Expired PAR-08-022: AHRQ Mentored Research Scientist Development Award (K01)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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 Mentored Research Scientist Development Award (K01)

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

Announcement Type
This is a new Funding Opportunity Announcement (FOA)

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

January 23, 2009 - This PAR has been reissued as (PAR-09-087).

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government 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. For general information on this transition, please see the electronic submission website at http://era.nih.gov/ElectronicReceipt/ and the transition timeline at http://era.nih.gov/ElectronicReceipt/files/Electronic_Receipt_Timeline_Ext.pdf. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-08-022

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: November 2, 2007
Application Receipt Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date: June, October, and February, annually
Earliest Anticipated Start Date: November, March, and July annually
Expiration Date: (Now Expired January 24, 2009 per PAR-09-087) Original Expiration Date: January 8, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The Agency for Healthcare Research and Quality (AHRQ) announces its interest in supporting the Mentored Research Scientist Development Award (K01) in health services research. The K01 provides specialized study support for research-trained doctorates (e.g., Ph.D., Sc.D., Dr.P.H.) who are committed to a career in health services research and have the potential to develop into independent investigators. The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Applications submitted in response to this FOA must be responsive to Agency goals and priorities, as described below. AHRQ will provide salary and fringe benefits for the K01 recipient for a requested percentage of the candidate s institutional salary, of up to $90,000 annually plus associated fringe benefits. Additionally, up to $25,000 per year for research development support, as detailed below, will be provided.

Eligible institutions include domestic institutions that are non-profit organizations, and are public or private such as universities, colleges, hospitals, and laboratories. Candidates must be U.S. Citizens or non-citizen nationals or individuals lawfully admitted for permanent residence, who hold a research-trained doctoral degree and can commit a minimum of 75% of full-time professional effort conducting research and relevant career development activities described in the application. The candidate must demonstrate that the requested period of research focus will foster his/her career as a highly productive investigator in the indicated field of research. In the last two years of K01 support, award recipients are permitted to reduce the level of effort required for the career award to a minimum commitment of 50% and replace that effort with Federal and/or non-Federal research support. Mentorship must continue during this period. Applicants can request three, four, or five years of support. For further information see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

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

The total amount and number of awards will depend upon the quality, duration, and costs of applications received as determined by the peer review process, available funds, program priorities, and Agency research objectives.

Interested applicants are encouraged to contact the relevant AHRQ staff person listed in Section VII prior to preparing an application to discuss issues of eligibility, program relevance, and review any specific provisions of the award.

Telecommunications for the hearing impaired is available at TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, 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 Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

Research Career Objectives

AHRQ announces its interest in supporting the Mentored Research Scientist Development Award (K01) in health services research. The K01 award provides support for a sustained period of protected time for intensive research career development under the guidance of an experienced mentor or sponsor in the field of health services research leading to research independence. The expectation is that through this period of career development and research training, awardees will launch independent research careers and become competitive for new Federal and non-Federal research project funding.

The candidate must devote a minimum of 75% of full-time professional effort to the goals of this award. The remainder must be devoted to other research related activities and/or teaching pursuits consistent with the objectives of the award. Both didactic and research phases of the award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. In the last two years of K01 support, award recipients are permitted to reduce the level of effort required for the career award to a minimum commitment of 50% and replace that effort with Federal and/or non-Federal research support. Mentorship must continue during this period.

All career development programs must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the plan for the career development program. Applicants must justify the need for this award and provide a convincing case that the proposed period of support will substantially enhance their careers as independent investigators in their chosen area of research. The sponsoring institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator.

Applications must be responsive to AHRQ’s mission. The mission of the Agency is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. AHRQ achieves this mission by supporting a broad program of health services research and by working with partners to promote improvements in clinical and health systems practices. AHRQ’s programs are designed to (1) improve clinical practice, (2) improve the health care system’s ability to provide access to and deliver high quality, high-value health care, and (3) provide policymakers with the ability to assess the impact of system changes on outcomes, quality, access to, cost, and use of health care services.

