have shown that the two groups are actually in accord on many points, particularly which issues are most important to address, says Karen L. Edwards, PhD, MS, professor of epidemiology at the University of Washington and director of the university's Center for Genomics and Public Health in Seattle.

"The most surprising result was the fact that it's not really us versus them," Edwards says. "Actually, both groups are dealing with the same challenges and unsure in some situations about what to do.

"I think both groups would like guidance and I think part of the tension has been that researchers look to the IRBs for guidance and where do the IRBs go for guidance?"

Edwards says the effort grew out of complaints she and others were hearing from colleagues about the difficulty of getting genetic research approved by IRBs. Recognizing a need to address the question more empirically, UW's Center of Excellence in Ethical, Legal and Social Implications Research teamed with the Center for Genetic Research Ethics and Law at Case Western Reserve University, the American Society of Human Genetics and Public Responsibility in Medicine and Research (PRIM&R) to examine investigators' and IRBs' attitudes about genetic research. They formed the Genetic Research Review and Issues Project (GRRIP) and obtained NIH funding to survey both groups.

'Considerable discussion'

The GRRIP group first conducted in-depth interviews with both researchers and IRB professionals, then used the information to develop questionnaires asking about the issues that most frequently caused "considerable discussion" between them during review.

The two groups reported spending the most time on roughly the same set of issues:

—Consent documentation;

—protection of subjects' personal information or samples;

—return of genetic research results to participants;

—reconsent from research participants for a new study or a change in study purpose.

Researchers' opinions were surprising similar to IRB professionals answers' on many of these issues. For example, 78 percent of IRB professionals and 82 percent of researchers thought there is a duty to return results from genetic research to participants if those results would affect a participant's health or health care. Only 44 percent of IRB professionals and 43 percent of researchers thought it was necessary to obtain reconsent from a participant in order to share his or her deidentified data with a researcher at another institution.

Despite these agreements, researchers reported problems with their studies' review by IRBs. Fifty-four percent of researchers said that IRB review resulted in "excessive delay of a project," while nearly 30 percent said their experiences with IRB review dissuaded them or their colleagues from pursuing a similar project in the future.

Edwards says that it can be quite frustrating for researchers to speak to colleagues at other institutions who seem to be having an easier time of it than they are.

"When somebody else at another institution gets something through easily and you can't get it through, then people go crazy," she says.

She says researchers also sometimes feel that IRBs tend to focus on risks that are theoretically possible but unlikely — such as harm occurring because of reidentification of a subject — while they themselves are struggling with more immediate problems, such as working out the wording of a consent document.

The survey notes that researchers who had themselves served on an IRB were about 80 percent more likely to report positive consequences of IRB review than those who had not. Taken together with reports from IRBs professionals that these studies take more time because of their complexity, Edwards suggests that recruiting genetic researchers to IRBs might result in a win for both groups.

"I think that's actually an important message," she says. "If the IRB does need expertise, I think there are certainly many researchers out there who would happily volunteer, but they don't know how, or have never been asked. In working on this project, I thought many times, 'Gosh, I've never been asked, I wonder how this works.'"

With the completion of the surveys, Edwards says she hopes the stakeholders her group brought into the project, including PRIM&R, can move forward with efforts to bridge the gap.

Moving forward

P. Pearl O'Rourke, MD, director of human research affairs at Partners Healthcare Systems in Boston, MA, was among the team that helped develop GRRIP's surveys.

She says the results are a "great first step" toward reaching a better understanding and hopefully a consensus on these issues that respects both investigators and IRBs.

"We're able to say, 'Listen, guys, we all share the same angst' — I think that was good," O'Rourke says.

But she says that consensus is still a long way off. And meanwhile, IRBs continue to grapple with the issues raised by genetic research — issues that are finding their way into all sorts of related protocols.

"An increasing amount of the research we do now has a genetic component," O'Rourke says.

"We're not there, yet, but perhaps that is good. There are a number of working groups looking at this issue and hopefully there will be some interim or even final reports that can inform the debate."

In the meantime, she expects many IRBs, especially those at institutions that review very few "genetic" protocols, to be conservative in their interpretation of the regulations as they relate to genetic research.

"Some of them are actually saying things like, 'Anything with genetics in it is more than minimal risk,'" O'Rourke says.

At her own institution, O'Rourke says she has the luxury of being surrounded by experts in the field who talk about these issues all the time, and of attending national meetings where they're being discussed further.

In the absence of agreed-upon guidance, IRBs must "in your own context, problem-solve the way you do any other problem-solving," O'Rourke says.

She says the research community also has to reach out better to the public to learn what is most important to them and to educate them about the issues.

"Public engagement and education have got to be a huge part of this," O'Rourke says.

Edwards agrees — based on what she learned during the GRRIP project, she now plans to interview research participants to gain their perspectives on these issues.

"It felt funny that the IRBs and researchers were making these decisions about what they thought research participants would want, and we've never asked them."


Edwards KL, Lemke AA, Trinidad SB, et al. Attitudes toward Genetic Research Review: Results from a Survey of Human Genetics Researchers. Public Health Genomics 2011 Apr 11. Epub.

Lemke AA, Trinidad SB, Edwards KL, et al. Attitudes toward Genetics Research Review: Results from a National Survey of Professionals involved in Human Subjects Protection. J Empir Res Hum Res Ethics 2010 Mar; 5(1):83-91.