Part I Overview Information


Department of Health and Human Services

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

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 National Research Service Awards (NRSA) Institutional Research Training Grants (T32)

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

Announcement Type

This Funding Opportunity Announcement (FOA) is a new RFA.

Request for Applications (RFA) Number: RFA-HS-12-008

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.225

Key Dates

Release/Posted Date: May 31, 2012
Opening Date:  August 13, 2012
Letters of Intent Receipt Date(s):  August 17, 2012
Application Receipt Dates(s):  September 12, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date: July 1, 2013
Additional Information To Be Available Date:  Not applicable
Expiration Date: September 13, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The Agency for Healthcare Research and Quality (AHRQ) will award National Research Service Award (NRSA) Institutional Research Training Grants (T32) to help ensure that a diverse pool of highly trained behavioral, social, and organizational sciences, engineering, biostatistics, clinical sciences, and health services researchers are available in adequate numbers and in appropriate research areas to advance the scientific disciplines and to address the mission of AHRQ. The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide especially the Specific Instructions for Institutional Training Grant Applications using the SF424 (R&R) Application (beginning in Part 1., Section 8.4). Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted below in Section IV of this announcement. If program-specific instructions in Section IV deviate from those in the Application Guide, follow the program-specific instructions.   Applications that do not comply with these instructions may not be accepted for review.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information

1. Mechanism of Support

2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information

2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
          
2. Technical Assistance
    B. Submitting an Application Electronically to AHRQ
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
   
A. Additional Review Criteria
   
B. Additional Review Considerations
   
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
2. Peer Review Contact
3. Financial/Grants Management Contact

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Through its NRSA Institutional Research Training Grant Awards (T32), AHRQ plans to fund a broad array of health services training programs focused on promoting improvements in clinical and health systems’ practices. These training programs are designed to provide didactic and/or experiential training for pre-doctoral and post-doctoral trainees interested in: (1) improving clinical practice or the health care system's ability to provide access to and deliver high quality, high-value health care; and/or (2) providing policymakers with the ability to assess the impact of system changes on outcomes, quality, access to, cost, and use of health care services. 42 U.S.C. 299a(b) authorizes AHRQ to provide training grants in the field of health services research.

Pressing health care issues are complex and influenced by environmental, systemic, and demographic factors that call for innovative approaches which integrate advances in behavioral, social and organizational sciences, economics, engineering, mathematics/statistics, clinical sciences, implementation sciences, and health services research. In order to address these challenges, it is important to ensure that a diverse and highly trained interdisciplinary research workforce is prepared with the skills and knowledge necessary to conduct, disseminate, and implement research that can be put into practice by consumers, health care providers, policy makers and health care delivery system administrators. 

Programs funded under this FOA  will recruit and train pre-doctoral and/or post-doctoral students in fields such as social, behavioral and organizational sciences, economics, engineering, mathematics/statistics, epidemiology, health policy, clinical sciences (e.g., Medicine, Nursing, Pharmacy), implementation sciences, and health services research.  The requirements of this announcement are intended to be sufficiently flexible to allow applicant institutions to tailor their proposed training program to take advantage of the resources available to them and their institutional strengths.  The intent is to develop researchers in each program who will work in a variety of settings and institutions. 

Applications 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; care coordination, care management, enhancing access to care, patient self-management; palliative care; improving diagnosis, treatment, patient access, and work flow while reducing costs or holding them constant; long-term care; reducing disparities in health care outcomes and quality among racial, ethnic, and underserved populations; enhancing the transparency and accountability of care delivery practices and outcomes; and contributing to evidence-based decision making by patients, providers, regulators, and payers.  AHRQ is especially interested in applications that propose to train researchers to address healthcare disparities and quality measurement and improvement.  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 stakeholders, such as providers and practitioners, administrators, payers, consumers, policymakers, and insurers.  The strategic research goals are:

AHRQ also 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

Applicants are required to address training in 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. 

Trainees must focus their research development and projects on health care delivery in the United States.

