CENTERS FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE RESEARCH NIH GUIDE, Volume 26, Number 34, October 10, 1997 RFA: OD-98-003 P.T. Office of Alternative Medicine National Institute of Child Health and Human Development National Institute on Drug Abuse Letter of Intent Receipt Date: December 1, 1997 Application Receipt Date: January 13, 1998 PURPOSE The Office of Alternative Medicine (OAM) was mandated by Congress in 1991 and permanently established within the Office of the Director, National Institutes of Health (NIH), through the National Institutes of Health Revitalization Act (Public Law 103-43, Section 404E). The mission of the OAM is to encourage and support the investigation of complementary and alternative medicine (CAM) practices, with the ultimate goal of integrating validated alternative medical practices into health and medical care. The OAM also is charged with training investigators who can help fulfill this mission. The demographics, prevalence, and patterns of use of alternative unconventional medicine in the United States have been described (Eisenberg et al., New England J. Med. 328: 246-352, 1993). The most relevant findings are the following: a) most people use CAM therapies for chronic rather than life-threatening medical conditions, b) users of alternative therapies do not inform their primary care physicians, c) extrapolation to the population of the United States suggests that Americans made approximately 425 million visits to providers of CAM therapy during 1990, and d) expenditures associated with CAM therapies appear similar to non-reimbursed expenses incurred for all hospitalizations in the United States. These findings indicate that alternative medicine modalities occupy a larger role in the health care of U.S. citizens than previously understood. The goal of this RFA initiative is to encourage research of CAM by establishing Centers for CAM Research. Such Centers will make the resources necessary for the conduct of high quality research available to investigators interested in CAM. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," an initiative for setting national health policy and priorities. Although "Healthy People 2000" does not specify a CAM objective, this RFA reflects several different priority areas, such as heart disease and stroke, maternal and infant health, substance abuse and HIV infection. Applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and not-for-profit organizations, public and private organizations such as universities, colleges, hospitals, laboratories, units of State or local governments, Federally recognized Indian Tribal organizations, and eligible agencies of the Federal government. Applications may include foreign components, but foreign organizations are not eligible to apply. Applications from minority and women investigators are encouraged. While applications must be submitted from a single institution, they may include subcontracted collaborative scientific arrangements with scientists from other institutions, as long as these arrangements are clearly delineated and formally and officially confirmed by signed statements from the responsible officials of each institution. However, a full institutional commitment must come from the parent institution receiving the award. Research conducted through the Center is expected to be multidisciplinary. As such, support will not be provided for applications with research activities focused exclusively in one research domain, such as only basic research or clinical research, or epidemiological research. MECHANISM OF SUPPORT Support of this program will be through the P50 Specialized Center Grant mechanism. This mechanism supports any part of the full range of research and development from basic to clinical and intervention studies. In addition to support for research projects, support is also provided for career development, for specialized resources and for shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed program. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy statement. Applications from institutions not previously funded for Centers for CAM Research will compete on an equal basis with competing continuation applications. It is expected that RFAs similar to this one will be issued in FY 1998 and FY 1999. FUNDS AVAILABLE Up to $2,400,000 in total costs (direct plus indirect) will be committed in the first year to fund 2-4 awards from qualified applicants. These awards may be up to five funded years. This funding level is dependent on the receipt of applications of high technical and scientific merit, and the continued availability of funds. Because the nature and scope of applications may vary, it is anticipated that the award size could vary. GENERAL OBJECTIVES 1. Background Despite the broad use of alternative medicine treatments (NEJM, 1993, 328:246-252) there is a relative paucity of data available to demonstrate convincingly whether many of these CAM practices lead to positive clinical outcomes, improve quality of life, reduce or eliminate adverse symptoms, prevent disease, or promote or enhance health, and are efficacious, safe, and/or beneficial. A similar conclusion was reached in a 1990 report on unconventional cancer treatments by the U.S. Office of Technology Assessment. This report urges a systematic analysis of alternative treatments and their effect on major disease, health and wellness (U.S. Office of Technology Assessment, OTA-H-405, 1990, p.225). 