Current pressing health care issues are increasingly viewed as influenced by complex systems that call for a new approach that integrates advances in behavioral sciences, clinical sciences, and health services research. In order to address these challenges, AHRQ will fund research that can be put into practice in primary care and by other health care providers, policy makers, and health care delivery system administrators. The goal is that Agency-funded research will be implemented to improve the health care of all Americans. Specific areas of research interest to the Agency are as follows:

1) Translational Research. This may include testing strategies for adoption and implementation of evidence-based tools and interventions; assessing the degree to which tools and interventions that have been proven successful in a few health care settings or outside of health care are appropriate to other health care settings and non-traditional health care settings, and the degree to which practices that worked well with one population fit other populations, especially AHRQ priority populations; and identifying successful past efforts to adopt and implement evidence-based tools and interventions and replicating them across a number of different organizations and settings.

2) Patient Safety and Quality. AHRQ’s mission includes supporting and promoting the development of multidisciplinary research to examine the scope and impact of medical errors on the health care system and offer solutions to create a culture of safety and high quality. This includes examining 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. Of special interest is the identification of known risks and hazards that threaten patient safety in ambulatory settings, especially among patients with chronic illness. Key areas needing attention are those pertaining to complex information management, coordination of care across multiple settings, health information technology applications, patient-centered care, and medication management in ambulatory settings.

3) Quality Improvement (QI). A more rigorous and systematic approach to QI evaluation is needed to ensure future investments in improving health care are grounded in science and provide value. These types of initiatives can help develop strong partnerships between multidisciplinary researchers and frontline providers and policymakers in health care who actually implement quality improvement strategies are needed. In addition, contributions to quality improvement theory development, testing of new and promising conceptual frameworks, innovative research designs, and methods for quality improvement are of interest to AHRQ.

4) Patient-Centered 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 care processes that lead to greater patient empowerment, improved patient-provider interaction, easier navigation through health care systems, and improved access, quality, and outcomes.

5) Payment, Markets, and Organization. To understand the impact of changes in organizational structure and processes, new technologies, and management innovations, and to discover ways to create a more efficient and higher-quality health system, AHRQ encourages research on system design and change, and the incentives, market forces, policies and regulatory structures most conducive to facilitating such changes. Examples include 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.

6) Health Care Disparities. AHRQ is especially interested in supporting research to reduce and eliminate health care disparities including the examination of approaches to reduce racial, ethnic, and socioeconomic disparities.

7) Large-Scale Data Base Methods. The Agency is interested in the use and application of large-scale survey and administrative data bases such as MEPS, HCUP, Medicare and Medicaid as related to clinical or organization improvement and/or policy needs assessment, development or evaluation.

AHRQ encourages applicants to partner with AHRQ-sponsored networks such as Primary Care Practice-based Research Networks (PBRN, see http://www.ahrq.gov/research/pbrn/pbrninit.htm) and Accelerating Change and Transformation in Organizations and Networks (ACTION, see http://www.ahrq.gov/research/action.htm) in their career development activities and research projects.

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 K01 award mechanism.

The K01 provides funding for specialized study for research-trained doctorates (Ph.D., Sc.D., Dr.P.H) who are committed to a career in health services research and have the potential to develop into independent investigators. As an applicant, the candidate and his/her mentor will be jointly responsible for planning, directing, and executing the proposed projects. The purpose of the K01 is to provide support and protected time for a period of three, four, or five years for an intensive, supervised career development experience leading to research independence in health services research. The application, if funded, is not renewable and is not transferable from one Principal Investigator (PI) to another.

AHRQ also funds two other career development (K award) grants: The K08 (Clinical Scientist Development Award, see http://grants.nih.gov/grants/guide/pa-files/PAR-07-443.html) and the K02 (Independent Scientist Award, see: http://grants.nih.gov/grants/guide/pa-files/PAR-07-444.html).

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review. Further information on non-modular budget format can be viewed at: http://grants.nih.gov/grants/funding/phs398/phs398.html.

