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/about/organix.htm)

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

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

Announcement Type

This is a re-issue of PAR-04-039.

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

• July 17, 2009 - This PA has been reissued as (PAR-09-212).
• January 28, 2009 - See Notice (NOT-HS-09-005) Extending the expiration date.
• January 28, 2008 - See Notice (NOT-HS-08-006) This Notice extends the expiration date.
• March 28, 2007 - See Notice (NOT-HS-07-003) the purpose of this notice is to inform the research community of a change in the receipt dates.

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 (R&R) forms and Application Instruction 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 should be started at least four weeks in advance of the planned submission. (See Section IV).

Program Announcement (PA) Number: PAR-06-118

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release Date: January 13, 2006
Opening Date: March 10, 2006 (Earliest date an application may be submitted to Grants.gov)
Application Submission Dates(s): April 10, August 10, December 10, annually until April 10, 2007, then Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): within 3 months of submission
Earliest Anticipated Start Date: within 5 months of submission
Expiration Date: Now Expired July 18, 2009 (per issuance of PAR-09-212); New Date May 8, 2010 (per issuance of NOT-HS-09-005)(Extended to March 17, 2009 per NOT-HS-08-006) Original Expriation Date: March 17, 2008.

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

The Agency for Healthcare Research and Quality (AHRQ) announces its continued interest in the health services research dissertation grant program (R36). This program supports research undertaken as part of an academic program to qualify for a doctorate. The AHRQ dissertation award supports dissertation research costs for students in accredited research doctoral programs in the United States (including Puerto Rico, and other U.S. Territories or possessions). Dissertation applications must focus on methodological and research topics that address the mission and research interests of AHRQ noted below.

This Funding Opportunity Announcement (FOA) will use the dissertation grant (R36) award mechanism. The total direct costs awarded under this FOA for dissertations must not exceed $35,000 for the entire project period, which should be a minimum of nine months and not to exceed 17 months in duration. The proposed grant start date should not be sooner than five months after the submission deadline.

While grant awards are made to institutions rather than individuals, this FOA and its instructions are written to potential applicants to inform them of this funding opportunity and facilitate the submission of grant applications. For the purpose of this FOA, AHRQ will make grants only to domestic non-profit organizations. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is 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 may apply for this award provided that:

• You are registered in an accredited research doctoral degree program;
• You are in good-standing in that program;
• You will have completed all non-dissertation requirements for your degree by the anticipated start date of the award (except a clinical internship where that is required to follow the dissertation phase);
• Your doctoral committee has approved your dissertation proposal by the time of the grant award; and,
• You are a U.S. citizen, non-citizen national (e.g., residents of U.S. territories), or permanent resident by the time of award.
• Note that 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. However, as these awards cover full-time effort and provide a small amount that may be used to support dissertation research expenses, such students may only receive the up to $15,000 allowed for additional, non-salary expenses, and must provide a statement that these expenses are not supported through the active training grant or fellowship. The request for support must also satisfy institutional policies.
• Applications must be prepared using the SF-424 Research and Related (R&R) grant application instructions and forms. Applicants must download the SF-424 (R&R) application forms and instructions for this FOA through the Grants.gov/Apply web site (see: http://www.grants.gov/Apply).
• Telecommunications for the hearing impaired: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism 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. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

AHRQ announces its continued interest in supporting the health services research dissertation grant program.

The mission of AHRQ 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, emergency preparedness, 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 patient safety and quality of care. 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

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 Program. It updates and supersedes the AHRQ Grants for Health Services Research Dissertation PAR-04-039, published December 16, 2003.

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

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the dissertation grant (R36) award mechanism. As an applicant, you 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 be returned without review.

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 dissertations must not exceed $35,000 for the entire project period, which should be a minimum of nine months and not to exceed 17 months in duration.

