Suit Puts Focus On Advisory Panel Consensus-Building

A recent legal flap that may force the National Academy of Sciences (NAS) to open the proceedings of its advisory committees to public scrutiny has focused the attention of researchers and government officials on how advisory panels produce reports. NAS-through its operating arm, the National Research Council (NRC)-is frequently called on to give status reports on various scientific and medical issues and policies, as are advisory panels convened by other agencies. The resulting reports frequently help resolve scientific disputes, gauge the status of research disciplines, examine standards of care, and influence policy and funding decisions. DO YOUR DUTY: UC-Santa Cruz’s M.R.C. Greenwood believes it’s a scientist’s responsibility to participate in national committees that produce reports. Because of the potential impact government advisory panels may have, Congress passed the 1972 Federal Advisory Committee Act (FACA). The act states that panels formed to advise the federal government must open their proceedings to the public. In May 1994, the Animal Legal Defense Fund (ALDF) filed suit against the Department of Health and Human Services (HHS) and the National Institutes of Health. The suit sought access to deliberations of an NRC committee that had been asked by NIH to revise the Guide for Care and Use of Laboratory Animals. NAS joined in the defense of this suit to prevent research council committees from being federally controlled and subject to FACA. The academy was concerned that such public scrutiny would affect the agency's independence and the "candid exchange among committee members," notes E. William Colglazier, executive officer of NAS and NRC. CONCERNED: NAS's E. William Colglazier worries that a recent court ruling that NRC committee meetings should be open may compromise the academy’s independence. In January, three United States Court of Appeals judges reversed an earlier decision in favor of the defendants. They rejected NAS's argument that it is not a government body and is immune from such laws. In May, the U.S. Court of Appeals for the District of Columbia refused to reconsider the ruling. The academy may appeal to the Supreme Court. Both NAS and NIH advisory processes are far from simple. When the academy is asked by Congress or various federal agencies to investigate an issue, the NAS governing board determines if the organization should tackle the topic based on its timeliness and the breadth of expertise and available information necessary to address it. Study committee members, including non-experts, are recommended by various academy board and commission members in the field of interest, and ultimately appointed by the NRC chairman. A resulting committee report undergoes peer review. The study committee subsequently addresses reviewer concerns and questions before producing a final draft. Photo: Ingbert Grüttner STAY THE COURSE: Rodney Nichols of the New York Academy of Sciences explains that advisory panel members keep reports on track. "They [review committee members] look to make sure the text and conclusions flow logically," notes Rodney Nichols, president and CEO of the New York Academy of Sciences who has participated in past NRC panels. "They make sure that the NRC committee hasn't gone off course and that it actually answered the questions it set out to answer." Final approval lies with the NRC chairman. The NIH study process is slightly different. Congress, government agencies, the health-care community, and the public all can submit proposals for an NIH Consensus Development Conference. Such conferences produce consensus statements-in effect, resolutions to a medical dispute or controversial issue in clinical practice. For a topic to be considered by NIH's Office of Medical Applications of Research (OMAR), which oversees the consensus-development process, several criteria must be met. The issue should be of public health importance. In addition, there should be a controversy or gap between current knowledge and practice, as well as an available base of scientific information. OMAR and a particular NIH institute, division, or center cosponsor the conference and work together to choose conference panel members, who write the advisory reports. Panel members in an NIH consensus conference include scientists, medical professionals, and public-interest advocates. During the conference, they listen to testimony and evaluate evidence from experts in various fields under discussion. At the end of the conference, recommendations are made to the sponsoring institute or agency that had originally requested the report. Both NRC and NIH advisory processes bring together diverse committees to produce reports. Group report-writing offers some advantages over individual studies. One is obtaining a consensus, contends D.W. Powell, chairman of internal medicine at University of Texas Medical Branch at Galveston. He believes that the consensus conference method of "bringing together some very good minds to address a scientific or policy controversy in a short period of time" is perhaps the best way of examining the issues in a fast, concise manner, with opportunities for public input. Powell chairs the consensus development committee on management of hepatitis C, which met March 24 to 26. He notes that a tremendous amount of homework is done by staff and unpaid committee members in preparation for the conference. After the conference it takes some two months to finalize a report, with constant rewrites. Despite the workload, Powell sees the process as worthwhile. "The best part is that the people doing it are tackling a cutting-edge or emerging area of science and for the first time are putting it together in a coherent way, knowing their conclusions and recommendations will have a real effect," he says. "You get a sense that [the activity] is really worthwhile." ON THE SHELF: Rockefeller’s Jesse Ausubel points out that Congress doesn’t use many of the reports it commissions. Panel reports serve several purposes, notes Jesse Ausubel, director of the program for the human environment at Rockefeller University. He previously served as director of programs for the National Academy of Engineering and as a staff officer of the NAS Board on Atmospheric Science and Climate. Panel reports may help determine if a specific project-say, a space station-is technically feasible or add specific knowledge to a field. Such was the case in 1979, for example, when an NAS report argued that the global rise in temperature in response to doubling of