CAREER DEVELOPMENT IN AGING AND GENETIC EPIDEMIOLOGIC RESEARCH METHODOLOGY Release Date: September 23, 2002 RFA: AG-03-001 National Institute on Aging (NIA) (http://www.nih.gov/nia/) Letter of Intent Receipt Date: November 18, 2002 Application Receipt Date: December 18, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The National Institute on Aging (NIA) invites applications for the Mentored Clinical Scientist Development Award (KO8) or the Mentored Research Scientist award (KO1) for career development in study design, data collection, and analytical methods for genetic epidemiologic research that focuses on aging- related topics. The purpose of this Request for Applications (RFA) is to develop expertise in genetic epidemiologic methods and techniques that can aid in identifying effects of genetic factors and elucidating gene- environment dynamics, such as gene-environmental interactions, gene- environment correlations, and age-related changes in gene expression on: rates of age-related behavioral, physiologic and pathologic changes, differences in age of onset of diseases and disabilities, and/or broader outcomes not encompassed by disease diagnoses, such as exceptional longevity, in human populations. These award mechanisms provide support for a period of supervised research and study for either clinically trained junior investigators without substantial research experience, but with commitment and potential to become productive, independent researchers in aging and genetic epidemiology (KO8), postdoctoral research scientists who wish to substantially expand their knowledge and capabilities into aging and genetic epidemiologic research (KO1), or experienced investigators in genetics, epidemiology, biostatistics, or related fields who wish to develop their research approaches by learning aging and genetic epidemiologic methods that can be applied to their substantive areas of investigation (KO1). RESEARCH OBJECTIVES Background Genetic epidemiology in age-related research is gaining importance with the increasing number of research questions focusing on age-related outcomes. Paralleling this is the growing demand for expertise in study design, data collection and analytic outcomes. With this growth of the field, it is essential to develop an enriched pool of qualified scientists with expertise in a variety of related research areas. The expected expansion of the field requires an increased emphasis on training in methods unique to population- based research on age-related diseases and survival outcomes such as age of disease onset and disability, age-related rates of change, and exceptional survival phenotypes, i.e., unusually long survival before the occurrence of significant morbidity (health span), or disability (active life expectancy). Objectives of Career Development The objective of this career development initiative is to produce, through comprehensive research training, a well-qualified cadre of investigators in the genetic epidemiology of aging, capable of successfully competing for NIH and other research support for studies that focus on the identification of genetic factors that contribute to aging-related outcomes such as rates of age-related behavioral, physiologic and pathologic changes, differences in age of onset of diseases and disabilities, and/or broader outcomes not encompassed by disease diagnoses, such as exceptional longevity, in human populations. Identification of potential genetic and environmental factors, and their interactions, that act protectively against development of diseases and disability and that help to promote healthy aging and prolonged survival in the absence of morbidity are of interest. Investigators supported under this RFA will be expected to develop the experience and expertise necessary to direct population- and family-based studies in these areas. Candidates are expected to attain the skills to develop well-formulated, hypothesis-driven approaches. They are also expected to attain the skills to develop and carry out longitudinal data analyses, advanced statistical and analytical approaches to the study of complex age-related traits, identify biomarkers and endophenotypes, and develop new methodologic approaches to address gene- gene and gene-environment interactions affecting age-related outcomes. Candidates should develop skills to test hypotheses in broad multi-level contexts, and the ability to test and develop appropriate genetic epidemiologic and behavior-genetic models in order to pinpoint fruitful areas for preventive interventions. Candidates should aim to gain expertise in the determination of appropriate assessment measures and epidemiologic databases as well as alternate designs that can accelerate the understanding of age- related survival outcomes. Some examples of topics to be incorporated into a career development plan that would be responsive to this RFA include, but are not limited to the following: o Selection and definition of appropriate qualitative and quantitative aging- related phenotypes, including, but not limited to, age of onset of diseases and/or disabilities, rates of age-related physiologic and pathologic changes, survival time in the absence of one or more diseases or disabilities, and/or exceptional longevity. Selection of appropriate study designs (e.g., association and linkage approaches) for assessment of genetic and environmental factors that contribute to aging-related outcomes and expansion of analyses to understudied populations. Elements of various phenotypes and study designs should take into account issues unique to aging populations (e.g., missing parental data, ease of locating living relatives of older study subjects, ease of collecting detailed health histories and genetic information on study subjects and their family members retrospectively, selection of appropriate unrelated controls in the absence of available family members, the potential to follow offspring of older subjects to examine familial patterns of aging-related outcomes prospectively). Power considerations and cost effectiveness of optimal designs should be addressed. o Application and development of methods (e.g., survival analysis, frailty models, multivariate models) to analyze age-related data (e.g., life table data) including those derived from other pertinent fields such as demography and gerontology should be included. Benefits of combining some current methods (e.g., linkage and association methods), and the development