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

Disclosure of Research Results in Genotype-driven Recontact

Similar to the general statement about the acceptability of recontact, there was considerable variation in responses to the general statement, "Each participant should be offered his/her individual genetic results from the first study when contacted about taking part in the second study." Although 42% agreed with this statement, most either disagreed (21%) or selected "neither agree nor disagree" (32%). This distribution again suggests that other factors may have an important influence on IRBs' opinions about this issue. When asked:

  • 87% of respondents said that statements in the consent form for the first study concerning disclosure of individual genetic research results would be important;

  • 86% said that the level of clinical validity of the first study's findings would be important (clinical validity was defined as "the accuracy with which the presence of a gene variant predicts the presence of a clinical condition or predisposition"); and

  • 76% said that the level of clinical utility of the first study's findings would be important (clinical utility was defined as "the availability and effectiveness of interventions aimed at avoiding the adverse clinical consequences of a gene variant").

We also asked respondents to consider disclosure of research results in the context of the hypothetical scenario (Box 1). In response to this scenario—in which the consent form for the first study did not include any statements either allowing or prohibiting such disclosure, and in which the first study's findings were described as having uncertain validity and utility—42% said the researcher definitely or probably should offer to disclose eligible participants' individual genetic results from the first study as part of her explanation of the purpose of the second study. More, however, either said she definitely or probably should not (28%) or were undecided (22%). This represents a statistically significant departure from responses to our question about the general statement, "Each participant should be offered his/her individual genetic results from the first study when contacted about taking part in the second study" (p < 0.001) (Figure 2). Compared to their responses to this general statement, answers to our scenario-specific question moved in a negative direction (less favorable toward offering results) for 30% of chairs.

Figure 2.

General vs. Scenario-Specific Views About the Disclosure of Individual Genetic Research Results During the Recruitment Process

We probed about alternative statements concerning the disclosure of results that could have been included in the hypothetical first study's consent form. Excluding respondents who already indicated that the researcher "definitely should" offer individual results (n = 24), 77% were more likely to favor disclosure if the original consent form had stated, "We will offer to disclose your individual genetic research results if they have potential clinical consequences for you and/or your family members."

We also probed about alternative descriptions of the nature of the hypothetical first study's results. One alternative provided an example of findings with limited clinical utility:

Although additional research is needed, it appears that this gene variant conveys a small increase in risk for heart disease compared to that in the general population. At this time, recommendations for people who have this variant would be the same as for the general population: stop smoking, follow a heart healthy eating plan, be physically active each day, and maintain a healthy weight.

This kind of finding did not have a definitive effect: excluding chairs who already indicated that the researcher "definitely should" offer results (n = 24), only 30% said they would be more likely to favor disclosure. A second alternative provided an example of findings with potentially more utility:

Although additional research is needed, this particular gene variant is in a biologic pathway that suggests that, for people who have the variant, diet and exercise alone may not be effective in reducing future risks associated with heart disease. Further, a specific class of cholesterol-lowering drug might be indicated.

This kind of finding was viewed more positively; again excluding chairs who already indicated that the researcher "definitely should" offer results (n = 24), over half (53%) said they would be more likely to favor disclosure.

Taken together, these results again highlight the importance chairs assigned to information conveyed during the consent process for the original study, this time about disclosure of results. They also suggest that, at a minimum, the clinical validity of the results from the original study will be a significant factor in the minds of many chairs when considering whether such results should be offered in the context of genotype-driven recruitment. Several chairs offered comments at the end of our survey reflecting this opinion:

In general I favor personal autonomy, but I draw the line at informing people about findings whose significance is not clear even to the researchers. It is bad enough that we burden patients with information we believe to be true that later turns out to be wrong. We should not load them with information whose significance is unclear even to us.
I am very reluctant, whether one is dealing with a medical device, a new assay, or genetic test results, to allow the results to enter into real-time decision making…. The subject could make decisions based on the results that could place them at risk for additional negative consequences—all because they agreed to participate in a research protocol. Placing a subject at avoidable risk "because they agreed to receive the results" is insufficient. The risk versus benefit ratio determination is independent of whether the volunteer states they want to assume the risk, in my view. "Do no harm" and "autonomy" are obviously in tension here. I will always give "do no harm" the right of way.

One chair's comment serves as a reminder that how results are communicated can be as important as the content of those results:

One concern is whether the participants who are re-contacted and given some form of individual genetic information will be able to comprehend the information accurately. If it is technically precise it may not be comprehensible. If it is stated in layman's terms, it may be so inaccurate as to give rise to unfounded anxiety. So, I would pay close attention to the manner in which individual genetic information is presented to participants.

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