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

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Institutional Research Training Grant Mechanism (T32).  The PD/PI will be solely responsible for planning, directing, and executing his or her training program

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

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.  Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.

AHRQ intends to allocate approximately $7 million annually for five years of support to fund 12 to 18 programs.  The total costs for a grant requested under this FOA will not exceed $600,000 annually for the entire project period. Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the noncompeting annual progress report. An application with a budget request that exceeds $600,000 in total costs in any given year or that exceeds five years in duration will not be reviewed.

Allowable Costs        

A. Stipends: 

Applicants should estimate stipend levels based on justifiable projections and needs.

B. Tuition and Fees:

AHRQ will provide funds for tuition and fees for eligible NRSA trainees.  At present, the formulas for predoctoral and postdoctoral trainees are listed below:

Costs associated with tuition and fees are allowable only if they are required for specific courses as part of the approved research training program and are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. Tuition at the post-doctoral level is limited to that required for specific courses in support of the approved training program which should be identified in the application

Applicants should note that these formulas are for budgeting and award calculation purposes.  Grantees are to state full tuition and fee costs in the budget justification, then show the tuition formula calculation to determine the appropriate amount to be included in the budget request. Note that if the applicant’s actual tuition rates differ for in-state vs. out-of-state trainees, and/or for pre-doctoral vs. post-doctoral trainees, these different rates must be clearly stated, even if the current request does not include trainees with differing tuition rates.   The final determination of eligible support from AHRQ will be applied at the time of award. 

”Trainee Costs” include funds awarded in the stipends and tuition/fees budget categories. These costs may not be used for other purposes and therefore may not be re-budgeted into other budget categories such as travel or Training Related Expenses. Unless otherwise restricted, re-budgeting into or within Trainee Costs (stipends and tuition/fees) is allowable without prior approval of AHRQ.

C.  Trainee Travel:

Applicants may request up to $2,000 travel funds annually per trainee.  Priority for use of these funds must be given to attendance at the Annual AHRQ NRSA Conference.  Compliance must be documented annually in the Noncompeting Continuation report.  It is expected that the number of positions supported annually by each T32 Institutional Research Training Program will coincide with the number of trainees attending the conference annually.  Exceptions can be requested in advance for individual and infrequent circumstances such as the following:  clinical responsibilities, exam schedule, personal emergencies.

If funds are prioritized so that the same number of trainees supported by the program annually is equal to the number attending the annual NRSA/AHRQ Research Trainees Conference, or an individual exception has been granted, remaining travel funds can be used to support other professional travel to scientific meetings and workshops that the institution determines to be necessary to the training experience. 

Funds may not be expended to cover the costs of travel between the trainee’s place of residence and the training institution, except in cases of extreme hardship.

D. Training Related Expenses (TRE):

Funds provided as Training Related Expenses are intended to help defray other research training expenses such as staff salaries, consultant costs, equipment, research-related costs, and faculty/staff travel directly related to the research training program. Training Related Expenses also include health insurance coverage for individuals and/or families, but only to the extent that the same health insurance fees are charged to regular non-Federally-supported students and postdoctoral fellows.  Current TRE support per pre-doctoral trainee is $4,200, and per post-doctoral trainee is $7,850. Funds are provided as a lump sum on the basis of the number of trainees supported. No further itemization or explanation is required.  

E. Facilities and Administrative Allowance:

Facilities and administrative costs based on 8% of modified total direct costs (excluding tuition/fees and expenditures for equipment) may be requested and are included in the total cost cap of the award.

F. Stipend Supplementation, Compensation, and Other Income:

AHRQ Institutional Research Training Program trainees receive stipends to defray living expenses.  Stipends may be supplemented by an institution from non-Federal funds provided this supplementation is without any additional obligation to the trainee.  An institution can determine the amount of stipend supplementation, if any, it will provide according to its own formally established policies governing stipend support.  These policies must be consistently applied to all individuals in a similar status regardless of the source of funds.  Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which funds are derived.  Under no circumstances may PHS funds be used for supplementation.

