PRIMARY CARE PBRNS: COMPETITIVE CONTINUATIONS Release Date: February 22, 2001 RFA: RFA-HS-01-004 Agency for Healthcare Research and Quality Application Receipt Date: April 13, 2001 PURPOSE The Agency for Healthcare Research and Quality (AHRQ) announces the availability of one-year cooperative agreement research grants to provide continuing support of primary care practice-based research networks (PBRNs) and to assist PBRNs in addressing data-related issues. Although grants will be awarded competitively, applicants are limited to recipients of planning grants awarded by AHRQ in September, 2000, under RFA-HS-00-004, Primary Care Practice-Based Research Networks. RFA-HS- 00-004 supported PBRN planning efforts to establish or augment electronic collection and aggregation of practice-derived data, increase network capacity to study the health care of racial and ethnic minority and/or underserved populations, create systems to facilitate the implementation of research findings by network clinicians, and identify potential sources of ongoing network support. The current solicitation builds upon this effort by helping PBRNs address specific data-related issues identified through planning activities. Funds are available to support PBRN surveys of network clinicians and practices, using standardized instruments. These network-defining surveys will provide baseline data on the clinicians enrolled in the network, the services provided, and the characteristics of patients receiving those services. Potential uses of the data include practice benchmarking and guiding the selection and design of specific PBRN research projects. PBRNs can also apply for additional funds to pilot test and evaluate electronic methods of collecting and aggregating practice-derived research data or to assess clinician and patient knowledge and attitudes about protecting the privacy and confidentiality of research data collected in primary care settings. AHRQ’s overall goal is to improve the capacity of PBRNs to expand the primary care knowledge base and to establish mechanisms to assure that new knowledge is incorporated into actual practice and that its impact is assessed. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS In September, 2000, AHRQ awarded planning grants (P20s) to nineteen PBRNs under RFA-HS-00-004. Funded activities have included the planning and development of network infrastructure needed to enhance methods of PBRN data collection. This solicitation is a competitive continuation that extends the data-related activities, and only current recipients of PBRN planning grants are eligible to apply. For-profit organizations may participate in the grant projects as members of consortia or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHRQ encourages women, members of racial and ethnic minority groups, and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism in which substantial AHRQ scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. The dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the AHRQ Program Official(s). Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total project period for applications submitted in response to the present RFA may not exceed one year. The anticipated award date is September 28, 2001. This RFA is a one-time solicitation. AHRQ has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE AHRQ expects to award up to $1.5 million total costs (direct costs plus facilities and administrative costs) in fiscal year 2001 to support projects under this RFA. It is anticipated that up to 19 awards to conduct network-defining surveys will be made for up to $50,000 total costs (including direct plus facilities and administrative costs) for one year. In addition, up to 5 of these awards will compete for an additional $100,000 total costs (including direct and facilities and administrative costs) to pilot test electronic data collection methods or to conduct projects related to data safety and confidentiality. Although this program is provided for in the financial plans of AHRQ, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Definition of PBRN For the purposes of this RFA, 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. This definition includes a sense of ongoing commitment to the research endeavor, and an organizational structure that transcends a single study. RESEARCH OBJECTIVES Background Legislation passed by the one hundred sixth U.S. Congress and signed by the President in December, 1999, amended Title IX of the Public Health Service Act (42 U.S.C.299 et seq.) to mandate the establishment within the newly named AHRQ of a Center for Primary Care Research (CPCR) to serve as the principal source of funding for primary care practice research in the Department of Health and Human Services. In addition, AHRQ was directed to employ research strategies and mechanisms that link research directly with clinical practice in geographically diverse locations throughout the U.S., including provider-based research networks...especially (in) primary care. In response to these directives, AHRQ issued in February, 2000, the Request for Applications RFA-HS-00-004, Primary Care Practice-Based Research Networks, which offered one-year exploratory grants to assist new or established PBRNs in planning for activities to enhance their capacity to conduct research in primary care settings and translate research findings into practice. Awards were made in September, 2000, to 19 PBRNs comprised of over 5,000 primary care clinicians with practices in 49 states serving almost 7 million primary care patients. Each grant supported the development of a PBRN-specific plan to: (1) establish or augment electronic collection and aggregation of practice-derived data; (2) increase network capacity to study the health care of racial and ethnic minority and/or underserved