RESEARCH SCHOLAR DEVELOPMENT AWARD Release Date: May 15, 1998 PA NUMBER: PAR-98-072 P.T. National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications from outstanding intramural and extramural postdoctoral fellows for the Research Scholar Development Award (RSDA). The RSDA will provide support for postdoctoral fellows who are moving to assistant professor positions in an academic institution. The purpose of the RSDA is to ease the transition to an academic position by enabling the awardee to focus on the establishment of his/her research laboratory prior to submitting applications for grant support. This is a two-year pilot program. 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 PA, Research Scholar Development Award, is related to the priority areas of HIV infection, diabetes and chronic disabling conditions, maternal and infant health, sexually transmitted diseases, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY The candidate must have a health professional doctoral degree or its equivalent, such as Ph.D, M.D., D.O., D.D.S., D.V.M., O.D., D.P.M., Sc.D., D.N.S. and have demonstrated the capacity for highly productive, independent postdoctoral research in her or his chosen field prior to applying for this award. For this pilot applicants must be either (a) postdoctoral fellows in an NIAID intramural laboratory, or (b) postdoctoral trainees supported by an NIAID Institutional NRSA training grant (T32) or an NIAID Individual NRSA postdoctoral fellowship (F32). Minorities, women, and individuals with disabilities, meeting these requirements, are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals or must have been lawfully admitted for permanent residence. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT The NIAID RSDA program will use the NIH Career Transition (K22) award. The project period for this award is two years, awards are not renewable. NIAID intends to award 6-8 competing RSDAs per year for the two years of this pilot program. PROGRAM OBJECTIVES The primary objective of this Program Announcement is to help the awardee develop a strong, independent research career. This will be accomplished by supporting outstanding postdoctoral scientists as they move to their first academic position as assistant professors. The RSDA will ease the transition so the awardee can concentrate on establishing a viable research laboratory prior to applying for research grant support. Applications responding to this Program Announcement will be submitted in two phases. PHASE I OF THE RSDA APPLICATION: Because of the nature of this award, the applicant will not have identified a sponsoring institution at the time of submitting the Phase I portion of the RSDA application. Thus, the front page of PHS 398 will not require a sponsoring institution or institutional officials and signatures. The following items on form PHS-398 application are required for the first phase of an RSDA application: 1. Biographical Sketch A biographical sketch is required for the applicant, following the modified instructions below. Do not exceed the two-page limit. o Complete the education block at the top of the form page. o List current position(s) and those previous positions directly relevant to the application. o List peer-reviewed publications directly relevant to the proposed project with full citation. o Provide information on research projects completed during the last five years that are relevant to the proposed project. 2. Candidate The application must address the following issues regarding the candidate: o Establish the candidate"s commitment and potential to develop into a successful independent investigator in biomedical, behavioral, or public health research. o Summarize the candidate"s immediate and long-term career objectives, explaining how the award will contribute to their attainment. 3. Research Plan The candidate must describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design, and Methods. The Research Plan should be written by the candidate with help from the individual’s postdoctoral supervisor (i.e. the supervisor at the institution where the applicant is finishing his/her postdoctoral work). PHASE II OF THE RSDA APPLICATION: If the applicant receives a fundable score after the review of Phase I of the application, she or he will be notified in writing of NIAID’s commitment to make an award. The candidate will then have a period of up to 12 months to identify a suitable position as an assistant professor at an academic institution. When negotiations between the applicant and the institution are complete, Phase II of the application can take place. The following items are required for the second phase of an RSDA application: Budget: A detailed budget for Initial Budget Period - complete form page 4 of the PHS 398 (rev. 5/95). Budget for Entire Proposed Period of Support - complete the categorical budget table on form page 5 in the PHS 398 (rev. 5/95) for up to two years of support. Begin the budget justification on Form Page 5 (see Item 2 below), using continuation pages as needed. 2. Budget Justification o List the name, role on project and percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person. o Identify all consultants by name and organizational affiliation and describe the services to be performed. o Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project. Describe specific resources committed by the sponsoring institution to support the applicant s research. o Indirect costs will be calculated at the time of the award at an eight percent rate or at the institution’s actual rate, whichever is lower. Applicants will be asked to identify the indirect cost exclusions prior to award. 3. Career Development Plan Describe the career development plan, incorporating consideration of the candidate"s goals and prior experience. It should describe a systematic plan to obtain the necessary background and research experience to launch a career in biomedical or behavioral research. Statements from officials at the institution chosen by the RSDA applicant should strongly address the research career and academic plan for the candidate. 4. Environment and Institutional Commitment The sponsoring institution must document a strong, well-established research program in biomedical and behavioral research. The sponsoring institution also must provide a detailed statement of institutional resources committed to foster the candidate"s development into a productive, independent investigator. Prior to the award, the candidate and an appropriate official (Dean, departmental Chair, or equivalent) of the sponsoring institution must satisfactorily describe the elements of a research program that will maximize the candidate’s chances for a successful research career in an academic setting. COMMITMENT OF RSDA INVESTIGATOR: At least 75 percent of the recipient"s full-time professional effort must be devoted to the program while the remainder may be devoted to other research- related, clinical and/or teaching pursuits consistent with the objectives of the award. ALLOWABLE COSTS This award will provide up to a total of $150,000 (direct costs) in the first year, and up to $100,000 (direct costs) in the second year. a. Salary: The amount of funding that may be used to support the awardee s salary is limited to $50,000 per year (plus fringe benefits). If the salary negotiated between the awardee and the sponsoring institution is higher than $50,000, the institution may use non-Federal funds to supplement its contribution up to a level that is consistent with the institution"s salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the RSDA. The RSDA does not require that salary support be derived from the award, use of the entire direct costs for research-related expenses is allowed. The total salary requested must be based on a full-time, 12-month appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. b. Research-Related Expenses: These include salaries for technical support, consultant costs, equipment, supplies, travel, and other research-related