AHRQ MINORITY RESEARCH INFRASTRUCTURE SUPPORT PROGRAM (M-RISP) RELEASE DATE: November 4, 2003 PA Number: PAR-04-016 (See Notice NOT-HS-08-005) EXPIRATION DATE: February 2, 2007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: Agency for Healthcare Research and Quality, AHRQ (http://www.ahrq.gov) NOTE: THE POLICIES, GUIDELINES, TERMS, AND CONDITIONS STATED IN THIS ANNOUNCEMENT MAY DIFFER FROM THOSE USED BY THE NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER: 93.226 APPLICATION RECEIPT DATE: February 1 (annually) 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 Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This program announcement (PA) supersedes PAR-01-001, dated October 12, 2000. The Agency for Healthcare Research and Quality (AHRQ) has established the Minority Research Infrastructure Support Program (M-RISP) to increase the capacity of academic institutions predominantly or substantially serving minority racial and ethnic minority populations and the faculty at these institutions to conduct health services research that has the capacity for being disseminated, implemented and translated into practice and policy. The intent of the research infrastructure program is to strengthen the research environments of minority institutions through grant support to develop and/or expand existing capacities for conducting research in health services. To facilitate the goal of assisting minority institutions in increasing their capacity to conduct health services research, the M-RISP provides support for two types of primary activities: (1) Institutional research development support, to strengthen the institutional infrastructure and enhance the capability of individual faculty members to undertake health services research; and (2) Individual investigator research project support, for developing research scientists to conduct small grant research activities that can lead to successful applications for funding under regular health services research grant mechanisms. This Program Announcement (PA) expires three years from the release date shown above, unless reissued. RESEARCH OBJECTIVES Background The mission of the Agency for Healthcare Research and Quality (AHRQ) is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. AHRQ achieves its mission through health services research designed to (1) improve clinical practice, (2) improve the health care system’s ability to provide access to and deliver high quality, high-value health care, and (3) provide policymakers with the ability to assess the impact of system changes on outcomes, quality, access to, cost and use of health care services. A copy of AHRQ’s strategic plan is available at http://www.ahrq.gov (under the About AHRQ site). Through the M-RISP program, AHRQ seeks to expand the number of predominantly minority institutions and researchers with a demonstrable interest in racial and ethnic groups that have been shown to be underrepresented in health services research nationally. It is part of an integrated approach by AHRQ to develop and broaden the national infrastructure for conducting health services research. Through this program grantees must conduct health services research focused in one or more of the following areas: o Translating Research Into Practice and Policy (TRIPP): Applicants are encouraged to conduct research and evaluation projects related to the translation of research findings into measurable improvements in quality, patient safety, health care outcomes and cost, use, and access. Particular attention will be given to research that can bridge the chasm between promising prototypes and generalizable knowledge that can be applied in multiple settings and lead to systematic improvement on a large scale as well as those which take advantage of natural occurrences to study the impact of change. Projects that have identified an existing or potential user base are encouraged. o Patient Safety: One of the important elements in the AHRQ mission is to support the development of multidisciplinary research teams in building and implementing the knowledge base on the scope and impact of medical errors - particularly for diverse care settings and populations, identify the root causes of threats to patient safety and effective system approaches to prevent the occurrence of errors, study the effectiveness of various interventions to capture information on medical errors; and disseminate and evaluate the outcomes of promising interventions in a variety of health care settings and across a variety of health care professionals. o Bioterrorism: Applicants are encouraged to submit applications that investigate and evaluate promising practices and strategies being developed and implemented at the State, local, and health system level to promote health system readiness in response to bioterrorism. Also of interest is the application of available methods and tools that can be of assistance in developing systems capacity and enhancing readiness in rural as well as urban areas. Applicants are encouraged to review, Building the Evidence to Promote Bioterrorism and Other Public Health Emergency Preparedness in Health Care Systems at http://grants.nih.gov/grants/guide/pa-files/PAR-03-130.html. o Prevention: Applicants are encouraged to submit applications that relate to the Public Health Service’s health promotion and disease prevention objectives as outlined in Healthy People 2010". (http://www.health.gov/healthypeople). Of particular interest would be those research projects investigating the appropriate use of clinical preventive services, such as screening tests, immunizations, and counseling, which are based on the work of the U.S. Preventive Services Task Force (USPSTF). o Priority Populations/Health Disparities: AHRQ encourages applications that conduct and support research and evaluations and/or support demonstration projects with respect to the delivery of health care in inner-city and rural areas (including frontier areas); health care for priority populations, which include low income groups, minority groups, women, children, the elderly, and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. Further, the Agency supports the generation and dissemination of health services research to promote the equitable receipt of health care services for all Americans and eliminate health disparities among racial and ethnic minority populations. o Faith-Based and Community Initiatives: The Department of Health and Human Services (DHHS) supports the President’s Faith-Based and Community Initiatives which were created to focus on improving human services for our country’s