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PAUL B. BEESON CAREER DEVELOPMENT AWARDS IN AGING RELEASE DATE: September 8, 2003 RFA Number: RFA-AG-04-004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov/) The John A. Hartford Foundation (http://www.jhartfound.org/) The Atlantic Philanthropies (http://www.atlanticphilanthropies.org) The Starr Foundation (http://fdncenter.org/grantmaker/starr/) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute on Aging (NIA) (http://www.nia.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.866 LETTER OF INTENT RECEIPT DATE: November 17, 2003 APPLICATION RECEIPT DATE: December 17, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Allowable Costs o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Program Considerations o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations: PURPOSE OF THIS RFA The National Institute on Aging (NIA), the John A. Hartford Foundation, Atlantic Philanthropies, and the Starr Foundation are collaborating on this initiative to sustain and promote the research careers of clinically trained individuals who are pursuing research careers in aging. (The Hartford Foundation, Atlantic Philanthropies, and the Starr Foundation are collectively identified as "the participating foundations" later in this document). The program is named after Dr. Paul B. Beeson. Dr. Beeson was Chairman of Medicine at Emory and Yale Medical Schools, Nuffield Professor at Oxford University and Professor and distinguished VA Physician at the University of Washington. He chaired the first Institute of Medicine study on "Aging and Medical Education" in 1978. His leadership as an editor of the Cecil Textbook of Medicine greatly influenced medical education. From his research and patient care base, he grew increasingly interested in the process of aging, and this interest led to a commitment that included his editorship of the Journal of the American Geriatrics Society. He has profoundly influenced the career paths of many young physicians, including several who now form the core leadership in geriatric medicine. The aims of the Paul B. Beeson Career Development Awards in Aging (BCDA) program are: To encourage and assist the development of future leaders in the field of aging by supporting faculty members early in their careers to gain additional research training as needed and to establish independent programs in aging research. To deepen the commitment of research institutions to academic research in aging and to translating research outcomes to geriatric medicine by involving mentor and recipient in establishing and advancing the recipient's career in aging research. To expand medical research on aging broadly defined as including the biology of aging, maintenance of health and independence in old age, diseases and disabilities of old age and issues in their clinical management, and systems of care for the elderly. Overall the program will foster the independent research careers of clinically trained investigators whose research will enhance the health and quality of life of Americans, particularly older people. RESEARCH OBJECTIVES Despite multiple efforts and programs sponsored by the National Institutes of Health, other agencies, and private foundations, the numbers of clinically-trained individuals who are committing to and sustaining independent research careers in the biomedical sciences remain inadequate to address the opportunities for translational research, interdisciplinary collaboration, and groundbreaking basic research being generated by advances in genetics, biomedical engineering, and other life sciences. Within the field of clinical aging research the small numbers of individuals receiving training in geriatrics, and the smaller numbers pursuing clinical research remain wholly inadequate to address the burgeoning needs of the rapidly growing older population. The aging of the American population requires a substantial investment in current and future faculty who will devote their careers to advancing knowledge of effective prevention and management of illness and disabilities, and to inspire successive generations to do the same. This program provides support to junior to mid-career faculty members in strong research environments to enable them to gain skills and experience in clinical aging research and to establish an independent program of research in this field. If you are such a faculty member and wish to apply for this program you must identify a mentor. This individual should be a senior researcher in aging and/or geriatrics who agrees to commit time to supervising and guiding you during the period of the award. Mentors are encouraged to request limited support from the career development award to reflect their commitment to you (see below under Allowable Costs). Program: The BCDA is intended to provide you with the resources and time to establish yourself as an independent and funded investigator whose research focuses on clinically-relevant topics in aging. It is targeted primarily at individuals who have had some prior training in research coursework, methods, and resources related to aging research. Therefore the didactic plan is expected to be a relatively small part of the overall program and be tailored closely to the particular targeted aims of the research. Nevertheless candidates with limited prior research training and research experience will need longer periods of support on the BCDA than those with more research training and experience. Also, exceptionally, some candidates may require more extended periods of didactic training if changing areas or acquiring additional research skills. To accommodate these differences in prior experience or intended direction the initial BCDA award may be from three to five years. In addition, clinically-trained candidates with limited research experience are eligible for an up to two year competing continuation of the BCDA following completion of the initial award. Candidates who have a research doctorate earned prior to receiving the BCDA are not eligible for this competing continuation. Your program must be tailored to your individual needs and ensure that you will gain the experience, knowledge and skills necessary to carry out high quality clinically- relevant aging research. You and your mentor are jointly responsible for the preparation of the plan for this program. At least 75% of your full-time professional effort must be devoted to the goals of this award. The remainder may be devoted to pursuits consistent with the purpose of the award which must be designed to allow you to develop the necessary experience, knowledge and skills to become an independent researcher in a clinically-relevant field of aging. The BCDA program allows support for your salary, additional limited support for mentors, and for research/research development expenses to be used for research and training. The proposed training and research must focus on clinically-relevant research on aging and/or the aged. Your research project may be in the basic sciences, use animal models, or employ secondary data analysis as well as clinical and patient-focused methods. The full range of research methods is encouraged provided that the application makes clear the clinical-relevance of the proposed work. Mentor(s): You must name a primary mentor, who together with you is responsible for the planning, direction, and execution of the program. Your mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. You may also nominate co-mentors as appropriate to the goals of the program. