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INTERDISCIPLINARY HEALTH RESEARCH TRAINING: BEHAVIOR, ENVIRONMENT AND BIOLOGY RELEASE DATE: November 17, 2003 RFA Number: RFA-RM-04-010 (formerly RFA-MH-04-007, see NOT-OD-04-008) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) This RFA is developed as an NIH Roadmap initiative (http://nihroadmap.nih.gov/). All NIH Institutes and Centers participate in Roadmap initiatives. The RFA will be administered by the National Institute of Mental Health (NIMH) on behalf of the NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.282 LETTER OF INTENT RECEIPT DATE: February 11, 2004 APPLICATION RECEIPT DATE: March 11, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Program Objectives o Specific Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Program Directors o Special Requirements o Allowable Costs 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 Institutes, Centers and Offices of the National Institutes of Health invite applications for Interdisciplinary Health Research Training: Behavior, Environment and Biology. This institutional, postdoctoral National Research Training Award (NRSA) will support the establishment of programs that provide formal coursework and research training in a new interdisciplinary field to individuals holding advanced degrees in a different discipline. These training programs are required to include a behavioral or social science discipline, and we are especially interested in programs that integrate the behavioral and/or social sciences with the more traditional biomedical sciences. We encourage the development of programs that accept postdoctoral trainees with varied research backgrounds, provide multiple tracks of research training that enhance each trainee’s development of new, interdisciplinary knowledge and skills, while supporting opportunities for trainee interaction and research integration across the research tracks. The overall goal of NRSA training programs is to ensure that highly trained scientists will be available in adequate numbers and in appropriate scientific areas to carry out the Nation’s biomedical and behavioral health research agenda. Many of our most pressing health problems involve disease processes that are influenced by biological, behavioral, and social environment factors. The purpose of this NRSA program is to help ensure the development of a cadre of scientists with the requisite skills and knowledge to integrate multiple scientific approaches and to work in interdisciplinary research teams to solve these complex health problems. PROGRAM OBJECTIVES The National Institutes of Health (NIH) are engaged in a series of activities collectively known as the “NIH Roadmap” whose goal, in keeping with the NIH mission of uncovering new knowledge about the prevention, detection, diagnosis, and treatment of disease and disability, is to accelerate both the pace of discovery in these key areas and the translation of therapies from bench to bedside. In the course of developing the NIH Roadmap, it has become clear that increasingly, scientific advances are being made at the interfaces of traditional disciplines, and that approaches to science are becoming more integrative. This requires a cooperative effort, typically in the form of investigators from diverse research backgrounds working collectively across traditional disciplinary boundaries to answer scientific questions and achieve specific endpoints. This also requires a workforce capable of crossing disciplinary boundaries and leading and participating in integrative and team approaches to complex health problems. Building research teams for the future has therefore emerged as one of the major themes in Roadmap implementation. (Additional information about the NIH Roadmap can be found on the NIH website at http://nihroadmap.nih.gov/index.asp.) NIH is particularly interested in developing a new interdisciplinary research workforce. An interdisciplinary approach is distinguished from a multidisciplinary approach in that a multidisciplinary approach brings experts from diverse disciplines to address collectively a common complex problem, each from his or her unique perspective. By contrast, an interdisciplinary approach is what results from the melding of two or more disciplines to create a new (interdisciplinary) science. Biophysics, biostatistics, bioinformatics, bioengineering, social neuroscience, biodemography, behavioral economics and psychoneuroimmunology are just some examples of existing interdisciplinary sciences. NIH recognizes the value and enormous contributions that existing interdisciplinary approaches have made and are making to our understanding of health, disease, and disability. However, the Roadmap is focused on developing new interdisciplinary approaches and therefore the necessary interdisciplinary workforce. NIH is proposing a series of initiatives that aim to provide investigators with the training to effectively lead and engage in integrative and team approaches to complex biomedical problems. These initiatives fall into three categories: programs for long-term interdisciplinary research training; short-term courses and research experiences; and curriculum development. Collectively, the initiatives provide opportunities for integration of disciplines at all stages of investigators’ careers, facilitate communication among the disciplines, and ensure the development of necessary infrastructure to accomplish the building the workforce for the research teams for the future. Common features of the proposed initiatives include having: comprehensive integrative approaches to solving complex health problems; developing and implementing new curricula that integrate disparate disciplines; activities that promote cohesiveness among training program participants at all levels (faculty-student, student- student, and faculty-faculty); inclusion of training in the personal and professional skills necessary to lead and participate in multidisciplinary teams; outreach to the under-represented minority community to ensure their participation; monitoring of student progress and outcome; and self-evaluation of the training program. NIH