of new approaches to analyzing aging-related data should be included. Problems common to studies of older persons (e.g., missing parental genetic information, age misreporting, accurate age ascertainment), or longitudinal designs (sample attrition, missing data points) the effect of secular trends (e.g., cohort and gender effects), and frequent confounders (e.g., population admixture), including current methods, and the development of new methods to deal with them should be addressed. Benefits of pooling data (e.g., subdividing large heterogeneous samples into homogenous groups) and results (e.g., meta-analysis) should also be covered. o Identification of appropriate target populations (e.g., genetically homogenous populations, unrelated individuals, relative pairs, extended pedigrees) and advantages and disadvantages of using each for studies of aging-related outcomes should be discussed with emphasis on sampling strategies, statistical power, and ease of subject recruitment. A review of existing data (current and historical) sources that include information on older persons and their family members for selecting study subjects (e.g., existing longitudinal studies, family studies, twin registries and genealogic registries that include information on older-aged individuals) should be included. Methods to collect additional data, where appropriate, on older subjects and their family members should be incorporated. o Collection and storage methods, for clinical (e.g., health history), genetic (e.g., blood samples from study subjects and family members), environmental, demographic, familial (e.g., family structure), and other relevant data, focusing on data management and quality control should be covered and include attention to IRB issues regarding research protocols, including the types of information that can be collected (e.g., family names, blood samples from family members), proper guidelines for obtaining informed consent, proxy consent, data and biological sample sharing issues, and other ethical, legal and social issues. o Strengths and limitations of various genetic approaches (e.g., candidate genes, genome-wide scans), including a review of evolving methodologies from laboratory and statistical analysis perspectives including SNP (single nucleotide polymorphism) mapping and gene expression (e.g., microarray) analysis that can be used to identify genetic contributions (e.g., heritability, familial aggregation) to aging-related outcomes should be included. A review of candidate genes currently hypothesized to contribute to aging-related pathologies, approaches to identifying polymorphisms relevant to aging-related phenotypes, and ways to test the nature and strength of their relationships should be covered. Some candidates may have significant research experience in some areas within these topics and may choose to focus on other relevant areas as a means to expanding their expertise. Scope of Career Development The award period may be up to five years and must include a career development plan that incorporates didactic instruction and mentoring in genetic epidemiologic methods, relevant study design and analytical methods that cover issues specific to the study of older populations. The plan should be consistent with the goal of focusing on progression to independence as a researcher and with his or her previous research experience. For example, a candidate with limited research experience in aging and genetic epidemiology may need a designated period of didactic training and closely supervised research experience for a longer period as the most efficient means of achieving independence. Each candidate must have access to ongoing research projects that focus on aging-related issues in genetic epidemiology. The primary focus of candidate research questions on these projects with their mentor(s) must be on aging-related topics. The primary mentor must have expertise in genetic epidemiologic methods. Candidates are strongly encouraged to develop the substantive areas of their plan with an additional mentor with expertise in aging-related research. Additionally, significant interaction and cooperation with researchers with expertise in methods on aging-related research (e.g., gerontologists, geriatricians) and researchers from other areas related to genetic epidemiology (e.g. epidemiologists, demographers, geneticists and biostatisticians) must be clearly presented in the application. Mentors must also have participated in funded, peer-reviewed research programs in the areas of genetic epidemiology and aging-related research. The application must address the following issues: Candidate o The candidate's commitment to a career in aging and genetic epidemiologic research must be described; o The candidate's potential to develop into a successful independent investigator must be established; Mentor(s) The recipient must receive appropriate mentoring throughout the duration of the program. Where feasible women, minority individuals, and individuals with disabilities should be involved as mentors and serve as role models. Mentors must be recognized as accomplished investigators in the proposed research areas and have track records of success in training independent investigators. Candidates must name a primary mentor, with expertise in genetic epidemiology, who together with the applicant is responsible for the planning, direction, and execution of the career development plan. The mentor should have sufficient independent research support to cover the costs of the proposed career development plan in excess of the allowable costs in the award. Candidates are strongly encouraged to develop the substantive areas of their plan with an additional mentor with expertise in aging-related research. Both mentors may be from the candidate's institution, or one mentor can be from the candidate's institution and the other from another institution due to the rarity of combined genetic epidemiology and aging expertise. Statement (see instructions in PHS 398 Application Form) Environment and Institutional Commitment (see instructions in PHS 398 Application Form) Career Development Plan Applicants must provide detailed plans for: o Didactic instruction (i.e., a full description of the coursework to be covered) and the research components (i.e., a full description of research project(s) and research question(s) on which candidate will work) of the career development plan. o Means by which candidate needs and goals will be developed and addressed. Ongoing program evaluation and mechanisms to improve course content, mentoring, and supervised research experiences must be included. 