2. Center Concept: The OAM currently supports ten Centers for CAM Research in cooperation with five NIH Institutes. The Centers are viewed as a first step in expanding the national infrastructure for research of CAM. The Centers are designed to identify and evaluate promising CAM by establishing mechanisms for investigators to have their research ideas reviewed, developed and executed in a scientifically rigorous manner. The Centers evaluate research opportunities in their program area and prioritize research projects. The Centers facilitate collaborations between CAM practitioners and conventional scientists to conduct specific research projects. The results of these projects are published in the scientific literature and disseminated to the public. 3. Objectives of the RFA The expressed purpose of this RFA is to provide a mechanism to examine the potential efficacy, effectiveness, safety and validity of CAM therapies, and to provide scientific/technical assistance to investigators as they develop their research projects. The establishment and support of Centers for CAM Research, under the auspices of the OAM, will meet these objectives. The Centers will support a multi-disciplinary group of researchers and clinicians to perform basic, preclinical, clinical, epidemiologic and health services research of CAM in one of four research theme areas. The Centers will provide many of the resources necessary for the conduct of high quality research, including an environment for training future scientists. Finally, the Centers will encourage collaboration between basic and clinical scientists, and between the CAM and conventional medical communities. In general, insufficient scientific data are currently available that address safety and efficacy questions for CAM therapies. Many CAM practitioners are not currently affiliated with research institutions able to provide the research infrastructure necessary to facilitate the study of CAM. Research conducted at the Centers for CAM Research will provide useful data to determine the appropriateness of CAM approaches. It is expected that work begun at the Centers will provide the basis for subsequent investigator-initiated research grant applications to the NIH. Competing continuation (renewal) applications must demonstrate progress in the above areas as indicated by scientific progress, success in the initiation of competitively-supported research (both federal and non- federal sources of support can be applied to this criterion), the development of new CAM investigators, and collaborations with conventional scientists and CAM practitioners. Objectives: Specific objectives for the current Center applications include: o Performing research related to CAM treatments in one of four research theme areas: cardiovascular disease, drug abuse, HIV/AIDS, or pediatric disorders, o Establishing an advisory committee to provide program direction and advice to the principal investigator of the Center, including prioritization of research protocols and utilization of core facilities, o Developing a mechanism for scientific/technical merit review of proposed studies from investigators, o Developing workshops, seminars, etc. for training purposes, o Establishing a system to identify and support junior investigators in their career development, o Investigating basic mechanisms of CAM therapeutic and diagnostic interventions, o Conducting controlled trials of sufficiently developed CAM interventions or pilot trials for the purpose of developing controlled trials, and o Acting as an institutional focus for training in research methodology, bioethics, biostatistics, clinical trial design, epidemiological studies, health services studies and basic laboratory methods as they relate to CAM, RESEARCH ACTIVITIES The overall goals and objectives of the Center’s research agenda for the requested funding period should be explicitly stated in the application. This should include identification of the Center’s research direction, as well as specific disease entities and target populations to be studies. 1. Research Theme Areas Applicants should develop a multidisciplinary research focus and five-year research agenda in one of the four following themes. The application should describe how the Research Theme will be integrated with one or more of the high priority CAM Program Areas (item 2). o HIV/AIDS Background: HIV/AIDS is the seventh leading cause of death in the United Stated. As of December 1995, the Centers for Disease Control and Prevention (CDC) estimated that more than 500,000 individuals in the United States had contracted AIDS. While the number of HIV-positive individuals is not exactly known, estimates have been placed as high as 900,000 in 1992 (JAMA, 1996, 276:126-131). Worldwide figures for HIV/AIDS are even more staggering. The United Nations estimates that 21.8 million people are living with HIV/AIDS. This figure may grow to between 60 and 70 million adults infected with HIV by the year 2000. In 1995 alone, more than 1.3 million people worldwide died of HIV-associated illnesses. Although the newest combination anti-viral therapies show great promise, issues of cost and compliance will almost certainly prevent their general use worldwide. Goal: The goal of the Centers for CAM Research on HIV/AIDS is to identify and support the development of improved interventions to prevent and treat HIV infection and its sequelae, including cachexia, neuropathies, and opportunistic infections. The Center will validate that these approaches are safe and effective. o Drug Abuse and Addiction Background: Although illegal drug use has steadily declined since the 1980s, 12% of the U.S. population reported use of an illegal drug in 1993. In this same year, about 35% of high school seniors reported having used marijuana or hashish and 3.3% reported using