PREDOCTORAL RESEARCH TRAINING IN COMPLEMENTARY AND ALTERNATIVE MEDICINE Release Date: December 9, 1999 PA NUMBER: PAR-00-023 (Reissued as PAR-07-384) National Center for Complementary and Alternative Medicine PURPOSE The National Center for Complementary and Alternative Medicine (NCCAM) plans to provide predoctoral National Research Service Awards (NRSAs) to individuals for research training in specified areas of biomedical and behavioral research related to Complementary and Alternative Medicine (CAM) to help ensure that highly trained scientists will be available in adequate numbers and in appropriate research areas and fields to meet the nation"s health research needs. As such, this program is intended to provide a mechanism to train future generations of outstanding scientists committed to pursuing a research career in CAM. Potential applicants should contact the appropriate NCCAM Program Staff and the NCCAM website, listed under INQUIRIES, prior to preparing an application, to obtain current information about program priorities with regard to predoctoral fellowships. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS- led national activity for setting priority areas. This Program Announcement (PA), Predoctoral Research Training in Complementary and Alternative Medicine, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" on the web at: http://odphp.osophs.dhhs.gov/pubs/hp2000 ELIGIBILITY REQUIREMENTS It is important that prospective applicants consult "National Research Service Awards Guidelines," published in the NIH GUIDE, Volume 26, Number 21, June 20, 1997. It can be found on the web at: http://grants.nih.gov/grants/guide/notice-files/not97-009.html Citizenship: Applicants must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) at the time of award. Degree Requirements: Applicants must have received, as of the activation date of the award, a baccalaureate degree and must be enrolled in a program leading to a research doctorate such as the Ph.D. or D.Sc., or a combined clinical and research degree such as D.C., D.O., M.D. or N.D./Ph.D. by the proposed fellowship activation date. Research training applied toward preparation of a dissertation is permitted. NRSAs do not support study leading to the D.C., D.O., M.D., N.D. or similar professional degrees unless they are part of a combined degree program. Sponsorship: Prior to formal submission of a fellowship application, an applicant must arrange for appointment to an appropriate institution and acceptance by a sponsor to supervise the research training experience. The institutional setting may be a domestic or foreign (if clearly justified), private (profit or non-profit) or public institution, including the NIH intramural programs and other Federal laboratories. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality work. An NRSA may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. An individual may not have more than one competing NRSA application pending with PHS concurrently. An NRSA recipient may, however, accept concurrent educational remuneration from the Department of Veterans Affairs (VA) and loans from Federal funds. Receipt of non- Federal funds during the Fellowship is allowable if it is in accordance with the sponsoring institution"s policy and does not detract from or prolong the approved research training program. MECHANISM OF SUPPORT The mechanism of support is the NRSA Individual Predoctoral Fellowship (F31) which is intended to provide biomedical or behavioral research training experiences to individuals committed to pursuing a research career in complementary and alternative medicine. Women, minorities, and individuals with disabilities are encouraged to apply. Period of Support By law, an individual may receive no more than five years of support in the aggregate at the predoctoral level under the NRSA program, including any combination of support from individual and institutional awards. The applicant and the institution must observe this limitation of support when requesting the duration of the fellowship. Accurate information regarding previous NRSA support must be included in the application and will be considered at time of award. Recommendations of review committees are generally for two or three years of support for individual fellows. However, up to five years of support can be considered with adequate justification documented in the application. Allowable Costs Stipends: The annual stipend for predoctoral fellows will be at the level established for that fiscal year. Applicants should consult with Institute Program Staff for the latest stipend level. Alternatively, applicants may obtain information about current stipend levels and other policy documents from the URL for "NIH Research Training Opportunities: National Research Service Award (NRSA) Training Grants and Fellowships at: http://www.nih.gov/training/nrsa.htm The Tax Reform Act of 1986, Public Law 99-514, describes the tax liability of all persons supported under the NRSA program. The stipend is not a payment for services performed, i.e., it is not a salary. Further, NRSA fellows are not considered to be in an employer-employee relationship with the NIH or the sponsoring institution, and it is unallowable for institutions to seek funds for, or to charge individual award recipients for, costs normally considered employee benefits. The stipend may be supplemented by the sponsoring institution without obligation to the trainee fellow. PHS grant funds may not be used for this purpose. An institution may also provide additional funds to a fellow in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a laboratory assistant on a limited part-time basis apart from the normal training activities. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow"s training, nor be for the same research program. Research Allowance: An allowance of up to $3,000 per predoctoral fellow per twelve month period will be provided to the sponsoring institution to help defray such expenses as research supplies, equipment, travel to scientific meetings, and related items for the individual fellows, and to otherwise offset, to the extent possible, appropriate administrative costs of graduate research training. The allowance is provided only upon official activation of the award, and the sponsoring institution is expected to administer the allowance and disburse the funds. If an individual fellow is not in a training status for more than six months of the award year, only one-half of that year"s allowance may be charged to the grant. Tuition and Fees: Tuition and fees will be funded in accordance with the NIH policy, "Tuition Costs on NIH NRSA Training Grant and Fellowship Awards--New Policy," NIH Guide, Vol. 25, No. 2, February 2, 1996, which is available on the web at: http://grants.nih.gov/grants/guide/notice-files/not96-020.html. NIH will reimburse 100 percent of the cost of tuition up to $2,000 and 60 percent of tuition costs above $2,000 for the predoctoral fellow. Tuition, for the purposes of this NRSA policy, means the combined cost of tuition, fees, and self-only health insurance. RESEARCH OBJECTIVES The applicant should provide evidence of potential for a productive research career based upon the quality of previous research training and academic record. The applicant must propose a research training