Small Research Grants for Primary Care Practice-Based Research Networks (PBRNs)

RFA Number: RFA-HS-05-011

Part I Overview Information

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Center for Primary Care, Prevention, and Clinical Partnerships (CP3), http://www.ahrq.gov

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

Update: The following update relating to this announcement has been issued:

• November 5, 2004 (NOT-HS-05-002) - This Notice is to inform potential applicants of a change in receipt dates for RFA-HS-05-011.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release Date: October 28, 2004
Letters Of Intent Receipt Date(s): January 18, 2005
Application Receipt Dates(s): February 18, 2005
Peer Review Date(s): March 2005
Earliest Anticipated Start Date: July 1, 2005
Expiration Date: February 19, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary

Through the Small Research Grants for Primary Care Practice-Based Research Networks (PBRNs) RFA, AHRQ will support new and emerging PBRNs in the conduction of exploratory/pilot projects or feasibility studies. This RFA will use the R03 award mechanism. AHRQ intends to commit approximately $1,000,000 in FY05 to fund approximately ten new grants in response to this RFA.

Any domestic institution affiliated with a primary care PBRN may submit an application if it is included in any one of the following categories: Public and private non-profit organizations, such as universities, hospitals or clinics, and professional associations; units of state and local government; eligible components of agencies of the Federal Government; tribes and tribal organizations; and eligible faith-based and community-based organizations. For the purpose of this RFA, AHRQ will make grants only to non-profit organizations. 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.

Applications must be prepared using the PHS 398 research grant application form (rev. 5/2001). The instructions found in this RFA supercede the instructions for the PHS 398. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.

Telecommunications for the hearing impaired: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
A. Cooperative Agreement Terms and Conditions of Award
3. Award Criteria
4. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations and References

Part II - Full Text of Announcement

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. PBRNs that have yet to be awarded an R01-level (or equivalent) research grant are especially encouraged to apply. 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.

AHRQ is particularly interested in studies that explore (1) network strategies for assuring that research evidence is translated into actual practice and that its impact is assessed, (2) optimal methods of delivering preventive services and managing chronic diseases in primary care settings, (3) innovations in improving quality and ensuring safety in primary care practice, (4) strategies to decrease health and health care disparities including those that incorporate the methods of community-based participatory research, (5) methods for improving systems capacity and responses to emerging public health threats, including acts of bioterrorism, and (6) innovative uses of information technology in primary care practices.

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.

Authorities and regulations under which these grants will be funded are described in Section VIII.

1. 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 provided support for primary care PBRN research efforts and infrastructure development through a series of grant solicitations. In 2000-2001, nineteen networks were given awards for planning and infrastructure development efforts. The next year, AHRQ provided funds through RFA-HS-02-003 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. In 2003, AHRQ awarded eight small research grants to PBRNs for exploratory and feasibility studies through RFA HS-03-006. The current RFA renews AHRQ's support to networks for conducting exploratory/pilot projects and feasibility studies, although this solicitation is primarily directed to new and emerging primary care PBRNs. More established networks are encouraged to submit applications to AHRQ in response to PAR-04-041, for projects to evaluate strategies to translate evidence into sustainable improvements in clinical practice and outcomes.

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, 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 (Lindbloom, 2004).

A 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. This initiative primarily is intended to support PBRN efforts to refine innovative research questions derived from primary care practice, especially as they relate to improving the quality and safety of practice. Work supported by this initiative may provide important information about the feasibility of data collection in network practices, data that is critical to larger, related projects potentially fundable both by AHRQ and the National Institutes of Health (Sung, 2003). Strengthened with the results of preliminary and exploratory studies, primary care practice-based research networks should be better positioned to compete for funds that will allow them to continue to make significant contributions towards improving the quality, safety, efficiency, and effectiveness of health care for all Americans.

An additional critical element to the sustained success of any PBRN is an infrastructure that not only serves research but also coordinates diverse network activities, including recruitment and retention of practices, quality improvement efforts, network communications, and the translation of research into practice. A secondary aim of this grant program is to assist new and evolving PBRNs in developing and maintaining such network infrastructure.

Methodological Considerations

Funds available through this RFA provide PBRN investigators the opportunity to explore the feasibility, as well as the development, of projects investigating issues important to primary care practice, and to generate preliminary data. The funds are not intended to supplement ongoing research or to support large-scale undertakings or analyses of secondary data sources. 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. 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, multi-method 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;

o optimal methods of delivering preventive services, managing chronic diseases, and providing care for people with disabilities in primary care settings;

o innovations in improving quality and ensuring patient safety in primary care practice;

o elucidation of primary care-based strategies for diminishing disparities in health care delivery and health outcomes for AHRQ priority populations, including projects that incorporate the methods of community-based participatory research. AHRQ priority populations include: women, children, the elderly, minority communities, low-income populations, people living in inner cities, rural, and frontier areas, and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care;

o methods for improving primary care system capacity and responses to emerging public health threats, including acts of bioterrorism; and,

o innovative uses of information technology in primary care practices.

