SMALL RESEARCH GRANTS FOR PRIMARY CARE PRACTICE-BASED RESEARCH NETWORKS (PBRNs) RELEASE DATE: April 28, 2003 RFA: HS-03-006 Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER(S): 93.226 LETTER OF INTENT RECEIPT DATE: June 23, 2003 APPLICATION RECEIPT DATE: July 24, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations o References PURPOSE OF THE RFA The Agency for Healthcare Research and Quality (AHRQ) invites primary care practice-based research networks (PBRNs) to apply for small research grants to conduct exploratory/pilot projects or feasibility studies. A PBRN is defined as a group of ambulatory practices devoted principally to the primary care of patients, affiliated with each other (and often with an academic or professional organization) in order to investigate questions related to community-based practice and to improve the quality of primary care. This definition includes a sense of ongoing commitment to network activities and an organizational structure that transcends a single project. Although a major objective is to encourage creative, investigator-initiated research within PBRNs, AHRQ is particularly interested in studies that explore (1) network strategies for assuring that new research evidence is translated into actual practice and that its impact is assessed; (2) innovative uses of information technology in primary care practices; (3) the feasibility of implementing electronic health records in primary care and assessing the impact on safety, quality, effectiveness and efficiency of care; (4) optimal methods of delivering preventive services in primary care settings; (5) methods for improving community-based detection and responses to emerging public health threats (including acts of bioterrorism); and (6) elucidation of primary care-based strategies for diminishing disparities in health care delivery and health outcomes for AHRQ priority populations. This includes delivery of health care in inner city and rural areas (including frontier areas); it also includes health care for: 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. The funds are not intended to supplement ongoing research or to support large-scale undertakings or analyses of secondary data sources. It is expected, however, that results generated from these projects will serve as a basis for planning future, larger scale research. RESEARCH OBJECTIVES Background As part of the December, 1999, legislation (P.L. 106-129) reauthorizing and renaming the agency, AHRQ was directed, in amended section 911 (42 U.S.C. 299b), to employ research strategies and mechanisms that link research directly with clinical practice in geographically diverse locations throughout the country, including the use of "provider-based research networks...especially (in) primary care." To address issues of disparities in the health care quality, outcomes, cost and access for various segments of the U.S. population, amended section 901(b)(2) authorized the agency to implement research strategies and mechanisms that specifically include PBRNs. In response to these directives, AHRQ has over the past three years provided support for primary care PBRN research efforts through the issuance of several requests for applications. Most recently, RFA-HS-02-003 provided funds in September, 2002, for infrastructure support and exploratory projects to 36 PBRNs comprised of over 10,000 primary care clinicians with practices in 50 states serving almost 10 million primary care patients. The current RFA is directed to new or existing primary care PBRNs, including (but not limited to) those previously or currently funded by AHRQ. It provides awards for innovative exploratory or pilot projects, or feasibility studies, likely to lead to larger scale undertakings by the network. Objectives and Scope A major goal of primary care PBRNs, some of which have existed in the U.S. for over twenty years, has been to involve busy community-based clinicians and their staffs in activities directed by investigators experienced in clinical and health services research. The best of PBRN investigative efforts have linked relevant clinical questions with rigorous research methods in community settings and have produced scientific information that not only is externally valid, but, in theory, more easily assimilated into everyday practice. (Nutting, 1999) Leaders of PBRNs in the U.S. and other countries have also recognized the potential of primary care networks to expand their purposes beyond traditional research to the nurturing of an evidence-based culture in primary care practice. (Thomas, 2001). Many PBRNs have begun to envision their networks as places of learning, where clinicians are continually engaged in reflective inquiries about practice, and clinicians and their patients in the community are united with science to search for answers that can provide a basis for improved delivery of primary care. A critical element to the success of any PBRN effort is an infrastructure that not only serves research but also coordinates diverse network activities, such as recruitment and retention of practices, quality improvement efforts, and the translation of research into practice. Ideally, a network's infrastructure includes, in addition to leadership and support personnel, an electronic data system that is capable not only of collecting, transferring and aggregating primary research data but also of disseminating new information quickly and measuring subsequent changes in practices and/or patient outcomes. Such systems have the ability to inform future research needs, help transform the culture of practice, and