AHRQ GRANT PROGRAM FOR LARGE CONFERENCE SUPPORT RELEASE DATE: May 8, 2003 PA NUMBER: PA-03-117 (This PA has been reissued, see PA-06-378) CFDA NUMBER: 93.226 EXPIRATION DATE: April 28, 2006 Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Where to Send Inquiries 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 PA The Agency for Healthcare Research and Quality (AHRQ) announces its continued interest in supporting conferences through its Large Grant Program for Conference Support. AHRQ Large conference grants are those with direct costs of more than $50,000 per year or with a project period of longer than 1 year, but not exceeding 5 years. This Program is intended to complement and promote AHRQ's core research by providing a mechanism for Agency stakeholders and others to (1) develop health services research agendas and identify strategies and mechanisms for studying them; (2) discuss and develop consensus around health services research methodological and technical issues; (3) disseminate health services research information and facilitate adoption of research findings from AHRQ-sponsored research and research training grants in the formulation or evaluation of health policy, management of health care programs, and use or purchase of health services; and (4) develop partnerships with stakeholder organizations and build their capacity to participate in research activities and use the results of health services research. This announcement describes the procedures and criteria for the Program. It updates and supersedes the "Health Services Research Conference Grants," PA-91-061, published in the NIH Guide for Grants and Contracts on May 31, 1991. RESEARCH OBJECTIVES Conference Objectives AHRQ seeks to support conferences that help to further its mission. The mission of AHRQ 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 transfer of knowledge about improvements in clinical and health systems practices, the prevention of diseases and other health conditions. AHRQ also strongly encourages applicants to demonstrate consideration of research issues critical to priority populations, including: individuals living in inner city and rural (including frontier) areas; low-income and minority groups; women, children, and the elderly; and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care. The types of conferences eligible for support include: 1) Research development - conferences to define issues or problems in the financing, organization, and delivery of health services or to develop research agenda or strategies for studying them; 2) Design and methodology - conferences to address methodological, data development, and technical issues of major importance in the field of health services research are addressed or new conceptual frameworks, research designs, tools, and methodologies; and 3) Dissemination conferences - to synthesize, summarize, and communicate research findings to a broad range of organizations and individuals that have the capability to use the information to further AHRQ's mission. Dissemination conferences include conferences that are intended to develop strategies for translating and disseminating research for public and private decision makers, including the development of strategies to foster and document the impact of health services research. AHRQ is especially interested in supporting conferences that demonstrate strategies which include plans for disseminating conference materials and products beyond the participants attending the event. Such strategies might include, but are not limited to, submitting articles for publication, posting information on a Web site with a provision for active marketing of the site, and seeking out formal opportunities to discuss conference information with others. AHRQ's Mission 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. This Program Announcement (PA) expresses AHRQ's interest in supporting conferences that focus on the Priority Program Areas identified in the "AHRQ Health Services Research - Program Announcement" (http://www.grants.nih.gov/grants/guide/pa-files/PA-00-111.html). That PA outlines broad research interests in the following areas: o Improvements in health outcomes. Drawing from literature on variations in clinical practice and associated outcomes, the documented increase in the prevalence of chronic disease, and growing interest in the impact of different delivery modalities and financing arrangements on the outcomes of care, AHRQ seeks to support research to understand and improve decision- making at all levels of the health care system, the outcomes of health care and, in particular, what works, for whom, when, and at what cost. o Quality measurement and improvement. AHRQ is interested in a broad array of research topics, including studies to develop valid and reliable measures of the process and outcomes of care, causation and prevention of errors in health care, strategies for improving measurement and reporting in order to strengthen programs of quality improvement and patient safety, and dissemination and implementation of validated quality improvement and patient safety mechanisms. o Strategies to improve access, foster appropriate use, and reduce unnecessary expenditures. This area focuses on issues pertaining to the types of health care services Americans use; the cost of these services and sources of payment; determinants of access to care; and whether particular approaches to health care delivery and financing, or characteristics of the health care market, alter behaviors in ways that improve access and promote cost-effective use of health care resources. Accordingly, AHRQ strongly encourages applicants to propose conferences which focus on the above-described subjects as well as conferences that address aspects of these research subjects critical to the above-referenced priority populations. AHRQ encourages conference planners to disseminate tools and data either developed or supported by AHRQ, for example, the CAHPS products, related Medical Expenditure Panel Survey products (MEPS), data and quality indicators from the Healthcare Cost and Utilization Project (HCUP), Evidence-based Practice Centers (EPCs) Reports, National Quality Measures Clearinghouse (NQMC); and research