program which falls into one of the research areas relevant to the mission of the NCCAM. The research training experience must provide enhancement in the conceptualization of research problems and in research skills such as biostatistics, experimental design, pharmacology, epidemiology, manuscript preparation, clinical research, etc. The research training will occur under the guidance and supervision of a committed sponsor who is an active and established investigator in the area of the applicant"s proposed research. The research training program should be carried out in a research intensive environment that includes appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant so that the applicant can grow as a creative scientist. The application must include evidence that instruction in the principles of responsible conduct of research will be incorporated into the proposed research training plan. Applications without plans for training in responsible conduct of research will be considered incomplete and may be returned without review. SPECIAL REQUIREMENTS Awards must be activated within six months of receipt of award notice (see below for application receipt, review, and start dates). No funds may be disbursed until the individual has started training under the award and an Activation Notice (PHS 416-5) has been submitted to and accepted by the NCCAM. Individuals are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program. 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 was 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: 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 on the web at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. Schedule Application Receipt Dates: Apr 5 Aug 5 Dec 5 Initial Review Dates: Jun/Jul Oct/Nov Feb/Mar Earliest Start Dates: Sep 1 Jan 1 May 1 Applications received after these receipt dates are subject to assignment to the next cycle or may be returned to the applicant. APPLICATION PROCEDURES Prospective applicants should contact the NCCAM Program Staff listed under INQUIRIES for pre-application consultation and information regarding the application process. The Individual National Research Service Award application kit PHS 416-1 (rev. 12/98) must be used in applying for fellowships. These forms are available at most institutional office of sponsored research and may be obtained 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, FAX: (301) 480-0525, Email: GrantsInfo@nih.gov. Application kits are also available on the web at: http://grants.nih.gov/grants/forms.htm The number and title of this program announcement must be typed in Item 3 on the face page of the application form. At least three completed letters of reference in sealed envelopes must be attached to the application. Applications without the required number of reference letters will be returned without review. An original and two copies of the completed and signed application are to be submitted 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an NCCAM peer review group convened in accordance with the standard NIH peer review procedures. As part of the merit review, all applications will receive a written critique and will be assigned a priority score. If an application lacks significant and substantial merit, it may be designated as "not recommended for further consideration (NRFC)." Review Criteria The F31 individual predoctoral fellowship is designed to train future generations of outstanding scientists committed to pursuing a research career in complementary and alternative medicine. The review of an application should focus on the following: the applicant, the research training plan, the sponsor, and the institutional environment/commitment. Information from the letters of reference should be used to inform considerations of these factors, and the final priority score should reflect the overall evaluation of the entire application. Applicant: o the applicant"s potential for, and commitment to, a productive scientific career. The reviewers may take into account the applicant"s history as a student, as well as past and current involvement in research activities. o the applicant"s commitment to CAM research. Research Training Plan: o objectives, design, and direction of the proposed research program, o specificity and clarity of the description of the research skills and knowledge to be acquired, o overall coherence and potential of the research training plan to provide the fellow with individualized supervised experiences that will develop research skills, o clarity, completeness, originality, and significance of the goals of the proposed research training plans, o adequacy of knowledge of relevant literature and current methods in the proposed research area, o adequacy of plans for the protection of human subjects, animals, or the environment, to the extent they may be adversely affected by the research proposed, o adequacy of plans to include women, children and minorities as subjects in research, if applicable, o adequacy of plans to receive training in the responsible scientific conduct of research. Sponsor: o caliber of the sponsor as a researcher, including successful competition for research support, o evidence of the proposed sponsor"s understanding of and commitment to fulfilling the role of sponsor and mentor, o evidence of an understanding of the applicant"s research training needs and a demonstrated ability, on the part of the sponsor, to assist in meeting those needs, o past research training record of the sponsor in terms of the rate at which former predoctoral trainees obtain their doctoral degree and go on to postdoctoral or other scientific careers. Institutional Environment/Commitment: o training environment including the institutional commitment to CAM research training and career development, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, subject populations) and the availability of research support. AWARD CRITERIA The responsibility for award decisions resides solely with authorized Program Staff of the Institutes. The following criteria will be used in making award decisions: (1) overall merit of the application, (2) relevance of the application to the research priorities and mission of the NCCAM and program balance, and (3) availability of funds. INQUIRIES Inquiries are encouraged. Prospective applicants are encouraged to visit the NCCAM Internet Website in order to obtain current information about program priorities, research topics of interest, and policy guidelines at: http://altmed.od.nih.gov/ Direct inquiries regarding programmatic issues to: Neal B. West, Ph.D. 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 Direct inquiries regarding fiscal matters to: Suzanne White* Grants Operations National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7150 Rockville, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3301 Email: whitesa@qwgate.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 Nos. 93.272, 93.278, and 93.282. 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 66 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS policy as stated in the NIH Grants Policy Statement (October 1, 1998). PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the nonuse 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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