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 the AHRQ include support for this program, awards pursuant to this funding opportunity 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 organization has the following characteristics:

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.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is 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:

• You are registered in an accredited research doctoral degree program;
• You are in good-standing in that program;
• You will have completed all non-dissertation requirements for your degree by the anticipated start date of the award (except a clinical internship where that is required to follow the dissertation phase);
• Your doctoral committee has approved your dissertation proposal by the time of the grant award; and,
• You are a U.S. citizen, non-citizen national (e.g., residents of U.S. territories), or permanent resident by the time of award.

Note that 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. However, as these awards cover full-time effort and provide a small amount that may be used to support dissertation research expenses, such students may only receive the up to $15,000 allowed for additional, non-salary expenses, and must provide a statement that these expenses are not supported through the active training grant or fellowship. The request for support must also satisfy institutional policies. Recipients of mentored career development awards are not eligible for dissertation support.

2. Cost Sharing or Matching

AHRQ does not require cost sharing for applications submitted in response to this FOA.

3. Other-Special Eligibility Criteria

Not Applicable.

Section IV. Application and Submission Information

Registration and Instructions for Submission via Grants.gov

To download an Application Package and Application Guide for completing the SF424 (R&R) forms for this FOA, 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:

• Grants.gov (http://www.grants.gov/GetStarted) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

The Project Director/Principal Investigator (PD/PI) should work with his or her institution/organization to make sure both the institution and the individual applicants are registered in the NIH Commons.

Several additional separate actions are required before an applicant institution can submit an application through Grants.gov. See "Preparing for Electronic Receipt" at http://era.nih.gov/ElectronicReceipt/preparing.htm.

1) Organization/Institutional Registration in Grants.gov/Get Started

• 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.

2) Organization/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.

3) Principal Investigator Registration in the eRA Commons: Refer to the eRA Commons User Guide

• The individual designated as the PD/PI on the application must also be registered in the Commons.
• The PD/PI must hold a PD/PI account and be affiliated with the applicant organization.
• This registration must be done by an organization official or their delegate who is already registered in the Commons.
• It is not necessary for Principal Investigators (PD/PIs) to register with Grants.gov. The individual designated as the PD/PI on the application must, however, be registered in the eRA Commons.

NOTE: Both the Principal Investigator (PD/PI) and Signing Official (SO) need separate accounts in Commons since both need to verify the application.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take two weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The 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 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: [email protected].

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 and the SF424 (R&R) Application Guide (MS Word or PDF) instructions.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/Apply will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (An application cover component)
Research & Related Project/Performance Site Locations

Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Appendices copies of official transcripts, and copies of any survey instruments or discussion guides if applicable. (Note: Appendices are to be attached to the PHS 398 Research Plan component, above.)

Optional Components:
PHS 398 Cover Letter -- see instructions for appropriate use. This does not replace required letters, noted below, which should be included under Section 5.5, line item 13 (Letters of Support)

R& R Sub-award Budget Attachment Form not relevant for dissertation applications submitted to AHRQ.

Additional Instructions:
The following instructions are to be used in conjunction with the SF424 (R&R) Application Guide accompanying the SF 424 (R&R) application form:

SF 424 (R&R) (An application cover component) -- Section 4.2

Line item 8, check if the application is new (first time submitted to AHRQ) or a resubmission (an application which has been previously submitted to the AHRQ but was not funded and is being resubmitted for new consideration). NOTE: AHRQ will only accept one resubmission for dissertation applications.

Line item 11, enter the title of the dissertation research project.

Research & Related Project/Performance Site Locations Section 4.4

Line item 7, Project Narrative, AHRQ will use this upload for a description of the Relevance and Impact of the proposed research on policy or health practice. A separate component will be used for the Research Plan itself (see below Section 5.5).

Line item 8, Bibliography and References, was previously section G., Literature Cited, of the PHS 398.

Line items 9 and 10, Facilities and Other Resources and Equipment Resources, are equivalent to PHS 398 Resources Format Page.

Line 11, there are no other attachments to upload for this announcement.

