THE CLINICAL INVESTIGATOR AWARDS (KO8) INDEX CLINICAL INVESTIGATOR AWARD (CIA) National Institute on Aging National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences National Cancer Institute National Heart, Lung, and Blood Institute GUIDELINES National Center for Nursing Research GUIDELINES CIA Supplemental Instructions to the PHS 398 Application Form CLINICAL INVESTIGATOR DEVELOPMENT AWARD (CIDA) National Institute of Neurological Disorders and Stroke ANNOUNCEMENT CLINICAL INVESTIGATOR AWARD(CIA) NATIONAL INSTITUTE ON AGING NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NATIONAL INSTITUTE OF ARTHRITIS, MUSCULOSKELETAL, AND SKIN DISEASES NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES NATIONAL CANCER INSTITUTE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GUIDELINES I. PURPOSE The Clinical Investigator Award (CIA) is designed to provide the opportunity for promising clinically-trained individuals to develop into independent biomedical investigators. It enables candidates to investigate a well-defined problem under a sponsor (or sponsors) competent to provide guidance in the chosen area of research. The award is intended to facilitate transition from postdoctoral training to a career as an independent investigator. POTENTIAL APPLICANTS ARE ENCOURAGED TO CONTACT THE INDIVIDUAL NIH STAFF MEMBERS WHOSE NAMES ARE APPENDED TO THE MAIN TEXT FOR SPECIFIC DETAILS CONCERNING THE INSTITUTES' SPECIAL AREAS OF INTEREST. Policies and guidelines in this combined announcement were effective for CIA applications received on or after February 1, 1985. Awards based on applications received prior to that date will be guided by the program announcements and policies in effect at the time. II. ELIGIBILITY Applications may be made by institutions on behalf of candidates who hold the M.D. or equivalent degree (D.D.S., D.V.M., or equivalent). Ordinarily those holding the Ph.D. are ineligible. Exceptions may be made to this requirement (1) for individual's with Ph.D's unrelated to the biomedical and behavioral sciences or (2) for those who were involved in other than research activities after receipt of the Ph.D. where the elapsed time was such as to require 2 or more years of development to update basic science skills. Individuals who are, or have bee, principal investigators on PHS supported research grants or who have, or have had, comparable responsibility for the conduct of a research project, are not eligible. In general, candidates should have no fewer than 3 years and no more than 7 years of postdoctoral experience. (In selected circumstances, these restrictions may be waived, but this will require special justification.) Candidates should provide evidence of a serious intent to enter upon an academic research career. Only U. S. citizens or non-citizens lawfully admitted for permanent residence are eligible. It is expected that CIA applicants will have completed their clinical training and will have had some postdoctoral research experience before the award is initiated. The grantee institution must be a domestic university, medical school, or comparable institution with strong, well-established research and training programs in the chosen area, adequate numbers of highly trained faculty in clinical and basic science disciplines, and interest, capability, and commitment to provide guidance to clinically trained individuals in the development of research independence. III. CONDITIONS OF THE AWARD Three of the participating Institutes specify a minimum of 3 years and six offer up to 5 years support. (For details, see the CIA Supplemental Instructions which follow.) The award is non-renewable, usually non-transferable, and is based on a full-time (75-100 percent) research development effort. The award provides salary support not to exceed $40,000 annually. The actual salary must be consistent with the established salary structure of the grantee institution for persons of equivalent qualifications, experience, and rank. Supplementations of salary from non-government sources is allowable. Up to a total of $10,000 annually may be requested for supplies, equipment, travel, tuition, etc. (In the case of NIAMS and NIDDK, up to $20,000 may be provided annually for personnel other than the awardee, supplies, travel, equipment, etc.) The indirect cost rate may not exceed 8 percent of the total allowable direct costs. The grantee institution's share of the fringe benefits may be paid as a direct cost (if not treated as an indirect cost) on that portion of the salary provided by the Clinical Investigator Award. Applicants may not hold or apply for research project grants or their equivalent at the time of CIA application, not may they apply concurrently for a PSA or other type of NIH Academic Award. However, they may apply for, and hold, the regular research project grant or First Independent Research Support and Transition Award subsequent to award of the CIA. Candidates must be nominated by an institution on the basis of qualifications, interests, motivation and potential for an academic or research career. The institution should provide evidence of its commitment to the candidate's research development. The candidate's sponsor(s) must provide a description of the development and research plan for the candidate, an updated curriculum vitae with bibliography and research support, and a letter indicating his/her willingness to provide guidance and support for the period of the award. Candidates must provide a full description of the proposed research and career development plan for the period of the award. IV. REVIEW CRITERIA Applications for the NIH Clinical Investigator Award will receive initial technical merit review by an initial review committee appointed by the Institute and secondary review by the corresponding Advisory Council or Board. Criteria for review include: A. The Candidate's potential for a career in independent research; B. The candidate's commitment to a research career; C. The overall merit of the candidate's plan for research and the development of research skills; D. The quality of the candidate's clinical training and experience; E. The institution's ability to provide adequate facilities, resources, and opportunities necessary for the candidate's research development; F. The quality of the faculty in the departments relevant to the area of study; G. The ability and plans of the sponsor or sponsors who will guide the candidate in his/her career development; H. The candidate's conformance to the eligibility requirements; (see Section II of this announcement.) I. NIEHS applicants will also be evaluated regarding their plans for development of a clinical research program at their home institutions. V. METHOD OF APPLYING Applications should be submitted on the research grant application Form PHS 398, Revised 10/88). If unavailable at the applicant institution's office of sponsored programs, it may be requested from the: Office of Grants Inquiries Division of Research Grants Westwood Building, Room 449 National Institutes of Health Bethesda, MD 20892 Telephone: (301) 496-7441 Applications for CIA must be received by the NIH for review by the following receipt dates: Application Initial Council Earliest Receipt Dates Review Meeting Start Date February 1 June Sept/Oct. December 1 June 1 Oct/Nov. Jan/Feb. April 1 October 1 Feb/March May/June July 1 RESEARCH AREAS OF EMPHASIS AND STAFF CONTACTS NATIONAL INSTITUTE ON AGING Research in Geriatric Medicine Organic Brain Diseases of Old Age Clinical Nutrition and Aging Clinical Immunology and Aging Clinical Pharmacology and Aging Endocrinology and Aging Maturity Onset Diabetes and Aging Dermatology and Aging Epidemiology and Aging Inquiries about the program should be directed to: Associate Director, PEA National Institute on Aging 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-9374 NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID supports the development of basic research skill in the fields of immunology, allergy and immunologic diseases, bacteriology, virology, mycology, parasitology, and epidemiology. Inquiries about the program should be directed to: Chief, Allergy and Clinical Immunology Branch Westwood Building, Room 757 Bethesda, MD 20892 Telephone: (301) 496-7551 or Chief, Clinical and Epidemiological Studies Branch Building 31, Room 7A49 Bethesda, MD 20892 Telephone: (301) 496-5893 NATIONAL INSTITUTE OF ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES Arthritis, Musculoskeletal, and Skin Diseases Inquiries about the program should be directed to: Deputy Director, Extramural Programs Westwood Building, Room 403C Bethesda, MD 20892 Telephone: (301) 496-7495 NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES Diabetes, Endocrine, and Metabolic Diseases Digestive Diseases and Nutrition Kidney, Urologic, and Blood Diseases CIA candidates should have between 4 and 7 years of postdoctoral experience including at least 2 years of clinical training and 2 years of research training. Inquiries about the program should be directed to: Director, Division of Extramural Activities Westwood Building, Room 657 Bethesda, MD 20892 Telephone: (301) 496-7793 NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT Research on Maternal and Child Health and Reproductive Sciences: Pregnancy and Perinatology Congenital Abnormalities Clinical Nutrition Reproductive Biology Child and Adolescent Development Mental Retardation Fertility and Infertility Inquiries about the program should be directed to: Deputy Director, NICHD Building 31, Room 2A04 Bethesda, MD 20892 Telephone: (301) 496-1848 NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES This award seeks to foster the development of clinical investigators in the field of environmental health/human toxicology and to support clinicians who work with research teams on problems arising from the exposures of human populations to environmental chemicals. (It is not meant to support the activities of "poison centers" and related researchers who deal with the effects of acute exposures to self-inflicted or accidentally inflicted toxic materials or clinical research on the toxicities of pharmaceuticals and other drugs.) Inquiries about the program should be directed to: Program Director, Research Manpower Development Section P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (301) 541-7634 NATIONAL CANCER INSTITUTE This award is intended to promote research career development in any of the basic and applied sciences relevant to cancer. The NCI is especially interested in the research career development of physicians trained in the following areas: Surgical Oncology Radiation Oncology Preventive Oncology Epidemiology and Nutrition Inquiries about the program should be directed to: Chief, Cancer Training Branch Blair Building, Room 717 8300 Colesville Road Silver Spring, MD 20892 Telephone: (301) 427-8898 NATIONAL HEART, LUNG, AND BLOOD INSTITUTE Cardiovascular, pulmonary, blood diseases, and blood-banking sciences. Inquiries about specific programs should be directed to: Research Training and Development Officer Division