Director's Council of Public Representatives

Spring 2000 Meeting Minutes

3rd Meeting of the Director's Council of Public Representatives
Thursday–Friday, April 6–7, 2000
8:30 a.m.
Building 31C, Conference Room 6
National Institutes of Health
Bethesda, Maryland

The Council of Public Representatives convened its third meeting at 8:30 a.m., Thursday, April 6, Building 31, Conference Room 6, National Institutes of Health, Bethesda, Maryland. The meeting was open to the public.

Dr. Ruth Kirschstein, Chair, Council of Public Representatives, and Acting Director, National Institutes of Health (NIH), presided.

Council Members Present:

• Theodore Castele
• Robin Chin
• Luz Claudio
• Mary desVignes-Kendrick
• Melanie C. Dreher
• Pam Fernandes
• David Frohnmayer
• Vicki Kalabokes
• Barbara Lackritz
• Joan Lancaster
• Debra R. Lappin
• Lydia Lewis
• Roland McFarland
• Isaac Montoya
• Rosemary Quigley
• Maurice F. Rabb
• Bob Roehr
• Thomas Vaalburg
• Doug Yee

Council Members Absent:

• Michael D. Anderson

Others Present:

• Public Observers
• Members of Staff, NIH

Executive Summary

The Acting Director of the National Institutes of Health (NIH), Dr. Ruth Kirschstein, began the third meeting of the Director's Council of Public Representatives (COPR) by describing recent activities of COPR members, including their participation in the Government Performance and Results Act (GPRA); the participation of five COPR members in the June NIH budget retreat; reviews of several Institute directors who have served at NIH for terms exceeding five years; and the participation of several members as part of an Advisory Committee to the Director working group that is reviewing gene transfer clinical studies. Dr. Kirschstein also presented an update of several key issues affecting NIH, including the development of draft guidelines for overseeing the use of human embryonic stem cells in research and a review of early budget negotiations before congressional appropriations committees.

Dr. Steven E. Hyman, Director of the National Institute of Mental Health (NIMH), described a growing awareness among administration officials and global leaders of the important impact of mental illness on public health and on the economy, particularly in developing countries. NIMH has developed a new series of effectiveness trials in which a variety of treatments may be tested in relevant settings. He said that concerns about recent increases in the use of Ritalin and other psychoactive drugs to treat preschool children have helped lead Surgeon General David Satcher to convene a conference that will review available data on such use of medications in young children, and consider the design of additional preschool population studies. Dr. Hyman also answered questions concerning a recent report from the National Alliance for the Mentally Ill (NAMI). Dr. Hyman expressed concern over the inaccurate characterization of congressional instructions to NIMH. While the five disorders of greatest concern to NAMI are at the core of the NIMH mission, the Congress and the American people have many additional concerns within the NIMH mission, such as childhood mental disorders, eating disorders, youth violence, and the most common forms of depression. He also stated that it is vital for NIMH to continue supporting robust basic research on brain and behavior, and that it is the job of the NIH to make clear the importance of such basic research.

Dr. Francis Collins, Director of the National Human Genome Research Institute (NHGRI), said that sequencing of the human genome began as a pilot project in 1996, but the large international effort to map and determine the DNA sequence of the human genome really began in 1999, and is ahead of schedule and under budget. Access to data that this effort is generating continues to be a controversial subject, and the NIH position on patenting of gene sequences is that stringent criteria for their utility need to be met before patents are issued. Although genomic studies will provide insights into virtually every human disease, legislation or other assurances are needed to protect individuals against genetic discrimination. Moreover, a major effort is needed to evaluate genetic tests and to inform clinical practitioners as well as the public about their proper uses.

Dr. Yvonne Maddox, NIH Acting Deputy Director, said that a new NIH health disparities program of action involves all of NIH as well as other agencies within the U.S. Department of Health and Human Services (DHHS). Each of the Institutes at NIH submitted draft plans for this program to a working group early in April 2000; the plans are being used to set the overall NIH Strategic Research Agenda that will be discussed at the FY 2002 budget planning retreat scheduled for this summer. Health disparities are defined as differences in the incidence, prevalence, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups.

Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), said that almost every disease entails health disparities and, therefore, every institute at NIH is studying health disparities. Dr. Fauci also pointed out that there are different types of health disparities. Some disparities are biological in nature. In addition to biological disparities, Dr. Fauci stressed other important factors that may have an impact on health disparities, such as social or economic factors. The goal of the NIH strategic research plan is to formulate a comprehensive approach to address the many aspects of health disparities. Dr. Fauci stated that the NIH plan would address questions like: Is there a disparity related to this disorder, and if so, is there a biological reason for that? If there is a biological reason for the disparity, can we address that via biomedical research? Dr. Fauci emphasized that some of the appropriate approaches may be from a research or a research training standpoint. Dr. Fauci described the overall NIH health disparities plan and stated that the plan includes the following goals: (1) Developing a five-year research agenda, (2) Recruiting and training a substantial number of investigators from minority groups, (3) Extending community outreach programs and developing partnerships, (4) Defining goals and evaluating progress in ways that enable Congress to track these programs, and (5) Enhancing public awareness of these efforts.

Dr. Gary Ellis, Director of the NIH Office for Protection from Research Risks, said that some news media accounts of patient risks stemming from clinical research exaggerate those risks while others understate them. Not all research involving human subjects is covered by regulations, as there is no federal statute extending these protections to everyone in the private sector. This NIH office oversees institutional review boards (IRBs), which are charged with responsibility for assuring the risks to subjects are minimized and there is proper informed consent-an important protective component for those who participate in such studies. Although the death in 1999 of a young man who was participating in a gene transfer protocol has focused attention on risks stemming from gene therapy research, public concern could well be directed more broadly to include other areas of clinical research, according to Dr. Ellis.

Dr. Wendy Baldwin, NIH Deputy Director for Extramural Research, said that IRBs may not have adequate resources in terms of information and funding to fulfill their mandates, and described several NIH efforts to augment those resources and to improve bioethics training among researchers. She said that OPRR is being moved from NIH to DHHS and a new committee is being established to advise OPRR. She suggested that COPR direct its initial efforts in this area to learning more about the array of reviews of human subject protections now under way.

COPR members reviewed recent activities of the council as well as its mandate and charter, and considered how best to involve the 260 members of the COPR Associates in forthcoming activities. Ms. Anne Thomas, Director of the NIH Office of Communications and Public Liaison, said that her office would draft a prototype message for this purpose and also would prepare a COPR handbook for review by the council members.

Dr. Kirschstein said that she would remind the Institute advisory councils about COPR and recommend to them that they invite COPR members to their meetings. Although COPR members said that they want to keep their agenda as flexible as possible, they agreed to establish several specific working groups, including groups focused on: (1) human research protections; (2) underserved populations; (3) outreach to other public advisors involved in NIH activities and institute committees; and (4) a process for identifying and recruiting new members to replenish the council as current members depart.

