AHRQ GRANTS FOR HEALTH SERVICES RESEARCH DISSERTATION RELEASE DATE: December 16, 2003 PA NUMBER: PAR-04-039 (This PAR has been reissued, see PAR-06-118) (see addendum NOT-HS-04-004) EXPIRATION DATE: January 13, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) Note: The policies, guidelines, terms, and conditions stated in this Announcement may differ from those used by the NIH. CFDA NUMBER: 93.226 (AHRQ) APPLICATION RECEIPT DATES: (Effective 2005) February 17, June 15, October 15 THIS PA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations o References PURPOSE OF THIS PA The Agency for Healthcare Research and Quality (AHRQ) announces its continued interest in supporting the health services dissertation research small grant program. This program supports research undertaken as part of an academic program to qualify for a doctorate. The AHRQ dissertation award R36 supports dissertation research costs of students in accredited research doctoral programs in the United States (including Puerto Rico, and other U.S. Territories or possessions). The dissertation will focus on areas relevant to health services research, with emphasis placed on methodological and research topics that address the mission of AHRQ. The total direct costs for applications submitted under this PA must not exceed $30,000 for the entire project period, which is expected to range from a minimum of 9 months to a maximum of 17 months. AHRQ will return without review any application that exceeds this amount. RESEARCH OBJECTIVES The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. The research sponsored and conducted by the Agency provides better information that enables better decisions about health care. Research that promotes the improvement of health care quality will be the Agency’s highest priority during the next few years. Accordingly, the Agency has identified the following strategic goals and research priorities, each of which will contribute to improving the quality of health care for all Americans. Research applications must address one of these areas: 1. Support improvements in health outcomes. 2. Strengthen health care quality measurement and improvement. 3. Identify strategies to improve access, foster appropriate use, and reduce unnecessary expenditures related to healthcare. 4. Medical Errors/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. 5. Translating Research Into Practice and Policy (TRIPP): 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 interest lies in 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. Some of these topics are described in Translating Research into Practice - Joint Program Announcement , http://grants.nih.gov/grants/guide/pa-files/PA-02-066.html. 6. Bioterrorism: Applicants are encouraged to submit applications that investigate and evaluate promising practices and strategies being developed and implemented at the State, local, and health system level to promote health system readiness in response to bioterrorism. Also of interest is the application of available methods and tools that can be of assistance in developing health system readiness capacity and enhancing readiness in rural as well as urban areas. http://grants.nih.gov/grants/guide/pa-files/PAR-03-130.html 7. 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 recommendations or the priority areas of the U.S. Preventive Services Task Force (USPSTF). Information and announcements describing AHRQ's general research areas of interest are available at http://www.ahrq.gov (see Funding Opportunities). For a description of recent research topics of interest to the Agency, applicants are encouraged to review the following research solicitations: o Impact of Payment And Organization on Cost, Quality And Equity http://grants.nih.gov/grants/guide/pa-files/PA-01-125.html. o Patient-Centered Care: Customizing Care to Meet Patients' Needs http://grants.nih.gov/grants/guide/pa-files/PA-01-124.html. Dissertation applicants are further encouraged to address health services 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. http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html MECHANISM OF SUPPORT This PA will use the dissertation research grant (R36) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project under the supervision, and with the approval, of a university approved and appointed doctoral committee. No supplemental funds will be awarded. AHRQ does not require cost sharing for applications submitted in response to this Program Announcement. AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Public or private non-profit academic institutions o Domestic and foreign institutions o Units of State and local governments o Faith-based and community initiative o Tribes and Tribal Organizations The institution from which the applicant is applying must be the institution at which the candidate is pursuing his/her research doctoral studies. If applying from a foreign institution, applicants must demonstrate the relevance of the proposed research to the U.S. healthcare delivery system. For the purpose of this PA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as member of consortia or as subcontractors. Organizations describes in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. The dissertation candidate will be the designated Principal Investigator. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs. SPECIAL REQUIREMENTS Eligible applicants must: o be matriculated students in an eligible, accredited doctoral program who are at the dissertation stage. o be in good-standing at their academic institutions. o have completed all non-dissertation requirements (and non-clinical internship requirements) for their degrees, with the exception of the defense and approval of their dissertation by their committee (evidence of completion of this must be sent to and received by the Division of Scientific Review staff (noted under Inquiries below) within 60 days of the appropriate application submission date noted above. o be a U.S. citizen, non-citizen national (e.g., residents of U.S. territories), or permanent resident by the time of award. o devote a minimum of 40 hours per week to their dissertation and limit additional employment compensation activities to 20 or fewer hours per week. A statement affirming these time commitment plans must be included with the budget justification. Note