Stroke genetic research and adults with impaired decision-making capacity: A survey of IRB and investigator practices

Background and Purpose: In stroke and other brain disorders, severely affected phenotypes often impair decision-making capacity. Severity is in part under genomic control. Therefore, scientifically valid research into genetic risk may require inclusion of such impaired individuals. U.S. Federal regulations do not detail rules governing enrollment of adults with impaired decision-making capacity into genetic research. Rather, policy and practice are locally determined. This study was conducted to obtain data on how investigators and IRBs handle surrogate authorization to enroll probands into a genetic study where some may lack capacity because of ischemic stroke. Methods: Sequential surveys of sites from an ongoing North American study investigating genetic risks for ischemic stroke (2003: 49 sites, response rate≤100%; 2007: 53 sites; response rate≤91%) assessed whether and how investigators enroll adults with impaired decision-making capacity and determined frequency of IRB approval for enrollment by surrogate authorization. Results: Approximately 40% of sites report that their IRBs do not approve surrogate authorization to enroll stroke patients-43% (21/49) in 2003 and 35% (17/48) in 2007. Thirty-three percent of sites report evaluating eligible adults who lacked capacity to provide their own informed consent; 18% (9/49) in 2003 and 15% (7/48) in 2007 have enrolled these individuals. Surrogate enrollment is the most common method used. Most sites have not enrolled any individual lacking capacity to give his or her own consent. Conclusions: Our study suggests that enrollment by surrogate authorization into stroke genetic research is often not approved by IRBs, and even when allowed is frequently not used. For disorders like stroke, this situation has significant implications for scientific validity.