Acting Director's Report

Acting Director of the National Institutes of Health (NIH), Dr. Ruth Kirschstein, began the third meeting of the Director's Council of Public Representatives (COPR) by introducing Dr. Yvonne Maddox, who is the Acting Deputy Director of NIH. Dr. Kirschstein noted that all of the COPR members have been reappointed through the spring of 2001, when one-third of them will cycle off active membership.

Dr. Kirschstein highlighted recent activities of COPR members, including the participation by 15 of them during October 1999 with members of the Advisory Committee to the Director (ACD) in preparing a review of research outcomes of NIH conducted under the mandate of the Government Performance and Results Act (GPRA). She said that a final version of that report was recently submitted to the House of Representatives Appropriations Subcommittee to help in its review of the fiscal year (FY) 2001 NIH budget proposal. Another activity in which COPR members participated was a FY 2001 budget planning retreat, held in June 1999. A similar retreat is being planned for June 2000, to which five COPR members will be invited, according to Dr. Kirschstein.

Dr. Kirschstein said that former NIH Director Harold Varmus asked COPR members to participate in several continuing review activities, such as the review of individual Institute directors who have served at NIH for terms exceeding five years. Two such reviews have been completed this year, and two remain to be conducted. In addition, COPR members Rosemary Quigley, Bob Roehr, and Debra Lappin are serving as part of an ACD working group that is reviewing gene therapy and gene transfer clinical studies. Dr. Kirschstein also noted that NIH is working closely with officials at the Food and Drug Administration (FDA) to improve the safety and monitoring of such clinical protocols.

Meanwhile, COPR member Dr. Ted Castele participated in a public advocacy forum that focused on activities of the National Institute of Dental and Craniofacial Research, while Ms. Joan Lancaster participated in recent discussions that focused on studies of the elderly that were conducted by the National Institute of Nursing Research. Dr. Melanie Dreher is involved in a broad review of efforts to reduce the regulatory burden on researchers and grantee institutions; this review is looking at several issues, including the protection of human subjects, ethical issues involving research, the use of animals in research, and medical waste management.

Dr. Kirschstein also presented an update of several key issues affecting NIH, including the development of guidelines for overseeing pluripotent stem cell research and a review of early budget negotiations before congressional appropriations committees. She said that NIH is reviewing hundreds of comments on its draft stem cell guidelines, which will be revised by this summer. The NIH Office of Science Policy is writing a charter for an oversight body that will conduct public review of research proposals involving human stem cells. She also said that Senator Arlen Specter (R-PA) and Senator Tom Harkin (D-IA) have submitted a bill that explicitly would permit federal support of such research.

Dr. Kirschstein and the Institute Directors appeared before the House of Representatives Appropriations Subcommittee over a three-week period in a series of hearings to review the NIH FY 2001 budget proposal this spring as well as before the comparable Senate Subcommittee in a briefer hearing. Although these hearings have been cordial, the questions often have been more pointed than during the past two years, according to Dr. Kirschstein. She said that some members of Congress are asking whether NIH can use its increased funding wisely, while others are focusing their questions on spending for specific diseases, such as diabetes, Parkinson's disease, and Alzheimer's disease, and also on health disparities. Markup of the NIH budget proposal was delayed, while the overall federal budget resolution was being considered.

In response to a question about the delayed obligations in the FY 2000 NIH appropriation, Dr. Kirschstein explained that a last-minute compromise was worked out that requires NIH to delay spending $3 billion until the last day of the fiscal year; an earlier proposal would have had NIH spending $7.5 billion on the final day of the fiscal year, which could have proved burdensome. More recently, Congress lifted that last-day spending requirement.

Dr. Kirschstein briefly reviewed several recent NIH staff changes, including the departure of Dr. Neal Nathanson, Director of the Office of AIDS Research, who is returning, in September, to the University of Pennsylvania; Dr. Hal Slavkin, Director of the National Institute of Dental and Craniofacial Research, who will become Dean of the Dental School at the University of Southern California; and Dr. Norman Anderson, Director of the Office of Behavioral and Social Sciences Research, who joined the Harvard School of Public Health in April. Dr. Alan Spiegel was named the Director of the National Institute of Diabetes and Digestive and Kidney Diseases last November.

NIMH Director's Presentation

Dr. Steven E. Hyman, Director of the National Institute of Mental Health (NIMH), described several recent interactions with the public, including a first-ever White House Conference on Mental Health, presided over by Tipper Gore; the first Surgeon General's Report on Mental Health; and a more recent expression of concerns from the White House over the widespread use of psychotropic drugs such as Ritalin for treating preschool children that will lead to a conference sometime this summer.

Dr. Hyman stated that the recent increased attention in mental health issues may stem from dedicated interest from administration officials and from many influential members of Congress. There has also been increased interest in mental health issues from the recent report, "Global Burdens of Disease," prepared by experts from the World Bank, the World Health Organization, and the Harvard School of Public Health. Dr. Hyman said that this report recognizes a new paradigm in which fundamental economic improvements in developing countries depend directly on improvements in public health. This new paradigm is shaped by a new understanding worldwide, that when measures of disability adjusted life years (DALYs) are looked at, it is clear that dealing with mental disorders becomes a critical ingredient to improving public health in developing countries.

Although the "Global Burdens" report and others like it indicate that health burdens are difficult to define precisely, they now explicitly include mental disorders as an important component contributing to those health burdens, according to Dr. Hyman. Depression, for example, affects up to 10 percent of the population and is ranked as the fourth leading contributor to disability adjusted life years (DALYs), noted as one of the most widely used measure of health burdens. Dr. Hyman stated that this particular report is one of several recent indicators that some people are coming to appreciate the importance of mental diseases, particularly their impact on the economy, and to realize that in many cases effective treatments are available.

Dr. Hyman said that a large segment of the public is still asking why is it taking so long to understand mental illnesses and to mark progress in combating them. One major reason is that the brain is the most complicated biological structure to study. Another problem is that many NIMH-sponsored clinical trials in the past were designed more as typical, albeit short-term, drug-evaluation protocols than as experiments to understand the fundamentals of brain function and behavior in realistic settings. Hence, NIMH has moved to develop a new series of effectiveness trials in which specific mental health research hypotheses may be tested in relevant settings that will be able to provide information to practitioners on real consumers in realistic environments, according to Dr. Hyman. To better ensure that these studies are both relevant and scientifically rigorous, last year three members representing the public interest were added to each of the study sections that evaluate clinical research proposals. He said that this new approach within the study sections is working very well and has added an important component to improve the public health impact of these studies.

Dr. Hyman said that a recent report published in the Journal of the American Medical Association indicates a substantial increase in the use of several psychotropic drugs to treat preschool children. This increase is not uniform across the population, but instead tends to be very specific to certain segments. For example, Ritalin treatment has increased sharply among upper-middle-class Caucasian boys. Although this drug is safe and effective for treating well-characterized cases of attention deficit disorder, its use for other less well-characterized behavioral disorders may not be indicated. To address such questions, Surgeon General David Satcher plans to convene a conference that will review available data on Ritalin use and discuss the design of additional preschool population studies. Dr. Hyman said that, because such studies raised perplexing ethical issues, it would be important to involve educators as well as representatives of the general public. Focusing on the needs of children is an essential component of these deliberations.