recognizes that multidisciplinary approaches may be a necessary step in the evolution of interdisciplinary research training, and currently offers many opportunities and mechanisms to support multidisciplinary research training. Thus, for the purposes of the Roadmap’s interdisciplinary research training RFAs (including this RFA), activities that facilitate communication among different disciplines, promote but perhaps do not completely achieve integration of different disciplines in the proposed project period, or propose training in multidisciplinary approaches as a precursor to interdisciplinary research training, are acceptable if they include a detailed plan with appropriate milestones for achieving the Roadmap goal of developing interdisciplinary research training. SPECIFIC OBJECTIVES Numerous reports from the NIH and the National Academies of Science have concluded that in order to successfully advance our understanding of health and disease, researchers will need to integrate multiple disciplinary perspectives, methodologies and levels of analysis. Common to these reports is a recommendation to increase interdisciplinary research training. (See list of reference reports and associated URLs below.) Interdisciplinary research and training are not new concepts. There are many instances of the integration of disciplines in trying to meet scientific challenges, and of programs that provide interdisciplinary research training. However, what each of the recent reports indicates is lacking, and therefore is needed, is research training that integrates three primary areas of science -- biology, behavior, and the social environment. Examples of research areas that might benefit from such an interdisciplinary approach include, but are not limited to, the following: o The mechanisms by which interactions between genetics and the environment influence molecular, cellular, and organismal function, thus impacting physiology and health o Elucidation of the biological mechanisms by which racial, ethnic, socioeconomic and gender inequality affects physiology (at all levels) and thus, health outcomes o The study of mental disorders by approaches that integrate neuroscience, genetics, behavioral science, computational science/modeling, and clinical sciences, using both animal models of these disorders and human populations, to understand the confluence of genetic, biological, behavioral and environmental factors involved in the etiology, treatment and prevention of these disorders o Cognitive rehabilitation, which can be addressed by merging cognitive neuroscience, physical and occupational therapy, and clinical neurology o Management of the multiple conditions of senescence: clinical symptoms (cardiovascular, neurological, and endocrine changes; frailty, cancer) in light of age-associated changes in psychological and social factors o Treatment of drug addition based on the translation of basic behavioral science, cognitive and affective and social neuroscience research into novel behavioral therapies o Understanding the roles of biological, social and psychological factors in the etiology and maintenance of conditions with pain as a primary symptom o The regulation of energy balance, as determined by genetics, neural and endocrine function, and behavioral, societal and cultural factors o The influence of social interactions on health and disease In order to work collaboratively to tackle these complex health-related problems, researchers will need training in the conceptual models and methods of disciplines that address these different areas of influence. Moreover, progress in integrating these scientific fields requires quantitative capabilities to link across multiple levels of analysis (molecular, genetic, cellular, physiological, cultural, social, community, population) and improved modeling to allow for prediction of outcomes – multi-directionally and among all intermediate steps between the molecular and population levels. For this NRSA we envision programs that will provide formal coursework and research training in a new discipline for individuals holding advanced degrees in a first field. The postdoctoral fellows and the program faculty are expected to represent multiple disciplines so that the trainees’ benefits will accrue not simply from instruction in another field, but from a rich, integrative research environment created by established investigators working collaboratively in an interdisciplinary fashion. One of the program disciplines must be in the behavioral or social sciences and we are especially interested in programs that integrate the behavioral and/or social sciences with more traditional, biomedical disciplines (e.g., genetics, molecular biology, cell biology, physiology, immunology, biochemistry, neuroscience, genomics, etc.). A definition of behavioral and social sciences research for the NIH can be found at http://obssr.od.nih.gov/funding/definition.html. For example, a program centered on gene-social environment interactions could be designed to accept trainees with genetics, cell and molecular biology, social psychology and computational science backgrounds. Individuals would receive training in fields different from their own and the program as a whole would provide opportunities for all trainees to engage in integrative research seminars and broad discussion of gene-environment interactions and health. These individuals would emerge from such a program poised to work collaboratively to model the influence of the social environment on gene expression, cellular function and ultimately, physiology and health. Another example might be a program that trained a gerontologist in epidemiology, an epidemiologist in cognitive neuroscience and a cognitive neuroscientist in gerontology, economists and demographers in behavior genetics and or neuroscience, to facilitate the design of epidemiological surveys of the elderly to include measures of age-related changes in brain function and cognition and the impact of changing cognition on decision making in the areas of health and finances. A program focused on the health effects of stress might provide training in the neural and endocrine