Do human subject safeguards matter to potential participants in psychiatric genetic research?

• Published in: Journal of psychiatric research Vol. 116; pp. 95 - 103
• Main Authors: Roberts, Laura Weiss, Kim, Jane Paik, Tsungmey, Tenzin, Dunn, Laura B.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.09.2019
• Subjects: Adult; Biomedical Research - standards; Female; Genetic Research; Humans; Male; Mental Disorders - genetics; Mental illness; Middle Aged; Non-genetic research; Patient Participation; Patient Rights; Research ethics; Research Subjects; Safeguards; Genetic research; Research ethics; Non-genetic research; Mental illness; Safeguards
• DOI: 10.1016/j.jpsychires.2019.06.004
• ISSN: 0022-3956; 1879-1379

Despite longstanding concerns about the adequacy of human research protections in mental illness investigations, minimal work has focused on the perspectives of key stakeholders regarding these safeguards. This investigation examined the perspectives of potential research participants regarding safeguards for psychiatric genetic research. Individuals with mental illness (n = 71), first-degree family members of individuals with mental illness (n = 54), and individuals with no personal or close family history of mental illness (n = 57) provided responses to items regarding perceptions of: 1) protectiveness of a range of research safeguards in genetic research on mental illness; 2) influence of these safeguards on research participation decision-making; and 3) importance of these safeguards depending on the nature of the research (i.e., genetic vs. non-genetic mental illness research; and genetic research on mental illness vs. physical illness). Potential research participants perceived existing safeguard procedures as generally protective. The three groups did not differ in their ratings of protectiveness, with the exception of the safeguard domain of “Informed Consent or Alternative Decision-Making Procedures,” which was viewed as more protective by family members of people with mental illness than by individuals with mental illness or comparison participants. Safeguard procedures were perceived as strongly influential with respect to willingness to enroll in psychiatric genetic research. These findings suggest that the presence of safeguards positively influences enrollment decision-making by research volunteers and indicate that potential psychiatric genetic research participants find safeguards to be protective, underscoring the responsibility to implement safeguard practices conscientiously.