support strategies to accelerate continuous quality improvement within practices. However, numerous barriers, such as the cost of purchasing, implementing and maintaining sophisticated information technology and training appropriate staff, have to date prevented most primary care PBRNs from developing these systems. Assuring adequate protection of the privacy and confidentiality of patient data is another critical challenge. Primary care clinicians have recently participated in the development and testing of various information technologies, such as decision support systems and tools for managing medical information, that enhance practice and potentially improve patient outcomes. (Ebell, 2001) More work is needed, however, to determine when and how such new technologies can be adopted into practices that participate in PBRN activities and the extent to which these technologies improve quality, safety, and efficiency. Certain observers have argued that the demands of primary care clinicians for the information necessary for optimal patient care can be satisfied only if clinicians use electronic medical records (EMRs). EMRs have been praised for their ability to help solve record movement problems, improve the quality and coherence of the care process, and assist clinical research, outcomes management, and process improvement. (McDonald, 1997) Although robust EMR systems are now available, only about 5% of U.S. primary care providers use them. (Bates, 2003) PBRNs could potentially help define the barriers to adopting EMRs as well as the benefits realizable through their routine use in primary care practice. In light of recent events in the U.S., there is considerable urgency to develop an infrastructure capable of detecting and responding effectively to emerging public health threats, including acts of bioterrorism. Early detection of such threats depends largely on the ability of front line clinicians to collect, analyze and communicate information. Also critical are systems for providing bidirectional information flow between these clinicians and local, state, regional and national public health officials. Most surveillance systems currently in use within primary care practice were not designed specifically to detect bioterrorism, but instead were created for detecting and managing naturally occurring illnesses such as influenza. (Buffington, 1993) PBRNs can potentially serve as settings to develop and test "dual function" systems for recognizing and responding to bioterrorism threats through the adaptation of clinical surveillance systems originally developed for other purposes. Information technology linkages between PBRN practices, public health agencies, and emergency response networks would be a critical element of such systems. Another major challenge facing PBRNs is identifying and obtaining adequate and sustained funding for network research. Historically, it has been difficult for PBRNs to obtain funding through the traditional basic research project grant (R01) mechanism. Most often, applications are denied either for lack of preliminary data or for research methods that are adapted to the realities of practice settings but appear insufficiently rigorous in peer review. At the same time, few funding opportunities currently exist for PBRNs to generate preliminary data as evidence of feasibility or to pilot test new projects or research methods. There is a clear need for a source of funds to support network efforts to refine innovative research questions and related hypotheses through pilot testing of original ideas derived from primary care practice. Such testing could provide important information about the feasibility of data collection in network practices, data that may be critical to the successful funding of larger, related projects, and to the design of appropriate methods for translating study results into actual practice. Methodological Considerations Funds available through this RFA provide PBRN investigators the opportunity to (1) explore the feasibility, as well as the development, of projects investigating issues important to primary care practice, and (2) generate preliminary data. The funds are specifically intended to support the study by PBRNs of original ideas or research approaches where preliminary data as evidence of feasibility are sparse or do not exist. The funds are not intended to supplement ongoing research or to support large-scale undertakings or analyses of secondary data sources. Rather, proposed projects are intended to serve as a basis for planning and strengthening future research grant applications (R01s) from PBRNs. Proposed projects can involve descriptive or interventional studies, qualitative and/or quantitative work, multimethod designs, or simple hypothesis testing. While the range of questions that PBRNs can propose is broad and detailed in the AHRQ Small Research Grant Program Announcement (PAR- 01-040), AHRQ has a particular interest in the following areas of investigation: o network strategies for assuring that research evidence is translated into actual practice and that its impact is assessed. In particular, there is a need for research that explores the application across multiple practices of promising translational prototypes (e.g., evidence-based approaches for treating a specific disease or system changes that improve the quality or efficiency of care) and also assesses resultant changes in the quality and/or cost-effectiveness of health care delivery or health care outcomes. o innovative uses of information technology in primary care practices. Of particular interest are projects