LIMITED COMPETITION FOR AHRQ BUILDING RESEARCH INFRASTRUCTURE AND CAPACITY PROGRAM: PHASE II RELEASE DATE: April 11, 2003 RFA: HS-03-004 Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.226 LETTER OF INTENT RECEIPT DATE: June 13, 2003 APPLICATION RECEIPT DATE: July 15, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THE RFA This solicitation is the second phase of the Building Research Infrastructure and Capacity (BRIC) program initiated by the Agency for Healthcare Research and Quality (AHRQ) in 2001, and is limited to the current recipients of the initial BRIC planning grants. The original BRIC concept was initiated in response to Congressional intent to broaden geographic distribution of health services research funding by enhancing the competitiveness for funding among institutions in states where the success rate for applications to AHRQ had historically been low. In Phase I, two-year planning grants (P20s) were awarded to six sites located in states which had not previously received significant health services research funding from AHRQ. Importance in this new competitive solicitation will be placed on Phase I accomplishments and a demonstration of the need for continued support to further develop institutional research infrastructure. Phase II will provide additional support for the refinement, expansion, and implementation of plans developed among grantees supported in Phase I, including resources for the conduct of pilot research projects. RESEARCH OBJECTIVES Background BRIC is designed to build, increase, strengthen, and sustain the health services research competitiveness of institutions and organizations within eligible states. 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 will conduct health services research focused in one or more of the following areas: o Translating Research Into Practice (TRIP): Applicants are encouraged to conduct innovative and rigorous research and evaluation projects related to the translation of research findings into measurable improvements in quality, patient safety, healthcare 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. o Patient Safety: One of the important elements in the AHRQ mission is to support the development of multidisciplinary research teams in building 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 systems 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. 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 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 healthcare in inner-city and rural areas (including frontier areas); healthcare for priority populations, which include low income groups, minority groups, women, children, the elderly, and individuals with special healthcare needs, including individuals with disabilities and individuals who need chronic care or end-of-life healthcare. Further, the Agency supports the generation and dissemination of health services research to promote the equitable receipt of healthcare services for all Americans and eliminate health disparities among racial and ethnic minority populations. o Faith-Based Initiatives: The Department of Health and Human Services (DHHS) supports the Presidents' Faith-Based and Community Initiatives which were created to focus on improving human services for our country's neediest populations. As such, 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 healthcare research findings more effectively through faith-based and other community organizations. o AHRQ Data: 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/), and other AHRQ sources. Additional information is listed below in the AHRQ Data Section under Submitting An Application. Objectives and Scope To facilitate the above goals, Phase II of the BRIC program will provide support for two types of primary activities: Institutional Research Development Support: Infrastructure development such as: o those involving collaborative linkages with senior scientists across multiple components of the applicant institution (e.g., schools, colleges, divisions, and departments) and/or in other institutions; o provision of resources for data management and statistical analyses, including data access or linkage and data dissemination systems; o developing the capacity of state administrative data for use in research projects and conducting state or community level analyses using AHRQ Quality Indicators (i.e., Prevention Quality Indicators, Inpatient Quality Indicators, or Patient Safety Indicators) applied to state inpatient administrative data; o Center development, including limited support for equipment and staff involved in the coordination of research activities across participating components; o mentoring of junior faculty on research projects in which the latter play a major role. For individual faculty development, support may be requested for activities such as enrolling in advanced seminars in scientific techniques, and for pilot work to serve as a basis for developing individual research projects. Individual Investigator Research Projects -- BRIC funds may be requested for small-scale or pilot research projects. These projects may support junior faculty members as Principal Investigators. The intent of this component is to support research activities that will lead to publications; or that serve as pilot, developmental, or feasibility studies for future larger-scale projects; or that form the solid basis of a research application for funding under other research grant programs. These projects should be designed to take advantage of the infrastructure development being supported by the program. Applicants are required to propose a minimum of one Individual Investigator Research Project but may propose a maximum of three. Application Characteristics An AHRQ BRIC application must present a plan that: (1) describes past accomplishments based on the original BRIC grant, (2) assesses current institutional and faculty capacity to conduct health services research; and (3) describes activities that will be undertaken to develop and strengthen the institutional research infrastructure. Support can be requested for Institutional Research Development Support AND an Individual Investigator Research Project(s) or for Individual Investigator Research Project(s) only. All applications must provide: o A list of accomplishments, including output (e.g., description of what BRIC support has enabled the program to put in place that did not exist prior to the grant, how BRIC support has contributed to the development of a sustainable health services research program, examples of viable and long-lasting research linkages and collaborations that have been formed within and across institutional bounds) and outcome measures (e.g., research presentations, publications, development of grant applications, receipt of additional research funding). o Identification of sources of health services research funding at the institution. What funding sources, other than AHRQ, (including public and private) are available at the institution to conduct health services research? What possible sources are