Section II. Award Information

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review.

2. Funds Available

AHRQ intends to commit approximately $1 million in FY 2005 to fund ten new grants in response to this RFA. If additional funds become available, AHRQ reserves the option to fund additional grants under this RFA. Budget requests for the full period of support may not exceed $100,000 in total costs (i.e., direct costs plus facilities and administrative costs) for the entire project period. Grant support should not exceed 24 months. 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.

Section III. Eligibility Information

Any domestic institution affiliated with a primary care PBRN may submit an application if it is included in any one of the following categories:

• Public or private non-profit institutions, such as universities, clinics, colleges, and professional associations
• Units of State government
• Units of local government
• Eligible Agencies of the Federal government
• Faith-based and community-based organizations
• Tribes and Tribal 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 members of consortia or as subcontractors. Organizations described in sections 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

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 always encouraged to apply for AHRQ programs.

2. Cost Sharing
AHRQ does not require cost sharing for applications submitted in response to this RFA.

3. Other-Special Eligibility Criteria

Applications will be accepted from any primary care PBRN that meets or surpasses the criteria indicated in the Qualifications section (below), 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. However, this RFA is primarily designed to support the development of new and emerging PBRNs, and funding preference will be given to networks that have not received R01-level funding from AHRQ or NIH.

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). Additionally, applications must provide a complete funding history of the network including a listing of funded projects, funding source, and funding amounts.

Applications must comply with the above special requirements as well as the Qualifications described below 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. Funded applicants will be able to request consultative services from the PBRN Resource Center, although successful completion of the proposed project should in no way be contingent upon the receipt of such services.

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 within the network. Background literature and a rationale for the research question must be provided. 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 must develop and present a rigorous plan for research and data analysis. 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 a 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.

Section IV. Application and Submission Information

State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 07/00), and follow those requirements for copy submission. You can obtain this form from http://www.psc.gov/forms/PHS/phs.html. 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.

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsections III.3 and VI.2. for additional information.

SUPPLEMENTARY 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 Federal-Wide Assurance (FWA), if known. Applicants not having a Human Subjects Assurance should refer to the OHRP website http://www.hhs.gov/ohrp 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. Specific budget items must be related to the project, but may serve a purpose towards network development that exceeds the scope and duration of the project.

3) Biographical Sketches. A biographical sketch (short professional bio) 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:

o Section I. The Practice-Based Research Network (not to exceed five pages)

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 reliable information, if available, 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 Other-Special Eligibility Criteria , Qualifications (section III.3). A complete description of the funding history of the PBRN (list of each grant or contract by name, its source of funding, and amount of funds awarded) must be included, either in this section or as an appendix to the application.

b) Current institutional and 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

c) Network director and staff. The PBRN director and any network support staff should be identified, and their network roles and qualifications briefly described.

d) This section should also include a description of the mechanism used for obtaining advice and feedback from the patient communities served by the network practices.

o 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 within 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 how it may be generalizable to primary care practice.

b) Methods. A rigorous research plan must be presented, even if the purpose of the project is primarily hypothesis generating. 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. Include here (or in a separate section) a description of the plan proposed to assure that human subjects will be protected in the course of this project, including protection of the confidentiality of personally identifiable data. See applicable confidentiality statute at 42 USC 299c-3 c and d.

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. Briefly describe the training and experience of the principal investigator (and any co-investigators) that specifically qualify him/her to carry out the proposed project.

3. Submission Dates

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date(s): January 18, 2005
Application Receipt Dates(s): February 18, 2005
Peer Review Date(s): March 2005
Earliest Anticipated Start Date: July 1, 2005

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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 IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Natalie Alter
Center for Primary Care Research
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1569
FAX: (301) 427-1597
Email: NAlter@ahrq.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all appendices must be sent to:

Natalie Alter
Center for Primary Care Research
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1569
FAX: (301) 427-1597
Email: NAlter@ahrq.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

The NIH & AHRQ will not accept any application in response to this funding opportunity 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 a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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. It is very important to note that limitations on number of pages and size of font must be observed; applications violating these requirements will be returned without review.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an AHRQ application. The AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

The RFA is also available on AHRQ's Web site, http://www.AHRQ.gov, (see under Funding Opportunities).

4. Intergovernmental Review

This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/gps/index.html (See also Section VI.3. Award Criteria.)

6. Other Submission Requirements

o Priority Populations

The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) reauthorized the Agency and directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. To implement this directive, AHRQ published a notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this RFA should address the requirements of including priority populations as specified in the Notice.

o Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees and/or contractors are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will take place in close coordination with OCKT and the press offices of the grantee's or contractor's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

o HCUPS & MEPS

Applicants are encouraged to make use of AHRQ'S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP inpatient databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP databases include: the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of over 1,000 hospitals, the Kids' Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states. More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, noninstitutionalized population. MEPS comprises three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.