2. Funds Available

Because the nature and scope of proposed research and career development plans vary widely across applications, 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, the submission of a sufficient number of meritorious applications as determined by the peer review process, and degree of relevance to Agency priorities.

Allowable Costs:

Salary: AHRQ will provide salary and fringe benefits for the K01 recipient for a requested portion of the candidate’s institutional salary, of up to $90,000 annually plus associated fringe benefits.

The institution may supplement AHRQ’s contribution up to a level that is consistent with the institution’s salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may Public Health Service (PHS) funds be used for salary supplementation, except as noted below for the last two years of the proposed award. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose and direction of the K01. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution’s salary scale. The total salary requested must be based on a full-time 12-month staff appointment. It must be consistent with both the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort are provided in addition to salary.

Research Development Support: AHRQ will provide up to a total of $25,000 per year for the following expenses: a) tuition, fees, and books related to career development; b) research expenses such as supplies, equipment, and technical personnel such as statisticians working with research data; c) travel to one research conference and any justifiable long-distance, training-related travel costs; d) statistical services including personnel and computer time. All expenses must be directly related to the proposed research career development.

Ancillary Personnel Support: Salary for secretarial and/or administrative assistance, etc. is not allowed.

Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your institution/organization has any of the following characteristics:

Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
Units of local or State government;
Eligible agencies of the Federal government.
Indian/Native American Tribal Government (Federally Recognized);
Indian/Native American Tribal Government (Other than Federally Recognized);
Indian/Native American Tribally Designated Organizations.

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus 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. Because the purpose of the K01 program is to contribute to the improvement of the health of the U.S. population, 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.

Applicants requesting foreign training must show in the application that the foreign institution and sponsor offer unique opportunities that are not currently available in the United States. Only if there is a clear scientific advantage will foreign training be considered for support.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities as the Principal Investigator (PI) is invited to work with his/her sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

The candidate must have a research doctoral degree and successfully demonstrate that he/she is engaged in a career in health services research. Examples of suitable academic training include, but are not limited to, Ph.D., Sc.D., Dr.P.H.

Candidates must identify mentor(s) with extensive and appropriate health services research and mentoring experience for the proposed research development plan. Candidates may request three, four, or five years of support. Length of proposed effort must be commensurate with the skills and experience obtained to-date relative to the proposed career development plan and fully justifiable, demonstrated needs. Skills possessed and planned development activities required must be detailed, including a description of specific skills to be gained from any proposed courses to be taken. Proposed formal coursework should be at a level commensurate with the specific skills required to complete the proposed research plan.

Candidates must be able to commit a minimum of 75% of full-time professional effort conducting research career development and research activities associated with the award. The remaining 25% effort must be devoted to other research related activities, clinical duties, and/or teaching pursuits consistent with the objectives of the award. The candidate must have a full time appointment at the academic institution that is the applicant institution. Candidates who have a joint VA/university appointment must have a 40 hour commitment to the university and may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. In the last two years of K01 support, award recipients are permitted to reduce the level of effort required for the career award to a minimum commitment of 50% and replace that effort with Federal and/or non-Federal research support.

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

An applicant may not apply concurrently for any other DHHS award that duplicates any of the provisions of this award, nor have another application pending award. Individuals are not eligible for K01 awards if they are current or former Principal Investigators on large DHHS research grants (R01), research demonstration grants (R18), FIRST awards (R29), comparable mentored career development awards (K08, K23), SBIR/STTR awards, sub-projects of program projects (P01) or center grants (P50), and the equivalent. Current and former PIs of small research grants (R03), dissertation grants (R36), or exploratory/development grants (R21) are eligible to apply. Former National Research Services Award (NRSA) trainees/fellows, or those nearing completion of their training, are also eligible. However, if awarded a K01 grant, the candidate can no long accept salary support from any other Public Health Service funded grant.

