and Human Services (HHS)
EXPIRED
INTERVENTIONS AND PRACTICE RESEARCH INFRASTRUCTURE PROGRAM (IP-RISP) RELEASE DATE: October 28, 2003 PA NUMBER: PAR-04-015 EXPIRATION DATE: May 1, 2006 (This PA has been reissued as PAR-06-441) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 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 This program announcement supercedes three prior announcements for the support of research infrastructure: Interventions and Practice Research Infrastructure Program (PAR-00-096), Interventions Infrastructure Program (PAR-99-064), and the Research Infrastructure Support Program (PAR-94-096). The National Institute of Mental Health (NIMH) seeks to expand the number of partnerships between community-based, clinical/services settings and academic institutions. The goal is to enhance the national capacity to provide evidence- based mental health care in community settings that is sensitive to the social and cultural needs of patients and providers and to the feasibility concerns of the community organizations involved. This program announcement (PA), Interventions and Practice Research Infrastructure Support Program (IP-RISP), responds to recommendations made by the National Advisory Mental Health Council’s (NAMHC) report, Bridging Science and Service (http://www.nimh.nih.gov/research/bridge.htm). The IP-RISP seeks to foster an active, synergistic partnership between mental health researchers and community-based, clinical/services staff, clinicians and patients/clients to: (1) advance our knowledge about developing research infrastructure in community settings and the establishment of collaborative partnerships; (2) identify and incorporate those factors (e.g., organizational, sociocultural, interpersonal) in community settings that may be associated with quality care and optimal outcomes for patients and clients; and (3) test adapted, evidence-based interventions (treatment, rehabilitative, and preventive) in community settings. RESEARCH OBJECTIVES Background The 1999 NAMHC report, Bridging Science and Service, was written to focus the attention of NIMH and the research community on the gulf between what is known about treatments for mental illness and what is available and provided to people in the community who need care. The report’s conclusions indicate that many changes need to take place to bridge that gulf. Three of the recommendations focused on increasing academic-community partnerships in research: o NIMH should revise and renew program announcements (PAs) in the spirit of the Public-Academic Liaison (PAL) Program to maintain and promote existing partnerships between academic researchers and public care systems, health plans, both carve-outs and health maintenance organizations (HMOs), and employers providing health benefits and their representative groups. o NIMH should stimulate new alliances by providing developmental funds to establish shared research resources such as data banks, staff time, consultant time, etc. o NIMH should commit resources to identify, describe, and disseminate models of successful partnerships. This PA is designed to provide tangible support and encouragement for researchers and community mental health providers to establish working and sustainable partnerships to make evidence-based mental health services available and acceptable for people in need of mental health care. The IP-RISP mechanism is applicable to a wide range of possible partnerships. Community settings may include general and primary health care, public or tribal health and mental health clinics, community-based specialty care, long-term care facilities, schools, family service or faith-based organizations, State or tribal components of the Cooperative State Research, Education, and Extension Service, and elements of local and/or State correctional systems. The ultimate goal of the IP-RISP partnerships is to make available evidence- based care for those in need of mental health care. However, to make that goal possible, NIMH expects the partnerships to be: sustainable, even after NIMH infrastructure funding has ended; synergistic, leading to mutual learning for both researchers and community providers; productive, with additional mental health services research grant applications submitted; receptive to providing information to others seeking to form partnerships; and based in theoretical and/or conceptual models of action research, human behavior, and/or organizational/systems behavior so that the mechanisms or process underlying successful partnerships can be understood and tested in other settings. A plan for continuous assessment and improvement of the infrastructure development is required. The result should be an environment capable of nurturing and sustaining researchers, providers, and the infrastructure development and research plans. The application must present a focused and linked two-part plan for five years of proposed NIMH IP-RISP funding. The plan should include: (1) background information on the community setting needs for research infrastructure; (2) evidence of the fit and strengths of the partner institutions; (3) description of the activities that have been and will be undertaken to develop and strengthen the unique community-academic partnership; (4) at least two pilot or developmental/exploratory studies intended to provide the data and foundation for subsequent research applications from the partnership in mental health interventions and services research. The partnership development activities and the research studies should be unambiguously linked and justified; both development and research activities should have clearly articulated and justified aims and methods. Listed below are examples of research topics that can contribute to scientific knowledge about mental health interventions in diverse, community settings. The list is not exhaustive; it is meant only to be illustrative. Also consider all the research questions presented in the Research Programs page of the Services Research and Clinical Epidemiology Branch website: http://www.nimh.nih.gov/srceb/resprogs.cfm. The IP-RISP research projects are not expected to be major research proposals, providing definitive data. They are intended to provide preliminary data to be used to guide the design of larger scale, more complex research applications. IP-RISP projects are similar to the ones typically supported under the NIMH developing grant mechanism (R34): From Intervention Development to Services: Exploratory Research Grants, http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html o Assess and test methods to more quickly and effectively synthesize and incorporate existing evidence into clinical practice o Determine patient, provider and contextual factors that may enhance or detract from the effective delivery of interventions o Evaluate the effectiveness, safety, and costs of efficacious interventions but not adequately tested in practice settings o Evaluate alternative methods of adapting assessment and treatment protocols originally developed in academic settings o Determine whether fidelity (by patients and providers) to adapted interventions is related to patient outcomes o Test methods to improve the recruitment and retention of patients and providers in community-based intervention studies o Determine whether patient and provider treatment choice is related to positive patient outcomes o Determine different stakeholders perceptions