Ahrq R36 Dissertation Grants

Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Office of Extramural Research, Education and Priority Populations (OEREP), (http://www.ahrq.gov)

Title:AHRQ Grants for Health Services Research Dissertation Program (R36)

Announcement Type

This Funding Opportunity Announcement (FOA) is a re-issue of PAR-09-212, which was previously released July 17, 2009.

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

  • August 4, 2015 - This PA has been reissued as PA-15-318.
  • February 20, 2014 - See Notice NOT-HS-14-009. Notice of Correction to Section IV. Application and Submission Information 6. Other Submission Requirements.
  • January 31, 2014 - See Notice NOT-OD-14-047. NIH and AHRQ Extend Due Dates for Applications Due Jan 31-Feb 3 to Feb 4.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Program Announcement (PA) Number: PA-12-256

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.

Note regarding applicability of NIH Grants Polices and related Guidance:  The policies, guidelines, terms and conditions stated in this FOA are not identical to those used by the NIH.  This FOA will reference NIH grants policies and guidance where these issuances are applicable or relevant to submissions.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: August 7, 2012
Opening Date:  October 1, 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):  (Extended to February 4, 2014 per NOT-OD-14-047 , Originally February 1), May 1, August 1, and November 1 annually, beginning November 1, 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:August 2, 2015

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The overall goal of the AHRQ Health Services Research Dissertation Grant Program is to help ensure that a diverse pool of highly trained health services researchers is available in adequate numbers and appropriate research areas to address the research mission and priorities of AHRQ.  This program is authorized by 42 U.S.C. 299a(b), which provides that AHRQ may provide training grants in the field of health services research.  The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans in the United States.

  • Purpose: This announcement represents the continuation of an AHRQ program that provides support to individuals who are conducting research undertaken as part of an accredited academic program to qualify for a research doctorate degree.
  • Mechanism of Support: This Funding Opportunity Announcement (FOA) utilizes the dissertation research grant mechanism (R36).
  • Funds Available and Anticipated Number of Awards: The total amount to be awarded and the number of awards will depend upon the quality and merit of applications received and the availability of funds.
  • Budget and Project Period: The direct costs awarded to a grant under this FOA will not exceed $40,000 for the entire project period, which must be a minimum of nine months and may not to exceed 17 months from the time of award.  Individuals supported under National Research Service Award (NRSA) mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for a dissertation award.  However, such individuals may only request up to $20,000 direct costs for additional, non-salary expenses, and no funds may be requested for salary support.  In such instances, the application must include a statement describing the expenses requested under the dissertation grant application which are not supported through the active training grant or fellowship. The proposed start date be at least 4 months after the application submission deadline
  • Application Research Strategy Length:The R36 application Research Strategy component of the PHS398 (Items 2-5) may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. Specific Aims is limited to 1 page. This does NOT include the Plan for Instruction in the Responsible Conduct of Research, which may not exceed one page.
  • Eligible Institutions/Organizations: For this FOA, AHRQ will make grants only to domestic non-profit organizations. The applicant organization must be the doctoral granting institution at which the student is registered and matriculating.  Individuals cannot apply to AHRQ directly. Further details are available in Section III.
  • Eligible Project Director/Principal Investigator (PD/PI). Also referred to as the ‘Candidate’, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their mentor and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for AHRQ support.  Candidates must be U.S. citizens, non-citizen nationals, or permanent residents by the time the award is issued.  Candidates must be full-time students in good standing, who are enrolled in an accredited research doctoral program in such fields as the social or behavioral sciences, mathematics, engineering, health services research, nursing, social sciences, epidemiology, biostatistics, health policy, and health informatics.  Candidates with more than part-time employment (defined as greater than twenty hours per week), in addition to the requirements of their current, full-time academic student appointments, are not eligible to apply for this grant mechanism.  Students must complete all non-dissertation requirements for their doctoral degree by the time of submission of the application (except in cases where a clinical internship is required to follow the dissertation phase).  Approval of the dissertation proposal by the doctoral committee is required before the grant award is issued. 
  • Number of PDs/PIs: Only one PD/PI may be designated on the application and this individual must be the student seeking dissertation support.
  • Number of Applications: Candidates may only have one individual dissertation grant application pending peer review within the Public Health Service at any time. 
  • Resubmissions: One resubmission is allowed.  A resubmission application must include an Introduction addressing the previous peer review critique (Summary Statement), not to exceed 1 page.  Resubmission applications to this FOA have the same due dates as new applications.
  • Renewals:  Awards are not renewable.
  • Application Materials: See Section IV for application materials.
  • General Information: For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936. 

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.

Required Application Instructions


Applicants must complete the application for individual research grants (R36), not the Individual Fellowship Application (e.g., NRSA F31, F32).  It is critical that applicants follow the instructions in the SF 424 (R&R) 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 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
    3.A. Submission, Review, and Anticipated Start Dates
    3.A.1. Letter of Intent
3.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
2.A. Additional Review Criteria
2.B. Additional Review Considerations
2.C. Resource Sharing Plan(s)
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

Applications for dissertation research grants must be responsive to AHRQ’s mission, which is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.  The research sponsored and conducted by the Agency develops and presents scientific evidence regarding all aspects of health care in the United States.  It addresses issues of organization, delivery, financing, utilization, patient and provider behavior, outcomes, effectiveness and cost.  It evaluates both clinical services and the system in which these services are provided.  These scientific results improve the evidence base to enable better decisions about health care, including such areas as disease prevention, appropriate use of medical technologies, improving diagnosis and treatment in cost-effective ways, long-term care, and reducing racial and ethnic disparities. 

