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 Individual Awards for Postdoctoral Fellows (F32)

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 updates and supersedes PA-99-005 released on October 16, 1998.

Note: The PHS 416-1 (rev. 9/2008) must be used for December 2008 application receipt dates. See also: NOT-OD-09-004.

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAR-06-409

Catalog of Federal Domestic Assistance Number(s)
93.225

Key Dates
Release Date: May 12, 2006
Application Receipt Date(s):  April 5, August 5, December 5 annually (beginning August 5, 2006 and ending December 5, 2008)
Peer Review Date(s):  February, June, October annually
Earliest Anticipated Start Date(s):  6 months from receipt of application
Expiration Date:   December 6, 2008 - (New Expiration Date December 9, 2009 per NOT-HS-08-010)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The Agency for Healthcare Research and Quality (AHRQ) announces its continuing interest in supporting the postdoctoral National Research Service Award (NRSA) individual fellowships (F32) in health services research.  These postdoctoral research fellowships provide opportunities for one to three years of academic training and/or supervised experience in applying quantitative and/or qualitative research methods to the systematic analysis and evaluation of health care services.  The program emphasizes methodological and research topics that address the mission of AHRQ.

This Funding Opportunity Announcement (FOA) updates and supersedes the “National Research Service Award: Individual Postdoctoral Fellowships” PA-99-005, published in the NIH Guide for Grants and Contracts on October 16, 1998.

Individuals must submit the application using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form (PHS 416-1, rev. 06/02) available at: http://grants.nih.gov/grants/funding/416/phs416.htm   See Section IV.1 for application materials.

This FOA will use the individual Postdoctoral Fellowship Award mechanism (F32) issued under the auspices of the Kirschstein-NRSA Act.  While grant awards are made to institutions rather than individuals, this FOA and its instructions are written to potential applicants to inform them of this funding opportunity and facilitate the submission of grant applications.  Eligible organizations include domestic public or private non-profit institutions such as universities or colleges, clinics and hospitals.  For eligible Principal Investigators, see Section III.1.B.

Telecommunications for the hearing impaired is available at: TTY 301-451-0088.

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(s) 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. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
      A. Receipt and Review and Anticipated Start Dates
           1. Letter of Intent
      B. Sending an Application 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. Sharing Research Data
      D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.  AHRQ strives to achieve its mission by supporting research which directly relates to accomplishing one of the following broad-based goals:

Historically, research supported by AHRQ has focused on a variety of specific topics across its three broad-based goals, including the organization and delivery of health care, health information technology, and financing, patient and provider behavior, and disparities in health care.  It continues to evaluate both clinical services and the system in which these services are provided.  The expectation is that scientific findings stemming from the research will improve the evidence base to enable better decisions about health care, including those related to disease prevention, emergency preparedness, appropriate use of medical technologies, improving diagnosis and treatment in cost-effective ways, long-term care, and reducing racial and ethnic disparities. 

Applicants to this Funding Opportunity Announcement (FOA) must address at least one of the three broad-based goals of AHRQ in their proposed research.  Further, they are strongly encouraged to:

Current AHRQ priority areas of research interest include:

1) Translating Research into Practice and Policy

AHRQ's mission includes a significant commitment to translating research into practice and policy (TRIPP).  Within this area, investigators conduct research and evaluation projects related to the translation of research findings into measurable improvements in quality, patient safety, healthcare outcomes and cost, use, and access.  For example, AHRQ TRIPP-related research projects 1) test strategies for adoption, implementation, and routinization of evidence-based clinical and organizational interventions; 2) assess the degree to which interventions that have been proven successful in just a few health care settings or outside of health care are appropriate to other health care settings and the degree to which practices that worked well with one population fit other types of populations - especially racial and ethnic minorities, children, elderly, rural populations, and other priority populations; and, 3) identify successful past efforts to adopt, implement, and routinize evidence-based clinical and organizational interventions, and then take these "to scale" by replicating them across a number of organizations.

