NIMH RESEARCH CAREER AWARD FOR TRANSITION TO INDEPENDENCE Release Date: March 7, 2001 PA NUMBER: PAR-01-065 (This PA has been reissued, see PAR-05-109) (See update, NOT-MH-05-008) (See addendum NOT-MH-03-001) National Institute of Mental Health (http://www.nimh.nih.gov) Letter of Intent Receipt Date: June 18 Application Receipt Date: July 18 PURPOSE The National Institute of Mental Health (NIMH) invites applications from intramural and extramural scientists for the NIMH Research Career Award for Transition to Independence program. This initiative is designed to attract and train outstanding physician scientists and senior postdoctoral investigators (with at least 2-3 years of postgraduate research experience), who wish to further their basic or clinical career development experience by initially training within the NIMH Division of Intramural Research Programs (intramural phase), and then transitioning to an independent research program at a domestic U.S. extramural institution (extramural phase). As such, the program is intended to provide support for highly motivated and qualified candidates to focus on gaining significant experience in interdisciplinary mental health research fields in an NIMH intramural laboratory for a period of up to 3 years, followed by continued research support for up to 2 years for an independent research project at an extramural institution. The aggregate period of NIMH support under this award cannot exceed 5 years. During the extramural phase of this award, the NIMH expects K22 awardees to apply for investigator initiated research grants (e.g., R01, R03, or R21). HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This Program Announcement (PA), NIMH Career Award for Transition to Independence is related to numerous priority areas in this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELGIBILITY REQUIREMENTS The candidate must have a (normally limited to health professionals) doctoral degree such as Ph.D., M.D., or equivalent, and at least 2, but no more than 5 years of postdoctoral training (exclusive of clinical training) at the time of application. Individuals who have been principal investigators on NIH research project grants, program projects and center grants, or career development (K) awards are NOT eligible. Former principal investigators of an NIMH Small Grant (R03), Academic Research Enhancement Awards (AREA)(R15), or Exploratory/Developmental Grants (R21) remain eligible. Physician scientists and postdoctoral candidates for the NIMH K22 may not have pending Federal career development or research awards or concurrently apply for any other of these types of awards, and must terminate or transfer any active extramural support prior to activation of the K22 award. A candidate for the NIMH Research Career Award for Transition to Independence may neither concurrently apply for any other PHS award that duplicates the provisions of this award, nor have another application pending award by the PHS. Fellows who meet the requirements and are currently working at the NIMH Division of Intramural Research Programs are eligible to apply, provided that the research experience proposed promotes new areas of professional growth and development. Physician scientists and postdoctoral fellows supported by an NIMH Institutional NRSA training grant (T32) or an NIMH Individual NRSA postdoctoral fellowship (F32) are encouraged to apply; however, applicants should request start dates that allow for the completion of the NRSA training experience. The candidate must be an outstanding clinical or basic science investigator, with demonstrated potential for a highly productive research career. During the intramural phase of the award, the candidate will devote 100 percent effort to research activities. During the extramural phase, the candidate must spend a minimum of 75 percent effort on research and career development activities. (See section on Mechanism of Support for more on the 2 phases of the award.) Minorities, women, and individuals with disabilities are encouraged to apply. Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Card (I-151 or I-551) or some other verification of legal admission as a permanent U.S. resident, at the time of the award. MECHANISM OF SUPPORT The NIMH Career Award for Transition to Independence will use the career transition award (K22) mechanism. The entire project period for this award is five years, and consists of an intramural phase and an extramural phase. The intramural phase will provide support for 3 years, and upon recommendation for continued funding based on a formal NIMH progress review, the extramural phase will provide support for up to an additional two years. K22 awards are not renewable and NIMH general policy on career awards limits one mentored career award per individual. Further information about NIMH career awards can be found at: http://www.nimh.nih.gov/grants/training.cfm. PROGRAM OBJECTIVES The NIMH Division of Intramural Research Programs provides a unique and rich environment for research training and career development for senior postdoctoral fellows and beginning investigators. Intramural basic and clinical scientists are among the leaders in the mental health research fields. The NIMH Research Career Award for Transition to Independence is intended to provide an opportunity for the most promising and exceptionally talented new investigators, early in their career; to develop an independent research career, with funds available for both salary and research expenses. Each awardee, along with their intramural mentor, will be responsible for all aspects of their research program, including the design and execution of the research and the management of research funds. In addition to working in his/her mentor’s laboratory, the investigator has ample opportunity to interact with and