Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
Center for Outcomes and Effectiveness (COE)

Title:  Patient-Centered Outcomes Research -- Dissemination by Health Professionals Associations (PCOR-DHPA) (R18)

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 RFA.

Request for Applications (RFA) Number: RFA-HS-12-006

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov(http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: February 27, 2012
Opening Date:  March 25, 2012
Letters of Intent Receipt Date(s):  April 2, 2012
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s):  April 25, 2012
Peer Review Date(s): Generally four months after receipt date 
Earliest Anticipated Start Date(s): Generally four months after peer review date 
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date:  April, 26, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity announcement (FOA) solicits Research Demonstration and Dissemination Projects (R18) grant applications from health professionals associations to disseminate patient-centered outcomes research using innovative educational methods. 

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.

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 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
          1. Letter of Intent
          2. Technical Assistance
    B. Submitting an Application Electronically to AHRQ
    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. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
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

Patient-Centered Outcomes Research

AHRQ:  AHRQ’s mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.  AHRQ achieves this mission by supporting a program of health services research and by working with partners, including patients and health care providers, to identify and prioritize topics that will promote improvements in clinical and health systems practice that benefit patients.  To this end, the Agency supports research on patient outcomes and effectiveness.  Among other things, this research compares the effect of different interventions on the same health condition.  By measuring actual outcomes under real world conditions, researchers develop scientific evidence about what works best, for whom, and under what circumstances.  Patients and practitioners can then more knowledgably choose among treatment options.  Health care managers and purchasers can identify potentially effective strategies to improve the quality and value of care.  Stakeholders and policymakers can evaluate proposed improvements using a common nomenclature and the same underlying evidence. 

PCORI:  The independent Patient-Centered Outcomes Research Institute (PCORI) supports research about the best available evidence to help patients and their health care providers make more informed decisions (http://www.pcori.org).  PCORI has the mission of funding evidence-based research to help patients better understand the value of prevention, treatment, and care options available; and of the science that supports those options. 

Outcomes research:  This FOA supports dissemination of existing knowledge about what health care options (including diagnoses, treatments, interventions, health services systems, and models of health care delivery) work best for patients, rather than generation of new knowledge.  Examples of existing research appear on AHRQ-related Websites and publications (http://www.ahrq.gov, http://www.ahrq.gov/clinic/, http://www.effectivehealthcare.ahrq.gov/index.cfm).  The professional literature provides additional sources of patient-centered outcome research.  Applications may propose dissemination of the results of AHRQ-related research, findings published by PCORI, and/or other government-funded research relevant to comparative clinical effectiveness research.  In the latter case, the disseminated research should have validity, generalizability, accuracy, reliability, precision, usability, etc. comparable or superior to AHRQ-related results. 

Associations:  Health professionals associations can play an important role in disseminating patient-centered outcomes research.  Many associations have an extended history of maintaining the skills and improving the education of their members.  In some cases, they have already created systems for continuing their members’ education on an on-going and sustainable basis.  Some also educate patients, clients, public, or another wider audience.  AHRQ has previously had few opportunities to leverage the specific expertise of health professionals associations.  Section III.1.A further describes the institutions eligible to apply. 

Dissemination

Background: Previous distribution of health care outcomes information to health professionals has classically taken the form of academic papers, textbooks, periodicals, pamphlets, lectures, broadcasts, and other traditional forums.  However, research suggests that the instructional methods (e.g., passive reading and one-way listening) have limited effect on provider behaviors or patient-centered health outcomes.  Some literature also describes modest experimentation with group discussions (e.g., interactive grand rounds), paid opinion leaders (e.g., academic detailing), hands on demonstrations (e.g., by medical equipment salesmen), clinical simulations, standard patients, virtual patients, recertification, virtual learning environments, and other initiatives.  The limited number of studies and small sample sizes make it difficult to draw any firm conclusions about the uptake or outcomes of such interventions.  Physicians and other health care providers increasingly look to social media to obtain the most up-to-date information about health care. 