of Blood Diseases and Resources Federal Building, Room 5A08 Bethesda, MD 20892 Telephone: (301) 496-1817 Chief, Research Training and Development Division of Heart and Vascular Diseases Federal Building, Room 3C-02 Bethesda, MD 20892 Telephone: (301) 496-1724 Letters of reference, inquiries regarding review procedures, and two copies of the application should be directed to: Executive Secretary Research Manpower Review Committee Westwood Building, Room 550 5333 Westbard Ave. Bethesda, MD 20892 Telephone: (301) 496-7361 CLINICAL INVESTIGATOR AWARD (CIA) NATIONAL CENTER FOR NURSING RESEARCH GUIDELINES I. PURPOSE The Clinical Investigator Award (CIA) is designed to provide the opportunity for promising clinically-trained individuals to develop into independent clinical investigators. It enables candidates to investigate a well-defined problem under a sponsor competent to provide guidance in the chosen area of research at an NIH supported center program or in one of the General Clinical Research Centers (GCRC) supported by the Division of Research Resources (DRR). The CIA is targeted to those nurse scientists who have held the doctorate for at least 2 years, have had some research experience, have defined an area of clinical research interest and are now seeking a supervised research experienc. The award is intended to facilitate transition from postdoctoral training to a career as an independent clinical investigator. The candidate is expected to conduct a clinical research project in aan area related to the promotion of health, prevention of disease, mitigation of acute and chronic illnesses or disabilities, or in other areas which support the mission of the National Center for Nursing Research (NCNR). II. ELIGIBILITY CRITERIA The candidate must: Be a nurse and a U.S. citizen, a noncitizen national of the U.S., or have been lawfully admitted to the U.S. for permanent residence. In general, be at least 2 years, but not more than 7 years, beyond the doctorate, or equivalent degree. It is expected that CIA applicants will have had some postdoctoral research experience before the award is initiated. Be able to submit a clinically oriented research project to be conducted under this support. Be able to identify a sponsor working the NIH supported center who is recognized as an accomplished investigator in the research area proposed. The sponsor should have experience in training independent investigators and be willing to provide the guidance for the awardee's development and research plan. The sponsor does not have to be the director of the center, but the candidate must have the approval of the center director to allow him/her to pursue the research and share in the center's resources. Commit a substantial portion of effort (at least 75 percent) to the proposed activity. The grantee institution must be a domestic university, nursing school, or comparable institution with strong, well-established research and training programs in the chosen area and/or strong ties to the institutions housing the center program which is to support the CIA candidate. The center director must have interest, capability, and commitment to provide the environment to support clinically trained individuals in the development of research independence. III. CONDITIONS OF THE AWARD Awards may be made for a period of 3-5 years and are not renewable. Allowable direct costs will not exceed $60,000 a year. The award provides salary support, not to exceed $40,000 annually. The actual salary must be consistent with the established salary structure of the grantee institution for persons of equivalent qualifications, experience, and rank. Research costs, as justified, can be up to a level of $20,000 direct costs per year. Indirect costs will not exceed 8 percent of the direct costs, exclusive of tuition fees and equipment expenditures. IV. METHOD OF APPLYING AND REVIEW PROCESS Applications will receive initial scientific and technical review by the Nursing Science Review Committee. Second level review, for program relevance, will be by the NCNR National Advisory Council. When the research is to be conducted under the auspices of the NIH-funded General Clinical Research Center, the concurrence of the GCRC Committee of the NIH Division of Research Resources is required. Applications will be reviewed three times a year according to the following schedule: Applications Initial Council Earliest Received by: Review Review Starting Date February 1 Feb/March May/June July 1 June 1 May/June Sept/Oct. December 1 October 1 Feb/March May/June July 1 Applications should be submitted on the research grant application (Form PHS 398, Rev. 10/88). If not available at the institution's office of sponsored programs, it may be requested from the: Office of Grants Inquiries Division of Research Grants Westwood Building, Room 449 Bethesda, MD 20892 Telephone: (301) 496-7441 V. REVIEW CRITERIA The following characteristics will be considered: Background and potential of the candidate as an independent investigator in clinical nursing research; Scientific merit of the research project and soundness of the plan to strengthen the candidate's clinical research development; Plan for the center's support of the candidate during the period of the award. VI. RESEARCH AREAS OF EMPHASIS: Health Promotion and Diseases Prevention Acute and Chronic Illiness Nursing Systems For further information, please contact: National Center for Nursing Research NIH Building 31, Room 5B03 Bethesda, MD 20892 Telephone: (301) 496-0523 CIA SUPPLEMENTAL INSTRUCTIONS TO THE PHS 398 APPLICATION FORM Applications must be submitted on Form PHS-398 (Rev.10/88 ) which is available at most grantee institutions, or may be obtained from the Division of Research Grants, NIH. Items in the Specific Instructions (pages 12-23) of the application kit which require additional explanation for the Clinical Investigator Award are listed below. If additional space is needed to complete any of the items, use continuation pages and identify each item with its number and title. SECTION 1 (pages 12-19 of PHS 398) (Form PHS-398, Page 1) Item 1. Title of Application. Give title of proposed research project. Do not exceed 56 typewriter spaces. Item 2. Response to Specific Program Announcement: Check the box marked "yes" and state the title as "_____________ Clinical Investigator Award," supplying the appropriate institute initials. Item 3. Principal Investigator/Program Director. Provide information on the candidate only. If the candidate is not located at the applicant organization at the time the application is submitted, the MAILING ADDRESS (Item 3e) and TELEPHONE (Item 3h) should indicate where the applicant can be reached in the interval prior to the requested award date; the remaining items (3d, 3f, 3g) should reflect the candidate's projected position at the applicant organization. Item 6. Total project period is 3 years for NICHD, NCI, and NIAID and 5 years for NIA, NIAMS, NIDDK, NIEHS, and NHLBI, and 3 to 5 years for NCNR. Item 11. Special Note. Applications to the NIEHS program that provide for two sponsoring institutions should name here the home institution. (Form PHS-398 Page 2.) Description. Consider this as an abstract of the application itself, not just the research plan. Summarize the three principal components of this application, i.e., the candidate, the research, and the environment. Key Personnel Engaged on Project. The candidate and primary and secondary sponsor(s) (if applicable) should be listed here. (Form PHS-398 Pages 4 and 5.) Budget. Follow PHS-398 instructions except as shown below: Salary of Awardee. The awardee will be provided his/her salary support not to exceed the NIH ceiling amount per year (plus fringe benefits) during the period of the award. Information must be given to support the total salary and fringe benefits to be provided the awardee including any grantee institution supplementation. Fringe benefits may be requested on the NIH component only. The following details must be listed as part of the budget justification: 1. How the amount of the total salary was derived, showing the relevant parts of the salary structure, including examples of salaries being paid to comparable staff members. 2. If the total salary includes grantee institution supplementation, the proposed supplemental amount must be indicated and the source(s) of that supplemental support identified. 3. Indicate whether or not professional fees will be generated by the candidate from clinical practice, professional consultation, or other comparable activities, and describe the full circumstances, amounts, and plans of the sponsoring institution relating to the dispostion of such fees. Research Support. Up to $10,000 annually may be requested for supplies, equipment, travel, tuition, etc. (except in the case of NIAMS, NIDDK, and NCNR which provide up to $20,000 annual support for personnel other than the candidate, supplies, equipment, travel, and tuition) essential to the awardee's proposed research program. Requests in all budget categories must be justified. Biographical Sketch. Indicate explicitly citizenship status. Where applicable, submit notarized statement of alien registration. Candidate should include information on internships, residencies, research assistantships, and fellowships. For all positions, indicate whether full- or part-time. In addition, list all of the candidate's publications as part of the biographical sketch. Other Support. The research support funds that will be available to the candidate during the period of the proposed award must be identified. Resources and Environment. a) The application must describe the resources and space available to the candidate. If more than one institution is involved identify resources and space at each institution. b) A letter from each institution indicating commitment of space and resources must be submitted as part of the application. SECTION 2 RESEARCH PLAN (pages 19-22 of PHS-398) In addition to the narrative for the Research Plan (20 page limitation for Section A-D), as outlined on page 20 of FORM PHS-398, applicants for the Clinical Investigator Award must address the following sections 1 and 2 below (additional pages may be used): 1. Candidate's Plans and References. a) Career Plans. Provide a brief summary of immediate and long-term objectives and plans, explaining how the requested award would contribute to their attainment. b) Other Activities. Provide a description of each of the activities, other than research, to be engaged in during the proposed award period, and an explanation of how the activity is related to research career development. Include an estimate of the percentage of the total work effort that will be given to research (including clinical research), teaching, practice and consultation, administration, and academic studies. c) References. List the names and addresses of three (3) individuals well acquainted with the candidate's professional training and research competence. Choice of references should be diversified to include individuals capable of assessing at