ALZHEIMER’s DISEASE CLINICAL RESEARCH AND TRAINING PROGRAM: MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARDS IN ALZHEIMER’s DISEASE AND RELATED DEMENTIAS Release Date: May 2, 2001 RFA NUMBER: RFA-AG-01-005 National Institute on Aging (http://www.nih.gov/nia/) Letter of Intent Receipt Date: June 1, 2001 Application Receipt Date: July 12, 2001 PURPOSE The National Institute on Aging (NIA) will accept applications for the Mentored Clinical Scientist Development Award (K08) or Mentored Research Scientist Award (K01) in the area of Alzheimer’s disease and related dementias research. NIA will offer the K08 or K01 award to support the development of outstanding academic physician scientists. These mechanisms provide support for a period of supervised research and study for either clinically trained professionals with little research experience but who have the commitment and the potential to develop into productive, independent investigators (K08) or for clinically trained professionals with substantial research experience who wish to redirect their career to concentrate on Alzheimer’s research (K01). The award period is three years and must include a plan to obtain and integrate a fundamental and theoretical understanding of dementia with a period of intensive clinically oriented and/or laboratory research. The proposed research should have both intrinsic importance and be a suitable vehicle for learning the skills necessary to become an independent physician-scientist concentrating on dementia research and practice. The scope and nature of the proposed research should also be suitable for potential development into an independently funded research endeavor. Whenever possible the research program should be designed to elicit results that can be translated into clinical practice. This award will support developmental experiences in either clinical or laboratory research. Because of the focus on a progression to independence as a researcher, the prospective candidate for the K08 or K01 award should propose a period of development consistent with this goal and his or her previous research and clinical experience. For example, a candidate with limited experience in dementia research may need a designated period of didactic training and closely supervised research experience for a longer period as the most efficient means of attaining independence. A candidate with substantial previous research experience, such as an investigator in another field redirecting his/her career focus into dementia research, may require a shorter didactic training period appropriate for the transition to independence. In all cases, the candidate must provide evidence of having attained a broad understanding of theoretical aspects of the relevant clinical or basic science related to Alzheimer’s disease and related dementias, or that s/he will attain the same during the course of this award. All applicants are strongly encouraged to contact NIA staff listed below to discuss issues of eligibility and the specific provisions of this award as it pertains to NIA programmatic interests. While NINDS is not a sponsor of this RFA, the Institute has strong interest in research in Alzheimer's disease and related dementias (see: http://www.ninds.nih.gov/about_ninds/clusters/neurodegeneration.htm). 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 Request for Applications (RFA), Alzheimer’s Disease Clinical Research and Training Program, 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/. ELIGIBILITY REQUIREMENTS The candidate must have an M.D. degree or its equivalent, must have completed postgraduate clinical training in a clinical area pertinent to the goals of this RFA such as Geriatric Medicine, Neurology, Psychiatry or Neuropathology and have secured a faculty appointment in an appropriate research-intensive environment with established facilities for Alzheimer’s disease research comparable to an NIA- sponsored Alzheimer’s Disease Center, must identify a mentor with extensive Alzheimer’s disease research experience, and must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development related to Alzheimer’s disease and related dementias. Applications may be submitted, on behalf of candidates, by domestic organizations, public or private, such as medical schools. Minorities and women 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 Receipt Card (I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Former or current principal investigators on NIH research project(R01), FIRST Awards(R29), sub-projects of program project(P01) or center grants (P50), or the equivalent, are not eligible for the K08 award but may apply for the K01 award. Candidates for these K awards may not concurrently apply for any other PHS award that duplicates the provisions of this award. Both K08 and K01 recipients are encouraged to apply for independent research grant support during the period of this award. Recipients would be allowed to maintain the award if other PHS support is procured, as long as the new support does not interfere with the ability to meet the K08 or K01 requirements. MECHANISM OF SUPPORT Awards in response to this Request for Applications will use the K08 or K01 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and his/her mentor on behalf of the applicant institution. The project period is limited to three years. Awards are not renewable. FUNDS AVAILABLE The NIA has set aside funds sufficient to make five awards in the first year of the program and an additional five awards beginning in the second year. Awards are contingent upon availability of funds and receipt of a sufficient number of applications of outstanding scientific and technical merit. It is anticipated that this RFA will be reissued in 2002. RESEARCH OBJECTIVES A. Environment: The institution must have well-established research programs in Alzheimer’s disease research including clinical facilities and basic laboratories similar to those of an NIA-sponsored Alzheimer’s Disease Center. The institution must have experience with clinical career development programs and qualified faculty in clinical and basic research related to Alzheimer’s disease and other neurodegenerative diseases to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate, mentor and institution must be able to describe an in-depth, broadly based career development program that will maximize the use of relevant research and educational resources. B. Program: The goal of this program is to train junior and mid level physicians to focus their careers on Alzheimer’s disease research and to apply basic knowledge of the disease process to clinical care of patients. There is a critical need to build better bridges between Alzheimer’s laboratory research and cutting edge new methods of diagnosis, treatment and prevention of the disease. Well-trained physician scientists are needed to provide the next generation of leadership for research and treatment of Alzheimer’s disease and the related dementias. The award provides for three consecutive 12 month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other clinical and teaching pursuits consonant with the objectives of the award. Both the didactic and basic science components must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. C. Mentor(s): The recipient must receive appropriate mentoring throughout the three-year program. The mentor(s) must have expertise in Alzheimer’s disease and related dementias and have a funded research program. Where feasible, women and minority mentors should be involved as role models. D. Allowable Costs: 1. Salary: NIA will provide salary for the K08 or K01 recipient at a maximum of $ 100,000 per year. The institution may supplement the NIA contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K08. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a 100%, 12-month staff appointment. It 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. 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. 2. Research Development Support: NIA will provide up to $50,000 per year for: (a) research expenses such as supplies, equipment and technical personnel; (b) statistical services including personnel and computer time;(c) travel to research meetings or training; (d) tuition, fees, and books related to career development. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. Facilities and Administrative (F&A) costs: F&A costs will be reimbursed at 8 percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. E. Evaluation: In carrying out its stewardship of human resource related programs, the NIA may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their 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. F. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee 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. The funds may be used for health-related research purposes. 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, 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 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 rebudgeted. NIA will consider approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of NIA. G. Special Leave: Leave 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 3 months. For longer periods, prior written approval of NIA is required. To obtain prior approval, the award recipient must submit a letter to NIA describing the plan, countersigned by his or her department head and the 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 career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of NIA 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. H. Termination or Change of Institution: When a grantee institution plans to terminate an award, NIA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: The new institution submits an application to transfer the award, complete with the requisite information concerning all aspects of the career development plan, mentoring, and institutional support (as described elsewhere in this RFA); The period of support requested is no more than the time remaining within the existing project period; and The application to transfer an award is submitted at least 60 days prior to the requested start date at the new institution to allow time for review by NIA staff. 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 therefore, the effective date, and the right to appeal the decision. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for 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 relate 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. 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 identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 IC staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES All candidates are strongly encouraged to contact the program staff person listed below under INQUIRIES. Such contact should occur early in the planning phase of application preparation and will help ensure that applications are responsive to the career development goals and policies of NIA. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms 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, email: GrantsInfo@nih.gov. Applications are also available on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html The RFA label available in the PHS 398 (rev. 4/98) 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 online 2 of the face page of the application form and the YES box must be marked. A sample RFA label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf format. Submit a signed, original of the application, including the Checklist, and three signed photocopies of the application 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, send two additional copies of the application to: Mary Nekola, Ph.D. Chief, Scientific Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205 It is important to send these copies at the same time as the original and three copies are sent to the Center for Scientific Review. These copies are used to identify conflicts and to help ensure the appropriate and timely review of the application. Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The application must address the following issues: 1. Candidate Describe the candidate's commitment to a career in clinical or laboratory-based biomedical research related to Alzheimer’s disease and related dementias. Establish the candidate's potential to develop into an independent investigator. Describe immediate and long-term career objectives, explaining how the award will contribute to their attainment. For K01 applicants, outline previous research experience and the rationale for redirecting research interests to Alzheimer’s disease. A commitment of at least 75 percent effort to research career development activities. Letters of recommendation. Three sealed letters of recommendation addressing the candidate's potential for a research career must be included as part of the application. 2. Career Development Plan Describe the career development plan incorporating consideration of the candidate's goals and prior experience. Where necessary, it must describe a systematic plan to obtain both the necessary didactic training and research experience to launch an independent research career related to Alzheimer’s disease and other dementias of aging. Candidates interested in clinical research must describe the availability of courses such as research design, biostatistics, epidemiology, and ethical and regulatory issues at their institution and the integration of these studies into their career development plan. Candidates with limited research training may require a phased developmental period including didactic training during the first year of the award while gradually phasing in a period of intense, supervised research experience. Candidates with more experience at the time of application may need a shorter developmental period and may already have an adequate theoretical background. In any case, the career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher. 