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Advisory Council Minutes
June 2002 (historical)
Minutes of the 47th meeting
June 20, 2002
8:30 a.m. to 1:00 p.m.
Department of Health and Human Services
Public Health Service
National Arthritis and Musculoskeletal
and Skin Diseases Advisory Council
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CALL TO ORDER
The 47th meeting of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Advisory Council was held on June 20, 2002, on the National Institutes of Health (NIH) Campus, Building 31, Confere.nce Room 6 and called to order at 8:36 a.m.
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Attendance
Council members present
Mr. Chris Allen
Dr. Gunnar Andersson
Dr. John P. Atkinson
Dr. Paul Bergstresser
Ms. Priscilla Ciccariello
Dr. Sue K. Donaldson
Dr. Michael M. Frank
Ms. Victoria Kalabokes
Dr. Cato Laurencin
Dr. Matthew H. Liang
Ms. Jean Mandeville
Dr. Richard Moxley
Dr. Robert J. Oglesby
Dr. Francesco Ramirez
Ms. Mary Elizabeth Replogle
Dr. Dennis R. Roop
Dr. Linda J. Sandell (via teleconference)
Dr. Oretta Mae ToddCouncil members absent
Dr. Bess Dawson-Hughes
Staff and Guests
Extramural program and senior staff, NIAMS, and guests attending the meeting included the following:
Staff
Dr. Deborah Ader, Health Science Administrator, Rheumatic Diseases Branch
Dr. Janet Austin, Director, Office of Communications and Public Liaison
Dr. Tommy L. Broadwater, Chief, Grants Review Branch
Dr. Julia B. Freeman, Director, Centers Program
Ms. Janette D. Gabriel, Equal Employment Opportunity, Outreach and Training Officer
Dr. Elizabeth Gretz, Health Science Administrator, Rheumatic Diseases Branch
Dr. Steven J. Hausman, Deputy Director
Ms. Margaret Kerza-Kwiatecki, Associate Director for Management and Operations
Ms. Anita Linde, Senior Progam Analyst
Dr. Peter Lipsky, Scientific Director
Dr. Richard W. Lymn, Director, Muscle Biology Branch
Dr. Joan A. McGowan, Director, Musculoskeletal Diseases Branch
Dr. Alan N. Moshell, Director, Skin Diseases Branch
Dr. James Panagis, Director, Orthopaedics Program
Dr. Susana Serrate-Sztein, Director, Rheumatic Diseases Branch
Ms. Helen M. Simon, Director, Office of Program Planning
Dr. William Sharrock, Director, Bone Biology Program
Ms. Christine Steyer, Director, Human Resources Management Branch
Ms. Robyn J. Strachan, Budget Officer
Ms. Eileen D. Webster-Cissel, Contracts Management OfficerIn addition, other staff members of NIAMS were present for portions of the meeting.
Guests
Mr. Edgar Dews
Mr. Doug Hussey
Dr. John Ruffin
Dr. Cheryl Kitt
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CONSIDERATION OF THE MINUTES
The minutes of the 46th Council meeting, held in January 2002, were approved.
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FUTURE COUNCIL DATES
Future Council meetings are planned on the following dates:
September 26-27, 2002
January 23-24, 2003
May 22-23, 2003
September 25-26, 2003
January 29-30, 2004
June 3-4, 2004
September 20-21, 2004Dr. Katz indicated that these dates will be distributed to anticipated new NIAMS Advisory Council members.
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DIRECTOR'S REPORT AND DISCUSSION
Dr. Katz reported the highlights of NIAMS activities. He noted that more detailed updates of several recent activities are posted on the NIAMS Web Site by Mr. Raymond Fleming as "NIAMShorttakes."
Personnel Changes
The new Director of the NIH, Dr. Elias Zerhouni, was sworn in on May 20, 2002. Dr. Zerhouni formerly served as Executive Vice President at Johns Hopkins University. Dr. Katz plans to invite Dr. Zerhouni to a future Council meeting. Dr. Zerhouni would like time to become oriented to the NIH and to formulate his ideas before attending a Council meeting.
