This Program Announcement expires on August 1, 2004, unless reissued. MECHANISM FOR TIME-SENSITIVE RESEARCH OPPORTUNITIES Release Date: September 5, 2001 PA NUMBER: PAR-01-136 (This PAR has been reissued, see PAR-05-150) National Institute of Mental Health ( Letter of Intent Receipt Date: 4 weeks prior to the planned submission date Application Receipt Date: 9th of each month THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS FOR ALL APPLICATIONS SUBMITTED IN RESPONSE TO THIS PA. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT PURPOSE The National Institute of Mental Health (NIMH) encourages investigator- initiated research applications that seek to address problems of major public mental health significance in which the opportunity to conduct research is time limited. This Program Announcement (PA) responds to recommendations made by the National Advisory Mental Health Council’s Bridging Science and Service Report ( The purpose of this PA is to enhance research activity and enable portfolio development in rapidly evolving areas (e.g., service systems, health care financing, and policy research) in which research opportunities are fleeting. This PA is intended to support innovative lines of inquiry through scientific partnerships between researchers and community partners (e.g., providers, payers, health authorities) the latter of whom cannot delay policy or program changes in order to allow investigators time to obtain baseline research data about such changes. This PA provides a mechanism for accelerated review and award to support opportunities for such research. All eligible applications responding to this PA will be subject to an accelerated review and award process. Eligible studies selected for funding are intended to be awarded within 4-6 months after the application receipt date. However, administrative requirements and other unforeseen circumstances may delay issuance dates beyond that timeline. Investigators pursuing support for mental health research in the immediate aftermath of a disaster are referred to Rapid Assessment Post-Impact of Disaster (RAPID), October 1995 revision, at 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, Mechanism for Time-Sensitive Research Opportunities, is related to on or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, providers, public and private health care purchasers, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for this time sensitive mechanism. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Small Grant (R03), Exploratory/Developmental Grant (R21), and Research Project Grant (R01) award mechanisms. The Small Grant (R03) provides two years of funding with a maximum of $50,000 direct costs for each year. Information and application instructions for the NIMH Small Grant are available in the NIH Guide for Grants and Contracts at The Exploratory/Developmental Grant (R21) provides up to two years of funding with up to $100,000 in total direct costs annually for one-time grants for studying innovations in research directions, approaches, concepts, technologies, techniques or methods. Information and application instructions for the NIMH Exploratory/Developmental Grant are available in the NIH Guide for Grants and Contracts at The Research Project Grant (R01) provides up to five years of funding that is commensurate with the science proposed. This PA will provide support for the initial competing award. Funding beyond that period may be requested through the regular research grant application process. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. For all competing R03 and R21 applications, and those R01 applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at R01s greater that $250,000 per year require detailed budgets and do not follow Modular Grant format. RESEARCH OBJECTIVES Background In 1999, the National Advisory Mental Health Council of the National Institute of Mental Health (NAMHC) issued a report, “Bridging Science and Service,” which discussed the need for NIMH to play a larger role in bridging the domains of efficacy, effectiveness, practice, and service systems research. The report noted that the usual time for grant review and funding has precluded seizing certain unique, but time-limited research opportunities, and has thus limited the scope or application of scientific knowledge under circumstances in which that knowledge was needed. Specifically, in areas such as evolving service systems, changes in health care financing, and policy research, there are often opportunities for collaborations, particularly with purchasers and policy-makers, which would become unavailable by the time the existing review and award process was completed. The NAMHC recommended that NIMH develop a means of responding rapidly to investigators who propose to take advantage of such opportunities. This PA was developed in response to these recommendations. Research Objectives and Scope This PA encourages research grant applications that make use of time-limited opportunities for investigation, particularly with community partners (e.g., public mental health or health care systems, long-term care providers, prisons, jails and other correctional system settings, health care providers, payers, health authorities, etc.) Specifically, the goal is to fund innovative research partnerships in which the expedited initiation of a study is necessary in order to take advantage of a rapidly evolving change in a health care system or public policy. Eligible studies might propose a partnership in order to recruit research participants or to simply share data, methods and resources. The distinguishing feature of an eligible study is that rapid review and funding significantly enhance the study’s scientific value and feasibility. It should be clear that the research question(s) could only be answered if the project is initiated with minimum delay. Examples Examples of appropriate studies include, but are not limited to, the following: o Examining the impact of rapid changes in legislation that affect mental health systems o Evaluating the impact of systems interventions implemented as an immediate response to administrative or policy directives o Determining the impact of new payment mechanisms including