Dr. Hyman said that a recent report from the National Alliance for the Mentally Ill (NAMI) was highly critical of the NIMH research portfolio, alleging that the Institute's research portfolio neglects the five key mental illnesses that Congress has mandated it to study. For example, the report implies that NIMH redirected funds from research on schizophrenia to support research on AIDS-related mental illnesses, and it also recommends that NIMH not perform basic scientific research but focus only on specific diseases. Dr. Hyman said that the report is inaccurate on several counts, and that many members of the NAMI board of trustees had expressed to him disagreement with its conclusions. He also said that Congress requires NIMH to study mental illnesses beyond the five disorders that NAMI highlighted. Dr. Hyman pointed out that, in fact, the suggestions and encouragement from Congress was actually larger in areas other than the five areas of particular concern to NAMI. Some of these other areas included youth violence, eating disorders, and Alzheimer's disease. He also reminded the group that in reference to the report's implications about redirected funds to AIDS research, there actually is a separate AIDS budget and clearly stated that these are not fungible funds. Dr. Hyman also mentioned that it is vital for NIMH to continue supporting robust basic research.

Discussion

Ms. Lydia Lewis said that it continues to frustrate members of the mental health community that many physicians as well as members of the public do not recognize mental illnesses as real diseases. She said that it is important to deliver this science-based message to the general public. In response, Dr. Hyman said that this message is being heard in some sectors, particularly regarding schizophrenia and autism. It will help as basic research provides additional insights into the components of the brain that are involved in additional specific diseases. Although many physicians are not properly trained to deal with such illnesses, former practices based on beliefs that blamed many mental conditions on one's parents are being replaced by an understanding of the biological bases of those conditions.

In response to a comment from Dr. Melanie Dreher, Dr. Hyman agreed that mental illnesses could cause problems for entire families. He said that NIMH is seeking ways to collaborate with other Institutes and to develop new ways to improve family support systems.

In response to a question regarding genetic determinism from Mr. David Frohnmayer, Dr. Hyman stated that, while genetic studies are contributing a great many insights into mental illnesses, genes are interacting in these diseases in complex and non-linear ways. Moreover, non-genetic factors are also important contributors to mental illness. Thus, information about an individual's genetics, although helpful in establishing his or her risk for specific mental illnesses, is not determinative and should not be used to determine one's employment or insurance status.

Ms. Debra Lappin said that, because the health care system often fails to meet the mental health care needs of enrollees, NIMH officials should do more to inform health care providers and representatives of the insurance industry about the research being done on and progress being made to understand and treat mental illnesses. Dr. Hyman commented that NIMH has been providing the Senate with information about the impact of parity in insurance coverage and other health insurance issues as they affect quality of mental health care. He also said that managed care, rather than fee-for-service insurance coverage, is better equipped to provide parity for mental health needs to enrollees. One especially useful role NIMH plays is to provide burden-of-illness data to insurance companies, explaining in concrete terms how big an impact illnesses such as depression have on employees in the workplace. Hence, NIMH is redesigning certain clinical trials to delineate more clearly such impacts.

In response to a question from Dr. Luz Claudio, Dr. Hyman answered that although many specific mental illnesses strike more or less equally among very different population groups, the kinds of diagnoses, treatments, and other interventions that are available to those different groups tend to vary widely, as do outcomes. Dr. Claudio and Dr. Hyman agreed that access to health care as well as cultural differences influencing beliefs and perceptions also have an impact on the number of diagnoses, and thus apparent prevalence rates of mental illnesses in different communities. Dr. Mary desVignes-Kendrick noted that often physicians are told to assess a child's mental health status too quickly, perhaps within 15 minutes, an inadequate amount of time in which to conduct such evaluations. Dr. Hyman said that budget increases would help NIMH to reassess prevalence rates for specific illnesses among different populations.

Dr. Isaac Montoya praised NIMH for their efforts on handling the critical NAMI report and asked how COPR might assist NIH in managing similar situations in the future. Dr. Hyman said that it would be helpful if he or other NIH officials could receive comments from COPR members on tentative responses to such criticisms-in other words, if COPR could serve as a sounding board.

In response to a comment from Ms. Barbara Lackritz about how many school children now receive medication for mental illnesses, Dr. Hyman said that public health experts and educators have drifted apart from one another and he is eager to see things change. One point Dr. Hyman and Ms. Lackritz agreed on was the importance of bringing together the public health and education community on these issues. An example of this would be bringing the two communities closer together by sharing research and best practices on the most modern behavioral techniques for behavior management.

NHGRI Director's Presentation

Dr. Francis Collins, Director of the National Institute of Human Genome Research (NHGRI), said that public interest in human genomics continues to rise and that a special one-day consumer-oriented conference held last November will be repeated this fall. He said that genome studies will provide insights into virtually every human disease, from cystic fibrosis with a high genetic impact to others such as AIDS or other infectious diseases in which host factors play a substantial but considerably lesser role. The sequencing of the human genome began as a pilot project in 1996, but the large international effort to map and determine the DNA sequence of the human genome began on a large scale in 1999, and is ahead of schedule and under budget, according to Dr. Collins. The overall program has reached a number of important milestones, including genomic sequences of several model organisms, including yeast, Escherichia coli, C. elegans, and, very recently, the fruit fly Drosophila melanogaster. After genomic mapping was done in adequate detail, sequencing of the human genome began as a pilot project in 1996, with a goal of determining the entire sequence by 2005. During the past 14 months, however, progress has steadily accelerated, and the sequencing completion date has been moved up to 2003 with a "working draft" (90% of sequence in high accuracy) this year.

By late March, about two-thirds of the human genome sequence was available in working draft form, and about 20 percent was considered unequivocally finished, according to Dr. Collins. The sequencing of chromosome 22, for example, was completed and published late in 1999. At least a dozen new disease-associated genes have been identified because specialists in those diseases have free and immediate access to sequence data through GenBank. The NIH position on patenting of gene sequences is that stringent criteria for their utility need to be satisfied before patents are issued. In other words, the bar for obtaining patents needs to be set high.

Dr. Collins said that single nucleotide polymorphisms (SNPs)-each representing a misspelling in a particular DNA sequence-occur in an average of one per one thousand nucleotides throughout the human genome. Many SNPs play a role in, or are markers for, disease susceptibility. A group known as the SNPs Consortium is investing $50 million into a focused effort to identify those disease-associated SNPs, according to Dr. Collins. This consortium consists of NIH, ten pharmaceutical companies, several additional technology-oriented corporations, and the Wellcome Trust; the data being assembled are being retained in the public domain.

