IRB Chairs' Perspectives on Genotype-driven Research Recruitment

Laura M. Beskow, MPH, PhD; Emily E. Namey, MA; Patrick R. Miller, PhD; Daniel K. Nelson, MS; CIP, Alexandra Cooper, PhD


IRB. 2012;34(3):1-10. 

In This Article

Study Methods

Sample Assembly

We searched the National Institutes of Health's database of grant awards[9] for new research projects awarded in the period from 2000 to 2010 using the phrase "gene OR genetic OR genome OR genomic." This search resulted in a list of 599 uniquely-named institutions in the United States that had received such funding. We removed institutions from the list (n = 65) that were unlikely to have conducted human subjects research involving genetic analyses (e.g., institutions dedicated to wildlife or agriculture, professional societies).

We attempted to match each remaining institution (n = 534) to an IRB organization (IORG) registered in the United States using a comprehensive roster obtained from the Office for Human Research Protections.[10] For 13 of the institutions, the matching IORG's registration had expired or been deactivated. For 89 institutions, we were unable to identify a matching IORG. To account for the fact that many of these might use a commercial IRB, we added 30 such IRBs to our sample from a publicly available list.[11] The remaining 432 institutions mapped to 376 IORGs. Because an IORG can operate multiple IRBs, our final task was to identify one chair for each of the 376 IORGs and 30 commercial IRBs to whom we could direct our survey. We e-mailed the Human Protections Administrator at the IRBs with multiple chairs and asked for assistance identifying the chair with most experience reviewing human genetic research. In addition, the survey communications that went to all chairs included the statement, "If you are an IRB chair but would prefer to recommend another chair at your institution who has more experience reviewing human genetic research, please let us know and we will direct our invitation to that person."

Instrument Development

We drafted our survey instrument based on our knowledge of the issues and literature concerning research recruitment, informed consent, disclosure of individual genetic research results, human research protections, and survey methodology. We revised the instrument based on iterative rounds of comments from all coauthors, as well as on feedback from cognitive pretesting conducted among nine local IRB chairs and senior members.

The final instrument (available upon request) consisted of 40 questions—primarily multiple choice and five-point scale items—and took approximately 20 minutes to complete. The survey included a narrative description and diagram explaining the concept of genotype-driven recruitment. Many of the sections also included a lead-in statement, such as:

Imagine that you have a protocol to review where researchers want to undertake genotype-driven recontact for research recruitment (i.e., they would like to contact the subset of participants in one study who were found to have a particular gene variant in order to invite their participation in a second study to learn more about that gene variant). Understanding that your thinking may change based on the details of a particular protocol, what is your general inclination with regard to each of the following statements.

Survey Implementation and Analysis

We implemented the survey on the Web using Checkbox Survey Software. The survey was fielded in October and November of 2010. Responses were downloaded from Checkbox for descriptive analysis using Stata 11.0. We assessed differences in responses to general vs. scenario-specific questions using Fisher's exact chi-square tests.

When asked about certain ethical dilemmas, IRB chairs selected as deserving more weight avoiding unwelcome researcher contact and avoiding disclosure of unwanted genetic information.