Dr. Roderic Pettigrew was appointed the first permanent Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). Dr. Pettigrew is a professor of radiology, medicine, cardiology, and bioengineering, and Director of the Frederik Philips Magnetic Resonance Research Center at Emory University. He is expected to begin his appointment in September 2002. NIAMS plans to collaborate with NIBIB.
Dr. Cheryl Kitt will replace Dr. Hausman as the new Director of the Extramural Program at NIAMS in mid-July 2002. Dr. Kitt serves as Administrative Team Leader for the Systems and Cognitive Neuroscience cluster and as Program Director for Research on Pain, Neuroendocrinology, Neurotoxicity, Sleep and Circadian Rhythms, and Women's Health Research at the National Institute of Neurological Disorders and Stroke. She also is a member of the NIH Interagency Task Force on Pain, Interagency Work Group on Temporomandibular Disorders, and the Pain Consortium.
Dr. Tommy Broadwater, current Chief of the NIAMS Review Branch, has accepted a position as Senior Advisor to the Director of the National Center on Minority Health and Health Disparities. The recruitment process for a new Chief of the NIAMS Review Branch has begun. In the interim, Dr. John Lymangrover has agreed to serve as Acting Branch Chief.
Ms. Sharon Monsky, who served two terms as a NIAMS Advisory Council member, passed away on May 11, 2002. She was an important advocate for persons with scleroderma.
Update on the Budget
NIAMS currently is operating with the fiscal year (FY) 2002 appropriation of approximately $449 million. The NIAMS FY 2002 Funding Plan is available on the NIAMS Web Site. In FY 2003 the proposed budget increase for the NIH exceeds 15 percent. Significant budget increases are proposed for biodefense and cancer research. The proposed NIAMS budget for FY 2003 is approximately $487 million (an increase of 8.5% over FY 2002). The NIAMS funding success rate is anticipated to be approximately 22 percent.
Recent Scientific Advances
The NIAMS and Muscular Dystrophy Association collaborated to fund development of a double-transgenic mouse with increased levels of insulin-like growth factor (IGF-1) and muscular dystrophy by the Mouse Model Consortium. The increased levels of IGF-1 appeared to increase muscle mass in mice with muscular dystrophy by at least 40 percent and to relieve some secondary symptoms of the disease. IGF-1 appeared to both enhance muscle regeneration and reduce muscle cell death. These findings have significant implications for the treatment of muscular dystrophy.
Dr. John Davis and colleagues at the University of Southern California have discovered that etanercept rapidly alleviates the pain and stiffness associated with ankylosing spondylosis in 80 percent of their study subjects. A large, Phase 3, multicenter trial of this drug is planned.
The first large-scale linkage study of hand osteoarthritis in the general population recently was published by Dr. David Felson and colleagues in Research Reports on Osteoarthritis. The study found eight genetic regions that may be linked to hand osteoarthritis.
A NIAMS-funded study conducted by Dr. Sandy Williams indicated that the enzyme CEMK is a key activator of slow-twitch muscles involved in sustained exercise. Dr. Williams developed a mouse model that produced high levels of CEMK in the muscle. This muscle showed increased numbers of mitochondria (mimicking the effects of exercise). As a result of these findings, the popular press has lauded CEMK as potentially providing a base for the development of an "exercise pill."
Highlights of Recent NIAMS Activities and Plans for the Future
Dr. Katz and several other NIH directors recently traveled to Wisconsin at the request of the Congressman for that state. Dr. McGowan will participate on a similar visit in Rhode Island on the topic of women's health led by Congressman Patrick Kennedy in July 2002. Dr. Katz also recently participated in events sponsored by the NIAMS Coalition, the American Academy of Orthopedic Surgeons, and the Scleroderma and Lupus Foundations.
The National Academy of Sciences (NAS) Institute of Medicine (IOM) began a study of the organization of the NIH. Some Council members may be asked to participate in this study.
On June 21, 2002, NIAMS is scheduled to celebrate the first anniversary of its Community Health Center in the Cardozo area of Washington, D.C. The NIAMS Community Health Center is a component of the Health Partnership Program.