Special Requirements: Each career development program must be tailored to meet the individual needs of the candidate. The candidate and mentor(s) are jointly responsible for the preparation of the plan for the career development program. The appropriateness of the mentor’s skills and background in health services research must be fully documented and its relevance to the career development plan of the candidate fully explained. The sponsoring institution must demonstrate a commitment to provide the environment and resources needed for the candidate to perform the activities included the career development program. It is anticipated that the K01 awardees will apply for independent funding during the latter period of this award and that the sponsoring institution will provide the resources required for them to do so.

In addition to information about the applicant candidate, key elements of the award include:

Environment: The applicant institution must have a well-established record of health services research career development activities and qualified research faculty to serve as mentor(s). The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the applicant. The candidate, mentor, and institution must describe a career development program that maximizes the use of relevant research and educational resources, and propose qualified faculty as mentors in the specific area.

Career Development Program: The award provides three, four, or five consecutive 12-month budget periods. At least 75% of the recipient’s full-time professional effort must be devoted to the program. The remainder of the applicant’s time should be devoted to other research related activities, clinical duties, and/or teaching pursuits consistent with the objectives of the award. The candidate is expected to further develop knowledge in health services research and enhance research skills relevant to his/her career goals. The candidate will need to propose appropriate coursework and didactic experiences as part of his/her training experience. In the last two years of K01 support, award recipients are permitted to reduce the level of effort required for the career award to a minimum commitment of 50% and replace that effort with Federal and/or non-Federal research support. Salary and fringe benefits would be reduced concomitantly with the reduction in effort.

Mentor(s): The candidate must name a primary mentor, who together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

Research Plan: The research plan must be described as outlined in Form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/preliminary Studies, Research Design and Methods.

Training in the Responsible Conduct of Research: Candidates must describe plans to participate in courses related to instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of the candidate’s participation. No award will be made if an application lacks this component.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a 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 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS for Career Development Awards are located in the PHS 398 instructions, Part 1, Section III, starting on page 51.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review, and Anticipated Start Dates
Application Receipt Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date: June, October, and February, annually
Earliest Anticipated Start Date: November, March, and July annually

3.A.1. Letter of Intent

Not applicable.

3.B. Sending an Application to AHRQ

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in 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, two additional copies of the application, and all copies of the appendix material must be sent to:

Kay Anderson, Ph.D.
OEREP/DRE
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1555
FAX: (301) 427-1562

3.C. Application Processing

Applications must be received on or before the application receipt 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 the Center for Scientific Review (CSR) at NIH and AHRQ, and responsiveness by the AHRQ Referral Officer. Incomplete and 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 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 (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.

o Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ's confidentiality statute, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of the CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.

4. Intergovernmental Review

This FOA 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 principals, 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

Citizenship: Applicants must meet the citizenship requirements as described in the Eligibility section of this announcement prior to award (Section III).

Concurrent Awards: Applicants must be aware of the AHRQ policies associated with other federally sponsored support as described in Section III.3 above.

Salary Support: The salary requested for the candidate must be consistent with the established salary structure for full-time staff appointment and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department.

An AHRQ policy change (see http://grants1.nih.gov/grants/guide/notice-files/NOT-HS-04-002.html) now allows AHRQ career development award recipients in the final two years of their award, to receive salary support from both their K award and another PHS research grant or subproject. The K award recipient must be the named Principal Investigator on a competing research project grant (R01, R03, R18, R21, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.)

Research Development Support: The research development support costs must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research and/or career development activities. Salary for ancillary personnel support, such as mentors, secretarial and administrative assistants is not allowed.

6. Other Submission Requirements

Using the Supplementary Instructions in the PHS 398 Research Career Awards (instructions, Part III), the following information must be included in the application:

Candidate

Describe the candidate's commitment to a career in health services research. Include a description of all the candidate's professional responsibilities in the grantee institution and elsewhere and show their relation to the proposed activities on the career award.

Discuss prior training and how it relates to the objectives and long-term career plans of the candidate.
Discuss the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.
Describe the candidate s long-term commitment to a career in health services research.
Establish the candidate s potential to develop and into an independent health services researcher.
Describe immediate and long-term career objectives, explaining how the award will contribute to their attainment, including a plan and proposed timeline for achieving independent research support by the end of the award period.
Describe the candidate’s need for the award, given where he/she is in their career.
Describe the proposed time commitment relative to proposed tasks over the course of the grant period.

