and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Issuing Organization
Agency for Healthcare Research
and Quality (AHRQ), (http://www.ahrq.gov)
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, (http://www.ahrq.gov)
Title: Research Centers in Primary Care Practice Based Research and Learning (P30)
Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.
Announcement Type
This Funding Opportunity Announcement (FOA) is a new FOA .
Request For Applications (RFA) Number: RFA-HS-12-002
Catalog of Federal Domestic Assistance
Number(s)
93.226
Key Dates
Release Date: November 28,
2011
Letters of Intent Receipt Date(s): January 6, 2012
Application
Receipt Dates(s): January
26, 2012
Peer
Review Date(s): approximately
three months after receipt date
Earliest Anticipated Start Date: approximately
three to four months after peer review
Additional
Information To Be Available Date: Not applicable
Expiration Date: January 27, 2012
Due Dates
for E.O. 12372
Not
Applicable
Additional Overview Content
Executive Summary
While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.
It is critical that applicants follow the instructions in the PHS 398 application guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
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 or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
B. Submitting an Application
to AHRQ
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section VI. Award
Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. 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
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The Agency for Healthcare Research and Quality (AHRQ) solicits applications for Center Core grants (P30) to support Centers of Excellence in Primary Care Practice-Based Research and Learning. Centers will provide infrastructure and promote clinical, behavioral and translational research activities consistent with AHRQ priorities. Applications must consist of a primary organization with a consortium of 3 or more regional PBRNs (including one affiliated with the primary organization) or a national PBRN that meets the criteria described below. Centers will foster synergy and improve coordination of research, support emerging research opportunities, and promote efficiencies through resources shared by multiple independent PBRNs or a National Research Network. The Center will provide the support necessary to permit the consortium of PBRNs or the national PBRN to be more competitive for subsequent research awards.
An application that proposes a Center based on a consortia must include 3 or more individual PBRNs with a combined membership of 120 or more member primary care practices. A ‘member practice’ is considered to be a primary care practice that has contributed data to a research study within the past five years and is devoted primarily to patient care activities. The PBRNs in the consortia must span at least two distinct primary affiliation organizations. At least three of the PBRNs in the consortia should be well established with a track record of funded research grants resulting in peer-reviewed publications.
For the purposes of this FOA, a ‘national network’ is defined as a PBRN with at least 120 member practices located in at least 10 different U.S. states.
For purposes of this application primary care is the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients without regard to gender, and practicing in the context of family and community.
Throughout this FOA, the terminology used for P30 applications from either Consortiums or National PBRNs is "Center applications" and the corresponding terminology for P30 awards to support each is "Center awards." "Core" or "core facilities" are defined as entities providing services or expertise. All eligibility requirements and specific descriptions provided in this FOA for PBRN consortia also apply to the national PBRN applications.
The purpose of this FOA is to support infrastructure activities. Infrastructure components that are allowed include personnel, limited local travel, meeting expenses, and limited computer hardware and software.
The Centers funded under this FOA will be eligible for limited-competition AHRQ funding opportunities (see Justification below, Section II.4). It is expected that funded Centers will respond to limited-competition rapid-cycle AHRQ funding opportunities to conduct research. These FOAs are expected to provide rapid-turnaround results and findings to AHRQ within 12 to 36 months. AHRQ expects to utilize both R and U mechanisms for these limited competition FOAs including, but not limited to, R03, R21, R18 and corresponding U mechanisms.
Background
AHRQ is authorized to employ research strategies and mechanisms that link research directly with clinical practice in geographically diverse locations, including the use of provider-based research networks, especially (in) primary care. 42 U.S.C. § 299b(b)(1). In addition, the agency is authorized to conduct and support research on disparities in the quality, outcomes, cost and access to health care for various segments of the U.S. population, through the implementation of research strategies and mechanisms that specifically include primary care practice-based research networks (PBRNs). 42 U.S.C. § 299a-1.