2) Patient Safety and Quality

One important element in the AHRQ mission is to support and promote the development of multidisciplinary research to examine the scope and impact of medical errors on the healthcare system and offer solutions to create a culture of safety.  Research on patient safety and quality improvement examines threats to patient safety, their root causes, and possible effective system approaches to prevent the occurrence of errors among diverse populations and settings of care.  AHRQ-supported research also examines the effectiveness of various interventions designed to capture information on medical errors, and the use of information technology to reduce errors and increase efficiency.  AHRQ promotes dissemination of findings and evaluation of outcomes for promising interventions in a variety of health care settings and across a variety of health care professions.

3) Patient-Centered Care

One critical set of issues facing public and private policymakers concerns the challenge of designing patient-centered processes to improve the quality and safety of care delivery. Patient-centered care is defined as health care that establishes a partnership among practitioners, patients and their families (when appropriate) to ensure that decisions respond to and respect patients' wants, needs and preferences and solicit patients' input on the education and support they need to make decisions and participate in their own care.

Essential dimensions of patient-centered care include but are not limited to: 1) accessible and customized information, communication, and education; 2) continuous collaboration, coordination and integration of care among providers, across conditions and settings; 3) shared decision-making of clinicians with patients and their families; 4) self-efficacy and self-management skills for patients; 5) patients' experience of care; 6) provider-patient partnership; and, 7) enhanced cultural competence of health care providers. AHRQ supports patient-centered care research focusing on the redesign and evaluation of new care processes that lead to greater patient empowerment, improved patient-provider interaction, easier navigation through healthcare systems, and improved access, quality, and outcomes. Specific strategies could include, but are not limited to, electronic clinical communication, self-management programs, web-based applications for patients and/or health care providers, and shared decision-making programs. 

4) Payment and Organization

One dilemma currently facing America is how to improve health care quality and access while costs continue to soar.  There is now a recognition that a first fundamental step in dealing with this dilemma is through innovations in organization and payment structures.  To understand the impact of changes in organizational structure and processes, new technologies, and management innovations, and to discover ways to create a less wasteful and higher-quality health system, AHRQ encourages research on system design and change as well as processes resulting in planned and unplanned change.  Evaluation of innovations led by public and private sector leaders are of particular interest.  For example, evaluation of innovations in prescription drug payments and cost-sharing, value-based purchasing, improving care processes within a health care organization, pay-for-performance incentives, state malpractice reforms, and response to Health Savings Accounts or consumer directed health options, are of interest.

5) Care of Individuals with Multiple Health Conditions

While many studies have focused on the efficacy and effectiveness of disease-specific interventions, limited work has addressed the unique needs of sicker patients – those with multiple co-morbid conditions and those in need of multiple risk-behavior interventions.  From the perspective of chronically ill, sicker patients and their care givers, the health system does not appear patient-centered or coordinated.  In a recent Commonwealth Fund study of sicker adults in six countries, many of the problems related to care of these patients appeared universal, though there were some issues unique to the United States.  While most of the sicker adults had seen multiple physicians and were taking multiple medications, 53 percent of patients reported taking 4 or more medications and 43 percent of patients reported 4 or more physicians.  In addition, patients in the U.S. were least likely to have the same physician for five or more years.  This priority specifically examines gaps in patient-centered care for the complicated patient with multiple conditions and risk factors.  Among the areas of potential focus are the value of a medical home, care coordination, medication therapy management, patient education and self-efficacy, and health professions education, for patients with multiple chronic illnesses and those who need for multiple risk-behavior interventions.  Also, studies examining clinical and system approaches to reduce racial, ethnic and socioeconomic disparities in the care of sicker adults are encouraged.

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

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the individual Postdoctoral Fellowship Award (F32) mechanism issued under the auspices of the Kirschstein National Research Service Award (NRSA) Act.

Individual award recipients are solely responsible for planning, directing, executing the proposed project.

