EXPLORATORY PROGRAM GRANTS FOR FRONTIER MEDICINE RESEARCH Release Date: June 12, 2000 RFA: AT-00-002 National Center for Complementary and Alternative Medicine Letter of Intent Receipt Date: August 7, 2000 Application Information Meeting: September 7, 2000 Application Receipt Date: November 14, 2000 PURPOSE Despite the broad use of complementary and alternative medicine (CAM) treatments (Eisenberg et. al., 1998) there is a relative paucity of data that convincingly demonstrates safety, efficacy, effectiveness, and mechanisms of CAM practices. 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 the effect of alternative treatments on major disease, health and wellness (U.S. Office of Technology Assessment, OTA-H-405, 1990, p.225). The National Center for Complementary and Alternative Medicine (NCCAM) has established several extramural CAM research centers and supports a growing portfolio of research, training, and career development grants. However, the NCCAM has not succeeded in stimulating sufficient research activity in the area known as Frontier Medicine. Frontier Medicine can be defined, for purposes of this initiative, as those CAM practices for which there is no plausible biomedical explanation. Examples include bioelectromagnetic therapy, biofield/energy healing, homeopathy and therapeutic prayer/spiritual healing. Despite the fact that these therapies are used extensively by the U.S. public, there are very little high-quality data available to elucidate or demonstrate the safety, efficacy, effectiveness and/or mechanisms underlying these approaches. Researchers and Frontier Medicine practitioners have very diverse backgrounds, and the latter generally carry out their professional activities in relative isolation from and without the infrastructural support provided by conventional medical and academic institutions. No NIH-supported centers of excellence currently exist that bring together a critical mass of experienced Frontier Medicine researchers in the kind of supportive, yet scientifically rigorous environment that is necessary to conduct quality biomedical research. This initiative will establish Exploratory Program Grants for Frontier Medicine Research, the purpose of which will be to create an infrastructure to nurture and therefore advance this field of biomedical research by providing the institutional support and resources necessary for rigorous scientific investigation. Each of these Exploratory Program Grants will serve as a focal point to: (1) facilitate synergistic collaborations among exploratory/developmental research subprojects; (2) provide an enriched training and career development environment; and (3) create the opportunity for small pilot/feasibility research projects. The Exploratory Program Grants will serve to develop the fields in ways that will increase the likelihood that efficacious therapeutic paradigms will emerge from the existing Frontier Medicine approaches, and thus increase the probability that some of these will become integrated with and will make a contribution to interdisciplinary healthcare. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Title of RFA, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may include foreign components, but foreign organizations are not eligible to apply. To be considered, applicant organizations must have: (1) a minimum of three independent investigators who together represent experience in both basic and clinical research; (2) access to a patient care and service facility; and (3) the capacity to design, conduct, and evaluate three to four research projects that include at least one basic (mechanistic) study and one clinical study. Phase III trials (see "SPECIAL REQUIREMENTS - Research Project" for definition) and surveys will not be considered. Although applications must be submitted from one institution, they may include subcontracted collaborative scientific and clinical arrangements with scientists from other institutions, including foreign 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. NIH staff (See INQUIRIES below) should be consulted if there are questions regarding any of the above requirements or exclusions. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included within the application. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the NIH P20 Exploratory Grants mechanism. This mechanism supports the full range of research and development from basic to clinical and intervention studies. NCCAM's P20 Exploratory Program Grants assemble critical masses of basic and/or clinical scientists to work together collaboratively. The essential characteristics of this P20 Exploratory Program Grant include: (1) a strong, focused scientific program of Frontier Medicine research that will have a clear impact on human disease and associated quality-of-life or disability issues; (2) a strong, innovative program to establish and monitor pilot/feasibility studies that can respond quickly to new research opportunities; (3) a strong career development program to develop and expand the scientific cadre of investigators dedicated to Frontier Medicine research; and (4) a shared administrative core that can increase the functional capacity of the Exploratory Program Grant activities. Applicants will be responsible for the planning, direction, and execution of the proposed Exploratory Program Grant. Awards will be administered under the NIH Grants Policy Statement. FUNDS AVAILABLE The NCCAM anticipates making up to four awards with an estimated overall commitment of $2.4 million total costs for the initial year's funding. Funding levels are 