Career Development Plan

Describe the career development plan incorporating consideration of the candidate’s goals and prior experience. This should be a systematic plan to obtain the necessary health services research background and research experience to launch an independent research career. More junior candidates with little previous research experience may require a phased development period in which the first year(s) of the award is largely of a didactic nature followed by a period of intense, supervised research experience. Candidates with more experience at the time of application may need a shorter developmental period and may already have an adequate theoretical background. In any case, the career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a health services researcher. The adequacy of the proposed length of support must be well justified and will be evaluated by peer review and agency decision makers. The candidate must describe the content of specific courses and training experiences proposed relative to specific skills required to complete the proposed research plan, as well as skills possessed to date relative to career plans. The plan should:

Show a logical progression from the candidate's prior research and training experiences to the research experiences that will occur during the K01 award period and then to independent investigator; justify the need for further career development to become an independent investigator; and utilize the relevant research and educational resources of the institution.
Reflect that the candidate and the primary mentor are responsible for the preparation of the career development plan. A timeline is often helpful. The mentor may form an advisory committee to assist with the development of a program of study or to monitor the candidate’s progress through the career development program.
Explicitly describe the didactic and research aspects designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals.
Describe the professional responsibilities/activities (including other research projects) beyond the minimum required 75% effort commitment to the K01 award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.

Research Plan

A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided.

Organize the research plan as indicated in the Form PHS 398, following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods. The candidate should consult with mentor(s) regarding the development of this section. The section must:

Describe how the research will advance AHRQ’s mission and goals, and expected impact of the research on practice and/or policy.
Provide a timeline for the proposed length of study detailing the research progression.

Training in the Responsible Conduct of Research

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review. Although the AHRQ does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regard the use of human subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of the candidate’s participation. Applicants must document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction.

An award cannot be made if an application lacks this component.

Mentorship Requirements

The candidate must name a primary mentor who, together with the applicant and other mentors, is responsible for the planning, direction, and execution of the program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators.
The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
AHRQ encourages women, individuals from diverse racial and ethnic groups, and individuals with disabilities to be involved as mentors to serve as role models.
The application must include a statement from the mentor providing: 1) information on their research qualifications and previous experience as a research supervisor, relative to the research and career development plans of the applicant; 2) a mentoring plan describing the frequency and nature of the supervision and mentoring that will occur during the proposed award period and 3) a plan for transitioning the candidate from the mentored phase of their career to the independent investigator phase during the project period of the award.
Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate.
The mentor or department chair must agree and provide a statement in the application documenting that this amount of the candidate’s time will be protected.
The mentor must agree to provide annual evaluations of the candidate’s progress for the duration of the award as required in the Annual Progress Report, Form PHS 2590 (see Section VI.3 Reporting).
Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.

Environment and Institutional Commitment to the Candidate

The sponsoring institution must define and document a strong, well-established research and training program related to the candidate's area of interest, including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K01 award.

Describe the resources and facilities that will be available to the candidate.
Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
In a clear statement, provide assurances that the candidate will be able to devote a minimum of 75% of his/her effort in developing his/her research program, that the remaining percent effort being devoted to activities related to the development of their research career, and that the candidate will be released from normal clinical, teaching or administrative duties. In the event the candidate decreases his/her K01-devoted time to 50% during the last two years of the grant term due to additional support as described above, the sponsoring institution should indicate their willingness to continue their support at this reduced level.

Letters of Reference

Include with the application three sealed letters of reference from well-established researchers addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator. The mentor(s) must also submit letters of reference, but these letters will be considered independently of the three required reference letters. All sealed letters of reference should be attached to the face page of the application.

Budget

Budget requests must be provided according to the instructions in the Form PHS 398. The request for tuition and fees, books, travel, research development, support, etc., must be justified and specified by category.
The application should include detailed budgets for the initial budget period and the entire proposed project period.
Other Scientific Support for the Principal Investigator and all key personnel listed on page two of the application should be submitted.
For detailed budget questions, contact the Grants Management person listed in Section VII below.