Future Events
A conference on How to Address the Burden of Skin Diseases is scheduled for September 2002 at the NIH. Experts in the field of skin research and experts in the measurement of disease burden will participate in this meeting to recommend approaches for measuring the burden of skin disease. Dr. Moshell is organizing this meeting.
NIAMS is participating in the Bone and Joint Decade (2002-2011) proclaimed by President Bush on March 21, 2002. In the fall of 2002, NIAMS will meet with the leaders of the various organizations involved in this effort to identify opportunities to enhance information dissemination by capitalizing on the Bone and Joint Decade's international collaboration. Dr. McGowan has agreed to serve as the NIAMS point person for the Bone and Joint Decade. Mr. Fleming has extensive experience developing and disseminating information for the Brain Decade and is expected to have a key role in disseminating information for the Bone and Joint Decade. More information on the Bone and Joint Decade is available on the NIAMS Web Site. NIAMS involvement in this effort may be an agenda item for a future Council Meeting.
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COUNCIL OF PUBLIC REPRESENTATIVES (COPR) ACTIVITIES
Ms. Kalabokes delivered a presentation on the NIH Council of Public Representatives (COPR). COPR was formed in 1999 in response to an Institute of Medicine report recommendation (not a Congressional mandate) to serve as a liaison between the public and the Director of the NIH. COPR members have diverse experience and expertise but are asked, as public representatives, not to promote their own agendas.
Over 250 people have been nominated to serve on the COPR, but only 20 are selected to serve for a single term of 4 years. Most of the nominees who are not selected to serve on the COPR become COPR Associates. New COPR members are selected primarily from the pool of COPR Associates. COPR Associates also are selected to serve on various advisory boards, councils, and special committees that address a particular Associate's area of expertise. Nominations for new COPR Associates are requested through the Federal Register every 2 years. The myriad roles of the COPR are to: (1) provide the NIH Director with current, public-oriented viewpoints regarding issues that are important to the NIH (e.g., treatment of clinical trial participants); (2) work with the NIH Offices of Public Liaison (OPLs) to improve public understanding and knowledge of the NIH; (3) serve as a sounding board for scientific issues that are important to the public (committees are formed to address these issues, which include health disparities and bioterrorism); (4) identify alternative mechanisms to broaden the base of public input; (5) encourage broad representation of the public on standing and ad hoc policy and program advisory boards and national councils; and (6) identify best practices for receiving public input and advocate replication of these practices across the NIH. COPR has several working groups, including a group to plan COPR meeting agenda and select invitees. All working groups collaborate with the NIH Director. In addition, five members of the COPR are chosen each year to attend the NIH Budget Retreat to advise Institute Directors about budget priorities. COPR members also have presented to several Institute Advisory Councils, served on review panels for Institute Directors, and participated in the Government Performance and Results Act review of NIH research. Ms. Kalabokes, who is a member of the first COPR, noted that COPR members interact by e-mail daily.
A meeting is scheduled between the COPR and Dr. Zerhouni in August 2002 to report the accomplishments of the COPR and discuss what Dr. Zerhouni believes should be the role of the COPR. At this meeting, COPR members will emphasize the importance of retaining the current COPR infrastructure and plan because the development of infrastructure and processes involved considerable time and effort and now is well established and effective.
The COPR Web Site is under development. The COPR plans to include a listserv for the public members of each Institute Advisory Council on its Web Site. Each listserv would include topics for which the COPR is seeking input. The Web Site also will contain minutes of all COPR meetings and COPR reports.
Discussion
Dr. Liang asked what the COPR is doing to align public health problems with the NIH research portfolio. COPR members are serving on liaison committees with other Department of Health and Human Services (DHHS) entities that can best address a specific public health problem. The COPR also has a working group on research priorities and their alignment with public health problems.