neediest populations. Research is encouraged which uses faith- based and/or community organizations as subject recruitment sites and/or study implementation sites for health services research. Also of interest are projects which develop and coordinate outreach efforts to disseminate health-related information or to translate or implement health care research findings more effectively through faith-based and other community organizations. For research that is designed to use existing data, AHRQ encourages research applications that will use data from the Medical Expenditure Panel Survey (MEPS) (http://www.meps.ahrq.gov/), the Healthcare Cost and Utilization Projects (HCUP) (http://www.ahrq.gov/data/hcup/), the National CAHPS Benchmarking Database (NCBD) (http://www.ahrq.gov/qual/cahpfact.htm#cahpsbenchmarking ) and other AHRQ sources. Additional information is listed below in the AHRQ Data Section under Submitting an Application. Information and announcements describing AHRQ research interests can be found at http://www.ahrq.gov (See Funding Opportunities ). M-RISP provides support for two primary activities: Institutional Research Development (Core) M-RISP provides support to strengthen the institutional infrastructure so as to enhance the capability of individual faculty members to undertake health services research. Requests may be made for infrastructure enhancements such as support of collaborative linkages with senior scientists in other institutions, provision of resources for data management and statistical analyses, and laboratory development, including limited support for equipment. For individual faculty development, support may be requested for activities such as enrolling in advanced seminars in scientific techniques, but not for participation in a formalized, structured, didactic training program which could lead to an advanced degree. Individual Investigator Research Projects In addition to capacity development support, an M-RISP grant provides support for at least two initial or developmental research sub-projects from at least two or more faculty members who serve as Individual Investigators of these sub-projects. The intent of this component of M-RISP is to support research activities that will lead to successful applications for funding under other AHRQ or other health services research grants programs. Individual Investigator projects should be designed to take advantage of the infrastructure development being supported by the M-RISP program. Application Characteristics All applicants for new and competing continuation awards must include both short-term goals for the project and long-term plans that go beyond the duration of the requested project period. Short-term goals should address planned accomplishments during the duration of the grant. Long-term goals should address projected impact of the grant on the capacity of the institution and faculty to conduct health services research into the future and the impact of such research on health care delivery or policy at the local, State, regional, or national level. Specifically, the research plan must (1) assess the current institutional and faculty capacity to conduct health services research; (2) identify unmet needs; and (3) describe activities that will be undertaken to develop and strengthen the institutional research infrastructure. The plan should include both an institutional research development program and two or more individual investigator projects. Up to three years of support can be requested by new applicants and up to five years for competitive renewals. The application should contain the following: Institutional Research Development Plan o Specific aims. o Summary of relevant ongoing health services research. o Assessment of institutional capacity to conduct state of the art research on health services related issues; identification of gaps which M-RISP is intended to fill. o Design and procedures to be used to accomplish the specific aims of the research infrastructure development plan over the time period of the proposed project (3 years for new applications; up to 5 years for competitive renewal applications), including plans for administrative structure, recruitment and retention of persons skilled in health services research, staff training and mentoring, statistical and other consultation and data management, and collaboration with other institutions. o Description of equipment, space, and other facility resources available to support the development plan and extent to which enhancement of these resources is needed. o Description of institutional financial or other in-kind support for the proposed minority health services research infrastructure development. Applications for competitive renewal must describe the progress of prior supported individual investigators as well as the institution in terms of publications, recognition (e.g., publicity, honors and awards), ability to apply for and secure independent grant support, results of collaborations formed in terms of building the capacity of research at the institution and the formation of viable research partnerships, and the impact of research completed on local, State, regional or national health care delivery or policy. The Institutional Research Development Plan section of the application is limited to 25 pages. Individual Investigator Research Projects o Linkages to overall institutional capacity development plan o Specific aims o Background and significance o Progress report/preliminary studies o Literature review o Research plan, including experimental design and methods o Protection of human subjects o Consultants and collaborators o Consortium/contractual arrangements o Detailed budgets for each project The research plans for each Individual Investigator Research Project is limited to 10 pages (not including the list of references). MECHANISM OF SUPPORT This PA will use the resource-related research projects mechanism (R24). This mechanism is used to support research projects that enhance capabilities to contribute to extramural research of the Public Health Service (PHS). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. AHRQ is not using the Modular Grant Application and Award Process. Allowable Costs Each application should include proposals and separate budgets and budget justifications related to both primary activities (Institutional Research Development (Core) Support and Individual Investigator Research Projects) and indicate how the infrastructure support will enhance the individual research projects. AHRQ recognizes that different types of institutions will require different types of research infrastructure development activities and initiatives, depending upon particular needs and circumstances. Accordingly, this announcement provides general rather than specific guidance as to the types of development activities appropriate under M-RISP. Support may be requested for, but is not limited to, the following: o Salary support for persons engaged in the project proportional to the level of effort devoted to the project o Limited specialized research training for junior investigators related to enhancing capability to conduct research o Scientific and statistical consultation, including expenses incurred by a scientific advisory committee o Biostatistical and data management services o Research technicians and assistants o Research instruments o Small, project-specific equipment o Pilot and feasibility studies o Research subject costs o Data acquisition costs o Travel to scientific meetings Applicants should refer to the PHS Grants Policy Statement at http://grants.nih.gov/grants/policy/gps/index.html for general information regarding allowable costs. A new AHRQ M-RISP grant application must not exceed $500,000 in total costs per year including negotiated F&A. The infrastructure Core component of new M-RISP grant applications must not exceed $100,000 per year, total costs. Individual Investigator projects for these applications must not exceed $100,000 per year, total costs. Support can be requested for up to three years for new applications. Applications that exceed these budget ceilings will be returned without review. A competing renewal AHRQ M-RISP grant application should not exceed $275,000 in total costs per year including negotiated F&A. The infrastructure Core component of competing renewal M-RISP grant applications should not exceed $75,000 per year, total costs. Individual Investigator projects for these applications should not exceed $100,000 per year, total costs. Support can be requested for up to five years for competing renewal applications. Competitive renewal applications require new individual investigators of sub- projects. Support for each proposed individual investigator research project cannot exceed three years. AHRQ does not require cost sharing for applications submitted in response to this Program Announcement. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Non-profit organizations o Domestic organizations only o Public and private non-profit institutions, such as universities, and four-year colleges, conducting health services research o Tribes and Tribal organizations For the purpose of this PA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors. Organizations described in section 501(c) 4 of the Internal Revenue Codes that engage in lobbying are not eligible. Partnerships between predominantly minority and other academic institutions that will result in strengthening predominantly minority institutions in their health services research capability are encouraged. The applicant must indicate which of the following eligibility conditions apply to the institution and must furnish evidence to document eligibility: o An academic institution with at least 55 percent minority (African American, Hispanic, American Indian or Alaskan Native, Asian or Pacific Islander) student enrollment. o An institution with more than 30 percent minority student enrollment in each of the past three years that can provide evidence of efforts to recruit members of ethnic or racial minority groups into scientific careers. Additionally, the institution should show evidence of demonstrated commitment to minority faculty recruitment and development in expenditure of resources, as well as documented institutional need for support in its research development program. Potential applicants who intend to apply under this eligibility criterion are advised to consult with AHRQ program staff (as listed under Inquiries) before submitting an application. o An Indian tribe may apply in conjunction with one or more institutions of higher learning that offer undergraduate and graduate degrees in health services research related fields. Such applicants must have a recognized governing body and perform substantial governmental functions, or qualify as an Alaska Regional Corporation (ARC) as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.). 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 always encouraged to apply for AHRQ programs. SPECIAL REQUIREMENTS Priority Populations The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) reauthorized the Agency and directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. To implement this directive, AHRQ published a notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this PA should address the requirements of including priority populations as specified in the Notice. o Publication Transmittal: General AHRQ Requirements In keeping with the Agency’s efforts to translate the results of AHRQ-funded research into practice and policy, grantees and/or contractors are to inform the Office of Communications and Knowledge Transfer (OCKT) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will take place in close coordination with OCKT and the press offices of the grantee’s or contractor’s institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media. AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency-sponsored work. Applicants are to agree to notify AHRQ immediately when a manuscript based on work supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active. To receive an award, applicants must agree to submit the original and 2 copies of an abstract, executive summary, and full report of the results in the format prescribed by AHRWQ no later tan 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format uses (WP5.1 or WP6.0 is preferable). 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 regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Shelley Benjamin, M.S.W. Health Science Administrator Office of Extramural Research, Education and Priority Populations Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1528 FAX: (301) 427-1562 Email: SBenjamin@AHRQ.gov o Direct your questions about peer review issues to: Patricia Thompson, Ph.D. Director, Division of Scientific Review Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1556 FAX: (301) 427-1561 Email: Pthompso@AHRQ.gov o Direct your questions about financial or grants management issues to: George Skip Moyer Grants Management Specialist Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1452 FAX: (301) 427-1462 E-mail Address: Smoyer@ahrq.