that test the end user value of wireless handheld devices or desktop workstations that automate common clinician practices, such as prescribing, note-taking, clinical decision-making, and providing patient education. o feasibility of implementing electronic medical records (EMRs) in primary care and assessing their impact on safety, quality, effectiveness and efficiency of care. PBRNs are encouraged to partner with public and private EMR developers in pilot testing the benefits and barriers to adoption of EMRs in primary care settings. Projects that focus on the interfaces between new primary care EMR systems and existing electronic data sources (e.g., laboratory systems, pharmacy systems) are strongly encouraged. o optimal methods of delivering preventive services in primary care settings, especially those aimed at promoting healthy patient behaviors. o methods for improving community-based detection and responses to emerging public health threats, including acts of bioterrorism. Of special interest are projects that pilot test (through exercises or demonstrations) adaptations of primary care surveillance systems to respond to a bioterrorist event and also link primary care practices to local, state, regional or national public health departments. MECHANISM OF SUPPORT This RFA will use the R03 award mechanism. As an applicant, you will be solely responsibility for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is September 30, 2003. AHRQ is not using the Modular Grant Application and Award Process. FUNDS AVAILABLE AHRQ intends to commit approximately $500,000 in FY03 to fund five new grants in response to this RFA. The budget limit on small project grant applications is $100,000 total costs (i.e., direct costs plus facilities and administrative costs) for the entire project period. Grant support should not exceed 24 months, and budget requests for the full period of support may not exceed $100,000 in total costs. Applicants responding to this RFA will not be required to match or share in project costs if an award is made. Although the financial plans of AHRQ provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution is domestic and included in any one of the following categories: o Domestic o Public and private non-profit organizations, such as universities, hospitals or clinics, and professional associations. o Units of State and local government o Eligible components of agencies of the Federal Government o Eligible faith-based or community-based organizations While foreign organizations are not eligible, the research network supported by the applicant may include individual clinical practices located outside the United States. For the purpose of this RFA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as member of consortia or as subcontractors. Organizations described in sections 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 a primary care PBRN to develop an application for support. AHRQ encourages new investigators (as defined in the PHS 398 application instructions) to apply as Principal Investigators. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are also encouraged to apply for AHRQ programs. SPECIAL REQUIREMENTS Applications are encouraged from newly formed PBRNs as well as existing networks, including (but not limited to) those that are currently receiving, or have in the past received, funds from AHRQ, other Governmental agencies, or private sources. The application must provide a description of the PBRN's current state of development as well as its size, patient population served, leadership/management staff, and affiliations (if any). Applications must comply with the above special requirements in order to be considered responsive to this RFA. PBRN Resource Center Recognizing the diverse needs of individual networks and the importance of regular communication with and among funded PBRNs, AHRQ has established a PBRN Resource Center through Indiana University and the National Opinion Research Center. The Resource Center will conduct an assessment of each PBRN funded through this RFA in order to define and prioritize the specific resource needs of the network. Funded networks will be expected to cooperate fully in this process with the Resource Center, which will later provide consultative services and technical expertise, as appropriate, to each PBRN. In addition, the Resource Center will assist AHRQ in convening two annual meetings of representatives of recipient PBRNs during the period of funding. Required Elements The applicant is expected to provide a concise, clearly stated research question and to describe the process that was used to generate and develop the original idea with the network. While originality of the research question or approach and the potential significance of the proposed project will be major considerations in the evaluation for funding, the applicant is responsible for developing a rigorous plan for research and data analysis. Background literature and a rationale for the research question must be provided. Applicants must also describe the steps taken to optimize levels of study participation and the potential implementation of research results by network membership. The responsibility for directing the exploratory or pilot project should be assigned to a senior level person with appropriate research training and experience. This person may be the network director or another investigator. He/she must be directly affiliated with the applicant organization and should devote not less than 10% of his/her time to the project over the period of funding, although salary support for