Informed consent for biobanking: consensus-based guidelines for adequate comprehension.

PURPOSE: Federal regulations and best practice guidelines identify categories of information that should be communicated to prospective biobank participants during the informed consent process. However, uncertainty remains about which of this information participants must understand to provide valid consent. METHODS: We conducted a Delphi process to define "adequate comprehension" in the context of biobanking consent. The process involved an iterative series of three online surveys of a diverse panel of 51 experts, including genome scientists, biobank managers, ethics and policy experts, and community and participant representatives. We sought consensus (>70% agreement) concerning what specific details participants should know about 16 biobank consent topics. RESULTS: Consensus was achieved for 15 of the 16 consent topics. The exception was the comprehension needed regarding the Genetic Information Nondiscrimination Act. CONCLUSION: Our Delphi process was successful in identifying a concise set of key points that prospective participants must grasp to provide valid consent for biobanking. Specifying the level of knowledge sufficient for individuals to make an informed choice provides a basis for improving consent forms and processes, as well as an absolute metric for assessing the effectiveness of other interventions to improve comprehension.Genet Med 17 3, 226-233.

Using Cognitive Interviews to Enhance Measurement in Empirical Bioethics: Developing a Measure of the Preventive Misconception in Biomedical HIV Prevention Trials.

BACKGROUND: We describe our use of cognitive interviews in developing a measure of "preventive misconception" to demonstrate the importance of this approach to researchers developing surveys in empirical bioethics. The preventive misconception involves research participants' false beliefs about a prevention trial, including beliefs that the interventions being tested will certainly be effective. METHODS: We developed and refined a measure of the preventive misconception using qualitative interviews that focused on cognitive testing of proposed survey items with HIV prevention trial participants. RESULTS: Two main problems emerged during initial interviews. First, the phrase "reduce your risk," used to elicit beliefs about risk reduction from the use of study medications, was interpreted as relating to a reduction of risky behaviors. Second, the phrase "participating in this study," intended to elicit beliefs about trial group assignment, was interpreted as relating to personal behavior changes associated with study participation. Additional interviews using a revised measure were no longer problematic in these ways, and participants felt the response options were appropriate for conveying their answers. CONCLUSIONS: These findings underscore the importance of cognitive testing in developing surveys for empirical bioethics.