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 will vary. Although this program is provided for in the financial plans of NCCAM, the award of grants pursuant to this RFA is contingent upon the availability of funds Applicants may request up to three years of support. Applications submitted in response to this RFA are limited to a maximum of $600,000 total costs (direct costs and Facilities and Administration costs) in the first year of the award. Future increases are limited to three percent per year. RESEARCH OBJECTIVES 1. Background The demographics, prevalence, and patterns of use of CAM in the United States have been described (Eisenberg et al., 1998). The most relevant findings are the following: a) extrapolation to the population of the United States suggests that Americans made approximately 629 million visits to providers of CAM therapy during 1997; and b) expenditures associated with CAM therapies exceeds non-reimbursed expenses incurred for all hospitalizations in the United States. These findings indicate that CAM occupies a larger role in the health care of U.S. citizens than previously understood. Despite this broad use, there are, in general, insufficient scientific data that address safety and efficacy questions for CAM therapies. And the CAM therapies for which the least amount of research-based knowledge exists are those in the category of Frontier Medicine. 2. Goals A. General: NCCAM's Exploratory Program Grants for Frontier Medicine Research will provide focal points for initiating and maintaining state-of-the-art research to improve treatment and prevention of human disease or the quality-of-life associated with these conditions. These Exploratory Program Grants will be expected to conduct a focused group of research activities, and to contribute significantly to the research by providing administrative core research resources, career development of new investigators, and an expanded base of collaborative research with scientists and clinicians (both CAM and conventional) in other institutions locally and worldwide. The exploratory/developmental research projects should take maximum advantage of new research opportunities, and are expected to establish the methodological feasibility and strengthen the scientific rationale for proceeding to trials on the use of CAM. The pilot/feasibility research program should establish a flexible means to respond quickly to new research opportunities. Career development of new and established investigators will generate a cadre of scientists who could leave the Center with research experience to develop independent CAM research programs. To facilitate achieving the Exploratory Program Grant goals, each application will propose an administrative core that will provide centralized leadership, coordination, and advisory activities, as well as specialized multi-user resources (i.e., research/clinical trial design, data management, quality control, and biostatistics). B. Specific Objectives: Specific objectives for the Exploratory Program Grant applications include: o Performing research related to Frontier Medicine approaches in one of the listed research practice areas (see RESEARCH ACTIVITIES below); o Investigating basic mechanisms of Frontier Medicine therapeutic and diagnostic interventions; o Conducting exploratory/developmental studies or Phase I and II trials of sufficiently developed Frontier Medicine interventions to facilitate the design and eventual conduct of randomized, masked, controlled trials; o Acting as an institutional focus for training in research methodology, bioethics, biostatistics, clinical trial design, and basic laboratory methods that relate to Frontier Medicine; o Provide plans for establishing an Advisory Committee (see "SPECIAL REQUIREMENTS" for Advisory Committee composition) to provide program direction and advice to the Principal Investigator of the Exploratory Program Grant, including prioritization of pilot/feasibility studies, and utilization of the administrative core facilities; o Developing a mechanism for scientific/technical merit review of proposed pilot/feasibility studies from investigators; o Developing workshops, seminars, websites, etc. for training and dissemination of information about Frontier Medicine research to health care providers and the public; and o Establishing a system to identify and support basic and clinical investigators in their career development, including promotions and tenure. RESEARCH ACTIVITIES The overall goals and objectives of the Exploratory Program Grant's research agenda for the requested funding period should be explicitly stated in the application. This should include identification of the Exploratory Program Grant's research direction, as well as specific disease entities and target populations to be studied. For the purpose of this RFA, each application for an Exploratory Program Grant must include modalities from only one of the following broad program areas in Frontier Medicine: o Bioelectromagnetic Therapy (e.g., diagnostic and therapeutic application of electromagnetic (EM) fields including pulsed EM fields, magnetic fields, Direct Current (DC) fields, artificial light therapy, etc. Note: This category does not include the study of electromagnetic fields as risk factors for disease); o Biofield (e.g., energy healing, etc. Note: This category involves systems that use "subtle energy" fields in and around the body for medical purposes. Examples include Therapeutic Touch, Reiki, Huna, laying-on-of-hands, external Qi-Gong, etc.); o Homeopathy; or o Therapeutic Prayer; Spiritual Healing; Distance Healing; or other examples