regulation of the stress response, the interactions between stress and the immune system, and the impact of the social environment on stress and immune system function. Trainees emerging from such a program will be competent to lead an interdisciplinary research team working on the mechanisms by which psychosocial interventions prevent the immunosuppression that often results from chronic stress. A program focused on obesity and type II diabetes might train individuals from various disciplinary backgrounds in metabolic endocrinology and energy balance, the genetics of obesity, and the role of psychosocial factors in the development and treatment of obesity and diabetes. Trainees completing such a program would be suited to function in highly interdisciplinary teams to take advantage of the integrated knowledge and approaches from multiple disciplines in developing more effective obesity and diabetes prevention and treatment strategies. Reference reports: Institute of Medicine (2000) Bridging the Disciplines in the Brain, Behavioral and Clinical Sciences. Committee on Building Bridges in the Brain, Behavioral and Clinical Sciences. TC Pellmar and L Eisenberg, eds. Division of Neuroscience and Behavioral Health. Washington, DC: National Academy Press. http://books.nap.edu/books/0309070783/html/index.html Institute of Medicine (2001) Exploring the Biological Contributions to Human Health: Does Sex Matter? Committee on Understanding the Biology of Sex and Gender Differences. TM Wizemann and M-L Pardue, Eds. Board on Health Sciences Policy. Washington, DC: National Academy Press. http://books.nap.edu/books/0309072816/html/index.html Institute of Medicine (2001) Health and Behavior: The Interplay of Biological, Behavioral, and Societal Influences. Committee on Health and Behavior: Research, Practice and Policy, Board on Neuroscience and Behavioral Health. Washington, DC: National Academy Press. http://books.nap.edu/books/0309070309/html/index.html National Institute of Mental Health (1999) Bridging Science and Service. http://www.nimh.nih.gov/research/bridge.pdf National Institute of Mental Health (2000) Translating behavioral science into action. http://www.nimh.nih.gov/council/bswreport.pdf National Research Council (2000) Addressing the Nation’s Changing Needs for Biomedical and Behavioral Scientists. Committee on National Needs for Biomedical and Behavioral Scientists. Washington, DC: National Academy Press. http://www.nap.edu/books/0309069815/html/ National Research Council (2001) New Horizons in Health: An Integrative Approach. Committee on Future Directions for Behavioral and Social Sciences Research at the National Institutes of Health. BH Singer and CD Ryff, Eds. Commission on Behavioral and Social Sciences and Education. Washington, DC: National Academy Press. http://books.nap.edu/books/0309072964/html/index.html National Research Council (1997) Between Zeus and the Salmon: The Biodemography of Longevity. Committee on Population. K.W. Wachter and C.E. Finch, Eds. Commission on Behavioral and Social Sciences and Education. Washington, DC: National Academy Press. http://books.nap.edu/catalog/5740.html National Research Council (2001) Cells and Surveys: Should Biological Measures Be Included in Social Science Research? Committee on Population. C.E. Finch, J.W. Vaupel, and K. Kinsella, Eds. Commission on Behavioral and Social Sciences and Education. Washington, DC: National Academy Press. http://books.nap.edu/catalog/9995.html MECHANISM OF SUPPORT This RFA will use the Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) mechanism. This award will only support postdoctoral trainees. The applicant will be solely responsible for planning, directing and executing the proposed project. The earliest anticipated start date for award of grants under this RFA is September 30, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The National Institutes of Health intend to commit approximately $2.1 million in fiscal year 2004 to fund approximately 6-8 training programs with 4-5 training slots/program in response to this RFA. The total project period for an application submitted in response to this RFA may not exceed 5 years. Because the nature and scope of proposed program may vary, it is anticipated that the size of each award will vary. Awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. Furthermore, the duration of the award and the number of funded training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations. Funds for continuation beyond the initial year are determined by the success as described in the annual progress report, the timely submission of all required forms, and the availability of funds. This RFA may be re-issued in the future if it is determined that such interdisciplinary research training remains relevant to the mission of each Institute. ELIGIBILE INSTITUTIONS Because training program applications in response to this RFA have special eligibility requirements, application formats, and review criteria, it is critical that prospective applicants consult with the program staff listed under INQUIRIES. Prospective applicants should also consult the NRSA Guidelines (http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm) and the omnibus NIH NRSA Institutional Research Training Grants Program announcement (http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html). Applications may be submitted by domestic, non-profit organizations, public and private, such as universities, colleges, medical schools, or from comparable institutions of higher education that have strong, well-established research and training programs. Foreign institutions are not eligible for NRSA institutional research training grants. The applicant institution must have adequate numbers of highly trained faculty researchers in the biomedical, behavioral, social and/or computational sciences. The environment must stimulate and allow for interactions among the involved disciplines and support cross- disciplinary research opportunities. Proposals from multiple institutions working collaboratively are encouraged. INDIVIDUALS ELIGIBLE TO BECOME PROGRAM DIRECTORS The Program Director must be an established researcher with acknowledged accomplishments in interdisciplinary research and training, and be capable of providing both administrative and scientific leadership to the program. Individuals from racial and ethnic minority groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Trainees: Individuals selected to participate in these training programs must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence at the time of appointment to the training program. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible for NRSA support. Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Other eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., Dr.P.H., D.S.W., D.P.M., Sc.D., D.Eng., Pharm.D., Psy.D., D.N.Sc., or N.D. (Doctor of Naturopathy). Individuals currently supported by other Federal funds are not eligible for trainee support from these programs at the same time. Further, NRSA fellowships are not given for study leading to a M.D., D.O., D.D.S., or other similar professional clinical degree, or master’s clinical degree. Similarly, trainees may not accept NRSA support for studies that are part of residency training leading to clinical certification in a medical specialty or subspecialty. However, funds provided by this award may be used to support full or partial completion of a Master’s degree or certificate program in a health-related research field (e.g., M.S., M.P.H.). Additional information may be obtained in the NRSA Guidelines at: http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm. Trainees are customarily appointed for full-time, 12-month continuous periods. All trainees are required to pursue their research training on a full-time basis, at a minimum of 40 hours per week. The amount of the stipend and tuition (defined for the purposes of NRSA as the cumulative amount of tuition, all fees, and health insurance) for each full appointment period must be obligated from funds available at the time the individual begins training. See http://grants.nih.gov/grants/guide/notice-files/not96-020.html for additional details on allowable stipend/tuition fees. By law, an individual trainee may receive no more than 5 years of NRSA support in the aggregate at the predoctoral level, and no more than 3 years of NRSA support in the aggregate at the postdoctoral level. Exceptions to this limitation require a waiver from the director of the funding institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval. Payback Requirements: Pursuant to the NIH Revitalization Act of 1993, postdoctoral trainees receiving NRSA support incur a service payback obligation only during their first 12 months of postdoctoral support. The second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Therefore, the payback agreement must be signed and submitted with the appointment form for only the initial year of support. Recruitment: The primary objective of the NRSA program is to prepare qualified individuals for careers that have a significant impact on the Nation's research agenda. Within the framework of the program's longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting individuals from racial or ethnic groups underrepresented in the biomedical and behavioral sciences. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups. Duration of training and the transition of trainees to individual support mechanisms: Studies have shown that the length of the appointment to a training grant for postdoctoral trainees with health- professional degrees strongly correlates with subsequent application for and receipt of independent NIH research support. Training grant Program Directors, therefore, should limit appointments to individuals who are committed to a career in research and plan to remain on the training grant or in a non-NRSA research experience for a cumulative minimum of 2 years. It has also been shown that transition to independent support is related to career success. Therefore, Program Directors should encourage postdoctoral trainees to apply for the individual postdoctoral fellowships (F32) or mentored career development awards (K awards). During the review of training grant applications, peer reviewers will examine the training record to determine the average duration of training appointments for health- professional postdoctoral trainees and whether there is a record of transition to individual support mechanisms. Past studies have shown that health professional trainees, who train in combined programs with postdoctoral researchers with an intensive research background, are more likely to apply for and receive research grant support. Programs located in clinical departments that focus on research training for individuals with the M.D. or other health- professional degrees should consider developing ties to basic science departments or modifying their program to include individuals with research doctorates when this approach is consistent with the goals of the program. Applications should describe the basic science department's contribution to the research training experience and also indicate whether both health professional trainees and trainees with research doctorates will be included in the training program. Evaluation: Program Directors are encouraged to develop methods for ongoing evaluation of the quality of the training program. Although the T32 application process requires extensive career tracking information, it is often useful to obtain more proximal feedback from trainees. For example, Program Directors are encouraged to develop plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements. Annual Meeting: Program Directors are required to attend an annual, 1- day meeting with other Program Directors and NIH staff in the Washington, DC area. Funds to cover the costs of travel to this meeting should be requested in the budget. Conditions of Award: Grants must be administered in accordance with the revised NIH Grants Policy Statement (NIHGPS, available at: http://grants.nih.gov/grants/policy/nihgps_2001). The provisions of the revised NIHGPS are effective for all funded NIH grants and cooperative agreements with budget periods beginning on or after March 1, 2001. The applicant