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models. In addition your institution must have a well-established research and clinical career development program with an emphasis or specialty in geriatrics and/or other areas of aging-related research. It must have faculty qualified in aging research to serve as mentors. Your institution must be able to demonstrate a commitment to your development as a productive, independent investigator in aging-related research. MECHANISMS OF SUPPORT This RFA will use the NIH Patient-Oriented Research Career Development Award mechanism (K23); and the NIH Mentored Clinical Scientist Development Award mechanism (K08). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation although NIA and the participating foundations intend to re-issue this announcement if funds remain available. The anticipated award date is July 1, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated NIH mentored career development award applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. Competing Continuations. You may be able to seek a competing continuation following your initial award if you have limited research training and experience at the time of initial application. Clinically- trained applicants with no prior NIH career development or similar award from other sources prior to the initial BCDA may seek support for one competing continuation of the BCDA. This continuation may not request support for more than two additional years. However, if you possess a research doctorate you are not eligible for the two-year continuation. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. If you are seeking to pursue patient-oriented research you should seek a K23 BCDA. If your own research project focuses on research in the basic sciences, uses animal models or secondary data-analysis with no direct contact with human participants, then you should seek a K08 BCDA. FUNDS AVAILABLE The National Institute on Aging and the participating foundations intend to commit (in combination) approximately $2.5 million in FY 2004 to fund 10 to 12 new grants in response to this RFA. You may request a project period of three, four or five years (note considerations under Program above) and a budget for direct costs of up to $200,000 per year. The maximum allowable direct costs across all years are $800,000 for five year awards, $700,000 for four year awards and $600,000 for three year awards. Budgets for competing continuations will be limited to $300,000 across the two years with no more than $200,000 allowed in any one year. Although the financial plans of NIA and the participating foundations provide support for this program, awards pursuant to this RFA are contingent on the availability of funds and the receipt of a sufficient number of meritorious applications. NIA and the participating foundations also intend to reissue this RFA in future years contingent on the continuing availability of funds and receipt of meritorious applications. ALLOWABLE COSTS 1. Salary: The NIA and the participating foundations will provide salary and fringe benefits for you. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at your 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. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Note that the maximum salary support that NIA may provide is limited by the NIH legislative limit. Information on the current legislative limit is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-034.html. Foundation funds are not restricted in this way and therefore total salary may be above the NIH legislative limit if consistent with the salary structure of the institution, and if the NIA contribution is no more than the prevailing legislative limit. At least 75% of full-time effort must be devoted to the goals of this award. Because the salary amount provided by this award is based on your full-time institutional salary, you may not use other PHS funds to supplement the salary. However, you may use foundation funds in this way with the permission of the sponsoring foundation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the BCDA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. 2. Research Development Support: These expenses include: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; (d) statistical services including personnel and computer time. 3. Ancillary Personnel Support: Salary for secretaries and administrative assistants is not allowed. Funding for mentors is encouraged but is limited to no more than 5% effort for mentors for up to three years. 4. Facilities and Administrative Costs: These costs, will be reimbursed at 8 percent of modified total direct costs and only on the NIA portion of the BCDA. The NIA portion to which F&A costs may be applied should be calculated at $100,000 per year for the purpose of calculating these amounts. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Foreign institutions are not eligible to apply Also note the institutional requirements described under Research Objectives and under Review Considerations. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS You must have a clinical doctoral degree (e.g., MD, DO, DDS) or its equivalent. Note that, under some circumstances, individuals with doctoral degrees that require a dissertation or thesis as the final (non-clinical) stage of the doctoral program may apply for the BCDA program. These may include individuals holding both MD and PhD degrees as well as individuals with PhDs in clinical fields (such as clinical psychology, nursing or physical therapy). However, such individuals are not eligible for a competing continuation of the BCDA. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. You also must have completed your clinical training, including specialty and, if applicable, subspecialty training prior to receiving an award. However, you may submit an application prior to the completion of clinical training. You must identify a mentor with extensive research experience, and must be willing to spend a minimum of 75 percent of full-time professional effort conducting research career development and research on aging. At the time of award, you must be a citizen or noncitizen national of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Ineligible individuals include current and former principal investigators on NIH research project (R01), FIRST Awards (R29), sub- projects of program project (P01) or center grants (P50). Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible. You cannot hold the BCDA concurrently with another NIH career development award or similar award. You must terminate the other career development award in order to receive the BCDA. Normally support from the prior career development award and support from the BCDA should add to no more than five years. We encourage you to apply for independent research grant support during the period of this award. PROGRAM CONSIDERATIONS Evaluation: In carrying out their stewardship of human resource related programs, NIA or the participating foundations may request information essential to assess the effectiveness of this program. Accordingly, you are hereby notified that you may be contacted after the completion of this award for periodic updates on various aspects of your employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. Other Income: You may not retain fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award. Such fees must be assigned to your grantee institution for disposition by any of the following methods: o The funds may be expended by your institution in accordance with the 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 should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. o You 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 your grantee institution. If you currently receive salary and fringe benefit support from an NIH- supported research or research training grant, the salary funds from the BCDA will replace your current support. Under most circumstances the funds that are released will be returned to the Institute that supports the other award. However, under unusual circumstances the principal investigator of the other grant may seek approval from that Institute to use the funds for research within the scope of the prior award. G. Special Leave: Leave to another institution, including a foreign laboratory may be permitted if the experience that you propose is directly related to the purpose of your award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of NIA and the participating foundations is required. To obtain prior approval, you must submit a letter to NIA and the participating foundations describing the plan, countersigned by your department head and appropriate institutional official. 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 BCDA will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of NIA and the participating foundations 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 you are eligible. Under unusual and pressing circumstances, you may submit a written request to NIA and the participating foundations, requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case, will it be permissible to work at a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, your grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to your scientific development. Further, you must provide written assurance of your intent to return to full- time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIA together with the leadership of the participating foundations 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 NIA and the participating foundations shall notify both you and your institution in writing of this determination, the reasons for it, the effective date, and the right to appeal the decision. If you plan a change of institution, you must submit to NIA and the participating foundations in advance of the change a written request for transfer, countersigned by the appropriate institutional business official, describing the reasons for the change and including the new sponsor's name and biosketch. You must establish in this request that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer reviewed research program. Additionally, the new sponsor must have the appropriate research expertise to supervise the program and sufficient research support to ensure continuation of the research program to the end of the award (initial award). Staff at NIA and the participating foundations will review this request and may require a review by an initial review group and/or the appropriate national advisory council or board. Upon approval of this request, a new BCDA application must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than the time remaining within the existing award period. When a mentor at your grantee institution is to be replaced, the institution must submit a letter from the proposed mentor documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for your career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. Staff within NIA, and the participating foundations will review the request, and will notify the grantee institution of the results of the evaluation. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or when an institution relinquishes an award. SPECIAL REQUIREMENTS You and your primary mentor should commit to attending one annual meeting a year as a condition of accepting a BCDA. You should budget funds for your individual travel to and from the annual Beeson meeting for one meeting a year. (The location of the meeting will vary from year to year.) WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Robin A. Barr, D. Phil. Office of Extramural Affairs 7201 Wisconsin Avenue, Room 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-2945 Email: BarrR@nia.nih.gov o Direct your questions concerning peer review issues to: Mary Nekola, Ph.D. Chief, Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 Bethesda, MD 20892-2292 Telephone: (301) 496-9666 FAX: (301) 402-0066 Email: nekolam@nia.nih.gov o Direct your questions about financial or grants management matters to: Linda Whipp Grants Management Officer National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892-2292 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: whippL@nia.nih.gov LETTER OF INTENT You are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Your name, address, and telephone number o Names of all key personnel including proposed mentors o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Mary Nekola, Ph.D., Chief Scientific Review Office National Institute on Aging Gateway Building, Room 2C212 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 FAX: (301)402-0066 Email: nekolam@nia.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. This initiative is a collaboration among NIA and the participating foundations. Submission of an application is explicit approval for NIA to share the application and the written results of its review (the summary statement) with the collaborating partners. NIA and the foundations will jointly consider the applications to determine responsiveness to the RFA (see below under PEER REVIEW PROCESS) and jointly consider the results of review in order to develop a funding plan (see below under AWARD CRITERIA). SUPPLEMENTARY INSTRUCTIONS: The instructions provided here are in addition to the instructions in the PHS 398 (rev. 5/2001 section on career development awards (Section IV). Please refer to that section in preparing your application. If you intend to use the resources within a General Clinical Research Center (GCRC) during the course of your award include a letter of agreement from either the GCRC program director or the principal investigator with the application. The application must contain the following: Candidate o A description of your commitment to a career in clinically-relevant aging research o Evidence of your potential to develop into an independent investigator. o A description of your immediate and long-term career objectives, explaining how the award will contribute to their attainment. o A commitment of at least 75 percent effort to the BCDA program. o Three sealed letters of recommendation addressing your potential for a career in clinical aging research. The mentor's statement (see below) must not