populations; (3) create systems to facilitate the implementation of research findings by network clinicians and practices; and, (4) identify potential sources of ongoing network support. The current RFA builds upon the earlier solicitation by providing funds to support PBRN efforts to address specific data-related issues identified through the planning activities. Objectives and Scope Since the first primary care PBRNs were established in the U.S. in the late 1970s, the major goal of these networks has been to link relevant clinical questions with rigorous research methods in community settings to produce scientific information that not only is externally valid but, in theory, is more easily assimilated into everyday practice (Nutting, 1999). To date, however, the range of research conducted by PBRNs has been limited. The majority of studies published by PBRNs have been observational, typically describing the practice patterns of primary care, with many fewer intervention studies being successfully completed. The unavailability of adequate funding for large, expensive primary care research has been a major barrier. However, another factor limiting the ability of many PBRNs to conduct more sophisticated research has been the inadequacy of network-defining data needed to determine the feasibility of, and lay the methodological groundwork for, such studies. For example, before a PBRN can realistically propose to conduct a randomized trial or effectiveness study focusing on a specific clinical condition or patient population, it must have reliable patient demographic information as well as data on the incidence or prevalence of the condition among patients served by network clinicians. This is particularly true for studies involving minority populations or conditions seen less commonly in primary care settings. Administrative or billing data routinely collected in primary care practices are often inadequate for this purpose. Since few if any standards currently exist for office-based coding of demographic and other research-related information, the data are often incomplete or incompatible from practice to practice and cannot be easily aggregated for the purpose of characterizing the network as a whole. A few networks have been able to gather data on network demographics by systematically collecting information on the total number and age-sex distribution of patients in their practices, as well as the general characteristics of their providers. However, even this basic level of information is lacking for the majority of PBRNs (Green, 1999). Collecting, transferring and analyzing research data is another major challenge for primary care PBRNs. Since office computers in primary care are typically used only for billing purposes, the potential to gather research data electronically is usually not realized. As a result, most PBRN studies currently involve large volumes of hand- written information from network practices that often are widely dispersed geographically. The administrative burden placed on the research team, as well as the practices, can be considerable. One obvious solution is the development of a computer-based research infrastructure that is integrated as much as possible with the computer system currently in use in the network practices. While the cost of establishing a comprehensive electronic medical record system across an entire network can be prohibitive, the use of less expensive applications, including software upgrades to existing office computers, may be realistic for many PBRNs. The accuracy and comprehensiveness of research data collected by various electronic methods in busy office settings, however, are yet to be tested. Studies are needed that compare the integrity of information gathered electronically to that collected by usual collection methods currently employed by PBRNs. Since clinicians and/or their staff are often involved, if not directly responsible, for recording the research information, much consideration also needs to be given to factors that sustain or reduce their motivation to collect accurate and comprehensive data. Information systems that interfere with the efficiency of providing patient care are unlikely to be acceptable to primary care clinicians or their staff whereas those that save the clinician time or enhance quality of care are likely to be welcomed (Hogg and Lemelin, 1993). Network clinicians may be further motivated to use information systems that assist with prompt and appropriate dissemination of new research evidence and help measure subsequent changes in practice. Data collected as part of PBRN research efforts may be useful in developing benchmarks for network clinician practices and in enhancing collective understanding of strategies intended to accelerate improvements in the processes and outcomes of primary care practice (Wasson, 1997). Access to personal health information is often critical to studies conducted by primary care PBRNs. At the same time, the use of this information raises concerns about privacy (whether participants should provide the data) and confidentiality (how the data may be used later). In recent years, these concerns have intensified as a result of public reports of the disclosure of sensitive, personal information without the knowledge or consent of the individual involved (Institute of Medicine, 2000). Although the large majority of such reports involve non-health related information, numerous policies have been proposed to grant patients significant new rights to understand and control how their health information is used. The federal cornerstone of such policies is the Health Insurance Portability and Accountability Act of 1996 (HIPAA) which provided the U.S. Department of Health and Human Services with the authority to craft regulations to control the flow of sensitive patient information and