cocaine. Drug use in the U. S. resulted in more than 400,000 drug- related emergency room episodes in 1993, a 10% increase from 1991. According to the CDC, smoking tobacco remains the leading cause of preventable deaths in the U.S. It has been projected that there are 400,000 smoking related deaths each year at a cost of approximately $50 billion in direct medical care costs. In the thirty years since the release of the Surgeon General"s initial report on the effects of smoking tobacco, 10 million U.S. citizens have died from causes attributable to smoking, with 2 million deaths occurring from lung cancer alone. Intensive efforts have been made to identify the actions of addictive drugs and the mechanisms by which they affect fundamental brain process. Despite progress in these areas, safe and effective therapies to treat substance abuse and addiction are still few, with pharmacotherapeutic approaches often proving ineffective. Goal: The Centers for CAM Research on Drug Abuse and Addiction will support innovative, integrated research to identify potential CAM therapies to prevent or treat drug abuse and addiction, and to validate that these approaches are safe and effective. The application should address both therapies to reduce or stop substance abuse in the short-term, as well as those that can prolong abstinence in the long-term. o Pediatric Care Background: Eisenberg"s survey on the prevalence of CAM use in the U.S. (NEJM, 1993, 328:246-252) did not address use in those less than 18 years old. Yet anecdotal reports indicate that millions of children are treated with CAM therapies. In the only published survey documenting CAM use by children, Spigelblatt et al., (Pediatrics, 1994, 94:811-814) reported that 11% of children attending a university health clinic used some form of CAM, with chiropractic, homeopathy, naturopathy and acupuncture being the most frequently used modalities. However, few studies have investigated the efficacy of CAM in this patient population. Goal: The Centers for CAM Research in Pediatrics will provide an opportunity for nurturing investigators in pediatrics interested in CAM. The Centers should assess the use of CAM in the pediatric population and develop research opportunities accordingly. The Centers will facilitate studies investigating the safety and efficacy of CAM in the pediatric population. o Cardiovascular Disease Background: About 22 million United States citizens suffer from some form of heart disease, with one-third of all individuals over the age of 65 afflicted. Despite recent technologic and pharmacologic advances, ischemic heart disease is still the leading cause of death in the United States with more than 700,000 deaths in 1995. Congestive heart failure and angina are two of the most common reasons for hospitalization, together being responsible for more than 1.5 million hospitalizations per year. The economic burden of ischemic heart disease alone was estimated as $54.2 billion in 1992. Goal: The Centers for CAM Research in Cardiovascular Disease will develop an innovative research approach to the study of cardiovascular disease according to the following prioritization list: 1) congestive heart failure, 2) coronary artery disease (including myocardial infarction), 3) atherosclerotic manifestations (including peripheral artery disease), 4) hypertension, and 5) the prevention and treatment of cardiovascular risk factors. The Center"s goal is to reduce the mortality and/or morbidity associated with these conditions through the development of safe and effective CAM treatment and prevention strategies. 2. CAM Program Areas: For the purpose of this RFA, investigators must include modalities from at least two of the following broad program areas in CAM: o Alternative Medical systems (e.g., oriental medicine, ayurvedic, native American, homeopathy, naturopathy), o Manipulative and body-based systems (e.g., chiropractic, osteopathic, massage therapy or unconventional applications of integrated conventional and physical therapies), o Biofield (e.g., energy healing, intentional effects on living systems), o Bioelectromagnetics (e.g., diagnostic and therapeutic application of electromagnetic fields including pulsed EM fields, magnetic fields, DC fields etc. Note: This category does not include the study of electromagnetic fields as risk factors for disease), o Pharmacologic Therapies (e.g., metabolic therapies, immunoaugmentative therapies as used by CAM practitioners or the public), o Herbal Medicine (Note: This category does not include isolation of the active ingredients from herbal preparations for the purpose of drug development) (Note: Studies incorporating the following three CAM program areas must focus on the more unconventional uses of these approaches and involve collaborations with expert practitioners of these approaches), o Mind-Body Medicine (e.g., meditation, imagery, hypnosis, biofeedback, music therapy, yoga, spirituality, and consciousness and biological effects, with focus on their novel scientific and clinical uses), o Health Promotion and Disease Prevention (e.g., changes in lifestyle, including risk reduction, when applied as complete systems for chronic disease management [prevention and treatment] across multiple diagnostic categories), o. Biological-based Therapies (e.g., diet-based therapies and nutritional supplements as used in unconventional practices). 