AHRQ recognizes trainees may seek part-time employment incidental to their training program to offset their expenses.  Funds characterized as compensation may be paid to fellows only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets the conditions for compensation of students.  In addition, compensation must be in accordance with organizational policies applied consistently to both federally and non-federally supported activities and must be supported by acceptable accounting records that reflect the employer-employee relationship.  Under these conditions, the funds provided as compensation (salary, fringe benefits, and/or tuition remission) for services rendered, such as teaching or laboratory assistance, are not considered stipend supplementation; they are allowable charges to Federal grants, including PHS research grants.

Compensation may not be paid from a research grant that supports the same research that is part of the trainees’ planned training.  Compensated services should occur on a limited, part-time basis apart from the normal full-time research training activities.

Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainees approved AHRQ Institutional Research Training program.

Program Directors must approve part-time employment on research grants to verify that the circumstances will not detract from or prolong the approved training program for the trainee.

G. Educational Loans or G.I. Bill: 

An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill).  Such funds are not considered supplementation or compensation. 

AHRQ Grants Policy: All AHRQ grant awards are subject to the requirements of the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf ) which will apply to the applications submitted and awards made in response to this FOA.

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.  For-profit organizations 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.

AHRQ encourages institutions that have not previously received support from AHRQ to apply. Applicants are encouraged to develop partnerships with entities such as ACTION, CERTS, DEcIDE Network, EPCS, PBRNS, health care plans, state and local governments, VA Medical Centers and other applied settings.  Seasoned behavioral sciences, engineering, mathematics/statistics, clinical sciences, and health services research training programs are also strongly encouraged to partner with multiple components at their existing institutions, with newly emerging  behavioral sciences, engineering, mathematics/statistics, clinical sciences, and health services research training programs at other institutions and with emerging centers of excellence.

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 Training Program 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 with the skills, knowledge, and resources necessary to carry out the proposed research training program 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.

The Program Director, who will be the PD/PI for the grant application, should be an established health services researcher with a successful past training record, and available resources to conduct the proposed training program at the institution.  The Program Director will be responsible for the selection and appointment of eligible trainees to the Institutional Research Training Grants, for the overall direction, management and administration of the institutional research training program, program evaluation, and the submission of all required forms and reports in a timely manner.

2. Cost Sharing or Matching

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

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments.  Applicant institutions that plan to provide support should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.  This can be included at the end of the budget justification section of the application, but institutional support dollars are not to be included in the detailed budget request.

3. Other Special Eligibility Criteria

Mentors

Mentors should be recognized as accomplished investigators in health services research or other closely related fields and have track records of success in providing the types of training activities and mentoring experiences required for the proposed training program.  Where feasible, women, individuals from diverse race and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

Trainees

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment, i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of legal admission as a permanent resident.  Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island).  Individuals on temporary or student visas are not eligible for NRSA support. It is the grantee institution’s responsibility to ensure that a trainee’s citizenship status at the time of appointment meets these criteria.  In addition, trainees must be able to commit full-time effort in the program at the time of appointment.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own consistently-applied policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment.

Pre-doctoral trainees must have received a baccalaureate degree by the beginning date of their AHRQ  Institutional Research Training grant appointment, must be training at the post-baccalaureate level, and be enrolled in a program leading to a Ph.D. (or its equivalent) doctoral degree program related to or applied to the mission of AHRQ. Students in doctoral health-professional programs or individuals in postgraduate clinical training leading to a doctoral degree, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

No individual trainee may receive more than 5 years of any type of NRSA support at the pre-doctoral level, including any combination of support from institutional training or individual fellowship awards. Any exception to the maximum period of support requires a waiver from AHRQ based on a review of the written justification from the individual trainee, and endorsed by the PD/PI and the sponsoring grantee institution.  Trainees seeking additional support are strongly advised to consult with the AHRQ since this is extremely rare.

Post-doctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., Sc.D., Dr.P.H., M.D., D.D.S., Pharm.D., D.O., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following:  D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is required.

Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. The program may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported full-time post-doctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board

No individual trainee may receive more than 3 years of any type of NRSA support at the post-doctoral level, including any combination of support from institutional training or individual fellowship awards.  Any exception to the maximum period of support requires a waiver from AHRQ based on a review of the written justification from the individual trainee, and endorsed by the PD/PI and the sponsoring grantee institution.  Trainees seeking additional support are strongly advised to consult with AHRQ staff, since this is extremely rare.

Section IV. Application and Submission Information


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

Registration:

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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

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

1. Request Application Information

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

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

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

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).  Applicants must also follow the Supplemental Instructions to the SF424 (R&R) in Section 8.7 for preparing the Research Training Program Plan Component. Applicants must also follow program-specific instructions noted in Section IV of the FOA. If program-specific instructions in Section IV deviate from those in the Application Guide, the program-specific instructions must be followed.  

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
SF 424 (R&R) Budget Component
PHS398 Cover Page Supplement
PHS 398 Research Training Program Plan (for Institutional Research Training Program)
PHS398 Checklist
(See Section IV.6, “Special Instructions,” regarding appropriate required budget component.) 

Optional Components:
PHS398 Cover Letter Component

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 third party agreement to be administered by the prime institution.  When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.  All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.  See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times
See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Release Date: May 31, 2012
Letters of Intent Receipt Date(s): August 17, 2012
Application Receipt Dates(s):  September 12, 2012
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date: July 1, 2013 
Additional Information To Be Available Date:  Not applicable
Expiration Date:  September 13, 2012

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions.  Please include the name and email address of the Principal Investigator.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application.  However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.

The letter of intent can be sent electronically, and should be sent to:

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

3.A.2. Technical Assistance

Submit all inquiries in writing to TrainingTA@ahrq.hhs.gov.

3.B. Submitting an Application Electronically to AHRQ

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

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

3.C. Application Processing

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

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments.  Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review in the PHS, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-Award Costs:  Pre-Award Costs are not allowable charges for either stipends or tuition on institutional training grants since stipends and tuition costs may not be charged to the grant before the trainee appointment is actually made.

Concurrent awards:  A NRSA appointment may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Taxability of Stipends:  Section 117 of the Internal Revenue Code applies to the tax treatment of scholarships and fellowships. Degree candidates may exclude from gross income (for tax purposes) any amount used for course tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. Nondegree candidates are required to report as gross income any monies paid on their behalf for stipends or any course tuition and fees required for attendance.

The taxability of stipends in no way alters the relationship between NRSA recipients and sponsoring institutions. NRSA stipends are not considered salaries. In addition, NRSA trainees are not considered to be in an employee-employer relationship with AHRQ or the sponsoring institution solely as a result of the NRSA award. The interpretation and implementation of the tax laws are the domain of the IRS and the courts. AHRQ takes no position on what the status may be for a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations.

Service Payback:  As specified in the NIH Revitalization Act of 1993, Public Law 103-32, T32 Institutional Research Training Grant recipients incur a service payback obligation for the first 12 months of post-doctoral support with the 13th and subsequent months of postdoctoral support serving to pay back this obligation month by month.  

6. Other Submission Requirements

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

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

Organizational DUNS

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

PHS398 Research Training Program Plan Sections

All application instructions outlined in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts.

Special Application Requirements for this FOA

Page Limitations

Research Training Program Plan -- SF 424 (R&R), under Section 8.7 - Research Training Program Plan Component: combined components 2.2 (Background), 2.3 (Program Plan), and 2.4 (Recruitment and Retention Plan to Enhance Diversity) is limited to 25 pages.  Any discussion of specific aims must be included within the 25-page limit.

Note that the required plans for instruction in the Responsible Conduct of Research (RCR) will have page limits separate from the page limits for the Research Training Program Plan Component.  Applications without plans for instruction in responsible conduct of research will be considered incomplete and will not be reviewed.  Specifically, the plan for instruction in RCR (Item 2.5) will have its own separate page limit (3 pages).