Ms. Mandeville asked about the specific approaches that the COPR uses to increase public awareness about the NIH. Ms. Kalabokes responded that the COPR works closely with NIH Offices of Public Liaison (OPL) and involves COPR Associates in OPL outreach activities as appropriate. COPR also is involved in, and has initiated, NIH Town Meetings around the United States. The COPR conducted a retreat with a facilitator to identify more effective approaches for increasing public awareness about the NIH. Ms. Ciccariello asked how the public is made aware that the COPR exists at the NIH. It was explained that COPR uses the NIH Communication Offices and COPR Associates to publicize COPR in local media around the United States. COPR also has a work group to develop approaches for improving public awareness of COPR.
Dr. Donaldson proposed that the NIAMS Advisory Council specifically communicate to Dr. Zerhouni how the COPR enables NIAMS to fulfill its mission. Council members agreed to draft a formal letter to Dr. Zerhouni to communicate the value of the COPR to NIAMS. Dr. Lipsky recommended that the letter include specific examples of how the COPR has benefitted NIAMS and helped NIAMS fulfill its mission. Ms. Kalabokes agreed to compile specific examples of how the COPR has supported the mission of NIAMS and other Institutes. One such example is a case study of informed consent for victims of a tragedy. Ms. Kalabokes agreed to distribute the final report of this case study and the NIH Director's response to it to Council members.
Dr. McGowan noted that the COPR could support NIAMS by assisting in the formation of an observational study monitoring board (OSMB) for the Osteoarthritis Initiative. This board should be comprised of scientists and advocates and/or lay members of the public (i.e., patients, caregivers). Ms. Kalabokes recommended including both advocates and a few "average" patients on this OSMB. The COPR is discussing approaches for overcoming barriers to including lay individuals on NIH boards. Privacy concerns must be addressed in recruiting patients to boards.
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UPDATE ON THE STATUS OF THE OSTEOARTHRITIS INITIATIVE
Dr. Lester, the Project Officer for the Osteoarthritis Initiative, noted that the Osteoarthritis Initiative is progressing well. NIAMS expects to make awards for the clinical sites and the data coordinating center by the end of July 2002. Six Institutes or NIH Centers are involved in this collaborative Initiative. The Osteoporosis Initiative may serve as a model for future public/private collaborative initiatives with significant public health implications. The Initiative involves industry (four major pharmaceutical companies), academia, government agencies, and private foundations. Private funding for this Initiative is channeled through the Foundation for NIH.
Dr. Lester delivered a detailed presentation on this Initiative. The goals of the Osteoarthritis Initiative are to create a resource to aid in the identification and evaluation of biomarkers as candidates for surrogate endpoints for osteoarthritis. A 5-year, prospective, natural history, cohort study is planned to examine individuals at high risk for osteoarthritis. Research questions that will be addressed include: (1) Are there structural features of a joint associated with onset and progression of osteoarthritis? (2) Are there biochemical or structural markers that would allow the assessment and development of disease-modifying therapies? (3) What are the research tools (resources and knowledge) needed to develop reliable biomarkers of disease that could serve as surrogate endpoints?
Major challenges to the formation of the Osteoarthritis Initiative related to intellectual property and use of specimens. A declaration of exceptional circumstances is being signed by the NIH Director to prevent the patenting of any developments resulting from research supported by this Initiative. Partners agreed that resources will not be encumbered by patents and intellectual property. Access to biospecimens will be controlled by an unbiased committee to be formed by the Government. All organizations eventually will have access to clinical and imaging data as well as biological specimens produced and compiled through this Initiative. Organizations can use these data and biospecimens with a patented process for research and development, and the only condition of this access is that the results of the organization's research and development be made available to the public.
The first Osteoarthritis Initiative Steering Committee meeting is scheduled for July 25-26, 2002. Each of the four industry partners (GlaxoSmithKline, Merck, Novartis, and Pfizer) plans to send scientists to this meeting and to elect two representatives to serve on the Steering Committee. Several NIH Institutes also are partners, including NIAMS, the National Institute on Aging (NIA), National Institute of Dental and Craniofacial Research (NIDCR), National Center for Complementary and Alternative Medicine (NCCAM), National Center on Minority Health and Health Disparities (NCMHD), and the Office of Research on Women's Health (ORWH). Two representatives from each of these Institutes or Offices also will serve on the Steering Committee. The Food and Drug Administration (FDA) also will send representatives to Steering Committee meetings. In addition, the Steering Committee will obtain input from the public, voluntary and scientific organizations, and the international research community. Two representatives from each clinical site and the data coordinating center also will serve on the Steering Committee.
