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Move will elevate stature and effectiveness, feds say
A move by the U.S. Department of Health and Human Services (HHS) is expected to change a longstanding perception of how human research is regulated by the federal government. By the spring of 2000, HHS will move the Office for Protection from Research Risks (OPRR) from its current location within the National Institutes of Health (NIH) to the HHS Office of the Secretary. The move will give the OPRR — the agency in charge of enforcing federal protections for human and animal research subjects — more autonomy.
"The way it works now is that office resides within NIH. One perspective is that it is the fox guarding the hen house in that the people charged with oversight are essentially answering to the people who do the research. It is a question of perceived — and to some extent real — independence to do the tasks that they are asked to do," notes Jeffrey P. Kahn, PhD, MPH, director of the Center for Bioethics at the University of Minnesota. Kahn also is co-author of the books Ethics of Research with Human Subjects: Selected Policies and Resources and Beyond Consent: Seeking Justice in Research.1,2
According to the Nov. 4 HHS statement announcing the move: "The Advisory Committee to the director of NIH has recommended that the OPRR be relocated in the Office of the Secretary to elevate its stature and effectiveness. Secretary Donna E. Shalala has accepted the recommendation and directed that OPRR be relocated to the Office of Public Health and Science within the Office of Secretary."
The relocation essentially moves the office up a level in terms of the chain of authority — the new position is within the office of the Secretary of Health and Human Services. The NIH is a division of HHS.
Track record is troubled
Founded in 1972 by then-NIH director Robert Q. Marston, OPRR is the federal office that develops and implements regulations governing the use of human research subjects in federally funded studies. Institutions seeking to conduct biomedical or behavioral research using federal funds must sign an "assurance" with OPRR that specifies the policies and procedures they will put in place to ensure compliance with all OPRR regulations. (For more information on research ethics, see Medical Ethics Advisor, July 1999, pp. 73-83.)
In addition, each institution must form an institutional review board (IRB), made up of medical experts, ethicists, and members of the population studied, that approves research protocols and monitors ongoing studies to ensure compliance.
In addition to rule-making, OPRR is charged with monitoring institutional compliance with the assurances as well as the effectiveness of its protocols and IRB oversight.
Last year, well-publicized rule violations at prominent research institutions — notably Duke University Medical Center in Durham, NC, and the University of Colorado Health Sciences Center in Denver — have prompted Congress, medical ethicists, and several patient advocacy groups to call for an overhaul of existing protections for human subjects. (See MEA, July 1999, pp. 73-78.)
Concerns arise over independence
Following an initial recommendation from the president’s National Bioethics Advisory Commis sion (NABC) last year, the NIH Advisory Com mittee to the Director convened a seven-member review panel, consisting of legal experts, medical ethicists, and research scientists, to evaluate OPRR’s effectiveness. In its report, the review panel indicated that OPRR was perceived to be unduly influenced by the pro-research endeavors at the NIH.
"OPRR’s connection to NIH confers status by virtue of association with one of the premier research institutions in the world and provides OPRR, in theory, with immediate access to scientific expertise," the report reads. "While this aspect of the NIH connection enhances the status and reputation of OPRR in the scientific community, the relationship to NIH increases the public perception that OPRR will be biased in the direction of protecting research interests at the expense of protections for human subjects and animals."
The concerns are more than hypothetical, the report continues. Interviews with OPRR staff indicated that, at times, their policy recommendations had been modified before reaching the Office of the Secretary, "thus subsuming their intentions to the agendas of other divisions within the NIH."
According to the HHS statement, the move also will eliminate the concern that location within the NIH diminished the OPRR’s contact with other HHS agencies as well as other federal agencies outside HHS.
Top-level changes: The right solution
However, some experts feel that relocating OPRR will do little to alleviate the real problems involved in protecting human subjects in the rapidly expanding arena of biomedical research.
In 1998, the University of Pennsylvania Center for Bioethics’ Human Research Ethics Group published recommendations for improving protections for human research subjects.3 Significantly, the recommendations called for increased supervision of research by the IRB at each center and for extending the protection of the IRB process beyond just those studies receiving federal funds.
"I am not sure what moving the OPRR from one level to another will do to address the sort of fundamental issues that were raised in the study that came out last year," says David Magnus, PhD, director of graduate studies at the Center for Bioethics. "Most of the key issues that were raised are really things that rise at the local level."