2. Funds Available

Although the financial plans of AHRQ provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

No supplemental funds will be awarded.

AHRQ is not using the Modular Grant Application and Award Process.  Follow the instructions in the PHS-416-1 for preparing the application budget.

Allowable Costs:

The fellowship award provides an annual stipend to help meet the fellow's living expenses, an allowance for tuition and fees and health insurance in accordance with NIH policy, and an annual institutional allowance. 

The stipend for each subsequent year of support is the next level of experience using the stipend schedule in effect at that time.  Stipends will be adjusted on the anniversary date of the award and will not be changed mid-year to accommodate an increase in the level of experience.  No departure from the published stipend schedule may be negotiated between the institution and the fellow.

For fellows sponsored by domestic non-federal institutions, the stipend will be paid through the sponsoring institution.  For fellows sponsored by Federal institutions, the monthly stipend payment will be deposited in the fellow's U.S. bank account or paid directly to the fellow by U. S. Department of Treasury check.

The Institutional Allowance is adjusted from time-to-time.  Prospective applicants are advised to check for the current Institutional Allowance in the most recent documentation related to stipends at http://grants.nih.gov/training/nrsa.htm.

Funds are not available to cover the cost of travel between the fellow's place of residence and a training institution.  However, in cases of extreme need or hardship, a one-way travel allowance may be authorized by the awarding component.  Such travel must be paid from the institutional allowance.

Awards for fellowship training may only be made to domestic institutions.  However, limited travel to a foreign site may be permitted with sufficient justification and prior AHRQ approval. 

Supplementation of Stipends and Compensation:

The sponsoring institution is allowed to provide funds to the fellow in addition to the stipends paid by the AHRQ.  Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met.  Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow's approved training program.

Concurrent Awards: 

A NRSA fellowship may not be held concurrently with another Federally-sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Tax Liability:

Section 117 of the Internal Revenue Code applies to the tax treatment of all scholarships and fellowships.  Under that section, non-degree 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.  Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between trainees or fellows and their institutions.  Stipends are not considered salaries.  In addition, trainees supported are not considered to be in an employee-employer relationship with the AHRQ or the awardee institution. It is therefore, inappropriate and unallowable for institutions to charge costs associated with employment (such as FICA, workman's compensation, or unemployment insurance) to the fellowship award.  It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts.  The AHRQ takes no position on the status of 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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

For the purpose of this FOA, AHRQ will make grants only to non-profit organizations.  For-profit organizations may participate in projects as members of consortia or as subcontractors only.  Foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations and foreign institutions will be returned without review.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.   

Individuals from underrepresented racial and ethnic groups, women, as well as individuals with disabilities, are always encouraged to apply for AHRQ programs.  The Secretary, U.S. Department of Health and Human Services (DHHS), is required by law to give special consideration to physicians and other health professionals who agree to undertake a minimum of 2 years of research training.  AHRQ recognizes the critical importance of training clinicians to become researchers and encourages them to apply.

Citizenship.  By the time of award, candidates for the postdoctoral fellowship award must be citizens or non-citizen  nationals of the United States, or must have been lawfully admitted to the  United States for Permanent Residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status).  Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible.   If the applicant has been lawfully admitted to the United States for permanent residence, the appropriate item should be checked on the Face Page of the application.  Applicants who have applied for and have not yet been granted admission as a permanent resident should check the Permanent Resident block on the Face Page of the PHS 416-1 application, and also write in the word "pending."  A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award.  The fellowship application should identify the number of the PA in Item 3.  Individuals may apply for the F32 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided. 

Degree Requirements.  Before a Kirschstein-NRSA postdoctoral fellowship award can be activated, the individual must have received a Ph.D., M.D., D.O., D.C., D.D.S.,  D.V.M., O.D., D.P.M., Sc.D., Dr.P.H., D.N.S., N.D., Pharm.D., D.S.W., Psych.D., or equivalent doctoral degree from an accredited domestic or foreign  institution.  Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable.

