Director's Council of Public Representatives
Fall 2001 Meeting Minutes6th Meeting of the Director’s Council of Public Representatives The Council of Public Representatives convened its sixth meeting at 8:30 a.m., Tuesday, October 23, Building 31C, 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. Executive SummaryNational Institutes of Health (NIH) Acting Director Dr. Ruth Kirschstein chaired the 6th Meeting of the Director's Council of Public Representatives (COPR) on October 23, 2001. She welcomed continuing COPR members, five new members, and Mr. Doug Yee, who (participating by telephone from Hawaii) agreed to extend his tenure on COPR for one year. She briefed council members on recent appointments and departures of several NIH officials and on the status of the NIH budget, which remained at fiscal year (FY) 2001 levels during October under a continuing resolution but will likely increase to about the President's requested level of $23 billion for FY 2002 when the Congress finalizes an appropriations bill. Dr. Kirschstein described several recent events, including one dedicating a new plaza at NIH to honor former Representative Paul Rogers and a new laboratory building named in honor of former Representative Louis Stokes; a week-long visit to NIH in August by Mr. Tommy Thompson, Secretary of Health and Human Services (HHS); a symposium celebrating 50 years of neuroscience research; several press conferences to announce important health-related research findings; and an announcement in October that researchers at the new NIH Vaccine Research Center would soon begin a phase I clinical trial of a promising vaccine candidate for acquired immunodeficiency syndrome (AIDS). Dr. Kirschstein also mentioned recent notable awards to NIH grantees, including the Lasker Award to Dr. Mario Capecchi and Dr. Oliver Smithies and Nobel Prizes to Dr. Barry Sharpless and Dr. Leland Hartwell; she further noted that President Bush recently presented NIH Acting Deputy Director Dr. Yvonne Maddox with the Presidential Distinguished Service Award. Dr. Kirschstein said that NIH was responding to the September 11 attacks and subsequent bioterrorism incidents in several ways, including through immediate blood collection and donation efforts; dispatching medical assistance teams to damage sites; enhancing security on campus; and providing leadership and expertise in testimony to Congress, information to the news media, and planning for research into bioterrorism countermeasures, such as vaccine development and testing as well as through basic studies of the bacterial pathogen responsible for anthrax. COPR members presented a series of brief reports describing some of their recent NIH-related individual activities on a range of topics, including visits to research foundations, attendance at award ceremonies, participation in reviews of research proposals and in meetings where research is discussed, forthcoming efforts to provide technical assistance to institutions in Hawaii that will make them more competitive when proposing biomedical research projects, development of workshops for future conferences on biomedical research, and involvement in efforts to assess and enhance COPR activities. Dr. Stephen Straus, Director of the NIH National Center for Complementary and Alternative Medicine (NCCAM), described the Center's approach to evaluating alternative medical practices through rigorous research and to communicating its findings to the public. He said the Center's budget has grown substantially to $89.2 million for FY 2001 and is expected to be about $100 million for FY 2002. The Center's strategic plan calls for investing in research, much of it clinical; training researchers to evaluate complementary and alternative medicine (CAM) and practices; expanding outreach programs; and integrating proven alternative practices with conventional medicine. Ms. Debra Lappin, who chaired the COPR Working Group on Human Research Protections, summarized recommendations in the working group's recently completed report, which was presented to Dr. Kirschstein. Ms. Lappin said that the working group aimed at representing the interests of participants in clinical trials. She said that the web of existing protections for such participants could be strengthened by improving their abilities to protect themselves, and she urged NIH to provide leadership and to help implement the working group's six global principles. These principles include recognizing informed consent as an ongoing process, providing participants with full information about trials, improving institutional review boards, informing participants of conflicts of interest involving clinical trial investigators, ensuring the privacy of participants, and developing model programs for training investigators about patient protections and enhancing public education about clinical trials. Dr. Mark Rohrbaugh, Acting Director of the NIH Office of Technology Transfer (OTT), described the OTT mission, which focuses on moving research-derived information and materials into uses that benefit other researchers and yield products and medical practices that improve the health of the general public. The portfolio of inventions within the NIH Intramural Program, which accounts for about 70 percent of all inventions through federal programs, brought in more than $52 million in royalties in FY 2000, with most of that revenue being generated from a handful of inventions, including an AIDS test kit, a hepatitis A vaccine, and the anticancer drug Taxol; it generates about 300 disclosures and 175 patent applications per year. Mr. Theodore Roumel, Assistant Director of the NIH OTT, outlined the legislative underpinnings of these technology transfer programs and described some of the policies NIH has developed for implementing them. Dr. Wendy Baldwin, NIH Deputy Director for Extramural Research, summarized efforts to implement President Bush's decision to permit federal funding of human embryonic stem cell research with the cell lines that meet the criteria he set forth on August 9, 2001. For instance, NIH is developing a Web site-based registry listing those cell lines and providing other information helpful to researchers who plan on using such cells. Dr. Rohrbaugh then described an agreement, which specifies research terms for several such cell lines, that was negotiated between NIH and WiCell, a subsidiary of the Wisconsin Alumni Research Fund (WARF) that holds a patent for those cell lines. He said similar negotiations are under way with others who hold patents on additional human embryonic cell lines that meet the President's criteria. COPR members agreed to several dates for future meetings, and several members suggested holding meetings more frequently than twice per year. Other members also called for finding ways for COPR to be more involved in the process the NIH uses to set research priorities, remaining involved in COPR activities after formal membership lapses, and playing an active role in choosing new members. NIH Director's ReportDr. Ruth Kirschstein began the 6th Meeting of the Director's COPR by welcoming several new members to the council, including Dr. Evelyn Bromet, Dr. Ellen Grant Bishop, Dr. Robert Martin (who could not attend), Dr. Rodrigo Munoz, and Dr. Leonard Tamura as well as continuing COPR member Mr. Doug Yee, who participated by telephone. Mr. Yee recently agreed to remain on COPR for an additional year. Dr. Kirschstein summarized several personnel changes at NIH. For instance, Dr. Richard Klausner, Director of the NIH National Cancer Institute (NCI), left to direct the Case Institute of Health, Science, and Technology, which was recently established by Stephen Case, founder of America Online. Dr. Alan Rabson is now serving as Acting Director of NCI. Dr. Kirschstein said that when Mr. Charles Leasure replaced Mr. Tony Itteilag as NIH Deputy Director for Management, Mr. Itteilag became her senior advisor. Meanwhile, Dr. Donna Dean, who also is a senior advisor to Dr. Kirschstein, is Acting Director of the new NIH Institute of Biomedical Imaging and Bioengineering (NIBIB). Searches are underway for a director of NIBIB, and for a director for the NIH National Institute of Neurological Disorders