results derived from the previous examples as well as from the Centers for Education and Research on Therapeutics (CERTs), Excellence Centers To Eliminate Ethnic/Racial Disparities (EXCEED), Patient Safety Initiative, Translating Research into Practice (TRIP); and U.S. Preventive Services Task Force materials, and descriptive material about the National Guideline Clearinghouse. Depending on the particular conference design and topic and goal, possible dissemination avenues for AHRQ products could include advertisements in affiliated newsletters, AHRQ's logo on the conference web page with a link to AHRQ's website, the inclusion of a promotional insert in participant packets relevant AHRQ material(s) in the conference notebook or briefing packet or display table or AHRQ exhibit booth space at the meeting, recognition in conference program, verbal recognition at various conference functions or participation by an AHRQ topic expert in panel discussions/presentations. MECHANISM OF SUPPORT This Program Announcement will use the conference grant (Rl3) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 5 years. Applicants will not be required to match or share in project costs if an award is made. Applicants should refer to the AHRQ web-page at http://www.ahrq.gov for "Funding Opportunities." Program Announcements and Requests-for-Proposals posted on the site may provide potential applicants for conference support with information on current AHRQ priorities, recent initiatives, and appropriate program staff contacts. Large conference grant applications are reviewed using the timeline as set forth in the Receipt and Review Schedule Section of this Program Announcement. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o Domestic o Public and private nonprofit organizations, including universities, clinics, units of State and local governments o Tribes and tribal organizations o Foundations o Scientific or professional societies o Faith-based or community-based organizations An individual is not eligible to receive a grant in support of a conference. In the case of an international conference, the U.S. representative organization of an established international scientific or professional society is the eligible grantee. For the purpose of this PA, AHRQ will make grants only to non-profit organizations; however, for-profit organizations may participate in grant projects through consortium arrangements or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue code that engage in lobbying are not eligible. Applicants may request full or partial support for conferences. Where partial support of a conference is requested, the peer review will consider the overall structure and design of the conference as well as the sub- component for which support is being requested. AHRQ encourages investigators and new investigators (as defined in the PHS 398 application instructions) who are women, members of racial and ethnic of minority groups, and persons with disabilities to apply as Principal Investigators. WHERE TO SEND INQUIRIES 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 your questions regarding program matters to the offices listed below by specific program areas: 1. Improving Health Outcomes Heddy Hubbard, R.N., M.P.H. Acting Director Center for Outcomes and Effectiveness Research Telephone: 301/594-1485 E-mail: hhubbard@ahrq.gov 2. Quality of Care Daniel Stryer, M.D. Acting Director Center for Quality Improvement and Patient Safety Telephone: 301/594-6672 E-mail: dstryer@ahrq.gov 3. Evidence-based Practice and Technology Assessment Jean Slutsky, P.A., M.P.H. Acting Director Center for Practice and Technology Assessment Telephone: 301/594-4026 E-mail: jslutsky@ahrq.gov 4. Primary Care Helen Burstin, M.D. Director Center for Primary Care Research Telephone: 301/594-1357 E-mail: hburstin@AHRQ.gov 5. Cost and Financing Steven B. Cohen, Ph.D. Director Center for Cost and Financing Studies Telephone: 301/594-6171 E-mail: scohen@AHRQ.gov 6. Organization, Delivery, and Markets Irene Fraser, Ph.D. Director Center for Organization and Delivery Studies Telephone: 301/594-6824 E-mail: ifraser@AHRQ.gov 7. Training and Career Development Francis Chesley, M.D. Director Office of Research Review, Education, and Policy Telephone: 301/594-6410 E-mail: fchesley@AHRQ.gov 8. Minority Health Kay Felix-Aaron, M.D. Office of Priority Population Research Senior Advisor for Minority Health Telephone: 301/594-6198 E-Mail: kfaaron@ahrq.gov 9. Children's Health Denise Dougherty, Ph.D. Senior Advisor for Child Health Telephone: 301/594-2051 E-mail: ddougher@AHRQ.gov 10. Clinical Preventive Services David Atkins, M.D. Medical Officer Center for Practice and Technology Assessment Telephone: 301/594-4016 E-mail: datkins@AHRQ.gov 11. Cost-effectiveness Analysis and Other Methodological Advances Joanna Siegel, Sc.D., R.N. Center for Outcomes and Effectiveness Research Telephone: 301/594-0667 E-mail: jsiegel@ahrq.gov o Direct your questions about peer review issues to: Pat Thompson, Ph.D. Director Division of Scientific Review Office of Research Review, Education, and Policy Telephone: 301/594-1404 E-mail: pthompso@ahrq.gov o Direct your questions about financial or grant management matters to: George (Skip) Moyer Division of Grants Management Telephone: 301/594-1842 Fax: 301/594-3210 E-mail: smoyer@AHRQ.gov SUBMITTING AN APPLICATION The following directions apply to applications for conference grants of more than $50,000 in direct costs per year or requesting more than one year of support but not exceeding 5 years. Applicants proposing conference grants for $50,000 or less in total direct costs should read the "Small Grant Program for Conference Support," published in the NIH Guide for Grants and Contracts on October 2, 2000 (http://grants.nih.gov/grants/guide/pa-files/ PAR-00-141.html). Applicants are required to seek approval from AHRQ staff at least 6 weeks prior to the anticipated submission of any application requesting $500,000 or more in direct costs for any year. If staff is contacted less than 6 weeks before submission, there may be insufficient time to make a determination about assignment prior to the intended submission date. Applicants proposing conference grants for $500,000 or more for any year should read the "Advance Approval of Unsolicited Applications That Request More Than $500,000 Direct Costs in Any One Year," published in the NIH Guide for Grants and Contracts on August 22, 1997 (http://www.ahrq.gov/fund/advance.htm). 