Developments: This FOA solicits applications from health professionals associations to develop dissemination programs that integrate patient-centered outcomes research into clinical practice using multi-factorial mechanisms such as education, credentialing, scientific programs, social media platforms, and other innovative methods.   Applicants may wish to consider both educational theory (what learning methods work most effectively) and the relevance of “new media.”  Experiments with computer-based training, long distance learning, broadcasting, videos, and other technologies have had mixed results.  More recent developments such smart phones, social networking (community-based sites, third-party anonymous sites, crowd-sourcing), Internet games, social media, blogs, online message boards, virtual communities, podcasting, etc. remain largely untested for their effectiveness in promoting health.  Accordingly, voluminous opportunities exist for assessment of these innovations.

Audience: Applications may find it helpful to explicitly define their target audience; usually the constituency of the organization or a portion of that constituency.  Dissemination intended to directly change the behavior of all health professionals might employ a different subject and format than a program aimed at influencing a narrow allopathic subspecialty (e.g., hard tissue plastic surgeons, oculoplasticians) or a specific allied health profession (e.g., pediatric occupational therapists, aviation paramedics).  A program with a nonspecific audience would likely need above-average strengths in other areas to successfully compete. 

Design

Plan: Applications must detail a multistep development plan of up to three years for a patient-centered outcomes research dissemination infrastructure.  Propose its relationship to the governance of the health professionals’ organization or association, if applicable.  Describe anticipated milestones and itemized aims for each year of the grant budget period, if pertinent.

People: Key personnel should include a multidisciplinary team of junior and senior-level health services investigators with experience in medicine, public health informatics, clinical and health sciences research, epidemiology, statistical design, health organization design, and/or administration, as appropriate. Some proposed interventions may require systems engineering, behavioral economists, translational sciences, marketing, public relations, communications, and/or medical education specialists.  A well-coordinated, well functioning team might also demonstrate experience in patient-centered outcomes research translation and dissemination methods, clinical care communications, marketing and media campaigns with use of social networking, and/or knowledge and skill sets in multi-stakeholder engagement.  A proven record of collaborative partnerships, capacity and ability to scale up quickly, and formation of partnerships within their realm of professional associations, state, regional, and/or local communities would add credibility to multilateral interventions.

Need: Demonstrate demand for the proposed intervention (e.g., a survey of professional organization demographics, inquiry of partnering stakeholders working with the professional association, poll of internal membership needs for improving their role and function in enhancing healthcare service delivery), if appropriate. Needs assessment may include, but is not limited to, activities such as: focus group interviews, literature scan for existing validated methods, and review of the grey literature for tools, instructional techniques of patient-centered outcomes, and health services research dissemination methods used by health professionals’ organizations.

Subject: Identify a primary PCOR issue or topic (i.e., outcomes research on a clinical area or disease treatment, adherences, preferences, care transition model, or systems pathway).  Ideally, it should fall within one or more of AHRQ’s priority conditions and populations.  The PCOR issues should have direct significance to one or across multiple health professionals associations, specialties, or subspecialties.  The applicant should consider examining widely used evidence-based resources (i.e., recent systematic reviews, meta-analyses, registry data, surveillance, surveys, etc.) that describe the importance and burden of the issue.  Absent such data sources, reviews of case reports and surveys of the grey literature may be used to guide topic selection.  If limited to specific health provider audiences, then provide a brief justification for a targeted dissemination of valid patient-centered outcomes research findings (e.g., www.effectivehealthcare.ahrq.hhs.gov; decision aid of therapies to primary care providers within a health maintenance organization’s multicenter electronic clinic visit template; pilot use of previously tested, patient oriented techniques to midwives, dissemination to health professionals serving priority populations).