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. Applications submitted in the Modular format will be returned without review.

Priority Populations

The Healthcare Research and Quality Act of 1999, 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. This authority is also found at 42 USC 299. 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.

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, 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.

o 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 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 care 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 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.

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. The review criteria 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 be returned to the applicant without further consideration.

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

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

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:

Scientific merit of the proposed career development research project as determined by peer review.
Availability of funds.
Responsiveness to research objectives of AHRQ.
Relevance to program priorities.
Portfolio balance within AHRQ and DHHS.

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed career development plan and research project will have a substantial impact on the pursuit of the candidate’s health services research career goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Significance
Approach
Innovation
Investigator
Environment

Note that an 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.

Significance: Does this career development research project address an important problem? If the aims of the proposed research are achieved, how will knowledge relevant to health care delivery be advanced? What will be the effect of this study on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the career development research project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the career development research project original and innovative? For example: Does the study challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Investigator: Is the principal investigator appropriately trained and well suited to carry out this career development plan and research project? Is the work proposed appropriate to the experience level of the principal investigator?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed career development research study benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed career development plan and research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these 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 a major scientific impact and thus deserve a high priority score. The review criteria focuses on the following components:

Candidate

o Quality of the candidate’s research, academic and clinical record relevant to proposed plans and research;

o Commitment to a health services research career.

Career Development Plan

o The appropriateness of the mentor’s skills and background in health services and their relevance to the career development plan of the candidate;

o Demonstration of the mentor’s adequate level of commitment to the candidate;

o Likelihood that the proposed development plan will contribute substantially to enable the candidate to become a stellar health services researcher;

o Appropriateness of the content, the phasing, and the proposed duration of the career development plan and support provided, including facilities;

o Consistency of the career development plan with the candidate’s previous research and training as well as proposed career goals; and,

o Quality of the proposed training in responsible conduct of research.

Research Plan

Reviewers recognize that applicants will have variable amounts of previous research experience. All applications must include a fundamentally sound research plan.

o Appropriateness of the research plan to the stage of research development;

o Scientific and technical merit of the research question, design, and methodology;

o Innovativeness of the approaches proposed;

o Relevance of the proposed research to the candidate’s career objectives;

o Relevance of the proposed research to AHRQ’s goals and priorities; and,

o Adequacy of the plan s inclusion of both genders, minorities and their subgroups, as well as attention to AHRQ priority populations, as appropriate for the scientific goals of the research.

Environment and Institutional Commitment

o Applicant institution s commitment to the scientific and career development of the candidate;

o Adequacy of research facilities;

o Quality and relevance of the environment for the research to be conducted by the candidate;

o Applicant institution s commitment to an appropriate balance of research and clinical responsibilities including the level of effort proposed by the candidate.

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:

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 noted in the FOA?

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

Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see discussion on Priority Populations in Section IV.6 on Special Requirements, above, and Inclusion Criteria included in Section VIII on 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 Part II, Human Subjects Research Supplement In the PHS Form 398.

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

2.B. Additional Review Considerations

Not Applicable.

2.C. Sharing Research Data

Data Confidentiality

Pursuant to 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 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 RFA will also be obtained and managed in accordance with 45 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 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 applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents for, as appropriate, 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 AHRQ 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 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 the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate seven 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 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 and certification of IRB approval of the project's proposed use of human subjects. As a result of preaward review by Program or Grants Management staff, submission of additional supporting or clarifying material may be required. For details regarding IRB certification in applications, 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).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official. If a grantee does not have access to e-mail, a hard copy of the notice of Grant Award will be mailed to the business official. The NGA signed by the 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 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.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement 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 your recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm). I

A. Evaluation:

In carrying out its stewardship of human resource-related programs, the AHRQ may begin requesting 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 program.

B. Other Income:

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and if the retention of such pay is consistent with the policies and practices of the grantee institution.

Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution, with disposition by any of the following methods:

The funds may be expended by the grantee institution in accordance with the established policies of the grantee institution.
The funds may be used for health-related research purposes.

Usually, funds budgeted in an AHRQ-supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. AHRQ will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of AHRQ.

C. Special Leave:

Leave to another institution, including a foreign health services research program, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval from AHRQ is required. Details on the process of submission of prior approval requests can be found in the HHS Grants Policy Statement at http://www.ahrq.gov/fund/download/HHSGPS_107.doc , Requesting Prior Approval.

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the K01 award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval from AHRQ and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to AHRQ requesting a reduction in professional effort below 75%. Such requests will be considered on a case-by-base basis during the award period. In no case will it be permissible to work at less than 50% effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75% as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program:

Individual awards are made for career development at a specific institution in a specific program. A change in the specified scientific area of the research component or the career development program requires prior approval by AHRQ. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by AHRQ staff to ensure the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, AHRQ staff could recommend that the award be terminated.

E. Change of Institution or Termination:

Consultation with AHRQ program staff is strongly encouraged when either termination or a change of institution is being considered.

A change of grantee institution request will normally be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part, with grant funds. In reviewing a request to transfer a grant, AHRQ will consider whether there is a continued need for the grant-supported project or activity and the impact of the any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, AHRQ may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the grantee is moving to another eligible institution, career award support may be continued provided:

A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative view by AHRQ staff.
The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program.
All conditions of the award are met at the new institution.
The period of support requested is no more than the time remaining within the existing award.

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. AHRQ can terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, AHRQ shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the Health and Human Services (HHS) Grants Policy Statement, found at http://www.ahrq.gov/fund/download/HHSGPS_107.doc.

The Progress Report must include Sections a through f as described on pages 11-15 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions.

Evaluation of the awardee s progress will encompass the following:

A demonstration of progress toward the aims of the research as described in a brief summary of the studies and results obtained during the prior funding period;
A description of career development and research-related activities undertaken during the prior funding period;
A list of accomplishment such as publications, professional presentation, new collaborations, or project-generated resources made during the prior funding period;
A brief explanation of plans to address the specific aims during the next year of support;
A description of proposed career development and research-related activities for the next year of support with a clear indication of percent effort devoted to research/career development training and other activities; and,
An annual evaluation statement of the candidate’s progress, as required in the Form PHS 2590 continuation application instructions (item J. Sponsor’s Report).

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. AHRQ will provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs. This report must be submitted for each budget period no later than 90 days after the close of the budget period. A hard copy of the report should be submitted to the AHRQ FSR Coordinator.

A final Progress Report, Financial Status Report, and Final Invention Statement are required at the end of the project.

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 Contact(s):

AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the FOA. Written and telephone inquiries concerning this FOA are encouraged.

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

Kay Anderson, Ph.D.
Office of Extramural Research, Education, and Priority Populations (OEREP) Division of Research Education (DRE)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1555
Fax: (301) 427-1562
E-mail: Kay.Anderson@ahrq.hhs.gov

2. Peer Review Contact(s):

Direct your questions about peer review issues of grant applications made in response to this FOA to:

Ali Azadegan, D.V.M.
Office of Extramural Research, Education, and Priority Populations (OEREP) Division of Scientific Review (DSR)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1869
Fax: (301) 427-1562
E-mail: Ali.Azadegan@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Al Deal
Office of Performance Accountability, Resources, and Technology (OPART) Grants Management (GM)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1806
Fax: (301) 427-1462
E-mail: Al.Deal@ahrq.hhs.gov

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate: e.g., because of the lack of connection between the study and the health of women or particular minorities.

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

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

Human Subjects Protection:

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

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

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 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 under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study, statutorily protected under 42 USC 299c-3(c), is exempted from disclosure under "the (b)(3) exemption in FOIA. 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 they constitute 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.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ-supported projects, 42 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 2010:

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of 42 USC 299 et seq. and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92 and applicable authorizing 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 PHS mission to protect and advance the physical and mental health of the American people.