An Observational Study Monitoring Board (OSMB) of 9-13 members is being formed for this Initiative. Members of this OSMB will advise investigators and the NIAMS and NIA directors regarding risks to subjects and progress of the study. A public database also will be established to address research questions related to the Initiative.
Discussion
Dr. Sandell inquired about the timeline and mechanism for sample distribution for the Osteoarthritis Initiative. The Steering Committee and OSMB likely will determine the mechanism for the sample distribution. Dr. Lester indicated that access to biospecimens is likely to be very limited during the first year of this study because of the longitudinal nature of the study and because DNA will not be extracted until the subjects return for a second visit. She expects that biospecimens will become more readily available during the third year of the study. Dr. Sandell also inquired as to how the Initiative's databases will interface with other patient databases outside of the study. Dr. Lester plans to propose some ancillary epidemiological studies to stimulate biomarker development and examine risk factors for osteoarthritis. All studies of the biospecimens would need to be funded outside of the Initiative. These biospecimens likely will be reserved for use with well-validated markers.
Dr. Andersson asked whether the study may include biomechanical markers. These types of markers were not mentioned in the Statement of Work (SOW) in the initial Request for Proposals (RFP). However, studies of biomechanical biomarkers could easily be added to the Initiative's protocol. The Steering Committee likely will discuss the addition of biomechanical markers, taking into consideration both the importance of biomechanics as a potential confounder and the increased burden on the subjects in adding biomechanical measures. Dr. McGowan noted that biomechanics is an important risk factor and target for preventive intervention but is not likely to be impacted by a drug. Drug development is the focus of the Osteoarthritis Initiative.
Dr. Liang asked how the investigators and partners will work with the various Institutional Review Boards (IRBs) for this study. Dr. McGowan responded that the common concerns of IRBs - subject safety and access to treatment - have been addressed through the creation of an OSMB and the fact that the study neither provides nor impedes use of any treatment. The OSMB can recommend terminating a study or prescribing a specific treatment to all participants when appropriate. The directors of NIAMS and NIA will make final decisions based on input from the OSMB.
Mr. Allen suggested that some commitment be made to the development of affordable drugs when that development relies on the use of data or biospecimens produced by the Osteoarthritis Initiative. Dr. Lester responded that any development of osteoarthritis drugs will not depend solely on the data and biospecimens produced by this Initiative, so the NIH does not have authority to make this type of commitment. However, partners for this Initiative can request that Congress and pharmaceutical companies commit to affordable osteoarthritis medications. Dr. Lester noted that investigators may not know how to make this type of request and recommended including more policy experts on the advisory committees for this Initiative. Dr. McGowan added that the four pharmaceutical companies participating in this effort receive no benefit with regard to early or expanded access to data and biospecimens produced by the Initiative.
Mr. Allen also asked about the inclusion of quality of life as a marker for this study. The clinical centers that will participate in this Initiative have been asked to focus on quality of life and daily activities of subjects. Data also will be collected on disparities in incidence and/or treatment of osteoarthritis.
Dr. Laurencin inquired about the relative levels of funding from each partner and the number of years for which the funding is committed. The funding is committed for 7 years. About one-third of the funding comes from the private sector, and two-thirds of the funding comes from the Government. Each company provides the same amount of funds.
Dr. Moxley requested that the final consent form and accompanying educational materials developed for the Osteoarthritis Initiative be shared with other investigators on the NIAMS Advisory Council. Dr. Lester agreed to share the consent form as it develops.