the cost- effectiveness of alternative treatments o Identifying, describing, or tracking individual and/or family outcomes resulting from changes in services or changes in eligibility for benefits o Determining the impact of new dissemination or implementation strategies o Examining the impact of new quality improvement programs ADDITIONAL PROTECTIONS FOR PRISONERS IN RESEARCH INVOLVING HUMAN SUBJECTS It is not uncommon for persons receiving or in need of mental health services to come in contact with or be confined within the criminal justice system. Researchers must therefore be aware of the additional human subjects protections required for "prisoners," a term defined by the Department of Health and Human Services (DHHS) to include adults, adolescents, and children who are either confined or detained involuntarily in an institution or facility by virtue of criminal or civil statutes or commitment procedures. All investigators proposing research involving prisoners or individuals who may enter prisoner status during study involvement should read the Code of Federal Regulations, Title 45, Public Welfare, Part 46 "Protection of Human Subjects," which is available on the web at the following URL address: Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 ( A complete copy of the updated Guidelines is available at The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this PA. Although the 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 NIMH staff to estimate the potential review workload and plan the expedited review. The letter of intent is to be sent to Denise Juliano-Bult, M.S.W. at the address listed under INQUIRIES, approximately 4 weeks prior to the planned submission date. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program staff listed under INQUIRIES with any questions regarding their proposed project and the goals of this PA. The PHS 398 research grant application instructions and forms (rev. 5/2001) at are to be used in applying for these grants and will be accepted at the application deadlines described below. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: Applicants planning to submit an investigator-initiated new (type 1) grant application requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS PA Applications must be received by the ninth of each month. Applications which are received after the ninth will automatically be processed the following month. Applications not received as a single package on the receipt date or not conforming to the instructions contained in PHS 398 Application Kit (as modified in and superseded by, the special instructions below, for the purposes of this PA), will be judged non-responsive and will be returned to the applicant. Along with the specific aims, background and significance, preliminary studies, and research design and methods (Sections A to D), the research plan must include a justification for why the proposed study requires accelerated review and award. Justification must include an explanation of how the study’s goals cannot be achieved without rapid review and award, or how rapid review and funding would significantly enhance the efficiency or scientific value of the study. Methods of data collection and analysis, and power calculations must be included, along with a justification for the required sample size. There must also be a discussion of the statistical procedures that will be used to analyze the data. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at is to be used in applying for these grants, with modular budget instructions beginning on page 13 of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Jean 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) REVIEW CONSIDERATIONS Applications will be assigned to NIMH. An appropriate scientific review group convened by NIMH will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Is the research question one that cannot be adequately answered unless the review and funding of the project is expedited? Does the research opportunity address an important problem? If the aims of the application are achieved, will scientific knowledge be significantly advanced? What will be the effect on the concepts or methods that drive the relevant fields? (2) Approach: Does the approach justify the need for rapid review and funding? Is the approach likely to successfully develop the partnership(s) needed to carry out the study and complete work in the time period proposed? 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 proposed 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: Are the investigators appropriately trained and experienced, and well suited to carry out this work, including maintenance of the working partnership? Do the collaborators adequately demonstrate both the capability and the commitment to carrying out the work proposed? (5) Environment: Do the environment(s) in which the work will be done contribute to the probability of success? Do the proposed investigations take advantage of unique features of the environment(s) and support the justification for rapid review and funding? Is there evidence of institutional support from both sides of the partnership? Are collaborating community partners committed to the rapid nature of the project? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o Evidence that all the research partners are committed to the success of the project. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of the proposed plan to share data, if appropriate. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Potential applicants are strongly urged to contact the Program Officer, Denise Juliano-Bult, before submitting an application under this program announcement, to determine whether the proposed work meets the guidelines described herein, particularly with respect to eligibility for rapid review and funding. Denise Juliano-Bult, M.S.W. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7137, MSC 9631 Bethesda, MD 20892-9631 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-1638 FAX: (301) 443-4045 Email: Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52, 45 CFR 66 and 45 CFR 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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