protect patients privacy and confidentiality. The final regulations, which will come into full effect in two years, have the goal of protecting all medical records and other individually identifiable health information held or disclosed by health plans or health care providers. These regulations are likely to have a significant effect on procedures used by anyone to collect, analyze and report research data, especially patient-level data. The impact may be even more acute, however, on research conducted by PBRNs, since many network studies involve the collection of patient-level data from a variety of practices and a very large number of patients. Often it is not feasible to obtain consent from every patient in a large, geographically dispersed primary care population for every study being conducted, particularly when the data being analyzed were previously collected for some other purpose. At the same time, it is critical that the privacy and confidentiality of research subjects be adequately protected. While institutional review boards (IRBs) will play a key role in dealing with these difficult issues, much is yet to be learned about the knowledge and attitudes of patients and clinicians with regard to appropriate and inappropriate uses of patient-level health information for research purposes. Methodological Considerations All applications must include a plan for the PBRN to administer standardized, network-defining surveys. Guidance on applying to conduct network-defining surveys is provided in the section entitled SPECIAL REQUIREMENTS. In addition, applicants may request funds to conduct special data-related research projects. The special project should focus EITHER on pilot testing of information technology OR an investigation of data privacy and confidentiality issues within PBRNs. Applicants proposing to pilot test methods of electronic data collection in PBRN settings are strongly encouraged to focus on a single information technology. Examples of appropriate technologies include hand-held computerized devices, internet applications, electronic medical record systems, or special modifications of computer-based systems currently being used in practices for billing or administrative purposes. Since limited funding is available for purchasing equipment or software, applicants are strongly encouraged to partner with vendors or other companies that produce or test computer-based technology designed for use in primary care settings. Priority will be given to projects that (1) propose a controlled design, comparing the reliability of an electronic data collection method to the PBRN’s usual method of research data acquisition, and (2) intend to use the standardized survey instruments recommended for network-defining activities (see above) in both experimental and control settings. Evaluative strategies that focus on data quality, including completeness and accuracy of information collected, and the efficiency of the collection process are strongly encouraged. Methods for special projects assessing issues related to data privacy and confidentiality can include (but are not limited to) rigorous qualitative studies or surveys of network patients and clinicians. Potential research questions include, but are not limited to, the following: o To what extent do patients object to the use of their primary care medical records for research purposes? To what extent are these concerns mollified if personal identifiers are removed from the extracted information and only composite results reported? o Under what circumstances would patients provide general consent allowing their clinician to share, for research purposes, any anonymized information from primary care medical records, test results, or data obtained from personal interviews or observations? o Should clinicians always be informed, and their consent requested, when they (the clinicians) are the actual subjects of the research? o To what extent should the clinician be involved in the process of informed consent for research focused on patients under his/her care? SPECIAL REQUIREMENTS FOR NETWORK-DEFINING SURVEYS PBRNs funded to conduct network-defining surveys will be required to work closely with CPCR, which will serve as a Coordinating Center. Grant recipients will be expected to send appropriate representatives to two (two-day) planning and training meetings, to be held in Rockville, MD. Travel and lodging expenses for up to two representatives from each network to attend these meetings will be paid for by AHRQ, and applicants should not include these expenses in their budget requests. Grant recipients will participate, as a group, in Phase I survey activities in close collaboration with CPCR. These activities, to be completed during the first grant recipients meeting, include agreement on the survey instruments to be used in the research, methods for sampling, and procedures for standardized data collection. The survey instruments chosen for this activity, and to be used uniformly by grant recipients, are likely to be adaptations of the instruments used for the National Ambulatory Medical Care Survey (NAMCS), which have the approval of the Office of Management and Budget (OMB). A copy of the 1999-2000 version of the NAMCS instrument is available at the Website of the National Center for Health Statistics, http://www.cdc.gov/nchs/data/ahcd/patrec99.pdf. Two types of subjects will be surveyed: participating network clinicians and a random sample of the patients cared for by these clinicians. Prior to applying, applicants should carefully consider (with the guidance of an appropriate IRB) whether explicit consent is required of both types of subjects and should address this issue in their applications. Phase II survey activities include the actual collection, aggregation, and transmission of survey data by PBRNs. It is