IRB Chairs' perspectives on genomics research involving stored biological materials: ethical concerns and proposed solutions
Wolf, Leslie E.
Catania, Joseph A.
Dolcini, M. Margaret
Pollack, Lance M.
Journal of Empirical Research on Human Research Ethics 2008 December; 3(4): 99-111
WE EVALUATED 55 IRB CHAIRS' perspectives on ethical issues in a hypothetical study involving mental health related genomics research using stored specimens to identify potential barriers and solutions to such research. Most Chairs identified the ethical issues of consent and confidentially as important. The majority of Chairs expressed concern about using materials in new research, especially concerning a mental health condition, that was not discussed in the original consent. Few Chairs considered permissible strategies, such as de-identification and waiver of consent, which could allow the proposed research to go forward without consent. Chairs who reviewed more protocols and had attended conferences on human subjects protection identified more of the salient ethical issues in the scenario. Our study could not determine whether Chairs were not familiar with the strategies of de-identification and waiver of consent, or believed that they did not adequately protect participants who had provided specimens for research. Thus, our findings suggest that investigators and IRBs should consider future use of specimens and obtain appropriate consent before collection of specimens. Furthermore, our findings suggest that IRBs can improve review of genomics research involving stored specimens by redesigning forms to prompt IRB members to consider some strategies, such as de-identification and Certificates of Confidentiality, that are recommended for this type of research and by sending members to conferences on human subjects protections and research ethics.
Confidentiality; Consent; Ethics; Forms; Genomics; Health; Irbs; Investigators; Mental Health; Research; Research Ethics; Review; Genetics, Molecular Biology and Microbiology; Human Experimentation Policy Guidelines / Institutional Review Boards; Informed Consent or Human Experimentation; Information Science Ethics;
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