INTERVENTIONS AND PRACTICE RESEARCH INFRASTRUCTURE PROGRAM (IP-RISP) Release Date: May 24, 2000 PA NUMBER: PAR-00-096 (superceded by PAR-04-015) National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) seeks to expand the number of partnerships between typical clinical/services settings and academic institutions in order to enhance the national capacity to transfer state-of-the- art interventions into those non-academic settings. This Interventions and Practice Research Infrastructure Program (IP-RISP) is in response to recommendations made by the National Advisory Mental Health Council’s Bridging Science and Service Report (http://www.nimh.nih.gov/research/bridge.htm). This IP-RISP seeks to foster the scientific interaction of mental health intervention/treatment and services researchers with typical clinical/services settings, clinicians and patients/clients to: (1) study and conduct interventions (treatment, rehabilitative, and preventive) in non-academic health care settings, and (2) describe practice patterns and care variations in those settings. These two scientific aims should also seek to identify and utilize those factors (organizational, sociocultural, interpersonal) in day-to-day practice settings which may be associated with quality care and optimal outcomes for patients and clients. This program announcement clarifies and supercedes the prior announcements for the support of the Interventions Infrastructure Program (PAR-99-064) and the Research Infrastructure Support Program (PAR-94-096) and will govern all applications submitted in FY 2000 and beyond. 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 Program Announcement (PA), Interventions and Practice Research Infrastructure Program, is related to the priority area of Mental Health and Mental Disorders. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, 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) resource related research projects (R24) award mechanism. This mechanism is used to support projects that enhance capabilities to contribute to extramural research of the PHS. 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 and is not renewable. These grants are not transferable. The funding cap for each year for the IP-RISP awards is $400,000 maximum direct costs, plus negotiated indirect costs. Annual awards will be made subject to continued availability of funds and progress achieved. Because the R24 mechanism may have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. RESEARCH OBJECTIVES Background This Interventions and Practice Research Infrastructure Program (IP-RISP) is designed to enable partnerships between clinical practice/service settings, with little or no research, and academic institutions with ongoing interventions or health services research. The primary aim of these partnerships is to enhance the national infrastructure for mental health research focused on either the delivery of interventions in non-research settings and/or practice research (i.e., research which examines how and which treatments/services are provided to which individuals in typical settings [e.g., variations in care]) and focuses on characterizing and improving care in these settings. Little is known about how to best incorporate interventions into diverse settings or about what mental health care is in the day-to-day practices of different providers. These partnerships can help bridge the science-service gaps highlighted in the recent report of the National Advisory Mental Health Council (http://www.nimh.nih.gov/research/bridge.htm) This IP-RISP provides support for research infrastructure development by partnering academic settings with non-academic clinical and services settings which have large and diverse patient and provider populations but may lack the resources needed to conduct strong scientific research programs. Such settings may include general and primary health care, community specialty care, long-term care, public mental health or health care systems, and prisons, jails and other correctional system settings. The non-academic settings can benefit from research by providing empirical validation for treatment approaches and variations in care, creating robust evaluations of programmatic benefit and outcome, and assessing ways to improve care. The academic settings can benefit from these partnerships by strengthening and diversifying their study populations and perspectives. A central principle underlying the IP-RISP is that different clinical/service settings will require different types of research infrastructure support and development activities which should be guided by focusing on specific research needs and questions. A substantial part of the support should be targeted to the non-academic clinical/service settings. Examples of types of support under this program are: o Database construction or conversion, ongoing data management, and related technical support o Systems and personnel to follow patients and clinicians longitudinally o Developmental, pilot, and feasibility studies o Protocol adaptation and instrument development for use in studies in non- academic settings o Research training for junior or non-research investigators and staff o Partial salary support for persons engaged in the project (including practice site staff) o Methodological and statistical consultation, including expenses incurred by scientific and practice advisory committees o Research subject costs The application must present a focused plan for the proposed IP-RISP. It should, using targeted research questions, (1) assess the current practice/service setting needs for research infrastructure, (2) identify the fit with and strengths of the partner academic institution, and (3) describe