expected that PBRNs will contact all clinicians currently enrolled in their network and be able to survey 100% of those willing to participate. Applications should include, in an appendix to the application, a list of the names and practice addresses of those clinicians who have agreed to participate. If the PBRN plans to survey less than 100% of those network clinicians willing to participate, the rationale for this approach should be included in the application, along with a detailed description of the proposed sampling method. Applicants are not expected, however, to provide a plan for random sampling of the patients cared for by participating clinicians, since standard methods for this procedure will be finalized through collaboration during Phase I of the project. The final patient sampling plan will attempt to take into account such factors as practice-to-practice variations in patient volume and seasonal variation in the occurrence of health conditions. The methods proposed by the PBRN to assure that information collected in the surveys is complete and as accurate as possible should be described. While the intent of the survey activities is to provide each PBRN with data that will inform future activities of the network, AHRQ recognizes that funds offered under this initiative are likely to be inadequate to support complete survey data analyses by recipient PBRNs. As the Coordinating Center, CPCR will perform these functions for the PBRNs as part of the Phase III survey activities. At the end of the survey period, each PBRN is to mail one copy of their data, stripped of personal identifiers, to CPCR. Data submitted by each PBRN will be aggregated and analyzed, and summary reports will be provided for individual PBRNs during the second meeting of grant recipients, also to be organized and paid for by CPCR. Applications should include a statement indicating the PBRN’s willingness to cooperate with CPCR in all phases of the survey activities. They should also say what summary data will be most valuable to them and address how the PBRN proposes to use the summary data. (See RIGHTS IN DATA). Data Privacy All information about identifiable individuals or organizations obtained for the research purpose of carrying out a demonstration project supported pursuant to this RFA under AHRQ’s statutory authority is protected by a federal confidentiality statute, section 924 of the Public Health Service Act, 42 USC 299c-3(c). Under this law, the only permissible uses or disclosures of the information are those agreed to by the subject individuals and organizations or by those who supply the information to the researchers. There are substantial statutory penalties (up to $10,000) for improper use or disclosure of this information. Thus, 42 USC 299c-3(c) provides a Federal statutory basis for resisting any Federal or state court order or subpoena to the extent that carrying out the order or subpoena would violate the protective restrictions of the statute. Upon request, AHRQ will provide legal assistance in defending adherence to these statutory confidentiality protections with respect to identifiable data obtained in carrying out Agency research activities. Note that identifiable data obtained by AHRQ-supported researchers is protected by this law when it is obtained to carry out AHRQ-supported research, but this law would not protect against access to this same information in medical records if it were gathered and recorded there for other purposes. If providers collect certain information solely for purposes of this research, it should be so marked and if necessary to protect its confidentiality, kept separately. Note also that this law does not protect or restrict aggregate and nonidentifiable statistical or data analysis and conclusions developed by the researchers that would not disclose information about any identifiable individuals or establishments Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c-3(c)), information obtained in the course of any AHRQ-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the possible uses and purposes of the data collection. In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of such identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf. The application of these confidentiality and security standards to subcontractors and vendors should be addressed as necessary. Rights in Data AHRQ grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a 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 research 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 through the media and other appropriate channels in coordination with AHRQ’s Office of Health Care Information but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. 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). 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 "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 are 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/notice-files/NOT-OD-00-048.html. AHRQ also encourages investigators to consider including children in study populations, as appropriate. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, 42 CFR Part 67 Subpart A, and other HHS, PHS grants administration policie statements. Applicants should be familiar with the Agency’s grant regulations, 42 CFR Part 67 Subpart A, and particularly sections 67.18-67.22. The cooperative agreement (U01) is an assistance mechanism (rather than an acquisition mechanism) in which substantial AHRQ scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the AHRQ purpose is to support and/or stimulate the recipient’s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. 