This does not preclude the use of secondary data sources or primary data collection.

o Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. In consultation with CMS, previously called Health Care Financing Administration (HCFA), AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ's confidentiality statue, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under INQUIRIES.

o Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, the AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency-sponsored research. Applicants are to agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

To receive an award, applicants must agree to submit an original and two copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (Word Perfect, or Word, or ASCII format).

The past cooperation of applicants with regard to the submissions described in this section may be considered in the application review to assess applicants' potential for responsible stewardship of awarded funds.

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 using Form Page 4 (Detailed Budget for Initial Budget Period) and Form Page 5 (Budget for Entire Proposed Period of Support). Applications submitted in the Modular format will be returned without review.

1. Criteria

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness. Merit Review Criteria are described in section V.3 below.

2. Review and Selection Process

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. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration.

3. Merit Review Criteria

As part of the merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score.
• Receive a written critique

In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the scientific merit of the proposed project and the potential of the PBRN to complete the proposed activities successfully: The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application.

1. Technical merit of the proposal

o Approach

o Significance

o Innovation

o Investigator

2. Potential for success

o PBRN readiness

o Scope of work

o Environment

o PBRN sustainability

The application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Technical merit of the proposal

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?

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?

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?

Investigator: 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

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?

Scope of work: Is the proposed work appropriately 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?

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?

PBRN sustainability: How will completion of this project advance the mission and research capabilities of the PBRN and contribute to the PBRN's sustainability? How well will completion of this project prepare the PBRN for future research and funding success?

3. A. Additional Review Criteria:

In addition to the above criteria, your application will also be reviewed with respect to the following:

Protection: 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.

Inclusion: The adequacy of plans to address the needs of both genders, 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.)

3.B. Additional Review Considerations
Not Applicable

3.C. Sharing Research Data

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 protected health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) became mandatory for covered entities on April 14, 2003. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, for example, health care plans, will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) satisfied that any identifiable health information will be appropriately safeguarded by the investigators. The HHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/

The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

3.D. Sharing Research Resources

Rights in Data

Section VI. Award Administration Information

After the peer review of the application is completed, the Principal Investigator will receive a written critique called a summary statement.

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Notification will be made electronically to the designated administrative/institutional official.

2. Administrative Requirements

All AHRQ grant and cooperative agreement awards are subject to the terms and conditions of the Public Health Service (PHS) Grants Policy Statement as part of the notice of grant award, found at http://grants1.nih.gov/grants/policy/gps/index.html. For terms of the award, see http://grants1.nih.gov/grants/policy/gps/5award.htm#terms, and see http://grants1.nih.gov/grants/policy/gps/5award.htm#fund for the award and funding process.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator, as well as to the appropriate institutional official, at the time of award.

3. Award Criteria

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Program balance across funded PBRN activities with respect to type and focus of investigations

4. Reporting

Project Monitoring Requirements

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually: http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the PHS Grants Policy Statement.

Section VII. Agency Contacts

1. Scientific/Research Contacts:

Direct your questions about scientific/research issues, including information on the inclusion of women, minorities, and children, and other priority populations in the study to:

David Meyers, M.D.
Center for Primary Care Research
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1634
FAX: (301) 427-1595
Email: DMeyers@ahrq.gov

2. Peer Review Contacts:

Direct your questions about peer review issues to:

Carl Ohata, Ph.D.
Health Scientist Administrator
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1549
FAX: (301) 427-1547
Email: cohata@ahrq.gov

3. Financial or Grants Management Contacts:

Direct your questions about financial or grants management matters to:

George Gardner
OPART / Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1453
Fax Number: (301) 427-1462
Email: GGardner@ahrq.gov

Section VIII. Other Information

It is the policy of AHRQ that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES).

AHRQ also encourages investigators to consider including children in study populations, as appropriate.

Public Access to Research Data through the Freedom of Information Act:

The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal act is taken, having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data is not subject to this disclosure requirement. Furthermore, even if a Federal regulation action is taken in reliance on AHRQ-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if it constituted trade secrets or commercial information collected. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this RFA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) issued the last modification the "Standards for Privacy of Individually Identifiable Health Information", was mandated by the "Privacy Rule," on August 14, 2002. This regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). Mandatory compliance with the Privacy Rule (for those classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply).

Decisions about applicability and implementation of the Privacy Rule reside with covered entities. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff of a covered entity. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/, 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.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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

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.

Lindbloom EJ, Ewigman BG, Hickner JM. Practice-based research networks: the laboratories of primary care research. Med Care. 2004 Apr;42(4 Suppl):III-45-9.

Nutting PA, Beasley JW, Werner JJ. Practice-based research networks answer primary care questions. JAMA 1999;37:1092-1104.

Sung NS, Crowley WF Jr, Genel M et al. Central challenges facing the national clinical research enterprise. JAMA 2003 Mar 12;289(10):1305-6.

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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