In lieu of an abstract, here is a brief excerpt of the content:

  • New Home for OPRR

On 3 June 1999, the Office for Protection from Research Risks Review Panel 1 issued its findings and recommendations regarding the appropriate organizational location of the Office for Protection from Research Risks (OPRR) and the potential need for OPRR to have increased authority to carry out its mission. OPRR provides guidance on and reviews, oversees, and enforces regulations pertaining to research involving human subjects and animals. Since the Report was issued, Department of Health and Human Services (DHHS) Secretary Donna Shalala has accepted all of the Review Panel’s recommendations. OPRR will be relocated to the Office of Public Health and Science within the Office of the DHHS secretary and will report to the assistant secretary for health. The position of OPRR director will be upgraded to Senior Executive Service level, and an independent advisory committee will be established.

The following excerpts are from the “Report to the Advisory Committee to the Director, NIH from the Office for Protection from Research Risks Review Panel.” The page numbers provided refer to the Journal’s downloaded version of the online Report, the full text of which is available on the World Wide Web at http://www.nih.gov/grants/oprr/references/060399b.htm.

The Office for Protection from Research Risks Review Panel (Review Panel) was convened to consider two issues involving the Office for Protection from Research Risks (OPRR) and to make recommendations based on the review to the National Institutes of Health (NIH) Director’s Advisory Committee. The objectives of this review were to:

  1. 1. Ensure that the organizational locus of OPRR continues to be the most appropriate for OPRR’s mission and future directions of research; and

  2. 2. Advise whether there is a need for OPRR to have additional delegated authority to accomplish its mission.

. . . Based on the interviews conducted, the material reviewed, and discussions that occurred among the Review Panel members, the Review Panel arrived at the following findings and recommendations [p. 1]: [End Page 285]

I. OPRR should be administratively relocated from its present location within the NIH.

. . . [I]n its present location, as a part of the NIH and reporting to supervisors within the NIH, OPRR is not perceived as an independent office. . . . This perception of dependence and the concerns about conflicts of interest that arise therefrom compromise the ability of OPRR to function most effectively in providing ethical and regulatory leadership in the arenas of research with human subjects and with animals. After considering the advantages and disadvantages of OPRR’s current location, the Review Panel concluded that relocating OPRR was the only way to address these perceptions and concerns and to ensure OPRR’s independence and maximize its effectiveness [pp. 5–6].

II. OPRR should be located in the Office of the Secretary of the Department of Health and Human Services (DHHS) and report to either the Surgeon General or the Assistant Secretary for Health: Locating OPRR outside of the NIH will strengthen its ability to interact with other agencies within DHHS and with other Departments.

. . . At issue here is not a superficial concern about location on an organizational chart, but a substantive concern that the interests of the human subjects and animals involved in research will not be adequately protected if the entity charged with their protection does not have the actual and perceived authority to achieve cooperation or compliance from other entities in the government. . . . The Review Panel considered several possible administrative locations including within the Executive Office of the President, other locations within DHHS, or an independent agency, but concluded that it should be in the Office of the Secretary. Relocating OPRR to the Office of the Secretary will make OPRR more effective in exercising a leadership role in the research community on issues relating to the protection of human subjects and the welfare of animals [p. 9]. . . .

III. A relocated OPRR would best be able to reap the benefits of the move if the director of the office were to be a member of the Senior Executive Service.

. . . Reclassifying the position of director as a member of the Senior Executive Service (SES) should permit a director of OPRR to be recruited who will be able to fulfill...

Share