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NIH COMPREHENSIVE STRATEGIC PLAN AND BUDGET TO REDUCE AND ULTIMATELY ELIMINATE HEALTH DISPARITIES
Dr. Ruffin, along with Mr. Doug Hussey and Mr. Edgar Dews of the NCMHD, attended this Council meeting and presented an overview of the activities of the NCMHD and how NIAMS can continue to effectively interact with the NCMHD. NIAMS has a 10-year history of collaboration with the NCMHD and the former Office of Research on Minority Health (ORMH). During this period, the NCMHD and the ORMH have invested from $12 to $14 million in NIAMS projects. The NCMHD also has committed to funding the Osteoarthritis Initiative each year for the next 7 years.
Dr. Ruffin emphasized that the inclusion of larger numbers of minority investigators in biomedical research is key to eliminating health disparities. Dr. Ruffin distributed some copies of an ORMH Fact Finding Team Report that made 13 recommendations for reducing health disparities and increasing minority participation in biomedical research, which were the basis of ORMH activities. Dr. Ruffin also distributed copies of Public Law 206-525 that led to the creation of the NCMHD and that describes the new responsibilities of this Center. He noted that the NCMHD is required to address health disparities among a broader range of populations than was the former ORMH, which focused on racial/ethnic minorities. NCMHD efforts can focus on any group exhibiting significant disparities in overall rate of disease compared to the general population based on incidence, prevalence, mortality, and survival. The NCMHD also differs from the ORMH in that it can provide grants. Dr. Ruffin emphasized, however, that the NCMHD will continue to collaborate with the NIH Institutes and Centers (ICs) as the ORMH did. The NCMHD can fund projects or portions of projects that are expected to increase understanding of health disparities (e.g., recruitment of minority populations to studies of health disparities). The NCMHD also operates the Health Disparities Loan Repayment Program and the Clinical Research Loan Repayment Program. In addition, the NCMHD also developed three mechanisms for establishing Centers of Excellence for Health Disparities around the United States. The first mechanism (R24) is a planning grant that allows institutions to develop infrastructure for creating a Center of Excellence for Health Disparities. The second mechanism (P20) is a cooperative agreement that provides guidance and support from NIH as an institution to establish a Center of Excellence for Health Disparities. The third mechanism (P60) provides only research support and is designed for more research-intensive institutions that do not need support to create a Center of Excellence for Health Disparities. The first round of applications for these three funding mechanisms is under review and awards are expected in September 2002.
Mr. Hussey discussed the NCMHD comprehensive strategic research plan and budget for the conduct and support of all NIH activities to reduce and eliminate health disparities (FY 2002-2006). This plan will serve as a broad, binding statement of policies that relate to NIH health disparity research and collaboration between the ICs to conduct this research. The plan has detailed priorities, objectives, and action plans for the attainment of research, research infrastructure, and community outreach goals. The initial NIH-wide plan to reduce health disparities was developed prior to the enactment of Public Law 206-525 that involved the directors of all ICs. Feedback on this plan was solicited and received online from a wide range of stakeholders over a period of almost 2 years. This feedback was shared with the ICs, who were asked to submit proposals for intramural and extramural activities to reduce and eliminate health disparities to the NCMHD for inclusion in the comprehensive research plan and budget. The NCMHD is incorporating comments from the NIH and IC directors into the strategic plan before approval by the NIH director. This plan will continue to be evaluated and revised over the next 5 years and will be posted on the NIH Web Site for feedback.
Discussion
Dr. Todd asked about approaches the NCMHD will use to reach stakeholders outside of the research community. In response it was explained that the NCMHD is discussing the development of new mechanisms for community-based organizations (CBOs) to collaborate directly with the NIH rather than through universities.
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PLANNING FOR APPLICATIONS GREATER THAN $500,000
Funding of unsolicited applications for more than $500,000 per year requires approval from the NIAMS director and now is part of the Institute's planning process. New NIH policy requires that applicants notify the Institute no less than 6 weeks before submitting an investigator-initiated application for funding of $500,000 or more in direct costs.
Dr. Hausman conducted an informal survey of other NIH extramural research directors to discover the procedures they use to determine acceptance of an application for more than $500,000. He received responses from 18 Institutes indicating that:
Program staff determine acceptance of large (over $500,000) applications in seven Institutes. In another seven Institutes, senior management makes this decision. In two Institutes, the staff person who makes this decision depends on the amount of funding requested. In one Institute, the director makes this decision.