AHRQ has defined a PBRN 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. Between 2000 and 2005, AHRQ funded 4 major competitive grant programs for PBRNs. From 2007 through 2012, AHRQ funded PBRN research through a Master Contractor Task Order mechanism. AHRQ has also supported PBRNs through a national resource center, an annual national conference, peer learning groups, an electronic PBRN research repository, and a secure web-based PBRN portal. AHRQ has provided direct funding for more than 68 PBRNs through targeted grant and contract programs, and has provided technical and networking assistance for many more. In 2011, over 130 primary care PBRNs are registered with the AHRQ funded PBRN Resource Center. (www.pbrn.ahrq.gov )
Much of the early work of PBRNs provided descriptions of the content and practice patterns of primary care, while more recent research from a few networks has included implementation research, comparative effectiveness studies and randomized clinical trials. The emerging body of research by PBRNs demonstrates the capacity and ability of these networks to link relevant clinical questions with rigorous research methods in community settings to produce important scientific information that not only is externally valid but, in theory, is more easily assimilated into everyday practice.1 Although a few PBRNs are national in scope, the majority are local or regional in nature. Some exist within the organizational structure of professional associations, others exist within academic departments, and others are independent organizations.
Challenges Faced by PBRNs
Although primary care PBRNs are ideally positioned to conduct relevant research in real-world settings, they continue to face a number of challenges, many of which are described below.
A Supportive Infrastructure
Most, if not all, primary care PBRNs share the challenge of sustaining an infrastructure capable of recruiting, engaging and retaining participating practices, maintaining resources that support data collection and other research activities across widely dispersed practice locations, dissemination of research findings to members who participate in studies, and the resources necessary to generate fundable research proposals. Although there is considerable variation in the status of current PBRN infrastructural support, few have significant sustainable funding from any academic institution or other organization. All appear to rely heavily on volunteerism for central staff support and the cooperation of participating practices and investigators. Much of the core infrastructure required to maintain a viable research network of primary care practices centers around the personnel, supplies and travel required to engage member clinicians in a sustainable partnership.
Clustering of Data
A second, commonly under-recognized challenge of PBRN research is the issue of clustering or nesting of data within practices of PBRN members. Clustering arises when interventions are randomized to groups of individuals (such as to practices, clinics, or physicians) and there is variation both within and between practices (or clinics or physicians) in the way patients are treated. Clustering also occurs when outcomes for individuals within a given PBRN practice are more similar than those across PBRN practices. If clustering is ignored, the chance of a false positive (that is, concluding that an intervention works when it does not) can be very large, often greater than 50%, calling into question the validity of the results from any intervention study done in a PBRN setting. For example, given a common values for the intra-class cluster coefficient (ICC) (0.03), if a PBRN study has only 10 treatment and 10 control practices, the Minimum Detectable Effect (MDE) of an intervention may be as high as 66% when measured among all patients. MDEs fall as the number of practices increase, but even a study with 100 treatment practices may have MDEs as high as 20%. Without a substantial number of member practices to draw from, PBRNs are unlikely to have the ability to conduct a study with a reasonable MDE, usually 5-10%. Thus AHRQ is interested in using this Center grant to support a larger infrastructure of practices affiliated with each Center (see II. 3.d. below). Responsive applications must address both the number and diversity of practice settings available for research studies.
PBRN Researchers/Investigators
Although ideally suited to conduct research in “real-world” settings, some PBRNs struggle with maintaining a consistent stream of funded research. Many/most PBRNs are affiliated with an academic health center (AHC). These AHCs often have investigators who are trained in research methods that are not always well- suited for the PBRN environment. In addition, some PBRNs have had the experience of being approached by an academic investigator 1 or 2 weeks before an application deadline with a request for a letter of support to conduct their research protocol in the PBRN. PBRNs need academic investigator partners who are sensitive to the participatory nature of PBRN research and who can adapt study designs to meet the needs of busy primary care practice settings.2
Special Requirements
Each Center must be comprised of two cores: an administrative core, and a research core.
The administrative core must consist of, at a minimum, a Center Director and a Center Coordinator. The administrative core will be responsible for member recruitment and retention activities. It will also be responsible for dissemination and communication activities as well as facilitating learning activities across the member practices. The administrative core will allow for coordination among individual networks in a Center that brings together multiple networks.
The research core must consist of personnel with an appropriate background and experience in PBRN-specific research methodologies. They will provide core expertise to develop new projects, conduct research, and analyze and evaluate findings. They will also be responsible for outreach and educational activities to funded academic investigators potentially interested in partnering with the PBRN for future funded research.