AHRQ has identified strategic goals as priority research areas.  Applied research applications must address one of these areas.  Applicants are strongly encouraged to focus on topical areas unique to AHRQ, demonstrating how expected results can be used or made available for use to enhance healthcare quality.  Results should be directly relevant to customers, such as providers and practitioners, administrators, payers, consumers, policymakers, and insurers.  The strategic research goals are:

  • Safety/quality – Reduce the risk of harm from health care services by promoting the delivery of appropriate care that achieves the best quality outcomes
  • Efficiency – Achieve wider access to effective health care services and reduce health care costs
  • Effectiveness – Assure that providers and consumers/patients use beneficial and timely health care information to make informed decision choices.

AHRQ has specific research portfolio areas of interest which include comparative effectiveness/patient-centered outcomes, health information technology (health IT), value, patient safety, prevention and care management, and healthcare innovations.  To learn more about AHRQ’s focus within these portfolios of work, please visit http://www.ahrq.gov/fund/portfolio.htm

Candidates are required to address health services research issues critical to AHRQ priority populations, including: individuals living in inner city and rural (including frontier) areas; low-income and minority groups; women, children, the elderly; and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care. 

Candidates must conduct dissertation projects which focus on health care delivery in the United States. AHRQ will not accept international health care research projects.

This FOA describes the procedures and criteria for the AHRQ dissertation grant program.  It updates and supersedes the AHRQ Grants for Health Services Research Dissertation PAR-09-212, published July 17, 2009.

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

Section II. Award Information

1. Mechanism of Support

 This FOA will use the research dissertation grant (R36) award mechanism.  Candidates will be solely responsible for planning, directing, and executing the proposed project.

AHRQ is not using the Modular Grant Application and Award Process.Applications submitted in modular format will not be reviewed.

2. Funds Available

The direct costs awarded to a grant under this FOA will not exceed $40,000 for the entire project period, which must be a minimum of nine months and may not to exceed 17 months from the time of award.  Facilities and Administrative (F&A) costs (i.e., overhead or indirect costs) are limited to 8% of modified total direct costs.

Individuals supported under National Research Service Award (NRSA) mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for a dissertation award.  However, such individuals may only request up to $20,000 direct costs for additional, non-salary expenses; no funds may be requested for salary support.  In such instances, the application must include a statement describing the expenses requested under the dissertation grant application which are not supported through the active training grant or fellowship.  The request for support must also satisfy applicant institutional policies.  Recipients of mentored career development awards are not eligible for dissertation support.

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 include support for this program, awards pursuant to this FOA are contingent upon the availability of funds. 

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:

  • Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus AHRQ will make grants only to non-profit organizations.  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.

For dissertation grants, the applicant organization must be an accredited doctoral granting institution at which the student is registered and matriculating.  Individuals cannot apply directly.

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 at the dissertation stage of training 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. Candidates are eligible to apply for this award provided that they:

  • Are U.S. citizens, non-citizen nationals, or permanent residents by the time of the grant award
  • Are full-time students in good standing, who are enrolled in an accredited research doctoral program in such fields as behavioral sciences, health services research, nursing, social sciences, epidemiology, biostatistics, health policy, health informatics, engineering, and mathematics
  • Will have completed all non-dissertation requirements for their doctoral degree by the time of submission of the application, including completion of their qualifying exams.  The only exception allowable will be the completion of required clinical internships that follow completion of the dissertation.
  • Have received approval of the dissertation proposal by the doctoral committee by the time of the grant award

Candidates with more than part-time employment in addition to the requirements of their current, full-time academic student appointments (defined as greater than twenty hours per week), are not eligible to apply for this grant mechanism.

As noted above, individuals supported under National Research Service Award (NRSA) mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for a dissertation award, with funding limitations as described above.  In such instances, the application must include a statement describing the expenses requested under the dissertation grant application which are not supported through the active training grant or fellowship.  The request for support must also satisfy applicant institutional policies.  Recipients of mentored career development awards are not eligible for dissertation support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of applications:  AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review by the Public Health Service unless the applicant withdraws the pending application.  This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique.  Note such an application is considered a "resubmission" for the SF 424 (R&R).

Resubmissions:  Applicants may submit one resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).  Resubmissions should follow the submission date schedule noted in Section IV.3.

Renewals:  Renewal applications will not be allowed for this mechanism.

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

  • Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
  • If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
  • The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
  • Direct questions regarding Grants.gov registration to:
    Grants.gov Customer Support
    Contact Center Phone: 800-518-4726
    Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
    Email support@grants.gov

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.

  • The individual designated as PD/PI on the application must be registered also in the NIH eRA Commons. 
  • The PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
  • The PD/PI at the applicant organization must be affiliated with that organization. A PD/PI located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
  • This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

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 throughGrants.gov/Apply.  Do not use the Individual Fellowship Application.

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 301-710-0267; 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 throughGrants.gov/Applyand in accordance with the SF424 (R&R) Application Guide (https://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/APPLYincludes 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

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: October 1, 2012
Application Due Date(s):  February 1, May 1, August 1, and November 1 annually, beginning November 1, 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

A letter of intent is not required for this funding opportunity announcement. 

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/web/grants/applicants/apply-for-grants.html  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 AHRQReferral Office by email Gerald.Calderone@ahrq.hhs.govwhen 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 due 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.  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.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://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.