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. 3. Research Plan Describe the research plan and the use of a clinical science or laboratory approach to a research project that will likely lead to increased knowledge or better treatment of Alzheimer’s disease and/or related dementias. The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/ Preliminary Studies, Research Design and Methods. The candidate should consult with the mentor regarding the development of this section, but the proposed research should derive from the candidate's own background, research interests, and career goals. The proposed research should also be suitable for development into a project capable of generating independent funding. 4. Mentor's Statement The application must include information on the mentor(s) including information on research qualifications and previous experience as a research supervisor for training scientists in Alzheimer’s disease, related dementias, or other neurodegenerative diseases. The applications must also include information describing the nature and extent of supervision that will occur during the proposed award period. 5. Environment and Institutional Commitment The sponsoring institution must document a strong, well-established research and training program related to Alzheimer’s disease and other neurogenerative disease including a high-quality research environment comparable to an NIA-sponsored Alzheimer’s Disease Center with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to the candidate's development into a productive, independent investigator. The statement should indicate that the institution sponsoring the investigator must treat the individual as a faculty member. 6. Budget Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, research development support, etc., must be justified and specified by category. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIA. Incomplete and/or nonresponsive applications will be returned to the applicant. Applications that are complete and responsive to the RFA will be evaluated for scientific merit and training potential by an appropriate peer review group convened by NIA in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications 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 second level review by the National Advisory Council on Aging. The following review criteria will be applied: 1. Candidate Quality of the candidate's academic and clinical record, Potential to develop as an independent clinical or laboratory based researcher in the field of Alzheimer’s disease; and Commitment to a career in Alzheimer’s research and clinical practice. 2. Career Development Plan Likelihood that the career development plan will contribute substantially to the scientific development of the candidate; Probability of development of a competitive independent research program; Documentation of local expertise in Alzheimer’s disease and other neurodegenerative diseases and appropriateness of the content and duration of the proposed didactic and research phases of the award; Consistency of the career development plan with the candidate's career goals and prior research experience; and, Quality of the proposed training in responsible conduct of research. 3. Research Plan Reviewers recognize that applicants will have variable amounts of previous research experience and 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. Although it is understood that K08 and K01 applications do not require the level of detail necessary in regular research grant proposals, a fundamentally sound research plan must be provided. In general the plan for the first year should be spelled out in detail while less detail is expected with regard to research planned for the later years of the award. The application should outline the general goals for years two and three. The following details should be provided: The significance of the area of dementia research in which the candidate proposes to establish independence; Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills as described in the career development plan; Scientific and technical merit of the research question, design and methodology and its likelihood to advance dementia research; Relevance of the proposed research to the candidate's career objectives; and Adequacy of the plan's attention to gender and minority issues associated with projects involving human subjects. 4. Mentor Appropriateness of mentor's statement of support and research qualifications in Alzheimer’s disease and related dementias; Quality and extent of mentor's proposed role in providing guidance and advice to the candidate; Previous experience in fostering the development of Alzheimer’s researchers; and History of research productivity and support and Adequacy of support for the proposed research. 5. Environment and Institutional Commitment Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; Adequacy of research facilities (comparable to those of an NIA- sponsored Alzheimer’s Disease Center) and the availability of appropriate educational opportunities; Quality and relevance of the environment for scientific and professional development of the candidate; and Applicant institution's commitment to an appropriate balance of research and clinical responsibilities including the level of 75 percent effort proposed by the candidate. 6. Budget Justification of the requested budget in relation to career development goals and research aims. Schedule: Letter of Intent Receipt Date: June 1, 2001 Application Receipt Date: July 12, 2001 Date of Initial Review: November 2001 Review by Advisory Council: January 2002 Anticipated Award Date: March 2002 AWARD CRITERIA Funding decisions will be made based on the merit of the proposal, the research environment of the applicant institution, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this Request for Applications are strongly encouraged especially during the planning phase of the application. Direct inquiries regarding programmatic issues to: Creighton H. Phelps, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Ave., Suite 3C307 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: phelpsc@nia.nih.gov For questions about grants management, contact: Deborah Stauffer Grants Management Specialist National Institute on Aging 7201 Wisconsin Ave., Suite 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 492-3672 Email: ds63p@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review The 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.