Guest Post: Minimal Risk and Minimal Experience: Can Researchers Competently Navigate OHRP’s New Risk Categories?

The much-anticipated Notice of Proposed Rulemaking—offering the first changes to the Common Rule since its publication in 1991—has now been released. in the interest of providing PRIM&R’s community with as much exposure to the issues raised within it, and the writing and scholarship around the proposed rules changes, PRIM&R and other organizations are cross-posting their thoughts.  This post, from Dr. Celia B. Fisher at Fordham University, focuses on the proposed changes to minimal risk.  It originally appeared on Ethics & Society, the Fordham University Center for Ethics Education blog.

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 to 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.

At present, there is a serious gap in research ethics training in the majority of social science training programs. Currently, to maintain federal funding, most institutions simply rely on investigators taking a single web-based tutorial to demonstrate familiarity with research ethics.

Regulations that rely solely on investigator judgment to ensure research participant protections should not go into effect without requirements that institutions increase research ethics training within their academic programs as well as for their research faculty and staff. Otherwise, the burden unfairly falls upon prospective participants who will serve as guinea pigs for a rush to modernization.

At minimum, the future development of the web-based decision-tool should include clear criteria for when additional studies require additional review, and penalties for institutions who do not effectively monitor the “excused” process.

Once these regulations go into effect it will be years before we will know whether they have adequately protected research participants—and we may not wish to wait until participants experience serious harms before instituting much-needed ethics training.

Celia B. Fisher, PhD, is the Marie Ward Doty University Chair, professor of psychology, and director of the Fordham University Center for Ethics Education and the Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute. She has served on the National Academies’ Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences Committee, the Secretary’s Advisory Committee on Human Research Protections, chaired the Environmental Protection Agency’s Human Studies Review Board, and received the 2010 Health Improvement Institute’s Lifetime Achievement Award for Excellence in Human Research Protection.