first hand the several stages in the candidate's development. One of these letters of reference should be from the Chief of Service under whom the candidate trained. If this is not possible, please explain. The candidate is responsible for assuring that all references are submitted by the application receipt date. Reference reports must be submitted directly to the individual BID offices listed on the attached page. 2. Sponsor's Plans. The primary sponsor should describe in detail: a) his/her concept of the research and career devlopment plans of the candidate; be approximately nine months after initial receipt. b) specific plans for providing guidance and counseling to the candidate with his/her career development plans; c) how the supervision provided to the candidate will promote his/her development into an independent investigator by the end of the award. This plan must bear the signature, the typed name, and title of the sponsor as well as the date signed. The sponsor should provide a brief curriculum vitae and bibliography with the application. Letters of commitment from each secondary sponsor should be included in the application. Application Receipt Dates for the Clinical Investigator Award are: February 1 June 1 October 1 The original and 4 copies of completed applications are to be forwarded to the Division of Research Grants. Refer to PHS-398, pages 10-11, for information regarding submission of the application. Two copies of the completed application should be submitted to the Review Office Institute (see page 5 for a listing) to which the candidate is applying. Individuals BID Offices NIA: Chief, Scientific Review Office Office of Planning and Extramural Affairs National Institute on Aging, NIH Building 31, Room 5C-12 Bethesda, Maryland 20892 NIAMS: Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH Westwood Building, Room 403C 5333 Westbard Avenue Bethesda, Maryland 20892 NIDDK: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases, NIH Westwood Building, Room 406 5333 Westbard Avenue Bethesda, Maryland 20892 NIEHS: Executive Secretary NIEHS Special Review Committee National Institutes of Environmental Health Sciences, NIH P.O. Box 12233 Research Triangle Park, North Carolina 27709 NICHD: Office of Scientific Review National Institute of Child Health and Human Development, NIH Landow Building, Room 6C-08 Bethesda, Maryland 20892 NHLBI: Executive Secretary Research Manpower Review Committee National Heart, Lung, and Blood Institute, NIH Westwood Building, Room 550 5333 Westbard Avenue Bethesda, Maryland 20892 NCI: Referral Officer Grants Review Branch National Cancer Institute, NIH Westwood Building, Room 826B 5333 Westbard Avenue Bethesda, Maryland 20892 NIAID: Program and Project Review Branch, EAP National Institute of Allergy and Infectious Diseases, NIH Westwood Building, Room 706 5333 Westbard Avenue Bethesda, Maryland 20892 NCNR: National Center for Nursing Research, NIH Building 31 - Room 5B03 Bethesda, Maryland 20894 CLINICAL INVESTIGATOR DEVELOPMENT AWARD (CIDA) NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE ANNOUNCEMENT The National Institute of Neurological Disorders and Stroke (NINDS) announces the availability of a Clinical Investigator Development Award (CIDA). The intent of the NINDS through this mechanism is to prepare clinically- trained persons for academic research careers in the medical sciences related to the neurological and communicative disorders. The award bridges the gap between postdoctoral training and a secure academic appointment and completes the development of research capability of a candidate who already has some research experience. AMOUNT OF AWARD. This career development award provides a stipend up to $40,000 per year. Since salary levels are set by the sponsoring institution, it is permissable to supplement the CIDA stipend with non-Federal funds to an amount consistent with usual scale for other individuals at the grantee institution with similar experience and responsibility. A research allowance of up to $10,000 in the first and last years and of up to $20,000 in the middle years of the CIDA may be requested. The research allowance will be awarded in amounts justified in the application and consistent with recommendations of the initial review group and the National Advisory Neurological Disorders and Stroke Council. DURATION OF AWARD. The usual duration of award will be five years; however, this award provides the flexibility of 3 to 5 years of support of candidates who have prior research experience, as outlined below. ELIGIBILITY. M.D. - (or other health professional degree, e.g., D.D.S., D.O., D.V.M.) with or without M.S., M.P.H., Dr. P.H. and/or Ph.D. Candidates having completed residency training. Applicant organizations may propose a program of development of 3, 4, or 5 consecutive years of support, the application must provide sufficient details about rrelevant post research experience to assure reviewers that the intended academic development could be accomplished in the proposed time frame. Candidates within the residency training period, or who have not had residency training. In all cases, at least two years of post-M.D. experience in clinical or basic science areas is a prerequisite. Programs may be proposed for a continuous 3 to 5 year period, or as a split award in which Part A (two consecutive years) may be separated from Part B (up to three consecutive years). Part A can provide for a 2-year period of research training usually in a basic science environment; Part B can provide for a 3-year period of sponsored research experience. Parts A and B may be separated by a period not exceeding 2 years. Parts A and B must both be proposed in the initial application when such a split award is comtemplated. Ph.D. with professional experience in clinical areas (e.g., neuropathology or epidemiology). Candidates must have at least two years of postdoctoral experience. Applicant organizations may propose a program of development of 3, 4, or 5 consecutive years. If requesting less than five years of support, the application must provide sufficient details about relevant past research experience to assure reviewers that the intended academic development could be accomplished in the proposed time frame. Development Plan. The candidate's academic research development plan should include research and research training requiring at least 75 percent of time and effort. Related clinical and teaching activities not to exceed 25 percent time and effort may be requested, but must be described in the proposal. Application Schedule. Receipt dates for applications are February 1, June 1, and October 1. Initial review will be by an NINDS initial review group, with secondary review by the National Advisory Neurological Disorders and Stroke Council. Earliest award dates will nine months after initial receipt. THIS ANNOUNCEMENT IS NOT INTENDED TO PROVIDE ALL DETAILS NEEDED TO APPLY FOR THE CIDA. FOR FURTHER INFORMATION ABOUT THIS PROGRAM, INCLUDING GUIDELINES, DETAILS OF THE APPLICATION PROCESS, AND APPLICATION INSTRUCTIONS, PLEASE CONTACT: Deputy Director Extramural Activities Program National Institute of Neurological Disorders and Stroke 1016 Federal Building Bethesda, MD 20892 Telephone: (301) 496-4188 CONSORTI.DRG GUIDELINES FOR ESTABLISHING AND OPERATING CONSORTIUM GRANTS A. Purpose. This issuance revises policy for the establishment and operation of a consortium grant with a sound administrative base among the participating institutions and between the NIH awarding unit and the grantee institution. B.Background. In the 1970s, NIH began to receive research grant applications in which support was sought for a single project involving multiple institutions. The inter-institutional administrative and programmatic arrangements were reflected by various types of collaborative agreements - some adequately serving their purposes and some not. As the need for, and interest in, the consortium type of grant grew, NIH began to receive an increasing number of consortium grant applications reflecting the involvement of a greater number of collaborating institutions applying their talents to an increasing portion of the research endeavors. Thus, this policy has evolved from experience with the first consortium grant and has been developed through cooperative efforts of grantee institutions and the NIH in recognition of the special needs of these particular grants. C.Applicability. This policy is applicable to any NIH grant-supported research project which embodies the characteristics of the consortium grant as defined below. D.Definition. A consortium grant is defined as: A grant to one institution in support of a research project in which any programmatic activity is carried out through a collaborative arrangement between or among the grantee institution and one or more other institutions or organizations which are separate legal entities, administratively independent of the grantee. The involvement of the non-grantee (collaborating) institution is that of actually performing a portion of the programmatic activity as opposed to simply providing a routine service to the grantee such as equipment fabrication or repair, data processing, or performing routine analytical testing services. E.Policy 1. The NIH may make an award for the support of a project to a grantee institution on behalf of a named principal investigator or program director even though one or more institutions other than the grantee are collaborating in the project by carrying out portions of the planned program activity. A proper certification reflecting inter-institutional understanding and basic agreement must be developed between the grantee and each individual collaborating institution. 2. To be eligible for the award of such a grant, the grantee institution must ensure that it will, in fact, perform a substantive role in the conduct of the planned research project activities and not be primarily a conduit for the transmission of funds to another party or multiple parties. In general it is expected that a significant portion of the research activity will be carried out at the grantee institution. 3. Consortium arrangements which have not been proposed and documented in a grant application may not be entered into after a grant award has been made without the specific written prior approval of the awarding unit. 4. Only the grantee institution will receive entitlement credit for a Biomedical Research Support Grant. No proration of entitlement to other consortium institutions is allowed. F.Conditions of Application and Award 1. Agreement prior to application submission. Prior to submission of an application for a consortium grant the applicant institution and each collaborating institution should thoroughly explore and reach at least tentative agreement on the scientific, administrative, financial, and reporting requirements for the grant. 