In addition to ensuring compliance with .116(b)(9)(i), IRBMED follows principles regarding informed consent considerations consistent with NIH guidance (regardless of study funding). Per NIH Guidance:
“In general, participants should be given the choice about whether or not they wish to have their data and biospecimens stored and shared for future use. Providing options for participants to agree to data and biospecimen storage and sharing is particularly important in studies that offer the prospect of direct benefit to the participant. Requiring storage and sharing may be considered undue influence if the participant does not want to agree to sharing of data and biospecimens but feels compelled to agree anyway to join a possibly beneficial research study. If the primary research study offers no prospect of direct benefit, it may be reasonable to consider requiring storage and sharing in the primary protocol (e.g., if the primary protocol is a repository protocol with the sole purpose being to collect data and/or biospecimens for future use). In this case, there is no reason to participate if the participant does not want to provide consent for storage and sharing.”
Therefore, if the research offers the potential for direct benefit that is only available in the context of a research study, the direct benefit of the primary intervention has the potential to unduly influence subjects into agreement. To prevent this, subjects should opt-in to future unspecified research, and also have the opportunity to withdraw consent for future unspecified research at a later date. Section #III below for additional details.