of prayer and/or spirituality as direct clinical interventions. SPECIAL REQUIREMENTS Applications must include ALL the following elements to be considered responsive to the RFA. 1. A strong institutional commitment: An institution receiving this award should incorporate the Exploratory Program Grant high 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 Exploratory Program Grant's research effort will be given a high priority within the institution relative to other research efforts. The institution should demonstrate commitment to the scientific value of the proposed research and willingness to consider this research as support for tenure and promotion. This institutional commitment may be in the form of commitments to recruit scientific talent, provision of discretionary resources to the Exploratory Program Grant director, faculty appointments for Exploratory Program Grant investigators, assignment of clinical and research space, support for training and career development, or other ways to be proposed by the applicant. 2. A qualified Principal Investigator (PI): A leader should be selected as PI who can oversee and conduct planning activities and provide direction to the Exploratory Program Grant. The PI should have documented experience both as a scientist and as administrator of a research program. The PI is required to commit a minimum of 30% effort (15% as the PI plus 15% as a research project primary investigator [see # 5 below]) and has to be the primary investigator on one (but not more than two) research projects. 3. Linkages to the CAM community: The applicant needs to document that linkages to the relevant CAM communities exist and that certified or licensed CAM practitioners provide appropriate input to, and participate in, Exploratory Program Grant research projects. 4. A substantial patient population: The grant application must demonstrate and document access to a patient population that is able to participate in, and can benefit from, the innovative research activities of the Exploratory Program Grant. 5. Research projects: Each Exploratory Program Grant application should include three to four exploratory/developmental research projects. At least three projects are required to start in year-01 of the award. Start of the fourth project can be postponed until the second year of the award. Each of these projects must request at least one, but not more than three years of support in the application. At least three of the submitted projects that begin in year-01 of the award must be judged meritorious by the peer-review panel for the application to meet the minimal requirements of a P20 Exploratory Program Grant. Failure to meet this requirement will remove the application from funding consideration. Research project primary investigators are each required to commit at least 15% time to these projects. Combined support for the 3 or 4 research projects included in the Exploratory Program Grant is limited to a maximum of $320,000 (direct costs) per year. The research must be oriented toward the most critically needed areas of CAM research, and toward collaborative activities that address new innovative possibilities in CAM research. Whenever feasible, collaborations with appropriate certified, licensed or otherwise qualified CAM practitioners are required. Research projects should be interactive with each other whenever possible. Research projects can be basic (mechanistic) or clinical studies other than a Phase III trial (defined below). Applications that do not meet this basic requirement will be ineligible for funding. Epidemiological studies and health services studies and surveys WILL NOT be accepted under this RFA. For the purpose of this RFA, a Phase III trial is defined as a broadly based prospective investigation usually involving a substantial number of human subjects either at a single site or at multiple sites. The primary objective of such trials is to evaluate an experimental intervention in comparison with a standard or control intervention, or to compare two or more existing treatments. In Phase III trials, the primary endpoint is usually a significant change in some clinical outcome. The definition includes interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Research components involving phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). In addition, NCCAM requires that all masked clinical trials, regardless of size, establish an independent data and safety monitoring board. Funds should be budgeted for these activities. They should not duplicate internal review and monitoring systems that are already in place at the institution. Collaborative arrangements within the Exploratory Program Grant, within the parent institution and with other institutions are encouraged. All collaborations with scientists outside the immediate Exploratory Program Grant should be documented with appropriate letters of commitment as applicable. Collaborations with other institutions, including foreign institutions, may involve subcontracting arrangements but an award will be made to one institution only; that institution is expected to demonstrate the full institutional commitment noted in item 1 above (Strong Institutional Commitment). 