and Human Services (HHS)
EXPIRED
Part I Overview Information
Department of Health and Human Services
Participating
Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Components of
Participating Organizations
Office of Extramural Research, Education and
Priority Populations (OEREP), (http://www.ahrq.gov)
Title: AHRQ Grants for Health Services Research Dissertation Program (R36)
Announcement Type
This Funding Opportunity Announcement (FOA) is a re-issue of PAR-09-212, which was previously released July 17, 2009.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PA-12-256
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Note regarding applicability of NIH Grants Polices and related Guidance: The policies, guidelines, terms and conditions stated in this FOA are not identical to those used by the NIH. This FOA will reference NIH grants policies and guidance where these issuances are applicable or relevant to submissions.
Catalog of Federal
Domestic Assistance Number(s)
93.226
Key Dates
Release/Posted Date: August 7, 2012
Opening Date: October 1, 2012
NOTE: On-time submission requires that applications be
successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization).
Application
Due Date(s): (Extended to February 4, 2014 per NOT-OD-14-047 , Originally
February 1), May 1, August 1, and November 1 annually,
beginning November 1, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest
Anticipated Start Date(s): Generally four months after
peer review date
Additional Information to Be Available Date
(Activation Date): Not Applicable
Expiration Date: August 2, 2015
Due Dates for E.O. 12372
Not
Applicable
Additional Overview Content
Executive Summary
The overall goal of the AHRQ Health Services Research Dissertation Grant Program is to help ensure that a diverse pool of highly trained health services researchers is available in adequate numbers and appropriate research areas to address the research mission and priorities of AHRQ. This program is authorized by 42 U.S.C. 299a(b), which provides that AHRQ may provide training grants in the field of health services research. The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans in the United States.
While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
3.A. Submission, Review, and
Anticipated Start Dates
3.A.1. Letter of Intent
3.B. Submitting an Application
Electronically to AHRQ
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
2.A. Additional Review Criteria
2.B. Additional Review
Considerations
2.C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Applications for dissertation research grants must be responsive to AHRQ’s mission, which is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. The research sponsored and conducted by the Agency develops and presents scientific evidence regarding all aspects of health care in the United States. It addresses issues of organization, delivery, financing, utilization, patient and provider behavior, outcomes, effectiveness and cost. It evaluates both clinical services and the system in which these services are provided. These scientific results improve the evidence base to enable better decisions about health care, including such areas as disease prevention, appropriate use of medical technologies, improving diagnosis and treatment in cost-effective ways, long-term care, and reducing racial and ethnic disparities.
AHRQ has identified strategic goals as priority research areas. Applied research applications must address one of these areas. Applicants are strongly encouraged to focus on topical areas unique to AHRQ, demonstrating how expected results can be used or made available for use to enhance healthcare quality. Results should be directly relevant to customers, such as providers and practitioners, administrators, payers, consumers, policymakers, and insurers. The strategic research goals are:
AHRQ has specific research portfolio areas of interest which include comparative effectiveness/patient-centered outcomes, health information technology (health IT), value, patient safety, prevention and care management, and healthcare innovations. To learn more about AHRQ’s focus within these portfolios of work, please visit http://www.ahrq.gov/fund/portfolio.htm
Candidates are required to address health services research issues critical to AHRQ priority populations, including: individuals living in inner city and rural (including frontier) areas; low-income and minority groups; women, children, the elderly; and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care.
Candidates must conduct dissertation projects which focus on health care delivery in the United States. AHRQ will not accept international health care research projects.
This FOA describes the procedures and criteria for the AHRQ dissertation grant program. It updates and supersedes the AHRQ Grants for Health Services Research Dissertation PAR-09-212, published July 17, 2009.
See Section VIII, Other Information
- Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
This FOA will use the research dissertation grant (R36) award mechanism. Candidates will be solely responsible for planning, directing, and executing the proposed project.
AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.
2. Funds Available
The direct costs awarded to a grant under this FOA will not exceed $40,000 for the entire project period, which must be a minimum of nine months and may not to exceed 17 months from the time of award. Facilities and Administrative (F&A) costs (i.e., overhead or indirect costs) are limited to 8% of modified total direct costs.
Individuals supported under National Research Service Award (NRSA) mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for a dissertation award. However, such individuals may only request up to $20,000 direct costs for additional, non-salary expenses; no funds may be requested for salary support. In such instances, the application must include a statement describing the expenses requested under the dissertation grant application which are not supported through the active training grant or fellowship. The request for support must also satisfy applicant institutional policies. Recipients of mentored career development awards are not eligible for dissertation support.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ include support for this program, awards pursuant to this FOA are contingent upon the availability of funds.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
You may submit an application(s) if your institution/organization has any of the following characteristics:
AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus AHRQ will make grants only to non-profit organizations. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
For dissertation grants, the applicant organization must be an accredited doctoral granting institution at which the student is registered and matriculating. Individuals cannot apply directly.
HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.
1. B. Eligible Individuals
Any individual at the dissertation stage of training with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support. Candidates are eligible to apply for this award provided that they:
Candidates with more than part-time employment in addition to the requirements of their current, full-time academic student appointments (defined as greater than twenty hours per week), are not eligible to apply for this grant mechanism.
As noted above, individuals supported under National Research Service Award (NRSA) mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for a dissertation award, with funding limitations as described above. In such instances, the application must include a statement describing the expenses requested under the dissertation grant application which are not supported through the active training grant or fellowship. The request for support must also satisfy applicant institutional policies. Recipients of mentored career development awards are not eligible for dissertation support.
2. Cost Sharing or Matching
This program does not require cost sharing for applications in response to this FOA.
3. Other-Special Eligibility Criteria
Number of applications: AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review by the Public Health Service unless the applicant withdraws the pending application. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF 424 (R&R).
Resubmissions: Applicants may submit one resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement). Resubmissions should follow the submission date schedule noted in Section IV.3.
Renewals: Renewal applications will not be allowed for this mechanism.
Section IV. Application and Submission Information
To download a SF424 (R&R)
Application Package and SF424 (R&R) Application Guide for completing the
SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically
button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four to six weeks. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.
Do not use the Individual Fellowship Application.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
one FOA.
For further assistance, contact GrantsInfo -- Telephone
301-710-0267; Email: [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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget (See Section IV.6, Special Instructions,
regarding appropriate required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
SPECIAL INSTRUCTIONS
Applications Involving a Single Institution
When a single institution is involved, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
3. Submission Dates and Times
3.A.
Submission, Review, and Anticipated Start Dates
Opening
Date: October 1, 2012
Application Due Date(s):
February 1, May 1, August 1, and November 1 annually, beginning November 1, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest
Anticipated Start Date(s): Generally four months after
peer review date
A letter of intent is not required for this funding opportunity announcement.
3.B. Submitting an Application Electronically to AHRQ
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
3.C.
Application Processing
Applications must be received on or
before the application due date described above (see Section
IV.3.A. for all dates). If
an application is received after that date, the application may be delayed in
the review process or not reviewed.
Submission to Grants.gov is not the last step. Applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review. Incomplete or non-responsive applications will not be reviewed.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5.
Funding Restrictions
For
efficient grant administration, AHRQ grant administration procedures will be
used and conducted in accordance with the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy
Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm
AHRQ Dissertation (R36) awards DO NOT allow pre-award costs.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
AHRQ requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Special Instructions for PHS398 research Plan Component (Section 5.5 of SF424 (R&R) Application)
PHS 398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Additional Instructions: In preparing the application, the following instructions are to be used in conjunction with the instructions provided in the SF424 (R&R) Application Guide:
Research Strategy: Part of the research strategy must describe any potential outcomes, products and/or impact of the proposed dissertation on policy or practice, as well as dissemination plans, which involve traditional academic as well as nontraditional means of communicating relevant research findings to policymakers or health care delivery personnel. A clear description of the unique contribution of this effort must be included, especially if the research builds upon ongoing or previously conducted work by the principal investigator, or other dissertation committee member/faculty. Note: As described in the SF 424 (R&R), the Project Summary/Abstract and Project 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:
Research & Related Senior/Key Person Profile: The dissertation candidate, who must be matriculated in an accredited doctoral program, will be the designated PD/PI. The mentor for the PD/PI must be listed as a key person. The only other listed key persons are the other members of the dissertation committee. Attach a biographical sketch for the PD/PI, mentor, and all other key personnel. It is strongly encouraged that the doctoral dissertation committee includes recognized health services researchers with appropriate interdisciplinary or multidisciplinary expertise necessary to fully support the research activities.
Budget: AHRQ does not accept modular budgets. The budget component is described further below.
Allowable Costs: The Candidate is the person completing the dissertation. Stipend/salary compensation can be requested for the Candidate up to the current fiscal year NRSA pre-doctoral stipend level (information for FY 2012 can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-033.html). Salary must be consistent with the established salary structure at the institution if it were using its own funds to support other staff members of equivalent qualifications, rank, and responsibilities at the institution. Fringe benefits can be requested only if the candidate is employed by the applicant organization.
Salary may not be requested for any personnel other than the Candidate. Funds may not be requested for consultant costs.
Include equipment, travel, and other expenses costs as appropriate. General purpose equipment items, such as personal computers, must be separately listed and estimated under equipment costs. Justifiable costs associated with data collection/coding, such as the need for additional data transcription services (other than that provided by the Candidate) for qualitative data, are allowable. Candidates can request up to $1,500 in travel costs to attend appropriate scientific meetings or conferences focusing on his/her research topic that take place in the United States, Mexico or Canada. The applicant must provide justification for each budget item requested in the detailed budget for the total period of support being requested. In particular, proposed computer-related purchases need to be fully justified in terms of not being readily available to the student for the conduct of the research.