Special Requirements

The proposed NRSA training must offer an opportunity for individuals to broaden their scientific background or to extend their potential for research in health services related areas.  Fellowship awardees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program.  Research clinicians must devote full-time to their proposed research training and must restrict clinical duties within their full-time research training experience to activities that are directly related to the research training experience.  A NRSA fellowship (F32) may not be used to support studies leading to the M.D., D.O., D.D.S., Pharm. D., or other similar health-professional degrees.  These awards may not be used to support the clinical years of residency training.

Duration of Support.  Individuals may receive up to three years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants (T32) and individual fellowship awards (F32).   Applicants must consider any prior NRSA postdoctoral research training in determining the duration of fellowship support requested.  Training beyond the 3-year aggregate limit may be possible under certain exceptional circumstances, but a waiver from the AHRQ is required. Individuals seeking additional NRSA support beyond the third year are strongly advised to consult with relevant AHRQ staff before preparing a justification.  Any waiver will require a detailed justification of the need for additional research training.  

Sponsor.  The applicant must identify an individual who will serve as a sponsor or mentor and will supervise the training and research experience.  The applicant’s sponsor/mentor should be an active investigator in the area of the proposed research who will directly supervise the candidate’s research.  The sponsor/mentor must also document the availability of staff, research support, and facilities for high-quality research training.  The applicant must work with his/her sponsor/mentor in preparing the application. 

In most cases, the F32 supports research training experiences in new settings in order to maximize the acquisition of new skills and knowledge.  However, applicants may propose postdoctoral training experiences at their doctorate institution or at the institution where they have been training for more than a year.  In such cases, the applicant must carefully document the opportunities for new research training experiences specifically designed to broaden their scientific background.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Service Payback:

Pursuant to the NIH Revitalization Act of 1993, postdoctoral trainees receiving NRSA support incur a service payback obligation only during their first 12 months of postdoctoral support.  The second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation.  Therefore, the payback agreement must be signed and submitted with the activation notice for only the initial year of support.  Those who do not pay back their obligation through continued supported training may satisfy their obligation by serving in a position in which healthcare-related research, research training, or teaching are the primary activities.  Such individuals must engage in research, research training, or teaching at a rate of 20 or more hours per week averaged over a full work-year.  Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country.  Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions.  Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research.

Payback service positions are arranged by the individual, not by AHRQ.  AHRQ will review and approve the activity at the end of the year in which it occurs.  Service to satisfy any outstanding obligation must be initiated within two years after termination of NRSA support, and must be performed on a continuous basis. For individuals who fail to fulfill their service obligation, the United States is entitled to recover the total amount of funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the U.S. Department of Treasury.  Financial payback must be completed within three years, beginning on the date the United States becomes entitled to recover such amount.

Under certain conditions, the Secretary, DHHS, may extend the period for starting service, permit breaks in service, extend the period of repayment, or otherwise waive the payback obligation when compliance would constitute a substantial hardship against equity and good conscience. Policies regarding the payback obligation are explained in the Kirschstein-NRSA Section of the NIH Grants Policy Statement available at http://grants.nih.gov/grants/policy/policy.htm.  Specific questions may appear in a list of Frequently Asked Questions that appears on the Web at http://grants.nih.gov/training/faq_fellowships.htm.  Other questions on payback should be directed to the appropriate AHRQ contact.

Leave Policies:

In general, fellows may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution.  For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday.  Fellows may receive stipends for up to 15 calendar days of sick leave per year.  Sick leave may be used for the medical conditions related to pregnancy and childbirth.  Fellows may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the institution.

A period of terminal leave is not permitted and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from  AHRQ  for an unpaid leave of absence. 

