AHRQ SMALL RESEARCH GRANT PROGRAM Release Date: January 2, 2001 PA NUMBER: PAR-01-040 Agency for Healthcare Research and Quality (formerly AHCPR) Application Receipt Dates: March 24th, July 24th, November 24th March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date. The non-AIDS portion of this funding opportunity expires on the date indicated below. A replacement R03 (PAR-06-448) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R03 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006 (Expiration date previously extended, see NOT-HS-05-007) PURPOSE The mission of the Agency for Healthcare Research and Quality (AHRQ), formerly known as the Agency for Health Care Policy and Research (AHCPR), is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. AHRQ achieves this 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. AHRQ’s research agenda is designed to be responsive to the needs of consumers, patients, clinicians and other providers, institutions, plans, purchasers, and public policymakers for the evidence-based information they need to improve quality and outcomes, control costs, and assure access to needed services. AHRQ is especially interested in research involving collaborative efforts between researchers and medical and public health or healthcare provider, purchasers or payer organizations. AHRQ announces a program of small research grants designed to provide support for new investigators or researchers new to health care services issues and encourage preliminary, exploratory, or innovative research in new or previously unexamined areas. This announcement replaces the following earlier announcements: 1) AHCPR Small Project Grant Program, published in the NIH Guide for Grants and Contracts on February 23, 1996, 2) AHCPR Small Project Grant Program - Addendum, published also in the Guide, on January 29, 1999, and 3) AHRQ Small Research Grant Program Addendum, published in the Guide on July 13, 2000. 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/ ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic public or private non-profit organizations, including universities, clinics, units of State and local governments, and nonprofit firms and foundations. For the purpose of this PA, AHRQ, by statute, can award grants only to non-profit organizations. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHRQ encourages investigators who are women, members of racial and ethnic minority groups, and persons with disabilities to apply as Principal Investigators. AHRQ also encourages new investigators (as defined in the PHS 398 application instructions) to apply as Principal Investigators. Projects must be self-contained. They may be conceptually linked to future or past projects but must contain all the elements of a stand-alone effort that can be reviewed and evaluated on its own for both scientific merit and budget. The request may not be used to supplement currently supported projects, provide interim support for projects under review by the PHS, or obtain funding as a competing continuation of a small grant. Requests for support for dissertation research will not be considered under this small grant program. Applications to support dissertations should be submitted for consideration under the AHRQ Small Grant Program for Health Services Dissertation Research (see Inquiries ). MECHANISM OF SUPPORT Grants provided under this Program Announcement (PA) will use the small research grant (R03) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the proposed Principal Investigator. The budget limit on small project grant applications is $100,000 total costs (i.e., direct costs plus facilities and administrative costs) for the entire project period. Projects may not exceed $100,000 in total costs. Grant support will normally not exceed 24months. RESEARCH OBJECTIVES Background Title IX of the Public Health Service (PHS) Act (42 U.S.C. 299 et seq. amended, Sec. 922) gives AHRQ flexibility in review procedures for awarding small grants. AHRQ uses the small grant authority to support three kinds of activities: conferences, doctoral dissertations, and small research grants. This Program Announcement describes the third of these activities, the AHRQ Small Research Grant Program. Under this program, AHRQ provides support for focused, developmental, and innovative research projects. Focused Research Projects Projects can be descriptive or involve the testing of hypotheses. Projects must be discrete, that is, only projects that can be completed within the budgetary and time constraints imposed by the small grant program are eligible for support. Projects can use any of a variety of methods: opportunistic, qualitative research, quantitative analysis of existing secondary data, policy research, evaluations of demonstrations or programs, case studies, historical, legal, or ethical analysis, or primary data collection and analysis. Developmental Research Studies Developmental projects can involve feasibility studies or pilot projects. They can also include formative or exploratory activities such as construction or modification of a survey instrument, research to test the design of a large-scale study, and collection and analysis of quantitative or qualitative information for the purpose of hypothesis generation. Innovative Research Projects Innovative projects involve the study of a novel issue or problem