2. Application preparation. The application form for consortium grants is the same form used for other NIH research proposals (Form PHS 398). For consortium arrangements the application must include the following additional information: a. A list of all proposed performance sites both at the applicant institute and at the collaborating institutions. b. A separate, detailed budget for the initial and future years for each institution and, where appropriate, for each unit of activity at each institution. c. A composite budget for all units of activity at each institution for each year, as shown under b. above, as well as composite budget for the total proposed budget for each year. d. An explanation of the programmatic, fiscal, and administrative arrangements made between the grantee institution and the collaborating institutions. e. The following statement, accompanied by signatures of the appropriate administrative officials from each of the collaborating institutions, must be included as part of the application: "The appropriate programmatic and administrative personnel of each institution involved in this grant application are aware of the NIH consortium grant policy and are prepared to establish the necessary inter-institutional agreement(s) consistent with that policy." 3. Written agreement. The grantee institution must formalize in writing the agreement negotiated with each collaborating institution. The agreement must state the programmatic, fiscal, and administrative arrangement ensuring the compliance with all pertinent Federal regulations and policies and facilitating a smoothly functioning collaborative venture. Based upon the amount of information pertaining to the written agreement(s) which might be provided with the application, the awarding unit may determine that it is necessary to obtain more specifically detailed information from the grantee institution. The grantee can comply with such a requirement either by submitting copies of the actual written agreement(s) or by providing similarly clarifying information in some other format. Generally such information, needed for administrative review as to completeness will be required prior to the time of grant award statement issuance. Any review and acceptance by the awarding unit of the information provided does not constitute a legal endorsement of the written agreement(s) by the Federal Government. Nor does such acceptance establish NIH as a party to any of the agreement provisions. When requested, if it is not possible for the grantee institution to provide the NIH awarding unit with the additional documentation prior to award, it may be necessary to impose appropriate award restrictions, pending receipt and acceptance of the material. As a general rule it should not be necessary to request detailed information concerning the written agreement during noncompetitive continuation application review unless the relationship between the grantee institution and its collaborating institution(s) is going to be significantly modified in any of the programmatic, fiscal, or administrative aspects. Accordingly, it is the responsibility of the grantee to provide an explanation of any significant proposed modification of the written agreement(s) in the continuation application or by letter if the decision on a change is made after application submission. Based on the type of explanation provided, the awarding unit will make a determination as to the possible need for more information to facilitate its review. As in the above paragraph, the grantee, when asked for more details on the approach taken in the agreement(s), would have the option of submitting copies of the actual agreement(s) or presenting similar information in some other format. a. Programmatic considerations. The agreement must identify the principal investigator and the responsible persons at each collaborating institution and describe their responsibilities in the project. Procedures for directing and monitoring the research effort must also be delineated. b. Fiscal considerations. The agreement must cite specific procedures to be followed in reimbursing each collaborating institution for its effort and must include dollar ceiling, method and schedule of reimbursement, type of supporting documents required for reimbursement, an procedures for review and approval of expenditure of grant funds at each institution. c. Administrative considerations. Where policies of the collaborating institution differ from those of the grantee institution, (e.g. travel reimbursement, salaries and fringe benefits) a determination should be made and included in the agreement as to which policies will be applied. Usually the policies of the institution where the costs are generated are applied to those costs, provided any such policies are in compliance with those of NIH. 4. Assurances required by NIH. The grantee institution has the specific responsibility for ensuring that all required assurances are obtained. The written agreement between the grantee institution and each collaborating institution must reflect the intent to fulfill all the requirements of the NIH and incorporate an understanding concerning at least the applicable assurances listed below: a. Protection of Human Subjects. Title 45, Code of Federal Regulations, Part 46 (45 CFR 46) requires that grantee institutions and collaborating institutions, when conducting some or all of the research involving human subjects, must have on file with or must submit to HHS upon request an Assurance of Compliance, approved in accordance with the regulations, setting forth the institutional policies and procedures established for the protection of human research subjects. Further information on the requirements of 45 CFR 46 may be obtained from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 4B09, Bethesda, Maryland 20205. b. Care and treatment of laboratory animals. In accord with PHS Grants Administration Manual Chapter 1-43 each grantee or collaborating institution receiving funds for research involving live, vertebrate animals must have on file with or submit upon request to PHS an Animal Welfare Assurance. The Assurance document commits the institution to comply with the Animal Welfare Act (P.L. 89-544, as amended) and the Guide for the Care and Use of Laboratory Animals (NIH Publication No. 80-23, Rev. 1978, or succeeding editions). Further information may be obtained from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 4B09, Bethesda, Maryland 20205. c. Non-Discrimination. Each domestic collaborating institution or organization must comply with Title VI of the Civil Rights Act of 1964 and Section 504 of the Rehabilitation Act of 1973, as amended (Handicapped Individuals). The grantee must ensure that all collaborating institutions have on file with the HHS Office for Civil Rights, valid Assurances of Compliance with the Civil Rights Act of 1964 (Form HHS 441) and Section 504 of the Rehabilitation Act of 1973, as amended (Form HHS 641). d. Patents and inventions. The fact that two or more institutions share in the grant-supported project does not alter the grantee institution's responsibilities concerning patents and inventions. The grantee institution should obtain appropriate patent agreements to fulfill the requirements from all persons who perform any part of the work under the grant and may be reasonably expected to make inventions. The grantee should insert into each such written agreement a clause making the patent and inventions policy applicable to each collaborating institution and its employees. Agreements should also be obtained by the grantee to govern disposition of rights to inventions resulting from screening compounds synthesized under the grant. e. Student unrest provisions. Each collaborating institution will be responsible for carrying out the provisions relating to remuneration from grant funds to any individual who has been engaged or involved in activities described as "student unrest." (General Provisions of the DHHS Appropriations Act each year since FY 1970.) f. Recombinant DNA Research. The grantee institution, the collaborating institutions, and their respective principal investigators should refer to the most recent guidance from NIH concerning recombinant DNA research to determine the requirements necessary for the preparation of applications involving recombinant DNA experiments. g. Other. Any other assurance normally required of the grantee institution for the program in question is also required of the collaborating institutions. G. Eligible Costs 1. Direct Costs. In general, any item of cost that is allowable under NIH policy for research grants may be requested in the application on behalf of both the grantee and collaborating institution(s). The expenditures are to be made in accordance with the NIH policies generally applicable to research grants. The requests for costs such as foreign travel, alterations and renovations, and research patient care must be accompanied by special justification. It should be noted that no collaborating institution or organization which otherwise meets the eligibility criteria for receiving NIH grants in its own right can be paid a fee (over and above allowable direct and indirect costs) from grant funds for its participation in the consortium arrangement. 2. Indirect costs. Indirect costs for the grantee institution will be awarded routinely through the NIH Indirect Cost Management System (ICMS) of the Federal Assistance Accounting Branch, Division of Financial Management. If indirect costs for a collaborating institution are required from the grant, they must be requested on the application budget page as direct cost. The amount to be requested is determined by applying the DHHS-negotiated indirected cost rate for the collaborating institution to the appropriate direct cost base being requested for that institution. In such cases, the indirect cost amounts requested for collaborating institutions should be viewed as fixed maximum amounts for each year. The amounts requested for a collaborating institution's indirect costs for future years should reflect anticipated increases or decreases in indirect cost rates for the periods of requested support. That is, indirect cost rates used for collaborating institutions may vary - up or down - from the rate applicable at the time the competitive (new, renewal, or supplemental) application is submitted. Any such variance from already negotiated rates should, however, be accompanied by an explanation. While consortium arrangements may include the involvement of foreign institutions it should be noted that such institutions, whether serving as grantee or collaborator, cannot receive indirect costs. H. Other Administrative Considerations 1. Rebudgeting authority of collaborating institutions. Rebudgeting between budget categories on the part of non-grantee collaborating institutions must have the prior approval of the grantee institution unless the grantee institution has established in the written agreement moderate levels of rebudgeting authority within PHS policy limitations with each of the collaborating institutions. In any case, the grantee institution must be responsible for assuring that the combined rebudgetings of both the grantee institution and collaborating institution are consistent with PHS policy and that rebudgeting requests receive appropriate review (including those types of rebudgeting requests which require the review and prior approval of an awarding unit). 