of quality of care and develop instruments to assess the relationship between various definitions of quality and patient/client outcomes o Test the effectiveness of evidence-based care for subsyndromal and comorbid populations. o Determine how economic factors (e.g., at the patient and community organization levels) affect the provision and receipt of services and pharmaceuticals o Test state-of-the-art dissemination and implementation strategies Listed below are examples of research questions that can inform our understanding of community-academic partnerships. Again the list is not exhaustive; it is meant only to be illustrative. o What theoretical conceptualizations best explain the functioning of the partnership? o How do provider and patient perceptions of researchers (and vice versa) change over time and is change related to patient outcomes? o What factors best predict individual provider-researcher alliances? o What are provider concerns about evidence-based practice and what processes are acceptable for working through barriers and addressing concerns? o What mechanisms can be implemented and accepted by providers and researchers to allow for sharing of power/control and trust? o How do financial constraints for the community partner affect the research relationship? Are there innovative ways that researchers can help alleviate stress caused by financial cutbacks? o Under what circumstances do conflict resolution procedures aid the collaborative partnership? Allowable costs A central principle of the IP-RISP is that different partnerships will require different types of research infrastructure and development support. A substantial part of the support should be targeted to the community settings. Examples of types of support under this program are: o Database and information management system construction or conversion, ongoing data management, and related technical support o Research on the partnership process o Training and supporting research assistants from the community or the partner setting o Treatment protocol and instrument adaptation and/or translation o Partial salary support for persons engaged in the research of the partnership (including practice site staff) o Methodological, statistical, or theoretical consultation o Costs related to subject recruitment and retention. o Costs related to testing dissemination and implementation strategies MECHANISM(S) OF SUPPORT This PA will use the NIH resource related research projects (R24) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This mechanism is used to support projects that enhance capabilities to contribute to extramural research of the PHS. 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. Although the Facilities and Administrative (F&A) costs associated with all contractual and consortium arrangements are considered as direct costs to the applicant organization, for the purposes of this program announcement, these will not count against the program direct costs cap of $400,000 per year. (However, these costs should be indicated as instructed on Form 398, rev. 5/01.) This PA uses just-in-time concepts. Follow the instructions for non-modular research grant applications. 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 (an) application(s) if your institution and partnering institution(s) have 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, local, and tribal governments o Eligible agencies of the Federal government o Domestic o Faith-based or community-based organizations o Foreign institutions are not eligible to apply INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are strongly encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your 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: Junius J. Gonzales, M.D. 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: [email protected] 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) 443-4720 Email: [email protected] o Direct your questions about financial or grants management matters to: Joy Knipple Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: [email protected] SUBMITTING AN APPLICATION 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: [email protected]. The title, Interventions and Practice Research Infrastructure Program (IP-RISP), and number of this program announcement (PAR-04-015) must be typed in Item 2 of the face page of the application form and the YES box must be checked. APPLICATION PAGE LIMITS: The description of Sections A-D should be limited to a total of no more than 30 pages and should be equally balanced between descriptions of the infrastructure and research plans. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent 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: [email protected] APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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 Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Mental Health Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning your application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 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 in community settings? Will the infrastructure development contribute to broader theoretical and conceptual frameworks? APPROACH: Is the approach appropriately conceived? Is the approach likely to successfully develop the partnerships needed to carry out relevant and wide- reaching studies? Does the applicant exhibit knowledge of and appreciation for the challenges involved in building infrastructure and conducting research in practice settings? Thus, does the applicant acknowledge potential problem areas and consider alternative tactics? Is the infrastructure proposed adequate to sustain research capacity? How well linked are the research aims and the plans for infrastructure development? INNOVATION: Does the applicant acknowledge the complexity of the specific settings, populations, and professions engaged in each study? Does the IP-RISP employ novel concepts, approaches or methods? Are the aims (for both the infrastructure development and research plans) original and innovative? Does the project challenge existing paradigms or develop new methodologies for both research and establishing partnerships? INVESTIGATOR: Do the partners have a commitment to the mission of the IP-RISP and the necessary expertise to organize, administer and direct the IP-RISP? Is the work proposed appropriate to the experience level of the principal investigator and to that of other key personnel? 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 and leadership from all partners? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: INFRASTRUCTURE: Is there specificity in the infrastructure plans that are tailored to the organizations involved, the nature of the partnership and the services/interventions research aims? Are the infrastructure aims informed by a conceptual framework and/or theory? Do they propose an assessment of the feasibility, progress, and accountability? Are there plans to assure the sustainability of the infrastructure after the grant is over? Will the knowledge gained about infrastructure development be transferable to other sectors? 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS 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 clinical research 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance 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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