that individuals supported under T32 institutional training programs and F31 awards (Ruth L. Kirschstein National Research Service Award predoctoral fellowships) are also eligible to apply for a dissertation award. However, no funds from the R36 dissertation award may be used to supplement the stipend paid by the F31 or T32 mechanism. o Priority Populations The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) reauthorized the AHRQ and directed the Agency, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. To implement this directive, AHRQ published a notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this PA who seek funding from AHRQ should address the requirements of including priority populations as specified in the Notice. o Publication Transmittal: General AHRQ Requirements In keeping with the Agency=s efforts to translate the results of AHRQ-funded research into practice and policy, grantees and/or contractors are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will take place in close coordination with OCKT and the press offices of the grantee=s or contractor=s institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into the following areas: application process, programmatic, scientific/research, peer review, data sources and financial or grants management issues. o Direct your questions regarding programmatic issues, including information on the inclusion of women, minorities, and children, and other priority populations in study to: Greta Drott Division of Research Education/Dissertation Program Office of Extramural Research, Education and Priority Populations Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1530 FAX: (301) 427-1562 Email: training@ahrq.gov o Direct your questions about peer review issues to: Scott Andres, Ph.D. Division of Scientific Review Office of Extramural Research, Education and Priority Populations Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1546 FAX: (301) 427-1562 Email: sandres@AHRQ.gov o Direct your questions about application process to: Debbie Rothstein, Ph.D. Office of Extramural Research, Education and Priority Populations Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1525 FAX: (301) 427-1562 o Direct your questions about financial or grant management matters to: Catherine Dwyer Center/Office name Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1457 FAX: (301) 427-1462 Email: cdwyer@ahrq.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. To ensure equity among applicants, however, applicants using this form must observe page number and font size requirements specified in the Form PHS 398. SUPPLEMENTARY INSTRUCTIONS: In addition to the instructions in the PHS 398 form, the following special instructions should be followed. In instances in which instructions in the PHS 398 differ from those in this PA, the instructions in the PA take precedence. o The graduate student should be identified as the Principal Investigator and the applicant organization should be the doctoral granting institution at which the student is registered and matriculated. o The section entitled Research Plan, excluding references, may not exceed 15 pages. o The only acceptable appendix material is a copy of any survey instrument(s) being used in the proposed research application. o A list of literature citations is required, but will not be counted toward the 15 page limit requirement for the Research Plan. o The application must identify all members of the faculty committee by listing the names on Page 2. As explained in form PHS 398, a brief biographical sketch (see Biographical Sketch Format Page) should be provided for dissertation committee members, consultants, and other key personnel. It is strongly encouraged that the doctoral dissertation committee includes recognized health services researchers with appropriate interdisciplinary or multidisciplinary expertise. o A letter from the faculty committee or the university official directly responsible for supervising the dissertation research must be submitted with the grant application. The letter must certify that: 1. The dissertation application must reflect the actual work to be conducted by the applicant. If the applicant has successfully defended his/her application, the letter should appropriately indicate that the faculty committee has approved the dissertation proposal. If this certification has not yet been obtained, the letter should indicate the proposed date of the dissertation defense. Certification that the defense has been successfully completed needs to be received by the Division of Scientific Review, AHRQ, (as noted above). If not received within 8 weeks, the application will be returned without review. 2. The candidate demonstrates future career objectives and potential as a health services researcher. 3. An institutional infrastructure exists to support the candidate and proposed research application. 4. A collaborative process was established between the applicant and advisors in the development, review, and editing of the research application. 5. The applicant has completed all requirements for the doctoral degree, except the dissertation and the proposal defense (as noted above under item 1.) o The applicant should also include a brief cover letter from him/herself, which discusses his/her career goals, his/her background and interest in health services research, how the proposed dissertation will contribute to career goals and the relevance of the proposed dissertation to AHRQ/DHHS priorities and interests, as described above. o Section C of the application should be used as an extension of the literature review or publications of the faculty dissertation committee as they relate to this research. o Applicants should give special attention to the sections of the application dealing with human subjects protection and inclusion of priority populations. It is important to discuss this with appropriate committee members and officials at the institution prior to submission. Special attention should be paid to the definition of human subjects, as described in the PHS 398 and the Priority Populations Inclusion Policy of AHRQ as described above under Priority Populations http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html. For those projects involving human subjects or individually identifiable data, IRB approval is required prior to grant