BEHAVIORAL SCIENCE TRACK AWARD FOR RAPID TRANSITION (B/START) RELEASE DATE: October 20, 2003 PA NUMBER: PAR-04-010 (Announcement being discontinued after expiration, see NOT-MH-05-015) March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expires on the date indicated below. A replacement R03 (PAR-06-141) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and AIDS-related R03 and R21 Applications. EXPIRATION DATE: March 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.242 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 This PA replaces PAR-00-119. The National Institute of Mental Health (NIMH), through the issuance of this Program Announcement (PA), intends to facilitate the entry of new investigators into the field of behavioral science research to advance the mission of reducing mental illness and behavioral disorders through research. NIMH invites newly independent investigators to submit applications for small-scale exploratory or pilot research projects related to the behavioral science mission of the NIMH. This includes basic research on psychological and behavioral processes (e.g., cognition, emotion, personality, social cognition), research incorporating neural and other biological approaches if the research has a primary focus on behavior, research on mental illness (risk factors, diagnosis, treatment, and prevention), and research on mental health services (e.g., organization, financing, delivery, and effectiveness; psychosocial rehabilitation, adherence). Funding of B/START awards is relatively rapid, i.e., within approximately six months of the date of receipt of the application. RESEARCH OBJECTIVES Research areas relevant for support by NIMH can be found at the following URL: http://www.nimh.nih.gov/grants/program_contact.cfm. To be appropriate for a B/START award, research in these areas must, in addition, be primarily focused on behavioral science research questions. That is, research on neural, genetic, or other biological processes would be appropriate for a B/START award only if incorporated within a project whose overall emphasis is on understanding behavioral processes or outcomes. Examples of the latter include individual mental function (e.g., cognition, emotion, personality); mental health disparities; developmental and environmental influences on behavior; behavioral or psychosocial factors in risk, treatment, and prevention of mental disorder; psychosocial rehabilitation; adherence; and behavioral factors in mental health service delivery. MECHANISM OF SUPPORT This PA will use the NIH Small Grant (R03) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The total project period for a B/START application may not exceed one year. The total direct costs for the project may not exceed $50,000. Grant funds may be used for expenses clearly related and necessary to conduct the research project, including both direct costs that can be specifically identified with the project plus allowable facilities and administrative (F&A) costs of the institution. Replacement of the Principal Investigator on a B/START award is not permitted. Transfer of a B/START award with the Principal Investigator to another institution for the remainder of the grant period may be requested. B/START awards are not renewable. If a B/START application is unsuccessful in obtaining funding on the first submission, it may be revised (amended) and resubmitted one time. Additional revision and resubmission of a B/START application is not permitted. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, B/START applications may request up to two modules of $25,000 direct costs each. Because B/START grants have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under WHERE TO SEND INQUIRIES) prior to submitting an application. There are alternative mechanisms of support for individuals interested in pursuing periods of supervised training and career development activities. Such individuals are encouraged to consider applying for NIMH individual postdoctoral fellowships or NIMH mentored career development awards. Additional information regarding Institute-wide training initiatives and support mechanisms can be found at http://www.nimh.nih.gov/grants/training.cfm. 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. ELIGIBLE INSTITUTIONS You may submit application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS To be eligible for a B/START award, the proposed Principal Investigator must be independent of a mentor at the time of award, but be in the beginning stages of his/her research career (typically not more than five years from receipt of the doctorate or, if applicable, from the end of postdoctoral training). If the applicant is in the final stages of training, s/he may apply, but no B/START award will be made to individuals still in training status. The proposed Principal Investigator may not have been designated previously as Principal Investigator on any PHS-supported research or career grant (except a dissertation research grant) or have received similar support from another federal agency, e.g., the National Science Foundation. However, previous funding as a trainee through the National Research Service Award (NRSA) program (i.e., Institutional Training Grant or Individual Fellowship), or through training support from another agency, is permissible. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. 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, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Mary Ellen Oliveri, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7220, MSC 9651 Bethesda, MD 20892-9651 Telephone: (301) 443-3942 FAX: (301) 443-9876 Email: moliveri@nih.gov Emeline M. Otey, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6186, MSC 9624 Bethesda, MD 20892-9625 Telephone: (301) 443-3728 FAX: (301) 443-4611 Email: eotey@nih.gov Enid Light, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: elight@nih.gov o Direct your questions about peer review issues to: Michael Kozak, Ph.D. 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: kozakm@mail.nih.gov o Direct your questions about financial or grants management matters to: Ms. Carol J. Robinson Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6118, MSC 9605 Bethesda, MD 20892-9605 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3858 FAX: (301) 443-6885 Email: crobinso@mail.nih.gov SUBMITTING AN APPLICATION Prior to submitting an application, investigators are strongly encouraged to contact the program contacts listed under WHERE TO SEND INQUIRIES in order to assess the responsiveness of their proposed project to the mission of NIMH and to the goals of this PA. Applications judged not to be responsive or not appropriately focused on mental-health-relevant behavioral processes and research questions (as addressed in PURPOSE and RESEARCH OBJECTIVES) may be returned to the applicant without review. 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) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: For B/STARTs, there is an exception to the standard deadlines as noted at: http://grants.nih.gov/grants/dates.htm. In order to permit expedited funding, revised (amended) applications are due on the same dates as new applications (February 1, June 1, and October 1). (As noted in MECHANISM OF SUPPORT, B/STARTs are allowed one revision only.) SPECIAL INSTRUCTIONS FOR A B/START APPLICATION: All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions: o The title, Behavioral Science Track Award for Rapid Transition (B/START), and number of the program announcement (PAR-04-010) must be typed on line 2 of the face page of the application form and the YES box must be marked. o For revised (amended) applications, the Introduction to Revised Application must not exceed one page. o Sections a-d of the Research Plan must not exceed seven pages in total. o Appendix. The appendix may include original, glossy photographs or color images provided that a photocopy (may be reduced in size) is also included within the page limits of the research plan. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the appendix. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: B/START applications must be submitted in modular 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 budgets. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. For the B/START, applicants may request up to two modules (maximum of $50,000 direct costs) for a period of one year. 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) To permit an expedited review of the application applicants must simultaneously send two complete copies to: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, 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@mail.nih.gov APPLICATION PROCESSING: Applications must be mailed on or before the applicable receipt date (see APPLICATION RECEIPT DATES). The Center for Scientific Review (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. 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. PEER REVIEW PROCESS B/START applications are evaluated for scientific and technical merit by appropriate reviewers selected by NIMH in accordance with NIH peer review procedures. REVIEW CRITERIA The B/START award is a mechanism for pilot or preliminary research conducted by investigators new to the grant process. Because of the restricted length of the research plan, a B/START application will not have the same level of detail or extensive discussion found in R01 applications. Accordingly, reviewers should evaluate the overall conceptual framework, general approach to the problem, and promise of the application, placing less emphasis on methodological details and other indicators traditionally used in evaluating scientific merit. Supportive preliminary data are not required. Reviewers will evaluate the following aspects of B/START applications: o Significance o Approach o Innovation o Investigator o Environment Reviewers will address and consider each of these criteria in assigning an application’s overall score, weighting them as appropriate for each application. An application does not need to be strong in all categories to be judged worthy of a high priority score. (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 investigator appropriately trained and well suited to carry 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 assessed. 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. ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Appropriateness to the goals of the B/START program o Availability of funds o Program priority REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING 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 and Safety 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 research involving human subjects 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modifications to the Standards for Privacy of Individually Identifiable Health Information, the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at 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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