2. Audit guidelines. All costs incurred in the consortium grant will be subject to audit by the cognizant Federal audit agency. Upon request, cognizant Federal auditors will be provided access to records supporting grant-related costs of the collaborating institutions. 3. Equipment accountability and disposition. If the grantee is a non-profit organization, title to all equipment purchased with grant funds resides with the grantee. Further, if the grantee qualifies under a Federal statute as being exempt from further accountability to the Government for the equipment, the grantee may determine the diposition of the equipment at any appropriate time. Such a determination could enable the grantee to make arrangements as part of the written agreement for transfer of equipment items to the collaborating organizations early in the project (perhaps at time of acquisition) or as late as the time of project termination. If the grantee is a for-profit entity, title to all equipment purchased with grant funds is retained by the Federal Government. Disposition of such Government-owned equipment will be determined by the awarding unit at the time of project termination. 4. Grant related income. The written agreement should establish the understanding that the grantee institution is accountable to the NIH for all grant related income generated by the grant supported activities. In accordance with PHS policy, the grantee is responsible for maintaining records of the receipt and disposition of grant related income in the same manner as required for the grant funds that gave rise to the income. The collaborating institution(s) will maintain records as necessary for the grantee institution to fulfill its responsibility. 5. Publications. The grantee institution and the collaborating institution(s) should have an initial, general agreement regarding authorship on research reports and other publications. I. Reporting Requirements. In order for the grantee institution to satisfy all of the various reporting requirements (e.g. progress report, report of expenditures, invention statement), it is necessary for each collaborating institution to provide the grantee with certain kinds of documentation. The written agreement must reference this need by stating the kinds of documentation required by the grantee as well as the timing of their submission. J. Effective Date. This policy is effective as of March 22, 1985. FIRST.DRG THE FIRST INDEPENDENT RESEARCH SUPPORT AND TRANSITION (FIRST) AWARD (R-29) - April 1989 (This document replaces the previous February 17, 1989 announcement) The National Institutes of Health (NIH) announces the continuing availability of the FIRST Award (R-29). Based on earlier review experiences the objectives and features of the R-29 mechanism are further defined and clarified. I. OBJECTIVE The objective of the FIRST award is to provide a sufficient period of research support for newly independent biomedical investigators to initiate their own research and demonstrate the merit of their own research ideas. These grants are intended to underwrite the first independent investigative efforts of an individual; to provide a reasonable opportunity to demonstrate creativity, productivity, and further promise; and to help in the transition to traditional types of NIH research project grants. The award is not intended for persons in mid-career who may be in transition to another endeavor. FIRST awards generally will provide funds for 5 years during which time the newly independent investigator can establish his or her own research program and make significant and innovative contributions to laboratory or clinical science disciplines in biomedical research. II. ELIGIBILITY To be eligible for a FIRST award, the proposed principal investigator (PI) must be genuinely independent of a mentor yet at the same time must be at the beginning stages of his or her research career with, for example, no more than five years research experience since completing postdoctoral research training or its equivalent. If the applicant is in the final stages of training, it is permissible to apply, but no FIRST award will be made to persons in training status. In addition, the proposed PI must otherwise be eligible to serve in the same capacity on a traditional research project grant (R-01) awarded to the applicant institution. The applicant investigator must never have been designated previously as PI on any PHS-supported research project OTHER THAN a PHS small grant (R-03), an Academic Research Enhancement Award (R-15) or certain research career awards (K series) directed principally to physicians, dentists or veterinarians with little research experience. (Current or past Research Career Development Awardees are not eligible.) Subproject leaders on multicomponent awards such as Program Project grants (P-01), Center grants (P-50) or Minority Biomedical Research Support grants (S-06) may also be eligible, however potential applicants in these categories are urged to contact the appropriate person from the awarding unit listed in VIII below. An important principle to remember with regard to eligibility is that the more extensive the prior independent research experiences, regardless of funding sources, the greater likelihood there will be diminished enthusiasm among reviewers for the FIRST award application. III. GENERAL FEATURES A. PRE-AWARD 1. Only domestic organizations and institutions are eligible to receive FIRST awards. 2. A FIRST award is for a distinct research endeavor and may not be used merely to supplement or broaden an ongoing project at the applicant institution. 3. An individual may submit only one FIRST award application to the Public Health Service (PHS) for any particular receipt date and may not submit any other type of research grant application (including research career applications) to the PHS during that particular review cycle. Applications for other projects may be submitted while the FIRST award is in force provided that the time and effort is less than 100% on the FIRST award. 4. FIRST award applications must request 5 years of research support. Applications submitted to the NIH in which the request is for less than 5 years of support will be designated as R01s and so reviewed unless the applicant withdraws the application. 5. The principal investigator must make a commitment of no less than 50% effort to the proposed project. Up to 100% effort may be requested if a greater commitment of the principal investigator is required to do the research. The request for effort of the applicant investigator will be reviewed and reductions may be recommended. 6. Application page limitations apply to the Research Plan (Section 2) of the PHS 398 application form. Sections A-D of the Research Plan, as described on page 20 of the instructions for the PHS 398 (Rev. 10/88), are limited to a total of 20 pages including tables, figures and chemical structures. Applications exceeding the 20-page limitation will be returned. If appendix material is submitted, six collated sets must be included with the application package. Identify each of the six sets with the name of the principal investigator and the project title. This material will not be routinely duplicated and will be used in a limited way by members of the initial review group. 7. In very unusual circumstances, FIRST awards may be recommended by the initial review group or the awarding Institute for periods of less than five years. B. POST-AWARD 1. The total direct cost award for the 5-year period may not exceed $350,000. The direct cost award in any budget period should not exceed $100,000. Indirect costs will be paid to the grantee institution in accord with applicable policy of the Department of Health and Human Services (DHHS). The authority to carry over unobligated direct cost funds from one budget period to the subsequent one under certain conditions will be a feature of this award and may be accomplished at the discretion of the principal investigator and the grantee institution. If funds have been restricted by a specific term or condition on the Notice of Grant Award, they may not be automatically carried over without the prior approval of the awarding unit. Carryover is effected by notification on the financial status report, which the grantee submits within 90 days of the termination of each budget period. A revised Notice of Grant Award will not be issued to reflect the carryover. Indirect costs will be paid to the awardee institution in accord with applicable DHHS policy. 2. FIRST awards are not renewable. The PI on a FIRST award may submit a traditional research project grant (R-01) application to continue and extend the research supported by a FIRST award. 3. Grantee Institutions may extend the final budget period of the project one time for a period up to one year beyond the original termination date shown on the Notice of Grant Award. Such an extension may be made only when any one of the following applies: a. additional time beyond the established expiration date is required to assure adequate completion of the originally approved project scope or objectives; b. continuity of Public Health Service (PHS) grant support is required while a competing application is under review; or c. the extension is necessary to permit an orderly phaseout of a project that will not receive continued support. The fact that funds remain at the expiration of the grant is not in itself sufficient justification for an extension without additional funds. The grantee institution must notify the awarding unit of the extension prior to the expiration date of the project period. Upon notification, the awarding unit will issue a revised Notice of Grant Award to change the termination date. Grantees may not extend project periods previously extended by the awarding unit. 4. Replacement of the PI on a FIRST award will not be approved. Transfer of the FIRST award with the principal investigator to another institution for the remaining performance period may be requested. 