Instructions for completing the data tables for an Institutional Research Training grant application can be found at http://grants.nih.gov/grants/funding/424/index.htm#DataTableInstruct.  These tables do not count toward the 25-page limitation of the Research Training Program Plan.  Tables other than those listed should not be included, unless they pertain to the Research Training Program Plan and then should be part of the 25-page limit for that section.

Training Program and Environment (Component of Program Plan)

The application must include a statement from the applicant institution (institutional letterhead and signature) describing the commitment to the planned program. The institution must assure that essential time will be allowed for the Training PD/PI, other faculty and mentors, and note what the time commitment of the PD/PI would be.  The program must include information on planned didactic as well as applied and experiential research training, based on trainees’ varying levels of experience and needs.  Information about planned courses, core competencies to be delivered and the manner in which they will be assessed, curricula, seminars, workshops or tutorials that will be incorporated into the training program should be included in the application.  In addition, the plan must describe mentoring plans or contracts, and individuals who will be available to serve as primary (key) mentors in the program.

The program should develop trainees’ skills in: understanding research; conducting research that is relevant and applicable to health care delivery and/or policy; identifying problems in the process of conducting research; and raising questions and proposing solutions to resolving complex problems within the field of health services research. Trainees should be prepared to utilize their research education as a springboard to their future research careers. Programs should provide all trainees with additional professional development skills and career guidance including instruction and training in grant writing, the protection of human subjects, interdisciplinary team work, and communication of research to researchers and the impact of their research to stakeholders invested in the applications of their research. 

The application should describe the collaborative environment and infrastructure available for interdisciplinary training. Evidence of this infrastructure could include collaborative research projects, co-authored publication, joint service on dissertation committees, collaborative teaching, and regular interactions in journal clubs and seminars. For a successful program, it is expected that special efforts will be made to integrate the science and the trainees into a cohesive program where there is close and constant interchange of ideas, information, mentorship and an array of applied and experiential training experiences.

A description of any proposed rotations/practicum in health services research which will be made available for each trainee should be included in the training plan. These are not required, but are highly encouraged.  They should be designed to take advantage of health services research experiences not available at, but complementary to, those at the applicant institution. If proposed rotations/practicum is included in the plan, documentation of commitment on the part of the stakeholder group(s) should be included in the application, as a separate attachment in the appendices.

The application must describe a training program that is scientifically distinct from other existing institutional research training programs funded by NIH or HRSA.  Training programs must be unique to AHRQ and AHRQ’s mission and research priorities, as outlined above.

Program Faculty (Component of Program Plan)

Applicants need to demonstrate the suitability of the Program Director, mentors, and key faculty; their availability; their roles; and their responsiveness to students.  The application must include information about the program faculty who will be available to serve as mentors and provide guidance and expertise to trainees proposed in the application.  It must also describe the complementary expertise and experiences of the proposed mentors, including active research and other trainee activities in which the mentors are engaged, as well as track records of mentoring and training.  A description of specific mentoring plans and commitment of major faculty and external non-academic partners in the specific research objective areas proposed is also required and their input should be demonstrated in the application. The faculty should have experience in specific methodological and topical areas related to behavioral sciences, engineering, mathematics/statics, clinical sciences, and health services research. Sufficient staff and facilities are also required in order to carry out the proposed program, including such items as computers, office space, data, and data processing/analytic support.

Program Evaluation (Component of Program Plan)

The application must include a formative and outcome evaluation plan that involves external input and addresses both the academic program offered and the outcomes as evidenced in the career paths and trajectories of trainees. This should include plans to obtain feedback from current and former trainees to help identify strengths and weaknesses and to provide suggestions for program improvements.  Evidence of a productive health services career can include a record of successful competition for research grants/contracts, receipt of special honors or awards, a record of publications, non-traditional academic measures of success (e.g., use of research by stakeholders), promotions, and any other accepted measures of success consistent with the nature and duration of the training period and program emphasis.