being investigated for future funding in order to sustain research capacity? What long-range funding goals and streams are anticipated to be tapped to maintain the viability of the research programs in the future? How has BRIC increased the institution's probability of successfully competing for future AHRQ and other federal funding? How are accomplishments and plans anticipated to prepare applicants to secure alternative support? o A description of what applicants anticipate a successful research infrastructure will look like at their institutions after three and five years of AHRQ support, how they would measure success at different points in time, and what they anticipate this funding will allow them to do five and ten years after receipt of initial AHRQ funds. With regard to specific future plans, the application should contain the following: Institutional Research Development Plan o Specific aims. o Summary of Phase I proposed goals and accomplishments, highlighting achievements as well as problems encountered and how they were resolved. o Summary of recently completed, ongoing, and planned health services research at the site. o Assessment of institutional capacity to conduct state-of-the-art research on health services related issues and identification of gaps which Phase II is intended to fill. o Design and procedures to be used to accomplish the specific aims of the research infrastructure development plan over the proposed project period, including plans for administrative structure, recruitment and retention of persons skilled in health services research; staff training and mentoring; statistical and other data management consultation; and collaboration with other institutions or components of the applicant institution. o Description of institutional financial or in-kind commitment (office space, protected research time) to support the proposed health services research infrastructure development, including letters of support from administrative officials at the institution. The Institutional Research Development Plan section of the application is limited to 15 pages. Individual Investigator Research Projects should include: o Linkages to overall institutional research 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, where applicable o Consultants and collaborators o Consortium/contractual arrangements o Detailed budgets for each project Applicants must submit at least one Individual Investigator Research Project but not more than three. The research plan for the Individual Investigator Research Projects are limited to 15 pages each (not including the list of references). MECHANISM OF SUPPORT This RFA will use the R24 award mechanism. This mechanism is used to provide support for enhancing the capability to conduct innovative research which will significantly contribute to the mission and efforts of the Public Health Service (PHS). As such, it is expected that the primary components of these projects will involve activities designed to foster the development of appropriate resources that support the implementation of research capabilities. It is expected that proposed projects would eventually make a substantial contribution in the field of health services research. Each applicant will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is September 2003. AHRQ is not using the Modular Grant Application and Award Process. FUNDS AVAILABLE AHRQ intends to commit approximately $1 million in FY2003 to fund up to six competitive grants in response to this RFA. It is anticipated that award size may vary based on request for Institutional Research Development Plan support and/or Individual Investigator Research Project(s). Applicants must limit their request to a TOTAL cost of $200,000 per year for up to three years. Up to $50,000 of this total can be budgeted for each individual research project. Applicants will not be required to match or share in project costs if an award is made. This RFA is a one-time solicitation and there are no plans for it to be reissued. Although this Program is provided for in the financial plans of AHRQ, awards pursuant to the RFA are contingent upon the availability of funds for this purpose. Funding beyond the initial budget period (i.e., the second year of the planning grant) will depend upon progress made in the first year of the grant and the availability of funds. ELIGIBLE INSTITUTIONS In 2001, AHRQ awarded six BRIC planning grants (P20s) under RFA-HS-01- 001. Support was provided for planning activities related to the development of a health services research infrastructure within selected states which had not historically received significant health services research funding from the Agency. This solicitation is a competitive continuation that extends these activities and only current recipients of the initial BRIC planning grants are eligible to apply. The purpose of these awards is to allow these grantees to build on their current work in progress and to conduct health services research projects. Because the existing BRIC recipients possess the research objectives to enable them to build on the existing work and because continuity in the research is necessary, this will be a limited competition. In addition, ongoing evaluation of the BRIC program requires a longer period of funding be in place for the current awardees in order to determine the appropriate structure for future Agency programs of a similar nature. For-profit organizations may only participate in the grant projects as members of consortia or as subcontractors. SPECIAL REQUIREMENTS Applicants should include projected expenses for traveling up to two members of the BRIC research team to an annual meeting of grantees and for attendance and presentation of research findings at least one meeting (subject to approval of AHRQ program staff), for each Investigator (or suitable team member) involved in a proposed research project. Data Privacy All information about identifiable individuals or organizations obtained for the research purpose of carrying out a demonstration project supported pursuant to this RFA under AHRQ's statutory authority is protected by a Federal confidentiality statute, section 924 of the Public Health Service Act, 42 USC 229c-3(c). Under this law, the only permissible disclosures of identifiable research information collected are those promised to, or agreed to by the subject individuals and organizations or those who supply the information to the researchers. There are substantial statutory penalties (up to $10,000) for improper use or disclosure of this information. Thus, 42 USC 299C-3(c) provides a Federal statutory basis for resisting any Federal or state court order or subpoena to the extent that carrying out the order or subpoena would violate the protective restrictions of the statute. Upon request, AHRQ will provide legal assistance in defending adherence to these statutory confidentiality protections with respect to identifiable data obtained in carrying out Agency research activities. Note that identifiable data obtained by AHRQ-supported researchers