organization must submit a Statement of Appointment form (PHS 2271) along with the signed Payback Agreement, at the time a postdoctoral trainee is appointed. No funds may be provided until such documents are submitted and accepted by the funding institute. At the end of the total support period for each individual trainee, the applicant must submit a Termination Notice (PHS 416-7) to NIH. Failure to submit the required forms in a timely manner may result in an expenditure disallowance or a delay in any future funding of the grant. Awardees may use some of their time in course studies and clinical duties if such work is closely related to and necessary for the research training experience. No appointment for less than 12 months may be made without prior approval of the NIH program staff. Trainees supported by academic institutions should refer to the NIH NRSA guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for guidance regarding vacations and requested leave. ALLOWABLE COSTS o Annual Stipends The annual stipend for postdoctoral trainees is dependent on the number of full years of relevant experience at the time of the initial appointment. Applicants should consult with institute program staff for the latest stipend level. Alternatively, applicants may obtain information about current stipend levels and other policy documents from the URL for "Ruth L. Kirschstein National Research Service Award Research Training Grants and Fellowships" at: http://grants.nih.gov/training/nrsa.htm. The stipend is provided as a subsistence allowance for trainees to help defray living expenses during the research training experience. The stipend is not a payment for services performed. Trainees are not considered to be employees of the PHS or their sponsoring organization. Taxability of Stipends Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, degree candidates (e.g., predocs) may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. Non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. The taxability of stipends, however, in no way alters the relationship between NRSA trainees, and institutions. NRSA stipends are not considered salaries. In addition, trainees supported under the NRSA are not considered to be in an employer-employee relationship with NIH or the institution in which they are pursuing research training. Therefore, it is inappropriate and unallowable for institutions to seek funds for or to charge institutional research training grant awards for costs that would normally be associated with employee benefits (e.g., FICA, workman's compensation, and unemployment insurance). It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. PHS takes no position on what the status may be for a particular taxpayer, and it does not have the authority to dispense advice to trainees or institutions about their tax liability. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations. o Tuition Applicant organizations can request funds for tuition, which includes all fees and health insurance. Such costs will be provided according to existing NIH policies on Ruth L. Kirschstein Research Training Opportunities - National Research Service Award Research Training Grants and Fellowships, at the following website: http://grants.nih.gov/training/nrsa.htm. o Travel Applicants may also request funds for certain types of training-related travel for trainees, (e.g., to attend professional meetings and other meetings directly related to their training). Annual levels are anticipated to be up to $1,000 per postdoctoral fellow. The National Heart, Lung and Blood Institute allows annual travel expenses of up to $1400 per fellow. In addition, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent institution must be justified considering the type of opportunities for training available, the manner in which these opportunities differ from and complement those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and goals. This type of research training requires prior approval from the NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised. Additionally, as noted above, funds to support travel of the Program Director to the annual meeting in the Washington, DC area should be requested. o Training-Related-Expenses The applicant organization may also request funds for other Training- Related Expenses (TRE) such as personnel directing the program, consultants, project specific supplies, travel, reproduction and printing costs, rental equipment, minor equipment items, and other items that are directly related to the recruitment, selection, placement, monitoring and retention of the students. Funds for such other training-related expenses are intended to provide the applicant with only partial support for the costs of the proposed research training and for meeting the costs of the trainees’ research projects. Ordinarily, under NRSA Awards, up to $3,850 per postdoctoral trainee is provided on an annual basis for the other training-related expenses that are deemed essential to carry out the training program for the NRSA awardees appointed under the grant. However, for the purpose of these Interdisciplinary Research Training programs, the Training-Related-Expenses may exceed $3,850 per trainee by allowing up to five percent of the Program Director’s salary plus fringe benefits, per year, plus up to $5,000 annually for administrative costs associated specifically with the interdisciplinary nature of the proposed training program (e.g., coordination among multiple institutions). All budget items within the TRE category must be explained in detail and be fully justified at the level requested. The type and amount of fiscal or in-kind costs to be contributed by the grantee organization should be identified and discussed in detail. Grantees are expected to be familiar with and comply with applicable cost policies, and the NRSA Guidelines. Funds may be used only for those expenses that are directly related and necessary to the research training not otherwise available and must be expended in conformance with DHHS Cost Principles, the NIH Grants Policy Statement (rev. 03/01/01), the NRSA regulations and guidelines, and conditions set forth in this document. o Facilities and Administrative (F&A;) Costs: These costs are limited to 8 percent of allowable direct costs (excludes all tuition costs, health fees, and equipment). STIPEND SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH. Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program. Stipend Supplementation: Supplementation or additional support to offset the cost of living may be provided by the grantee institution. Supplementation does not require additional effort from the trainee. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal Agency. Compensation: An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting the research training experience. Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Postdoctoral trainees in their first and third years of training may also be eligible to participate in the NIH Extramural Loan Repayment Program. Concurrent Awards: An NRSA may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. Other important information items regarding terms and conditions are located in the NRSA Guidelines (http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm) and in the revised NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2001/index.htm). 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: Nancy L Desmond, Ph.D. National Institute of Mental Health Division of Neuroscience & Basic Behavioral Science 6001 Executive Blvd., Room 7197, MSC 9645 Bethesda, MD 20892-9645 (USPS) Rockville, MD 20852 (FedEx, UPS, etc.) Telephone: (301) 443-3563 FAX: (301) 443-1731 E-mail: ndesmond@nih.gov Direct inquiries about peer review issues to: Michael Kozak, Ph.D. Review Chief National Institute of Mental Health 6001 Executive Blvd Rm 6138 Bethesda, Maryland 20892-9605 Rockville, Maryland 20852 (overnight) Telephone: (301) 443-6471 Fax: (301) 334-4270 E-mail: mkozak@mail.nih.gov Direct inquiries about financial or grants management matters to: Rebecca D. Claycamp, CRA Chief Grants Management Officer National Institute of Mental Health 6001 Executive Boulevard, Room 6122, MSC 9605 Bethesda, Maryland 20892-9605 Rockville, Maryland 20852 (overnight) Telephone: (301) 443-2811 Fax: (301) 443-6885 E-mail: rc253d@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 Program Director 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 NIH program 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: Nancy L Desmond, Ph.D. National Institute of Mental Health Division of Neuroscience & Basic Behavioral Science 6001 Executive Blvd., Room 7197, MSC 9645 Bethesda, MD 20892-9645 (USPS) Rockville, MD 20852 (FedEx, UPS, etc.) Telephone: (301) 443-3563 FAX: (301) 443-1731 E-mail: ndesmond@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 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. SUPPLEMENTARY INSTRUCTIONS The following information should be provided IN ADDITION to that specified by the PHS 398 instructions. Background: Provide a rationale and overall conceptual framework for the interdisciplinary research training program. Indicate how the proposed program is innovative and distinct from, yet integrated with existing training programs. Describe how training in behavioral or social science disciplines might be integrated with biomedical science training (if applicable). Program Direction: Describe the Program Director’s accomplishments and leadership in interdisciplinary research and training. Describe the administrative structures that allow and encourage interdisciplinary and/or cross-departmental research opportunities and how these will affect training opportunities for the fellows. Program Faculty: Describe each faculty member’s interdisciplinary research and training accomplishments and the extent to which participating faculty members cooperate and collaborate in pursuing interdisciplinary research relevant to the program. Inclusion of investigators from the behavioral or social sciences is required. A definition of behavioral and social sciences research for the NIH can be found at http://obssr.od.nih.gov/funding/definition.html. Proposed Training: Describe the proposed interdisciplinary training program. Describe the course work and research experiences. For programs with multiple tracks, provide course work and research experiences for each track, as well as opportunities and experiences for trainee interaction and research integration that span the whole program. Describe formal endpoint(s), if any, to be achieved by the trainees (e.g., Master’s degree, certificate). Provide the proposed distribution of trainees by original discipline (e.g., genetics, biochemistry, physiology, cell biology, molecular biology, psychology, sociology, epidemiology, mathematics). Describe plans for provision of training in the personal and professional skills necessary to lead and participate in multidisciplinary teams. NIH Roadmap Goal: For programs that facilitate communication among different disciplines, promote but perhaps do not completely achieve integration of different disciplines in the proposed project period, or propose training in multidisciplinary approaches as a precursor to interdisciplinary research training, include a detailed plan with appropriate milestones for achieving the NIH Roadmap goal of developing interdisciplinary research training. Program Evaluation: Provide plans for monitoring trainee progress and overall program evaluation. Describe the measures (e.g., publications, grant proposals and awards, career trajectory of trainees) that will be used to assess the success or failure of the program. Include in the evaluation plan an assessment of the program’s impact on the culture for doing interdisciplinary research at the participating institution(s). Input for evaluating the program should be obtained from faculty and trainees. Institutional Support: Describe support (financial or otherwise) that the institution(s) will provide for the proposed training program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director or participating faculty, support for additional trainees in the program, or any other creative mechanisms to improve the climate for the establishment and growth of the training program. Trainee Recruitment: The NIH remains committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. As first announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit and retain underrepresented minorities in the training program. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993 (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html). Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the program; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. 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/labels.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 and all copies of the appendix material must be sent to: Jean G. Noronha, Ph.D. Referral Liaison Division of Extramural Activities National Institute of Mental Health 6001 Executive Blvd., Room 6147, MSC 9609 Bethesda, MD 20892-9609 (for courier service use: Rockville, MD 20852) phone: 301-443-3367 fax: 301-443-4720 e-mail: jnoronha@mail.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 the applicant 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. The CSR will not accept any application that is essentially the same as one already reviewed. 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 the relevant Institute(s), Offices or Center(s). Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific, technical, and educational merit by an appropriate peer review group 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, assigned a priority score o Receive a written critique o Receive a second level review by the appropriate National Advisory Council or Board. Notification Shortly after the review meeting, each applicant will be sent notification of the Initial Review Group’s recommendation and the name and phone number of the NIH official responsible for the application. When the NIH official receives the summary statement of the review, prepared by the Scientific Review Administrator after the review meeting, a copy will be forwarded to the applicant. Following Council or Board review the NIH program officer will notify each applicant of the final disposition of the application. REVIEW CRITERIA Major considerations in the review are the breadth, depth, and quality of the plan for implementing the interdisciplinary training program; qualifications, capability, and experience of the Program Director, faculty and participating institution(s) to implement the plan; plans for recruiting, selecting, and monitoring trainee progress; and adequacy of the facilities and resources. Detailed review criteria are listed below: BACKGROUND o Clarity of the program’s objectives, rationale, and overall conceptual framework o Adequacy in meeting the RFA’s intent to prepare candidates who can design and implement research that integrates research in behavioral or social science disciplines with research in other health- or biomedical disciplines o Evidence of institutional commitment to training and development of independent researchers o Evidence that the proposed program is innovative and distinct, yet integrated with other training programs at the institution, such as K30 or T32 programs PROGRAM DIRECTION o Qualifications of the Program Director to lead the interdisciplinary research and training program, including his/her research training record, as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers. Evidence of further career development can include receipt of fellowships or career awards, subsequent training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. o Appropriateness of the Program Director’s time devoted to administering the program o Adequacy of the administrative structures that allow and encourage interdisciplinary, cross-departmental and/or cross-institutional (if applicable) research and training opportunities PROGRAM FACULTY o Evidence of a multi- and interdisciplinary program faculty and their involvement in teaching and research activities (programs are required to include a behavioral or social science discipline) o Evidence of the availability and commitment of faculty mentors now and for the duration of the program o Quality of the training faculty in interdisciplinary research relevant to the program, as evidenced by, for example, publications, scientific accomplishments, experience in conducting funded interdisciplinary research, and success in placing former trainees in interdisciplinary research positions o Quality of mentoring as indicated by the faculty training record (see explanation of training record, under “Program Direction” above) o Evidence of cooperation and collaboration among program faculty in pursuing interdisciplinary research and training relevant to the program PROPOSED TRAINING o Adequacy of the nature and duration of proposed course work and research experiences for each research training track o Adequacy of the proposed research training tracks given program faculty expertise and size o Adequacy of the proposed plans for interdisciplinary research seminars and experiences that allow for trainee interaction and research integration across the whole program o Adequacy of the proposed number and distribution of trainees by degree and original discipline o Quality of plans to monitor progress of the trainees, of the program as a whole, and of the program’s impact on the culture for performance of interdisciplinary research at the participating institution(s) o Adequacy of the proposed plans for instruction in the responsible conduct of research (see below) o Adequacy of training in the personal and professional skills necessary to lead and participate in multidisciplinary teams o Adequacy of specific plan to track progress toward achievement of the NIH Roadmap goal of developing interdisciplinary research training RECRUITMENT, SELECTION, AND RETENTION OF TRAINEE CANDIDATES o Adequacy of the plans for recruiting qualified candidates from on- site programs, as well as strategies for recruiting regionally and/or nationally o Adequacy of the criteria and administrative procedures for selecting qualified candidates o Adequacy of plans for recruiting and retaining candidates from underrepresented minority groups. This assessment will include consideration of the racial and ethnic diversity of