Genetic review finds common ground

Survey: Researchers, review boards agree on issues

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

The results have shown that the two groups are in accord on many points, particularly regarding which issues are most important to address,1 says Karen L. Edwards, PhD, MS, professor of epidemiology at the University of Washington (UW) 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 review boards for guidance, and where do the review boards go for guidance?"2

Edwards says the effort grew out of complaints she and others were hearing from colleagues about the difficulty of getting genetic research approved by review boards. Recognizing a need to address the question more empirically, members of 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 in Cleveland, OH, and the American Society of Human Genetics and Public Responsibility in Medicine and Research (PRIM&R) Boston, to examine investigators' and review boards' 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 researchers and review board 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 review board professionals' answers on many of these issues. For example, 78% of review board professionals and 82% 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% of review board professionals and 43% of researchers thought it was necessary to obtain reconsent from a participant to share his or her deidentified data with a researcher at another institution.

Despite these agreements, researchers reported problems with their studies' assessment by review boards. Fifty-four percent of researchers said that review board evaluation resulted in "excessive delay of a project," while nearly 30% said their experiences with review board analysis 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.

Researchers also sometimes think that review boards 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, Edwards says.

The survey notes that researchers who had themselves served on a review board were about 80% more likely to report positive consequences of review board assessment than those who had not.1 Taken together with reports from review board professionals that these studies take more time because of their complexity, Edwards suggests that recruiting genetic researchers to review boards might result in a win for both groups.

"I think that's actually an important message," she says. "If the review board 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.

References

  1. 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. Web: http://www.ncbi.nlm.nih.gov/pubmed/21487211.
  2. 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; 5:83-91.