By Nanibaa’ A. Garrison, Ellen Wright Clayton and Ingrid A. Holm
Based on today’s publication of the paper A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States in Genetics in Medicine.
The recent Notice of Proposed Rule Making (NPRM) issued by the Office of Human Research Protections proposes to require researchers to obtain informed consent from virtually every patient and research participant for use of biospecimens for research. The proposed regulations also permit obtaining broad consent for future uses, without any IRB oversight unless individual results are going to be returned so long as an elaborate consent form is signed. The NIH Genomic Data Sharing Policy, which went into effect earlier this year, requires almost all investigators who receive NIH funding to seek broad consent from participants to allow their data to be shared with other investigators. Thus, in a short period of time, two major policies promoted broad consent for biobank research, changes in the practice of recruiting participants for research that make us take notice. They also raise new questions, including: What do research participants think about having their biospecimens and data shared, and about giving broad consent to do so?
Who is comfortable with Broad Consent?
The Electronic Medical Records and Genomics (eMERGE) Network’s Consent, Education, Regulation, and Consultation (CERC) working group set out to find some answers. As a part of this effort, we conducted a systematic review, which revealed that males, whites, older individuals, and more affluent individuals are generally pretty comfortable with broad consent that can be found here. By contrast, Asian and African American individuals are less comfortable with broad consent. Will these different levels of concern create a divide between those who will and will not participate? The consequences of lack of participation are clear – we will know less about how genetic variation in groups that do not take part affects health and less about how to provide optimal care.
A national cohort of whom?
The Precision Medicine Initiative (PMI) takes these efforts another step further with plans to create a national cohort of participants representative of the US population. Obtaining broad consent would allow investigators to pursue a wide range of scientific research studies without having to burden the participants with re-contact and re-consent for every use of their data and specimens.
In order to achieve a representative cohort, some investigators have focused time and energy on addressing concerns from communities that have historically been underrepresented in research, such as minorities. The root of mistrust in many of these communities may have arisen out of a history characterized by lack of continued communication with researchers who are using their data and specimens, never hearing from the researchers once enrolled, to say nothing of learning the results of the research. Additionally, some communities have experienced group harms based on inappropriate interpretations of results that were perceived as stigmatizing the community. Elaborate consent requirements will not address these concerns. It remains to be seen whether the community engagement envisioned by the PMI will suffice. If these efforts do not enhance participation, will the PMI be able to improve the health of all Americans?