These genome analysis efforts require the development and use of many specific tools, according to Dr. Collins. The NHGRI Human Genome Project has identified eight goals, including training, bioinformatics, biological functionality, development of improved sequencing technology, the study of variants, sequencing itself, and analysis of the ethical, social, and legal implications of this research. These efforts will have a great impact on human health, including on medical diagnosis, preventive medicine, pharmacogenomics involving the development of drugs specific to the molecular basis of disease, gene therapy, and the design of drugs tailored to specific diseases.

However, for the genome project to have such effects, legislation or other assurances are needed to protect individuals against genetic discrimination, according to Dr. Collins. In addition, a major effort is needed to evaluate genetic tests and to inform clinical practitioners as well as the public about their proper uses.

Discussion

In response to a comment from Dr. Maurice Rabb about sickle-cell trait screening programs during the 1970s, Dr. Collins said that there are sobering lessons to be learned from that period, such as the failure of insurance companies to distinguish between an individual carrying a genetic trait and a person actually having a genetic disease.

In response to a comment from Dr. Luz Claudio that minority communities are very concerned about genetic testing, Dr. Collins said that these concerns are reflected in a widespread reluctance among many individuals to participate in clinical studies.

Along similar lines, Ms. Barbara Lackritz said that cancer patients also are concerned that genetic information about them and their families will be misused. Ms. Pam Fernandes said that stringent safeguards to protect privacy will be needed. Dr. Collins said that laws guarding against abuse of participants or results from such studies (and similar guarantees against the misuse of medical records) are needed, other efforts will be required to re-build trust in such communities, and privacy safeguards will be essential.

In response to a comment from Mr. Doug Yee, Dr. Collins said that the involvement of scientists, including Dr. Eric Lander from the Whitehead Institute, in recent programs at the White House has generated considerable enthusiasm on the part of President Clinton and other top officials in genome research and its implications.

In response to a question from Dr. Ted Castele about the patentability of gene sequences, Dr. Collins said that genes and gene products potentially can be used in several ways, including to diagnose specific diseases or as tools for developing new treatments, and that the criteria for granting patents in this area are being made more stringent. In response to a question from Mr. Yee, Dr. Collins also said that it is difficult to explain the stock market response to the statement issued by President Clinton and U.K. Prime Minister Tony Blair about the value of genome sequencing information being in public databases for all scientists to use freely. Their statement endorsed the current practices of the Institute's human genome sequencing program.

In response to a question from Mr. Thomas Vaalburg about the degree of NIH/NHGRI cooperation involved in the fruit fly genome-sequencing program, including with researchers from the Celera Corporation, Dr. Collins said that a detailed memorandum of understanding specified that all the sequence data is deposited in GenBank. He also said that, although NHGRI and Celera Corporation covered the costs of sequencing Drosophila, the fruit fly, it was proving difficult to develop a similar cooperative program for the sequencing of the human genome. This difficulty is in large part because the business value of human genomic data is considered so much greater than data for Drosophila.

In response to questions from Mr. Frohnmayer about use of genomics data and on gene therapy research, Dr. Collins said that clinical research trials involving people with hemophilia and individuals with X-linked immunodeficiencies are showing progress, whereas studies of other disorders do not look so promising. In response to a question about genomics data, Dr. Collins said that the genome program depends on scientists working on specific diseases to use data made available through GenBank to further study those diseases.

Ms. Joan Lancaster asked about gene therapy procedures that might be aimed at enhancing individuals. Dr. Collins said that such research raises thorny ethical questions, and the science needed to implement such plans is a long way away from being available.

In response to a question about genetics and social hierarchies from Ms. Rosemary Quigley, Dr. Collins said that genetics research indicates that there is more variability within an ethnic or racial group than there is between two randomly picked individuals, each representing a different group. Thus, most recognized differences have more to do with cultural, economic, and social factors than with inherited differences.

Health Disparities Presentation

Dr. Yvonne Maddox, NIH Acting Deputy Director

Dr. Yvonne Maddox said that the new NIH health disparities program of action involves all of NIH as well as other agencies within the U.S. Department of Health and Human Services (DHHS). Although NIH has been involved for the past decade in minority health research through its Office of Research on Minority Health (ORMH), President Clinton's 1998 Race Initiative led to a DHHS response in six specific biomedical areas: infant mortality, cancer screening and management, cardiovascular diseases, diabetes, HIV/AIDS, and immunizations.

In December 1999, after it was recommended that NIH develop a strategic plan for dealing with health disparities research, a Trans-NIH Working Group on Health Disparities was reestablished within the NIH Office of Director to develop a plan of action for setting an overall NIH health disparities research agenda. The working group members include all Institute and Center directors, and directors of special OD components, such as the Office of Research on Women's Health, the Office of Research on Minority Health, the Office of Behavioral and Social Sciences Research, and the Office of AIDS Research. Each of these entities then developed their own draft plans, which were submitted to the Working Group early in April 2000, according to Dr. Maddox. In turn, those draft plans were to be used for setting the overall NIH plan and, once refined during the FY 2002 budget planning retreat, for setting overall research priorities.

The Working Group defines health disparities as differences in the incidence, prevalence, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups, according to Dr. Maddox. The current focus is on racial and ethnic minority populations and also disparities that arise from social and economic status. The Working Group draft plan calls for developing a five-year strategic research agenda, recruiting and training a substantial number of investigators from minority groups, extending community outreach programs and developing partnerships, defining goals and evaluating progress in ways that enable Congress to track these programs, and enhancing public awareness of this range of efforts.

Dr. Maddox said that the draft plans from the Institutes and other Offices are focused and innovative, describing new mechanisms for collaborations and for expanding efforts to recruit individuals from minority populations to participate in clinical research studies. Such efforts will be further enhanced as the number of investigators from minority populations increases, because their presence is expected to help develop a greater sense of trust among the population groups they represent. For instance, the participation of African American investigators in a cardiovascular study in Jackson, Mississippi, has helped to increase the participation of African Americans in that study.

In general, NIH is encouraging the career development of minority scientists through an increased focus on obtaining R01 grants and on their greater participation in the peer-review process, according to Dr. Maddox. In addition to a special focus on such investigators at NIH itself, there is an increased emphasis on partnerships with industry and foundations as well as intensified outreach to the general public. Several new programs are designed to interest students from minority groups in careers in the health sciences. Other efforts include the development of informational materials that are ethnically sensitive.

Dr. Maddox said that members of Congress have introduced several bills to establish a Center for Health Disparity Research at NIH, including one introduced by Representative Jesse Jackson Jr. (D-IL), H.R. 2391, another similar bill introduced by Senator Edward Kennedy (D-MA), S. 1880, and yet another bill introduced by Representative Bennie Thompson (D-MS), H.R. 3250. Because these bills differ in wording, there are potential administrative complications that will need to be faced as the individual bills are considered, including whether such a center is to be free-standing or housed within the NIH Office of the Director (OD). Meanwhile, the NIH Office of the Director will coordinate and accelerate development and implementation of the overall NIH health disparities research plan.

Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID)

Dr. Fauci mentioned that almost every disease entails health disparities and therefore, every institute at NIH is studying health disparities. Part of the NIAID mission, particularly as it concerns HIV/AIDS, tuberculosis, sexually transmitted diseases, autoimmune diseases, allergy, and asthma, is not merely to study the biological basis of these diseases, but how to address disparities in treatments and outcomes that may be associated with those or other diseases.

Sometimes disease disparities appear to have a direct biological basis, according to Dr. Fauci. For instance, African Americans who are infected with the hepatitis C virus do not always respond as well to antiviral therapy as individuals from other populations do. Moreover, African Americans have a higher incidence of autoimmune diseases than do others, whereas there is a higher than usual incidence of meningitis among Native American populations. Thus, one goal of research sponsored by NIAID is to understand the biological basis for those differences.

Other disparities may stem from uneven participation in available research and health care delivery programs, according to Dr. Fauci. For example, because the incidence of HIV infection is particularly high among African Americans, NIAID is mounting an effort to increase their participation in clinical trials to evaluate various antiviral drugs. Following a concerted effort by the AIDS clinical trials network, enrollment of African Americans in such trials has increased from 2 percent to 35 percent.

Another NIAID effort entails intensified recruitment of young people from minority backgrounds at the high school and college levels into clinical and research careers. Other efforts include outreach to minority communities through use of culturally sensitive materials.

Discussion

In response to a question from Dr. Isaac Montoya about potential collaborations with other federal departments, Dr. Maddox said that there have been some discussions with officials elsewhere, such as the Department of Labor, and ongoing collaborations with the Department of Education, but NIH needs to focus on its biomedical research mission. Dr. Fauci said that many of these discussions need to take place at the departmental level and that NIH must be careful not to dilute its own research efforts. Dr. Kirschstein stated that NIH should also concentrate on bolstering its research programs and on recruiting, training, and retaining scientists from minority backgrounds.

In response to a question from Dr. Maurice Rabb about the pending bill submitted by Rep. Jackson, Dr. Kirschstein said that NIH will establish an independent center if that proposal is signed into law. In any case, NIH will do more in the area of health disparities research and related activities, using its administrative authority to invest where it can. A pending administrative problem is that the current legislative proposal could lead to establishing a center that would effectively compete with many activities now undertaken by the NIH ORMH. She said that Dr. John Ruffin, the ORMH Director, is working closely with Rep. Jackson and his staff members to work out some of these potential difficulties.

Dr. Ted Castele said that NIH needs to educate the general public about health disparity issues, which are poorly understood.

Ms. Rosemary Quigley said that stepped-up recruitment of individuals from minority groups into biomedical career tracks, even if successful, does not guarantee that they will want to work on health disparities research. Dr. Maddox said that jump-starting such careers would have a positive impact on minority communities; moreover, NIH will be working with medical organizations, such as the Student National Medical Association, to address how to retain those recruits and encourage their interests in a broad range of areas. Efforts like these will help build increased awareness so that the physicians of tomorrow will bring a health disparities perspective to their careers and the communities they serve.

Dr. Kirschstein said that provisions might be attached to the NIH appropriations bill that would ease circumstances for medical students who face high indebtedness from tuition costs. NIH has proposed in its FY01 budget request $1.4M for a loan repayment program to assist medical students who are interested in conducting clinical research in the extramural community. NIH already has such a program for clinical researchers from disadvantaged backgrounds who participate in the intramural program.

Dr. Luz Claudio raised the point that the pool of minority scientists that currently exists is often "recruited" for too many additional administrative activities. The limited pool of minority scientists is in danger of being over extended. She also advised building-in evaluative procedures for these new programs. In response, Dr. Fauci said that NIAID is tracking M.D./Ph.D. candidates who enter the Institute's program. He and Dr. Rabb both said that many young scientists and clinicians from minority groups are returning to their communities once they have completed their professional training.

Human Subjects Protections

Dr. Kirschstein provided some background information about recent events affecting the NIH Office for Protection from Research Risks (OPRR), including the recommendation from a Working Group of the NIH Advisory Committee to the Director (ACD) that OPRR be moved to DHHS. HHS Secretary Donna Shalala accepted that recommendation, decided that the office should report to the Assistant Secretary of Health, and agreed that the office should have its own advisory committee. DHHS officials also conducted a management study, and concluded that OPRR's human subject protection duties belonged in the new entity, which is to be called the Office for Human Research Protections (OHRP), within the department. However, its animal protection duties are to remain at NIH.

COPR member Debra Lappin said that a small group within COPR has had several conference calls to discuss the protection of human subjects in research and what COPR might do in this area. For this reason, the members of this subgroup invited Dr. Gary Ellis to review the activities of OPRR, whose staff of 24 individuals oversees agreements of assurance with more than 4,000 institutions throughout the United States.

Dr. Gary Ellis, Director, NIH Office for Protection from Research Risks

Dr. Ellis said that news media and public perceptions of patient risks stemming from clinical research vary widely, with some recent descriptions exaggerating those risks and others understating them. The Declaration of Helsinki of 1964 is the premise on which such considerations are built; it states that concerns for human subjects must prevail in any accounting of research risks and whenever subjects are recruited to participate in studies. The challenge faced by OPRR is to identify ways of reducing risks to individuals who agree to participate in research projects of every kind.

The statutory authority for OPRR dates to 1974 and, since 1991, it has overseen the 16 other federal agencies and departments that are signatories of the Common Rule governing the treatment of human subjects in research. (Some federal agencies that fund human subjects research have not signed this rule.) OPRR oversees assurances, informed consent, and institutional review boards (IRBs) for federal grantees. FDA has comparable rules that apply to clinical trials conducted in the private sector for products that come under its regulatory jurisdiction. OPRR defines human research broadly, and extends the definition to include any deliberate collection of biomedical information for developing generalizable conclusions.

Despite this broad coverage, not all research involving human subjects is covered by regulations, as there is no federal statute extending these protections to everyone, according to Dr. Ellis. Research institutions that do not fall under federal oversight include certain colleges and universities that receive no federal funds, in vitro fertilization and diet clinics, private offices and clinics of physicians and psychotherapists, and companies developing genetic tests. He cited several anecdotal cases of abuse arising from facilities not subject to federal oversight, including psychotherapists who disclosed the names and conditions of their clients and a plastic surgery private practice that evaluated two cosmetic procedures on individual patients without their knowledge or consent.

Dr. Ellis said that OPRR receives a great many inquiries, and a smaller number of formal complaints. OPRR has no authority to pursue complaints or inquiries outside its particular jurisdiction. Several reports, including one prepared in 1996 by the federal General Accounting Office and another prepared by the DHHS Inspector General in 1998, warn that the effectiveness of IRBs is in jeopardy. However, neither report provides evidence of widespread harm to human subjects. Both recommend a constructive review of the system and better education of all who are involved with it.