seek guidance from other intramural and extramural scientists during his/her tenure at the NIMH. Transition from the intramural phase of support to the extramural phase is NOT automatic and is subject to review of the success of the awardees research accomplishments and the evaluation of a research plan to be carried out at the extramural institution. The review will be conducted by a formal NIMH scientific progress review committee, and will take place during the last (normally the third) year of the intramural phase. Individuals approved for the extramural phase will receive support through the K22 award mechanism. It is essential to document the extramural institution’s commitment to the retention, development, and advancement of the candidate during the period of the award. The extramural institution must be a domestic U.S. institution that demonstrates a commitment to the candidate by providing protected research time (minimum of 75% effort), space and other support needed to perform the proposed research. The extramural institution must describe the candidate’s academic appointment, bearing in mind that it must be tenure-track or equivalent, and that the appointment not be contingent on the transfer of the award to the institution. K22 awardees are expected to apply for an investigator-initiated research grant (R01, R03, and/or R21), in a research area relevant to the mission of the NIMH, during their tenure as a K22 awardee. It is expected that such an application will be submitted at the early stages of the final year of the K22 award in order to ensure continued support and a smooth transition to independence. Important Note: Acceptance into the NIMH Career Award for Transition to Independence Program does not imply a commitment on the part of the Institute to consider the awardee for a tenure-track position at the NIMH Division of Intramural Research Programs. The primary intent of this program is to develop outstanding mental health researchers who will pursue extramural research careers. However, awardees may wish to apply for available tenure- track position at the NIMH or another NIH Institute. The K22 award will be terminated if the candidate is offered and accepts such a position. NIMH DIVISION OF INTRAMURAL RESEARCH The Division of Intramural Research Programs at NIMH conducts a broad array of research activities that range from basic neuroscience and behavioral investigations conducted at the systems, cellular and molecular levels, to clinical investigations conducted into the diagnosis, treatment and prevention of mental illness. Major disease entities studied throughout the lifespan include mood disorders and anxiety, schizophrenia, obsessive- compulsive disorder, attention deficit hyperactivity disorder, and pediatric autoimmune neuropsychiatric disorders. Detailed information about these program investigators and their research projects can be obtained at: http://intramural.nimh.nih.gov. ALLOWABLE COSTS Intramural Phase: Funds for this phase of the award will be derived from the NIMH Division of Intramural Research Programs, and will include a full-time salary (12 month employment), technical support and research expenses (supplies, travel, equipment, and health care). There are no indirect costs associated with this phase, and total costs will not exceed $140,000 per year. Extramural Phase: Funds for the extramural phase will be provided through the non-competing K22, awarded to the domestic extramural institution to which the awardee is recruited. The NIMH will contribute up to 100 percent of the awardee's annual institutional base salary (based on a full time 12-month appointment) up to a maximum of $90,000. Note that these awards require a commitment of a minimum of 75 percent of full time professional effort, and the salary allowance will be commensurate with the actual level of effort directed to research and career development activities up to $90,000, plus applicable fringe benefits. This salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. In addition, NIMH will provide up to $50,000 for research costs including technical personnel, equipment, supplies, travel to research meetings or training, statistical services, including personnel and computer time, and other expenses. Salary for ancillary personnel support (secretarial and/or administrative assistance) is NOT allowed. Facilities and administrative costs (formerly called indirect costs) will be reimbursed at 8 percent of modified total direct costs. The 2 years of extramural support are NOT transferable to another institution. Salary supplementation using Federal funds is NOT allowed, and any institutional salary supplementation using non- Federal funds must NOT require responsibilities that may interfere with the awardees research and career development activities. 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 UPDATED NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html; a complete copy of the updated Guidelines are available at: http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relates to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators 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. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identity of the proposed mentor, as well as other key personnel (if applicable), and the number and title of the PA in response to which this application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of the subsequent application, the information that it contains allows NIMH staff to estimate the potential review workload and plan the review. The letter of intent should be sent to Barry B. Kaplan, Ph.D., at the address listed under INQUIRIES, by the letter of intent receipt date shown in the heading of this PA. APPLICATION PROCEDURES Prospective applicants should contact Barry B. Kaplan, Ph.D. at the NIMH Division of Intramural Research Programs at the address indicted under the INQUIRIES section, in order to initiate the process of identifying a mentor (if one has not already been selected), with whom the candidate can consult in preparing and submitting an application for the intramural phase of the award. Candidates from outside institutions or other NIH Institutes may obtain information about the NIMH Intramural Research Programs from the following Website: http://intramural.nimh.nih.gov. Fellows working at an NIMH laboratory may work with their current mentor, or with another intramural investigator, provided the research experience proposed in this application is in a fundamentally new area of research that will enhance the candidate’s scientific career. In any case, both the candidate and mentor must collaborate closely in completing the application and follow the appropriate instructions for current NIMH fellows. Applications for the intramural phase of the program must be submitted using form PHS 398 (rev. 4/98). 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) 710-0267; FAX (301) 480-0525, Email: grantsonfo@nih.gov. Forms are also available on the NIH Website at: http://grants.nih.gov/grants/funding/phs398/phs398.html. Identify the application as a response to this PAR. The title and number of the program announcement PAR-01-065, NIMH Research Career Award for Transition to Independence must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application and 3 signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) Receipt, Review, and Funding Schedule for K22 Awards: Letter of Intent Receipt Date: June 18 Application Receipt Date: July 18 Initial Scientific Review: October/November Second Level of Review by NIH Council: January Approximate Start Date: April 1 At the time of submission of the PHS 398 for the intramural phase of this program, 2 additional copies of the application should be sent to Jean G. Noronha, Ph.D., NIMH Referral Officer, at the following address. (These copies are used in planning the review process.) Jean G. Noronha, Ph.D. NIMH Referral Officer Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Telephone: (301) 443-3367 FAX: (301) 443-4720 E-Mail: jnoronah@mail.nih.gov APPLICATION CONTENTS Candidate o Describe the candidate’s commitment to a career in biomedical or behavioral research field relevant to the mission of NIMH. o Describe the candidate’s potential to develop into a successful independent investigator. o Describe the candidate’s current as well as long-term research and career objectives. o Include 3 sealed letters of recommendation detailing the candidate’s potential for a productive research career. Career Development Plan o Describe the career development plan incorporating consideration of the candidate’s goals and prior experience. A systematic plan should be presented for obtaining the necessary basic biomedical or behavioral science background and research experience to launch an independent research career. The career development plan must be specifically tailored to the needs of the candidate and the ultimate goal of achieving independence as a researcher. o Candidates must justify the need for a 3-year period of mentored research experience and must be able to provide a convincing case that the proposed period of support will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem. o Plans for research training activities including any course work that will promote the candidate’s scientific independence. Training in the Responsible Conduct of Research o Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component. Research Plan o The research plan should follow instructions outlined in form PHS 398 including sections on Specific Aim, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Mentor’s Statement (Intramural Phase) o The mentor must describe the elements of research training planned for the candidate, including any formal course-work, and specify how the candidate’s scientific and professional independence will be promoted. o The application must also include information describing the mentor’s research as it relates to the candidate’s research plan. o The mentor’s statement must include information regarding his or her research qualifications and previous experience as a research supervisor and mentor. o If more than one mentor is proposed, the respective areas of expertise and responsibility should be described. Budget o The applicant should work with the potential NIMH mentor to devise a budget for the Intramural Phase. Budget information for TOTAL DIRECT COST and cost justifications should be developed in accordance with the Budget instructions in form PHS 398. For candidates who receive approval for transition to the extramural phase, a budget will be submitted at that time as part of the form PHS 2590 non-competing application - see EVALUATION PROCEDURES, Extramural Phase (below). REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and responsiveness to the PAR by the appropriate NIMH staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsiveness to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applicants will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a secondary review by the National Advisory Mental Health Council. Review Criteria Candidate o Potential for carrying out independent research, based on experience level and training received leading up to the current application. o Potential to become an outstanding scientist who will contribute significantly to a mental health research field. o Evidence of research productivity, including quality of peer-reviewed scientific publications. o Ability to propose and carry out a significant, hypothesis-driven research project. o Ability to work within the highly interactive scientific environment of the NIMH