Intervention: Projects should propose an independent variable that leverages social media tools, medical informatics technologies, or other nontraditional educational methods.  Examples might include implementation of  AHRQ Effective Health Care (EHC) program online evidence-based-medicine educational ‘toolkits;’ inter-professional evidence-based care planning tools; short film documentaries or televised programs; town hall meetings between healthcare providers and patients; cellular, PDA, and e-tablet applications; social media venues such as Twitter, Facebook, WebMD, and small online communities composed of peers or experts; geo-informatics systems; mobile media campaigns; blogs; wikis; webinars; virtual meetings, message boards; instant text messaging; email; audio; video; pod casts, etc.  Alternately, the intervention could propose a combination of [1] translational marketing methods (e.g., electronic outreach, social marketing, trans-media public relations programs, interactive professional tools, new media navigators) and [2] traditional instructional methods (e.g., written materials, lectures, scientific meetings, seminars, brown-bag meetings, grand rounds) to reach diverse types of learners within the membership of a health care professionals organization or association.

Innovation: Describe how the dissemination plan uniquely employs proven or newly tested concepts, approaches, and tools. Illustrate how the proposed intervention can reduce barriers, enhance patient-centered outcomes, improve health professionals practice, advance education, coordinate care, etc.  Explain linkages to any anticipated measures, inputs, or outputs. 

Effectiveness: Propose investigational approaches to test programs for dissemination with consideration of (but not limited to) the following metrics : uptake of end-user application, portability and fluidity of dissemination plan within the scope of existing and evolving clinical practice; integration within medical school or health graduate degree education and curricula in patient-centered care; quality improvement programs with measured outcomes of success; implementation of screening, health media campaigns and/or guidance policies; effect on patient decision-making, use of decision aides for clinical decision-making; measurement of treatment adherence; observed benefits and harms in patient-centered outcomes; impact on clinician knowledge, clinician training, curricula development, education and subsequent clinician decision-making; impact on care coordination pathways, benefits and harms to health system flow processes within specialty clinics; use of ancillary health services and/or specialty care; study of PCOR continuous medical education within varied settings of healthcare delivery (i.e., rural practices, urban community clinics, retail-pharmacy health clinics, large health care organizations, hospital settings, etc.).

Scalability: Any proposed pilot project should discuss short-term (1-3 year) scalability of the dissemination infrastructure and long term (4+ years) milestones required to achieve any proposed extensions.  Such a pilot should address sustainability, feasibility, financing, and effectiveness for continuation after this project.   Alternately, such applicants should consider providing a “capstone” white paper with clear recommendations for next phase in infrastructure implementation prior to completion of the grant period.

Sustainability: An intervention that depends on continuation past the grant period should have a credible plan for sustainability.  If the Eligible Organization commitment to future support depends upon this intervention’s success, then [1] detail the required conditions and [2] outline the scope of resultant financial resources, internal infrastructure, business plan, educational systems, or other mechanisms.  An application with a self-funding mechanism (e.g., user fees, advertising, membership dues) would likely be more sustainable than an application than an application that proposes to solicit contributions or to apply for additional grants to sustain future activities.  The startup infrastructure might integrate into existing systems of quality improvement, education, certification, or other on-going mechanisms. 

Evaluation: If the application proposes a larger or longer dissemination intervention, then does it include methods for quantifying its results?  The measurement effort will vary depending upon the project’s scope.  Thus, a single-year project with a one-time, short-term intervention might omit a specific evaluation of the intervention, particularly where an existing government or trade association statistical series already assembles and distributes pertinent data.  A more sustained, expensive intervention might justify an independent measurement process.   

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the AHRQ Research Demonstration and Dissemination Projects Grant (R18) award mechanism.  The individual researcher sponsored by each organizational applicant 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 $2.5 million in FY 2012 to fund 25-50 awards.  Applications may be up to three years in duration with a budget supported by AHRQ not to exceed $100,000 per year total costs (including both direct and indirect costs) to the government.  Applications with project periods that exceed three years or budgets that exceed $100,000 total costs in any given year will not be reviewed.

Funding beyond the first year will be contingent upon a review by Agency staff of the annual non-competing continuation progress report.  An application with a budget that exceeds $300,000 total costs over a three year project period will not be reviewed.