carbon dioxide would be 1.5 degrees to 4.5 degrees. Ausubel explains that "the analysis proved to be important" for understanding global warming effects for predictive purposes, for example. Some reports outline plans, while others benchmark a field. Sometimes they present a broad-based overview of a specific area rather than answer a question or resolve a controversy. Whereas government agency-requested reports may be read by officials and professionals in the field, others may be a document of record for a discipline that occasionally might be used by policymakers. Different people appreciate different parts of the process. Some participants enjoy consensus-building and the group decision-making and the opportunity to make a difference in health and science policy. Chancellor M.R.C. Greenwood of the University of California, Santa Cruz, who served in the Clinton administration as the Office of Science and Technology Policy's (OSTP's) associate director for science, is a veteran of both NAS and NIH consensus statement reports. "I think that if you believe in the peer-review process, then you have to be prepared to participate," she says. "That means that at some time in your career, you've got to pay your dues, as members of study sections, or participating in consensus conferences that are trying to help agencies determine priorities for the future. If I'm going to get the benefits of other scientists working hard, then I have to be prepared to do it myself.""For me, [participating in national panels is] as important as creating new knowledge," states Shiriki K. Kumanyika, professor and head of the department of human nutrition and dietetics at the University of Illinois in Chicago, who was a member of a 1995 NIH Consensus Development Conference panel on physical activity and cardiovascular health. "[NAS's] Institute of Medicine doesn't make science policy, but we can recommend priorities and directions." Kumanyika notes that often the report-writing process is an "education." She points out that specific technical questions can overwhelm the process and the participants, who must rely on one another for some guidance and explanation. Not everyone is happy with the report-writing process. Some question whether the time, effort, and expense of many committee reports are justified, and assert that a way should be found to streamline the procedure. LONG HAUL : While Wisconsin’s James Crow thinks the NRC report process is worthwhile, he also considers it "time-consuming" and "difficult." James F. Crow, a professor, emeritus, of genetics at the University of Wisconsin, points to some problems in the NAS process. Crow chaired the NRC Committee on DNA Forensic Science Update, which published a report entitled The Evaluation of Forensic DNA Evidence in 1996 (Commission on Life Sciences, National Research Council, National Academy Press, Washington, D.C.). He contends that the process could have gone smoother if more members had had more experience working with DNA as evidence. "Most of us committee members had to learn a great deal for ourselves; general subject matter competence was not enough." The actual process may get bogged down for any number of reasons, contends D. Allan Bromley, Sterling Professor of the Sciences and Dean of Engineering at Yale University and former head of OSTP in the Bush administration. To Bromley, the most difficult part of consensus report-writing is setting priorities in a committee made up of people with varied backgrounds and agendas. "You're really talking about prioritization. Frequently the mechanisms we have in place [to write reports] take too long because people have so many interests." THINKING CONCEPTUALLY: Illinois’s Shiriki Kumanyika suggests that committee chair selection could be improved. The diversity of expertise and experience in NIH consensus panels also is a source of criticism, Kumanyika points out. "One of the reasons the NIH conferences are controversial is because the process uses non-experts," she says. In many cases, this brings questions about a report's completeness-did a particular group adequately understand all of the nuances involved and address the appropriate questions, given their short preparation time and lack of familiarity with a subject? At the same time, recommendations from consensus reports may be watered down, she notes. Kumanyika suggests that choosing committee chairpersons in general is difficult, and sometimes the wrong person can hamper a process. Some are excellent scientists, she points out, but "some aren't systematic, conceptual thinkers and not adept at putting together a lot of ideas [in a report format]." Report quality doesn't necessarily suffer, but "if they aren't particularly skillful at coordinating individual views, the process can be slower." One of the most serious critiques of reports is a lack of implementation. Ausubel laments that Congress will commission a report but not provide for dissemination and implementation of report findings. "People complain that a report just sits on a shelf," he observes. COMMON GROUND: Yale's D. Allan Bromley contends that setting priorities and achieving consensus remain among the most difficult challenges facing committees Yale's Bromley agrees that too many reports gather dust. He notes that the timeliness of a report can affect its value. "Frequently a problem or crisis arises and a decision needs to be made in a relatively short time. Far too many reports don't go anywhere because they come at the wrong time-the end of an administration or Congress." However, he acknowledges, there are no statistics to back up this assertion. Whether a report is used immediately, if at all, depends on each individual case. Each report is different in scope and potential use. Some have immediate impact, while others may languish in obscurity. Issues important to Congress or an agency initially may not continue to matter as much by the time a report comes out, he notes. At the same time, the visibility given a report's results-in congressional hearings, for example-can greatly increase the document's effects. Yet for all of the inherent shortcomings in report writing, Greenwood favors participating in the process. "I'd rather be the one who has something to say about issues such as science funding, for example. Better to be the master of your own fate."

Suit Puts Focus On Advisory Panel Consensus-Building

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Steven Benowitz

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June 1997

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