Division of Intramural Research Programs, and to collaborate with other scientists. Career Development Plan o Appropriateness of the career development plan, and the likelihood that the award will enhance the scientific development of the candidate. o Appropriateness of the content and duration of the proposed didactic and research phases of the award. o Consistency of the career development plan with the candidate’s career goals and prior research experience. o Quality of the proposed training in responsible conduct of research. Research Plan o Significance and innovativeness of the hypothesis-driven research plan, and appropriateness and rigor of the experimental design and methodology. o Appropriateness of the proposed specific aims for the intramural phase of research, and evidence of long-term viability of the proposed research for the extramural phase. o Clear potential of the proposed research to contribute significantly to the mental health scientific literature. o Where appropriate, adequacy of plans for the inclusion (recruitment and retention) of both genders, minorities, and children in the research plan. Mentor o Research qualifications, scientific stature, experience and track record as a research mentor. o Adequacy and extent of proposed supervision that will occur during the intramural award period, and the commitment of the mentor to the applicant’s continued career development. o Appropriateness of the mentor’s research interests and qualifications to the career development needs of the applicant. o Previous experience in fostering the development of new investigators. Budget o Appropriateness and adequacy of the justification for the requested budget in relation to the research plan and career development goals. SELECTION PROCEDURES Intramural Phase Following peer review, a NIMH selection committee, comprised of senior intramural scientists and extramural program staff, will be convened by the NIMH Division of Neuroscience and Basic Behavioral Science to evaluate the applications, taking into account the priority score and recommendation of the IRG, the program priorities of the Institute, and availability of funds. Funding decisions will be made based on the recommendations of the selection committee and secondary review by the National Advisory Mental Health Council. EVALUATION PROCEDURES Intramural Phase The awardee is expected to prepare an annual progress report, which will be evaluated by the mentor and the laboratory or branch chief (if not the same person), as well as the Scientific and Training Directors, NIMH Division of Intramural Research Programs. Extramural Phase During the last (normally the third) year of the intramural phase, the candidate must submit a non-competing application (PHS 2590) for the K22 award, through the institution in which he/she is (or will be) employed as an independent researcher. The NIMH selection committee will determine whether or not the candidate will be recommended for the extramural phase of support. The application must include a progress report with specific aims achieved to date, resultant publications, current research grant support, and any pending grant applications. In addition, the application must include a research plan for the extramural phase, including new specific aims, significance, research plan, continued career development plan, and available resources. Further, both the awardee and the new mentor must submit a statement of research and career development plans for the extramural phase. There should also be a description of the extramural institution’s commitment to the development of the awardee’s career. Candidates able to successfully enter the extramural phase of the award at the end of their second year will forfeit their third year of intramural support. Following are general criteria for selection into the extramural phase: o Successful completion of the intramural phase of career development as evidenced by specific aims achieved to date, resultant publications, etc. o Continued qualifications and clear potential of the awardee to make a significant contribution to the NIMH mission. o Quality of the proposed research project, and its scientific merit as determined by formal review. o NIMH Program priorities, and availability of funds. INQUIRIES Prospective applicants are strongly encouraged to contact the NIMH staff listed below for consultation throughout the application process. These consultations are critical, especially during the initial planning phase of the application, and after initiating negotiations with the prospective NIMH scientific mentor. Inquiries regarding the Intramural Phase should be directed to: Barry B. Kaplan, Ph.D. Division of Intramural Research National Institute of Mental Health Building 10, Room 4N-222, MSC 1381 Bethesda, MD 20892-1381 Telephone: (301) 496-4183 FAX: (301) 480-8438 E-Mail: barry.kaplan@nih.gov Inquiries regarding the Extramural Phase of this initiative should be directed to: Mark Chavez, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7197, MSC 9645 Bethesda, MD 20892-9645 Telephone: (301) 443-3563 FAX: (301) 443-1731 E-mail: mchavez1@mail.nih.gov Fred Altman, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6217, MSC 9621 Bethesda, MD 20892-9621 Telephone: (301) 443-9700 FAX: (301) 480-6000 E-Mail: faltman@mail.nih.gov Enid Light, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-3599 FAX: (301) 594-6784 E-Mail: elight@mail.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 E-Mail: dtrunnel@mail.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.281. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the NIH Grants Policy Statement (October 1, 1998). PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the 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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