This Program Announcement expires on March 2, 2006, unless reissued. COLLABORATIVE R01S FOR CLINICAL AND SERVICES STUDIES OF MENTAL DISORDERS AND AIDS (CSMD) Release Date: July 31, 2001 PA NUMBER: PA-01-123 (Reissued as PA-06-154) (The expiration date for this PA has been extended, see NOT-MH-06-101) (NIMH policy for recruitment, see NOT-MH-05-013) National Institute of Mental Health ( National Institute on Drug Abuse ( THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT PURPOSE The purpose of this Program Announcement (PA) is to support collaborative intervention trials and other clinical and services studies at two or more sites. The studies typically share a specific protocol across the sites and are organized in order to increase sample size, accelerate recruitment, or increase sample diversity and representation. Each site has its own principal investigator (PI) and the program provides a mechanism for cross-site coordination, quality control, database management, statistical analysis, and reporting. This PA supercedes PAR-98-017 published December 19, 1997. 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, Collaborative R01s for Clinical and Services Studies of Mental Disorders and AIDS, is related to one 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 and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. 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) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 5 years. 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 on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at RESEARCH OBJECTIVES Summary Collaborative studies are appropriate to address research questions that are beyond the capacity of any single-site investigation. Considerations such as increased sample size, representation, and diversity may all support the need for multi-site studies. The following are given as examples of the types of studies that can be supported under this mechanism these are meant to be illustrative only and are not intended to be restrictive or exclusive. o Large scale, public health oriented intervention studies (treatment, prevention, or rehabilitation) using pharmacologic, psychosocial, or somatic approaches individually or in combination in appropriate clinical populations o Large-scale human genetic studies, in which pedigree recruitment and ascertainment must occur in parallel fashion across multiple sites o Smaller scale studies of unique clinical populations or low base rate outcomes that would be difficult to recruit from a single clinical setting o Large scale studies of risk factors for psychopathology, particularly studies which are addressed to elucidate potential mechanisms of disorders o Studies of social or cultural processes as risk or protective factors for disorders, in which appropriate variation is sampled across multiple sites o Studies within the context of clinical trials that assess population pharmacokinetics, identify candidate biomarkers that correlate with treatment response, optimize procedures for assessing capacity and obtaining informed consent, or investigate methods to enhance recruitment, participation and retention of ethnically diverse participant samples o Studies of diffusion strategies (i.e., dissemination and implementation) to improve adoption of evidence-based treatments in practice settings (These can include patient, provider, or organizational level targets and may also consider the role and impact of differential incentives and resources to achieve adoption.) o For HIV/AIDS relevant applications, studies of the development of behavior change and prevention strategies to reduce the further spread of the epidemic, interventions to prevent the sequelae of HIV infection and adherence to HIV treatment regimens, central nervous system (CNS) effects of HIV infection and behavioral outcomes, clinical phenomena of HIV-related neuropsychological and neuropsychiatric disorders, mental health services relevant to HIV infection and the severely mentally ill, the development of therapeutic agents, behavioral issues in vaccine trials, the role of families in preventing and adapting to HIV/AIDS, and the history and prevention of HIV-related mental disorders o For applications relevant to drug abuse, all of the aforementioned issues may be addressed in populations with drug abuse and co-morbid mental disorders. Studies are sought that elucidate the mutual interactions between drug abuse and co-morbid mental disorders that have implications for epidemiology, genetics, etiology and pathogenesis, treatment, and other aspects of service delivery. For example, comparisons may be made among populations showing: (1) particular drug abuse patterns without other mental disorders, (2) mental disorders without drug abuse, (3) mental disorders that precede, occur simultaneous with, or follow the development of drug abuse and (4) non-substance-related forms of behavioral dependence, e.g., gambling. 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 are 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: 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. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), 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. APPLICATION PROCEDURES 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 standard application deadlines ( as indicated in the application kit. The receipt dates for AIDS-related research applications are: January 2, May 1, and September 1. 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 who are planning to submit an investigator-initiated new (Type 1), competing continuation (Type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year for any individual application or for the combined budget of a set of collaborative R01s, must contact the appropriate Institute program staff (see INQUIRIES) 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 who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement from Institute staff for acceptance of any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at: The application from each site must contain an OVERVIEW that is no longer than 2 pages. The overview should provide an overall rationale for applying as a collaborative study, the role of each site, the approach to project management, and any elements unique to this site. The RESEARCH PLAN - Section 2 A - D, should describe those aspects of the project that are common to all sites of the collaboration. Investigators should use this section to describe the research procedures or protocol, the study population from which samples are drawn, resources, data analyses, and any other characteristics that support each site"s importance to the overall project. Where there are even minor variations in the research plan between sites, these should be highlighted in a subsection of Section 2 D with the heading "ELEMENTS UNIQUE TO THIS SITE." Applications must describe a feasible mechanism for scientific integration of research procedures, overall managerial and administrative responsibilities, and cross-site comparability of training to assure reliability and quality control. The PIs may or may not wish to designate a Steering Committee or other decision making body, or identify one individual as the contact person for the group as a whole, for purposes of NIMH correspondence. Plans for ensuring access to data by all sites, analytic resources, publication and authorship rights, the possibility of public use research materials and data, or other means of distributing research materials to the wider scientific community, and a means of arbitrating disagreements on publication and other issues should be found in this section of the application. Any site that contracts out some portions of this work should list this fact under "ELEMENTS UNIQUE TO THIS SITE," and provide a full description of the nature, purpose and oversight of this contractual arrangement. Revised collaborative CSMD applications must include an Introduction and highlight the changes made in the Research Plan in response to the previous critique and describe in item (I) how the delay in initiating the collaboration will be managed. This is particularly important if some projects in the collaborative CSMD group were awarded and research on those projects has already begun. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS 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 The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. All collaborating sites must be listed under Performance site(s) on Page 2 of the application. Submit a signed, typewritten original of the application, including the Checklist, and five 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and 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 appropriate National Advisory 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: 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 method? 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 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 is to be performed 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? (6) Collaboration: Is there a feasible mechanism for collaboration to achieve scientific integration of research procedures, overall managerial and administrative responsibilities, appropriate quality control and reliability assurance, and planning for data management, analysis and reporting of results? 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 The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. A data and safety monitoring board comprised of individuals external to the study is required in all multi-site intervention studies. 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 Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Bruce B. Cuthbert, Ph.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Rm. 6184, MSC 9625 Bethesda, MD 20892-9625 Telephone: (301) 443-3728 FAX: (301) 443-4611 Email: Sander G. Genser, M.D., M.P.H. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Boulevard, Rm. 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 443-1801 FAX: (301) 443-4100 Email: Barry D. Lebowitz, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Rm. 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: Dianne M. Rausch, 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 6212, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: Steven J. Zalcman, M.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Rm. 7177, MSC 9639 Bethesda, MD 20892-9639 Telephone: (301) 443-1692 FAX: (301) 443-4822 Email: Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch Division of Extramural Activities 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: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH) and 92.279 (NIDA). 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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