an award. Allowable Costs Allowable costs include the following: the applicant’s salary; direct project expenses such as travel, data purchasing, data processing, and supplies. Fees for maintaining matriculation or other fees imposed on those preparing dissertations are allowable costs, provided the fees are required of all students of similar standing, regardless of the source of funding. Although all of the above costs are allowable, the following guidelines should be followed: o No salary support will be given for the dissertation committee. o All data costs are to be included in the $30,000 total direct cost limit for dissertation applications. o Travel costs are allowable for one professional conference. o Personal computer and statistical consultant service costs at a level not to exceed 80 hours are allowable. o Support for a research assistant is generally not permitted. In rare circumstances, it may be approved if the justification is acceptable to AHRQ staff. Applicants applying through institutions receive facilities and administrative (F&A) costs in addition to the direct costs of the project. For calculating F&A costs, dissertation research grants are considered training grants. Therefore, according to DHHS policy, the institution will receive F&A costs based solely on 8 percent of the total allowable direct costs exclusive of tuition and related fees, health insurance, and expenditures for equipment. Costs should be submitted in a non-modular (detailed) format. Other Conditions The following conditions apply to dissertation grants: o A Principal Investigator who discontinues or suspends a project during the grant period must inform the AHRQ immediately in writing. AHRQ may suspend or terminate the grant as requested by the Principal Investigator or on its own initiative. o AHRQ will accept one amended resubmitted application. When submitting an amended (revised) application the Introduction section must be limited to one page. o An abstract and Executive Summary of the dissertation constitutes the final report of the grant. The Executive Summary must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation and must be signed by the responsible officials. Two copies of the materials must be submitted to the AHRQ Division of Grants Management, listed under the Inquiries section. The final report and all financial status reports must be submitted in English. OTHER INSTRUCTIONS: Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Program (HCUP) or the Medical Expenditure Panel Survey (MEPS). The HCUP includes databases covering 1988-1997, with 1998 and 1999 data available in 2001. These all-payer databases were created through a Federal- State-industry partnership to build a multi-State healthcare data system. The main HCUP databases contain discharge-level information for inpatient hospital stays in a uniform format with privacy protections. The Nationwide Inpatient Sample (NIS) is a nationwide probability sample of about 1000 hospitals. The State Inpatient Databases (SID) contain inpatient records for all community hospitals in 22 states. Other HCUP databases contain ambulatory surgery data from nine states. These databases can be directly linked to county-level data form the Health Resources and Services Administration’s Area Resource File and to hospital-level data from the Annual Survey of the American Hospital Association. The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS comprises three component surveys: The Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The household component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov. This does not preclude the use of secondary data sources or primary data collection. 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 and AHRQ: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) At the time of submission, two additional copies of the application, labeled AAdvanced Copy (s)@ must also be sent to Greta Drott Division of Research Education/Dissertation Program Office of Extramural Research, Education and Priority Populations Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1530 FAX: (301) 427-1562 Email: training@ahrq.gov APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described in the heading of this PA. The CSR and AHRQ will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR and AHRQ will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgment of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this PA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. It is very important to note that limitations on number of pages and size of font must be observed; applications violating these requirements will be returned without review. Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an AHRQ application. The "AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications" was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). The PA is also available on AHRQ's Web site, http://www.AHRQ.gov, (see under Funding Opportunities). Application Preparation (for Using CMS Data) Purchase of CMS public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. In consultation with Center for Medicare and Medicaid Services (CMS), previously called Health Care Financing Administration (HCFA), AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ’s confidentiality statue, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed. Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS’s approval to do so. In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff. CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats. Questions regarding CMS data should be directed to the AHRQ program official listed under INQUIRIES. Assessment of AHRQ Grant Programs In carrying out its stewardship of research programs, the AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency-sponsored research. Applicants are to 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 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 (Word Perfect, or Word, or ASCII format). The past cooperation of applicants with regard to the submissions described in this section may be considered in the application review to assess applicants potential for responsible stewardship of awarded funds PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness to the PA by the Agency Referral Officer, program staff, and grant management staff. Incomplete