G13 - PLENARY: Ethical Review of Human and Animal Subjects Research Proposals

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Many in our field would describe the research projects with human and animal subjects conducted by our institutions as ethical or at least disagree with the characterization that they are unethical. But how and where is this ethical assessment made? When external assessments of research proposals are made, such as when grant funding is awarded, a scientific merit review is performed, but do study sections consider the ethics of the proposals they review? In some cases, there is no external body that reviews the research proposal, such as when internal funds are used. Often the IRB and IACUC are the last to review a project and may represent our best opportunity to ensure that research we conduct is indeed ethical. Opinions vary on whether IRBs and IACUCs do, should, or even can perform an ethical assessment of human and animal research proposals. Some suggest that IRBs and IACUCs should stick to their regulatory scope and that any discussion not directly supported by a regulatory requirement is out of scope. Is a review against regulatory standards enough to ensure that ethical reviews are conducted and if not, how do we ensure research gets adequate ethics review?