and Stroke. Its former director, Dr. Gerald Fischbach, is now Vice-President for Health Affairs at Columbia University College of Physicians and Surgeons. Still another formal search is under way for director of the NIH Office of Technology Transfer (OTT). NIH recently hosted several celebratory events: one to dedicate the plaza near Building 1 in honor of former Representative Paul Rogers, and one to open Building 50, the Louis Stokes Laboratory, is named in honor of the former member of Congress from Ohio, who continues to work on health disparities and minority health issues, according to Dr. Kirschstein. In August, Mr. Tommy Thompson, Secretary of HHS, spent almost a week in residence at NIH, when he visited many sites on campus and reviewed many NIH programs and office activities. During that week, he convened one of his periodic meetings with HHS agency chiefs. On October 9, as part of another celebration, NIH staff, researchers, journalists, and other luminaries such as actor Christopher Reeve commemorated 50 years of neurosciences research during a scientific seminar at NIH and at a formal event held at the Library of Congress. During the past few months, NIH convened several press conferences for major announcements, including one with Secretary Thompson shortly after President Bush outlined his policy for supporting research with human embryonic stem cells. Other recent press conferences dealt with the results of a major clinical trial on prevention of Type 2 diabetes, which endorses moderate exercise and diet, and another that dealt with the efficacy of dietary supplements such as vitamins C and E for preventing several eye diseases that are common among the elderly. On October 17, NIH announced that the NIH Vaccine Research Center, headed by Dr. Gary Nabel, has begun its first Phase I clinical trial evaluating the safety features of a candidate AIDS vaccine. NIH-supported researchers recently chosen for major awards include Dr. Mario Capecchi of the Albert Einstein School of Medicine and Dr. Oliver Smithies of the University of North Carolina for the 2001 Lasker Award for Basic Medical Research. Dr. Barry Sharpless of the Scripps Institute received the 2001 Nobel Prize in Chemistry, and Dr. Leland Hartwell of the Fred Hutchinson Cancer Research Center received the Nobel Prize in Medicine or Physiology. Dr. Yvonne Maddox, NIH Acting Deputy Director, was honored with the Presidential Distinguished Executive Award for merit. In addition, NIH was honored when its Web site was designated a "favorite" by Forbes, calling attention to the efforts of Ms. Anne Thomas and her staff, according to Dr. Kirschstein. Dr. Kirschstein said that NIH entered FY 2002 without a new budget but under a continuing resolution, which will maintain spending at FY 2001 levels at least through October 31. It appears likely that Congress will finalize a budget that comes close to meeting President Bush's request of $23 billion for NIH for FY 2002, but the final outcome depends on a conference to reconcile differences between the Senate and House versions of the appropriations bill. Dr. Kirschstein said that NIH responded to the September 11 attacks on the World Trade Center and Pentagon in several ways. First, the NIH Blood Bank stepped up collections of donated blood. Also, security was enhanced on the NIH campus, where 16,000 employees work and another 5,000 individuals visit daily. Some of those efforts aim directly at strengthening security for patients and their families at the NIH Clinical Center. Shortly after the attacks, nine NIH staff members were deployed to New York as part of a HHS disaster medical assistance team along with other NIH staff members who are commissioned officers. In addition, Dr. Kirschstein, Dr. Maddox, and other NIH administrators have conferred closely with Secretary Thompson and leaders at other HHS agencies, such as the Office of Emergency Preparedness and the Centers for Disease Control and Prevention (CDC), which works closely with state and local health departments and through its Epidemic Intelligence Service. Amid heightened concerns about anthrax, NIH is actively involved in responding to bioterrorism threats, with Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), and his staff working intensively on such matters, as is Dr. Steven Hyman, Director of the National Institute of Mental Health (NIMH), according to Dr. Kirschstein. She said that advances in understanding anthrax based on NIH-supported studies of the bacterium that causes the disease would be announced later in the day. Concerns about bioterrorism extend to other potential biological agents, especially smallpox, for which vaccination programs were discontinued nearly 30 years ago. Because supplies of the vaccine that protects against smallpox are low, NIAID will conduct a study with volunteers to determine whether the vaccine retains efficacy if administered in diluted form. Other efforts include projects to develop new and alternative vaccines against these and other disease agents that might be used in bioterrorist attacks. In response to a question from Mr. Bob Roehr, Dr. Kirschstein said that NIH researchers and administrators are in close contact with their counterparts at the Department of Defense about bioterrorist-related matters. She also noted that Dr. Fauci; Dr. Margaret Hamburg, former HHS Assistant Secretary for Planning and Evaluation; and other experts on bioterrorism issues have and will be appearing before the news media to help the public better understand the nature of these threats. Finally, Dr. Kirschstein honored six of the founding members of COPR whose terms are concluding: Dr. Mike Anderson, Dr. Melanie Dreher, Ms. Pam Fernandes, Ms. Joan Lancaster, Mr. Roland McFarland, and Mr. Tom Vaalburg. They received a letter of appreciation, a certificate, and a round of applause. COPR Members Report to NIH Director on COPR ActivitiesMs. Debra Lappin thanked Dr. Yvonne Maddox for meeting with her and Mr. Robert Wood Johnson IV, grandson of the founder of Johnson & Johnson and member of the Robert Wood Johnson Foundation, to discuss research on autoimmune diseases, which have affected his family in many ways. Mr. Roland McFarland described his involvement with the National Eye Institute's exhibit THE EYE SITE A Traveling Exhibit on Low Vision for Shopping Centers. He had several conversations with the local Los Angeles Host Committee and offered suggestions on the promotion of the exhibit as it toured five malls in the greater LA area from April–August 2001. He also attended the opening ceremony at the South Bay Pavilion in Carson, California. He commented that the event was very well attended with many senior citizens in attendance for the vision eye health fair. He also participated in selecting and presenting the annual Prism awards, which recognize entertainment programs for presenting important public health messages within their scripts. He promised to continue in his personal efforts to gain wider recognition for NIH. Dr. Isaac Montoya belongs to a working group of the NIH National Institute on Deafness and Other Communication Disorders that is concerned with programs that screen newborns for potential hearing problems. He also is serving as a public representative in a number of NIH grant reviews and in the development of specific requests for applications. Dr. Len Tamura is involved in initial discussions between COPR and several NIH Offices of Public Liaison (OPL), developing means for COPR to collaborate and communicate with the OPLs while focusing on common interests, particularly health disparities. Mr. Doug Yee, who asked several questions about a press conference on anthrax research that was scheduled for later that day, described his recent efforts to bolster biomedical research programs at the University of Hawaii. Those efforts include developing a workshop program and successfully applying for a Biomedical Research Infrastructure Network grant from NIH. Such grants, which are for a fixed sum (currently $2 million per state per year for 3 years) and are reserved for academic institutions in 23 specified states plus Puerto Rico, are intended to help academic consortia within each of those states to