During the project period, each Center must develop their infrastructure in two key areas as described below:
Implementation/Learning
By their nature, PBRNs often serve as informal structures where members not only acquire new knowledge, but adopt new practice behaviors as a result of their contact with each other and their participation in research studies. AHRQ is particularly interested in supporting a PBRN infrastructure that would accelerate both the generation of new knowledge and the implementation of knowledge back into the primary care practice setting in a manner that improves quality, patient safety and effectiveness of care. Responsive applications must address strategies to accelerate the implementation of new research knowledge into actual practice within the PBRNs through learning activities. The proposal should include novel/innovative dissemination and implementation strategies that the network has used successfully in the past or could be capable of using in the future and method of documenting or describing this activity and its results. Examples of diffusion strategies might include, but are not limited to: learning collaboratives, local peer champions, a cooperative extension agent model, academic detailing, and social media, in addition to more standard techniques including newsletters and websites.
Development of Funded Research
Responsive applications must include a description of plans for developing a cadre of PBRN investigators. These plans might include, but are not limited to: outreach and training seminars for currently funded academic investigators within affiliated academic health centers, work within institutional training programs to develop a cadre of junior investigators who will develop their own funded research, or partnering with other Centers or outside investigators for funded research. These plans might also include an assessment of the PBRNs capacity to employ research methodologies that are needed by a cadre of investigators who would work within the PBRN. This assessment should also include strategies to address these needs.
Plans and Justification for future Limited Competition Opportunities
This FOA provides no funds for specific research projects. Funds are intended to strengthen the research and dissemination/implementation infrastructure of the PBRNs. It is expected that as a result of the cohesive infrastructure and resources provided through P30 funding, Centers will begin to address the challenges faced by PBRNs and thus be better positioned to successfully conduct rapid cycle research in primary care settings and be responsive to limited competition AHRQ funding opportunity announcements. It is expected that Centers will develop the capacity to respond rapidly (often within 30 days) to FOAs and be able to begin research projects quickly after receiving an award. Additionally, AHRQ expects that the Centers will have expertise in successfully conducting primary care practice-based research and that they will build upon their expertise through on-going learning providing increasing value over time. It is also expected that Centers will be better positioned to compete for open competition research funding from AHRQ and other funders.
See ‘Section VIII: Other Information – Required Federal Citations’ for policies related to this announcement.
References
1. Westfall, J.M., Mold JW, Fagnan,Lyle. Practice-Based Research:"Blue Highways" on the NIH Roadmap. JAMA. 297: 403-406. 2007
2. Westfall JM,
Fagnan LJ, Handley M, Salsberg J, McGinnis P, Zittleman LK, Macaulay AC. Practice-based research is
community engagement. J Am Board Fam Med 2009;22:423-7.
1. Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the AHRQ Research Center Core Grant (P30) award mechanism. The individual researcher sponsored by each organizational grantee will be solely responsible for planning, directing, and executing his or her proposed projects.
AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.
2. Funds Available
AHRQ intends to commit up to $600,000 in total costs in FY 2012 to fund up to 5 Centers in response to this FOA. AHRQ intends to fund no more than 2 awards for national PBRN Centers. Applications may be up to 5 years in duration with a budget supported by AHRQ not to exceed $120,000 per year in total costs to the government. Applications with project periods that exceed 5 years or budgets that exceed $120,000 total costs in any given year will not be reviewed. Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the annual progress report (currently the PHS 2590).
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.
Section III. Eligibility Information
1. Eligible Applicants
You may submit an application(s) if your institution/organization has any of the following characteristics:
AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. A minimum of 10 percent effort must be devoted to the Center by the Center Director. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.
2. Cost Sharing or Matching
While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.
3. Other-Special Eligibility Criteria
Number of Applications. AHRQ will not accept more than one application from the same applicant institution. In addition, AHRQ will not accept similar grant applications with essentially the same research focus from different applicant organizations if the membership of the consortium is similar to other applications. For a consortium application, there must be one primary or lead PBRN affiliated with the applicant organization (listed as the PD/PI organization on the grant application). Also, there must be at least 2 additional PBRNs not affiliated with the applicant organization as part of the consortium. An individual PBRN may participate in more than one proposed consortium, but may only be the lead or applicant organization on one grant application.
Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Additional Eligibility Criteria. Applicants must have a demonstrated track record of success in practice-based research as demonstrated by multiple peer-reviewed publications of research findings and/or external funding for research studies.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The PHS 398 application instructions are
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. 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/us/. The D&B number should be entered on line 11 of the face
page of the PHS 398 form.
The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked.
3. Submission Dates and Times
See Section IV.3.A below
for details.
3.A. Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date(s): January
6, 2012
Application Receipt Dates(s): January 26, 2012
Peer
Review Date(s): approximately three months after receipt date
Earliest Anticipated Start Date: approximately
three to four months after peer review
3.A.1. Letter of Intent
To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions. Please include the name and email address of the Principal Investigator.