expenses. c. Ancillary Personnel Support: Salary for secretarial or administrative assistance is NOT allowed. RSDA awards will be made under Expanded and Federal Demonstration Project authorities to eligible institutions. After review of the initial Phase I applications for scientific merit, funding of the RSDA will depend largely on the institutional commitment of funds, time, and other resources toward the development of the RSDA applicant shown in the Phase II application. Fees resulting from clinical practice, professional consultation, or other comparable activities required by research and research-related activities of this award may not be retained by the RSDA recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: o The funds may be expended by the grantee institution in accordance with the HHS/NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. o The funds may be used for health-related research purposes. o The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks must be made payable to the Department of Health and Human Services, NIH, and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an HHS/NIH-supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be re-budgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of an RSDA career award must receive prior written approval of the program administrator. SPECIAL LEAVE Short leave periods to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the awarding organization is required. To obtain prior approval the award recipient must submit a letter countersigned by his or her department head and the appropriate local institutional official to NIAID describing the plan. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the awarding institute and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. TERMINATION OR CHANGE OF INSTITUTION When a grantee institution plans to terminate an award, the awarding institute must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. Changes of institution will only be considered under extremely special circumstances. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES Applications for Phase I are to be submitted on form PHS 398 (rev. 5/95) and will be accepted on the receipt deadlines indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, FAX (301) 480-0525, Email: [email protected]. Forms are also available on the NIH Website at http://www.nih.gov/grants/funding/phs398/phs398.html For purposes of identification and processing, item 2 on the face page of the application must be marked "YES." The PA number and the PA title must also be typed in section 2. The completed, signed original and five legible, single-sided copies of the application and five copies of the appendices must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) Potential applicants are encouraged to discuss their plans and objectives of their proposed application with the NIH staff member listed under INQUIRIES before submitting an application. REVIEW CONSIDERATIONS Applications received in response to this program announcement will be reviewed in accordance with the usual NIH peer review procedures. Applications will be reviewed for completeness by the NIH Center for Scientific Review (CSR). Applications that are complete will be evaluated for scientific and technical merit. Phase I of the review process will be undertaken by a review committee convened by the NIAID. For this phase, the applicant will submit a research proposal clearly delineating the scientific and technical aspects of the application, without necessarily having identified a sponsoring academic institution. The research proposal will be submitted from the institution at which the candidate is a postdoctoral trainee, and will be written under the guidance of the trainee’s advisor. As part of the initial merit review, all applications will receive a written critique. Only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score and will receive a second level review by the National Allergy and Infectious Diseases Advisory Council. The following review criteria will be applied in Phase I of the review process: 1. Candidate: Is the candidate appropriately trained and suited to the proposed career development activities, i.e., well trained and productive in his or her current field and prepared for the proposed research activities? 2. Career Development Plan: Is the career development plan proposed one which will give the candidate sufficient background and experience in research such that the candidate can establish an independent research career? 3. Research Plan: All candidates for this award must have had previous research experience as postdoctoral scientists. A strong research plan that is consistent with the career development plan and the candidate"s level of research development should be provided. 4. Significance: Does this project address an important problem? How well does the proposed research experience complement the proposed career development activities? 5. Approach: Are the methods adequately developed, well-integrated, and appropriate to the research plan and career development goals of the candidate? Does the candidate acknowledge potential problem areas and consider alternative tactics? In addition, all applications will also be reviewed with respect to the following criteria (if applicable), in accordance with NIH policy: a. The adequacy of plans to include both genders, minorities, and their subgroups and children as appropriate for the scientific goals of any clinical research activities. Plans for the recruitment and retention of subjects will also be evaluated. b. The adequacy of the proposed protection for humans, animals, or the environment to the extent they may be adversely affected by the activities proposed in the application. After the Phase I applications have been reviewed and have received a priority score, those applicants with fundable scores will be notified in writing of a conditional intent of the NIAID to make an award. This document may be used by the RSDA applicant to identify a suitable academic institution and enter into negotiations for a position as assistant professor. The second stage of the review process (Phase II) will take place after the candidate and officials from the chosen academic institution have negotiated a suitable position. The second stage of the application (Phase II) must include the items described earlier under the section PHASE II OF THE RSDA APPLICATION. The appropriateness and soundness of the arrangement negotiated between the applicant and the new sponsoring institution will be carefully assessed by NIAID staff. The institutional commitment of resources, time and other factors conducive to the research project and the career development of the RSDA applicant will be carefully examined. Applications from candidates appointed to assistant professorships at the same institution where they held a postdoctoral position must provide a strong justification for applying for the RSDA at that institution. AWARD CRITERIA Funding decisions will be made based on the recommendations of the initial review group for Phase I, staff recommendations after Phase II review, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged, especially during the planning phase of the application. Inquiries regarding programmatic issues may be directed to: Milton J. Hernandez, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C21 Bethesda, MD 20892-7640 Telephone: (301) 496-3775 FAX: (301) 402-0369 Email: [email protected] Direct inquiries regarding fiscal matters to: Barbara Huffman Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C17 Bethesda, MD 20892-7640 Telephone: (301) 496-3821 FAX: (301) 402-0369 Email: [email protected] AUTHORITY AND REGULATIONS The RSDA awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended. The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance Nos. 93.855 and 93.856. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The HHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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