4. Intergovernmental Review

This initiative is not subject tointergovernmental 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

AHRQ Dissertation (R36) awards DO NOT allow pre-award costs.

6. Other Submission Requirements

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

AHRQ requires the PD(s)/PI(s) 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.”

Special Instructions for PHS398 research Plan Component (Section 5.5 of SF424 (R&R) Application)

PHS 398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

  • Introduction (required attachment for resubmission and revision application) is limited to one page.
  • Specific Aims is limited to 1 page.
  • Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 6 pages.
  • Research Strategy should include the Significance, Innovation, and Approach.

Additional Instructions: In preparing the application, the following instructions are to be used in conjunction with the instructions provided in the SF424 (R&R) Application Guide:

Research Strategy:  Part of the research strategy must describe any potential outcomes, products and/or impact of the proposed dissertation on policy or practice, as well as dissemination plans, which involve traditional academic as well as nontraditional means of communicating relevant research findings to policymakers or health care delivery personnel.  A clear description of the unique contribution of this effort must be included, especially if the research builds upon ongoing or previously conducted work by the principal investigator, or other dissertation committee member/faculty. Note: As described in the SF 424 (R&R), the “Project Summary/Abstract” and “Project Narrativeare separate from the Research Strategy

Letters of Support: Two letters are required. (NOTE: these differ in content from the optional Cover Letter described in the SF424 (R&R) instructions). 

These letters are uploaded where indicated in the “Other Research Plan Sections” of the PHS 398 Research Plan.  Because only one pdf file is allowed for the Letter of Support item in the PHS Research Plan Component, combine these letters with any other optional Letters of Support (below) into one file.  Each letter is limited to a total of two pages.

The required letters are:

  • A letter from the faculty committee or the University official directly responsible for supervising the dissertation research must be submitted with the grant application.  The letter must specifically address the potential of the candidate, as well as the qualifications and experience of the candidate to conduct the study as proposed, both in terms of content and methodological expertise gained from coursework.  In addition, the letter must:
    • certify that the dissertation grant application reflects the planned dissertation work to be conducted by the Candidate;
    • certify that the Candidate has completed all other necessary requirements for completion of the doctorate degree, other than the dissertation proposal defense.  This includes certifying that all coursework required for the completion of the Ph.D. will be completed prior to submission.  (Please note that certification that the proposal defense has been successfully completed will be required prior to AHRQ issuing an award, should the application be selected for funding) 
    • acknowledge the existence of sufficient institutional infrastructure support for the candidate, including but not limited to items such as office space, computer access, mentoring plan, etc. 
    • include a mentorship description that clearly notes the frequency of meetings as well as content and methodological support to be provided. 
    • indicate that a collaborative process was established between the applicant and advisors in the development and review of this dissertation grant application.
  • A letter from the Candidate which must discuss career goals, background and interest in health services research, the anticipated manner in which the proposed dissertation will contribute to career goals, and the unique relevance of the proposed dissertation to AHRQ.

Research & Related Senior/Key Person Profile:  The dissertation candidate, who must be matriculated in an accredited doctoral program, will be the designated PD/PI.  The mentor for the PD/PI must be listed as a key person.  The only other listed key persons are the other members of the dissertation committee. Attach a biographical sketch for the PD/PI, mentor, and all other key personnel.  It is strongly encouraged that the doctoral dissertation committee includes recognized health services researchers with appropriate interdisciplinary or multidisciplinary expertise necessary to fully support the research activities.

Budget:  AHRQ does not accept modular budgets.  The budget component is described further below.

Allowable CostsThe Candidate is the person completing the dissertation.  Stipend/salary compensation can be requested for the Candidate up to the current fiscal year NRSA pre-doctoral stipend level (information for FY 2012 can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-033.html).  Salary must be consistent with the established salary structure at the institution if it were using its own funds to support other staff members of equivalent qualifications, rank, and responsibilities at the institution.  Fringe benefits can be requested only if the candidate is employed by the applicant organization.

Salary may not be requested for any personnel other than the Candidate.  Funds may not be requested for consultant costs.

Include equipment, travel, and other expenses costs as appropriate. General purpose equipment items, such as personal computers, must be separately listed and estimated under equipment costs.  Justifiable costs associated with data collection/coding, such as the need for additional data transcription services (other than that provided by the Candidate) for qualitative data, are allowable.  Candidates can request up to $1,500 in travel costs to attend appropriate scientific meetings or conferences focusing on his/her research topic that take place in the United States, Mexico or Canada. The applicant must provide justification for each budget item requested in the detailed budget for the total period of support being requested. In particular, proposed computer-related purchases need to be fully justified in terms of not being readily available to the student for the conduct of the research. 

The only allowable tuition-related costs are those associated with dissertation credits and matriculation fees that are required during the course of the grant period. Tuition related costs should be itemized in the budget.  If requested, health insurance fees should also be listed in the budget, as well as other direct costs associated with completing the dissertation, such as materials, supplies and ADP services.

Unallowable Costs:  Specific costs not allowed on dissertation research grants include:  alterations/renovations, space rental, contracting or consortium costs, consulting costs, dissertation defense or deposit fees, membership fees and costs associated with faculty/advisor mentor supervision. Salary support for individuals, other than the candidate, is not allowable. Computer and statistical consulting support is not allowable.  This list is not all inclusive, and the applicant should contact AHRQ staff regarding any other items being considered for which there are questions regarding whether or not the items are allowable.  