6. An Administrative Core: Each Exploratory Program Grant is required to have an administrative core that is responsible for the day-to-day administrative details, as well as program coordination and ongoing evaluation of the Center. The Career Development Program, the Pilot/Feasibility Research Program, and the Advisory Committee activities (items # 7-9 below) all fall within the responsibilities of the administrative core. The administrative core must also provide expertise and guidance in data management, biostatistics, and clinical trial design/coordination (These resources should not duplicate resources already available to Exploratory Program Grant investigators). The support for the administrative core is limited to a maximum of $120,000 (direct costs) per year, which includes $50,000 (direct costs) per year for the pilot/feasibility research program. 7. Career Development: The Program Grant application should demonstrate a consistent commitment to training and the career development of research project and pilot/feasibility project researchers. Recruitment should encourage the participation of Frontier Medicine practitioners (with, or without previous research experience) and of qualified women and minorities where possible. To this end, each applicant should include a clear policy and plans for recruiting minorities and women and scientists with disabilities. 8. Pilot/Feasibility Research Program: In each year of the award, the Exploratory Program Grant will allocate up to $50,000 (direct costs) to pilot/ feasibility projects that explore innovative ideas. It is important that Exploratory Program Grants use pilot/feasibility funds to stimulate projects that take maximum advantage of new research opportunities. These pilot/feasibility projects may be collaborative among scientists within the Exploratory Program Grant or with scientists outside the Exploratory Program Grant environment. Pilot/feasibility research projects should adhere to the list of Frontier Medicine program areas appearing in this announcement. Rebudgeting of Exploratory Program Grant funds to, or from, the pilot/feasibility research program will only be permitted with prior NCCAM staff approval. Applicants are not expected or required to identify pilot/feasibility research projects by the time of submission. However, the Exploratory Program Grant application should clearly describe the institutional review process that will be established to select and support pilot/feasibility research projects that represent the most innovative ideas and that are likely to have the greatest impact on Frontier Medicine research. The funds available for the pilot/feasibility research program ($50,000 [direct costs] per year) are intended to remain flexible and to support pilot/feasibility studies (up to $25,000 [direct costs] each per year) of a limited duration (two years or less), rather than the duration of the entire Exploratory Program Grant period. The expectation is that successful pilot/feasibility research studies will become fully developed exploratory/developmental grant applications (e.g. R21). NCCAM staff must be notified before the start of each pilot/feasibility project to verify human and animal subject assurances and Advisory Committee approval. 9. Advisory Committee: Scientific and administrative Exploratory Program Grant oversight is charged to a multidisciplinary Advisory Committee (AC) to be appointed on a rotating basis by the Principal Investigator. 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 twice a year and minutes of the meeting should be kept. These minutes shall be made available to NCCAM staff within 6 weeks of the meeting. The AC should consist of at least nine individuals familiar with the Exploratory Program Grant's research activities. The AC shall include at least one person with expertise in biostatistics and clinical trial design to assist with the review of projects and the optimal approaches for subsequent data analysis. The AC must have representation from the scientific, practitioner and lay communities in both CAM and conventional medicine. Members SHOULD NOT be identified until after an award is made. However, the process by which members will be chosen should be specified. Besides being intimately involved in prioritizing and selecting pilot/feasibility research projects submitted by Exploratory Program Grant or, if applicable, consortium investigators, the AC should periodically review Exploratory Program Grant operations to ensure that resources are used for the most scientifically worthy projects. The AC should take an active role in encouraging faculty members to perform research and assisting them to apply appropriate research concepts and methods. The AC should also be involved in the selection and mentoring of candidates for the career development program. Support for the AC should be explicitly budgeted and justified. 10. Investigational New Drug (or Device) applications (INDs): It is the sole responsibility of the applicant to obtain all necessary clearances from the Food and Drug Administration as required. It is expected that applicants will have started the IND process, if required, well before submission of the P20 application. In addition, applicants are strongly encouraged to consult their local Institutional Review Boards (IRBs) concerning IND status and the IRB approval process. 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 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under "INQUIRIES". Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by August 7, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCCAM staff to estimate the potential review workload and plan the review. Mail/Fax letters of intent to: Dr. Neal B. West Program Officer National Center for Complementary and Alternative Medicine Building 31/ Room 5B58 Bethesda, MD 20892-2182 Telephone: (301) 402-5867 FAX: (301) 402-4741 Email: westn@od.nih.gov APPLICATION INFORMATION MEETING In order to give potential applicants the opportunity to clarify any issues or questions concerning the RFA, an Application Information Meeting (AIM) will be held. At the AIM, potential applicants will have the opportunity to discuss application concepts and outlines of proposed applications with NIH staff. The AIM will be held at, or in close proximity to NIH on (Thursday, September 7, 2000). Although a registration fee is not associated with this meeting, pre- registration is encouraged. NCCAM has not allocated funds to pay for attendee travel to the AIM; all travel costs are the responsibility of the attendee. Additional information on the meeting, as well as registration materials can be obtained from the NCCAM Program Officer listed under "INQUIRIES". A summary of the presentations and issues discussed at the meeting will be made available through the NCCAM Web-site about one week after the AIM. Hard copies will be made available for those applicants without Web access. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms 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) 435-0714, Email: GrantsInfo@nih.gov. The application is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html. 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 Exploratory Program Grant application. The Table of Contents should list all items for which funding is sought, in addition to each specific activity required of the Exploratory Program Grant as outlined under "Special Requirements." Specifically list the locations of the checklist and the various supporting documents, including bibliographic sketches and other support pages. Each page of the application should be numbered consecutively. This numbering should be reflected in the Table of Contents. 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 required Exploratory Program Grant activity (e.g., Advisory Committee, Developmental Research Program, etc.), as well as each research project and the administrative core facility. This composite budget should be in tabular format, with each budget year being listed in a separate column and each Exploratory Program Grant activity, core or subproject being listed in a separate row. Budget Form pages 4 and 5 of PHS Form 398 should be completed for each Exploratory Program Grant activity, i.e., administrative core or project listed in the composite budget. These pages should be clearly labeled as to which Exploratory Program Grant activity they address. Bibliographic Sketches: Bibliographic sketches and other support pages are required for all proposed Exploratory Program Grant personnel and for all investigators associated with the mandatory research projects and the administrative core. These pages should be in alphabetical order following the budget pages and should not be duplicated in the descriptions of individual component projects and the core. Research Projects and Administrative Core: Each research project is allowed 15 pages, excluding bibliographies. NOTE: The section on the Administrative Core is to include descriptions and justifications of the Advisory Committee, the Developmental Research Program, and the Exploratory Program Grant's overall goals and objectives; this combined section is limited to 25 pages. Descriptions of the research projects and the administrative core should follow the PHS 398 format, section 9 (Research Plan) with the addition that each project should have its own title page and abstract. The research project title page should list all investigators and their associated institutions, as well as the direct and total costs for the project for each year of the award. In addition, each research project must document its relationships to other projects and to the Exploratory Program Grant. 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 Animal Care and Use Committee approval must be obtained for each research project listed, if appropriate, within 60 days of submission. Institutional Review Board approval(s) are needed before an award can be made. The RFA label available in the PHS 398 application package must be affixed to the bottom of the face page of the application. The affixed label should clearly display the RFA number: AT-00-002. 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. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a typewritten, signed original of the application, four signed photocopies, and the completed checklist in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) Applicants who prefer to use express mail or courier service should change the zip code above to 20817. At the time of submission, mail one additional complete copy of the application to the following RFA program administrator: Dr. Richard L. Nahin Director, DERTR National Center for Complementary and Alternative Medicine 9000 Rockville Pike Building 31, Room 5B58 Bethesda, MD 20892-2182 Telephone: (301) 496-4792 FAX: (301) 402-4741 Email: nahinr@od.noh.gov Applications must be received by November 14, 2000. If an application is received after the date, it will be returned to the applicant without review. 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 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 NCCAM 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, streamlined review, 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 NCCAM 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 Exploratory Program Grant will have a substantial impact on the pursuit of its goals. Major factors to be considered in evaluation of applications will include: 1. How the proposed Exploratory Program Grant combines basic and clinical research with the research theme and CAM program areas. 