PAR-02-166: NIMH COMPETING SUPPLEMENTS FOR EARLY CAREER DEVELOPMENT OF INTERDISCIPLINARY RESEARCH AND EDUCATION IN HIV/AIDS

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NIMH COMPETING SUPPLEMENTS FOR EARLY CAREER DEVELOPMENT OF INTERDISCIPLINARY RESEARCH AND EDUCATION IN HIV/AIDS RELEASE DATE: September 13, 2002 PA NUMBER: PAR-02-166 EXPIRATION DATE: October 2005, unless reissued. National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) APPLICATION RECEIPT DATE: Standard Receipt Dates See (http://grants.nih.gov/grants/dates.htm) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Mental Health (NIMH) announces a program for competitive supplements to support interdisciplinary research and education on active interdisciplinary HIV/AIDS research grants funded through the Center for Mental Health Research on AIDS (CMHRA). This competitive supplement program encourages and supports HIV/AIDS interdisciplinary research and career development for qualified candidates through an AIDS-expedited application process. This supplement program was developed in response to the recommendation from the report by the National Advisory Mental Health Council"s Behavioral Science Workgroup that "funding agencies should establish a grant supplement program to foster interdisciplinary training and research" (available at http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm). The goals of this initiative are to: (1) expand and foster the independent research capabilities of the candidate, and (2) strengthen the ongoing research program of the parent grant. It is anticipated that, as a result of successful research efforts provided through this supplement, the interdisciplinary-supported individual will be in a position to apply for a research (R) award or a career development (K) award. RESEARCH OBJECTIVES Background The complexity and interconnections of the rapidly growing area of the neuroscience and psychobiology of HIV-related disease underscores the need to provide research opportunities to young investigators so that they may break new ground in this area. It is anticipated that some of the most significant insights and advances in HIV disease are likely to emerge as a result of recognizing and appreciating the intricate interplay among the brain, environment and behavior. Interdisciplinary and translational research approaches among basic, clinical and services research are potentially powerful approaches to integrate the rapidly advancing findings in HIV/AIDS research. Yet, there seems to be disciplinary fragmentation, with researchers from basic, clinical and services areas working in different venues. Interdisciplinary research is defined as an integrated effort by a team of scientists using different concepts and different methodologies to address a common problem. Translational research is referred to as a form of interdisciplinary research that attempts to translate and apply research findings from one domain to another. Three major areas of HIV/AIDS research (HIV prevention science, NeuroAIDS, HIV therapeutics) would be facilitated and enriched through an organized research program with researchers employing different approaches. Research in these domains draws upon a number of disciplines such as epidemiology, neuropsychology, brain imaging, neuropathology, genetics, molecular biology, immunology, and behavioral and social sciences. It will be essential to transfer knowledge among these research domains to increase dissemination and utilization of research findings. Objectives The proposed research experience must encompass an interdisciplinary or translational research approach as defined above. In all cases, the proposed research must be an integral part of the ongoing interdisciplinary HIV/AIDS research program supported by the parent grant and have the potential to significantly contribute to the research career development of the interdisciplinary candidate. The research proposed should add a dimension that is consistent with the interdisciplinary approach of the existing parent grant and can realistically be expected to enhance the scope of the parent project. Supplemental awards will be consistent with the goal of broadening the existing research program and the overall programmatic balance and priorities of the CMHRA. As part of this research experience, the Principal Investigator (PI) must describe a plan by which the interdisciplinary candidate will have the opportunity to interact with individuals on the parent grant, in order to contribute intellectually to the research and to enhance his/her research skills and knowledge regarding the particular scientific areas. This will include the conduct of a research project that is supplementary, but directly related to the goals of the parent grant. Furthermore, the PI must demonstrate a willingness and understanding that the purpose of the award is to enhance the research capability of the interdisciplinary candidate and that the research experience is intended to provide opportunities to develop as an independent, competitive research investigator. Mentorship is a key part of this competitive supplement program that will complement the research and career development in interdisciplinary HIV research. It is expected that the PI will not only be involved in supervising the candidate"s scientific progress, but also will be actively engaged in the candidate"s mentorship and career development to increase his/her chances of pursuing a biomedical research career. The primary scientific mentor must be the PI of the grant requesting the supplement. Since interdisciplinary research involves more than one discipline, it may be necessary to identify a co-mentor in the secondary disciplines. Together with the candidate, the primary mentor is responsible for the planning, direction, and execution of the program. In addition, the primary mentor will assist the candidate in the development of a subsequent competitive research grant application with the pilot data supported by this supplement. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. MECHANISM OF SUPPORT This PA will use the NIH competing supplement mechanism to ongoing NIMH-funded R01 grants only. Applicants will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not be less than 1 year, thus, the remaining project period of the parent grant must be not less than 1 year at the time of award. Further, the duration of the entire supplement may not exceed the remaining period of support for the parent grant. Only one application may be submitted per parent grant. Direct costs for this supplement may not exceed $100,000 per year. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Since the direct costs of the supplements will always be less than $250,000 yearly, the modular format is required. FUNDS AVAILABLE NIMH intends to fund approximately 3-5 supplements. Funds will be provided to conduct interdisciplinary and translational research studies by scientists at the postdoctoral and junior faculty levels, located at the grantee institution and related directly to active interdisciplinary HIV/AIDS research grants. SPECIAL REQUIREMENT Only applications proposing research at the same site as the parent grant may be considered for this supplemental program. The work should be a logical extension of the goals and objectives of the parent grant, but may constitute new research or program expansion. A research plan redundant with any portion of the studies approved under the parent grant will not be supported under this supplement program. CANDIDATES Applications may be submitted on behalf of candidates who have the qualifications noted below. o Postdoctoral candidates. Postdoctoral research candidates includes individuals who have received a Ph.D., D.V.M., D.D.S., M.D., or a comparable doctoral degree from an accredited domestic or foreign institution. This program will provide support for candidates