5. Except as indicated above, all relevant portions of the PHS Grant Policy Statement are applicable to these awards. IV. ADDITIONAL DOCUMENTATION A. The following is to be addressed in a letter or memorandum from a suitable department head or dean and should be included with the application: Eligibility of proposed principal investigator independently to lead a research project at the applicant institution. Is this person otherwise qualified to be the PI on a traditional research project grant (R01)? Details of intended commitment of the institution to the project for the five-year period. B. In addition, three letters of reference are needed. These reference letters must be submitted with the application. Such letters are critically important and should reflects the investigator's research originality and potential for independent investigation. When the application is from the institution where the proposed PI received postdoctoral research training, it must be made absolutely clear that the FIRST award would be to support a research endeavor independent of that conducted in the former training environment. FIRST applicants are to request the letters of reference well in advance of the application submission, advising the referees to return the reference letters to the applicant in sealed envelopes as soon as possible. To protect the utility and confidentiality of reference letters, applicants are asked not to open envelopes. The sealed envelopes must be attached to the original applications. Applications received without the three reference letters will be returned to the applicant. V. REVIEW CRITERIA Review criteria and procedures are those of the regular NIH system of dual peer review: evaluation for scientific and technical merit by an initial review group (study section) taking into consideration the investigator's stage of development and merit of the proposed research, followed by recommendation of the cognizant national advisory council or board. In addition, the PI must demonstrate the potential to carry out independent research and clear evidence of ability to develop a sound research plan. The quality of education, scientific training, research experience, commitment to a research career, as well as the institutional commitment, will be important in the review process. VI. IMPLEMENTATION All awarding units of the NIH are authorized to use this mechanism. It should be noted that these applications compete for funding with traditional types of NIH research project grants and that the NIH has no special set-aside funds for FIRST awards. VII. HOW TO APPLY A. Applicants must use the PHS-398 (Rev. 10/88) application form and must provide relevant information on eligibility. (See Section II.) The acronym "FIRST" should be typed on line 2 of the application face page. B. Applications must be submitted to the Division of Research Grants (DRG) in accordance with regular receipt dates (See below). Assignment to the most appropriate Institute and initial review group will be carried out by the DRG according to established guidelines. The following table indicates the review and award cycle dates: Application Initial Council/ Earliest Receipt Review Board Start Dates Dates Dates Dates February 1 June/July September/October December 1 June 1 October/November January/February April 1 October 1 February/March May/June July 1 VIII. PARTICIPATING INSTITUTES, DIVISIONS AND CENTERS OF THE NATIONAL INSTITUTES OF HEALTH Additional information may be obtained by contacting: National Institute on Aging Associate Director Office of Extramural Affairs National Institute on Aging Building 31, Room 2C02 National Institutes of Health Bethesda, MD 20892 (301) 496-9322 National Institute of Allergy and Infectious Diseases (NIAID) Deputy Director Extramural Activities Program National Institute of Allergy and Infectious Diseases National Institutes of Health Westwood Building, Room 703 Bethesda, MD 20892 (301) 496-7688 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMSD) Deputy Director Extramural Activities Program Westwood Building, Room 403 National Institutes of Health Bethesda, MD 20892 (301) 496-7495 National Cancer Institute (NCI) Referral Officer National Cancer Institute Westwood Building, Room 828 National Institutes of Health Bethesda, MD 20892 (301) 496-3428 National Institute of Child Health and Human Development (NICHD) Special Assistant to the Director National Institute of Child Health and Human Development Building 31, Room 2A03 National Institutes of Health Bethesda, MD 20892 (301) 496-0104 National Institute of Deafness and Communication Disorders(NIDCD) Acting Associate Director for Extramural Programs Federal Building, Room 1C11 National Institutes of Health Bethesda, MD 20892 (301) 496-1804 National Institute of Dental Research (NIDR) Director Extramural Programs National Institute of Dental Research Westwood Building, Room 503 National Institutes of Health Bethesda, MD 20892 301) 496-7723 National Institute of Diabetes, and Digestive and Kidney Diseases (NIDDK) Director Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 657 National Institutes of Health Bethesda, MD 20982 (301) 496-7277 National Institute of Environmental Health Sciences (NIEHS) Science Administrator Extramural Programs, NIEHS P.O. Box 12233 Research Triangle Park, North Carolina 27709 919) 541-7724 National Eye Institute (NEI) Associate Director National Eye Institute Building 31, Room 6A51 National Institutes of Health Bethesda, MD 20892 (301) 496-5983 National Institute of General Medical Sciences (NIGMS) Deputy Associate Director Office of Program Activities National Institute of General Medical Sciences Westwood Building, Room 955 National Institutes of Health Bethesda, MD 20892 (301) 496-7063 National Heart, Lung, and Blood Institute (NHLBI) Deputy Director Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 7A17 Bethesda, MD 20892 (301) 496-7225 National Library of Medicine (NLM) Program Officer Biomedical Information Support Branch Extramural Programs, Room 5S-518 National Library of Medicine Bethesda, MD 20894 (301) 496-4221 National Institute of Neurological Disorders and Stroke (NINDS) Deputy Director Extramural Activities Program National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 National Institutes of Health Bethesda, MD 20892 (301) 496-4188 National Center for Nursing Research (NCNR) Director Division of Extramural Programs National Center for Nursing Research Building 31, Room 5B03 National Institutes of Health Bethesda, MD 20892 (301) 496-0523 Division of Research Resources (DRR) Deputy Director Division of Research Resources Westwood Building, Room 8A16 National Institutes of Health Bethesda, MD 20892 (301) 496-6023 F32.DRG NATIONAL INSTITUTES OF HEALTH - November 1, 1988 NATIONAL RESEARCH SERVICE AWARDS FOR INDIVIDUAL POSTDOCTORAL FELLOWS January 10, May 10, and September 10 are the annual receipt dates for individual National Research Service Award applications. The research areas in which applications are accepted are listed in the attachment to this document. The National Institutes of Health also provides individual awards to Senior Fellows. A description of this program and a reference to other individual fellowship programs and other agencies supporting individual National Research Service Awards are on page 6. Under authority of Section 487 of the Public Health Service Act as amended (42 USC 288), the National Institutes of Health (NIH) provides National Research Service Awards (NRSAs) to postdoctoral individuals for training experiences in biomedical and behavioral research. Awards are made to individual applicants, for specified training proposals, selected as a result of a national competition. The NRSA legislation requires recipients of support to pay back the Federal Government by engaging in biomedical or behavioral health-related research and/or teaching. See page 4 for details. Title 42 of the Code of Federal Regulations, Part 66, is applicable to these awards. The Catalog of Federal Domestic Assistance numbers 13.121, 13.122, 13.306, 13.398, 13.821, 13.837-13.839, 13.846-13.849, 13.853-13.856, 13.859, 13.862-13.871, 13.880, and 13.894 are applicable to these awards. ELIGIBILITY REQUIREMENTS. Individuals must be, at time of application, citizens or noncitizen 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). Noncitizen nationals are persons who, although not citizens of the United States, owe permanent allegiance to the United States. They are generally persons born in lands which are not States, but which are under United States sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible. Individuals must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.O., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr.P.H., or D.N.S., or equivalent degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree granting institution that all degree requirements have been met is also acceptable. Proposed training must encompass biomedical or behavioral research and offer an opportunity to research health scientists, research clinicians, etc., to broaden their scientific background, or to extend their potential for research in health-related areas. For those who have attained a health professional degree, the proposed training may be a part of a research degree program. Individuals are required to pursue their research training on a full-time basis. Fellows in clinical areas are expected to confine clinical duties to those that are part of the research training. An increased emphasis has been placed on the research training of physicians. The Secretary of Health and Human Services is required by law, in taking into account the Nation's overall needs for biomedical research personnel, to give special consideration to physicians who agree to undertake a minimum of 2 years of biomedical research. But, NRSAs are not made for study leading to the M.D., D.O., D.D.S, or other similar professional degrees. Neither will these awards support residency training. Before submitting an application, an applicant must arrange for appointment to an appropriate institution and acceptance by a sponsor, who will supervise the training and research experience. The institutional setting may be a private or public institution, including a Federal laboratory. The sponsor must document, in the application, the research training plan and the availability of staff and facilities to provide a suitable environment for performing high quality work. The candidate's sponsor should be a competent active investigator in the area of the proposed research activity, who will personally supervise the candidate's research. Individuals requesting foreign training must provide, in the application, justification, based on the nature of the facilities and/or training opportunity, of the particular suitability of the foreign site, rather than a domestic one, to the proposed research. Only in cases where there are clear scientific advantages will the foreign training be supported. When an applicant plans to continue training in the same environment and/or with the same sponsor, the opportunity for new training experiences which would broaden the candidate's scientific background should be well documented in the application. PERIOD OF SUPPORT. Fellowships may be requested for 1, 2, or 3 years. No individual may receive more than 3 years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional and individual awards. Any exception to the three-year limit requires a waiver from NIH. DOCUMENTS TO BE SUBMITTED. Individuals must submit the Application for Public Health Service Individual National Research Service Award (PHS 416-1) and, if a noncitizen, a notarized statement of permanent residence. In addition, applicants must submit with the application at least 3 letters of reference. LETTERS OF REFERENCE The NIH is working to reduce the time required for completion of the receipt, referral, review, and