Kennedy Institute of Ethics Journal

Kennedy Institute of Ethics Journal 10.3 (2000) 261-264

Bioethics Inside the Beltway

Federal Oversight and Regulation of Human Subjects Research--An Update

Carol Mason Spicer

On 6 June 2000, the Department of Health and Human Services (DHHS) announced the appointment of Edward Greg Koski, Ph.D., M.D., as the first director of the newly formed Office for Human Research Protections (OHRP) at DHHS. The announcement came almost exactly a year after the Office for Protection from Research Risks (OPRR) Review Panel issued its findings and recommendations on the appropriate organizational locus for OPRR, which operated under the auspices of the National Institutes for Health (NIH), and the potential need for the office to have increased authority to carry out its mission (see Kennedy Institute of Ethics Journal 9: 285-87). OPRR was the office responsible for providing guidance on and reviewing, overseeing, and enforcing federal regulations pertaining to research involving human subjects and animals at NIH-funded institutions.

In its 3 June 1999 "Report to the Advisory Committee to the Director, NIH from the Office of Protection from Research Risks Review Panel," the Review Panel recommended that OPRR be "administratively relocated" from NIH to DHHS. "Locating OPRR outside of the NIH will strengthen its ability to interact with other agencies within DHHS and with other Departments," the Review Panel concluded. The new Office for Human Research Protections, which officially came into existence in June, replaces OPRR and is located within the Office of Public Health and Science, Office of the Secretary, and will be under the direction of the Assistant Secretary for Health. OHRP will provide leadership for all 17 federal agencies that sponsor research involving human subjects under a regulation known as the Common Rule. (Oversight of research on animal subjects is now the responsibility of a separate, new Office of Laboratory Animal Welfare at NIH.)

Dr. Koski began work and planning with OHRP over the summer as a consultant; he officially takes over as director in September, leaving his positions as director of human research affairs at Partners HealthCare System, Inc., in Boston, and associate professor of anesthesia at Harvard Medical School. According [End Page 261] to the DHHS press release announcing his appointment, "Dr. Koski comes to the new position with a background not only in research management and patient protection, but also in basic and clinical research. His research experience includes clinical investigation over a range of disciplines, including human and animal physiology, biochemical pharmacology, neurosciences and regulatory biology" (<http://www.hhs.gov/news/press/2000pres/20000606.html>).

Dr. Koski assumes his new role in the midst of renewed efforts to strengthen protections for human research subjects, including those involved in gene transfer studies. DHHS must respond to criticisms from its own Office of Inspector General, members of Congress, and others regarding the insufficiency of current practices to protect human subjects adequately. Although there has been some speculation that the decision to relocate former OPRR director Gary Ellis within NIH--he is now at the Clinical Center--rather than to accept his offer to move to OHRP stems from the aggressiveness displayed by his office in temporarily shutting down research at seven institutions since mid-1998 for human subjects violations, DHSS recently has outlined several new initiatives designed to bolster protections for human research subjects.

On 23 May 2000, DHHS Secretary Donna Shalala announced new efforts in the areas of education and training, informed consent, improved monitoring of trials, conflict of interest, and civil monetary penalties (<http://www.hhs.gov/news/press/2000pres/20000523.html>). Except where noted, the following descriptions of the efforts in these five areas are taken from the 6 June 2000 HHS Fact Sheet "Protecting Human Research Subjects" (<http://www.hhs.gov/news/press/20000606a.html>).

"Education and Training. HHS will undertake an aggressive effort to improve the education and training of clinical investigators, IRB members, and associated IRB and institutional staff. NIH, FDA and the [Office for Human Research Protections] (OHRP) will work closely together to ensure that all clinical investigators, research administrators, IRB...