who wish to participate as postdoctoral researchers in ongoing research projects and career development experiences in preparation for independent careers in biomedical, behavioral and clinical research. It might be appropriate for residents who wish to take a hiatus from their clinical training to participate in research. The candidate must be affiliated with and located at the grantee institution. o Junior faculty candidates. This program aims to help implement career development programs that encourage junior faculty of the grantee institution to engage in interdisciplinary AIDS research. BUDGET INFORMATION Allowable costs may include salary and fringe benefits for the candidate, costs for consultants, supplies, travel to scientific meetings, tuition and fees, and any other essential costs related to the research and education plan associated with the parent grant, not otherwise available at the grantee institution. Funds will NOT be provided for off-site costs or rent, and any request for equipment must include compelling justification since this is a short-term program supplemental to an ongoing grant. The initial award period will be pro-rated to the end of the parent grant budget period. The salary must be consistent with the effort devoted to the supplement, the established salary structure at the grantee institution, and with salaries actually provided by the grantee from his/her own funds to other postdoctoral and junior faculty with equivalent qualifications, rank, and responsibilities in the applicable department. The total direct costs for each supplement may not exceed $100,000. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, review, and financial or grants management issues. o Direct your questions about scientific/research issues to: David M. Stoff, Ph.D. Center for Mental Health Research on AIDS Division of Mental disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6210, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-4625 FAX: (301) 443-9719 Email: dstoff@nih.gov o Direct your questions about review matters to: Michael Kozak, Ph.D. Chief, Extramural Review Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Telephone: (301) 443-1340 FAX: (301) 594-0702 Email: mkozak@mail.nih.gov o Direct your questions about financial or grants management matters to: Brian Albertini Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-0219 Email: albertinib2@mail.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) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted on January 2 and September 1 of each year for the next 3 years. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR COMPETITIVE SUPPLEMENT APPLICATIONS: There must be a minimum of 1 full year of support remaining on the parent grant at the time of the award of the supplement. The supplement cannot exceed the period of the parent grant support. To apply for a competitive supplement, the PI, on behalf of the proposed candidate, must submit the following information: o A completed Grant Application PHS 398 with appropriate signatures on the face page. Include the title and grant number of the parent grant on line 1 and the PA Number of this program announcement on line 2 with the type of supplement requested (i.e., Competitive HIV/AIDS Interdisciplinary). WHILE THE R01 APPLICATION IS ALLOWED 25 PAGES FOR THE RESEARCH PLAN SECTION, IT IS EXPECTED THAT FOR THIS SUPPLEMENT, THE RESEARCH PLAN WILL NOT EXCEED 15 PAGES. o Applications should have the normal Description on page 2 as described in PHS 398 which should describe the proposed supplemental activity and how it relates to the parent grant. o In addition to the Biographical sketch of the PI, one should be included for the candidate, that gives evidence of scientific achievements and interest. o Resources available, adequacy of the environment, and representation of expertise from multiple disciplines for interdisciplinary work. o A one page introduction, prepared by the Principal investigator, that includes the grant number of the funded grant or project, summary or abstract, and specific aims. o The Research Plan should provide a description of the supplemental project developed by the PI, in conjunction with the candidate, including: a. A description of the research project proposed. b. A description of how the proposed research relates to the specific research goals and objectives of the parent grant. c. Expected overall impact on ongoing research d. Methodology proposed, technical and/or analytical expertise used, statistical plan. e. Possible results, plans for independent confirmation and follow-up studies and for dissemination of results. f. A description of how the research experience will foster the independent research capabilities of the candidate. o A one-page statement from the candidate outlining his/her objectives and career goals. o A one-page statement from the mentor describing their supervisory experiences, and their plans for education and research development of the candidate. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application (the Research Plan is expected to be no longer than 15 pages), 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 Jean G. Noronha, Ph.D. NIMH Referral Liaison National Institute of Mental Health 6001 Executive Blvd, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: jnoronha@nih.gov APPLICATION PROCESSING: Applications must be received by or mailed on or before the application receipt dates listed in the heading of the program announcement. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and by NIMH program staff for adherence to the guidelines of this PA. Applications that are incomplete and those applications that do not adhere to the guidelines of this PA will be returned to the applicant without review. Applications that will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique and priority score o Receive a second level review by the National Advisory Mental Health Council 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Applications will be evaluated according to the following criteria: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Particular emphasis will be given to the interconnectedness of the questions being asked and the degree to which the proposal asks integrated research questions that include multiple disciplines. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the principal investigator appropriately trained and well suited to advise the candidate in carrying out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o the reasonableness of the proposed budget and duration in relation to the proposed research, and o the adequacy of the proposed protection for human subjects, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o The qualifications of the candidate including career goals, prior research training, research potential and any relevant experience. o The likelihood that successful research efforts by the candidate will make a significant contribution and provide data leading to submission of competitive grant applications by the candidate. o Prior and planned supervisory activities of the primary scientific mentor. o Qualifications of the primary mentor as an expert in a discipline that is a major thrust of the proposed project. o The adequacy of the research activities, resources, and expertise to support AIDS-related interdisciplinary efforts. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS 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. 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://grants.nih.gov/grants/stem_cells.htm 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 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 PA 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. 93.242 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 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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