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 301-710-0267, Email: GrantsInfo@nih.gov. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. See (http://www.psc.gov/forms/MSWPHS/PHS-5161-1.doc) To ensure equity among applicants, however, applicants using this form must observe page number and font size requirements specified in the Form PHS 398. AHRQ encourages use of Form PHS 398 in preference to Form 5161-1. The PA title and number must be typed on 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. Specific Application Instructions The proposed date for the conference must be included on page 2 of the application as a part of the conference description. The proposed location and facilities for the conference must be described on page 2 of the application under the section entitled "Performance Site(s)." The narrative portion of the application will substitute for the Research Plan described in form PHS 398 (Rev. 5/2001). The narrative portion should be responsive to the "Application Review Criteria" outlined in this PA, and describe the following: o General purpose of the conference, including how the conference might impact on the quality, appropriateness, and effectiveness of health services, access to such services, and how it might address issues related to priority populations described in the review criteria; o Planning process, including who assisted (or might assist) to plan the conference and the criteria for their selection; o Topics selected for discussion, including how health services research findings will be incorporated if a purpose of the conference is to disseminate information; o Format for the conference; o Proposed (or confirmed) speakers and discussants, including the criteria for selecting such; o Expected product(s) resulting from the conference, including how these products would be disseminated beyond those attending the conference; o Expected participants; and o Plans for evaluating the conference's success. The narrative portion may not exceed 25 pages in length and must include all material related to the project justification. A conference agenda or draft agenda, if available, should be added as an appendix. Although policies governing study populations are not directly relevant, applications for AHRQ-supported conferences will be expected to demonstrate consideration of the possible relevance of conference subject matter to the following priority populations: low income groups; racial and ethnic minority groups; women; children; the elderly; individuals with special health care needs, including individuals with disabilities and those who need chronic care and end-of-life health care; and individuals living in inner- city, rural, and frontier areas. Consideration for priority populations may be reflected in the design of the agenda, selection of topics and speakers, attendees, and the final product associated with the conference, whether it is a research agenda or conference proceedings. SENDING AN APPLICATION TO THE NIH and AHRQ: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) APPLICATION PROCESSING: Applications must be received by the receipt dates listed under RECEIPT AND REVIEW SCHEDULE below. 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 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 substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. 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. 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) 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, 7 days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594-6344. 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 conferences and 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 2 copies of an abstract, executive summary, and full report of the 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 uses (WP5.1 or WP6.0 is preferable.) PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness to the PA. Incomplete applications or applications not following instructions given in the PHS 398 form will be returned to the applicant without further consideration. Applications that are complete to the PA will be evaluated for scientific and technical merit by an appropriate review group convened in accordance with standard AHRQ peer review procedures. Reviewers may also take into consideration the extent to which the applicant responds to any suggestions or priority issues provided by AHRQ prior to submission of the application. 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 Conference Topic 1. The topic selected must complement existing Agency research activities and interests. 2. The conference must relate clearly and directly to the field of health services research and its goals of developing and translating research to improve our health care system. 3. The conference topic and objective(s) must be succinctly and clearly stated, and reflected in all aspects of the conference proposal. 4. Conference sessions should include health services research related, but not limited, to issues such as: o The quality, effectiveness, efficiency, appropriateness, safety, and value of health care services; o Quality measurement and improvement; o The outcomes, cost, cost-effectiveness, and use of health care services and access to such services; o Clinical practice, including primary care and practice-oriented research topics and methodologies; o System strategies to reduce medical errors and improve patient safety; o Health care technologies, facilities, and equipment; o Health care costs, productivity, organization, and market forces; o Health promotion and disease prevention; o Health statistics, surveys, database development, and epidemiology; o Medical liability; o Market dynamics and its impacts on cost, quality and access; o Delivery system organization; o Medical informatics; o Evidence-based medicine and practice and its implementation into care settings; o Systems re-engineering and other ways to improve health care systems to make them more effective and efficient; o Bioterrorism; o Using information technology effectively and appropriately within different settings; and o Disparities in access, quality, and utilization. 