Part-Time Training:

Under unusual and pressing personal circumstances, a fellow may submit a written request to AHRQ to permit less than full-time training.  Such requests will be considered on a case-by-case basis.  They must be approved by AHRQ in advance for each budget period.  The nature of the circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the fellow's position at the institution.  In each case, the fellow must submit a written request countersigned by the sponsor and an appropriate institutional business official that includes documentation supporting the need for part-time training.  The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the fellow intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the proposed research training program. In no case will it be permissible for the fellow to be engaged in supported research training for less than 50 percent effort.  Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from fellowship support.  The fellowship notice of award will be reissued and the stipend will be pro-rated during the period of any approved part-time training. Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral fellows. 

Other Special Requirements

No application will be accepted without the applicant signing the certification block on the face page of the application.  Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.  A Payback Agreement Form (PHS 6031) must accompany the Activation Notice for any award that occurs during the individual's initial 12 months of postdoctoral support. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to AHRQ.  If the fellow has a payback obligation, he or she 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 link to forms may also be found on the NIH Website at  http://grants.nih.gov/grants/forms.htm#trainingervice Payback:

Section IV. Application and Submission Information


1. Address to Request Application Information

The instructions for the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form (PHS 416-1, rev. 10/05) are available at: http://grants.nih.gov/grants/forms.htm#training

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

Telecommunications for the hearing impaired: TTY 301-451-0088.
 
2. Content and Form of Application Submission
 
Applications must be prepared using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form (PHS 416-1, rev. 10/05) available at: http://grants.nih.gov/grants/forms.htm training

The applicant must follow all general instructions for the PHS 416-1 AND the specific instructions included in this FOA. In instances in which the two differ, precedence is given to the instructions in this FOA.

Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 13b of the face page of the PHS 416-1 form.

The title and number of this funding opportunity announcement (FOA) must be typed on line three of the face page of the application form.

The following MUST be included with the application at the time of submission:

THREE reference letters in sealed envelopes must be included in the application. The sponsor cannot be used as a reference. 

Instruction in the Responsible Conduct of Research.  Applications must include the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction.  The amount and nature of faculty participation must be described.  No award will be made if an application lacks this component

See also Subsections III.3 and VI.2. for additional information.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt Date(s):  April 5, August 5, December 5 annually (beginning August 5, 2006 and ending December 5, 2008
Peer Review Date(s):  February, June, October annually
Earliest Anticipated Start Date(s):   6 months from receipt of application

3.A.1. Letter of Intent

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

3.B. Sending an Application to AHRQ

Applications must be prepared using   the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form PHS 416-1 and instructions as described above.  Submit a signed original of the application and one signed photocopy as per the instructions in the 416-1in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, one additional copy of the application, labeled “Advance Copy” and all appendix materials  must also be sent to:

Shelley Benjamin, M.S.W.
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone: (301) 427-1528|
FAX: (301) 427-1562
Email: Shelley.Benjamin@ahrq.hhs.gov

3.C. Application Processing
 
Applications must be received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review .

Upon receipt applications will be evaluated for completeness by AHRQ.  Incomplete 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 merit review unless the applicant withdraws the pending application. AHRQ will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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/.

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

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NRSA section of the PHS Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/gps/index.html.

6. Other Submission Requirements

Priority Populations

The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) in amending the PHS 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, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should address the requirements of including priority populations as specified in the Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ (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, the AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

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

Specific Instructions for Modular Grant applications.

AHRQ is not using the Modular Grant Application and Award Process.  Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process. Applications submitted in the Modular format will be returned without review.

HCUPS & 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 inpatient 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 databases include:  the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of approximately 1,000 hospitals, the Kids’ Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states.  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, noninstitutionalized population.  MEPS comprises 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.

This does not preclude the use of secondary data sources or primary data collection.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data.  Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave).  Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement.  References to data sharing may also be appropriate in other sections of the application.

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

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers.  However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.   