Level of Effort:  The candidate must devote at least 40 hours per week to the dissertation for a minimum of nine months beginning at the time of award.  The requested start date of award must be estimated to begin no less than four months from the submission date.  Receipt of additional compensation (e.g., pay) from other sources for performance of work that is distinctly separate from the actual work involved in the conduct of the dissertation is allowable, but cannot exceed a paid level of effort greater than 20 hours per week.

Facilities and Administrative Costs: (i.e., overhead or indirect costs) are limited to no more than eight percent of modified total direct costs.

Protection of Human Subjects:  A discussion of human subjects protection must be included if the proposed research involves any contact with or data on humans (e.g., patients, providers, administrators); including data obtained from secondary publicly or privately available data sources.  This section does not count toward the 10 page limitation.  If human subjects are involved, the applicant must also check ‘yes’ in the appropriate box described in the ‘Other Project Information Component Section’ of the SF424 R&R application form.

Targeted/Planned Enrollment: AHRQ requires completion of targeted/planned enrollment.

Other Project Information Component:

  • Instruction in the Responsible Conduct of Research:  A detailed plan for the Instruction in the Responsible Conduct of Research must be included (see NOT-OD-10-019). The plan must include the rationale, subject matter, appropriateness, format, frequency and duration of instruction.  Applications without plans for training in the responsible conduct of research will be considered incomplete and may be returned without review. No award will be made if an application lacks this component. For additional information, see the US DHHS Office of Extramural Research, NIH on Training in the Responsible Conduct of Research (http://grants1.nih.gov/training/responsibleconduct.htm) or the USDHHS Office of Research Integrity (http://ori.dhhs.gov/). The description of the plan for the Instruction in the Responsible Conduct of Research is limited to one page and must be placed in the Other Attachments section of the Research & Related Other Project Information, not in the Appendix.
  • Transcripts.  The application must include a transcript of the student's record to date in the doctoral program of which the dissertation is a part. The transcript must be placed in the “Other Attachments” section of the Other Project Information Component, not in the Appendix.

Appendix materials: The only acceptable Appendix materials are copies of any survey instruments or questionnaires, data collection or interview guides used in the proposed research, if applicable.

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 and will not undergo review.

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 not be reviewed if it does not comply with these requirements.

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

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.

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, 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:

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

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 dissertations are evaluated for scientific and technical merit through the AHRQ peer review system.  Reviewers will include in their overall and individual assessments both the research project and the potential of the candidate to become an independent health services researcher (based on assessments of such items as: letters submitted, biosketches, etc.)

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project and the candidate 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 review criteria below in the determination of scientific and technical merit of the proposed research project and the candidate, and give a separate score for each criterion.  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 the proposed dissertation project address an important problem unique to the mission of AHRQ?  If the aims of the project are achieved, how will scientific knowledge, health care delivery, or clinical practice be advanced?  What will be the effect of this research on the concepts, methods, technologies, treatments, services, preventative interventions, or health care policies that drive this field? 

Investigators. Are the PD/PI and mentor(s) appropriately trained and well suited to the proposed research project? Is there evidence that an appropriate level of effort will be devoted by the mentor(s) to ensure the successful completion of the dissertation project? Is there evidence that mentor(s) have been adequately prepared to actively work with the PD/PI and have actively worked with the PD/PI to date in the development of the proposed dissertation project? Does a viable mentoring plan and/or mentor/PD/PI agreement exist?  Does the PD/PI demonstrate potential to have a successful career in health services research?

Innovation.  Is the dissertation 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?  

Approach.  Are 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?   

Environment.  Does the scientific environment(s) in which the work will be done contribute to the probability of success?  Does the proposed research project benefit from unique features of the scientific environment(s)?  Is there evidence of institutional support (e.g., computers, data, and office space)?   

2.A. Additional Review Criteria

In addition to the above criteria, the reviewers will consider the following additional items in the determination of scientific merit and the rating, but will not give separate scores for these items.

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?

Inclusion. Are there adequateplans to address the needs of 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).

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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.

Resubmission Applications (formerly “revised/amended” applications). Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Budget and Period of Support. Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

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:

  • Scientific merit of the proposed project as determined by peer review
  • Availability of funds
  • Responsiveness to goals and objectives of the FOA
  • Relevance to program priorities and programmatic balance
  • Portfolio balance within AHRQ

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" (https://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.  See also Section IV.5., “Funding Restrictions.”

AHRQ Dissertation grants are included under expanded authorities, but pre-award costs are NOT allowed.  

The dissertation award terminates once the requirements for the doctoral degree are met. Should an award terminate before the reflected project period end date, the grantee is required to submit a letter to the AHRQ Grants Management Specialist, countersigned by an administrative official, indicating the expected end date. Unexpended funds are to be reported on the Federal Financial Report (FFR) and returned to the AHRQ within 90 days of the project period end date.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements 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 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 award.   

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

3. Reporting

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 and final 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.

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.

Scientific/Research Contact(s):

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

Brenda A. Harding, M.A.
Office of Extramural Research, Education and Priority Populations (OEREP)
Division of Research Education
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1527
Fax (301) 427-1561
Email address:  Brenda.Harding@ahrq.hhs.gov

1.  Peer Review Contact(s):

Direct inquiries regarding peer review issues to:

Ali Azadegan, D.V.M, Ph.D.
Office of Extramural Research, Education and Priority Populations (OEREP)
Division of Scientific Review
540 Gaither Road
Rockville, Maryland 20850
Telephone: (301) 427-1869
Fax: (301-427-1561
Email address:  Ali.Azadegan@ahrq.hhs.gov

2.  Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

Anna Caponiti
AHRQ Grants Management
Office of Performance Accountability, Resources and Technology
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1402
Fax: (301) 427- 1462
E-mail address: Anna.Caponiti@ahrq.hhs.gov

Section VIII. Other Information

Required Federal Citations

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 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. 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 https://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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



 

Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Office of Extramural Research, Education and Priority Populations (OEREP), (http://www.ahrq.gov)

Title:AHRQ Grants for Health Services Research Dissertation Program (R36)

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 re-issue of PAR-06-118, which was previously released January 13, 2006.