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and form (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 the Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: GrantsInfo@nih.gov. The title and number of this PAR must be typed in line 2 of the face page of the application form and the YES box must be checked. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications according to instructions provided in form PHS 398. Applications submitted in the Modular format will be returned without review. SUPPLEMENTARY INSTRUCTIONS: Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Program (HCUP). The HCUP includes databases covering 1988-1997, with 1998 and 1999 data available in 2001. These all-payer databases were created through a Federal- State-industry partnership to build a multistate healthcare data system. The main HCUP databases contain discharge-level information for inpatient hospital stays in a uniform format with privacy protections. The Nationwide Inpatient Sample (NIS) is a nationwide probability sample of about 1000 hospitals. The State Inpatient Databases (SID) contain inpatient records for all community hospitals in 22 states. Other HCUP databases contain ambulatory surgery data from nine states. These databases can be directly linked to county-level data form the Health Resources and Services Administration’s Area Resource File and to hospital- level data from the Annual Survey of the American Hospital Association. This does not preclude the use of secondary data sources or primary data collection. SENDING AN APPLICATION TO THE NIH and AHRQ: 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 (20817 for express/courier service) At the time of submission, two additional copies of the application, labeled Advanced Copy (s) must also be sent to: Shelley Benjamin, M.S.W. Health Science Administrator Office of Extramural Research, Education, and Priority Populations Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 (301 427-1528 (301) 427-1562 E-mail Address: Sbenjamin@ahrq.gov APPLICATION PROCESSING: Applications must be mailed on or before the receipt date described at the heading of this PA. The CSR and AHRQ 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 and AHRQ 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 acknowledgment of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this PA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. It is very important to note that limitations on number of pages and size of font must be observed; applications violating these requirements will be returned without review. Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an AHRQ application. The AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). The PA is also available on AHRQ’s Web site, http://www.AHRQ.gov, (see under Funding Opportunities). Application Preparation (for Using CMS Data) Purchase of CMS public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data, especially involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. In consultation with Center for Medicare and Medicaid Services (CMS), previously called Health Care Financing Administration (HCFA), AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ’s confidentiality statue, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed. Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS’s approval to do so. In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff. CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats. Questions regarding CMS data should be directed to the AHRQ program official listed under INQUIRIES. Assessment of AHRQ Grant Programs In carrying out its stewardship of research programs, the AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency-sponsored research. Applicants are to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active. To receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (WordPerfect , Word , or ASCII format). The past cooperation of applicants with regard to the submissions described in this section may be considered in the application review to assess Applicants potential for responsible stewardship of awarded funds. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness by the Agency referral officer, program staff, and grant management staff. Incomplete and/or non-responsive applications or applications not following instructions given in this PA will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. As part of the merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. o Receive a written critique. REVIEW CRITERIA In the written comments, reviewers will be asked to discuss aspects, see Special Review Criteria of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. General Review Criteria The General review criteria for grant applications are: o consistency with the Agency’s mission and research priorities; o significance and originality from a scientific or technical viewpoint, adequacy of the methods(s) and proposed approaches; o availability of needed data or adequacy of the proposed plan to collect data required for the project; o adequacy and appropriateness of the plan for organizing and carrying out the project, qualifications and experience of the Principal Investigator and proposed staff; o reasonableness of the proposed budget and the time frame for the project in relation to the work proposed; adequacy of the facilities and resources available to the applicant; o the extent to which women, minorities, and if applicable children, are adequately represented in study populations; and o the adequacy of the proposed means of protecting human subjects, if applicable. Special Review Criteria Specifically, criteria for review of the overall application include the following: o consistency with AHRQ’s research focus and mission. o merit of the proposed short- and long-term research development goals to be achieved by the institution, which should be described in sufficient detail in the application, and the short- and long-term plans proposed to achieve the research development goals. o evidence of strong commitment of the applicant institution to achieve the research development goals and to sustain those achievements. o plans to sustain and grow the research program of the institution and investigators being developed during the duration of the grant and subsequent to the grant. o probable long-term impact of the program on the research viability of the institution and research careers of the individual investigators being developed. o research qualifications and/or potential of existing and proposed personnel related to the M-RISP project. o plans for dissemination and translation of research