the trainee pool, but will also take into account the described recruitment and retention efforts as well as the availability of individuals from underrepresented groups within the relevant pool of applicants. o If appropriate, record of the research training program in retaining health-professional postdoctoral trainees for at least 2 years in research training or other research activities; o When appropriate, the concomitant research training of health- professional postdoctorates (i.e., individuals with the M.D., D.O., D.D.S., etc.) with basic science postdoctorates (i.e., individuals with a Ph.D., etc.) or linkages with basic science departments. BUDGET Appropriateness and justification for all items in the proposed budget; compelling justification for training-related-expenses in excess of $3,850 per postdoctoral trainee to support up to five percent of the Program Director’s salary (plus fringe benefits) and administrative costs associated with the unique, interdisciplinary nature of the training program. FACILITIES AND RESOURCES o Availability of facilities and resources for supporting and conducting interdisciplinary research and training o Extent of institutional support for trainees and the program TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH Every NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, http://grants.nih.gov/grants/guide/notice-files/not92-236.html.) Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review. o Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students or postdoctorates appointed to the program. o Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. o The rationale for the proposed plan of instruction must be provided. o Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and noncompeting applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students, postdoctorates, and research staff regardless of their source of support. NIH initial review groups will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Staff within the NIH awarding component will judge the acceptability of the revised plan. Following initial review, the appropriate NIH institute or center council, board, or other advisory group also reviews applications. These advisory groups will consider the assessment of the scientific and educational merit of the research training grant application as well as the initial review group's comments on the recruitment of individuals from underrepresented minority groups and the plan for instruction in the responsible conduct of research. USE OF HUMAN SUBJECTS IN RESEARCH If appropriate, the involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. Moreover, the adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be reviewed. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 11, 2004 Application Receipt Date: March 11, 2004 Peer Review Date: June/July, 2004 Council or Board Review: September, 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Applications are selected for funding primarily on the basis of scientific and educational merit and sound administrative organization. However, other factors are considered, such as: availability of funds, research program priorities, the balance among types of research training and career development supported by the IC’s, the acceptability of the plan for minority recruitment, and the acceptability of the plan for instruction in the responsible conduct of research. The NIH appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIH. 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 SAFETY AND MONITORING PLAN: 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 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 "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. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm 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. 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 http://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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA 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 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 487 f the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. 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 http://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.the plan for instruction in the responsible conduct of research. USE OF HUMAN SUBJECTS IN RESEARCH If appropriate, the involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. Moreover, the adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be reviewed. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 11, 2004 Application Receipt Date: March 11, 2004 Peer Review Date: June/July, 2004 Council or Board Review: September, 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Applications are selected for funding primarily on the basis of scientific and educational merit and sound administrative organization. However, other factors are considered, such as: availability of funds, research program priorities, the balance among types of research training and career development supported by the IC’s, the acceptability of the plan for minority recruitment, and the acceptability of the plan for instruction in the responsible conduct of research. The NIH appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIH. 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 SAFETY AND MONITORING PLAN: 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 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 "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. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm 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. 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 http://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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA 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 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 487 f the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. 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 http://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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