5. The conference should address issues related to priority populations-- low income groups; racial and ethnic minority groups; women; children; the elderly; individuals with special health care needs, including individuals with disabilities and those who need chronic care and end-of-life health care; and individuals living in inner-city, rural, and frontier areas--to the extent appropriate to the conference topic. 6. The topic selected must be important to Agency stakeholders such as consumers and patients; clinicians and other providers; institutions; plans; purchasers; and policymakers in all sectors (e.g., Federal, State and local governments; voluntary associations; international organizations; and foundations). 7. The outcome of the conference should have the potential to influence future research, policy, or practice, or enhance AHRQ's collaborative relationships. 8. Expected conference outcomes should have a national impact or make a significant contribution to a particular field. If the conference is regionally based, plans for a broad dissemination of conference materials and some indication of national relevance must be included. Conference Design 1. The conference must support one or more of the following purposes: disseminating and implementing health services research results, formulating a research agenda, or developing research methodologies, tools, and data sources. 2. If the meeting format includes a call for abstracts, the application should include a summary of the process for soliciting, reviewing and selecting research to be presented at the conference. 3. The conference format must support the conference purpose and facilitate expected outcomes. 4. The planning committee should include representation from the research and research-user communities, and include a process for outreach to a subset of the conference target audience. To the extent consistent with the conference design, topic and goal(s), the planning process also should include outreach to people of differing views, and outreach to women and members of minority groups and representatives of one or more of the other Agency priority populations. 5. Speakers selected or proposed, or criteria for speaker selection, must be appropriate for the session topic. A plan should be in place to identify other presenters if those originally sought are unavailable. 6. Evaluation of the conference results must be included in the design. Personnel 1. Conference planning staff and/or advisors must include persons with the requisite education, training and experience. 2. The applicant organization must have the institutional resources, infrastructure, and demonstrated capacity to support the proposed conference. Dissemination Activities 1. Plans must have been made to disseminate conference outcomes to an audience broader than the conference participants. 2. To the extent relevant to the particular conference topic, goal and format, the application should address opportunities for dissemination of germane AHRQ interest(s), i.e., research findings and publications, databases, tools. Budget 1. The budget must be adequate to support the conference design and must be justified. 2. Other resources necessary to produce the intended outcome should have been identified or obtained. Special Budget Requirements Applications may request full or partial support for conferences. However, applicants are encouraged to obtain multiple sources of funding as a means of maximizing limited AHRQ funds. Where partial support of a conference is requested from AHRQ, application reviewers will consider the overall structure and design of the conference as well as the sub-component for which support is being requested. Sources and amounts of other funding should be clearly identified. Applications must include a composite budget listing costs by category to be provided by other sources as well as costs being requested from AHRQ. Allowable and Unallowable Costs Expenses allowed follow the guidelines described in the form PHS 398 (rev. 5/01) and PHS Grants Policy Statement (April 1, 1994) Appendix 7. Areas of particular relevance to conference grants and exceptions to the general policies are described below. Direct Cost Expenditures a. Equipment. Grant funds may be used for rental of necessary equipment. Funds may not be used for the purchase of equipment. Rental expenses should be listed under the other expenses category. b. Travel. Proposed per diem or subsistence allowances must be reasonable and will be limited to the days of attendance at the conference plus actual travel time required to reach the conference location by the most direct route available. Travel costs are limited to the extent provided for by formal institutional travel policy. If the grantee institution has no formal travel policy, the institution is required to conform to the Federal guidelines for travelers as indicated at www.gsa.gov. The General Services Administration guidelines shall be applied in determining the amount of travel chargeable to grant funds. Where meals and/or lodging are furnished without charge or at a nominal cost (e.g., as part of the registration fee), the proposed per diem or subsistence allowance must take this into consideration. Transportation costs for those attending and participating in the conference and paid with grant funds may not exceed economy class fares. U.S. carriers must be used where possible. For local participants in the conference, grant funds may not be used to pay per diem or expenses other than local mileage. c. Supplies. Grant funds may be used for the purchase of conference supplies, provided the supplies are received and used during the project period. d. Conference Services. Grant funds may be used for necessary recording of proceedings, simultaneous translation, and subsequent transcriptions. e. Publication Costs. Grant funds may be used to pay for the publication and dissemination of conference proceedings. f. Registration Fees. Registration fees, when paid by the grantee to other organizations on behalf of attendees, may be paid from