3. Research Projects Applications must include three research projects proposed for Center use. These projects may be up to three years in length and may include pilot projects or subprojects of large, multicomponent studies. Projects already underway at the time of the application are applicable. However, for each project, a justification for use of the Center is required, including an estimate of resources to be used and a description of how the project contributes to the Center"s stated goals. The Center will provide limited support for these research projects. A total of $300,000 (total cost) will be available in Year One for the research projects outlined in the application. Additional projects may be added in subsequent years up to $400,000 (total costs) per year for all projects CENTER ACTIVITIES 1. General: On a continuing basis, the Centers will be expected to prioritize the top research projects within their emphasized program area and research theme (see above). This could be accomplished by holding research agenda conferences, conducting systematic reviews of the science in proposed areas of research, or by performing meta-analyses where appropriate. Within the first year, the Center should establish the infrastructure necessary to perform the research outlined in the application and begin this research. The Center will be expected to disseminate research findings in a timely manner through peer-reviewed publications. It is expected that new projects will begin by year three of the award up to a maximum of $400,000 (total costs) per year for all projects. Center investigators are expected to seek additional sources of research support. The Center must propose a mechanism for prioritizing research projects within its research theme area and utilization of core facilities, and a mechanism for scientific/technical merit review of the projects. This can be in the form of a scientific advisory board or can employ independent reviewers, in a manner similar to that used at NIH. Center resources may only be used for projects approved by the Center"s Advisory Committee. 2. Advisory Committee Scientific and administrative Center oversight is charged to a multidisciplinary Advisory Committee (AC) to be appointed by the Principal Investigator on a rotating basis. The AC shall not be chaired by the Principal Investigator who will serve in an ex officio capacity only. The AC should meet at least quarterly and minutes of the meeting should be kept. These minutes shall be made available to NIH staff upon request. The AC should be a cross-section of at least eight individuals familiar with the Center"s research activities. The AC shall include both a biostatistician and epidemiologist to assist with the review of projects and the optimal approaches for subsequent data analysis. The AC shall have representation from the scientific, practitioner and lay communities in both CAM and conventional medicine. Besides prioritizing research projects submitted by Center or, if applicable, Consortium investigators, the AC should periodically review Center operations to ensure that Center resources, especially core facilities, are used for the most scientifically worthy projects. The AC should take an active role in encouraging younger faculty members to perform research and assist them in applying appropriate research concepts and methods. Support for the AC should be explicitly budgeted and justified. 3. Career Development The Center is to serve as an environment for training scientists and health professionals in research on topics related to CAM. In addition, the Center should implement a program designed to introduce students, residents and fellows to both biomedical research and to CAM in an effort to attract these individuals into research careers in CAM. Formal courses or seminars may be set up for this goal. If applicable, existing institutional activities may apply. The courses should be relevant to diverse areas of research and could include an array of topics, such as biostatistics, design of clinical trials, computer skills and bioethics. Support for these activities should be explicitly budgeted and justified. Up to $100,000 (total costs) can be dedicated to the salaries of junior investigators who wish to pursue careers in CAM research. Candidates should be scientists or clinicians who have outstanding research potential, but who need additional training in either CAM or research methodologies appropriate to CAM. The candidates are expected to devote full-time to research and appropriate supplemental training. The application should propose the number of slots available, the criteria for eligibility and for selection of candidates, and describe the selection process. Also, the application should indicate prospective mentors who are already in place at the proposed Centers, briefly describe their research programs, provide examples of previous mentorships, and describe institutional activities that contribute to the environment for career development (e.g., existing training grants, institutional activities, and other relevant programs). The Center is expected to seek supplemental support for its training program through such mechanisms as the NIH National Research Service Award Institutional Research Training Grant (T32) or Individual Postdoctoral Fellowships (F32). 