the principal investigator's effort may be cost-shared by the applicant organization. Appropriate research assistant(s) or coordinator(s) may be hired to oversee the daily research activities. Support should also be requested, as appropriate, for statistical and other assistance. Qualifications Applicants should document in their proposals that the PBRN involved in this project meets, at minimum, the following qualifications: o The PBRN organizational structure includes a core of at least 15 ambulatory practices and/or 15 clinicians devoted to the primary care of patients. The majority of the practices should be located in the U.S. Applicants should refer to the Institute of Medicine report on primary care (Donaldson, 1996) for definitions of primary care and primary care clinician. o The network has an accepted statement of its purpose and research mission that includes an ongoing commitment to the research endeavor. o A director has been identified who is responsible for most administrative, financial and planning functions. o The director is, or will be, supported by a staff of at least one person. o A mechanism (such as a community advisory board) is in place to solicit advice/feedback from the communities of patients served by the PBRN clinicians. o An organizational structure exists that transcends a single study, including multiple systems of communication with and among participating practices in the form of regularly produced newsletters, e-mail or list-serves, conference calls, and/or face-to-face meetings of various combinations of network members. Priority Populations The Agency's authorizing legislation (refer to http://www.ahrq.gov/hrqa99a.htm) directs special attention in Agency programs to populations of inner-city areas and rural areas (including frontier areas); low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. Applications under this RFA should address attention to and potential benefits for these priority populations. Publication Transmittal: General AHRQ Requirements In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees and/or contractors are to inform the Office of Health Care Information (OHCI) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OHCI staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will take place in close coordination with OHCI and the press offices of the grantee's or contractor's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to submit to OHCI a brief plan describing how the product will be publicized. An OHCI staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: David Lanier, M.D. Center for Primary Care Research Agency for Healthcare Research and Quality 6010 Executive Blvd., Suite 201 Rockville, MD 20852 Telephone: (301) 594-1489 FAX: (301) 594-3721 Email: dlanier@ahrq.gov o Direct your questions about peer review issues to: Carl Ohata, Ph.D. Health Scientist Administrator Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400 Rockville, MD 20852 Telephone: (301) 594-6040 FAX: (301) 594-0154 Email: cohata@ahrq.gov Direct your questions about financial or grant management matters to: George Gardner Division of Grants Management Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-6826 FAX: (301) 594-3210 Email: ggardner@ahrq.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by June 23, 2003. The letter of intent should be sent to: Natalie Alter Center for Primary Care Research Agency for Healthcare Research and Quality 6010 Executive Blvd., Suite 201 Rockville, MD 20852 Telephone: (301) 594-7180 FAX: (301) 594-3721 Email: nalter@ahrq.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and form (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301-435-0714, Email: GrantsInfo@nih.gov. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. 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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SUPPLEMENTAL INSTRUCTIONS: The following supplemental instructions to the form PHS 398 should be used to guide the preparation of the R03 application: 1) Under "Performance Sites" (page 2), list only the official name of the PBRN and the address of the PBRN office. A complete list of the clinicians and practice sites to be involved in the project should be attached to the application as an appendix. If the proposed activities will involve human subjects (including surveys or interviews of network clinicians), the application should include documentation of Multiple Project Assurance (MPA) or Federalwide Assurance (FWA), if known. Applicants not having a Human Subjects Assurance should refer to the OHRP website http://www.hhs.gov/ohrp/assurances/assurances_index.html for information regarding Human Subject Assurances. 2) Detailed Budget. Budget requests may not exceed $100,000 total costs (direct plus facilities and administrative costs) for the entire project period. All budget items must be justified in terms of their support of the exploratory/pilot project or feasibility study. Requests for computer-related or other equipment must be well justified and within the scope of work proposed for the project. Since travel and lodging expenses for a network representative to attend up to two collaborative meetings annually in Rockville, MD will be paid for by AHRQ, these expenses should not be included in the budget request. 3) Biographical Sketches. A biographical sketch of the network director must be included, as well as sketches of other key personnel to be involved in the project. If an individual (other than the network director) will be serving as the Principal Investigator, his/her biographical sketch must also be included. 