develop the infrastructure considered vital for supporting biomedical research programs, according to Dr. Kirschstein. Part of the workshop Mr. Yee is planning will highlight Hawaiian programs in complementary and alternative medicine (CAM), some of which emphasize Asian practices. He said that Dr. Maddox; Dr. Stephen Straus, Director of NIH's NCCAM; and other NIH representatives will participate in technical assistance workshops in addition to special events and speaking engagements targeted specifically to the general public. Beyond that workshop program, other NIH officials will participate in a proactive compliance visit to the university, helping its officials to ensure that they understand standard practices for protecting human subjects as well as proper financial management practices in dealing with NIH grants, according to Dr. Wendy Baldwin, NIH Deputy Director for Extramural Research. Ms. Rosemary Quigley attended a consensus conference that focused on end-of-life issues for people with genetic diseases, which was convened by an organization that represents student nurses interested in research. Ms. Quigley, who spoke about public expectations for gene therapy research, said that Dr. Patricia Grady, Director of the NIH National Institute of Nursing Research, also attended that meeting, where she described COPR activities to the participants. Mr. Bob Roehr said that he is helping to plan workshops and other activities as part of the forthcoming annual meeting of the Association of Health Care Journalists, including visits by journalists to the NIH campus. The mini-workshops will focus on specific health-related topics, and the association is inviting HHS Secretary Thompson; Dr. Barry Kramer, Director of the NIH Office of Medical Applications Research; and other NIH representatives to participate. Ms. Pam Fernandes participated in an October press conference that was convened by the CDC to release a monograph on diabetes and women's health issues. She said the CDC is forming a task force to deal with these issues broadly, going beyond clinical approaches to consider socioeconomic effects and health disparities as they pertain to diabetes. Mr. Tom Vaalburg has worked with the COPR Coordinator, Ms. Jennifer Gorman, to develop a questionnaire for COPR members with which to conduct their preliminary evaluation of the Council after its first few years of activities. The results from that questionnaire plus extensive discussions led him and other COPR members to present a report that includes recommendations about COPR to Ms. Gorman and Ms. Anne Thomas, the NIH Associate Director for Communications, who serves as the designated federal official for the Council. Ms. Vicki Kalabokes recently participated in a meeting of the National Health Council, which invited several organizations with interests in specific diseases to evaluate biomedical research programs of nonprofit organizations and how they might be enhanced through interactions with NIH. She also described her involvement in a program called Breast Cancer Watch, whose initial focus is on Marin County, California, whose residents have the highest incidence of breast cancer in the country. She said that she will seek additional NIH participation in this program. The Science Underlying Complementary and Alternative MedicinePresentation by Dr. Stephen Straus, Director of the National Center for Complementary and Alternative Medicine (NCCAM) Dr. Straus said that the Center, which was formed in February 1999, is strengthening its communications programs, and he introduced three NCCAM staff members: Ms. Chris Thomsen, Ms. Irene Liu, and Ms. Anita Greene, representing NCCAM's Office of Communications and Public Liaison. He said that, although CAM is a complex issue and has led to a popular movement, NCCAM's principal responsibility is to inform the American public whether there is merit to specific CAM practices. CAM represents a diverse mix of health care practices outside the realm of conventional medicine that, for the most part, have not been validated by scientific methods, according to Dr. Straus. By complementary, he refers to practices that are used along with conventional medicine; by alternative, he refers to practices used instead of conventional medicine. According to national estimates, 42 percent of Americans use one or more of these practices and spend more than $27 billion per year on them in the aggregate. Despite this wide usage (and demographic trends indicate this usage will continue expanding), patients and their physicians seldom discuss such matters, which suggests less than ideal communications between them. Evidence about the safety and efficacy of such practices is largely anecdotal, according to Dr. Straus. However, many people adopt such practices assuming that they are safe because they are ancient practices passed from generation to generation; many people do not recognize that there are risks of toxicities and risks from not following other more conventional medical approaches that are proven safe and effective. Much of the NCCAM budget, which is expected to be $100 million in FY 2002, will be directed to clinical research studies that are designed to evaluate CAM practices that are currently being used by Americans. As defined in its strategic plan, NCCAM has four priorities: to invest in research; to train investigators; to expand outreach; and to facilitate integration of validated CAM approaches into mainstream medicine, according to Dr. Straus. In trying to meet these objectives, NCCAM faces many challenges, not least of which are the many entrenched practices and market disincentives now in place for those companies and individuals who market invalidated products or provide non-mainstream services. Based on such challenges and current American CAM use patterns, NCCAM plans to invest primarily in cancer research but also in neurosciences, cardiovascular disease, musculoskeletal disorders, women's health, aging, and health disparities. NCCAM will invest proportionately more in clinical research than do other NIH Centers and Institutes, according to Dr. Straus. The Center is now building the infrastructure needed for conducting such research, but it is also developing collaborative efforts with other NIH programs as well as identifying other means with which to leverage its research investments. Included in this infrastructure development are some 16 existing research centers, including 4 that conduct some form of research on botanical medicines in collaboration with the NIH Office of Dietary Supplements. NCCAM also established two major centers for cancer research, one at the University of Pennsylvania and the other at Johns Hopkins University. Meanwhile, additional programs are being established at other major cancer research centers that will encourage them to investigate CAM approaches within their patient populations. Dr. Straus described yet another CAM research center, this one focusing on arthritis, that was established at the University of Maryland Medical School in Baltimore, which will be collaborating with other medical centers. These CAM research programs reflect a broad need for insight into arthritis, a disease that affects aging Americans and that affects women disproportionately. Moreover, because a number of small-scale clinical trials indicated that glucosamine and chondroitin sulfate, which are used widely as dietary supplements, appear to have some effect on arthritis, NCCAM concluded that a larger-scale, Phase III evaluative clinical trial of those two agents is warranted. A multicenter, placebo-control, five-arm study was launched in 1999; it is directed by Dr. Daniel Clegg, a rheumatologist at the University of Utah. The study, which is cofunded with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), is now enrolling 1,588 patients with osteoarthritis and will also assign some patients to receive a proven cyclooxygenase-2 inhibitor. In a separate but related effort, Dr. Peter Lipsky, an investigator in the NIAMS Intramural Program, will work with NCCAM colleagues to evaluate the extract of a particular vine that traditional Chinese practitioners use to treat arthritis. Studies of such traditional medicines and