Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Applications for dissertation research grants must be responsive to AHRQ’s mission, which is to produce evidence to make health care safer, higher quality, more accessible, equitable and affordable, and to work within HHS and with other partners to make sure that the evidence is understood and used. Within the mission, AHRQ’s specific priority areas of focus are:

• Improve health care quality by accelerating implementation of Patient Centered Outcomes Research (PCOR)
• Make health care safer
• Increase accessibility by evaluating expansions of insurance coverage
• Improve health care affordability, efficiency and cost transparency

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 disparities based on race, ethnicity, gender, or socioeconomic status. AHRQ welcomes any area of health services research relevant to AHRQ's priority areas as a dissertation project topic. AHRQ research priority areas are described at http://www.ahrq.gov/funding/policies/foaguidance/index.html.

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.

Candidates are encouraged to address health services research issues critical to AHRQ priority populations, including: individuals living in inner city or 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 AHRQ PA-12-256, published August 7, 2012.

These projects are authorized by 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

All applications submitted and AHRQ grants made in response to this FOA are subject to the Office of Management and Budget's (OMB's) "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards," (the "Uniform Grant Guidance") at 2 CFR part 200, et seq, the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html and http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

You may submit an application(s) if your institution/organization is a (an):

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Unit of local or State government;
• Eligible agency 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 Organization.

The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Non-Profit Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. 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 to apply.

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.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Director/Principal Investigator (PD/PI)

The PD/PI must have an eRA Commons account. The PD/PI should work with his/her organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, he/she must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual at the dissertation stage of training with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (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. The PD/PI is also referred to in this PA as a "Candidate."

Only one PD/PI may be designated on the application.

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 (as defined by the student's institution) 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 allowed will be the completion of required clinical internships that follow completion of the dissertation;
• Do not have 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 appointment; and
• Are not recipients of mentored career development awards.

Information for candidates with active National Research Service Award (NRSA) support:

As noted above, individuals supported under NRSA mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for an AHRQ dissertation award.

The request for support must satisfy the applicant's institutional policies and the application must include a statement describing the expenses requested under the AHRQ R36 dissertation grant program which are not supported through the active NRSA training grant or fellowship. Individuals may only request up to $20,000 direct costs for additional, non-salary expenses; no funds may be requested for salary, fringe benefit, or stipend support.

This FOA does not require cost sharing.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

AHRQ will not accept duplicate or highly overlapping applications under review at the same time. This means that AHRQ will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Not Applicable

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional requirements:

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.

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 application page limitations. If human subjects are involved, the applicant must check yes in the appropriate box described in the Other Project Information Section of the SF424 R&R application form.

All instructions in the SF424 (R&R) Application Guide must be followed.

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 key persons to be listed 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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Budget Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ are to ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.

The applicant must provide justification for each budget item requested in the detailed budget for the total period of support being requested. Include salary, equipment, travel, and other costs as appropriate. The budget component is described further below.

Allowable Costs:

Stipend/Salary Compensation	Stipend/salary compensation can be requested for the Candidate up to the current fiscal year NRSA pre-doctoral stipend level (information for FY 2015 can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-048.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.
Tuition and Matriculation	Costs 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.
Data Collection/ Coding	Justifiable costs associated with data collection/coding, such as data purchase, the need for additional data transcription services (other than that provided by the Candidate) for qualitative data, survey incentives, or travel costs directly associated with data collection. Travel costs associated with data collection should be budgeted separately from any travel costs associated with conference attendance and should not be counted toward the $1,500 limit on scientific meeting/conference travel (see below).
Scientific Meeting/Conference Travel	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.
Equipment/Supplies	General purpose equipment items, such as personal computers, must be separately listed and estimated under equipment costs. 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.

Unallowable Costs:

Specific costs not allowed on dissertation research grants include: salary support for individuals other than the candidate, consultant/consulting costs (including computer and statistical consulting support), alterations/renovations, space rental, contracting or consortium costs, dissertation defense or deposit fees, membership fees, costs associated with faculty/advisor mentor supervision.

The above lists of allowable and unallowable costs are not all-inclusive, and the applicant should contact AHRQ staff regarding any other items being considered for which there are questions regarding allowability.