IRBs are charged with several responsibilities, including a continuing review at appropriate intervals of all ongoing protocols. Several examples, indicating that protocols often change as they proceed and thus risks to participant subjects may escalate, illustrate that this responsibility is not trivial and cannot be disregarded, according to Dr. Ellis.

Informed consent is another critical component of the system intended to protect human subjects from harm, according to Dr. Ellis. However, in practice, this concept often proves challenging to implement and, often, the process tends to underestimate risks and overestimate potential benefits. One major challenge is to provide informed consent documents that are written in simple language that subjects can fully understand. It also is important to avoid any form of coercion when recruiting individuals to participate in research of any kind.

Although the death in 1999 of a young man who was participating in a gene therapy protocol has focused attention on this area of research, public concern could well be directed more broadly to include other areas of clinical research, according to Dr. Ellis. An important consideration is that the need for research protection has received attention from President Clinton, who directed all federal departments in 1994 to assure compliance with applicable protective measures and has spoken out on this subject several times since then. In addition, members of the National Bioethics Advisory Commission (NBAC) in 1997 recommended universal protection for research subjects, regardless of whether protocols received federal funding or were protected under FDA regulations. Moreover, several congressional committees held hearings early during 2000 on this subject.

Discussion

In response to a comment from Ms. Barbara Lackritz, Dr. Ellis said the candidate subjects may demand to know full details about a protocol in which they have been asked to participate and that no one should sign an informed consent agreement until being fully satisfied with the disclosures. He also said that students involved in conducting research studies involving human subjects often do not receive adequate training from their mentors.

Ms. Lydia Lewis said that the NBAC 1998 report on research involving subjects with mental disorders is misleading inasmuch as some individuals with mental disorders can make fully informed decisions about participating. Dr. Ellis said that the title of that report is at fault and that NBAC members took great care to indicate that not all mental disorders lead to impaired decision making.

In response to a question from Dr. Isaac Montoya, Dr. Ellis said that systematic clinical evaluations intended to develop generalizable knowledge fall under the broad definition of research; thus, individuals who participate in such evaluations are entitled to full protection under current federal guidelines.

In response to a question from Mr. Bob Roehr about OPRR moving from NIH to DHHS, Dr. Ellis said that the office is under-staffed, with only two full-time investigators, an average investigational period of 23 months, and 163 cases now under investigation. The caseload could be much higher if the office operated proactively. Nonetheless, the recent wave of high-profile investigations and enforcement actions has intensified interest in protecting human subjects. For example, attendance at recent OPRR-sponsored workshops has increased substantially.

Dr. Wendy Baldwin, NIH Deputy Director for Extramural Research, said that IRBs may not have adequate resources in terms of information and funding to fulfill their mandates. A Web site is being established to provide useful information to IRBs, and steps are being taken to provide additional funding, possibly by raising the current 26 percent cap on indirect cost recovery from NIH research grants. In addition, a committee at NIH is reviewing how regulatory burdens could be reduced or simplified in ways that would make the job of IRBs easier, particularly in cases of multi-site clinical trials in which duplicative regulatory efforts often are required. NIH also has several training programs in bioethics for members of the research community, and a research program was recently begun whose aim is to better understand behaviors needed to achieve informed consent. Finally, NIH is working on a guidance document for investigators conducting research that involves subjects whose decision-making capabilities are impaired.

Ms. Rosemary Quigley recommended that COPR establish a working group, perhaps including COPR Associates among its members, to help deal with the many public misunderstandings that surround research involving human subjects. Ms. Debra Lappin said that it would be helpful for Dr. Baldwin to participate further during COPR deliberations and to explain more completely issues revolving around IRB operations.

April 7 Discussion

Ms. Debra Lappin reviewed several recent issues touching on the role of human subjects in research and on various measures to protect them from undue harm. She said that a federal working group is assessing current safeguards and a subcommittee of ACD is reviewing gene transfer and gene therapy clinical trials. Meanwhile, Ms. Jennifer Gorman from the NIH Office of Communications and Public Liaison (OCPL) prepared a fact sheet for COPR that summarizes how the federal system for protecting human research subjects is structured. One question facing COPR is whether it can complete its own report on this subject by next fall.

Dr. Baldwin said that a great deal is taking place, including the transfer of the OPRR to DHHS and the establishment of a new committee to advise the successor to OPRR. She said that COPR may want to delay trying to complete a report until it reviews what other groups are doing and becomes more familiar with the broad scope of these issues. She also provided COPR members with several relevant documents, including one describing bioethics training and research initiatives, resources that are available on the NIH Web site, guidelines for the participation in research of subjects whose decision-making capabilities may be impaired, and a proposal for just-in-time reviews by IRBs as a way of conserving their resources by delaying some phases of their reviews until grant proposals are provisionally approved.

Dr. Kirschstein said that there may be several congressional hearings on this topic before Congress adjourns before the November elections. She suggested that COPR devote part of its next scheduled meeting to developing a fuller understanding of these issues, with some attention to the forthcoming report of the ACD subcommittee on gene therapy and gene transfer research and also to the activities of NBAC as well as typical IRBs and institutional biosafety committees. She said that, following a request from several members of Congress, the ACD subcommittee also will address whether the NIH Recombinant DNA Advisory Committee should resume its consideration of individual research protocols, a potential change in activity that would not take place until it can be posted in the Federal Register. Later, in response to a question from Dr. Mary desVignes-Kendrick, Dr. Kirschstein suggested that there be a liaison between COPR and the new committee being formed to advise OHRP.

Mr. Roehr said that, following a successful conference call with the ACD gene therapy working group, it is time for COPR members to move beyond preliminary discussions about these issues. Dr. Montoya said that the IRB system may not be so damaged as some public reports suggest and that there may sometimes be maverick investigators at institutions where the IRBs are being well run. He also said that volunteer IRB members can become demoralized by excessive negative publicity. Dr. Luz Claudio said that, whatever the actual condition of the IRB system, these issues need to be addressed because the public perception is that the system is damaged. Several other members agreed, noting that public perceptions are far from uniform on this issue. Dr. Mary desVignes-Kendrick said that if COPR could identify gaps and recommend where additional resources are needed, it would be providing a useful service to the community.

Dr. Kirschstein said that care needs to be taken to explain to potential research subjects that such trials can mean that some of them will receive placebos or best-available conventional care rather than a particular experimental treatment. She also said that sometimes individuals refuse to participate because they do not understand how such trials are structured. Mr. Roehr said that the line between standard health care and treatment within clinical research projects is not so clear as it was a decade ago. Moreover, with other issues involving the participation of managed care organizations in clinical research programs in flux, COPR potentially can influence such organizations to be more receptive to having their members participate in clinical trials.

In response to a question from Mr. Doug Yee, Dr. Baldwin said that, although there are many partnerships involving university scientists and researchers in companies and these investigators embrace the principles of bioethics, there is currently not enough research being conducted on the ethical issues, practices, and principles involving human subjects.