herbs are also important because little is known about their toxicities, and even less is known about their potential for interacting with conventional medicines, including drugs and biologics. Dr. Straus said that NCCAM is launching other investigations, including some that will focus on end-of-life issues in collaboration with NCI and the National Institute of Nursing Research (NINR). Meanwhile, other NCCAM-sponsored investigations are nearing completion, including one to evaluate St. John's wort as a treatment for major depression. The results are expected to be made public within a few months. Other trials are looking at gingko biloba as a potential treatment for dementia, acupuncture for relieving osteoarthritis pain, intravenous magnesium for treating asthma, and EDTA chelation therapy for cardiovascular disease. Some such clinical trials will surely prove that certain CAM practices are not effective, as occurred in Italy after the retrospective evaluation of a multi-ingredient drug treatment (DiBella) that was widely used for several decades to treat cancer patients but was proved to be ineffective. NCCAM has a policy of being open about its funding decisions and has listed on its Web site all projects funded through FY 2001, including 123 new and continuing awards, according to Dr. Straus. The Center also has issued 10 awards, 8 to medical schools and 2 to nursing schools, to support model curriculum development. As part of the Center's outreach program, it is contributing CAM material to the Combined Health Information Database, in conjunction with PubMed at Medline that will be devoted to publications and fact sheets on CAM. He and other NCCAM representatives also are participating in town meetings, including two that have been held (one in Boston and one in Tucson) and one that is scheduled for early 2002 in Portland. Dr. Straus said that as NCCAM moves beyond its first years and appears now to have substantial and stable resources, it hopes to attract established researchers to participate in its programs. As these programs grow, NCCAM will continue to emphasize excellence and high ethical and regulatory practices and also to build a network of investigators who are committed to following these principles. COPR Discussion In response to a question from Dr. Melanie Dreher, Dr. Straus said that he works closely with Dr. Alan Leshner and his colleagues at the National Institute on Drug Abuse when reviewing applications for studies that involve using research-grade marijuana. NCCAM is funding such research, including studies of certain cannabinoid components that are not psychoactive but may have anti-inflammatory properties. In response to a two-part question from Dr. Ellen Bishop, Dr. Straus said that glucosamine and chondroitin sulfate would first be studied on their own as potential treatments for osteoarthritis rather than in conjunction with other anti-inflammatory agents. Regarding her second question, he said that NCCAM works closely with officials in several divisions of the Food and Drug Administration (FDA); some deal with dietary supplements and others deal with herbal medicines. Some NCCAM-sponsored studies will help to determine what doses of such materials are appropriate, and data that are developed might be used by product sponsors to present to FDA in their efforts to regulate such products. In response to questions and comments from Dr. Evelyn Bromet about mental health-related issues, Dr. Straus said that NCCAM is working closely with NIMH to evaluate St. John's wort through clinical trials to determine its efficacy in treating depression. Other studies focus on herbal products now being used to treat several other conditions, such as anxiety and sleep disorders. He also said that, although other NCCAM projects focus on posttraumatic stress disorder, the Center has not issued an initiative in response to the terrorist attacks of September 11, 2001. In reply to a question from Ms. Barbara Lackritz about two specific agents being used by cancer patients, Dr. Straus said that Echinacea is being studied for effects it might have in boosting immune system responses, while the Center also is sponsoring another study on Essiac (an herbal product—generally used as a tea). In addition, a member of the NCCAM staff focuses specifically on alternative approaches to treating cancer, and there are plans for developing more initiatives in this area. The Center also is trying to provide the public with useful information about these and other products, some of which do not work or may be harmful. Dr. Rod Munoz said that American patients often cross the U.S.–Mexican border to receive treatments in Mexico that they cannot receive in the United States. In response, Dr. Straus said that he often receives inquiries suggesting that NCCAM study such clinics, but the Center has no regulatory authority. He added that the federal government takes such matters seriously, but individual patients have the freedom to choose such treatments, even when they may endanger rather than improve or protect one's health. Mr. Bob Roehr mentioned a conference on placebos that NCCAM convened in November 2000 and called it fascinating. Dr. Straus said that British Medical Journal Books is publishing a book based on that conference; after the conference, 10 Institutes collaborated to develop three research initiatives to study placebos in clinical trials using sophisticated techniques such as functional magnetic resonance imaging and positron emission tomography scanning. In response to Mr. Roehr's question about whether the Center's budget meets its rapidly growing need to support large-scale clinical trials, Dr. Straus said that projecting those budget needs is difficult because it is too soon to determine how rapidly the scientific community will come forward with research proposals to study CAMs and practices. Since 1999, the Center has seen a 25-fold increase in proposals, and it is cofunding some of those proposals with other NIH Institutes. In response to a question about integrative medicine from Mr. Doug Yee, Dr. Straus said that this field is in search of a precise identity but it is based on the idea that alternative and complementary medical practices can be combined selectively with conventional medicine. Although there certainly is room for such CAM practices, they need to meet the high standards of safety and efficacy that conventional medicine is required to meet. Ms. Debra Lappin praised the NCCAM research programs, particularly those investigating arthritis, and said they were long overdue. She also called Dr. Straus's ability to grasp the importance of CAMs remarkable, calling it a transformation for someone who was trained in biomedical science. In response to her questions about psychoneural immunology and the impact of spirituality on the immune system, Dr. Straus said that the Center is supporting studies in these areas and recently appointed Dr. Michael Irwin from the University of California, San Diego, who specializes in such research, to its advisory board. Moreover, Dr. Marc Blackman, the new director of intramural research at the Center, also conducts such research focusing on connections among the cognitive, hormonal, and immune systems. In addition, Dr. Esther Sternberg from NIMH heads a trans-NIH neuroimmunology working group. These and other programs are part of the Center's placebo research initiative. Dr. Straus said that he does not consider himself transformed but, instead, the same trained scientist he has been but with a new venue. In response to a question from Ms. Pam Fernandes about supplements that athletes use to deal with stress and to boost immune responses, Dr. Straus said that the Center appreciates this challenge and is involved in evaluating several performance-enhancing substances, including ephedra, DHEA (dehydroepiandrosterone), creatine, and androstenedione. Moreover, NCCAM works closely with the Agency for Healthcare Research and Quality within HHS on such issues. In response to a question from Dr. Luz Claudio about integrating CAM into mainstream practices, particularly in terms of insurance companies reimbursing for such services, Dr. Straus said that members of a White House