the activities that will be undertaken to develop and strengthen the unique clinical practice-academic partnership. The plan should cover a period of five years and provide the partnership an improved capacity to conduct mental health interventions and/or practice research. Many of the research gaps in trying to bridge science and service fall in the interventions and practice research domains. The primary research challenge for the delivery of interventions in actual practice is to determine whether and how efficacious interventions can have a clear and beneficial effect when carried out in such settings with diverse and representative populations. Similarly, the primary research challenge for practice research is to carefully characterize variations in care for individuals in typical practice settings, track pathways into care, delineate real practice factors associated with those variations, and use that knowledge to direct quality improvement and dissemination. Both of these research challenges may be best approached by carefully considering the multiple dimensions of context relevant to clinical care in non-academic settings. Listed below are examples of research topics that can inform the practice- academic partnerships and contribute to scientific knowledge about mental health interventions in diverse, non-academic settings and mental health practice as delivered today. Interventions in Typical Clinical Settings: o Determining patient, provider and encounter factors that may enhance or detract from the effective delivery of interventions o Evaluating the effectiveness, safety, and costs of interventions proven efficacious in research settings, but not adequately tested in practice settings o Evaluating the methods (and their effects) of adapting assessment and treatment protocols originally developed in academic settings (including factors such as visit frequency and duration) o Assessing the levels of fidelity (by patients and providers) to adapted interventions, possible barriers to fidelity, and possible barrier reduction o Improving the recruitment and retention of patients and providers in real practice intervention studies o Describing the role and impact of patient and provider treatment choices on effective intervention delivery Practice Research: o Determining usual and/or best mental health practices in real settings, their relationship to patient, provider, and system factors, to outcomes, and to evidence o Describing different stakeholders perceptions of quality of care and appropriately incorporating these into quality assessments, improvement efforts, and day-to-day practice o Assessing and testing methods to more quickly and effectively synthesize and incorporate existing evidence into clinical practice o Using treatments and services delivered to better understand the needs and clinical characteristics of subgroups (e.g., person with subsyndromal conditions or comorbidity) o Characterizing system and organizational factors/processes that may impede the effective practice of care, and ways to improve those o Considering how economic factors (e.g., at the patient and provider levels) affect the provision and receipt of services and pharmaceuticals o Developing methods and instruments to better assess and characterize typical day-to-day practice (i.e., usual care) 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html 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. 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435- 0714, Email: GrantsInfo@nih.gov. The application is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html 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. 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 by NIMH 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 or board. 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 the IP-RISP address important problems? If the aims of the application are achieved, how will scientific knowledge of intervention effectiveness and real world practice be advanced? What will be the effect on the provision and receipt of care? (2) Approach: Is the approach to interventions and/or practice research appropriately conceived? Is the approach likely to successfully develop the partnerships needed to carry out relevant and wide-reaching studies? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the IP-RISP employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies? (4) Investigator: Are the investigators appropriately trained and well suited to carry out this work? Do the practice partners and academic personnel have a commitment to the mission of the IP-RISP and the necessary expertise to organize, administer and direct the IP-RISP? (5) Environment: Do the practice and academic environments in which the work will be done contribute to the probability of success? Do the proposed research projects take advantage of the unique features of the practice context (patients, providers, system)? Is there evidence of institutional support from both sides of the partnership? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications assigned to the Institute. 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: Junius J. Gonzales, M.D. Services Research & Clinical Epidemiology Branch Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7141 MSC 9631 Bethesda, MD 20892-9631 Telephone: (301) 443-3364 FAX: (301) 443-4045 Email: jgonzale@mail.nih.gov 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: Diana_Trunnell@nih.gov 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 and 45 CFR Part 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, and 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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