4. Core Facilities The grant will support core facilities, such as a shared core laboratory or computer facilities, to stimulate research contributing to the Center"s stated goals. At least two Center projects must utilize each proposed core facility at all times. The core facilities can only be used for protocols that have been reviewed and approved by the Advisory Committee. The Principal Investigator and Core Facility Director are responsible for the efficient and equitable utilization of the facility based upon recommendations of the Advisory Committee. No single investigator or laboratory (e.g., the Principal Investigator"s or Core Facility Director"s) should be allowed to monopolize the resources of the core facilities. The justification for the core facilities should include the ways in which the resources will facilitate investigations of CAM or help the Center achieve its stated goals. In addition, the applicant should describe how the core is integrated into at least two of the three proposed research projects. This section should present a clear picture of the facilities, techniques and skills that the core will provide. The role of the Core Facility Director and each key participant should be described. The applicant"s institution has to demonstrate a commitment to the core facility. This commitment may take the form of alterations and renovations to established the resource, the purchase of research equipment, the assignment of space, and/or the support of personnel. The core facility should not duplicate facilities already available to individual Center investigators, nor should core facility funds be used to support laboratories of individual investigators. However, the core facility funds may be used to support work proposed in, but not fully supported by, other NIH grants. The grant will support professional supervision of the core facility (e.g., Core Laboratory Director, up to 0.5 FTE), as well as technical assistance (up to 2.0 FTEs), supplies (including animals), and equipment (including computers) purchase and maintenance. All such support must be adequately justified in the application and detailed in the budget plan. In year one of the grant, up to $300,000 (total costs), including personnel, may be allotted to the core facility. In subsequent years, support for the core facility can be increased up to $400,000 (total costs), including personnel. 5. Key Personnel: Key personnel must have expertise in areas such as biostatistics, computer processing, data management, protocol design, survey design, questionnaire development, basic laboratory evaluations, patient record data analysis, patient registries, development of databases, clinical and behavioral epidemiology, health education, health promotion and clinical trial methodology. Examples of personnel positions supported by the Center grant include, but are not limited to: Principal Investigator/Center Director, Core Facility Director, Core Facility Technicians, Administrative Manager/Executive Director, Assistant/Secretary, Biostatistician/Epidemiologist, Analyst/Computer Specialist. Salaries of personnel should be charged to the grant in proportion to the time dedicated to Center activities. All positions must be adequately justified in the application, including a detailed description of the proposed duties and relevance to specific Center objectives. Institutions that do not have the full capability within their own institution to respond to this RFA are encouraged to involve other institutions, both CAM and conventional, through consortium agreements. SPECIAL REQUIREMENTS 1. Applicants should propose an appropriate structure for the Center to meet the research goals and objectives stated above. 2. The Principal Investigator (PI) must make a substantial commitment (50% minimum) to the Center. The PI should have the qualities, experience and administrative skills necessary to oversee Center activities and provide appropriate scientific expertise and mentorship. 3. The PI or Director of the Center will be a member of a coordinating committee consisting of all PIs or Directors of OAM-supported Research Centers. The purpose of the Committee is to share experiences, discuss common problems and solutions, help in the development of networks of investigators, establish common guidelines and procedures for pilot studies, share positive and negative results, identify new research opportunities and associated collaborations with other Centers. New Centers must agree to use any common guidelines and procedures developed and agreed upon by the Coordinating Committee (e.g., process for systematic review of literature, bibliographic database management, structure of research opportunity disposition summaries, report formats, etc.). The Chairperson will be selected annually by members of the Committee. The Director, OAM, or a designated other, will serve as an ex officio member of the Committee. The PI or Center Director is expected to attend and participate in at least two, two-day Coordinating Committee planning/progress meetings per year in Bethesda or Rockville, Maryland. A scientific presentation of Center-supported research is required once a year at these meetings. Funds should be included in the budget to cover these trips. 4. An institution receiving this award should incorporate the Center within its institutional priorities. The institution should demonstrate a strong commitment to the program"s stability and success. The application must provide a plan that addresses how the institutional commitment will be established and sustained, how it will maintain accountability for promoting scientific progress, and how the Center"s research effort will be given a high priority with the institution. This institutional commitment may be in the form of commitments to recruit scientific talent, provisions of discretional resources to the Center Director, faculty appointments for Center investigators, assignment of research space, cost sharing of resources, release from teaching duties for Center investigators or other ways to be proposed by the applicant. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided, that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. This policy applies to the pilot studies proposed under this RFA. LETTER OF INTENT Applicants are asked to submit, by December 1, 1977, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator (s), the identities of other key personnel and participating organizations or institutions, if any, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of applications, the information that it contains will be especially helpful to the OAM in planning for the review of applications, estimating the potential workload, and avoiding conflicts of interest in the review process. The letter of intent is to be sent to: Richard L. Nahin, M.P.H., Ph.D. Office of Alternative Medicine National Institutes of Health 9000 Rockville Pike Building 31, Room 5B-36 Bethesda, MD 20892-2182 FAX: (301) 480-3519 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: ASKNIH@od.nih.gov. Applications are also available on the World Wide Web at http://grants.nih.gov/grants/funding/phs398/phs398.html. Prior to writing the application, applicants should carefully read the instructions provided with PHS Form 398 and this RFA. The total page limitation of the application, as specified in the instructions of the Form PHS 398, does not apply to this RFA. Instead, the following stipulations apply: Table of Contents: Disregard the Table of Contents page from PHS 398 and, instead, write a Table of Contents appropriate for this Center grant application. The Table of Contents should list all items for which funding is sought, in addition to each specific activity required of the Center as outlined above. Specifically list the locations of the checklist and the various supporting documents, including bibliographic sketches and other support pages. Bibliographic Sketches: Bibliographic sketches and other support pages are required for all proposed Center personnel and for all investigators associated with the three mandatory research projects. These pages should not be duplicated in the descriptions of individual component projects and cores. Budget: For preparation of the budget, the applicant should present a composite budget for all years of support. This composite budget should include the direct costs for each Center activity (e.g., Advisory Committee, Assistance Activities, Career Development, etc.), as well as each research project and each core facility. This composite budget should be in tabular format and independent of Budget Form page 4 of the PHS Form 398. However, a Budget Form page 4 of PHS Form 398 should be completed for each item listed in the composite budget. Research Projects and Core Facilities: In addition, applicants may spend up to 25 pages to describe Center activities and up to 25 pages each for each of the three research projects and for each core facility, excluding bibliographies. Descriptions of the three research projects and the core facilities should follow the PHS 398 format, section 9 (Research Plan). Each of the six points listed under Human Subjects in the PHS 398 application must be addressed for those studies involving human subjects. Although not required at the time of the application, Institutional Review Board and Institutional Animal Care and Use Committee must be obtained for each project listed, if appropriate, within 60 days of submission. The RFA label available in the PHS 398 application package must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a typewritten, signed original of the application, four signed photocopies, and the completed checklist in one package to: CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants) NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, mail one additional complete copy of the application to: Richard L. Nahin, M.P.H., Ph.D. Office of Alternative Medicine National Institutes of Health 9000 Rockville Pike Building 31, Room 5B-38 Bethesda, MD 20892-2182 Applications must be received by January 13, 1998. If an application is received after the date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one previously reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS General Considerations Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the OAM. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, OAM staff will return the application to the applicant. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the CSR in accordance with the NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate National Advisory Council. Review Criteria All applications submitted in response to this RFA will be reviewed according to the following review criteria. Reviewers will consider these criteria when assigning a single overall score to each application. This single score should reflect their judgement that the proposed center will have a substantial impact on the pursuit of its goals. 1. Institutional Commitment (a) Evidence of the applicant institution"s commitment to research and to the proposed Center, this can include, but is not limited to, office and laboratory space, clinical support, administrative support, faculty release from academic duties, support for Center training agenda, etc, (b) Adequacy of institutional procedures and plans for monitoring, evaluating and assuming accountability for the general success of the Center and for assessing the needs of the Center, 2. Overall Program Organization, Capability and Research Agenda (a) The scientific and administrative qualifications and leadership capabilities of the Principal Investigator, adequacy of the time commitment of the Principal Investigator, (b) Relevance to CAM and CAM research, Demonstration that the appropriate CAM community linkages exist, (d) Ability to investigate research questions in multiple