Commission on Complementary and Alternative Medicine Policy are planning to advise Congress on these issues by March 2002. He noted that third-party payers are beginning to reimburse for some such services, often before credible evaluations are available. Dr. Mike Anderson thanked Dr. Straus for his presentation and called him a wonderful communicator. In response to Dr. Anderson's question about collaborations with Chinese scientists, Dr. Straus said that NCCAM is part of a global enterprise and supports several projects involving Chinese-born scientists, has recruited scientific staff members who grew up in Asia, and consults often with leading scientists from throughout Asia. NCCAM is being deliberate as it builds partnerships with such researchers. COPR Report on Human Research ProtectionsPresentation by Ms. Debra Lappin Before formally presenting her summary of the COPR Report on Human Research Protections to Dr. Kirschstein, Ms. Lappin thanked Dr. Kirschstein and several other NIH officials, including Dr. Baldwin, Dr. Belinda Seto, Dr. Lana Skirboll, Ms. Thomas, and Ms. Gorman as well as Ms. Debra Shuman, a writer, and Ms. Cate Timmerman, a consultant. She also thanked the members of the COPR Working Group who developed the report over the past 18 months but emphasized that the report represents the views of the entire COPR. In December 1999, three members of COPR were asked by former NIH Director Dr. Harold Varmus to serve on an Advisory Group to the Director to consider NIH oversight of human gene therapy research. By the following April, COPR decided to broaden this review to consider human research protections by forming a Working Group to identify and examine multiple issues of public concern. Later, there were major presentations on this topic during the October 2000 COPR meeting, and Working Group members devoted an entire day to this topic in April 2001, which led to a provisional consensus by the formal COPR meeting that month. The Working Group developed a draft report and continued to refine it by means of conference calls shortly thereafter, which led them to confer by means of a more formal, publicly held conference call, which was publicized in the Federal Register on October 2, 2001, and involved the full COPR, whose members further modified and then approved a final report. Ms. Lappin said that the COPR report, which represents the voice of members of the public who fund and participate in clinical trials, focuses on the NIH role in strengthening measures that protect such clinical trial participants. Although COPR recognizes a web of such protective measures, it concentrates on two—one that comes from the institutions conducting those trials and one that comes from the participants. In particular, the COPR report recommends steps by which participants can move toward becoming equal partners in the clinical research enterprise and, thus, being better equipped to protect themselves. One central recommendation in the report is that NIH take steps not only with the "high tech" of cutting-edge science but also with the "high touch" of human interactions that value and empower patients. The COPR report identifies six vital areas in which it sets forth general and specific recommendations for NIH to consider and endorse and then report back to COPR in terms of its efforts to implement them. The first area is informed consent, and the central principle that COPR sets forth is that informed consent should be considered an ongoing process and not a single-step procedure. Part of this process will be to make sets of frequently asked questions available to clinical trial participants as well as to provide them a straightforward path to obtain additional, detailed information about those trials. Patients also should be directed to third parties who are not directly involved in particular clinical trials but can provide additional information about them. The report also recommends a waiting period for reconsideration after a patient consents and before he or she actually enters a trial. The report urges that the role and performance of third-party patient advocates be critically reviewed. The second area addresses the availability and transparency of information describing clinical trials, with the report urging that investigators make the study protocol available to participants unless there are compelling reasons not to do so. NIH should take the lead to ensure that meaningful—suggesting aggregated and analyzed—information about adverse events is made available to patient participants in a timely fashion. As part of this effort, the National Library of Medicine should investigate ways to make relevant information available, particularly that published before 1966 and that is not available on Medline. In addition, the report recommends informing participants about the results of clinical trials before they are published. The third area deals with institutional review boards (IRBs). The report describes this system as being in a state of stress and recommends that NIH study whether there are structural remedies to correct the system and to improve the way it protects human subjects. The report further recommends that NIH study conflicts of interest within IRBs to determine whether they impair decision making as it pertains to protecting patients in clinical trials. The report further suggests that senior researchers be brought into IRBs. It also says that each IRB should include more than one representative of the public and that all IRB members need to be educated about their role in protecting patients who participate in clinical trials. Finally, the report recommends that NIH lead efforts to expand independent membership on IRBs. The fourth area addresses conflicts of interest. The report recommends that clinical trial participants be told of investigators with conflicts of interest and that consent forms delineate which such conflicts are significant and which are not. The fifth area deals with patient confidentiality and privacy issues, several of which could be dealt with through a restructured approach to informed consent. Indeed, as with informed consent, efforts to protect patient privacy should be ongoing throughout all clinical trials. Ms. Lappin said that the final in this series of recommendations in the report stands on its own. It recommends that NIH develop model programs for educating and training the public as a way to empower them when they participate in clinical research trials. These model programs also represent a sweeping effort to change the culture among those who conduct clinical research trials, leading them to respect research participants and treat them as equal partners. COPR Discussion Dr. Maddox, who led the discussion in Dr. Kirschstein's absence, and Dr. Baldwin thanked Ms. Lappin and other COPR members for their report. Dr. Maddox described the report as valuable for NIH and the wider biomedical research community, and Dr. Baldwin said that, in the report, COPR represented a voice for the public and for patients. Dr. Baldwin noted that NIH is sponsoring research on bioethics, some of it focusing on informed consent and how best to present complex information to patients in clinical trials. She said that the report provides useful suggestions for areas of additional research that she plans to use it to design forthcoming requests for research proposals in this area. According to Ms. Lappin, the report specifically recommends that NIH ensure that investigator-related conflicts of interest are dealt with at the institutional level, with assurances to patients that this institutional-level process will be considered when research proposals are being reviewed at NIH. Dr. Maddox said that members of the Working Group should consider presenting the report at the annual meeting of the Association of American Medical Colleges and in similar forums. Dr. Rod Munoz further suggested that the report be presented at the annual meeting of the American Psychiatric Association. Technology Transfer Activities at NIHPresentation by Mark Rohrbaugh, Ph.D., J.D., Acting Director of the NIH Office of Technology Transfer (OTT) Dr. Rohrbaugh said that technology transfer involves the movement of