Research & Related Senior/Key Person -- Section 4.5

The dissertation candidate, who must be matriculated in an accredited doctoral program, will be the designated PD/PI. The mentor for the PD/PI should 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 include recognized health services researchers with appropriate interdisciplinary or multidisciplinary expertise necessary to fully support the research activities.

Research & Related Budget Sections 4.6-4.8

AHRQ does not accept modular budgets. Applicants need to complete Section 4.6, R&R Budget Component.

For Section 4.7, applicants need to complete Section A. The Senior/Key Person is the applicant (the person completing the dissertation). Since no other personnel are eligible to receive financial support through the dissertation grant, Section B does not need to be completed.

Include equipment and travel costs in Sections C and D, as requested. Do not complete Section E related to participant/trainee support costs. As noted below, tuition remission and matriculation fees are not allowable. Other direct costs such as health insurance should be included under Section F, along with costs for materials, supplies, and ADP/computer services.

The section 4.8 does not pertain to dissertation grant budgets.

Allowable Costs: Total allowable direct costs include: stipend/salary compensation up to the current fiscal year NRSA predoctoral stipend level (in FY 2006 this is $20,772, see http://grants.nih.gov/training/nrsa.htm#policy), and up to $15,000 for other expenses, including travel to one scientific meeting. Total direct costs may not exceed $35,000. The additional amount may be used to cover health insurance for self and family members, as well as research costs of the dissertation. Travel costs included as part of additional expenses may not exceed $1,500. General purpose equipment items, such as personal computers, need to be separately listed and estimated under equipment costs (even if costing less than $5,000). The applicant must provide justification for each budget item requested in the detailed budget section for the total period of support being requested. Computer-related purchases need to be fully justified as not being readily available to the student for the conduct of the research.

Unallowable Costs: Specific costs not allowed on dissertation research grants are tuition, matriculation fees, alterations/renovations, space rental, contracting or consortium costs, dissertation defense or deposit fees, membership fees and costs associated with faculty/advisor mentor supervision. This listing is not exclusive, and the applicant institutions should contact AHRQ staff regarding any other cost item being considered.

Level of Effort: Although level of effort is reported in terms of months, it is expected that students will devote 100 percent time and effort (based on 40 hours per week) on the dissertation for a minimum of nine months beginning at the time of award. The time of award should be estimated to begin no less than five 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.

PHS 398 Cover Page Supplement Section 5-15

For section 5.4, Modular Budget Component, should not be submitted to AHRQ. AHRQ does not accept modular budgets.

For section 5.5, Research Plan Component, must be completed. If the application is a resubmission, Item 1 (Introduction to Application) must be completed, as described in the instructions. However, this section must be limited to one page.

Items 2-5 (Research Plan Attachments) must not exceed 10 pages. Note that this section will be called Research Plan in the system-generated Table of Contents. Part of the research plan should 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.

For sections 6-10, Human Subjects Sections, must be completed 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. These sections do not count toward the 10-page limitation. AHRQ does not require completion of item 8, Targeted/Planned Enrollment Table.

For sections 11-14, Other Research Plan Sections, need to be completed, as appropriate. For Section 13, Letters of Support, the following two letters are required (NOTE: these differ in content from the optional Cover Letter see SF 424 (R&R) instructions on the Cover Letter Component):

• 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 should 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 approved 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. Certification that the proposal defense had been successfully completed will be required prior to awarding the application. Acknowledgement of the existence of sufficient institutional infrastructure support for the candidate should 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 should clearly note the frequency of meetings as well as content and methodological support to be provided. The letter should 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 should 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.

For section 15, Appendix, needs to be completed. The only acceptable appendix materials are (a) a required copy of the official transcript; and (b) copies of any survey instrument(s) to be used in the proposed research.

3. Submission Dates and Times

Applications must be received by the receipt dates below.

3.A. Submission, Review and Anticipated Start Dates

Opening Date: March 10, 2006 (Earliest date an application may be submitted to Grants.gov)
Application Submission Dates(s): April 10, August 10, December 10, annually until April 10, 2007, then Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): within 3 months of submission
Earliest Anticipated Start Date: within 5 months of submission

3.A.1. Letter of Intent

A letter of intent is not required for this FOA.