is protected by this law when it is obtained to carry out AHRQ-supported research, but this law will not protect against access to this same information in medical records gathered and retained in their original clinical settings for other purposes. If providers collect certain information solely for purposes of this research, it should be so marked and if necessary to protect its confidentiality, kept separately. Note also that this law does not protect or restrict access or disclosures to aggregate and nonidentifiable statistical or data analysis and conclusions developed by the researchers that would not disclose information about any identifiable individuals or establishments. Identifiable patient health information collected by grantees under this RFA 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 privacy regulations, developed pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are effective and enforceable as of April 14, 2003. These regulations serve to limit the disclosure of personally identifiable patient information and define when and how such information can be disclosed, for instance to researchers. Thus, health care plans and providers subject to the HIPAA Privacy regulation 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/ In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of information that could be used to identify human research subjects. The description of the data protection 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. If the HIPAA privacy rules apply to data to be obtained, the application should indicate whether or not such data will be obtained pursuant to patient authorizations or with a waiver of authorizations from one or more IRBs or Privacy Boards. 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 OBM 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 for 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. The application of these confidentiality and security standards to subcontractors and vendors should be addressed as necessary. Priority Populations The Agency's authorizing legislation (refer to http://www.ahrq.gov/hrqa99a.htm) directs special attention in Agency programs to populations of inner-city areas and rural areas (including frontier areas); 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. Applications under this RFA should address attention to and potential benefits for these priority populations. 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 Health Care Information (OHCI) 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 OHCI 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 OHCI 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 OHCI a brief plan describing how the product will be publicized. An OHCI 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this RFA 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: Kay Anderson, Ph.D. Health Science Administrator Office of Research Review, Education, and Policy Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400 Rockville, MD 20852 Telephone: (301) 594-6061 FAX: (301) 594-0154 E-mail Address: KAnderson@ahrq.gov o Direct your questions about peer review issues to: Joan Hurley Office of Research Review, Education, and Policy Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400 Rockville, MD 20852 Telephone: (301) 594-6075 FAX: (301) 594-0154 E-mail Address: JHurley@ahrq.gov o Direct your questions about AHRQ data sources to: MEPS Household Component: Nancy Krauss Center for Cost and Financing Studies Telephone: (301) 594-0846 E-mail Address: Nkrauss@ahrq.gov MEPS Nursing Home Component: Jeffrey Rhodes Center for Cost and Financing Studies Telephone: (301) 594-0891 E-mail Address: Jrhodes@ahrq.gov HCUP: Kelly Carper Telephone: (301) 594-3075 E-mail Address: Kcarper@ahrq.gov, hcupnis@ahrq.gov, hcupsid@ahrq.gov Direct your questions about financial or grant management matters to: George Moyer Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1842 FAX: (301) 594-3210 E-mail Address: SMoyer@ahrq.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Kay Anderson, Ph.D. Health Science Administrator Office of Research Review, Education, and Policy Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400 Rockville, MD 20852 Telephone: (301)594-6061 FAX: (301)594-0154 E-mail Address: KAnderson@ahrq.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and form (rev. 5/2001). 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 301-435-0714, Email: GrantsInfo@nih.gov. USING THE RFA LABEL The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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. 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 (20817 for express/courier service) At the time of submission, two additional copies of the application, must also be sent to: Kay Anderson, Ph.D. Health Science Administrator Office of Research Review, Education, and Policy Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400 Rockville, MD 20852 Telephone: (301)594-6061 FAX: (301)594-0154 E-mail Address: KAnderson@ahrq.gov APPLICATION PROCESSING: Applications must be received by the receipt dates listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The CSR and AHRQ will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. 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. Given the nature of the Project and the speed with which successful applicants will need to begin work, the Agency has determined that IRB approval is required prior to peer review of all applications submitted in response to this RFA. All investigators/applicants proposing research involving human subjects should pay particular attention to the instructions in the form PHS 398 regarding human subject involvement. 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 RFA is also available on AHRQ's Web site, http://www.AHRQ.gov, (see under Funding Opportunities) 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 PA number). The RFA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, seven days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594-6344. Application Preparation (for Using CMS 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 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 299c3(c), the Privacy rules at 45 CFR Part 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, for the sole purpose of assuring that data confidentiality is maintained, 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. 