New Federal-wide Assurance System for the Protection of Human Research Subjects


Continued publicity and national attention to the federal role in the protection of human research subjects has resulted in a presidential panel making recommendations, accreditation standards being written, elevation from the National Institutes of Health (NIH) to the Health and Human Services (HHS) for the HHS Office of Protection of Human Subjects, congressional inquiries, proposed federal legislation, and several HHS/IG investigations. Less attention has been paid to simplifying the system so that it actually can pay more attention to the protection of subjects and less to bureaucratic procedures. Simplification of the assurance process by which institutions and institutional review boards are approved is the first major change to provide relief to this burdened and cumbersome process. ALL DOE sites using human volunteers will be affected by these new procedures, and Dr. Susan L. Rose of the Office of Science will be working with HHS to see that all DOE sites comply and have approved IRBs or that they designate an approved IRB to oversee the research at that site. This federal-wide process will begin in December and is expected to continue as implementation problems are resolved and the institutions coming up for renewal under the old system convert. Currently, all DOE labs doing such work are already assured by HHS or hold a DOE assurance. Dr. Rose, with the help of HHS, will educate the DOE sites through the DOE Human Subjects Working Group on what is expected of them and when. If the system works as billed, local IRBs will no longer be the sole benchmark for approval of research. This new registration system is expected to have the most impact for the DOE system where IRBs are not functioning well or for sites that only provide subjects for research and have no IRB at present, mainly beryllium studies and DOE workplace research conducted by academics.