Program in Bioethics and Humanities

Publication:  IRB Guidance

Lab Documents

Genomic research and the return of research results is challenging the tradition of informed consent. This report analyzes publicly accessible IRB websites for guidance in this area. Documents and templates from 20 U.S. IRBs were analyzed. Variability across IRBs and their guidance on genomic research results was substantial. Most documents stated that access to individual results would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that “significant new findings” would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on research results exceeded a ninth-grade level. The study suggests that IRBs may need to clarify what kind of results will and will not be returned, and prepare consent templates that are easier to understand for lay people. The full article text can be found here.