Following the study, the group concluded that the existing model for institutional review was inadequate to deal with the increasing number of studies that involve multiple institutions and many different investigators as well as both public and private funding, says Magnus.
"It is not clear whether or not this move will facilitate the things that are going to be necessary for IRBs to effectively do what our study called on them to do: perform all of the follow-up that is necessary, instead of the bureaucratic rule-solving that is taking place now."
Another recommendation of the OPRR review panel indicates that, although the office currently has the authority necessary to conduct the duties assigned to it, the office may not be able to fulfill its mission with the its current resources.
"Critiques of OPRR make clear that OPRR needs to exert more leadership in education and training, and in providing technical assistance to, and evaluation of, IRBs," the report says. "Where ver OPRR is located, more resources will need to be available to enable OPRR to fulfill the promise of even the current statutory and regulatory scheme."
Although research performed without HHS funds is outside OPRR jurisdiction, many in the bioethical and research communities feel that strengthening the office’s resources and authority would both improve its supervision of federally funded projects and its position of leadership in developing protections for all research subjects. 4
"The way the law actually reads is that only research that is federally funded has to follow the common rules," explains Kahn, "But, most institutions that receive federal funding sign a multiple project assurance, in which they agree that all research performed at that institution will be conducted under the same rules.
"So, it is not just federally funded research that has protection, but it is sort of black box. How many institutions don’t fall into that category? It is pretty hard to know. Pharmaceutical companies also have to follow federal rules and submit their data to the [U.S. Food and Drug Administration] FDA. So, there is federal oversight in the vast majority of publicly and privately funded research; the question is how much falls between the cracks."
Frankly, he adds, moving OPRR is not going to address that issue. Only comprehensive legislation by Congress can accomplish that. "It is an issue that Congress has talked about, at times, of fixing, by saying that all research performed within the United States will have to follow certain rules. But that has not ever happened."
However, the move may provide the opportunity for the office to re-examine its mission and resources, he notes. "How they will maintain their role as an oversight body, and as an educational body, or as a friend of researchers, as well as maintaining their police function . . . is not exactly clear. I think this is a good time for that mission to be clarified," he says.
Funding is a concern
Another major concern expressed in the report from the OPRR review panel regarding the move was the possible interruption or alteration in the funding stream for the office.
"OPRR’s current location within the funding stream of the NIH places OPRR among the privileged," the report states. "The Review Panel recognizes that any new organizational arrangement may disrupt what is now a reliable funding situation and exposes OPRR to the risk that it will be more vulnerable to legislative efforts to impose fiscal restraint or achieve other political goals."
Again, Magnus says, moving the office outside the NIH may have real little impact on how IRBs function at the local level. "The real issues have to do with how much time, how much funding is available, and what in terms of resources are we going to have allocated at the local level to make sure that IRBs can truly function in a way that is necessary to offer protections," he explains.
1. Sugarman J, Mastroianni A, Kahn J, eds. Ethics of Research with Human Subjects: Selected Policies and Resources. Frederick, MD: University Publishing Group; 1998.
2. Kahn JP, Mastroianni AC, Sugarman J, eds. Beyond Consent: Seeking Justice in Research. New York City: Oxford University Press; 1998.
3. Moreno J, Caplan A, Wolpe P, et al. Updating protections for human subjects involved in research. JAMA 1998; 280:1,951-1,958.
4. Report to the Advisory Committee to the Director, NIH from the Office for Protection from Research Risks Review Panel. June 3, 1999. World Wide Web: http://www.nih. gov/welcome/director/060399b.htm.
• HHS Fact Sheet: Protecting Research Subjects. Nov. 4, 1999. World Wide Web: http://hhs.gov/news/press/ 1999/991104c.html. Office for Protection from Research Risks: World Wide Web: http://www.nih. gov/grants/oprr/oprr.htm.
• David Magnus, PhD, Director of Graduate Studies, University of Pennsylvania, Center for Bioethics, 3401 Market St., Suite 320, Philadelphia, PA 19104-3308.
• Jeffrey P. Kahn, PhD, MPH, Center for Bioethics, University of Minnesota, Suite N504 Boynton, 410 Church St., Minneapolis, MN 55455-0346. Telephone: (612) 624-9440. Fax: (612) 624-9108.
• U.S. Department of Health and Human Services, Office of Public Health and Science, Hubert H. Humphrey Building, 200 Independence Ave. SW, Washington, DC 20201. Telephone: (202) 205-1842.