3.B. Sending an Application to AHRQ

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

Two steps are required for on time submission:

1) The application must be submitted to Grants.gov by the submission date (see Key Dates above).

2) Applicants must complete a verification step in the NIH eRA Commons within two business days of notification of the NIH validation. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the NIH Commons.

3.C. Application Processing

Applications may be submitted to Grants.gov on or after March 10, 2006 (i.e., the Open Date on Grants.gov) and must be submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission dates described in Section IV.3.A. If an application is not received by that date, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the Signing Official for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.

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

The NIH 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. The NIH will not accept any application that is essentially the same as one already reviewed. 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 SF424 (R&R).

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to the Scientific Review Group is also in the Commons.

The AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review by any component of the US Department of Health and Human Services, unless the applicant withdraws the pending application. The AHRQ will not accept any application that is essentially the same as one already reviewed. 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).

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

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

4. Intergovernmental Review

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

5. Funding Restrictions

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

6. Other Submission Requirements

Priority Populations

The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) reauthorized the Agency and directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should address the requirements of including priority populations as specified in the 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. Contact with the media will take place in close coordination with 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, the AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

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

Specific Instructions for Modular Grant applications.

AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will be returned without review.

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 their own auspices by mailing a disk or posting data on their institutional or personal website, 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.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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 (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness. Merit Review Criteria are described in Section V.2 below.

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

As part of the merit review, all applications will:

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

Applications submitted in response to this FOA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

• Technical merit of the proposed dissertation application and applicant potential as determined by peer review
• Availability of funds
• Relevance to program priorities
• Potential impact of findings on policy and/or practice

Review Criteria

Reviewers will be asked to balance the technical merit of the grant application with strong emphasis placed on their assessment of the applicant's potential as a future health services researcher, as reflected in accompanying letters, the quality and relevance of the written proposal, the caliber of the infrastructure to provide necessary guidance and support to the student, the dissertation chair or faculty advisor’s evaluation of the student, faculty biosketches, and background of the dissertation committee members.

The scientific review group will address and consider each of the criteria listed below in assigning an application=s overall composite score. Specific review criteria will include:

(1) SIGNIFICANCE/IMPACT: Does your study address an important problem from a scientific and/or translational perspective? If the aims of the application are achieved, how do they advance scientific knowledge or how usable are they to decision makers or consumers? What will be the effect of these studies on the concepts or methods that drive this field?

(2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics?

(3) INNOVATION: Does your project employ original concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR/MENTORING: Is the student-investigator appropriately trained and well suited to carry out this work? Is the proposed work appropriate to the mentor(s) experience and the quality of the dissertation award application? Are the mentors appropriately qualified to provide guidance as needed? Have the mentors indicated that they will commit sufficient time and attention to the student? Is evidence of strong mentoring seen in the quality of the dissertation application? Does the student-investigator hold promise to be a contributor to the field of health services research, as determined by his/her career plans, mentor (s) written assessments, the topic of the dissertation?

(5) ENVIRONMENT: Does the scientific environment in which the student’s work will be done contribute to the probability of success? Do the proposed experiments 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?

(6) BUDGET: Is the requested budget and proposed period of support reasonable in relation to the planned research and what has been accomplished to date?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

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

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 item 6 of the Research Plan component of the SF 424 (R&R).

Inclusion: The adequacy of plans to address the needs of genders, racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Adequacy of attention to other populations of special priority to AHRQ (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Required Federal Citations, below).

2.B. Additional Review Considerations

Not Applicable.

2. C. Sharing Research Data

Data Confidentiality

Pursuant to section 934(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute [42 U.S.C.299c-3(d)). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with 42 CFR Parts 160 and 164, a federal Privacy Rule developed by the Department of Health and Human Services 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, for example, health care plans will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) in order that any identifiable health information will be appropriately safeguarded by the investigators. The HHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/. These regulations are in addition to those privacy protections described in human subjects protections regulations 45 CFR 46, also known as the Common Rule.