findings. o anticipated impact of the proposed research for which infrastructure development support is requested from AHRQ. o discussion of existing or potential users of the proposed research. o justification and appropriateness of the requested budget and project goals, based on criteria delineated under Objectives and Scope. o strength of the existing partnership arrangements, both from the perspectives of assisting with the development of research infrastructures and contributing to the quality of the research proposed and produced. Criteria for review of each specific research project include: o Significance o Approach o Investigators o Environment o Budget o Significance: Does the study address an important problem that is relevant to the AHRQ mission? If the aims of the application are achieved, how do they advance scientific knowledge as outlined under Research Objectives? Does the study adequately prepare the Investigator to conduct health services research and serve as an important step or component in the development of future grant applications? Will the study likely result in publications? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed and appropriate to the aims of the project? Are potential problem areas acknowledged and alternative approaches addressed? o Investigators: Is the team appropriately trained and well-suited to carry out this work? Is the proposed work appropriate to the experience level of the Principal Investigator and to that of other researchers (if any)? o Environment: Does the scientific environment in which the work will be conducted contribute to the probability of success? Do the proposed projects take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? To what extent will the proposed research change/alter the environment, facilitate the institution’s ability to conduct, expand, and improve health services research, and/or secure institutional support for and commitment to the conduct of health services research? o Budget: Is the proposed budget and period of support reasonable in relation to the proposed research? ADDITIONAL REVIEW CRITERIA FOR COMPETITIVE RENEWALS: A major focus for the evaluation of an application will be the demonstration of the direct impact of past accomplishments and proposed plans on the achievement of short and long-term health services research goals and securing additional support for the research program at each institution. o past accomplishments, particularly those achieved during the first grant award period, relative to original proposed plans and future plans. o demonstration of the need for continued support, and the amount requested, to further develop the grantee’s research infrastructure component in order to make the institution capable of successfully completing the proposed research projects and competing for significant public and/or private funding. OTHER ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, each application will also be reviewed with respect to the following: o PROTECTION: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to address the needs of both genders, racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Adequacy of attention to other populations of special priority to AHRQ (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Agency policies and Requirements, below). ADDITIONAL CONSIDERATIONS DATA SHARING: Data Confidentiality Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute. [42 U.S.C.299c-3(d)) In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this PA will also be managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of patient-related health information. These regulations serve to limit the disclosure of personally identifiable patient information and define when and how such information can be disclosed. Thus, for example, health care plans and providers will require either patient authorization of disclosures of identifiable information to be made to researchers who are not their health care providers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) upon being satisfied that any identifiable health information will be appropriately safeguarded by the investigators. Additional information about the regulations and their implementation can be obtained from: http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application. Rights in Data AHRQ grantees may copyright unless otherwise provided in grant awards or seek patents for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, data bases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant- supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html). RECEIPT AND REVIEW SCHEDULE: Application Receipt Date: February 1 annually Peer Review Date: May annually Earliest Anticipated Award Date: September annually Expiration Date: October 2, 2007 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Programmatic priorities o Fit with existing M-RISP portfolio REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS: It is the policy of AHRQ that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). AHRQ also encourages investigators to consider including children in study populations, as appropriate. 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. If no Federal act is taken, having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data is not subject to this disclosure requirement and under FOIA, 5 USC 552(b), disclosure of identifiable data from a such study is exempted from disclosure under the exemption of material protected by statute, in this case AHRQ’s confidentiality statute, 42 U.S.C. 299c-3(c). It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if it constituted trade secrets or commercial information. However, courts have generally not regarded a researcher's interest in "his" data as proprietary. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Should applicants wish to place data collected under this PA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ-supported projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website http://www.hhs.gov/ocr/ provides information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/not-od-03-025.html. 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 health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. 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, Number 93.226. Awards are made under Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106- 129 (1999). See in particular, 42 U.S.C. 299a-1. Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 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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