The only allowable tuition-related costs are those associated with dissertation credits and matriculation fees that are required during the course of the grant period. Tuition related costs should be itemized in the budget. If requested, health insurance fees should also be listed in the budget, as well as other direct costs associated with completing the dissertation, such as materials, supplies and ADP services.
Unallowable Costs: Specific costs not allowed on dissertation research grants include: alterations/renovations, space rental, contracting or consortium costs, consulting costs, dissertation defense or deposit fees, membership fees and costs associated with faculty/advisor mentor supervision. Salary support for individuals, other than the candidate, is not allowable. Computer and statistical consulting support is not allowable. This list is not all inclusive, and the applicant should contact AHRQ staff regarding any other items being considered for which there are questions regarding whether or not the items are allowable.
Level of Effort: The candidate must devote at least 40 hours per week to the dissertation for a minimum of nine months beginning at the time of award. The requested start date of award must be estimated to begin no less than four months from the submission date. Receipt of additional compensation (e.g., pay) from other sources for performance of work that is distinctly separate from the actual work involved in the conduct of the dissertation is allowable, but cannot exceed a paid level of effort greater than 20 hours per week.
Facilities and Administrative Costs: (i.e., overhead or indirect costs) are limited to no more than eight percent of modified total direct costs.
Protection of Human Subjects: A discussion of human subjects protection must be included if the proposed research involves any contact with or data on humans (e.g., patients, providers, administrators); including data obtained from secondary publicly or privately available data sources. This section does not count toward the 10 page limitation. If human subjects are involved, the applicant must also check yes in the appropriate box described in the Other Project Information Component Section of the SF424 R&R application form.
Targeted/Planned Enrollment: AHRQ requires completion of targeted/planned enrollment.
Other Project Information Component:
Appendix materials: The only acceptable Appendix materials are copies of any survey instruments or questionnaires, data collection or interview guides used in the proposed research, if applicable.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process and will not undergo review.
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may not be reviewed if it does not comply with these requirements.
Priority Populations
The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. This authority is found at 42 USC 299(c). To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice. AHRQ policy also requires that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.
Publication Transmittal: General AHRQ Requirements
In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.
Assessment of AHRQ Grant Programs
In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.
AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.
HCUP & MEPS
Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.
The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.
Use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.
Health Literacy
AHRQ encourages applicants to write Informed Consent (IC) and HIPAA
Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants understanding.
IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.
Consumer Products
All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigator is planning to share the data.
Applicants who are planning to share data may wish to describe briefly the
expected schedule for data sharing; the format of the final dataset; the
documentation to be provided; whether or not any analytic tools also will be
provided; whether or not a data-sharing agreement will be required and, if so,
a brief description of such an agreement (including the criteria for deciding
who can receive the data and whether or not any conditions will be placed on
their use); and the mode of data sharing (e.g., under its own auspices by
mailing a disk or posting data on its institutional or personal website or
through a data archive or enclave). Investigators choosing to share under their
own auspices may wish to enter into a data-sharing agreement. References to
data sharing may also be appropriate in other sections of the application.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Section V. Application Review Information
1. Criteria
Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.
Merit Review Criteria: Merit Review Criteria, as described below, will
be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.
As part of the initial merit review, all applications will:
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research dissertations are evaluated for scientific and technical merit through the AHRQ peer review system. Reviewers will include in their overall and individual assessments both the research project and the potential of the candidate to become an independent health services researcher (based on assessments of such items as: letters submitted, biosketches, etc.)
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project and the candidate to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria. Reviewers will consider each of the review criteria below in the determination of scientific and technical merit of the proposed research project and the candidate, and give a separate score for each criterion. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the proposed dissertation project address an important problem unique to the mission of AHRQ? If the aims of the project are achieved, how will scientific knowledge, health care delivery, or clinical practice be advanced? What will be the effect of this research on the concepts, methods, technologies, treatments, services, preventative interventions, or health care policies that drive this field?
Investigators. Are the PD/PI and mentor(s) appropriately trained and well suited to the proposed research project? Is there evidence that an appropriate level of effort will be devoted by the mentor(s) to ensure the successful completion of the dissertation project? Is there evidence that mentor(s) have been adequately prepared to actively work with the PD/PI and have actively worked with the PD/PI to date in the development of the proposed dissertation project? Does a viable mentoring plan and/or mentor/PD/PI agreement exist? Does the PD/PI demonstrate potential to have a successful career in health services research?
Innovation. Is the dissertation project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?
Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Environment. Does the scientific environment(s) in which the work will be done contribute to the probability of success? Does the proposed research project benefit from unique features of the scientific environment(s)? Is there evidence of institutional support (e.g., computers, data, and office space)?
2.A. Additional Review Criteria
In addition to the above criteria, the reviewers will consider the following additional items in the determination of scientific merit and the rating, but will not give separate scores for these items.
Degree of Responsiveness. How well does the application address the purpose and objectives of this FOA? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?
Inclusion. Are there adequate plans to address the needs of genders, racial and ethnic minorities (and subgroups)? Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below).
Protection of Human Subjects from Research Risk. The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).
Privacy and Security Protections for Patients. The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.
Resubmission
Applications (formerly revised/amended applications). Are the responses to comments from
the previous scientific review group adequate? Are the improvements in the
resubmission application appropriate?
Budget and Period of Support. Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
2.B.
Additional Review Considerations
Not Applicable.
Data Confidentiality
The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/
The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.
Sharing Research Resources: Rights in Data
Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.
3. Anticipated Announcement and
Award Dates
Generally, applicants should anticipate eight months between the
application submission date and the earliest possible start date.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
AHRQ will request "Just-In-Time" information from the
applicant. Just-In-Time information generally consists of information on
other support, any additional information necessary to address administrative
issues, and certification of IRB approval of the project's proposed use of
human subjects. For details, applicants may refer to the "AHRQ
Revised Policy for Institutional Review Board (IRB) Review of Human Subjects
Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).
Once all administrative and programmatic issues have been resolved, a formal
notification in the form of the Notice of Award (NoA) will be generated
via email notification from the awarding component to the grantee business
official at the applicant organization. The NOA signed by the AHRQ grants
management officer is the authorizing document.
Selection of an application for award is not an authorization to begin performance. See also Section IV.5., Funding Restrictions.
AHRQ Dissertation grants are included under expanded authorities, but pre-award costs are NOT allowed.
The dissertation award terminates once the requirements for the doctoral degree are met. Should an award terminate before the reflected project period end date, the grantee is required to submit a letter to the AHRQ Grants Management Specialist, countersigned by an administrative official, indicating the expected end date. Unexpended funds are to be reported on the Federal Financial Report (FFR) and returned to the AHRQ within 90 days of the project period end date.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.
2. Administrative and National Policy Requirements
All AHRQ grant agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the notice of award.
As necessary, additional Terms and Conditions will be incorporated into the award statement.
3. Reporting
Expenditure data is to be reported on
the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial
expenditure reports for ALL grant programs as described in the HHS Grants
Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a
financial reporting period that coincides with the budget period of a
particular project. However, the due date for annual FFRs will be 90 days
after the end of the calendar quarter in which the budget period ends.
Note that this is a change in due dates of annual FFRs and may provide up to 60
additional days to report, depending upon when the budget period end date falls
within a calendar quarter. For example, if the budget period ends
4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the
calendar quarter of 6/30/2013).
A final Progress Report and final Federal Financial Report are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may be written or by telephone, and fall into three
areas: scientific/research (program), peer review, and financial or grants
management issues.
Scientific/Research Contact(s):
Direct your questions about general FOA issues, including information on the inclusion of priority populations to:
Brenda A. Harding, M.A.
Office of
Extramural Research, Education and Priority Populations (OEREP)
Division of Research Education
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1527
Fax (301) 427-1561
Email address: [email protected]
1. Peer Review Contact(s):
Direct inquiries regarding peer review issues to:
Ali Azadegan, D.V.M, Ph.D.
Office of
Extramural Research, Education and Priority Populations (OEREP)
Division of Scientific Review
540 Gaither Road
Rockville, Maryland 20850
Telephone: (301) 427-1869
Fax: (301-427-1561
Email
address: [email protected]
2. Financial/Grants Management Contact(s):
Direct inquiries regarding fiscal matters to:
Anna Caponiti
AHRQ Grants Management
Office of Performance Accountability, Resources and Technology
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1402
Fax: (301) 427- 1462
E-mail address: [email protected]
Section VIII. Other Information
Human Subjects Protection:
Federal regulations at 45 CFR Part 46 require that
applications and proposals involving human subjects research must be evaluated
in accordance with those regulations, with reference to the risks to the
subjects, the adequacy of protection against these risks, the potential
benefits of the research to the subjects and others, and the importance of the
knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.
Access to Research Data through the Freedom of Information Act:
OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ confidentiality statute, 42 USC 299c-3(c). NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.
Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.
Healthy People 2020:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to
the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authority of 42 USC 299 et
seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and
other referenced applicable statutes and regulations. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the HHS Grants Policy Statement. The HHS Grants Policy Statement
can be found at http://www.ahrq.gov/fund/hhspolicy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.
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