information and technologies developed in particular laboratories into more general research use or into wider use to benefit the public health. Part of this process depends on publishing findings in research reports or disseminating that information through other, comparable means. In addition, researchers may provide their colleagues with useful materials, such as reagents, cell lines, and mutant animals. Beyond that, researchers may obtain patents that protect their inventions, whose use may be licensed for commercial development and marketing. In addition to helping NIH researchers to obtain patents or make other arrangements for transferring technologies they have developed, the OTT mission includes developing NIH policies and providing guidance on patenting and related intellectual property issues in both the NIH intramural and extramural programs. During the past two decades, NIH-supported researchers have interacted more extensively with industry, particularly as biotechnology has grown in importance, according to Dr. Rohrbaugh. He noted that NIH issues about 40,000 extramural awards per year, which accounts for about 80 percent of its overall budget, to investigators at nearly 3,000 institutions. The NIH Intramural Research Program (IRP) consists of about 2,000 projects and accounts for about 10 percent of the overall budget. OTT is actively involved in identifying and evaluating, and then patenting and licensing where appropriate, the technologies and inventions that are being developed in the NIH IRP, according to Dr. Rohrbaugh. Some of this decision-making is based on OTT recognizing which technologies need to be fostered, often by being patented as a means to guarantee time-limited market exclusivity, for useful health-related products to reach the market. Other times OTT may elect to license unpatented materials, perhaps permitting a company to market those materials to other researchers. Another component of the OTT mission is in helping to develop policy on patenting, licensing, material transfer agreements, and similar intellectual property-related issues for HHS. These efforts carry implications for the wider scientific community, including NIH grantees and contractors. OTT, which has a staff of 67 with diverse backgrounds, including in science, law, and business administration, is located in the NIH Office of the Director and is administered under Dr. Michael Gottesman, Director of the Office of Intramural Research. OTT also works closely with 11 patent law firms under contract. Patents obtained (and related technology transfer activities conducted) by researchers working in the NIH IRP and the subsequent financial return under licenses to companies represent about 70 percent of all federal technology transfer royalty income, according to Dr. Rohrbaugh. OTT prepares more than 300 invention reports per year, applies for about 175 patents per year, and executes 180–200 licenses per year; the NIH portfolio includes more than 2,000 patents and nearly 1,500 active licenses and has led to nearly 200 technologies in the marketplace. Royalty income for FY 2000 was $52 million, some of which goes to NIH inventors but most of which returns to NIH Institutes or Centers. Most royalty income derives from only a few NIH technologies. Compared with research universities, NIH in 1999 ranked fourth (behind Columbia University, the University of California system, and Florida State University) in overall royalty income from its inventions. Dr. Rohrbaugh said that most NIH licenses are nonexclusive; more than 86 percent are with U.S. firms, with more than 52 percent with small companies, which by law are favored over large companies. Because patent applications cost more than $20,000 to pursue, with worldwide rights costing as much as $100,000, OTT does not file applications unless they are viewed as necessary to provide market incentives. Commercialized products based on NIH patents include the AIDS test kit, the anticancer drug Taxol, and a hepatitis A vaccine. NIH also enters into cooperative research and development agreements (CRADAs) with companies, in which NIH provides materials and expertise in exchange for various resources for research. Material CRADAs were introduced in 1996, an arrangement that governs exchanges of essential proprietary materials to NIH from companies. Presentation by Mr. Theodore Roumel, Assistant Director of OTT Mr. Roumel said that in the 1970s Congress considered, and by 1980 passed, two major technology transfer-related pieces of legislation to bolster the economy. The Stevenson–Wydler Act encourages federal laboratories to commercialize their research findings, whereas the Bayh–Dole Act assigns intellectual property rights to recipients of federal grant money (instead of assigning those rights to the federal government) while mandating those researchers to move their inventions into the marketplace. During that period, researchers at universities, including many who were receiving NIH support, were showing heightened interest in the newly forming biotechnology industry and the opportunities it presented to them to develop commercial products. Still another piece of legislation, the Federal Technology Transfer Act of 1986, put federally employed scientists more on a par with those in universities by allowing inventors in federal agencies to receive incentives such as royalties and also by enabling agencies to structure CRADAs with companies. Subsequent legislation in 1995, the Federal Technology Transfer Advancement Act, revised some of the details of that earlier legislation, permitting federal inventors to receive the first $2,000 of royalty income plus at least 15 percent of additional income. After the initial $2,000, NIH provides inventors 15 percent of the royalty income up to $50,000 and 25 percent of income over $50,000 to a cap of $150,000 per year. Mr. Roumel said that OTT reviewed its patenting policies during the 1990s, deciding to apply selectively only for those inventions that needed business partners to be commercially realized. This policy decision naturally led to a decline in the number of applications submitted by NIH but also lowered the cost of patenting. OTT, which receives visits from about 50 foreign government or industry representatives each year seeking advice on technology transfer operations, tells its visitors that infrastructure and expertise are essential for critically evaluating invention reports and reducing their overall number. Meanwhile, the Technology Transfer Commercialization Act of 2000 began as an effort to eliminate federal technology transfer activities and would have fostered bidding wars, according to Mr. Roumel. However, federal agencies developed a very different counterproposal that quickly was adopted by the Congress and signed by the President. One of the important policy issues that OTT helped to develop entails research tool guidelines and is called Sharing Biomedical Research Resources, according to Mr. Roumel. It arose in the mid-1990s following concerns expressed throughout the biomedical research community about scientists and companies who were unwilling to share research materials. Former NIH Director Varmus formed a study group that recommended drafting principles and guidelines that were issued by the NIH in 1999. The document was made a condition for receiving NIH grants and contracts in 2000. Mr. Roumel said that a provision of the Technology Transfer Commercialization Act of 2000 reflects concerns expressed in those NIH guidelines and mandates that inventions "made by non-profit organizations and small business firms…are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery." In part because of that mandate, other federal entities such as the Department of Energy as well as private foundations such as the Howard Hughes Medical Institute are now following the NIH "Sharing Biomedical Research Resources" guidelines in their programs. Mr. Roumel said that OTT staff members are joining with colleagues in the NIH Office of Extramural Research in site visits to NIH grantee institutions to determine how they meet Bayh–Dole and other legislative mandates as well as the NIH guidelines. In addition, after a recommendation from the NIH