Current Activities, Future Directions for COPR

[Thursday and Friday segments of the COPR deliberations are combined in this section.]

COPR Activities Presentation

COPR member Ms. Vicki Kalabokes, who moderated this session, said that the council is mandated to exchange information with the public. Although the breadth of capabilities among current COPR members is considerable, there is interest in expanding the capabilities by more actively involving the 225 COPR Associates in some of the council's activities.

Ms. Cate Timmerman of Palladian Partners, a contractor who is assisting the NIH, described salient demographic features of the COPR Associates. She said that they are associated with institutions in 37 states, and about one-quarter of them are interested in multiple diseases; other information is available as part of a database to which COPR members are entitled access because they are considered federal employees while they are engaged in NIH-related activity. She also said that NIH communicates frequently with the Associates, providing them a newsletter and other items describing ongoing COPR and COPR-related activities.

Ms. Anne Thomas, Director of the NIH Office of Communications and Public Liaison, said that COPR members can contact COPR Associates to determine whether they will participate in specific COPR-related activities. She said that she would draft a prototype message for this purpose that COPR members subsequently could review. Dr. Ruth Kirschstein said that, as a matter of privacy, individuals among the Associates may decline to participate or even to be contacted about pending COPR activities.

Mr. Bob Roehr asked whether additional information that would enable COPR members to contact and collaborate with members of the Institute advisory councils could be made available. Dr. Montoya suggested establishing a formal link between COPR and the members of those councils. Dr. Kirschstein said that one-third of the members of those councils are public representatives who help in deciding where to allocate NIH resources and thus the councils serve a different purpose from COPR.

Several suggestions were presented for how to communicate with and best involve the Associates in COPR activities. Ms. Pam Fernandes recommended that communications between COPR and the Associates be centralized, not fragmented and diffuse. Mr. David Frohnmayer said that COPR Associates might be affiliated with COPR by serving as members of working groups. Ms. Barbara Lackritz said that grouping Associates according to their interests might be helpful. However, Mr. Doug Yee recommended that the Associates not focus on their specialty interests when collaborating on COPR activities. Ms. Rosemary Quigley said that assigning each of the Associates to specific COPR members would help to personalize their contacts with the council.

Dr. Ted Castele said that it is important to define carefully what to expect from the Associates. Dr. Isaac Montoya suggested that the Associates help with future GPRA assessments. After further discussion, there was wide agreement among COPR members that the Associates should be considered as a pool of talented individuals from which to draw for involvement in specific, task-oriented assignments. Ms. Timmerman said that, as specific needs arise, there are efficient ways to contact all the Associates and to offer them opportunities to participate in COPR activities.

Ms. Thomas agreed to draft a general message for this purpose and also to enlist Associates to help the general public to better understand NIH through outreach efforts. Mr. Yee said that Rotary Clubs and other general public service organizations offer many opportunities to reach the general public with information about NIH programs. Information was also exchanged about the availability of a traveling exhibit sponsored the National Eye Institute.

COPR Roles and Functions and Core Operating Values

Ms. Anne Thomas said that some other federal agencies view COPR as a model and that delegations from the United Kingdom and Canada have visited NIH to learn more about its makeup and activities. She plans to write a booklet describing how COPR is constituted and the roles it can play--in part to help NIH, but also for other interested agencies.

In a presentation about the history and background of COPR, Ms. Thomas, explained how COPR was established. On September 23, 1998, NIH convened a public planning meeting where the participants concluded that a new entity was to be formed. This new entity would serve a different purpose from that of the long-standing NIH Advisory Committee to the Director (ACD) by providing publicly oriented views but also addressing issues of importance across the entire NIH. COPR would also be a sounding board for major issues, define mechanisms for obtaining broad public input for NIH, assure Congress that NIH has continuing access to such input, improve the understanding of NIH among health advocacy groups, and receive public input regarding the NIH administrative structure and decision-making apparatus.

Discussion

Ms. Lydia Lewis recommended that COPR members set priorities among the issues COPR might grapple with. Ms. Barbara Lackritz said that COPR's role is still evolving.

Ms. Debra Lappin said that, during the 1998 meeting, former NIH Director Harold Varmus helped to go beyond the initial mandate imagined for COPR by extending past its role as a vehicle for informing the public about NIH activities. Thus, it also serves as a means for members of the public to advise NIH on research priorities and to serve as a sounding board. Moreover, because COPR members do not depend on NIH for support and thus have no conflicts of interest, they are in a stronger position than they may realize to advise NIH.

Mr. David Frohnmayer said that COPR's figurative role as a firefighter—that is, in dealing in a timely fashion with controversies or other topical issues, such as the protection of human subjects in research settings—seems inevitable. Hence, COPR should not become rigid about the way it sets its own agenda. Mr. Bob Roehr agreed, noting that the council will need to react to events. He suggested that COPR might take the initiative on certain issues, maybe reach out to the advisory councils, or even build an education program about NIH in which other public advisors to NIH also participate.

Dr. Ruth Kirschstein said that she would remind the Institute advisory councils about COPR and recommend to them that they invite COPR members to some of their meetings. In response to a question from Mr. Frohnmayer about COPR's longer term future, she said that, although there is no absolute guarantee that the next NIH Director will embrace the concept, in all likelihood the COPR will continue to serve an important advisory role for NIH.

Dr. Isaac Montoya said that, although flexibility was useful for COPR, it also is important to have certain fixed functions and activities in the agenda, including receiving a report from the NIH Director on key current issues on which to provide input and also presenting a report from COPR members on important issues outside NIH of importance to it.

Ms. Thomas proposed several core operating values for COPR members to consider, including continuing open and direct dialogue between NIH and COPR on substantive issues, COPR striving to represent the views of the public at large, and all members actively engaging in ongoing activities.

COPR Interests and Operations

Establishment of COPR Working Groups

Dr. Baldwin pointed to an important area in which COPR members might provide NIH and the public with advice and improve understanding-namely the management, not the elimination, of conflicts of interest as they apply to research situations. These issues as they apply to clinical research have become increasingly complex, making it particularly difficult to handle potential conflicts as they involve institutions over and above individual investigators. Dr. Kirschstein said that these emerging conflicts of interest at the institutional level reflect the rapid growth of small biotechnology companies, many of which are founded by academic scientists and often involve their participation as officers or advisors.

Dr. Ted Castele agreed that this issue is of major importance and that providing guidelines is a valuable undertaking. Dr. Kirschstein said that COPR could form a working group that would include Dr. Castele, Dr. Montoya, and Mr. Yee. Dr. Kirschstein said that COPR should consider forming another working group to work with Ms. Thomas on identifying gaps in protections for human subjects. Ms. Lappin said that conflict of interest could be considered as a subcategory of concerns revolving around human subjects.

In response to a suggestion from Ms. Thomas that these issues can be brought together in a draft document, Ms. Fernandes said that COPR members could provide input to a writer who would prepare such a document. COPR members agreed to establish a working group for this purpose. Debra Lappin agreed to facilitate this group.