Update: The following update relating to this announcement has been issued:
  • August 8, 2012 - This PAR has been reissued as PA-12-256.
  • August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
  • September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011.  Adobe B1 forms are required for due dates on or after May 8, 2011.
  • February 12, 2010 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond.  If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions.  If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

Program Announcement (PA) Number: PAR-09-212

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).

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: July 17, 2009
Opening Date: October 1, 2009 (Earliest date an application may be submitted to Grants.gov)
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):   February 1, May 1, August 1, and November 1 annually, beginning November 1, 2009
Peer Review Date(s): Generally two months after receipt date
Earliest Anticipated Start Date(s): Generally two months after peer review date
Expiration Date:  August 2, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

  • Purpose: The overall goal of the AHRQ grants for Health Services Research Dissertation Program is to help ensure that a diverse pool of highly trained health services researchers is available in adequate numbers and appropriate research areas to address the research mission and priorities of AHRQ, noted below.  This announcement represents the continuation of an AHRQ program that provides support to individuals who are conducting research undertaken as part of an academic program to qualify for a research doctorate degree.
  • Mechanism of Support: This Funding Opportunity Announcement (FOA) utilizes the dissertation research grant mechanism (R36).
  • Funds Available and Anticipated Number of Awards: The total amount to be awarded and the number of awards will depend upon the quality and merit of applications received and the availability of funds.
  • Budget and Project Period:The total direct costs awarded under this FOA for dissertation grants must not exceed $40,000 for the entire project period, which must be a minimum of nine months and not to exceed 17 months in duration.  Individuals supported under Ruth Kirschstein National Research Service Award (NRSA) mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for a dissertation award.  However, such individuals may only request up to $20,000 direct costs for additional, non-salary expenses.  In such instances, the application must include a statement describing the expenses requested under the dissertation grant application which are not supported through the active training grant or fellowship. The proposed start date for the dissertation grant must be a minimum of four months after the application submission deadline.
  • Application Research Strategy Length:  The R36 Research Strategy section may not exceed 10 pages, including tables, graphs, figures, diagrams, and charts.
  • Eligible Institutions/Organizations:For the purpose of this FOA, AHRQ will make grants only to domestic non-profit organizations.  The applicant organization must be the doctoral granting institution at which the student is registered and matriculating.  Individuals cannot apply directly.  See Section III for further details.
  • Eligible Project Director/Principal Investigator (PD/PI). Also referred to as the Applicant or Candidate, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their mentor and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for AHRQ support.  Applicants must be U.S. citizens, non-citizen nationals, or permanent residents by the time of the award.  Applicants must be full-time students in good standing, who are enrolled in an accredited research doctoral program in such fields as the social or behavioral sciences, health services research, social sciences, epidemiology, biostatistics, health policy, and health informatics.  Students will have completed all non-dissertation requirements for their doctoral degree by the time of submission of the application (except a clinical internship where that is required to follow the dissertation phase).  Approval of the dissertation proposal by the doctoral committee is required by the time of the grant award.  See Section III for details.
  • Number of PDs/PIs: Only one PD/PI may be designated on the application and the individual must be the student seeking dissertation support.
  • Number of Applications: Applicants may only have one individual dissertation grant application pending peer review within the Department of Health and Human Services (DHHS) at any time. 
  • Resubmissions: One resubmission is allowed.  Resubmissions have the same due dates as new applications.
  • Renewals:  Awards are not renewable.
  • Application Materials:See Section IV for application materials.
  • General Information:For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • Hearing Impaired:Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    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

Applications for dissertation research grants must be responsive to AHRQ’s mission, which is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.  The research sponsored and conducted by the Agency develops and presents scientific evidence regarding all aspects of health care.  It addresses issues of organization, delivery, financing, utilization, patient and provider behavior, outcomes, effectiveness and cost.  It evaluates both clinical services and the system in which these services are provided.  These scientific results improve the evidence base to enable better decisions about health care, including such areas as disease prevention, appropriate use of medical technologies, improving diagnosis and treatment in cost-effective ways, long-term care, and reducing racial and ethnic disparities. 

AHRQ has identified strategic goals as priority research areas. Research applications must address one of these areas.  Applicants are strongly encouraged to focus on topical areas unique to AHRQ, demonstrating how expected results can be used or made available for use to enhance healthcare quality.  Results should be directly relevant to customers, such as providers and practitioners, administrators, payers, consumers, policymakers, and insurers.  The strategic research goals are:

  • Safety/quality – Reduce the risk of harm from health care services by promoting the delivery of appropriate care that achieves the best quality outcomes
  • Efficiency – Achieve wider access to effective health care services and reduce health care costs
  • Effectiveness – Assure that providers and consumers/patients use beneficial and timely health care information to make informed decision choices.