Sharing Research Resources

Not Applicable

Section V. Application Review Information


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

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate review group convened by AHRQ 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 be returned to the applicant without further consideration.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research and/or training experience will have a substantial impact on the pursuit of these goals.   Reviewers recognize that applicants will have variable amounts of previous research experience.  Those with limited research experience are less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced applicant.  Reviewers will consider the appropriateness of the research plan to the stage of the candidate’s research development.

The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application.  The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.  For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Candidate:  An assessment of the candidate's previous academic and/or research performance and the potential to become an important contributor to health services research.

Sponsor and Training Environment:  An assessment of the quality of the training environment and the qualifications of the sponsor as a mentor for the proposed research training experience.

Research Training Plan:  The merit of the research training plan and its relationship to the candidate's career plans and the Agency’s research priorities.

Training Potential:  An assessment of the value of the proposed fellowship experience as it relates to the candidate's needs in preparation for a career as an independent researcher.

2.A. Additional Review Criteria:

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

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.

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

While not a factor in the scientific merit or priority score, reviewers will also assess the adequacy of the plan for Responsible Conduct of Research.   This may include the rationale, subject matter, appropriateness, format, frequency and duration of instruction.  The amount and nature of faculty participation must be described. 

2.B. Additional Review Considerations

Not Applicable

2.C. Sharing Research Data

Data Confidentiality

Pursuant to section 934(c) of the (PHS) Act (42 USC 299c-3(c)), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute [42 U.S.C.299c-3(d)). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to 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 RFA will also be obtained and managed in accordance with 42 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans, for example, ordinarily will require either patient authorization of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) 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.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/.

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

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes.  In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ's OCKT wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will be able to access his or Summary Statement (written critique) via the 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 certification of IRB review and approval of the protection of human subjects.  For details, applicants may refer to the "AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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.

Notification will be made electronically to the designated administrative/institutional official. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions. “

 2. Administrative and National Policy Requirements

Awardees should be aware that compliance with the Paperwork Reduction Act (44 U.S.C. Ch. 35) might require Department and OMB review of data collection instruments in which case some grantee time may be required to explain, defend or amend data collection instrument items. (See also 5 CFR 1320)

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

Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Reporting

Awardees will be required to submit the PHS Noncompeting Progress Report for Continuation Support  Form 416-9 (see http://grants.nih.gov/grants/funding/416-9/phs416-9.htm) and financial statements as required in the PHS Grants Policy Statement.

The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions.

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; career development activities; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ will provide the timetable for these progress reports.

A final progress report and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Direct your questions about programmatic issues, including information on the Inclusion of Women, Minorities and Children, and other priority populations to:

Shelley M. Benjamin, M.S.W.
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone:  301-427-1528
FAX:  301-427-1562
Email:  Shelley.Benjamin@ahrq.hhs.gov

2. Peer Review Contacts:

Direct your questions about peer review issues to:

Yvette Davis, V.M.D., M.P.H.
Division of Scientific Review
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850                                                         
Telephone:  301-427-1551
FAX:  301-427-1562
Email: Yvette.Davis@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct your questions about financial or grant management matters to:

Dianna Bailey
Office of Performance Accountability Resources and Technology/DGM
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone:  301-427-1454
Fax:  301-427-1462 or 1464
Email:  Dianna.Bailey@ahrq.hhs.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal act is taken, having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulation action is taken in reliance on AHRQ-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if it constituted trade secrets or commercial information. 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.

Standards for Privacy of Individually Identifiable Health Information:

As indicated above, the Department of Health and Human Services (DHHS) issued the "Standards for Privacy of Individually Identifiable Health Information."  This regulation was mandated by the 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 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.

Healthy People 2010:

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov, Number 93.225.  Awards are made under the authorization of Sections 487, 901, and 935 of the Public Health Service Act as amended (42 USC 288, 299, and 299b-25).  Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92 (see    http://grants.nih.gov/grants/policy/gps/index.html).

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

Human Subjects Protection:

Federal regulations 45 CFR 46 require that applications and proposals involving human subjects research must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).


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