1. Awardee Rights and Responsibilities Those organizations awarded grants to conduct network-defining surveys have the responsibility for assuring that the appropriate representatives attend both working meetings organized by CPCR, recruiting network clinicians to participate in the survey, distributing survey materials to practices, instructing practice staff on the proper administration of the patient-level surveys, gathering and assuring the completeness of data recorded on survey instruments, making a copy of the survey data from which personal identifiers have been removed, and mailing that data to CPCR. Awardees will be required to accept and implement the common protocol and procedures agreed upon collaboratively. Awardees of grants to pilot test a computer-based technology or to assess data confidentiality and privacy issues have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish the results, interpretations, and conclusions of their studies. 2. AHRQ Staff Responsibilities In working with awardees who conduct network-defining surveys, AHRQ Program Official(s) will have substantial scientific and programmatic involvement in designing the general survey protocol, training network staff to administer surveys, and analyzing and reporting survey data. The dominant role and prime responsibility for pilot testing computer- based technology or assessing data confidentiality and privacy issues resides with the awardee(s) for the project as a whole, although the AHRQ Program Official(s) will have substantial scientific involvement through technical assistance, advice and coordination above and beyond normal program stewardship for grants. AHRQ reserves the right to terminate or curtail the study (or an individual award) in the event of substantial shortfall in participant recruitment, non-participation in required collaborative meetings, inadequacies in data reporting, quality control, or other major breach of the agreed-upon protocol. 3. Collaborative Responsibilities In conducting network-defining surveys, awardees will share responsibility with AHRQ Program Official(s) in selecting and refining survey instruments and in developing specific survey and sampling protocols. Awardees of projects to pilot test computer-based technology or assess data confidentiality and privacy issues will share with AHRQ Program Official(s) the responsibility of communicating to other awardees their intended research design and methods. It is hoped that the sharing of ideas and methods among awardees will allow for collaboration of efforts, when appropriate. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and AHRQ may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the individual awardee, a second member selected by AHRQ, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Applicants are encourage 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. 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. Beginning with applications submitted for the February1, 2001 receipt date, Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an 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). Given the nature of this project and the speed with which successful applicants will need to begin work, however, AHRQ has determined that IRB approval is required prior to peer review of applications submitted in response to this RFA. All investigators/applicants proposing research involving human subjects should pay particular attention to the instructions in the form PHS 398 regarding human subject involvement. Applications kits are available at most institutional offices of sponsored research. They may also be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail: grantsInfo@nih.gov. AHRQ applicants are encouraged to obtain application materials from the AHRQ Publications Clearinghouse (see INQUIRIES). The RFA label and line 2 of the application form PHS 398 (rev. 4/98) should both indicate RFA number. The RFA label must be affixed to the bottom of the face page. 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 also be typed on line 2 of the face page and the YES box must be marked. The sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Application Preparation The following supplemental instructions to the form PHS 398 should be used to guide the preparation of the cooperative agreement application: 1) In the Abstract ( Description, page 2), indicate if funds are requested to conduct a special data-related research project in addition to the request to administer network- defining surveys. 2) 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 surveys and research activities should be attached to the application as an appendix. Include Multiple Project Assurance (MPA) of Federalwide Assurances (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. 3) Detail Budget. If the applicant is proposing to conduct a data- related research project in addition to administering network-defining surveys, a separate budget request on a separate budget sheet should be included for each activity. Budget requests to administer network-defining surveys should not exceed $50,000 total costs (direct plus facilities and administrative costs). In general, allowable budget items for this activity include salary support for key administrative and clerical personnel, any required travel to and from network practices, telephone costs, copying, mailing and other justifiable operating expenses. Since CPCR will provide expertise in survey methodology to all successful applicants (during Phase I survey activities), requests for personnel or consultation services for this purpose will not be considered. Since travel and lodging expenses for up to two network representatives to attend the planning and training meetings in Rockville, MD will be paid for by AHRQ, these expenses should not be included in the budget request. Requests to cover the travel expenses of additional team member(s) to attend the meetings are allowable, but the application must justify the PBRN’s need for more than two representatives at these meetings. Budget requests to conduct a special data-related research project should not exceed $100,000 total costs (direct plus facilities and administrative costs). For applications proposing to pilot test technology in the PBRN, modest requests for the purchase of software or computer hardware are allowable, although these costs should not supplant funds required for evaluation activities. In-kind contributions of the applicant organization or its partners (including technology vendors or other commercial groups) should be acknowledged. For applications proposing to assess data privacy and confidentiality issues, requests for equipment are discouraged. The maximum budget request allowable from one applicant organization under this RFA is $150,000 (direct plus facilities and administrative costs). 