be included as one of the letters of recommendation. Career Development Plan o Describe a plan for your career development that integrates your goals and prior experience. It must show how you will obtain, or that you have obtained, the necessary theoretical and conceptual background, in addition to the research experience and skills, necessary to launch an independent career in clinically relevant aging research. You must describe available and appropriate courses on aging, including ethical and regulatory issues and integrate these studies into your career development plan. It is expected that most candidates will already have completed relevant coursework on aging and on aging-related research methods and resources. Therefore the didactic period will be brief and the bulk of the awards will consist of intensive supervised research experiences staged towards increasing independence for the candidate. In exceptional cases, less experienced candidates may require a phased developmental period in which the first one to two year(s) of the award are largely of a didactic nature followed by a period of intense, supervised research experience. The career development plan must be specifically tailored to your individual needs and the ultimate goal of achieving independence as a researcher on aging. Mentor's Statement o The application must include a statement from the mentor including information on his or her qualifications in your proposed research area and previous experience as a research supervisor. The application must also include information to describe the nature and extent of supervision that will occur during the proposed award period. o Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described. A co-mentor who is not your primary mentor may write a letter of reference for you. Research Plan o Describe the research plan following the instructions in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. You should consult with your mentor regarding the development of this section. Environment and Institutional Commitment o Your sponsoring institution must document a strong, well-established research and training program related to your area of interest including a high-quality research environment with staff capable of collaborating with you. Your institution must provide a statement of commitment to your development into a productive, independent investigator in clinically-relevant aging research. The institutional statement also must commit to provision of release time from normal clinical, teaching or administrative duties necessary to meet the 75% effort requirement of this award. Training in the Responsible Conduct of Research o You must either (a) describe plans to receive instruction in the responsible conduct of research, or (b) provide evidence that you have completed such a course in the past three years, or (c) show that you are teaching such a course. These plans or description of the course must detail the subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component. Budget o The total direct costs requested must be consistent with the amounts described under Allowable Costs in this BCDA announcement. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Mary Nekola, Ph.D., Chief Scientific Review Office National Institute on Aging Gateway Building, Room 2C212 Bethesda, MD 20892-9205 Telephone: (301) 496-9666 FAX: (301)402-0066 Email: nekolam@nia.nih.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to you without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIA and the participating foundations. Incomplete and nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Council on Aging REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed goals of the career development award will enable the candidate to have a substantial impact on clinically-relevant aging research. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Candidate o Career Development Plan o Training in the Responsible Conduct of Research o Research Plan o Mentor(s) o Environment and Institutional Commitment Candidate o Quality of your academic and clinical record, o Your potential through this award to develop as an independent researcher focusing on clinically-relevant aging research. Reviewers will consider the proposed duration of support along with the quality of the proposed career development and research activities. o Your commitment to a career in clinically-relevant aging research. Career Development Plan o Likelihood that the career development plan will contribute substantially to your scientific development and lead to your establishing and advancing an independent research career in clinical aging research; o Appropriateness of the content and duration of the proposed didactic and research phases of the award; and o Consistency of the career development plan with your career goals and prior research experience. Training in the Responsible Conduct of Research o Quality of the proposed training in responsible conduct of research. Research Plan Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Nevertheless, a fundamentally sound research plan must be provided. For candidates who require substantial didactic training as part of their program, the research plan may cover less than the full period of the award. o Scientific and technical merit of the research question, design and methodology; o Relevance of the proposed research to your career objectives; and o Appropriateness of the research plan to your stage of research development and as a vehicle for developing the research skills as described in the career development plan; Mentor/Co-Mentor o Appropriateness of mentor(s) research qualifications in the area of this application; o Quality and extent of mentor's proposed role in providing guidance and advice to you; o Previous experience in fostering the development of more junior researchers; o History of research productivity and support; and o Adequacy of support for the proposed research project. Environment and Institutional Commitment o Adequacy of research facilities and the availability of appropriate educational opportunities; o Quality and relevance of the environment for your scientific and professional development; o Your institution's commitment to your scientific development and assurances that your institution intends you to be an integral part of its research program; and o Your institution's commitment to an appropriate balance of research and clinical responsibilities including the commitment of 75 percent of your effort to research and research related activities. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, AND MINORITIES IN RESEARCH: The adequacy of plans to include subjects from both genders, and all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 17, 2003 Application Receipt Date: December 17, 2003 Peer Review Date: March 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 2004 AWARD CRITERIA Award criteria that NIA and the participating foundations will use to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Program balance. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety-monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the 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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