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

Disclosures

IRB. 2012;34(3):1-10. 

In This Article

Study Results

Participation Rate

Of the 406 IRB chairs invited, 201 (50%) completed the survey. Most were white, non-Hispanic males, age 50 or older; most reported more than four years of service as an IRB chair and had a professional background in medicine or social science (Table 1). Over 80% chose "academic institution" as the best descriptor of their current institution. Over 75% said they were familiar with the review of human genetic research, and 17% said they had been personally involved in reviewing a protocol involving genotype-driven recruitment.

Acceptability of Recontact for Genetic Research Recruitment

We asked a series of questions to establish baseline opinions about recontact—not necessarily genotype-driven—for the purposes of genetic research recruitment. There was considerable variation in responses to the general statement "Researchers should be allowed to contact participants in one genetic research study in order to invite their participation in another genetic research study." Although 37% of chairs agreed with this statement, most either disagreed (27%) or selected "neither agree nor disagree" (36%). These findings suggest that other factors might have an important influence when IRBs are reviewing protocols involving recontact. Indeed, in more detailed questions examining specific aspects of planned recontact:

  • 52% said it would be important that the second study focus on the same medical condition as the first;

  • 52% said it would be important that the second study involve the same researchers as the first; among those who indicated that it was not necessarily important for the same researchers to be involved (n = 90), 12% said it would be important that the second study at least be conducted at the same institution as the first;

  • 91% said it would be important that the possibility of such contact was disclosed during the consent process for the first study; and

  • among those who said that disclosures about recontact during the original consent process were important (n = 183), 91% agreed with the statement, "Participants in genetic research should have a choice at the time they consent to one study about whether they are willing to be contacted about other studies in the future."

In the specific context of genotype-driven research recruitment, a substantial majority of all chairs (90%) again indicated that statements in the original consent form regarding contact about future research would be an important consideration when determining whether such contact should be allowed. However, when we presented respondents with a hypothetical scenario in which a researcher submits a protocol involving genotype-driven recontact (Box 1), a somewhat different view emerged. In response to this scenario, in which the original consent form did not include any statements either allowing or prohibiting the possibility of contact about future research, half of chairs (51%) said they definitely or probably would allow the researcher to contact eligible participants. This represents a statistically significant departure from responses to our question about the general statement, "Researchers should be allowed to contact participants in one genetic research study in order to invite their participation in another genetic research study" (p = 0.004) (Figure 1). Compared to responses to this general statement, answers to our scenario-specific question moved in a positive direction (more accepting of recontact) for 34% of chairs.

Figure 1.

General vs. Scenario-Specific Views of the Acceptability of Recontact for Genetic Research Recruitment

We asked how alternative statements that could have been included in the hypothetical original consent form might modify chairs' opinions about the acceptability of recontact. Excluding respondents who already indicated they "definitely would" allow contact (n = 10), 84% said they would be more likely to allow recontact if the original consent form included the explicit statement, "We may contact you about participating in other research studies."

Taken together, these results suggest a high degree of consensus that consent disclosures about the possibility of future contact for the purpose of research recruitment are important and highly preferable, but that not all chairs necessarily view them as imperative. This opinion is captured by a comment offered by one chair in an open-ended text box at the end of our survey where we invited chairs to share any additional thoughts:

Autonomy is the most important principle in my opinion. We should give participants the right to be contacted, to know their results, and to participate in future research at the earliest opportunity (i.e., [during consent for] the original study). If that is not possible, then the decision must be based on other considerations such as the person making the contact, the medium of contact, etc. The latter case is necessarily a more difficult decision, but a blanket disapproval is not warranted, as it not only prevents the advancement of science, but also prevents giving subjects the opportunity to participate in science.

Comments from other chairs, however, demonstrate that some do consider such disclosures essential and may have little tolerance for their absence:

For me the answer depends on whether [participants] were told in the consent for study #1 that they might be contacted again at some future time. If that is not part of the original consent, the researchers would have a very steep slope to climb to convince me they should be allowed to re-contact these people.
If it is so important for future studies, investigators who did not have the simple common sense to ask permission for future contacts can just go out and replicate/extend their critically important research finding that spurs the "need" to contact people based on their private research records.

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