award of individual postdoctoral fellowship (F32) applications. The goal is to cut the current time of eight to nine months in half. Accomplishing this goal would benefit candidates and their sponsors by giving them more time for planning future research training activities. To help expedite the review process, NIH is now requiring that at least three completed, sealed letters of reference be submitted with each individual fellowship application. Four copies of the reference forms are included in each fellowship application. Candidates should: 1. Send these forms to their referees well in advance of the application submission date, and advise the referees to complete the form and return it to the candidate in a sealed envelope as soon as possible; 2. Request reference reports only from individuals who will be able to return them in time for the application submission. Consider any factor (e.g., illness or overseas sabbatical, etc.) that might cause an inordinate delay; 3. Choose individuals, other than the sponsor of the application, who can make the most meaningful comments about the candidate's qualifications for a research career; 4. If applicable, include a reference from the current mentor or immediate supervisor. If not submitting a reference from the thesis advisor or chief of service, explain why in Item 23 of the application; 5. Where possible, select at least one respondent who is not in the candidate's current department; and 6. Select graduate or medical school referees rather than those from undergraduate schools. To protect the utility and confidentiality of reference letters, candidates are asked not to open the envelopes. The sealed envelopes should be attached to the original application. Applications with fewer than three references will be returned. Candidates reapplying (competing continuations or revised applicants) must submit new reference forms to facilitate APPLICATION MATERIAL is available from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Bethesda, Maryland 20892. A self-addressed mailing label will expedite requests. CONCURRENT APPLICATIONS. An individual may not have more than one competing NRSA individual fellowship application pending with the Public Health Service concurrently. REVIEW CYCLES. Initial Second Earliest Application Review Level Possible Receipt Dates Meetings Reviews Start Dates January 10 March May/June June 1 May 10 July Sept/Oct October 1 September 10 November Jan/Feb February 1 SELECTION OF AWARDEES. Applications are subjected to a review process that is based upon two sequential levels of review. The initial review is performed by groups composed primarily of non-Federal scientists selected for their com- petence in particular scientific areas. These groups are called initial review groups (IRGs). An NIH health scientist administrator serves as executive secretary of the review group. The task of the IRGs is to evaluate the application for scientific merit based on the applicant's past academic and research accomplishments, the applicant's research career goals, the research training proposal, the sponsor and training environment, the reference reports, and other relevant information. After the IRG meets, the executive secretary prepares a summary statement for each application and forwards it to the appropriate NIH Bureau/Institute/ Division (BID) for the second level of review. The second level of review is made by a committee of BID staff members. At this level, award selection is made based on the initial review group's recommendation, the program interests of the BID, and the availability of funds. NOTIFICATION. The BID automatically forwards a copy of the summary statement to the applicant as soon as possible after receipt from the initial review group. Then, as soon as possible after the BID second-level review, they will send a final notice to each applicant. Any questions on initial review recommendations and funding possibilities should be directed to the appropriate BID. The executive secretary of the IRG cannot respond to such questions. The appropriate BID can be identified by matching the fifth and six digits of the number assigned to the application (e.g., 1F32GM07091-01) with BID list attached to this statement. ACTIVATION. An awardee has a period of up to 6 months from the issue date on the award notice to activate the award. Extension of the activation period maybe granted for good reason. STIPENDS AND OTHER TRAINING COSTS. Fellowship awards include a stipend for the fellow, an allowance to the sponsoring institution, and, for foreign training, travel costs. The stipend level is determined by the number of years of relevant postdoctoral experience at the time the award is issued. Relevant experience may include research experience (including industrial), teaching, internship, residency, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. Current postdoctoral stipends, effective for awards made on or after October 1, 1988, are as follows: YEARS OF RELEVANT EXPERIENCE ANNUAL AMOUNT 0 $17,000 1 18,000 2 25,000 3 26,250 4 27,500 5 28,750 6 30,000 7 or more 31,500 Upon request, NIH will provide funds of up to $3,000 per 12-month period to non-Federal nonprofit sponsoring institutions to help defray such awardee expenses as tuition and fees, health insurance, research supplies, equipment, travel to scientific meetings, and related items. An allowance of up to $2,000 is available for individuals sponsored by Federal laboratories for scientific meeting travel expenses, health insurance, and tuition and fees. Individuals affiliating with foreign sponsoring institutions will be provided also with a single economy or coach round-trip travel fare to the training site. No allowance is provided for dependents or for an individual's travel to a domestic training site. U.S. flag air carriers must be used to the maximum extent possible when commercial air transportation is the means of travel between the United States and a foreign country or between foreign countries. NRSA stipends may be supplemented by the sponsoring institution from non-Federal funds. No Federal funds may be used for stipend supplementation unless specifically authorized under the terms of the program from which funds are derived. Under no circumstances may the conditions of stipend supplementation detract from or prolong the training. An NRSA award 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. But, an individual may accept concurrent educational remuneration from the Veterans Administration (e.g., G. I. Bill) and Federal loans funds. PAYBACK REQUIREMENTS. Before individuals can receive an NRSA, they must sign an agreement that they will fulfill the legislatively mandated payback requirements. Recipients agree to engage in biomedical or behavioral health-related research and/or teaching for a period equal to the period of NRSA support in excess of 12 months. An individual's initial 12 months of postbaccalaureate NRSA support is excluded from payback obligation. All subsequent NRSA support is fully obligated. Recipients must begin to undertake the obligated service on a continuous basis within 2 years after termination of NRSA support. For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the amount of NRSA funds paid to the individual for the period for which an obligation exists, plus interest at a rate determined by the Secretary of the Treasury. TAXABILITY OF STIPENDS. The Tax Reform Act of 1986, Public Law 99-514, changes the tax liability of all individuals supported under NRSAs. In brief: Degree candidates who, prior to the enactment of Public Law 99-514, were able to exclude all monies received under an NRSA award from their reported income, may now exclude only course tuition, fees, books, supplies and equipment required for attendance. Non-degree candidates, who formerly were able to exclude from stipends $300 a month for a period not to exceed 3 years in a lifetime, will now be required to report all stipends and any monies paid on their behalf for course tuition and fees required for attendance. These new statutory requirements are applicable to taxable years beginning after December 31, 1986 for scholarships and fellowships granted after August 16, 1986. NIH is not in a position to advise students or institutions about their tax liability. Individuals should consult their Internal Revenue Service office about the applicability to their situations and for information on the proper steps to be taken regarding their tax obligations. In any event, changes in the taxability of stipends in no way alters the relationship between NRSA fellows, trainees and institutions. NRSA stipends are not now, and never have been, salaries. Individuals supported under the NRSA are not in an employer-employee relationship with either the Federal Government or the institution in which they are pursuing research training. ADDITIONAL INFORMATION. For additional information, see the official Guidelines for the NRSA program, NIH Guide to Grants and Contracts Vol. 13, No.1, January 6, 1984, usually available at institutional offices (e.g., sponsored research), or write to the Program Analyst, Office of the Chief, Referral and Review Branch, Division of Research Grants, National Institutes of Health, Bethesda, Maryland 20892. OTHER AWARDS SENIOR FELLOWSHIPS. The Senior Fellowship is designed to provide training for experienced scientists (at least 7 years of relevant postdoctoral professional and research experience at the time of the award) to make major changes in the direction of their research careers or to broaden their scientific backgrounds, by acquiring new research capabilities. These awards will enable individuals beyond the new investigator stage to take time from regular professional responsibilities to increase their capabilities to engage in health-related research. Individuals should request the Application for Public Health Service Individual National Research Service Award (PHS 416-1) and the information statement for Senior Fellowships from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Bethesda, Maryland 20892. PREDOCTORAL SUPPORT. Generally, NIH does not provide predoctoral support through individual awards. The exceptions are the Minority Access to Research Careers Program of the National Institute of General Medical Sciences, the oncology nurse fellowships of the National Cancer Institute, and fellowships through the Center for Nursing Research. NIH does provide predoctoral support through institutional training grants. Inquiries concerning this kind of support should be directed to the Graduate or Medical Dean of the institution where the individual would like to study. ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION. This agency provides support through individual National Research Service Awards at both the predoctoral and postdoctoral levels. For information and application forms, contact the appropriate institute of the Alcohol, Drug Abuse, and Mental Health Administration, Rockville, Maryland 20857. FOGARTY INTERNATIONAL CENTER The Fogarty International Center, NIH, provides postdoctoral opportunities for foreign scientists to study in the United States, and opportunities for U.S. scientists to study outside the U.S. For information, write the International Research and Awards Branch, Fogarty International Center, Building 38A Room 6l5, National Institutes of Health, Bethesda, MD 20892. NATIONAL CENTER FOR HEALTH SERVICES RESEARCH AND HEALTH CARE TECHNOLOGY ASSESSMENT This agency provides individual postdoctoral National Research Service Awards related to the entire range of issues around the organization, financing, and delivery of health services, with particular interest in primary care/health promotion and disease prevention, technology assessment, the role of market forces in health care delivery, and studies relevant to issues faced by State and Local governments. For information contact Dr. John Gallicchio (301) 443-3091, Room 18A20 Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857. ATTACHMENT National Institutes of Health Research Area List for Individual Postdoctoral National Research Service Awards For purposes of assignment to the appropriate NIH Bureau, Institute or Division, an application should be identified as responding to one of the announcement areas listed below. The areas are not meant to be rigidly exclusive, but to provide guidance to NIH's primary points of emphasis. Applicants should contact the individuals designated below for additional information concerning the areas of research. NATIONAL INSTITUTE ON AGING (AG) 1. The biology of aging, e.g., biophysical, biochemical, cellular, organ or organismic aging, the pathologic changes in aging experimental animals. 2. The special medical problems of aging and the aged, e.g., preventive medicine and aging, the aging nervous system, dementia, aging of the endocrine system, aging of connective tissue structures, pharmokinetics and pharmodynamics in the aged. 3. Psychological aspects of aging and the aged, e.g., cognitive personality, biobehavior and attitudinal changes with age. 4. Societal aspects of aging, e.g., population age-structure and its impact on economic, societal and individual function, retirement, social aspects of lifestyles, morbidity and longevity of aging in different cultures. 5. Epidemiology of health and disease in aging. Dr. Miriam Kelty (301) 496-9322 NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (AI) 1. Allergic and Immunologic Diseases and Basic Immune Mechanisms. Allergy Immunochemistry Immunology Immunopathology Immunogenetics Clinical Immunology Autoimmunity Transplantation Biology 2. Infectious Diseases and Basic Microbiological Mechanisms Bacteriology Virology Parasitology Mycology Pathogenesis of Infectious Diseases 3. Epidemiology of Allergic, Immunologic and Infectious Diseases Dr. William Bennett (301) 496-5030 NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES(AR) The Institute supports research training in basic and clinical disciplines where the project relates to the programs of the Institute. Major areas include: 1. Structure, function and physiology of connective tissue, joints, muscle, bone and skin 2. Metabolism of muscle, bone and skin 3. Development and genetic diseases of connective tissue, muscle, bone and skin 4. Exercise physiology of the musculoskeletal system and gait analysis 5. Rheumatic and connective tissue diseases and disorders 6. Bone diseases and disorders 7. Muscle diseases 8. Musculoskeletal disorders 9. Skin diseases and disorders Dr. Richard W. Lymn (301) 496-7495 NATIONAL CANCER INSTITUTE (CA) The goal of the Cancer Research Manpower Development Program is to ensure that an adequate number of highly competent basic and clinical cancer research specialists will be trained to meet needs in the following areas of cancer research: Etiology Prevention Detection Diagnosis Treatment Restorative Care (Support is also provided for individual predoctoral research fellowship for oncology nurses.) Dr. Vincent Cairoli (301) 427-8898 NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (HD) Awards provide opportunities for research training in the biological and/or behavioral science aspects of the areas listed below. Reproductive Sciences Fertility-Infertility Fertility Regulation Mechanism of Reproductive Hormone Action Disorders of the Reproductive System Demographic and Behavioral Sciences Causes and Consequences of Population Change Social and Behavioral Aspects of Reproduction Genetics and Teratology Normal and Aberrant Development Causes and Prevention of Congential Defects Pregnancy and Perinatology High-Risk Pregnancy Fetal Pathophysiology Disorders of the Newborn Endocrinology, Nutrition and Growth Maternal-Fetal, Infant, Child and Adolescent Nutrition Growth Factors Cultural and Behavioral Aspects of Nutrition Human Learning and Behavior Biological Bases of Behavioral Development Learning and Cognition Speech and Language Behavioral Pediatrics Mental Retardation and Developmental Disabilities Diagnosis, Pathophysiology, Epidemiology, Prevention and Amelioration Toxicology and Environmental Factors Behavioral and Social Science Research in Mental Retardation Ms. Hildegard Topper (301) 496-1848 NATIONAL INSTITUTE OF DENTAL RESEARCH (DE) DENTAL RESEARCH (DE) 1. Behavioral Studies 2. Cariology 3. Craniofacial Anomalies including Malocculsion, Acquired Disfigurement, Congential Craniofacial Defects, Developmental Biology) 4. Mineralization 5. Nutrition 6. Pain Control 7. Periodontal Disease 8. Restorative Material and Implants 9. Salivary Secretions 10. Soft Tissue Diseases Dr. Thomas M. Valega (301) 496-6324 NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (DK) Proposals should demonstrate capability to provide opportunity for (1) the clinically-trained to acquire expertise in scientific research (e.g., biochemistry, biophysics, cell biology, epidemiology, genetics, physiology, or psychology); and (2) the scientifically-trained to obtain further training in biomedical research or clinical investigation relating to: Diabetes, Endocrine, and Metabolic Diseases Dr. Lois Lipsett (301) 496-7433 Digestive Diseases and Nutrition Dr. Donald Murphy (301) 496-7455 Kidney, Urologic and Hematologic Diseases Dr. Charles Rogers (301) 496-7571 NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (ES) 1. Environmental Toxicology (including Teratogenesis, Carcinogenesis and Behavioral Toxicology) 2. Environmental Mutagenesis 3. Environmental Pathology - Pathophysiology 4. Environmental Epidemiology and Biostatistics Dr. Annette Kirshner (919) 541-0488 NATIONAL EYE INSTITUTE (EY) Laboratory and clinical research training related to vision and disorders of the visual system: 1. Retinal and Choroidal Diseases 2. Corneal Diseases 3. Cataract 4. Glaucoma 5. Strabismus, Amblyopia and Visual Processing Preference will be given to two-year research training programs in the following areas as they relate to the above: 1. Immunology 2. Genetics 3. Pharmacology 4. Epidemiology 5. Biostatistics 6. Physiology 7. Biochemistry 8. Developmental Biology 9. Psychophysics 10. Pysiological Optics 11. Experimental & Clinical Pathology 12. Visual Rehabilitation 13. Molecular Biology 14. Neurobiology Mrs. Carolyn Grimes (301) 496-5884 NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (GM) Research training in broad areas related to the scientific programs of the Institute will be supported. l. Cellular and Molecular Biology (including Basic Pathobiology) 2. Genetics (including Medical Genetics) 3. Pharmacological Sciences (including Clinical Pharmacology, Anesthesiology, Bio-related Chemistry) 4. Biophysics and Physiological Sciences (including Trauma, Burn Research, and Molecular Biophysics) (Support is also provided through the Minority Access to Research Careers Program Faculty Fellowships and Visiting Scientist Awards.) Dr. David Wolff (301) 496-7063 NATIONAL HEART, LUNG AND BLOOD INSTITUTE (HL) 1. Division of Heart and Vascular Diseases The research training may be in fundamental studies of basic processes and functions; behavioral studies, including risk factor modification (e.g., diet, smoking); genetics (including studies of populations); and primary or secondary prevention or clinical investigations directed toward long-term involvement in research toward increasing our knowledge and understanding in cardiovascular areas related to programs in: Hypertension Arteriosclerosis Coronary Heart Disease Cardiovascular Aspects of Diabetes Arrhythmias Heart Failure and Shock Cerebrovascular Disease Peripheral Vascular Disease NATIONAL HEART, LUNG AND BLOOD INSTITUTE (HL) (continued) Congential and Rheumatic Heart Diseases Cardiomyopathies and Infections of the Heart Circulatory Assistance Cardiovascular Devices and Technology Dr. Michael Commarato (301) 496-1724 2. Division of Lung Division The Division supports research training in fundamental and clinical disciplines. Training programs should be addressed to one or more of the following categories: Structure and Function of the Lung Pediatric Pulmonary Diseases Emphysema and Chronic Bronchitis Fibrotic and Immunologic Lung Diseases Respiratory Failure Pulmonary Vascular Diseases Epidemiology of Respiratory Diseases Ms. Diane Aiken (301) 4960-7668 3. Division of Blood Diseases and Resources The Division supports research training in programs which allow: 1) the clinically-trained to acquire expertise in basic science disciplines, such as biochemistry, physiology, genetics, cellular and molecular biology, biophysics, endocrinology, or immunology; and 2) the scientifically-trained to enhance their skills in biomedical research technologies and in clinical investigation related to: Thrombosis Hemostasis Red Blood Cell Disorders Sickle Cell Disease Blood Resources Transfusion Medicine Dr. Fann Harding (301) 496-1817 NATIONAL INSTITUTE OF NEUROLOGICAL AND COMMUNICATIVE DISORDERS NATIONAL INSTITUTE OF DEAFNESS AND COMMUNICATION DISORDERS Applications are accepted in the following four areas. Listed are examples of training disciplines in which 1. Basic Neurosciences Developmental Neurology Neuroanatomy Neurobiology Neurochemistry Neuroimmunology Neuropharmacology Neurophysiology Neuroradiobiology Neurovirology Sensory Physiology and Biophysics 2. Clinical Neurosciences Clinical Investigation Neuroepidemiology Neuropathology Basic Communicative Sciences Audiology Sensory Physiology and Biophysics Speech Pathology 4. Clinical Communicative Sciences Audiology Clinical Investigation Otopathology Speech Pathology Mr. Edward Donohue (301) 496-4188 NATIONAL CENTER FOR NURSING RESEARCH (NR) Nursing research and research training related to patient care, the promotion of health, the prevention of disease, and mitigation of the effects of acute and chronic illnesses and disabilities. In support of studies of nursing interventions, procedures, delivery methods, and ethics of patient care, NR programs are expected to complement other biomedical research programs which are primarily concerned with causes and therapy of disease. Dr. Adele Wood (301) 496-0523 DIVISION OF RESEARCH RESOURCES (RR) Laboratory Animal Science and Medicine Dr. Leslie Bullock (301) 496-5175