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

1.A. Eligible Institutions

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. 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

This program does not require cost sharing for applications in response to this FOA.

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 that plan to provide support 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 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.  Applicants may submit more than one application, provided each application is scientifically distinct.  However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

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. 

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application.  Several of the steps of the registration process could take four to six weeks. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:   
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget
(See Section IV.6., “Special Instructions,” regarding appropriate required budget component.) 

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS  

Applications Involving a Single Institution

When a single institution is involved, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.  All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.  See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  March 25, 2012
Letters of Intent Receipt Date(s):  April 2, 2012
Application Due Date(s):  April 25, 2012
Peer Review Date(s): Generally four months after receipt date 
Earliest Anticipated Start Date(s): Generally four months after peer review date 

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:

NewMediaGrants@ahrq.hhs.gov

The letter of intent is to be sent by the date listed in Section IV.3.A

3.A.2. Technical Assistance

Not Applicable.

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications must be received on or before the application receipt date described above (see Section IV.3.A. for all dates).  If an application is received after that date, the application may be delayed in the review process or not reviewed.

Submission to Grants.gov is not the last step.  Applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons.  The submitting AOR/SO receives the Grants.gov acknowledgments.  The AOR/SO and the PI receive Commons acknowledgments.  Information related to the assignment of an application to a Scientific Review Group is also in the Commons.  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/.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ.  Incomplete or non-responsive applications will not be reviewed.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

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.

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). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

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.

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.  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

PD/PI Credential (e.g., Agency Login)

AHRQ requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) 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:

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 instructions for the Research and Related Budget Components of the SF 424 (R&R).  Applications submitted in the Modular format will not be reviewed.

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. 

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with 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.effectivehealthcare.ahrq.gov/options/start-conversation/) 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, as 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 health services 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  

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Does the application propose dissemination of important and valid patient-centered outcomes research?  Does the scientific literature largely endorse the conclusions, guidelines, recommendations, or other outputs of this research?  Do significant numbers or proportions of practitioners not adhere to these recommendations?  How would the application control for variables and trends that affect acceptance of the recommendations?  Does the research foster multi-disciplinary teamwork in clinical care?  Does the research enhance professional interaction with peers and experts in a specific field? 

Investigators. Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Does the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?  

Innovation.  Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?  

Does the dissemination intervention show originality, innovation, and vision?  Does the intervention develop or employ novel concepts, instructional techniques, approaches, methodologies, tools, or technologies?  Does it address an innovative hypothesis or critical barriers to progress in the field? 

ApproachAre the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?   

Does the application propose a specific dissemination intervention?  If so, does the intervention relate to patient-centered outcomes research?  Does it have well defined, measureable inputs and outputs?  Is it feasible?  Could the intervention work well in the real world?  Does any evidence exist about its likely success (e.g., from the mechanism’s use in non-health fields)? 

Environment.  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?   

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be addressed and considered in the determination of scientific merit and the rating. 

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 Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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 support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. 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), which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.  

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.”

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, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary, additional Terms and Conditions will be incorporated into the award statement.

3. Reporting

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 Section 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 report 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 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

A final Progress Report, Federal Financial  Report, and Invention Statement are required when an award ends.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section VII. Agency Contacts


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 Contact(s):

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

Shilpa Amin, MD, MBsc
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850-6649
Phone: (301) 427-1491
Fax: (301) 427-1520
Barbara Bartman, MD, MPH
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850-6649
 Phone: (301) 427-1515
Fax: (301) 427-1520

David Hsia, JD, MD, MPH
 Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850-6649
Phone: (301) 427-1499
Fax: (301) 427-1520

E-mail communication to program staff may be sent to: NewMediaGrants@ahrq.hhs.gov

2. Peer Review Contact(s):

Direct your questions about peer review issues of grant applications made in response to this FOA to:

Nghia Vo, MD
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Phone: (301) 427-1191
Fax: (301) 427-1561
E-mail address:  nghia.vo@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

Nicole Williams
Office of Performance Accountability, Resources and Technology
Division of Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1015
Fax: (301) 427-1462E-mail address:  Nicole.Williams@ahrq.hhs.gov

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.html).
 
Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", 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). 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.

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/archive/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.

References:

1.  Van Rijswijk, L.andGray, M.  Evidence, research, and clinical practice: a patient-centered framework for progress in wound care.  Ostomy Wound Manage 2011 Sep;57(9):26-38

2.  Hughes, G. B.  Evidence-based medicine in health care reform

Otolaryngol Head Neck Surg 2011 Oct;145(4):526-9

3.  Khoury, M. J., Clauser, S. B., Freedman, A. N.et al. Population sciences, translational research, and the opportunities and challenges for genomics to reduce the burden of cancer in the 21st century. Cancer Epidemiol Biomarkers Prev 2011 Oct;20(10):2105-14

4.  Shekelle, P. G., Pronovost, P. J., Wachter, R. M.et al.  Advancing the science of patient safety Ann Intern Med 2011 May 17;154(10):693-6

5.  Gagyor, I., Bleidorn, J., Wegscheider, K.et al. Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices. Trials 2011;12:91

6.  Nguyen, P. L., Gu, X., Lipsitz, S. R.et al. Cost implications of the rapid adoption of newer technologies for treating prostate cancer. J Clin Oncol 2011 Apr 20;29(12):1517-24

7.  Navathe, A. S.andConway, P. H. Optimizing health information technology's role in enabling comparative effectiveness research. Am J Manag Care 2010 Dec;16(12 Suppl HIT):SP44-7

8.  Bonham, A. C.andSolomon, M. Z. Moving comparative effectiveness research into practice: implementation science and the role of academic medicine. Health Aff (Millwood) 2010 Oct;29(10):1901-5

9.  Bruce, A. A., Bauman, M. E., Black, K.et al. Development and preliminary evaluation of the KIDCLOT PAC QL: a new health-related quality of life measure for pediatric long-term anticoagulation therapy. Thromb Res 2010 Aug;126(2):e116-21

10.  No author given. A report from the Coalition for Health Services Research: "health reform: what it means for health services research". Health Serv Res 2010 Jun;45(3):ix-xxi

11.  Jaen, C. R., Crabtree, B. F., Palmer, R. F.et al. Methods for evaluating practice change toward a patient-centered medical home. Ann Fam Med 2010;8 Suppl 1:S9-20; S92

12.  Abernethy, A. P., Ahmad, A., Zafar, S. Y.et al. Electronic patient-reported data capture as a foundation of rapid learning cancer care. Med Care 2010 Jun;48(6 Suppl):S32-8

13.  Nunes, E. V., Ball, S., Booth, R.et al. Multisite effectiveness trials of treatments for substance abuse and co-occurring problems: have we chosen the best designs? J Subst Abuse Treat 2010 Jun;38 Suppl 1:S97-112

14.  Arellano, L. E., Reza, M., Blasco, J. A.et al. A content analysis of Health Technology Assessment programs in Latin America. Int J Technol Assess Health Care 2009 Oct;25(4):570-6

15.  Hoeks, S. E., Smolderen, K. G., Scholte Op Reimer, W. J.et al. Clinical validity of a disease-specific health status questionnaire: the peripheral artery questionnaire. J Vasc Surg 2009 Feb;49(2):371-7

16.  Tandon, R., Belmaker, R. H., Gattaz, W. F.et al. World Psychiatric Association Pharmacopsychiatry Section statement on comparative effectiveness of antipsychotics in the treatment of schizophrenia Schizophr Res 2008 Mar;100(1-3):20-38

17.  Themistocleous, G. S., Goudelis, G., Kyrou, I.et al. Translation into Greek, cross-cultural adaptation and validation of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). J Hand Ther 2006 Jul-Sep;19(3):350-7


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