This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application. However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.
The letter of intent can be sent electronically, and
should be sent to:
Leilani Liggins
Center for Primary Care, Prevention and Clinical
Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1500
Email: [email protected]
The letter of intent is to be sent by the date listed in Section IV.3.A.
3.A.2. Technical Assistance
AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. The conference call will take place on December 20, 2011 at 1:00 pm EST. To register to participate in the conference call, please send an e-mail request to [email protected]) by December 14, 2011. All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB December 16, 2011.
The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying. Participants are encouraged to submit questions via email prior to the conference call. Please submit up to five questions with your name and the name of your institution to [email protected] by December 14, 2011. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the conference call will be posted on the AHRQ web site.
3.B. Sending an
Application to AHRQ/NIH
Applications must be prepared using the forms found in
the PHS 398 instructions for preparing a research grant application. 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)
Personal
deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Leilani Liggins
Center for Primary Care, Prevention, and Clinical
Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone:
(301) 427-1637
FAX: (301) 427-1595
Email: [email protected]
3.C. Application
Processing
Applications must be received
on or before the application receipt date described
above (Section IV.3.A.). If an application is received after that date, the
application may be delayed in the review process or not reviewed. Upon
receipt, applications will be evaluated for completeness by the Center for Scientific
Review, NIH, and AHRQ. Incomplete and/or non-responsive applications will
not be reviewed.
AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit 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.
Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html).
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
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.
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. The applicant should obtain an estimate for the cost of the requested data, if possible. 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 the terms of the DUA and applicable law.
In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six 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 Agency Contacts (see Section VII).
To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.
4. Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
5. Funding Restrictions
For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm
Pre-award costs are allowable. A
grantee may, at its own risk and without AHRQ prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new award if such costs are necessary to conduct the
project and would be allowable under the grant, if awarded, without AHRQ prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain AHRQ approval before incurring the cost. AHRQ prior
approval is required for any costs to be incurred more than 90 days before the
beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on AHRQ either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
6. Other Submission Requirements and Information
Requirements for Management Structure and Processes
Quality of Proposed Response to Hypothetical FOA
In addition to a description of the proposed Center, applicants will be evaluated on the ability of the Center to plan for and conduct a successful research study, as demonstrated in the proposed response to the hypothetical Funding Opportunity Announcement (FOA) described below. For application purposes, the technical proposal response must be limited to 3 pages within the Research Strategy section of the proposal.
RFA Example: Patient Safety Culture in Primary Care: The Medical Office Survey on Patient Safety Culture (MOSOPS) was released by AHRQ In March, 2009 (see http://www.ahrq.gov/qual/patientsafetyculture/mosurvindex.htm ). The survey is intended to help a primary care medical office assess the extent to which its organization’s culture emphasizes the importance of patient safety, quality care, facilitates teamwork and open discussion about mistakes, and creates an atmosphere of continuous learning and improvement. The survey includes 52 items in 12 dimensions of organizational culture. In 2009, 11 PBRNs collectively recruited over 300 primary care offices to administer MOSOPS. Completed results from 292 PBRN medical offices came from 17 states. Areas of strengths in terms of percent positive scores were Teamwork (82%) and Patient Care Tracking/Follow-up (76%), while areas for improvement were Work Pressure and Pace (44%) and Information Exchange with Other Settings (51%). Prior patient safety work in primary care settings identified 2 high priority areas for potential intervention: laboratory errors and prescribing errors (see http://www.ncbi.nlm.nih.gov/pubmed/15335131). The purpose of this FOA is to provide rapid-turnaround results about the MOSOPS and the frequency of laboratory errors and prescribing errors in primary care settings. The proposed project should address the following questions:
1) are MOSOPS results related to frequency of laboratory or prescribing errors?
2) are specific MOSOPS sub-scales more strongly correlated with either laboratory or prescribing errors?
3) what additional practice characteristics are important mediators of the relationship between MOSOPS and either laboratory or prescribing errors and how might they be modified?
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Research Strategy Page Limitations
All application instructions outlined in the PHS398 Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
1) Under “Performance Sites” (page 2), list the official names of all
PBRNs affiliated with the Center (or the name of the National network) name of the Directors of each PBRN, and the address of each PBRN office. The names and addresses of individual member practices should not be listed in this section. A description of the practices affliated with the center, including geographical distribution, types of clinicians, and patient population served by the practices should be included in the Appendix.