CAM program areas, (e) Appropriateness of the match between the chosen Research Theme and Program Areas, (f) Quality and timeliness of the Center’s overall research agenda, as well as its potential impact on the state of the science, 3. Individual Research Projects Each research project will be reviewed according to the explicitly-stated set of five review criteria recently adapted by the NIH: (a) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (b) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (d) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (e) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support Each project will be reviewed for the adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects also will be evaluated. The adequacy of the proposed protection for humans, animals or the environment will be evaluate to the extent they may be adversely affected by the project proposed in the application. Each research project will be evaluated for relevance to the overall goals of the Center and for appropriate utilization of Center resources, 4. Core Facilities (a) Integration of cores into overall Center goals and individual research projects, (b) Adequacy of proposed core facilities and personnel, scientific and leadership ability of Core Facility Director, Potential of core to facility research on CAM, (d) Process for allocate of core resources, (e) Center oversight of core, 5. Advisory Committee The proposed organization and activities of the Advisory Committee will be evaluated, including description of process to prioritize research proposals, although it is not necessary to name members at this time, the process by which members will be chosen should be specified, 6. Training and Career Development (a) Adequacy of the plan to introduce students, residents and fellows to both biomedical research and to CAM, (b) Adequacy of the process for selecting candidates for career development and plans for seeking out minority and women candidates, Adequacy of the individuals available to serve as possible mentors of career development candidates, (d) Complementary activities that contribute to the environment for career development, (e) Capacity of the overall program to absorb career development candidates and prepare them for independent careers investigating CAM, 7. Other Considerations (a) Appropriateness of the proposed budget, (b) Demonstrated willingness to work as part of the OAM Centers Coordinating Committee, If a consortium is planned, the applicant must demonstrate the effectiveness of the relationships among the member institutions. The applicant should address both current relationships, as well as the functions and contributions of each consortium member in regards to proposed Center activities. In addition, the component institutions of the consortium must demonstrate adequate commitment to the Center, Additional factors to be considered in the evaluation of competing renewal applications from current Centers for CAM Research (a) Success of the Center in meeting its original goals, (b) Scientific accomplishments, Success in the initiation of competitively supported research (both federal and non-federal sources of support can be applied to this criterion), (d) The development of new CAM investigators, (e) Collaborations with conventional scientists and CAM practitioners. AWARD AND REPORTING REQUIREMENTS Applications recommended by the NIH Initial Review Group and by the appropriate national advisory council will be considered for award based on, a) scientific and technical merit as determined by peer review, b) program relevance and balance, c) availability of funds, d) responsiveness to the goals and objectives of the RFA. Award of funds for the approved future years of the grant will require submission of a noncompeting continuation application, PHS form 2590, to the appropriate Institute at least two months prior to the anniversary date of the award. In addition, an annual progress reports must be submitted to the OAM in accordance with guidelines established by the Coordinating Committee. Failure to supply either the PHS form 2590 or the annual report in a timely manner will impede release of outyear funding. Letter of Intent Due: December 1, 1997 Application Receipt Date: January 13, 1998 Review by Advisory Council: May, 1998 Anticipated Award Date: Summer, 1998 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues should be directed to: Richard L. Nahin, M.P.H., Ph.D. Office of Alternative Medicine National Institutes of Health 9000 Rockville Pike Building 31, Room 5B-38 Bethesda, MD 20892-2182 Telephone: (301) 496-4792 FAX: (301) 480-3519 Email: NahinR@OD31EM1.OD.NIH.GOV AUTHORITY AND REGULATIONS The Office of Alternative Medicine (OAM) was mandated by Congress in 1991 and permanently established within the Office of the Director, National Institutes of Health (NIH), through the National Institutes of Health Revitalization Act (Public Law 103-43, Section 404E). The congressional language states that "the purpose of the Office is to facilitate the evaluation of alternative medical treatment modalities. . ." The language continues that "in carrying out subsection b [its purpose], the Director of the Office [of Alternative Medicine] shall - support research training - for which fellowship support is not provided under section 487." This program is described in the Catalog of Federal Domestic Assistance Nos. 93.213. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Part 74 [and Part 92 when applicable for State and Local governments]. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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