The plan should include a system for tracking participants for at least a 10-year period following program completion. Evaluation results should be included in future competing continuation (renewal) applications and as part of the Final Progress Report.  For competing renewals, appendices are encouraged to include summaries of previous formative and outcome evaluations describing the above criteria. 

Trainee Candidates (Component of Program Plan)

The application must include a plan for recruiting and retaining high quality trainees from outside as well as inside applicant institutions. The plan should describe any recruitment and outreach plans to increase the depth and diversity of the applicant pool. The plan should guarantee existence of an adequate group of highly-qualified potential candidates available to embark on at least a two-year commitment to institutional research training in behavioral sciences,  engineering, mathematics/statistics, clinical sciences, and health services research that is responsive to AHRQ’s research priorities and mission. The application should describe the criteria to be used for candidate evaluation and selection. It should provide brief summaries of training plans that the program will employ. The application should contain a description of how the training plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competencies, and should distinguish the plan from fellowship training (if applicable).

Recruitment Plan to Enhance Diversity

AHRQ recognizes a unique and compelling need to promote diversity in the behavioral sciences, engineering, mathematics/statistics, clinical and health services research workforce. AHRQ expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the health care in the United States.

Accordingly,  AHRQ continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the behavioral/ social, and organizational sciences,  engineering, economics, mathematics/statistics clinical sciences and health services research such as:  individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The recruitment plan must include specific efforts designed to enhance diversity. If an application is received without a plan that specifically addresses efforts to enhance diversity, the application will be considered incomplete and will not be reviewed.

Training in the Responsible Conduct of Research

Every trainee supported by this training grant must receive instruction in the responsible conduct of research.  All applications must include a plan to provide such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction.  Training in the responsible conduct of research is described in NOT-OD-10-019.  Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan.  All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.  Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.  The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.  See SF424, Section 8.7. Research Training Program Plan Components, Item 5, Plan for Instruction in the Responsible Conduct of Research.

Other:  Applications lacking a recruitment plan, an evaluation and tracking plan, a plan for training in the responsible conduct of research, or a description of institutional commitment to the program and to the trainee candidates will be considered incomplete and will not be reviewed.

Number of Applications: Applicant organizations are strongly encouraged to collaborate internally and externally with organizations.  Applicant organizations may submit more than one application, provided each application is scientifically distinct.  However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization. Although more than one application per institution and its affiliate components (e.g., health plans, hospitals) may apply for support, AHRQ will generally support only one application per institution. 

Resubmission(s): Resubmission applications are not permitted in response to this FOA.

Renewals: Competing renewals are allowable.

Budget Component

Special Instructions for Modular Grant applications

AHRQ is not using the Modular Grant Application and Award Process.   Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process. Applications submitted in the Modular format will not be reviewed.

Warning: Please be sure to observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements. 

Applicants should follow the specific instructions on the Training Budget as described in the SF424 (R&R) instructions for the PHS 398 Training Budget, Section 8.5.  A detailed budget justification must be provided.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) instructions of the Research Training Program Plan Component, Section 8.7.  For competing renewals, appendices are encouraged to include summaries of previous formative and outcome evaluations, as noted above.  These materials can be used toward the evaluation of the past performance of the program. 

Do not use the appendix to circumvent the page limitations of the Research Training Program Plan. All appendix material must be submitted as PDF attachments.  A summary listing all of the items included in the appendix is required, and should be the first PDF file of the Appendix. Applications that do not follow the appendix requirements may be delayed in the review process.

Note the required Data Tables, described above, must not be included in the appendix materials.

Other 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.

Applicants’ use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency.   AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants’ understanding.

IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds.  Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.ahrq.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 and Resources) 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:

Applications submitted to AHRQ to support health services research and training are evaluated for scientific and technical merit through the AHRQ peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria  

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

Training Program and Environment

Program Faculty

Program Evaluation

Trainee Candidates

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the institutional research training program, level of trainee experience, and the particular circumstances of the trainee, the reviewers will address the following questions.

Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

2.A. Additional Review Criteria

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

Degree of Responsiveness:  How well does the application address the purpose and objectives of this FOA?  How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

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

Inclusion: Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements,” and inclusion criteria included in section VIII of Required Federal Citations, below.). 

Protection of Human Subjects from Research Risk:  The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See the “Human Subjects Sections” of the PHS398 Research Training Program 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.

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:

Note:  AHRQ will generally make only one award per applicant institution and its affiliate components and organizations.

2.B. Additional Review Considerations

Not applicable.

2.C. Resource Sharing Plan(s))

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ-supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied.   Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it.  There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d).  In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected.  The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded.  Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.  These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers.  Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators.  The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401. 

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects.  For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

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

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NOA are at the recipient’s risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5., “Funding Restrictions.”

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the 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 awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

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

Except where otherwise stated in the FOA, policies related to the following administrative requirements remain the same as those found in the NRSA guidelines which is located at http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch11.htm

3. Reporting

Grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590).  The annual progress report must include Section 2.2.6 items A through F as described in the general PHS form 2590 instructions, as well as sections G through J as described in Section 5.1.4 of the 2590 instructions, and Part 6 of the 2590 instructions entitled, “Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant.”  For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.  If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.

Please note: The Research Performance Progress Report (RPPR) is a Federal-wide progress report which will eventually replace the PHS 2950.  Grantees will be required to follow the new progress report guidelines when they become available.

Federal Financial Reports (FFRs; SF 425) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).  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 4/30/2012, the annual FFR is due 9/30/2012 (90 days after the end of the calendar quarter of 6/30/2012). Submit the Final Federal Financial Report (SF 425) as a PDF file to: GFFR@ahrq.hhs.gov.   AHRQ is NOT currently able to accept FFRs electronically via the eRA Commons.

Final Progress and Federal Financial Reports

A Final Progress Report and final Federal Financial Report are required when an award ends.  Evaluation results should be included as part of the Final Progress Report.

Trainee Reporting Requirements

Institutions must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the institutional research training grant. This form must be completed at the beginning of the initial appointment and annually thereafter.  An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.  AHRQ requires the use of xTrain for the electronic submission of Appointment Forms and Termination Notices.  More information on xTrain is available at xTrain (eRA Commons).  No funds may be provided in support of the trainee until the Statement of Appointment form submitted to and accepted by AHRQ.

A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (Form PHS 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed for eight weeks or more. Trainees with service payback requirements must notify the AHRQ of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied.  A completed Payback Agreement Form (PHS 6031) must be submitted for each post-doctoral trainee in his or her first 12 months of support.

Other Reporting Requirements

In carrying out its stewardship of human resource-related programs, the AHRQ may request information essential to an assessment of the effectiveness of this Program.  Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from a Trainee’s research, AHRQ support must be acknowledged by a footnote in language similar to the following: “This investigation was supported by the Agency for Healthcare Research and Quality (AHRQ) under Grant Award (number).  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the AHRQ.” 

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 sub-awards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable grants and cooperative agreements are required to report to the Federal Sub-award Reporting System (FSRS) available at https://www.fsrs.gov/ on all sub-awards over $25,000. See the AHRQ Grant Post Award Management web site at http://www.ahrq.gov/fund/postawrd.htm#terms for additional information on this reporting requirement.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by email, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1.  Scientific/Research Contact(s):

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

Shelley Benjamin, M.S.W.
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) 427-1528
Email address:  Shelley.Benjamin@ahrq.hhs.gov

2.  Peer Review Contact(s):

Direct inquiries regarding peer review issues to:

Nghia Vo, M.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1191
Fax: (301) 427-1562
E-mail address:  Nghia.Vo@ahrq.hhs.gov

3.  Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

Ms. Galen Gregor
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1457
Fax: (301) 427- 1462
E-mail address: Galen.Gregor@ahrq.hhs.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html).
 
Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information.  It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances.   Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement.  Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ confidentiality statute, 42 USC 299c-3(c).  NIH has provided general related guidance at http://grants.nih.gov/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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