2) Detailed Budget. In general, allowable budget items for these grants are limited to a portion of the salaries (plus applicable fringe benefits) of the Center Director, consultation fees, key personnel, travel and per diem expenses for outside consultants/advisors, supplies, travel and per diem expenses for the Center Director and/or other key personnel and other justifiable operating expenses of Center effort. Applicants should budget for 1 individual from the Center to travel to Washington, DC each year to meet with AHRQ staff and other Center representatives. The level of effort of personnel should reflect the commitment of the individual to the Center activities. The purchase of equipment should not exceed 5% of total direct costs. All requests for equipment, including computer software and licenses, must be well- justified.
3) Biographical Sketches. Include in this section a biographical sketch of
the Center Director (equivalent of Principal Investigator, or PI/PD) and Directors of all affiliate PBRNs if applicable, as well as any other key personnel involved in the proposed Center activities.
4) Resources available to the Center should be described once, either in a separate section following the biographical sketches or included in the narrative text (see below).
5) Research Plan. This narrative part of the application must contain the following elements:
a) A description of the existing or planned PBRN consortium or National PBRN. Describe each individual PBRN’s experience with practice-based research grant funding and peer reviewed publications as well as any history of collaboration. Describe the practices to be included in the Center, including geographical distribution of practices, types of clinicians, and patient population served by the practices, especially AHRQ priority populations. (http://www.ahrq.gov/populations/ ). Applications must clearly demonstrate the inclusion criteria described in this FOA.
b) If the PBRN networks are affiliated with an academic department or other research unit, the relationship with that institution, including the Institutional Review Boards at each institution should be described as well as a plan for organizing application for and ensuring compliance with IRB oversight for research projects.
c) Experience in conducting research. Include a summary of the research completed to date by each PBRN affiliated with the proposed Center, including sources and amounts of funding received for the research (a complete list of research may be included as an Appendix). A complete list of publications (if any) resulting from PBRN research should be included as an appendix and referenced in this section of the application. Emerging PBRNs should describe their research goals and objectives and provide examples of specific projects their networks are interested in (and capable of) pursuing.
d) How current or proposed research infrastructure supporting the Center will enhance the capacity of the PBRN consortium or national PBRN to conduct research. Describe and discuss the existing or planned infrastructure that will support the Center. This discussion should include details of any computer-based or other information systems currently in use (or planned) to collect and aggregate research data or communicate with clinicians as well as staffing and organization for practice outreach (recruitment and retention) and data collection. This discussion should also describe any planned capacity assessments and development of strategies to address identified needs, as well as the Centers ability to scale up or down depending on the needs for specific grant applications.
e) A plan for responding rapidly to AHRQ limited-competition funding opportunities should be described. The discussion should also include references to the existing, or proposed, mechanism for obtaining advice/feedback from the communities of member practices.
f) The current, or proposed, Center Director, affiliate PBRN Directors and any network support staff should be identified, including a description of their qualifications, their role on the project, and source of salary support (if any).
g) Directors of any PBRN-affiliate should provide a letter documenting support for the proposed Center. These and other letters of support should be included as an appendix and referenced in this section of the application.
h) A governance structure for the PBRN consortium should be described that specifies how priorities will be set, how resources will be equitably distributed and how decisions will be made. Evidence of clear channels of communication within and between all PBRNs and PBRN members should be described.
i) A list of consultants and other resources available to the PBRN consortium or national PBRN should also be described including areas of expertise.
j) Progress to date and future plans for enhancing the translation of research into practice by supporting the network as a learning community. Describe any formal or informal systems or mechanisms within the Center, current or planned, to disseminate and implement the results of research to PBRN clinicians and evaluate the impact of this information on practices.
k) Response to the hypothetical FOA described above.
Budget Component
Special Instructions for Modular Grant applications
AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using the detailed budget format. Applications submitted in the Modular format will not be reviewed.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CD only. Include five identical CDs in the same package with the application. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Priority Populations
The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, 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. Priority populations 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. This authority is found at 42 USC 299(c). To implement this statutory mandate, 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 FOA should consider and discuss including priority populations in the research design as specified in this Notice.
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 are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees 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. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees 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.
Assessment of AHRQ Grant Programs
In carrying out its stewardship of research programs, 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 must 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.
HCUP & 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 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 includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids’ Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). 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, non-institutionalized population. MEPS is composed of 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.
Applicants’ use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.
Health Literacy
AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants’ understanding.
IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.
Consumer Products
All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Section V. Application Review Information
1. Criteria
Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.