Most Institutes will accept large applications on any of the usual receipt dates.
Most Institutes have no specific guidelines for deciding to fund a large application. At one Institute, epidemiological cohort studies are ranked once a year and funding decisions are made based on rank.
Apparently, only the NIAMS tracks trends in the number of large applications received. No data on these trends are collected by the other responding Institutes. Two Institutes, however, indicated that the number of large applications may be increasing. Data suggest a general increase in the number of large, investigator-initiated applications received since 1996. All applications for more than $500,000 that were submitted to NIAMS before 1999 were funded. Since 1999, not all large applications were funded, but the rejection rates have been decreasing each year.
Large applications funded by NIAMS are both new and competitive renewals. Most focus on clinical research. Data on these applications were not analyzed by funding amount but Dr. Hausman observed that many applications were funded for close to $500,000. No data are available on multi-institutional grants, but Dr. Katz noted that many large grants are funded through a partnership of several ICs.
Discussion
Dr. Hausman asked participants to provide input regarding limitations that NIAMS should place on the submission times, numbers funded, and funding dates for the large, investigator-initiated applications. Ms. Ciccariello recommended maintaining the current process for the submission, review, and funding of these applications until the data collected on these applications reveal strong trends. Additional limitations may discourage translational research applications. Dr. Andersson added that a greater number of translational applications from clinicians can be expected in the future. Dr. Ramirez noted that the number of multicenter applications is likely to increase, which should increase the amount of funding requested. Dr. Liang added that investigators may need to obtain larger amounts of funding to achieve sample sizes that will provide definitive answers regarding many diseases that NIAMS addresses (e.g., lupus). The expected trend toward larger, multicenter studies, combined with the lower funding increases for NIAMS, may make maintenance of a high funding success rate for applications under $500,000 increasingly challenging. Dr. Ramirez asked what the Advisory Council could do to help maintain an adequate funding success rate. Dr. Katz responded that maintenance of an adequate success rate is still achievable with the current level of funding for NIAMS. He recommended, and participants agreed, that the Council regularly review approaches to funding over the next few years to ensure that an adequate success rate is maintained.
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REPORT OF RECENT MEETINGS
Scientific Planning Retreat
Dr. Donaldson delivered a summary of the annual NIAMS Scientific Planning Retreat of the Extramural Program held on April 15-16, 2002. The purpose of this Retreat was to conduct a business plan analysis of NIAMS as a research enterprise. Each program director and branch chief presented the state of the science and resources for his/her program or branch. They also discussed significant advances in science and opportunities for future advances in areas such as methodology and translation. New, unpublished results of important research also were presented at this meeting. Dr. Donaldson emphasized that the meeting was well planned, which resulted in productive discussion. A key topic discussed at this meeting was capacity building for research in different areas in terms of methods, technology, resources, mechanisms, and investigator interactions. Another key discussion topic was new disease paradigms, which resulted in several recommendations for mechanisms to promote interdisciplinary collaboration and new and diverse research strategies, including exploratory and prevention research. Initiatives recommended at this retreat for FY 2004 will be proposed at the next Advisory Council Meeting in September 2002.
An evening session was conducted to address genomic, genetic, proteomic, and phenomic (mostly mouse model) technologies. This session generated several hypotheses that cut across multiple disciplines. The session included a discussion of new approaches for matching the genotype to the phenotype. These approaches will require large amounts of funding for extensive datasets, coordination, and a centralized infrastructure. Participants in the session discussed the role of NIAMS in providing infrastructure and support for genetics and proteomics studies funded by the Institute.
The Third Annual Retreat of the NIAMS Intramural Program also was held recently. Details of this meeting will be shared at the next Advisory Council Meeting.
Discussion
Dr. Ramirez inquired as to how study sections are being refined to support new research paradigms for NIAMS. Dr. Katz responded that study sections are beginning to consider new paradigms. In addition, a special funding system has been developed to support research that extends beyond the scope of the traditional review and funding process. The NIAMS director makes the final decision regarding the funding of research proposals and can choose to support innovative research that study sections may reject.
