PRIM&R’s Recent Public Policy Comments

Posted by Amy Davis, Program Director

Last July, the Office for Human Research Protections (OHRP) published in the Federal Register, a “Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs”. Specifically, OHRP sought information on…

  • whether it should issue additional guidance recommending that institutions engaged in human subjects research conducted or supported by the Department of Health and Human Services (HHS), implement training and education programs for certain individuals involved in the conduct, review, or oversight of human subjects research; or
  • whether HHS should develop a regulation requiring the implementation of such training and education programs.

PRIM&R filed a response to this request which supported the promulgation of a new regulation requiring institutions engaged in human subjects research conducted or supported by HHS to implement ethics education programs for their employees and faculty who are directly involved in the conduct, review, or oversight of human subjects research. PRIM&R favors the development of ethics education focused on the application of sound ethical principles, rather than a more specific program of “training” which connotes memorizing and applying by rote rules or techniques. While many institutions already provide education to their investigators, IRB members, and staff, some do not. Requiring education will have the greatest and most needed impact on the latter institutions but, if handled correctly, such a requirement would broaden the understanding of ethical requirements at all institutions. Even institutions that have comprehensive training and education programs are vulnerable to gaps in the application of ethical principles and regulatory compliance. (See OHRP Compliance Oversight Determination Letters.) Education and training programs can help all research institutions cultivate a climate for the ethical conduct of research. An important qualification that PRIM&R included in its comments was that any regulation establishing such a requirement be broadly written to allow institutional discretion to develop the process, content, and evaluation of such education programs that are specifically tailored to the needs of the individual institution. It is not necessary, and could in fact be counterproductive, for such a requirement to prescribe the curriculum details for a broadly applicable education program. Research organizations include a broad range of institution types, ranging from large, non-profit academic research institutions to small, for-profit research firms. They conduct many different kinds of research, from community-based research to biomedical research involving new devices, drugs, or surgical techniques. Such unique entities demand tailored educational programs to meet their distinct needs. Regulations which attempt to define the precise curriculum and evaluation requirements for so varied an audience could result in generic programs that do not address specific circumstances of the individual institution. Programs that are created by and specifically tailored to each institution are more likely to facilitate the application of ethical and regulatory requirements that contribute to an institutional culture of ethical conduct. Furthermore, individuals who participate in such programs will be more receptive to and find more meaning in a program that is specifically relevant to their work.What do you think about OHRP’s request for information? Do you agree with PRIM&R’s position? Share your comments here, or join the discussion forum on PRIM&R’s Online Communities (PRIM&R members only).