Merit Review Criteria: Merit Review Criteria described below will
be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.
As part of the initial merit review, all applications will:
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support PBRN research are evaluated for scientific and technical merit through the AHRQ peer review system.
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Applications will be assessed in two general areas: 1) technical merit of the
proposed Center, and 2) potential of the Center to significantly enhance capacity to conduct practice-based research and translate research findings into practice. Peer reviewers will be asked to specifically comment in these two areas. The final priority scores will reflect the peer reviewer’s overall assessment based on their judgment of these two areas within each scored review criteria.
Significance.
Technical Merit
Enhanced Capacity
Investigators.
Technical Merit
Enhanced Capacity
Innovation.
Technical Merit
Enhanced Capacity
Approach.
Technical Merit
Enhanced Capacity
Is there evidence of the ability of the Center to scale up or down in capacity to respond appropriately to future research opportunities?
Environment.
Technical Merit
Enhanced Capacity
2.A. Additional Review Criteria
In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:
Degree of Responsiveness. How well does the application address the purpose and objectives of this FOA? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?
Budget and Period of Support. Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?
Inclusion. Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements,” and inclusion criteria included in section VIII of Required Federal Citations, below.)
Protection of Human Subjects from Research Risk. The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects section of the application.
Privacy and Security Protections for Patients. The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
2.B.
Additional Review Considerations
Not Applicable
2.C. Resource Sharing Plan(s)
Data Confidentiality
The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 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 this 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 FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. 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, health care plans ordinarily will require either patient authorization for 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), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS 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.hhs.gov/ocr/hipaa/
The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that 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.
Sharing Research Resources:
Rights
in Data
Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).
3. Anticipated Announcement and Award Dates
Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
AHRQ will request "Just-In-Time" information from the
applicant. Just-In-Time information generally consists of information on
other support, any additional information necessary to address administrative
issues, and certification of IRB approval of the project's proposed use of
human subjects. For details, applicants may refer to the "AHRQ
Revised Policy for Institutional Review Board (IRB) Review of Human Subjects
Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).
Once all administrative and programmatic issues have been resolved, a formal
notification in the form of the Notice of Award (NoA) will be generated
via email notification from the awarding component to the grantee business
official at the applicant organization. The NOA signed by the AHRQ 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 NOA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., “Funding Restrictions.”
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.
2. Administrative and National Policy Requirements
All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the notice of grant award.
As necessary, Terms and Conditions will be incorporated into the award statement.
When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.
The annual progress reports must include Sections 2.2.6 items A through F as described in the general PHS form 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.
The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable for these progress reports.
Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 4/30/2012, the annual FFR is due 9/30/2012 (90 days after the end of the calendar quarter of 6/30/2012).
A final Progress Report and Federal Financial Report are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the AHRQ Grants Process web site at http://www.ahrq.gov/fund/postawrd.htm#terms for additional information on this reporting requirement.
We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer questions
from potential applicants. Inquiries may be written or by telephone, and fall
into three areas: scientific/research (program), peer review, and financial or
grants management issues.
1. Scientific/Research Contacts:
Direct your questions about general FOA issues, including information on the inclusion of priority populations to:
Michael Parchman, M.D.
Center for Primary Care, Prevention and Clinical
Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1571
Fax: (301) 427-1595
E-mail address: [email protected]
2. Peer Review Contacts:
Direct your questions about peer review issues of grant applications made in response to this FOA to:
Nghia Vo, M.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1191
Fax: (301) 427-1562
E-mail address: [email protected]
3. Financial or Grants Management
Contacts:
Direct inquiries regarding fiscal matters to:
Anna Caponiti
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1402
Fax: (301) 427-1462
E-mail address: [email protected]
Section VIII. Other Information
Required Federal Citations
Inclusion of Women and Minorities in Research Study Populations:
Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.
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 NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).
Human Subjects Protection:
Federal regulations at 45 CFR Part 46 require that applications
and proposals involving human subjects research must be evaluated in accordance
with those regulations, with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the
knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Standards for Privacy of Individually Identifiable Health Information:
The HIPAA Privacy Rule, 45 CFR Parts 160 and 164, governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). 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 member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.
Access to Research Data through the Freedom of Information Act:
OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain 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 or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ Confidentiality Statute, 42 USC 299c-3(c). 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 FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 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.
Healthy People 2020:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," 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 2020" 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/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.
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 Public Health Service mission to protect and advance the physical and mental health of the American people.
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