Human subjects bill could supercede newly created protections office in HHS
Human subjects bill could supercede newly created protections office in HHS
Government tightens reins on human research
Ethics committees likely will play a larger role in monitoring the education of institutional review board (IRB) members and investigators if Congress has anything to say about it.
Last month, legislation was introduced in Congress to ensure human subjects are protected in research studies. U.S. Reps. Donna DeGette (D-CO), Henry Waxman (D-CA), and John Mica (R-FL) introduced the Human Research Subject Protections Act of 2000, which would establish standards for research institutions and increase funding for a new Office for Protection of Human Subjects (OPHS). The goal of the legislation, according to DeGette, is improved training of members of hospital IRBs and better informed consent processes. (For a summary of the bill, see p. 75.)
Days before the bill was introduced, Health and Human Services Secretary Donna Shalala announced that the newly created Office for Human Research Protections (OHRP) would have more control and independent authority to ensure human research subjects are protected. Details regarding the new office were published in the June 13 Federal Register. (See Medical Ethics Advisor, February 2000, pp. 13-17.)
The OHRP will be headed by E. Greg Koski, MD, a Harvard Medical School anesthesia professor. Koski currently oversees the protection of research subjects at a consortium of Boston-area hospitals, including Massachusetts General Hospital and Brigham and Women’s Hospital.
Two major announcements in such a short amount of time can be confusing, says Koski. "The bill recently introduced by Representatives DeGette, Mica, and Waxman has been in the pipeline for some time, as I understand it, and does reflect the recent initiatives of the Secretary to create the new office and strengthen protections for human subjects," adds Koski.
One of the key features of the bill is to bring all human research under the common rule, he notes. "That’s a step that I believe would be very valuable."
Education will be critical
"Regardless which office — the OHRP or the OPHS — will eventually be responsible for the oversight and control of human research protection, one of the overriding responsibilities between the two is the oversight of the education of IRB members and investigators on human research subjects protections," says Tom Tollison, assistant director of compliance and research contracts attorney for Banner Health System in Phoenix.
Tollison predicts that the ethics committee will be a critical element in the educational process. "I foresee a concerted effort between the research department and the ethics committee of the institution, whereby the research department will be responsible for the implementation of the educational programs, and the ethics committee will be responsible in an active advisory role for those programs," he explains.
While the legislation is not law yet and there’s no word from the new OHRP, the issue of educating IRB members will be critical, adds Tollison. The National Institutes of Health (NIH) is emphasizing education as well.
Beginning Oct. 1, 2000, the NIH will require investigators to provide a description of education completed for individuals identified as "key personnel" in the proposed research. Key personnel are defined as individuals responsible for designing and conducting the study.
All investigators need education in the basics of human subjects research, according to an NIH press release, but some institutions may elect to require more intensive study, especially in difficult topic areas or special patient groups. The NIH does not plan to issue a list of endorsed programs.
The NIH does offer a free curriculum for its own staff, however, that can be adapted and used in other institutions, and it offers an on-line tutorial for its investigators and researchers called Protection of Human Research Subjects: Computer-Based Training for Researchers. (See editor’s note below for more information.)
(Editor’s note: The NIH on-line tutorial can be downloaded from the NIH’s Web site: http://helix. nih.gov:8001/ohsr/newcbt. A bioethics education and curriculum development resource also is available from NIH. The site contains resources for a broad range of topics and provides links to additional resources. Visit the site at: http://www.nih.gov/sigs/bioethics.)
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