or the application of a novel methodological approach. These projects might employ techniques or theories from other fields not traditionally linked to health services research. Such projects have the potential for providing new insights into methodological or substantive issues. Because these projects may be groundbreaking, there is also a greater probability than with more conventional projects that they may not achieve the desired or planned outcome. New Investigators Although the focus of this Program is research, the Program also provides an opportunity for new investigators to submit applications or for established investigators to explore health care research issues in fields other than their primary area of research interest. AHRQ encourages submission of applications from such investigators. Research Priorities The following topics represent areas of research that the Agency is most interested in. o Accelerating and magnifying the impact of research on clinical practice and patient outcomes in applied settings. o Demonstrating that the translation of research into practice leads to measurable and sustainable improvements in health care. o Understanding how research and cost-effectiveness analysis is used in decision making by health care policymakers, administrators, and managers. Of particular interest are studies that enhance our understanding the ethical implications of the use of cost-effectiveness analysis by health care decision-makers. o Developing strategies to incorporate individuals values and equity considerations into cost- effectiveness analyses. o Improving the health care system’s ability to provide access to and deliver high quality, high- value health care. o Developing and evaluating decision support systems to support real-time detection of bioterrorist threats and management of bioterrorism. o Eliminating inequality in quality and outcomes associated with race and ethnicity. o Assessing the quality of care for vulnerable populations. o Evaluating quality and patient safety in ambulatory care. o Enhancing informed decision-making in primary care settings, including shared patient- clinician decision-making. o Using clinical informatics to improve primary care practice, including evaluation of its impact on quality, outcomes, cost and patient satisfaction. o Assessing the organization and delivery of preventive care and methods to improve both the amount and quality of clinical preventive services that are delivered. o Understanding the determinants of insurance coverage and access to care. o Improving methodologies to systematically review and evaluate preventive services, especially screening tests. o Improving the delivery of primary care services in rural and inner-city areas. o Assessing the special health care needs of low income populations. o Improving care at the end-of-life. o Providing policy makers with the ability to assess the impact of health care changes on outcomes, effectiveness, quality, access, cost and use of health services. o Developing methods and measures for identifying and preventing medical errors to enhance patient safety. o Evaluating the impact of chronic illness among workers and their dependents on health care outcomes and work productivity. o Developing methodological advances in health services research, especially cost-effectiveness analysis. o Assessments of the structure and effects of new, complex plan and provider organizations. o Providing empirical evidence about new models of incentive-driven behavior that will improve our understanding of health care markets in policy-relevant ways. o Providing evidence-based insight into the nature, extent, and effectiveness of value-based purchaser behavior. In all of the topics listed above the Agency is interested in an explicit focus on priority populations, which include low-income groups, minority groups, women, children, the elderly and those with special needs, and health care delivery in inner-city and rural areas. SPECIAL REQUIREMENTS Allowable Costs and Unallowable Costs Expenses allowed under the AHRQ Small Project Grant Program follow the guidelines described in the Application for a Public Health Service Grant (Form PHS 398, rev. 4/98) with some exceptions. Direct Cost Expenditures Equipment. It is not the intent of this program that funds be used to purchase equipment. With strong justification, however, funds may be approved for this purpose. Supplies. With strong justification, grant funds may be used for the purchase of supplies. These supplies must be received and used during the project period. Alterations and Renovations. Grant funds may not be used to support facility alteration or renovation of any kind. Subcontracts: Grant funds may be used for subcontracts, but not to the extent of exceeding funds budgeted for the grantee. The grantee, as the direct and primary recipient of grant funds, must perform a substantive role in carrying out project activities and not merely serve as a conduit for an award to another party or to provide funds to an ineligible party. Facilities and Administrative (F&A) Costs (Indirect Costs) Facilities and Administrative (F&A) Costs (F&A Costs are synonymous with indirect costs ) are allowable and will be calculated using the negotiated F&A cost rate agreement in effect at the time of the initial Notice of Grant Award. Data Privacy Pursuant to section 903(c) of the Public Health Service Act (42 USC 299a- 1(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 promises made or implied regarding the use and purposes of the data collection. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of such identifying information. 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 safeguarded. The grantee 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/handbook.pdf. Rights in Data AHRQ grantees may copyright or seek patents, as appropriate, 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 Federal government license to use these products and materials for AHRQ purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers, and subject to AHRQ budget constraints, final products maybe 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 in peer-reviewed journals and to market grant-supported products. 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 for 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 are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 also encourages investigators to consider including children in study populations, as appropriate. AHRQ program staff may also provide additional information concerning these policies (see INQUIRIES). APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev.4/98). State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev.5/96), and follow those requirements for copy submission. Applicants are encouraged to read all PHS Form 398 instructions prior to preparing an application in response to this PA. Application kits are available at most institutional offices of sponsored research or from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20982-7910, telephone (301)710-0267, email: grantsInfo@nih.gov . AHRQ applicants are encouraged to obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). On line 2 of the face page of the application, mark the yes box and type the PA number and title in the space provided. AHRQ encourages applicants to review all application form 398 instructions prior to completing an application. The PHS 398 type size requirements (p.6) will be enforced rigorously and non- compliant applications will be returned. Receipt dates for small research grant applications are three times annually: March 24th, July 24th, and November 24th. Application Preparation (for Using HCFA Data) 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 the 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. To avoid double counting, applicants should not include the cost of the data in the budget. Small research grant applicants should be aware that the costs of the grant, including the cost of HCFA data, can not exceed $100,000 total costs. In the event the total costs of the project plus the cost of HCFA data is greater than $100,000, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the HCFA data costs do not exceed $100,000. 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 HCFA to protect the confidentiality of data in accordance with standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data is restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee is required to return the data to HCFA or certify that the data have been destroyed. Grantees must also comply with the confidentiality requirements of Section 903(c) of the PHS Act. See the Data Privacy section for details on these requirements as well as references to Circular A-130 and its implementation guides from the National Institute of Standards and Technology. In developing research plans, applicants should allow time for refining, approving, and processing their 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 HCFA Administrator and may require meeting(s) with HCFA staff. HCFA 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 HCFA data should be directed to the AHRQ program official listed under INQUIRIES. AHRQ Data AHRQ encourages research applications that will use data from the Medical Expenditures Panel Survey, or MEPS (http://www.meps.ahrq.gov/), the Healthcare Cost and Utilization Project, or HCUP-3 (http://www.meps.ahrq.gov/Data_Public.htm), and other AHRQ sources. MEPS is a rich data source for healthcare utilization, expenditure, and insurance information. MEPS directly links data about persons and their families with information obtained from their employers, insurers, and healthcare providers. It is the third in a series of nationally representative surveys of medical care use and expenditures in the United States. Unlike its predecessors, MEPS is an ongoing survey. MEPS collects data on the specific health services that Americans use, how frequently they use them, the cost and source of payment for services, and information on the types and costs of private health insurance held by and available to the U.S. population. It provides a foundation for estimating the impact of changes in sources of payment and insurance coverage on different economic groups or special populations of interest, such as the poor, elderly, uninsured, and racial and ethnic minorities. Current information on the availability of MEPS data is on the MEPS section of the AHRQ Web site (http://www.ahrq.gov). 