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 Candidates must describe the research plan and the use of a genetic epidemiologic approach to an aging-related biomedical problem. 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, and Research Design and Methods. The candidate should consult with the mentor(s) regarding the development of this section. Data Sharing Plan Most projects will not involve the generation of independent data. However, for projects where the candidate will be generating independent data, a detailed plan for sharing data and biological samples must be included. The KO8/KO1 awards focus on progression to independence as a researcher. Thus, the prospective candidate should propose a period of training that is consistent with this goal and his or her previous research experience. For example, a candidate with limited research experience in aging and genetic epidemiology may need a designated period of didactic training and closely supervised research experience for a longer period as the most efficient means of achieving independence. A candidate with substantive previous research experience, such as an investigator in another field redirecting his/her career focus into aging and genetic epidemiology, may require a shorter didactic training period appropriate for achieving independence. Applicants are strongly encouraged to contact the NIA staff listed below in this document to discuss issues of eligibility and the specific provisions of the application as it pertains to NIA programmatic interests. Financial and Administrative Requirements The award provides funds for five consecutive 12-month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the program. The remainder may be 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. Allowable Costs: 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 this award. Under Institution 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. Research Development Support: NIA will provide up to $25,000 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. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. Facilities and Administrative Costs: F&A costs will be reimbursed at 8 percent of modified total direct costs, or at the actual F&A cost rate, whichever is less. 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. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and the career award recipient may not retain research-related activities of this award. 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. Special Leave: Given the highly specialized nature of aging-related genetic epidemiologic research, it may be appropriate for a candidate to take leave to go to another institution where research experience may be valuable to the purpose of the award. For example, if a co-mentor or collaborator specializing in an aging related field is located at a different institution than the primary mentor in genetic epidemiology at the applicant institution, special leave may be permitted. Only local, institutional approval is required. However, NIA must be notified, in writing that this leave will occur, one month prior to such leave. A detailed research plan for this period of time must be included with the written notification. Leave Without Award Support: Such leave may not exceed 12 months and 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. 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. MECHANISM OF SUPPORT This RFA will use the NIH KO8 and KO1 award mechanisms. 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 can last up to five years. Awards are not renewable. This RFA is a one-time solicitation. Future unsolicited, competing continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 2003. This RFA uses just-in-time concepts. FUNDS AVAILABLE The NIA intends to commit approximately $500,000 in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2003 to fund up to five awards. Although the financial plans of the NIA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) 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 Domestic institutions only INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Candidates for the KO8 Mechanism must have a clinical doctoral degree or its equivalent. Illustrative examples include, but are not limited to: M.D., D.D.S., D.M.D.,D.O., D.C., O.D., N.D. (Doctor of Naturopathy), D.V.M. or Pharm.D. Individuals with the Ph.D. or other doctoral degrees in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology and rehabilitation are also eligible. Individuals holding the Ph.D. in a non-clinical discipline but are certified to perform clinical duties should contact the NIA concerning their eligibility for a KO8 award. The candidate must be able to identify a mentor with extensive research experience. The candidate must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development. NIA does not require completion of postgraduate clinical training by the time of award Candidates for the KO1 mechanism must have a research or a health- professional doctorate or its equivalent, and must have demonstrated the capacity or potential for highly productive independent research in the period after the doctorate. The candidate must identify a mentor with extensive research experience. The candidate must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development during the entire award period. The candidate must clearly describe the need for intensive research supervision for a period lasting three, four, or five years leading to research independence. All potential applicants are strongly encouraged to contact the prospective NIH awarding component regarding their eligibility for the K01. Candidates for the KO1, under some circumstances, may have been principal investigators on NIH research or career development awards, provided the research experience proposed in this application is in a fundamentally new field of study or there has been a significant hiatus in their research career because of family or other personal obligations. Also, under some circumstances, current principal investigators on NIH research grants may be eligible if the proposed research experience is in a fundamentally new field of study. Current principal investigators on NIH career awards are not eligible. A candidate for the K01 award may not have pending nor concurrently apply for any other career development award. K01 recipients are encouraged to apply for independent research grant support during the period of this 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 by the time of award. Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as 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 for this award. Both KO8 and KO1 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. SPECIAL REQUIREMENTS Sponsors and awardees will meet as a group once a year, each year of the award period, in Bethesda, Maryland with NIH program staff to exchange information on the progress of the career development programs. Applicants should allow sufficient funds in their application budgets to support travel and lodging expenses to attend these meetings. 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: Winifred K. Rossi, M.A. Special Assistant for Planning Geriatrics and Clinical Gerontology Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E327, MSC 9205 Bethesda, MD 20892-9205 (Express: 20814) Telephone: (301) 496-3836 Email: rossiw@nia.nih.gov o Direct your questions about peer review issues to: Mary Nekola, Ph.D. Chief, Scientific Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212, MSC 9205 Bethesda, MD 20892-9205 (Express: 20814) Telephone: (301) 496-9666 Email: nekolam@nia.nih.gov o Direct your questions about financial or grants management matters to: Ms. Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 (Express: 20814) Telephone: (301) 496-1472 Email: whippl@nia.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel 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 IC 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: Winifred K. Rossi, M.A. Special Assistant for Planning Geriatrics and Clinical Gerontology Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E327, MSC 9205 Bethesda, MD 20892-9205 (Express: 20814) Telephone: (301) 496-3836 Email: rossiw@nia.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. 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: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 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 must be sent to: Mary Nekola, Ph.D. Chief, Scientific Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205, (Express: 20814) Telephone: (301) 496-9666 Email: nekolam@nia.nih.gov APPLICATION PROCESSING: 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 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 the NIA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o May 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 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 discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: (1) CAREER DEVELOPMENT PLAN o The integration of aging and genetic epidemiologic topics in didactic instruction and in mentored research experience provided to candidates o The Appropriateness of the interaction and cooperation with researchers with expertise in methods on aging-related research (e.g., gerontologists, geriatricians) and researchers from other areas related to genetic epidemiology (e.g. epidemiologists, demographers, geneticists and biostatisticians). o Likelihood that the career development plan will contribute substantially to the candidate's scientific development; o Probability of development of a competitive independent research program; o Consistency of the career development plan with the candidate's career goals and prior research experience; and, o Quality and thoroughness of the proposed training in responsible conduct of research. (2) 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: o The significance of the area of aging and genetic epidemiologic research in which the candidate proposes to establish independence; o The 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; o Scientific and technical merit of the research question, design and methodology and its likelihood to advance aging and genetic epidemiologic research; o Relevance of the proposed research to the candidate's career objectives; and o Adequacy of the plan's attention to gender and minority issues associated with projects involving human subjects. (3) CANDIDATE o Quality of the candidate's academic record o Potential to develop as an independent researcher o Commitment to a research career (4) MENTOR(S) o Appropriateness of mentor(s) research qualifications in genetic epidemiology and/or aging-related research o Quality and extent of mentor(s) proposed role in providing guidance and advice to the candidate o Previous experience in fostering and development of researchers o History of research productivity o Adequacy of support for the proposed research project (5) ENVIRONMENT AND INSTITUTIONAL COMMITMENT o Adequacy of research facilities and training opportunities o Quality and relevance of the environment for scientific and professional development of the candidate o 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 o Applicant institution's commitment to an appropriate balance of research and other professional responsibilities including the level of 75% effort proposed by the candidate ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent that they may be adversely affected by the projects proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, 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 included in the section on Federal Citations below). o DATA SHARING: The adequacy of the proposed plan to share data. (Most projects will not involve the generation of independent data. However, for projects where the candidate will be generating independent data, a detailed plan for sharing data must be included in the application.) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to career development goals and research aims. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 18, 2002 Application Receipt Date: December 18, 2002 Peer Review Date: March 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://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 AMENDMENT "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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 http://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. 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 No. 93.866, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and to 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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