AHRQ has particular interest in supporting dissertation projects in the following areas:  comparative effectiveness, health information technology (health IT), patient safety, prevention and care management, value, and healthcare innovations.  To learn more about AHRQ’s focus within these portfolios of work, please visit http://www.ahrq.gov/fund/portfolio.htm

In addition, particular opportunities emphasizing special dissertation areas of interest within AHRQ’s priorities are occasionally posted on AHRQ’s web site at http://www.ahrq.gov/fund/ragendix.htm.  Currently, one Special Emphasis Notice is posted which highlights interest in dissertation applications related to use of health IT.  The Notice emphasizes an interest in applications focusing on use of health IT to improve the quality and safety of medication management, patient-centered care, and/or health care decision making in one or more of the following care settings: ambulatory setting(s); transitions in care between ambulatory settings; or transitions in care between an ambulatory setting and non-ambulatory setting.   A direct link to this Notice can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-08-014.html.  This link will be deactivated upon expiration.  Applicants are encouraged to access AHRQ’s postings for updates. 

Applicants are further encouraged to address health services research issues critical to AHRQ priority populations, including: individuals living in inner city and rural (including frontier) areas; low-income and minority groups; women, children, the elderly; and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care. 

This FOA describes the procedures and criteria for the AHRQ dissertation grant program.  It updates and supersedes the AHRQ Grants for Health Services Research Dissertation PAR-06-118, published January 13, 2006.

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the research dissertation grant (R36) award mechanism.  Applicants will be solely responsible for planning, directing, and executing the proposed project.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.  Applicants should use the SF424 (R&R) Budget Component described in the SF424 (R&R) Application Package and Instructions Guide.

2. Funds Available

The total direct costs awarded under this FOA for dissertation grants must not exceed $40,000 for the entire project period, which must be a minimum of nine months and not to exceed 17 months in duration.  Individuals supported under Ruth Kirschstein National Research Service Award (NRSA) mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for a dissertation award.  However, such individuals may only request up to $20,000 direct costs for additional, non-salary expenses.  A statement must be provided indicating that the expenses requested under the dissertation grant application are not supported through the active training grant or fellowship. 

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 include support for this program, awards pursuant to this FOA are contingent upon the availability of funds.  Facilities and Administrative (F & A) costs (i.e., overhead or indirect costs) are limited to 8% of approved direct costs.

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:

  • Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
  • Units of local or State government;
  • Eligible agencies of the Federal government.
  • Indian/Native American Tribal Government (Federally Recognized);
  • Indian/Native American Tribal Government (Other than Federally Recognized);
  • Indian/Native American Tribally Designated Organizations.

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 domestic 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.

For dissertation grants, the applicant organization must be the doctoral granting institution at which the student is registered and matriculating.  Individuals cannot apply directly.

1. B. Eligible Individuals

Eligible individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with his or her institution 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 programs.  Applicants are eligible to apply for this award provided that they:

  • Are U.S. citizens, non-citizen nationals, or permanent residents by the time of the award; 
  • Are full-time students in good standing, who are enrolled in an accredited research doctoral program in such fields as the social or behavioral sciences, health services research, social sciences, epidemiology, biostatistics, health policy, and health informatics.
  • Will have completed all non-dissertation requirements for their doctoral degree by the time of submission of the application (except a clinical internship where that is required to follow the dissertation phase). 
  • Have received approval of the dissertation proposal by the doctoral committee by the time of the grant award. 

As noted above, individuals supported under Ruth Kirschstein National Research Service Award mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for a dissertation award, with funding limitations described above.  A statement must be provided in the application describing the expenses requested which are not supported through the active training grant or fellowship. The request for support must also satisfy applicant institutional policies.  Recipients of mentored career development awards are not eligible for dissertation support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of applications:  AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review by the Department of Health and Human Services (DHHS) unless the applicant withdraws the pending application.  This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF 424 (R&R).

Resubmissions:  Applicants may submit one resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Renewals:  Renewals will not be allowed for this mechanism.

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.

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

  • Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
  • If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
  • The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
  • Direct questions regarding Grants.gov registration to:
    Grants.gov Customer Support
    Contact Center Phone: 800-518-4726
    Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
    Email support@grants.gov

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.

  • The individual designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. 
  • The PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
  • A PD/PI at the applicant organization must be affiliated with that organization. A PD/PI located at another institution need not be affiliated with the applicant organization, but must be affiliated with his/her own organization to be able to access the Commons.
  • This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

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

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. AHRQ/NIH will accept electronic applications only from organizations that have completed all necessary registrations.

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 301-710-0267, 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 (https://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 NIH (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/APPLYincludes 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) PHS398 Cover Letter is optional.
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, regarding appropriate required budget component)  

Optional Components:
PHS398 Cover Letter is optional. This does not replace required letters, noted below, which must be included (Letters of Support).

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:

If 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 must submit its budget using the Research & Related Budget component.  All other institutions must 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 in the case of multiple institutions. 

3. Submission Dates and Times

See Section IV.3.A. For details.

3. A. Submission, Review, and Anticipated Start Dates
Opening Date: October 1, 2009 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s):   February 1, May 1, August 1, and November 1 annually, beginning November 1, 2009.     
Weekend/Federal Holiday Submission Dates. If a submission date falls on a weekend, it will be extended to the following Monday; any time the date falls on a Federal holiday, the submission date will be extended to the following business day. The application will be on time if it is submitted on or before the following business day.
Peer Review Date(s): Generally two months after receipt date
Earliest Anticipated Start Date(s): Generally two months after peer review date 

3. A.1. Letter of Intent

A letter of intent is not required for this FOA. This does not replace required letters, noted above.