grant funds, provided such fees cover only those allowable costs properly chargeable to the grant. g. Entertainment and Personal Expenses. Costs of amusement, diversion, social activities, ceremonial, and related incidental costs such as bar charges and personal telephone calls of participants or guests cannot be charged to the grant. h. Federal Employees. Grant funds may not be used to cover the cost of travel or any payment to a full-time Federal employee, except when that employee is on leave without pay status from his or her employing office. i. Honoraria. Honoraria or other payments given for the purpose of conferring distinction on or to symbolize respect, esteem, or admiration may not be paid from grant funds. Speaker fees for services rendered, however, are allowable. j. Alteration and Renovations. Grant funds may not be used to support facility alteration or renovations of any kind. k. Meals. When meals are an integral and necessary part of a conference (i.e., working meals where conference related business is transacted), grant funds may be used for such meals. Food costs that are not integral and necessary to the conference (e.g., preconference registration refreshments, continental breakfasts, coffee breaks, and receptions) are not allowable. Facilities and Administration Costs (F&A) F & A costs (indirect costs) will not be allowed on grants in support of conferences. 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 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/ If AHRQ funds will be used to support preparation of research papers for presentation, the awardee should ensure that computer systems containing confidential research 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/. 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. RECEIPT AND REVIEW SCHEDULE Application Receipt Dates: February 1, June 1, October 1 Peer Review Date: June, October, February Earliest Anticipated Start Date: August, January, May AWARD CRITERIA Applications will compete for available funds with other conference applications. The following will be considered in making funding decisions: o Merit of the proposed conference as determined by review o Availability of funds o Relevance to program priorities Conditions of Award In addition to standard grant requirements, the following terms and conditions of award will be set prior to the issuance of a Notice of Grant Award: 1. Agreement for up to 5 AHRQ staff to attend the conference without paying a registration fee. 2. Agreement to hold the conference within 12 months of the start date of the budget period. 3. Agreement to submit an original and two copies of an executive summary and one-page abstract of the conference and summary of participant's evaluation ratings/comments, which includes discussion of what you learned and what you might do differently in the future, to AHRQ no later than 90 days after the dates of the conference. At the time of the award, the project officer will determine how many copies of the conference products will be required for distribution to AHRQ staff and other DHHS colleagues. 4. To the extent relevant to the particular conference design, topic and goal, agreement to dissemination of germane AHRQ product(s). 5. Agreement to list AHRQ as a meeting supporter on conference materials, subsequent proceedings and references. 6. General program income subject to the additional costs alternative shall be reported on lines 10r and 10s, as appropriate, of the financial status report (FSR 269 long form). Refer to 45 CFR part 74 74.24 for information concerning program income. TIMELINE - Time from review of application to earliest anticipated award date: - 4 months for study section review. - Funding decision 6 months after submission date. - Earliest possible start date is 7 months after submission date. Date of conference: Within 12 months of start date of the budget period. Conference Summary: For large conference grants with project periods of one year or less, the conference summary is due 90 days after the project period. The conference summary must be included in the progress report summary of the PHS 2590 Non-competing grant progress report for grants that are approved for more than one year of support and as part of the final report that is required at the end of the project. Potential applicants are reminded that no public announcement of AHRQ's financial commitment can be made for a conference before the applicant receives a Notice of Grant Award. Prospective applicants should allow adequate time for application submission and review and award processing in their plans for conference development. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND ONE OR MORE OTHER AHRQ PRIORITY POPULATIONS 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 applicants proposing projects involving human subjects should read the amended "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on October 9, 2001 (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. AHRQ also strongly encourages investigators to consider including one or more AHRQ priority populations within the contexts of choosing conference presenters and presentations and of developing a research design appropriate to the scientific objectives of the planned study. The AHRQ Policy on the Inclusion of Priority Populations in Research was published in the NIH Guide on February 28, 2003 (http://grants.nih.gov/grants/guide/notice-files/ NOT-HS-03-010.html). All applicants proposing large conference projects should read this policy. Applicants may obtain copies of these guidelines and policies from those sources listed above or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ program staff may also provide 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 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 such study is exempted from 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 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 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 AHealthy 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 authorization of Title IX of the Public Health Service Act (42 U.S.C. 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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