Advisory Committee to the Director, OTT is meeting with company representatives to explain the guidelines and encourage voluntary compliance with them. OTT also is involved in discussions of bioethical issues, such as access to drugs, drug pricing, sharing of research findings, and conflict of interest as it relates to technology transfer. In addition, HHS officials ask OTT for advice about other related legislative proposals, such as those that deal with the fair pricing of drugs. OTT also has provided advice about intellectual property rights as they pertain to human embryonic stem cells and to the development of agreements being considered for NIH-supported researchers who seek to use such cells, according to Mr. Roumel. In addition, OTT provides advice on a wide variety of matters that affect international health organizations, including the World Health Organization, and organizations that deal with intellectual property issues, including the World Intellectual Property Organization and the World Trade Organization. OTT staff members also serve as advisors to other federal entities, including committees in the office of the U.S. Trade Representative. COPR Discussion In response to a question from Mr. Tom Vaalburg about the benefits OTT provides, Dr. Rohrbaugh said the products that might not otherwise be marketed but that now provide public health benefits are a prime example of such public benefits. He added that royalties to inventors represent an additional set of benefits. In response to a question from Dr. Isaac Montoya about transfers of technologies from the behavioral sciences, Dr. Rohrbaugh said that a good many research tools and other types of intellectual property that he did not list are being transferred to other researchers in those specialty areas. In response to another question from Dr. Montoya about small businesses participating in technology transfer activities, Dr. Rohrbaugh said that small businesses are defined legally as those that employ fewer than 500 individuals. NIH is involved with a wide variety of such companies, including very small start-up operations, and OTT makes a practice of carefully reviewing a new company's commercialization plans before entering into a technology licensing agreement with it. Dr. Baldwin said that NIH also can draw on programs mandated under the Small Business Innovative Research Act, which mandates a 2.5 percent set aside of NIH research funds for small businesses, which are proving to be an effective complement to other NIH basic research programs. In response to a question from Ms. Rosemary Quigley about exclusive licensing agreements, Dr. Rohrbaugh said that NIH uses them where necessary, typically when companies are reluctant to invest substantial money in the development of drugs or other therapeutics that they would be unlikely to recoup without exclusive marketing rights. Also, if a potential product appears to be useful for treating several different medical conditions, NIH is likely to limit the exclusivity to only one of those applications. In response to another question from Ms. Quigley about gene patenting, Dr. Rohrbaugh said that Patent and Trademark Office (PTO) officials issued new guidelines for researchers seeking patents for genes and gene fragments, more narrowly defining the PTO criteria for what is patentable. OTT did not agree with the final PTO guidelines, with PTO being more lenient in saying that gene segments were entitled to be patented where the inventors have attempted to show a use for the gene by simply comparing it with other useful DNA segments. Ms. Barbara Lackritz said that her survival depended on one of the drugs that was commercially developed on the basis of a licensing agreement between a company and NIH. She also said that there are community concerns that the patenting of genes and gene fragments could prevent companies from conducting research that leads to new and useful therapeutic or other products. Dr. Rohrbaugh said that NIH and members of the scientific community share this concern, there are ongoing discussions about these issues, and OTT continues to develop policies that address the concerns. He also said that patents per se are not the problem but rather what people do with those patents. In response to a question from Dr. Mike Anderson about patented drugs such as Bayer's Ciprofloxacin that may be needed to meet public health emergencies, Dr. Rohrbaugh said that other antibiotics are available for treating anthrax. He also noted that, even though Ciprofloxacin was developed without federal funds, the federal government has the authority to use patented inventions especially under certain circumstances such as public health emergencies, but companies are entitled to reasonable royalties for the government's use of such inventions. NIH Staff Reports on Stem Cell ResearchPresentation by Wendy Baldwin, Ph.D., NIH Deputy Director for Extramural Research, Development of Stem Cell Registry, and Grants and Funding Opportunities Dr. Baldwin summarized NIH efforts since August 9, 2001, to begin funding human embryonic stem cell research, after President Bush's decision to permit such studies with cell lines that meet his criteria for eligibility. He outlined four basic criteria: an embryo was created for reproductive purposes, it was in excess of clinical need, there was informed consent before the cells were produced, and donors receive no remuneration for furnishing the material. Officials in the NIH Office of Science Policy later identified about 64 cell lines worldwide that meet those criteria, and efforts are under way to develop a registry listing those cell lines. However, although NIH and HHS officials were moving steadily in September to implement the new policy, their efforts were disrupted when the World Trade Center and Pentagon were attacked. Those policy implementation efforts are back on track, according to Dr. Baldwin. A major part of that effort involves developing a Web site-based registry listing those cell lines and providing other information helpful to researchers who are planning on using such cells. Organizations that maintain and will provide those cells are being encouraged to develop their own Web sites with information supplementing that available from NIH. Additional information will be posted to deal with unusual issues, such as meeting import requirements imposed by other federal agencies and departments, including FDA and the U.S. Department of Agriculture. Another near-term aim is to have stem cell-based research follow routine NIH practices as much as is practical, according to Dr. Baldwin. However, until the registry is fully available, no one will be allowed to use federal funds to conduct research on human embryonic stem cells—hence, the sharp focus on readying that registry. Once that registry becomes available, NIH plans to assist researchers in their submissions of proposals, either for start-up work or for adding uses of such cells to ongoing projects. In general, the expectation is that the use of such cell lines will be mainstreamed and will occur widely among diverse research projects being supported by many NIH Institutes and Centers rather than by a very few. As these efforts build momentum, Dr. Baldwin and Institute and Center staff will review the field to determine whether there are any gaps where special needs might be met through training grants or similar instruments. Similarly, there will be special training for NIH staff to meet any specific policy needs that may emerge. Dr. Baldwin also will encourage researchers to submit inquiries through a special e-mail drop, dder@nih.gov, and there are plans to develop a set of "frequently asked questions" as part of the Web site. COPR Discussion In response to a question from Ms. Rosemary Quigley about a special advisory committee that was being established to deal with policy issues involving research on human embryonic stem cells, Dr. Baldwin said that President Bush plans to establish a commission to be led by Dr. Leon Kass of the University of Chicago that will deal with broad bioethical issues arising from such research. However, that commission will not deal with the pragmatic, implementation needs that she