D06 - The Limits of Permissible Research Without Consent

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All the major ethical codes addressing human subjects research emphasize the central importance of obtaining the voluntary informed consent of the participant prior to commencing any research activities. Nonetheless, longstanding ethics and regulations in the U.S. acknowledge that some research with human subjects is difficult or impossible to conduct with prospective consent, and that the importance of the research may outweigh this obligation under certain circumstances. Thus, there are established and evolving mechanisms that allow research to take place without obtaining consent at all, or with alterations of some elements of consent. That being said, it is important that these mechanisms are applied appropriately and conservatively to ensure that individuals are not being exploited or that consent is not waived for purposes of the convenience of the researcher. This session will review the complex regulatory requirements surrounding research without consent as it applies to different types of situations (e.g., eligibility screening, secondary research using previously collected information and/or biospecimens, cluster randomized trials, deception research, interview studies). Speakers will review what the regulations permit and require (including changes introduced with the 2018 revisions to the Common Rule), and use case-based discussion to highlight the ethical considerations where researchers may request to conduct their research without consent.