The Department recommends that institutions engaged in human subjects research and IRBs that review HHS conducted or supported human subjects research or FDA regulated human subjects research consider whether establishing policies and procedures addressing IRB member potential and actual conflicts of interest as part of overall IRB policies and procedures would help ensure that financial interests do not compromise the rights and welfare of human research subjects. As noted, 45 CFR (e) and 21 CFR (e) prohibit an IRB member with a conflicting interest in a project from participating in the IRB’s initial or continuing review, except to provide information as requested by the IRB