and/or non-responsive applications or applications not following instructions given in this PA will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. As part of the merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. o Receive a written critique REVIEW CRITERIA In the written comments, reviewers will be asked to balance the technical merit of the grant application with strong emphasis placed on their assessment of the applicant's potential as a future health services research, as reflected in accompanying letters, the relevance of the written proposal, the caliber of the infrastructure to provide necessary guidance and support to the student, the dissertation chair or faculty advisor evaluation of the student, faculty biosketches, background of committee, and accompanying letters of support. Specific review criteria will include: o Significance/Impact o Approach o Innovation o Investigator/Mentoring o Environment o Inclusion of Priority Populations o Budget The scientific review group will address and consider each of these criteria in assigning an application=s overall score, weighting them as appropriate for each application. (1) SIGNIFICANCE/IMPACT: Does your study address an important problem from a scientific and/or translational (i.e., is the work proposed or subsequent efforts stemming from it likely to be relevant to the delivery of clinical care, operations of health care delivery systems, or local, regional or national policy) perspective? If the aims of the application are achieved, how do they advance scientific knowledge or how usable are they to decision makers or consumers? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR/MENTORING: Is the student-investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the mentor’s experience level of the student-investigator? Are the mentors appropriately qualified to provide guidance as needed? Have the mentors indicated that they will provide sufficient time and attention to the student? Is evidence of strong mentoring seen in the quality of the dissertation application? Does the student-investigator hold promise to be a contributor to the field of health services researcher, as determined by his/her career plans, mentor(s) written assessments, the topic of his dissertation? Is evidence of strong mentoring seen in the quality of the dissertation application? (5) ENVIRONMENT: Does the scientific environment in which the student’s work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support in the form of adequate office, computer, methodological, and statistical support? (6) INCLUSION OF PRIORITY POPULATIONS: Does the applicant adequately address the priority population policy of AHRQ, found in http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html. For a list of frequently asked questions and answers with regard to the implementation of this policy, please see http://www.ahrq.gov/fund/ppopfaq.htm (7) BUDGET: the reasonableness of the proposed project budget and the requested period of support in relation to the proposed research; ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: 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). ADDITIONAL CONSIDERATIONS DATA SHARING: Data Confidentiality Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute [42 U.S.C.299c-3(d)). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this PA will also be managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of protected 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) became mandatory for covered entities on April 14, 2003. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, for example, health care plans, will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) satisfied that any identifiable health information will be appropriately safeguarded by the investigators. The HHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/ The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application. Rights in Data AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, 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, databases, 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 substantial or valuable 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.gpoaccess.gov/cfr/index.html). RECEIPT AND REVIEW SCHEDULE Application Receipt Dates: (Effective 2005) February 17, June 15, and October 15 annually (Applications considered for review must be post marked by the receipt date. If the receipt date falls on a weekend or Holiday, the receipt date will be the next business day.) Peer Review Date: May, September and January annually. Earliest Anticipated Start Date: 4 months after application receipt date. AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Agency portfolio balance o Relevance to program priorities, including those related to inclusion of priority populations. o The extent to which the application addresses an area that is unique to AHRQ. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS: It is the policy of AHRQ that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). AHRQ also encourages investigators to consider including children in study populations, as appropriate. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal act is taken, having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data is not subject to this disclosure requirement. Furthermore, even if a Federal regulation action is taken in reliance on AHRQ-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential 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 collected. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ’s authorities. 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 consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued the last modification the "Standards for Privacy of Individually Identifiable Health Information", was mandated by the "Privacy Rule," on August 14, 2002. This regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). Mandatory compliance with the Privacy Rule (for those 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 covered entities. 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 that may be used to determine whether a researcher is a staff of a covered entity. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements. 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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