2. Incorporation of appropriate CAM expertise, including certified or licensed CAM practitioners. 3. The integration of appropriate CAM and conventional medical expertise. 4. Scientific merit of each proposed research project. 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? (c) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (d) Investigator: Is the research project primary investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the research project primary 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 research project will receive a priority score. The score reflects not only the feasibility of the project and the adequacy of the experimental design, but also its relevance to the overall goals of the Exploratory Program Grant, the appropriate utilization of administrative core resources (e.g., experimental design, biostatistics), and the integration of CAM practitioners. Each research project also will be reviewed for the adequacy of plans to include both genders, minorities, children and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects also will be evaluated. In addition, the adequacy of the proposed protection for humans, animals or the environment will be evaluated to the extent they may be adversely affected by the project proposed in the application. 5. Scientific merit of combining the component parts into an Exploratory Program Grant (e.g., the whole must be greater than the sum of its parts); 6. Technical merit and justification of the administrative core; 7. Adequacy of facilities to perform the proposed research, including laboratory and clinical facilities, instrumentation, and data management systems, when needed; 8. Adequacy of plans for interaction among investigators, and the integration of the various research projects with the administrative core; 9. Qualifications, experience and commitment of the PI and his/her ability to devote time and effort to provide effective leadership; 10. Scientific and administrative structure, including internal and external procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; 11. Institutional commitment to the program, and the appropriateness of resources and policies for the administration of an Exploratory Program Grant; 12. The proposed organization and activities of the Advisory Committee will be evaluated, including the process to choose Committee members after an award is made; 13. Career Development Program including adequacy of the process for selecting candidates for career development and plans for recruiting minority and women candidates; and adequacy of the individuals available to serve as possible mentors of career development candidates; 14. Pilot/Feasibility Research Program including adequacy of the proposed process for continuously reviewing and funding projects for their quality, innovativeness and potential impact; and potential of the program to generate innovative, high-quality projects on a consistent basis. 15. Demonstration of an effective relationship among Consortium institutions, if any, including documentation of current relationships, as well as the functions, commitments and contributions each Consortium member will bring to the proposed Exploratory Program Grant; 16. The appropriateness of the budget for the proposed program and its individual components will be considered independently of the factors indicated above. A single numerical priority score will be assigned to the Exploratory Program Grant application as a whole. Although primary emphasis will be placed on scientific merit, innovativeness, and past progress (where applicable), significant consideration will be given to administrative structure, multidisciplinary interactions including those with CAM practitioners, potential for impacting on the disease/condition in question, and institutional commitment. AWARD AND REPORTING REQUIREMENTS Applications recommended by the NIH Initial Review Group and by the NCCAM Advisory Council will be considered for award based on: 1) scientific and technical merit as determined by peer review; 2) program relevance and balance; 3) availability of funds; and 4) responsiveness to the goals and objectives of the RFA. Letter of Intent Due: August 7, 2000 Application Receipt Date: November 14, 2000 Review by Advisory Council: May 2001 Anticipated Award Date: July 2001 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: Dr. Neal B. West Program Officer National Center for Complementary and Alternative Medicine Building 31, Room 5B58 Bethesda, MD 20892-2182 Telephone: (301) 402-5867 FAX: (301) 402-4741 Email: westn@od.nih.gov Inquiries regarding review issues should be directed to: Dr. Richard L. Nahin Director, DERTR National Center for Complementary and Alternative Medicine 9000 Rockville Pike Building 31, Room 5B58 Bethesda, MD 20892-2182 Telephone: (301) 496-4792 FAX: (301) 402-4741 Email: nahinr@od.nih.gov Inquiries regarding budget issues should be directed to: Suzanne White* Grants Operations Branch National Heart, Lung and Blood Institute National Institutes of Health Two Rockledge Center, Suite 7154, MSC 7926 6701 Rockledge Drive Bethesda, MD 20892-7952 Phone: 301-435-0170 Fax: 301-480-3310 Email: WhiteS@gwgate.nhlbi.nih.gov * Note: NHLBI is the Grants Management Service Center for the NCCAM AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.213. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 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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Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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