Bioethics Blogs

Minimal risk and minimal experience: Can researchers competently navigate OHRP’s new risk categories?

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By: Celia B. Fisher, Ph.D.

The U.S. Department of Health and Human Services has announced proposed revisions to modernize federal regulations governing the protection of research participants’ rights and welfare. The newly proposed regulations have many positive features that will improve the informed consent process through transparency and stricter requirements to protect participant privacy and enhance informed consent.

However, in an effort to streamline the process, proposed changes that exclude some research from institutional oversight, shift the burden of evaluating participant protections from Institutional Review Boards (IRBs) to individual researchers—some of whom are not well versed in research ethics, or have a clear conflict of interest in lessening participant protections to facilitate their research.

Under the new regulations, researchers will use a web-based “decision-tool” to independently determine whether their study involves procedures that because they are “inherently low risk” will be exempt or excluded from IRB review. The researchers will also be expected to use their professional judgment to put in place ethically appropriate confidentiality and informed consent procedures.

The new “excluded” category will primarily pertain to social science and behavioral research which as a group involve “benign interventions” of low risk compared to biomedical studies. To be sure, reducing the current unnecessary review time and effort for both IRBs and investigators is welcome.

However, there are instances in which oversight is needed ensure adequate participant protections including studies involving persons with known cognitive disorders who require additional informed consent protections, individuals engaged in illegal behaviors that require additional protections for research recruitment, or individuals asked to participate in deception studies designed to induce psychological, social or physical discomfort.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.