4) Research Plan. This narrative part of the application is limited to fifteen pages of text. It should be organized into two sections, as follows. Section I. The Practice-Based Research Network a) Description of the PBRN. Describe the practices included in the network, including geographical distribution of practices and types of clinicians. The applicant should provide any reliable information about the characteristics of the patient population currently served by network clinicians, including (if available) the percentages of minority and underserved patients. As noted above, a complete listing of network clinicians and practice addresses should be included as an appendix to the application. This description should document that the PBRN meets, at minimum, the qualifications outlined under SPECIAL REQUIREMENTS, "Qualifications." b) Current institutional or other resources available to the PBRN. This discussion (which may alternatively be included in the Resources section of the application) should describe the relationships between the network and any affiliated academic department or other organizational unit. A list of the consultants, co-investigators and other resources available to the network as a result of the affiliation should be included. Senior officials in any PBRN- affiliated organization(s) should provide a letter documenting support for the network's activities. These and other letters of support should be included as an appendix and referenced in this section of the application. A brief description of any computer-based or other information systems currently in use across the network should be included. The discussion should also include a description of the mechanism used for obtaining advice/feedback from the patient communities served by the network practices. c) Network director and staff. The PBRN director and any network support staff should be identified, including a description of their qualifications. d) Evaluation. Include a statement indicating the willingness of the PBRN to cooperate with the PBRN Resource Center and to participate in an AHRQ- supported evaluation of the agency's overall PBRN initiative, should the applicant be funded. Section II. Proposed Exploratory/Pilot Research or Feasibility Study a) Research issue/question. Define the research question(s) or issue(s) to be addressed and describe the mechanism used to generate and develop the study idea with the PBRN. Present background literature and a conceptual framework supporting the proposed question or approach. Explain why the question being explored may be significant to the future research efforts of the network and to primary care practice. b) Methods and plan. A rigorous research plan must be presented, even if the purpose of the project is primarily hypothesis testing. Instruments and methods for data collection must be specified and a timeline for completing each phase of the project provided. Describe the steps taken to optimize the level of study participation within the network and to increase the likelihood that findings will be implemented by PBRN membership. Discuss any similar or related work successfully completed in the past within the network. c) Analytic plan. Describe in detail the plan to aggregate and analyze the study data. The expected sample size should be discussed, including a contingency plan in the event study enrollment is less than anticipated. Indicate if the sample will be sufficient for subgroup analysis of the study population by race/ethnicity, insurance status, or other patient-specific variables. d) Potential problem areas. Discuss any methodological or logistical problems that could affect the timely completion of the exploratory or pilot project. Describe any backup plans or methods being proposed to address or resolve these problems, if needed. e) Investigators. Describe the training and experience of the principal investigator (and any co-investigators) that quality him/her to carry out the proposed project. 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 courier service) At the time of submission, two additional copies of the application must also be sent to: Natalie Alter Center for Primary Care Research Agency for Healthcare Research and Quality 6010 Executive Blvd., Suite 201 Rockville, MD 20852 Telephone: (301) 594-7180 FAX: (301) 594-3721 Email: nalter@ahrq.gov APPLICATION PROCESSING: Applications must be received by the receipt dates listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. The CSR and AHRQ will not accept any application in response to this RFA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how.Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission, http://forms.psc.gov/forms/FF99/PHS-5161-1/ phs-5161-1.html. 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 required at the time of submission of an application in response to this RFA. 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). However, due to time constraints IRB approval is required at the time of application submission. The RFA is also available on AHRQ's Web site, http://www.AHRQ.gov, (see under Funding Opportunities) and through AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA 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 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. In addition, to receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (WP5.1 or WP6.0 is preferable). PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness to the RFA. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. As part of the merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. REVIEW CRITERIA In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the scientific merit of the proposed project and the potential of the PBRN to complete the proposed activities successfully. 1. Technical merit of the proposal a) Approach. How clear are the goals and objectives of the proposed project? Is the research question or hypothesis clearly stated? Are the proposed methods and data analyses adequately developed and appropriate to the aims of the project? b) Significance. How important is the research question/hypothesis to be tested? If the aims of the project are achieved, how important will this preliminary work be to future network endeavors? c) Innovation. Will the proposed project employ novel and original concepts, approaches or methods? To what extent does the proposed project take advantage of unique features of the PBRN or employ innovative collaborative arrangements? d) Investigator(s). Is the investigator(s) appropriately trained and well suited to carry out this work? Is the proposed work appropriate to the experience level of the P.I. and other researchers (if any)? 2. Potential for success a) PBRN readiness. To what extent has the P.I. (or network director) involved network clinicians in the development of the research question? How well has the applicant considered the steps that will be necessary to implement in practice any findings that may result from this or related work? b) Scope of work. Is the proposed work sufficiently ambitious for the PBRN, given its level of development and prior experience? Will the PBRN realistically be able to complete the entire project within the proposed timeline? c) Environment. Is the administrative, organizational and management environment of the PBRN well established and stable enough to make the project's success likely? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to address the need of both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Adequacy of attention to other populations of special priority to AHRQ (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Agency policies and Requirements, below.) DATA SHARING: Data Confidentiality Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute. [42 U.S.C.299c-3(d)) In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this RFA will also be managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of patient-related health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are effective April 2003. These regulations serve to limit the disclosure of personally identifiable patient information and define when and how such information can be disclosed. Thus, for example, health care plans and providers will require either patient authorization of disclosures of identifiable information to be made to researchers who are not their health care providers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) upon being satisfied that any identifiable health information will be appropriately safeguarded by the investigators. Additional information about the regulations and their implementation can be obtained from: http://www.aspe.hhs.gov/admnsimp/ The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application. Rights in Data AHRQ grantees may copyright unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, data bases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant- supported products. AHRQ's Office of Health Care Information wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.access.gpo.gov/nara/cfr/index.html). RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 23, 2003 Application Receipt Date: July 24, 2003 Peer Review Date: August 2003 Earliest Anticipated Start Date: September 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Program balance among awardees with respect to type and focus of investigations REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS: It is the policy of AHRQ that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD -00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). AHRQ also encourages investigators to consider including children in study populations, as appropriate. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal act is taken, having the force and effect of law, in reliance upon an AHRQ supported research project, the underlying data is not subject to this disclosure requirement and under FOIA, 5 USC 552(b), disclosure of identifiable data from 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 RFA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c- 3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and 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 "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. REFERENCES Bates DW, Ebell M, Gotlieb E, Zapp J, Mullins HC. A proposal for electronic medical records in U.S. primary care. J Am Med Inform Assoc 2003;10(1):1-10 Buffington J, Chapman LE, Schmeltz LM, Kendal AP. Do family physicians make good sentinels for influenza? Arch Fam Med 1993;2:858-65 Donaldson MS, Yordy KD, Lohr KN, Vanselow NA, eds. Primary Care: America's Health in a New Era. National Academy Press, Washington, D.C. 1996 Ebell MH, Frame P. What can technology do to, and for, family medicine? Fam Med 2001;33(4):311-9 McDonald CJ. The barriers to electronic medical record systems and how to overcome them. J Am Med Inform Assoc 1997;4(3):213-21 Nutting PA, Beasley JW, Werner JJ. Practice-based research networks answer primary care questions. JAMA 1999;37:1092-1104 Thomas P, Griffiths F, Kai J, O'Dwyer A. Networks of research in primary health care. BMJ 2001;322:588-90


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