3. B. Submitting an Application Electronically to the AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/web/grants/applicants/apply-for-grants.html and follow Steps 1-4. Note: Applications must only be submitted electronically.   PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time(of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:

  • All registrations must be complete prior to the submission deadline
  • The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
  • Any system identified errors/warnings must be corrected and the submission process completed within the “error correction window.”

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

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!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov,NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

  • Initial application submission must be “on-time.”
  • The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings.  NIH may reject any application that includes additional changes.
  • Proof of “on-time” submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

  • If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
  • Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to “Reject” the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The “Reject” feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
  • If the two-day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
  • If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
  • Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

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

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. 

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

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. AHRQ will not accept any application that is essentially the same as one already reviewed. However, AHRQ will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://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. IRB approval is required prior to award.

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, must 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 must state explicitly in the “Research Design and Methods” section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research.  In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data.  This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

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

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

In developing research plans, applicants must 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 must 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

6. Other Submission Requirements

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

AHRQ requires the PD(s)/PI(s) 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 are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

  • Introduction (required for a resubmission or revision application) is limited to 1 page. 
  • Specific Aims is limited to 1 page.
  • Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 10 pages

Additional Instructions:   In preparing the application, the following instructions are to be used in conjunction with the SF424 (R&R) Application Guide:

Research Strategy:  Do not exceed 10 pages for the Research Strategy.   All tables, graphs, figures, diagrams, and charts must be included within the 10 page limit.  Part of the research strategy must describe any potential outcomes, products and/or impact of the proposed research on policy or practice, as well as dissemination plans, which involve traditional academic as well as nontraditional means of communicating relevant research findings to policymakers or health care delivery personnel.  A clear description of the unique contribution of this effort must be included, especially if the research builds upon ongoing or previously conducted work by the principal investigator, or other dissertation committee member/faculty.

If the application is a resubmission, an ‘Introduction to the Application for Resubmission’ must be completed.  This section must be limited to one page.   This introduction does not count toward the 10 pages limit for the Research Strategy described above.

Project Narrative:  within the Research Strategy, include a brief description of the “Relevance and Impact” of the proposed research on policy or health practice.  Use no more than two to three sentences for the narrative. 

Letters of Support and Appendix materials:  The only acceptable Appendix materials are (a) a required copy of the scanned official transcript from the current institution granting the Ph.D.; and (b) copies of any survey instrument(s) to be used in the proposed research, if applicable (See below for details for including the required Letters of Support and appendix materials).

Research & Related Senior/Key Person Profile:  The dissertation candidate, who must be matriculated in an accredited doctoral program, will be the designated PD/PI.  The mentor for the PD/PI must be listed as a key person.  Other key persons are the other members of the dissertation committee, as well as any other consultants involved in the research project.  Attach a biographical sketch for the PD/PI, mentor, and all other key personnel.  It is strongly encouraged that the doctoral dissertation committee includes recognized health services researchers with appropriate interdisciplinary or multidisciplinary expertise necessary to fully support the research activities.

Budget:  AHRQ does not accept modular budgets.  Below is a further description of the budget component.

Allowable Costs:  The Senior/Key Person is the applicant (the person completing the dissertation).  Stipend/salary compensation can be requested for the applicant up to the current fiscal year NRSA pre-doctoral stipend level (in FY 2009 this is $20,976, see https://grants.nih.gov/training/nrsa.htm#policy). 

Include equipment and travel costs as appropriate.  General purpose equipment items, such as personal computers, must be separately listed and estimated under equipment costs.  The applicant must provide justification for each budget item requested in the detailed budget for the total period of support being requested.  In particular, proposed computer-related purchases need to be fully justified in terms of not being readily available to the student for the conduct of the research.  Applicants can request up to $1500 in travel costs to attend appropriate scientific meetings.

The only allowable tuition-related costs are those associated with dissertation credits and matriculation fees.  Health insurance fees should also be listed, as well as other direct costs associated with completing the dissertation, such as materials, supplies and ADP services.

Unallowable Costs:  Specific costs not allowed on dissertation research grants include:  alterations/renovations, space rental, contracting or consortium costs, dissertation defense or deposit fees, membership fees and costs associated with faculty/advisor mentor supervision. This list is not all inclusive, and the applicant should contact AHRQ staff regarding any other items being considered for which there are questions regarding whether or not the items are allowed to be included.  

Level of Effort:  Students must devote at least 40 hours per week on the dissertation for a minimum of nine months beginning at the time of award.  The requested start date of award must be estimated to begin no less than four months from the submission date.  Receipt of additional compensation (e.g., pay) for performance of work that is distinctly separate from the actual work involved in the conduct of the dissertation is allowable, but cannot exceed a paid level of effort greater than 20 hours per week.

Facilities and Administrative Costs: (i.e., overhead or indirect costs) are limited to eight percent of approved direct costs less tuition-related costs.

Protection of Human Subjects:  A discussion of human subjects protection must be included if the proposed research involves any contact with or data on humans (e.g., patients, providers, administrators); including data obtained from secondary publicly or privately available data sources.  This section does not count toward the 10 page limitation.  If human subjects are involved, the applicant must also check ‘yes’ in the appropriate box described in the ‘Other Project Information Component Section’ of the SF 424 R&R application form.

Targeted/Planned Enrollment: AHRQ does not require completion of targeted/planned enrollment.    

Letters of Support: The following two letters are required (NOTE: these differ in content from the optional Cover Letter described in the SF 424 (R&R) instructions. Applicants must follow the specific instructions on Letters of Support as described in SF424 (R&R) Application Guide.