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 eight 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:

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

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement must be followed, with the following additional instructions:

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 Narrative are 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:

• 1. 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; and
  • Indicate that a collaborative process was established between the candidate and advisors in the development and review of this dissertation grant application.

2. 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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide with the following modification:

Acceptable Appendix materials are a copy of the official transcript of the candidate's doctoral program record, to date, and copies of any survey instruments or questionnaires, data collection or interview guides used in the proposed research, if applicable.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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/funding/grants/policies/hhspolicy.html.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

The PD/PI must include his/her eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to AHRQ. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ. Applications that are incomplete, non-compliant, or non-responsive will not be reviewed.

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

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

AHRQ supports research, evaluations, and demonstration projects concerning 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. 42 USC 299(c). 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 is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available 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.

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.

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.

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, 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 applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

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 requests that grantees notify the Office of Communications and Knowledge Transfer (OCKT) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the Uniform Grant Guidance (available in libraries and on the website of the Office of the Federal Register at https://www.federalregister.gov/articles/2013/12/26/2013-30465/uniform-administrative-requirements-cost-principles-and-audit-requirements-for-federal-awards).

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.

AHRQ's priority areas of focus are:

• Improve health care quality by accelerating implementation of patient-centered outcomes research (PCOR).
• Make health care safer.
• Increase accessibility by evaluating Affordable Care Act (ACA) coverage expansions.
• Improve health care affordability, efficiency, and cost transparency.

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.

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. Only the review criteria described below will be considered in the review process.

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific 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.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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) has been adequately prepared to actively work with the PD/PI and has 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?

Is the dissertation project original and innovative? For example: Does the project challenge current research or seek to shift clinical practice paradigms; 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?

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 candidate acknowledge potential problem areas and consider alternative tactics?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the candidate adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Degree of Responsiveness

Reviewers will assess how well the application addresses 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 of Priority Populations

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements ).

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable and whether the requested period of support is appropriate in relation to the proposed research.

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group in accordance with AHRQ review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the FOA.
• Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance.

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 eRA Commons.

Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.

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 and budgetary issues, verification of dissertation committee's approval of the candidate's dissertation proposal, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, 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).

If all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.

Selection of an application for award is not an authorization to begin performance.

Pre-award costs are NOT allowed. Any costs incurred before receipt of the NOA are at the recipient’s risk. See also Section IV.5., Funding Restrictions.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

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.

All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

A standard term and condition of award will be included in the Notice of Award (NOA) that states: in any grant-related activity in which family, marital, or household consideration are, by statute or regulation, relevant for purposes of determining beneficiary eligibility or participation, grantees must treat same-sex spouses, marriages, and households on the same terms as opposite-sex spouses, marriages, and households, respectively. By same-sex spouses, HHS means individuals of the same sex who have entered into marriages that are valid in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By same-sex marriages, HHS means marriages between two individuals validly entered into in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By marriage, HHS does not mean registered domestic partnerships, civil unions or similar formal relationships recognized under the law of the jurisdiction of celebration as something other than a marriage.

All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that grantees inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award. Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Progress reports are due 3 months before the anniversary of the award. In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. If applicable, detailed instructions on additional reporting requirements will be provided with the grant award.

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 (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 is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2015, the annual FFR is due 9/30/2015 (90 days after the end of the calendar quarter of 6/30/2015).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable AHRQ grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm) for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:
Gregory Stuppard, M.A.
Office of Extramural Research, Education and Priority Populations (OEREP)
Division of Research Education
Agency for Healthcare Research and Quality
Telephone: 301-427-1391
Email: Gregory.Stuppard@ahrq.hhs.gov

Direct your questions about peer review issues of grant application made in response to this FOA to:
Ali Azadegan, D.V.M., Ph.D.
Office of Extramural Research, Education and Priority Populations (OEREP)
Division of Scientific Review
Agency for Healthcare Research and Quality
Telephone: 301-427-1869
Email: Ali.Azadegan@ahrq.hhs.gov

Direct your questions regarding fiscal matters to:
Anna Caponiti
AHRQ Grants Management
Office of Performance Accountability, Resources and Technology (OPART)
Agency for Healthcare Research and Quality
Telephone: 301-427-1402
Email: Anna.Caponiti@ahrq.hhs.gov

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

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 in accordance with the OMB Uniform Grant Guidance 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.