Mr. Frohnmayer asked to what audience these documents would be directed, the general public or researchers. In response, Mr. Roehr said that the working group should assemble available information into guidance documents for patients who are potential subjects of clinical research trials. Dr. Montoya said that, in some cases, the goal is also to educate principal investigators (PIs) about issues affecting human subjects. Dr. Maddox said this good idea should be extended, ensuring that not only PIs but also other research team members who are involved in explaining informed consent documents also fully understand what they mean. Ms. Lackritz said that full disclosure is essential because patients are being discouraged from participating in clinical trials.

Dr. Kirschstein said that it might make sense to develop a single document for this purpose and that NIH will need to coordinate this overall effort. Ms. Lappin recommended presenting a patient-oriented document on the NIH Web site, and that COPR should think of itself as representing the public.

Mr. Frohnmayer said that, if the document becomes too prescriptive in language, attorneys representing universities and other research institutions will object to an outside agency attempting to set standards of care. Other participants suggested that formatting the documents as flow charts or as questions-and-answers might circumvent this difficulty. Dr. Montoya said that the document should not be aimed only at the middle class, but should also be directed at others who may be unable to read or represent disenfranchised community segments.

In response to a question from Dr. Maurice Rabb, Dr. Kirschstein said that NIH staff members will facilitate efforts of COPR members to interact with other NIH committees and federal agencies. One recurrent problem is that, despite widespread interest in biomedical research, members of the general public often do not connect such activities with NIH. Ms. Thomas said that her office could prepare a "Talking About the NIH" packet for COPR members to use as a tool for outreach when they talk with outside groups. She also said that members of her staff are working with Mr. Roland McFarland on television projects addressing some of these communication challenges. Ms. Pam Fernandes said that the public could better help in shaping policies if it understood more about NIH.

Additional Planning for the Future of COPR

Ms. Barbara Lackritz asked whether additional structuring of COPR would prove helpful, particularly as new members are recruited to the council. In response to questions about COPR's mission and how new members would be chosen, Ms. Anne Thomas said that information about these matters is contained in the COPR charter, which is available on the NIH Web site. Dr. Kirschstein added that, although the Institute of Medicine (IOM) provided a basic outline for COPR, the charter goes beyond those initial IOM recommendations. In response to a comment from Ms. Vicki Kalabokes, Dr. Kirschstein and Ms. Thomas agreed to draft a COPR orientation handbook for review by council members.

Mr. Roehr said, and others agreed, that setting explicit priorities for COPR by establishing a series of working groups risks excluding potentially important issues from the future agenda. Dr. Luz Claudio said that having a checklist of key issues would be helpful for COPR members. Mr. David Frohnmayer said that potential issues identified during the course of this (April 2000) meeting should be critically reviewed.

Dr. Isaac Montoya said that evaluating the success of COPR presents a challenge, with one possibility being to rely on public opinion polls. In response to a comment from Ms Fernandes, who said that keeping records of COPR accomplishments would help toward such evaluations, Dr. Kirschstein urged all members of COPR also to keep their own list of COPR activities.

In response to a comment from Ms. Lackritz, Dr. Kirschstein recommended that COPR establish a working group to deal with research involving under-served communities. Mr. Roehr said that it is important to undertake this effort across all the Institutes at NIH, as the public perspective changes shape in each different context. Dr. Kirschstein said that Mr. Roehr should take the lead in establishing a group to work with other public advisors at NIH. Dr. Yvonne Maddox said that inviting those public members to a COPR meeting could prove valuable in enlisting their cooperation. Mr. Roehr agreed to form such a working group.

Ms. Thomas asked COPR members to form a working group to develop a process for identifying and recruiting new members to replenish the council as current members depart. Ms. Thomas emphasized that whatever selection process was used to bring new members onto the Council would need to take into account an appropriate balance of many diverse factors, including gender, biomedical interests, and geographic representation. Ms. Kalabokes agreed to coordinate this working group.

Several other items were suggested for inclusion on the agenda of the next meeting: pain research; clustering of diseases and environmental factors; a review of NIH public education and outreach efforts; and how individual Institutes communicate their research achievements. COPR members agreed that responsibility for setting that agenda should not be assigned to a working group but should be settled through conference calls and e-mail messages among all the council members. That next meeting may be structured to permit time for the working groups to assemble separately either before or after the full council meets.

Summary and Conclusions

The Director's Council of Public Representatives (COPR) of the National Institutes of Health (NIH) met on April 6-7, 2000, to consider recent events affecting the visibility of mental health research issues, developments in the Human Genome Project, plans for a new trans-NIH health disparities research plan, several issues involving human subjects protections, and plans for the future activities of COPR.

The COPR acknowledged and commented on these reports, agreed to review several draft documents that NIH officials will prepare, and COPR members agreed to form several working groups to deal with a series of specific issues.

Table of Abbreviations

ACD	Advisory Committee to the Director	NCRR	National Center for Research Resources
AIDS	Acquired Immunodeficiency Syndrome	NIAMS	National Institute of Arthritis and Musculoskeletal and Skin Diseases
cDNAs	Copy DNAs	NIDA	National Institute on Drug Abuse
CDC	Centers for Disease Control and Prevention	NIDCR	National Institute of Dental and Craniofacial Research
COPR	Council of Public Representatives	NIDDK	National Institute of Diabetes and Digestive and Kidney Diseases
CSR	Center for Scientific Review	NIH	National Institutes of Health
DALYs	Disability Adjusted Life Years	NIMH	National Institute of Mental Health
DHHS	U.S. Department of Health and Human Services	NINDS	National Institute of Neurological Disorders and Stroke
DOE	Department of Energy	NHGRI	National Human Genome Research Institute
ELSI	Educational, Legal, and Social Implications	NLM	National Library of Medicine
FASEB	Federation of American Societies for Experimental Biology	NSF	National Science Foundation
FDA	Food and Drug Administration	OCPL	Office of Communications and Public Liaison
FOIA	Freedom of Information Act	OHRP	Office for Human Research Protections
FY	Fiscal Year	OMAR	Office of Medical Applications of Research
GPRA	Government Performance and Results Act	OPRR	Office for Protection from Research Risks
HIV	Human Immunodeficiency Virus	ORMH	Office of Research on Minority Health
IOM	Institute of Medicine	OSP	Office of Science Policy
IRB	Institutional Review Board	OTT	Office of Technology Transfer
IP	Intramural Program	PI	Principal Investigator
NAMI	National Alliance for the Mentally Ill	PNAS	Proceedings of the National Academy of Sciences
NAS	National Academy of Sciences	QALYs	Quality Adjusted Life Years
NBAC	National Bioethics Advisory Commission	SNP	Single Nucleotide Polymorphism
NCI	National Cancer Institute	TSC	The SNPs (single nucleotide polymorphism) Consortium
NCBI	National Center for Biotechnology Information	UK	United Kingdom

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