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EXTRAMURAL CLINICAL LOAN REPAYMENT PROGRAM
Dr. Broadwater indicated that the announcement for the new NIH loan repayment programs has been posted on the Web. The four types of loan repayment programs include: (1) Pediatric Research (clinical research only), (2) Extramural Clinical Research (by qualified health professionals), (3) Health Disparities Research (by qualified health professionals), and (4) Clinical Research by Health Professionals from Disadvantaged Backgrounds. Programs are restricted to individuals with doctoral degrees who are receiving up to $35,000 per year in NIH funding for research and who have an educational loan debt that is at least 20 percent of their income. The loan repayment program requires that recipients agree to perform 2 years of additional research. Dr. Katz added that recipients of K01, K03, K07, K12, K22, K23, and K25 grants will have more flexible eligibility requirements for the loan repayment program, but these requirements have not yet been specified.
The usual funding application review process can be used for loan repayment applications, but scientific review is not required because applicants already have NIH funding. This Council (or a subgroup) will review loan repayment program applications after they have been reviewed by an appropriate study section. The purpose of the review is to assess the research career goals of the applicant and determine whether his/her environment will enable these goals to be achieved. This review is based on: (1) a personal statement of research career goals and academic plans and how these will be fulfilled over the next 2 years; (2) a research statement by the applicant specifying how he/she will fulfill his/her 2-year research obligation; (3) a statement from the applicant's institution describing how the applicant's research will continue to be supported for the next 2 years; (4) a description of the applicant's current research; (5) a research training plan, if applicable; (6) a mentoring plan, if applicable; and (7) three letters of recommendation. The application and review process can be conducted online.
NIAMS received 15 loan repayment applications in FY 2002. Some ICs received significantly larger numbers of these applications.
Discussion
In response to questions from Drs. Andersson and Frank, Dr. Katz provided an overview of how the loan repayment funds are distributed across the NIH by research area and IC. Dr. Donaldson recommended that any future limitations on the loan repayment program be based on educational debt calculations used by universities. Dr. Katz responded that this program is being prospectively evaluated and any limitations would be added based on evaluation findings.
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CONSIDERATION OF APPLICATIONS
The Council reviewed a total of 729 applications in closed session requesting $147,340,257 and recommended for $106,619,440.
There being no other business, Dr. Katz adjourned the 47th meeting of the NAMS Advisory Council on June 20, 2002, at 4:06 p.m.
I hereby certify that, to the best of my knowledge, the foregoing summary and attachments are accurate and complete.
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Steven J. Hausman, Ph.D. |
Stephen I. Katz, M.D., Ph.D. |
National Arthritis and Musculoskeletal and Skin Diseases Advisory Council
CHAIRMAN
KATZ, Stephen I., M.D., Ph.D.
Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Bethesda, Maryland 20892
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ALLEN, Chris (2003) |
CICCARIELLO, Priscilla (2002) |
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ANDERSSON, Gunnar Bengt Johan, M.D. (2004) |
DAWSON-HUGHES, Bess, M.D. (2004) |
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ATKINSON, John P., M.D. (2003) |
DONALDSON, Sue K., Ph.D. (2002) |
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BERGSTRESSER, Paul R., M.D. (2003) |
FRANK, Michael, M., M.D. (2004) |
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KALABOKES, Victoria B. (2005) |
REPLOGLE, Mary Elizabeth, CPA (2005) |
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LAURENCIN, Cato T., M.D. Ph.D. (2005) |
ROOP, Dennis R., Ph.D. (2002) |
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LIANG, Matthew H., M.D. (2002) |
SANDELL, Linda J., Ph.D. (2002) |
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MANDEVILLE, Jean (2003) |
TODD, Oretta Mae, PhD., RN (2004) |
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MOXLEY, Richard T., M.D. (2005) |
EX OFFICIO |
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RAMIREZ, Francesco B., Ph.D. (2005) |
OGLESBY, Robert J., M.D. |
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EXECUTIVE SECRETARY |