4) Biographical Sketches. If different individuals will be serving as the Principal Investigator and the director of the PBRN, include a biographical sketch of each, as well as sketches of other key personnel to be involved in the project. 5) Research Plan. This narrative part of the application is limited to twenty-five pages of text which should be organized into sections, as follows. Sections I and II are required of all applicants. Section III is required of applicants proposing to conduct a data-related research project. Section I. The PBRN and Progress to Date on Planning Activities a) Briefly describe the PBRN, including any changes that have occurred in the leadership or infrastructure of the network, and any practices or clinicians added to the network since April, 2000. b) Describe and discuss the PBRN’s progress to date in achieving the planning goals and objectives proposed in the original (P20) application to AHRQ for a planning grant. This section should include a summary of any research begun or completed since April, 2000, including sources and amounts of funding received for the research. A list of articles (if any) resulting from PBRN research and published since April, 2000, should be included either in the text or as an appendix and referenced in this section of the application. Section II. Network-Defining Surveys a) Describe previous network experience (if any) in conducting clinician-level or patient-level surveys. Discuss potential challenges to the successful administration of surveys in the network and proposed methods of overcoming these obstacles. b) Document the ability to recruit a sufficient number of network clinicians to participate in the survey activities. The network staff to be involved in the project should also be identified, including a description of their qualifications. c) Describe the potential uses and importance of network-defining survey data to the PBRN. d) Describe plans to accommodate all requirements outlined in the Special Requirements section of the RFA. A statement should be included indicating the PBRN’s willingness to follow the common protocol that will be agreed upon in Phase I and to cooperate with CPCR staff in all phases of the survey activities. Section III. Special Data-Related Research Project (if applicable) a) Applicants proposing to pilot test computer technology for gathering PBRN data should discuss the rationale for their choice of the technology, describe the technology in terms that are easily understandable to the average practicing clinician, and describe the office settings in which it will be assessed. Previous experience using the same or similar information technology, by the applicant or others, should be described as well as the proposed evaluation strategy. The team members (or consultants) who will provide the necessary expertise in computer technology and evaluation should be identified, including a description of their qualifications. If the effort is to involve a collaboration with a vendor or other commercial company, that relationship should be addressed, and a letter from the research partner included indicating the company’s level of commitment to the research. b) Applicants proposing projects to assess data privacy and confidentiality issues in PBRNs should explain how the research questions to be addressed relate to proposed HIPAA regulations. If the project also relates to specific concerns that have arisen out of research activities within the applicant’s PBRN or other ambulatory health care settings, those concerns should be described. The application should include a description of how answers to the questions being posed may impact on future research efforts by the network. A complete and signed, typewritten original of the application, including the Checklist, and three signed photocopies, must be submitted 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 Advanced Copy (s) must also be sent 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 E-mail Address: dlanier@ahrq.gov Applications must be received by April 13, 2001. An application received after the deadline may be acceptable if it carries a legible proof-of-mailing date, assigned by the carrier, and the proof-of-mailing is not later than 1 week prior to the deadline date. If an application is received after that date, it will be returned to the applicant without review. In carrying out its stewardship of assistance 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 sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications or the impact from Agency sponsored research. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete but are not responsive to the 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 by the AHRQ in accordance with the review criteria stated below. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the objectives of the RFA. Although the technical merit of the proposed project is important, it will not be the sole criterion for evaluation of a study. Other considerations, such as importance and timeliness of the proposed study and access to subjects will be part of the evaluation criteria. General Review Criteria Applications will be assessed in two general areas: 1) technical merit of the proposal; and 2) potential of the PBRN to complete the proposed activities successfully. Peer reviewers will be asked to offer specific comments in these two areas, and final priority scores will reflect the peer reviewer’s overall assessment based on their judgements of the two review areas. 1. Technical merit of the proposal a) Clarity of project goals and objectives, and the extent to which they are consistent with the goals and objectives described in the RFA; b) Appropriateness of the proposed project to the PBRN’s level of development and prior research experience; c) Extent to which the application defines potential problem areas facing the PBRN in carrying out the proposed activities, and appropriateness of methods proposed to overcome these barriers; d) Qualifications and appropriateness of the key personnel designated to direct and conduct the activities. 2. Potential of the PBRN to complete the proposed activities successfully. a) Adequacy of clinicians committed to participate in the activity, or the adequacy of the patient population served by those clinicians; b) Adequacy and stability of the PBRN’s administrative, organizational and management capabilities; c) Evidence of institutional or other support; and d) Extent to which a one-year timeline is realistic for the PBRN to complete the activities being proposed. Special Review Criteria 1. The following additional special merit criteria are directed to proposals to administer network-defining surveys: a) Extent to which the application demonstrates an understanding of the proposed survey activities outlined in the RFA; b) Adequacy of PBRN plan to insure integrity of data collected through surveys; and c) Applicant’s commitment to participate and collaborate with CPCR in all phases of the survey activities. 2. The following special merit criteria are added for applicants who propose to pilot test office-based information technology: a) Extent to which the PBRN provides an appropriate testing site for the proposed information technology; and b) Extent to which the applicant intends to compare the new technology to usual methods of data collection in the PBRN, using standardized surveys in both arms of the project. 3. The following special merit criteria are added for applicants who propose to assess data confidentiality and privacy issues: a) Significance of the questions to be addressed. Are answers to these questions likely to advance understanding of best methods for PBRNs to use in protecting rights of data privacy and confidentiality? b) Adequacy and appropriateness of proposed research methods and analytical plan. The initial review group will also examine: the appropriateness of proposed project budget; the adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human subjects; and the safety of the research environment. AWARD CRITERIA No more than one award will be made to each successful applicant PBRN, and no award will exceed $150,000 total costs (direct plus facilities and administrative costs). The intent of this RFA is to continue funding those technically and scientifically meritorious applications unless these is reason to question the applicant’s willingness to participate in cooperative activities. Proposals to conduct special data-related research projects will compete for available funds with all other applications under this RFA. The following criteria will be considered in making these funding decisions: 1) quality of the proposed project as determined by peer review; 2) availability of funds; and 3) program balance with respect to the types of information technology being tested, data privacy/confidentiality questions being addressed, geographical location of PBRN, and study populations being targeted. INQUIRIES Copies of the RFA and copies of the grant application form PHS 398 (rev. 4/98) are available from: AHRQ Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907-8547 Telephone: 1-800-358-9295 TDD Service: 888-586-6340 The RFA is also available on AHRQ’s Web site, http://www.AHRQ.gov, and through AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The 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. AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the RFA. Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries 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 Direct inquiries regarding fiscal and eligibility matters to: George Skip Moyer Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1842 FAX: (301) 594-3210 Email: smoyer@AHRQ.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 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 Nutting PA, Beasley JW, Werner JJ. Practice-based research networks answer primary care questions. Journal of the American Medical Association 281:686-8, 1999 Green LA. The history of PBRNs: the establishment of practice-based primary care research networks in the United States. In: Practice-based research networks in the 21st century: the pearls of research. Proceedings from the conference convened by the AAFP Task Force to Enhance Family Practice Research. Leawood, Ks: American Academy of Family Physicians, 1999 Hogg WE, Lemelin J. Realizing the research potential of the office computer. In: Conducting research in the practice setting. Newbury Park: Sage Publications, 1993 Wasson JH, Jette AM, Johnson DJ et al. A replicable and customizable approach to improve ambulatory care and research. Journal of Ambulatory Care Management 20(1):17-27, 1997 Institute of Medicine. Protecting data privacy in health services research. Washington, D.C.: National Academy Press, 2000

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