described. An oversight committee that NIH officials had been planning to establish and that was to have reviewed prospective human embryonic stem cell lines will not be needed in light of the criteria described by President Bush on August 9. Dr. Evelyn Bromet asked about several hypothetical difficulties involving stem cell research: one involves possible refusals by companies that hold those cell lines to let specific other parties use them, and the other involves finding researchers who do not have a stake but are knowledgeable about such matters to review proposals to use those cells in specific research projects. In response, Dr. Baldwin said there are many challenges yet to be faced, including potential conflicts of interest, but as more investigators seek to do research on such cells, the need to find knowledgeable reviewers will likely be met. She also said that, insofar as some companies might restrict use of their stem cell lines, the problem is not unique to this field. However, because there are a number of lines and several sources for researchers to draw on, sufficient materials will likely be available. In response to a question from Ms. Barbara Lackritz about financial arrangements governing such uses of stem cell lines, Dr. Baldwin said those arrangements are likely to vary widely. In response to several questions from Mr. Doug Yee about the scope of federally and privately funded research involving uses of human stem cells, Dr. Baldwin said the research is being supported with funds from the private sector, but that federal funding is considered a significant addition for several reasons, including its size and scope, the rigorous review that proposals are given, and also because of the federal oversight to which this entire field will now be subject. Presentation by Dr. Mark Rohrbaugh, Ph.D., J.D., Acting Director of the NIH Office of Technology Transfer (OTT), Agreements with Holders of Stem Cell Lines Dr. Rohrbaugh said that NIH has been supporting research on nonhuman primate embryonic stem cells, including the studies of Dr. James Thomson at the University of Wisconsin, Madison, on Old and New World monkeys that led to broad patents covering methods to derive such cells from embryos. Dr. Thomson further pursued those studies in human embryonic stem cells with support from WARF and a company called Geron. WARF formed a subsidiary, WiCell, that owns the key patent covering this work, giving the WARF/WiCell group a dominant position and major control over commercial uses of this technology, according to Dr. Rohrbaugh. Dr. Rohrbaugh said that NIH negotiated an agreement with WiCell and WARF that specifies research use terms for several of their human embryonic stem cell lines. This agreement is applicable specifically to researchers working in the NIH Intramural Program, enabling them to study such cells, publish their findings, and apply for patents. It also specifies that additional licenses will need to be negotiated if NIH-discovered uses are to be commercialized and indicates that NIH investigators are free to study human embryonic stem cells obtained from other sources. WiCell/WARF will offer the same terms to other researchers receiving NIH funding, according to Dr. Rohrbaugh. He said that similar negotiations are under way with other parties who hold patents on additional human embryonic cell lines that meet President Bush's criteria. COPR Discussion Dr. Kirschstein said that more than 60 such cell lines meet President Bush's criteria; they were derived and are held by 11 separate entities. Dr. Rohrbaugh added that WARF/WiCell holds 5 such cell lines and they are probably the best characterized among that set of 64 or more lines. In response to a question from Mr. Bob Roehr about how stem cell lines differ from one another, Dr. Baldwin said little information is available to describe their diversity but noted that the lines certainly derive from different population groups. She pointed out that this research is at an early stage and not much has been published about it. Dr. Kirschstein added that some information about stem cell markers is already available, but detailed information about antigenic markers and about the ethnic and racial diversity of the cell lines is not available and may not become relevant until clinical applications are tested. In response to a question from Dr. Ellen Bishop about restrictions on WiCell/WARF, Dr. Rohrbaugh said that because private funds were used to develop that company's cell lines, it may use them freely. However, researchers supported with NIH funds who study those cell lines are expected to comply with NIH policies and guidelines. He also said that WARF and Geron are in a legal dispute over uses of these cell lines, with WARF maintaining that Geron's rights are restricted to six tissue types and therefore WiCell/WARF may form alliances with other companies regarding additional cell and tissue types and their uses. In response to a question from Dr. Luz Claudio about whether WiCell/WARF could withdraw from its agreement with NIH, Dr. Rohrbaugh said that it is legally binding. In response to another question from Dr. Claudio about whether proposals to use such cells will go to a single study section, Dr. Baldwin said that some Institutes may issue program announcements that will require special reviews. However, she expects proposals to come from many different areas and for them to be reviewed by many different study sections. Moreover, researchers also can apply for administrative or competitive supplements for their grants to fund uses of such cells. Final COPR Discussion on Other IssuesDr. Mike Anderson thanked Dr. Kirschstein for her leadership and NIH staff members for their efforts on COPR's behalf. Ms. Joan Lancaster also expressed her gratitude, as did Dr. Melanie Dreher. Ms. Vicki Kalabokes asked whether current COPR members could help to choose new members. Ms. Anne Thomas said that she and Ms. Jennifer Gorman would research Federal Advisory Committee Act (FACA) policies and guidelines concerning COPR involvement in this process. Dr. Kirschstein said that a working group might be formed to help develop this process, with another one to help set the agenda for future COPR meetings. In response to a suggestion from Mr. Bob Roehr that COPR meet more frequently, Dr. Kirschstein said that she would consider the possibility and also one for holding additional informal meetings. COPR meeting dates are set to fall between the meetings of the NIH Advisory Committee to the Director (ACD), and changing schedules for formal sessions could be complicated. She also noted that federal law specifies that an official be present at publicly convened advisory meetings. In response to Ms. Pam Fernandes, who asked about maintaining ties with COPR after her membership lapses, Dr. Kirschstein said that Ms. Fernandes and others will become COPR Alumni and will continue to receive information and occasional assignments. She also said that a regular e-mail listserve will provide information to COPR Alumni and COPR Associates. Dr. Evelyn Bromet asked whether COPR could develop a strategic plan, become more self-determining, set its agenda, and sometimes meet with ACD. Dr. Kirschstein said that such a meeting could be considered. Scheduling Future MeetingsDr. Kirschstein said that the next COPR meetings will be held April 15–16, 2002, and October 21–22, 2002. Additional meetings were tentatively scheduled for April 21–22, 2003, and October 20–21, 2003. Summary and ConclusionsThe Director's COPR of NIH met on October 23, 2001, to learn about recent events that affect NIH, programs in the NIH Center for Complementary and Alternative Medicine and the NIH Office of Technology Transfer, and recent efforts to begin the federal funding of research with certain human embryonic stem cell lines as well as to present its report on human research protections to the NIH Director. The COPR acknowledged and commented on these presentations, provided several specific recommendations to NIH about patient protection measures, and suggested an effort to develop a strategic plan and set its agenda for future meetings. List of Abbreviations
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