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 health care 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 from the Health Resources and Services Administration"s Area Resource File and to hospital-level data from the Annual Survey of the American Hospital Association. Special Application Instructions Specific Instructions for Form 398 (rev.4/98) are to be followed, with the following exceptions: o The section entitled Research Plan must not exceed 15 pages in length. Applicants determine the appropriate length of the areas that must be addressed in the Research Plan, but the statement must not exceed the 15 page limit. o In listing references, only literature immediately relevant to the application may be cited. The reference list is not counted as part of the 15 pages allotted for the Research Plan. o No appendices should be included with the application with the exception of proposed instruments. These should be attached only if they are judged to be crucial for the review of the project. The instruments will not count as part of the 15 pages. o If applicable, information such as letters of support, letters of participation, and statements of intent to establish a consortium can be placed directly before the Checklist page of the application. o 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 29892-7710 (20817 for express/courier service) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness to the PA by AHRQ staff. Incomplete and/or non-responsive applications or applications not following instructions given under Application Procedures will be returned to the applicant without further consideration. Accepted applications 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 peer review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. Review Criteria The review criteria for AHRQ grant applications are: o Significance and originality of the project. o Adequacy of the proposed methods. o Availability of data or adequacy of plan to collect data. o Adequacy of plans for organizing and carrying out the project. o Qualifications and experience of the investigators. o Adequacy of facilities and resources for the project. o Human subjects involvement and protection (when appropriate). o Representation of women and minorities (when appropriate). o Reasonableness of budget and time frame relative to proposed work. AWARD CRITERIA AHRQ sets aside funding each fiscal year for the Small Research Grant Program. The amount of the set-aside is dependent upon the availability of funds. In making funding decisions for small grants, the reviewers" assessment of technical merit is important, but is not the only factor used to determine which applications will be funded. Additional factors include the focus of the project, potential significance of the study, and the overall contribution the project will make to the field of health services research. The earliest possible date of award is 5 months after the receipt of the application by AHRQ. Applications not selected for funding under AHRQ"s Small Research Grant Program may be revised and resubmitted once for review and funding consideration. At AHRQ"s discretion, efforts may be made to resolve problems in applications deemed to hold promise. Applicants should not assume on the basis of efforts to resolve such problems that AHRQ is committed to making an award. 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 (WP5.1 or WP6.0 is preferable). Applicants must also agree 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 active or has ended. INQUIRIES Copies of the PA are available from: AHRQ Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907-8547 Telephone: 1-800-358-9295 TDD Service: 888-586-6340 This PA is also available on the AHRQ Web site (http://www.ahrq.gov), and through AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The PA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594-6344. The AHRQ Web site (http://www.ahrq.gov) also provides information on other grant solicitations and announcements (click on Funding Opportunities ). AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the PA. Written and telephone inquiries concerning this PA are encouraged. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Primary Care Research Kelly Morgan Telephone: (301) 594-1782 e-mail: kmorgan@ahrq.gov Outcomes and Effectiveness Research Joanne Book Telephone: (301) 594-4039 e-mail: jbook@ahrq.gov Cost, Financing, and Market Forces Achintya Dey Telephone: (301) 594-0890 e-mail: adey@ahrq.gov Organization and Delivery Irene Fraser, PhD Telephone: (301) 594-6768 e-mail: ifraser@ahrq.gov Quality Improvement and Patient Safety Elinor Walker Telephone: (301) 594-2049 e-mail: ewalker@ahrq.gov Inquiries Regarding AHRQ Data Sources MEPS Household Component Nancy Krauss Telephone: (301) 594-0846 e-mail: nkrauss@ahrq.gov MEPS Nursing Home Component Jeffrey Rhoades, PhD Telephone: (301) 594-0891 e-mail: jrhoades@ahrq.gov HIV Cost and Services Utilization Study Doris Lefkowitz, PhD Telephone: (301) 594-1077 e-mail: dlefkowi@ahrq.gov HCUP-3 Kelly Carper Telephone: (301) 594-3075 e-mail: kcarper@ahcpr.gov or hcupnis@ahcpr.gov or hcupsid@ahcpr.gov Direct Inquiries Regarding Fiscal and Eligibility Matters to: Michelle Burr Telephone: (301) 594-1840 e-mail: mburr@ahrq.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.226. Awards are made under authorization of Section 901(b), 902(c), and 925(c) of the Public Health Service Act, as amended (42 USC 299-299c-6). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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