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, approving, and processing any 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. AHRQ Data AHRQ encourages research applications to use data from the Medical Expenditure Panel Survey (MEPS) (http://www.meps.ahrq.gov/), the Healthcare Cost and Utilization Project (HCUP) (http://www.ahrq.gov/data/hcup/), and other AHRQ sources. MEPS is a rich data source that contains information on healthcare use, access, quality, and cost, as well as information on health insurance coverage for the civilian non-institutionalized population of the United States. The foundation of the MEPS collection is information about the specific types of health services Americans use, how often they are used, how much they cost, and who pays. MEPS contains information on quality of care from the consumer perspective (from CAHPS), on self-evaluations of health (including the SF-12 and EuroQual), and on quality of care measures for specific conditions such as diabetes, asthma, and hypertension. MEPS includes information on the receipt of specific clinical preventive services as recommended by the U.S. Preventive Services Task Force for men, women, and children. MEPS data have been fully released to the public for 1996 through 1999. Some data is available for 2000 and 2001. Additional data items that have not been approved for release to the public are available for research use at the CCFS data center. The MEPS website (http://www.meps.ahrq.gov) has information on data availability, the data center, and abstracts of important research that has already been conducted using the MEPS. These studies illustrate the breadth of possibilities for using the MEPS data. The HCUP includes databases covering 1988-2000. 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 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness to the RFA. Incomplete and/or non-responsive applications or those not following instructions given in this RFA will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA 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 Receive a written critique o 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 General review criteria for grant applications are: consistency with the Agency's mission and research priorities; significance and originality from a scientific or technical viewpoint, adequacy of the methods(s) and proposed approaches; availability of needed data or adequacy of the proposed plan to collect data required for the project; adequacy and appropriateness of the plan for organizing and carrying out the project, qualifications and experience of the Principal Investigator and proposed staff; 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, the extent to which women, minorities, and if applicable children, are adequately represented in study populations; and the adequacy of the proposed means of protecting human subjects, if applicable. Special Review Criteria 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. In addition, peer reviewers will assess the applicant's need for AHRQ support overall and specifically for the level requested, given the existing capacity at the institution. Specifically, criteria for review of the overall application include the following: o consistency with AHRQ's research focus and mission o merit of the research development goals to be achieved by the institution and described in sufficient detail with the application and the plan proposed to achieve the research development goals o probable long-term impact of the program o plans for dissemination efforts o past accomplishments, particularly those achieved in Phase I, relative to original proposed plans and future plans o probable impact of the proposed type of research for which infrastructure development support is requested from AHRQ 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 one or more of the proposed projects and competing for significant public and/or private funding in the conduct of health services research, given the overall health services research experience of the applicants and their institutions o research qualifications and/or potential of existing and proposed personnel related to the BRIC project o personnel and administrative strengths of the program o evidence of strong commitment of the applicant institution to achieve the research development goals and to sustain those achievements, preferably in the form of letters of commitment o plans to sustain the program after the period of grant support ends o justification and appropriateness of the requested budget and project goals, based on criteria delineated under Objectives and Scope o strength of the existing partnerships 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: 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: In addition to the above criteria, each proposed research project of the application will be reviewed with respect to the following: o Protections: 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 need of both genders, all 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.) 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 RFA 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 privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are scheduled to be effective and enforceable in April 2003. 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/ 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, 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 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 Health Care Information 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.access.gpo.gov/nara/cfr/index.html). Important legal rights and requirements applicable to AHRQ grantees are set out or references in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website http://www.access.gpo.gov/nara/cfr/index.html). RECEIPT AND REVIEW SCHEDULE: Letter of Intent Receipt Date: June 13, 2003 Application Receipt Date: July 15, 2003 Peer Review Date: August 2003 Earliest Anticipated Start Date: September 2003 AWARD CRITERIA: All applications will equally compete for available funds. The following will be considered in making funding decisions: quality/scientific merit of the proposed project as determined by peer review, how well the proposed research fits with AHRQ priorities and the overall Agency research portfolio, compatibility with other grantees with respect to cooperative activities, policy relevance, and types of populations included in the study. In carrying out its stewardship of research programs, the AHRQ, at some point in the future, may begin requesting 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 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 still active. To receive an award, applicants must agree to submit an original and two 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). 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. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). 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 action 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 requirement for disclosure under FOIA, 5 USC 552(b), disclosure of identifiable data from such study is exempted from FOIA disclosure under "the (b)(3) exemption." 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 RFA 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 possibly human subjects procedures given the potential for any anticipated 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 Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" 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). 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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