The awardee 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 websites 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.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce 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. The AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate a minimum of five month timeframe from application submission date to the funding decision.

Section VI. Award Administration Information

1. Award Notices

If an award is to be made, a formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The notice of grant award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Preaward costs are not allowable. Notification will be made electronically to the designated financial and grants management official, with a copy sent to the designated program contact, both noted below.

All of the information included in a paper NGA is included in an E-NGA. AHRQ strongly encourages grantees to take the steps necessary to establish a generic and stable e-mail address to allow the receipt of E-NGAs. Detailed instructions to obtain E-NGAs may be found at http://grants.nih.gov/grants/guide/notice-files/not98-129.html.

2. Administrative and National Policy Requirements

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

A Principal Investigator who discontinues or suspends a project during the grant period must inform the AHRQ program staff immediately in writing. AHRQ may suspend or terminate the grant as requested by the Principal Investigator or on its own initiative.

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 to the AHRQ a letter, 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.

3. Reporting

Closeout Reporting Requirements

• The final Financial Status Report submitted to this office must agree with the final expenditures reported on the PMS 272 to the Payment Management System. Use Standard Form 269 long form. It is available online at: http://grants.nih.gov/grants/fsr_sf269_long.pdf
• General program income subject to the additional costs alternative shall be reported on lines 10r and 10s, as appropriate, of the financial status report (FSR 269 long form). Refer to 45 CFR part 74 & 74.24 for information concerning program income.
• The Final Progress Report is needed to describe the results of the research funded by the Agency. It will be made available to the public, and, therefore, should not include any copyrighted, private, or proprietary information.
• The Final Progress Report is subject to a 20 page limit (minimum of 4 pages). Reports exceeding 20 pages will not be accepted.
• For further details on the requirements of the Final Progress Report, refer to the terms and conditions of the Notice of Grant Award and contact your project officer.

The AHRQ Grant Final Report Template is available online at http://ahrq.gov/fund/reptemp.htm

Section VII. Agency Contacts

We encourage your inquiries concerning this FOA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into the following areas: application process, programmatic, scientific/research, peer review, data sources, financial or grants management issues, and publication and/or communication issues.

Direct your questions regarding programmatic issues, including information on the inclusion of priority populations in study populations to:

Brenda A. Harding, MA
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: [email protected]

Direct your questions about peer review issues to:

Yvette Davis, VMD, MPH
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) 427-1551
FAX: (301) 427-1562
Email: [email protected]

Direct your questions about AHRQ data sources to:

Medical Expenditure Panel Survey (MEPS) Household Component
Doris Lefkowitz, Ph.D.
Center for Financing, Access, and Cost Trends
Phone: (301) 427-1477
E-Mail: [email protected]

Medical Expenditure Panel Survey (MEPS) Nursing Home Component

Jeffrey Rhoades, Ph.D.
Center for Financing, Access, and Cost Trends
Phone: (301) 427-1471
E-Mail: [email protected]

Healthcare Cost and Utilization Project (HCUP)

HCUP User Support
Phone: 1-866-290-HCUP (4287)
E-Mail: [email protected]

Direct your questions about financial or grants management matters to:

Alice Sobsey
Grants Management Specialist
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: 301) 427-1457
FAX: (301) 427-1462
Email: [email protected]

Direct your questions about communication issues and planned dissemination and/or publication of research findings to:

Barbara Kass
Office of Communications and Knowledge Transfer
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1261
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Inclusion of Women, Minorities, and Children in Research Study Populations:

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

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

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

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

Access to Research Data through the Freedom of Information Act:

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

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

Standards for Privacy of Individually Identifiable Health Information:

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

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

Healthy People 2010:

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/, Number 93.226. Awards are made under Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Human Subjects Protection:

Federal regulations 45 CFR 46 require that applications and proposals involving human subjects research must be evaluated 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).