  • A letter from the faculty committee or the University official directly responsible for supervising the dissertation research must be submitted with the grant application.  The letter must specifically address the potential of the candidate, as well as the qualifications and experience of the candidate to conduct the study as proposed, both in terms of content and methodological expertise gained from coursework.  In addition, the letter must certify that the dissertation grant application reflects the planned dissertation work to be conducted by the applicant, and that the applicant has completed all other necessary requirements for completion of the doctorate degree, other than the dissertation proposal defense.  This includes certifying that all coursework required for the completion of the Ph.D. must be completed prior to submission.  Certification that the proposal defense has been successfully completed will be required prior to awarding the application.  Further, the letter should acknowledge the existence of sufficient institutional infrastructure support for the candidate must also be included in the faculty letter, including but not limited to items such as office space, computer access, mentoring plan, etc.  The mentorship description must clearly note the frequency of meetings as well as content and methodological support to be provided.  The letter must also indicate that a collaborative process was established between the applicant and advisors in the development and review of this dissertation grant application.
  • A letter from the applicant must be submitted with the grant application.  The letter must discuss career goals, background and interest in health services research, the anticipated manner in which the proposed dissertation will contribute to career goals, and the unique relevance of the proposed dissertation to AHRQ.

Warning:  Be sure that the direct cost, project period, and page number limitations specified for this FOA are observed.  Any application not in compliance with the requirements will not be reviewed. 

Appendix Materials: The only acceptable appendix materials are (a) a required copy of the scanned official transcript from the current institution granting the Ph.D.; and (b) copies of any survey instrument(s) to be used in the proposed research, if applicable.  Do not mail transcripts to the AHRQ.

Do not use the Appendix to circumvent the page limitations of the Research Plan component.  Any application that does not comply with this requirement will not be reviewed.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health 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 https://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),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).  The NEDS, the newest addition to the HCUP databases, is the largest all-payer ED database in the United States and contains over 25 million (unweighted) records for ED visits at about 1,000 hospitals.  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.

Plan for Sharing Research Data

Data sharing is not required for this FOA.

Section V. Application Review Information

1. Criteria

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria are described below.  The review criteria described below will be considered in the review process.

2. Review and Selection Process

Review 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:

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

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 core 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 the proposed dissertation project address an important problem that is within the mission and priorities of AHRQ as described above? If the aims of the project are achieved, how do they advance scientific knowledge or how usable are they to decision makers or consumers?  What will be the effect of this research project on the concepts or methods that drive the field of study?

Investigators:Does the candidate have the potential for a promising career in health services research?  Does the mentor have the appropriate background and expertise in health services research?  Is there adequate demonstration of the mentor’s commitment to the student?  Is sufficient multidisciplinary expertise encompassed on the dissertation committee?

Innovation: Does the project contribute to existing literature?  For example, does the project address an innovative hypothesis?  

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project?  Are potential problem areas acknowledged and alternative tactics considered?

Environment:Does the scientific environment in which the student’s work will be done contribute to the probability of success?  Does the proposed project take advantage of unique features of the scientific environment or employ useful collaborative arrangements?  Is there evidence of institutional support in the form of adequate office, computer, methodological, and statistical support?

2. A. Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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).

Inclusion: Adequacy of plans to address the needs of 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.

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

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.

Dissemination Plans:   Does the applicant describe plans to disseminate the results of the dissertation research?   If appropriate, do the plans include dissemination strategies which avail policymakers, consumers, providers or other users of the results?  

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2. B. Additional Review Considerations

Not Applicable.

2. C. Resource Sharing Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data.  There are 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 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  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

AHRQ grantees may copyright, unless otherwise provided in grant awards, 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).

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:

  • Scientific merit of the proposed project as determined by peer review
  • Availability of funds;
  • Responsiveness to goals and objectives of the FOA; and
  • Portfolio and programmatic balance

3. Anticipated Announcement and Award Dates

Generally, applicants must anticipate a minimum of four 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 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" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization.  Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official.  The NOA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NOA are at the recipient’s risk.  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).

The dissertation award terminates once the requirements for the doctoral degree are met.  Should the award terminate before the reflected project period end date, submit a letter to AHRQ, counter-signed by an administrative official, indicating the expected end date.  Unexpended funds are to be reported on the financial status report (FSR) and returned to the AHRQ within 90 days of the expiration date.

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

3. Reporting

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

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).  This report must be submitted for each budget period no later than 90 days after the close of the budget period.  A hard copy of the report should be submitted to the assigned grants management specialist.

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 inquiries about general FOA issues to:

Brenda A. Harding, M.A.
Division of Research Education
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone:  (301) 427-1527
FAX: (301) 427-1562
Email: brenda.harding@ahrq.hhs.gov

2. Peer Review Contact(s):

Direct inquiries about peer review issues  toissues to:

Ali Azadegan, D.V.M., Ph.D.
Division of Scientific Review
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1689
Fax: (301) 427-1562
E-mail address:  Ali.Azadegan@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

Anna Caponiti
Division of Grants Management
Office of Performance Accountability, Resources and Technology
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1402
Fax: (301) 427- 1462
E-mail address: Anna.Caponiti@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 (https://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at https://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 https://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 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. 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:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) 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) 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 under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption” in FOIA, 5 USC 552(b)(3).  It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support.  Proprietary data might also be exempted from FOIA disclosure requirements under "the (b) (4) exemption", 5 USC 552(b) (4) for example, if it constitutes trade secrets or commercial information.  NIH has provided general related guidance at https://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 2010:

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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.

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