and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Components
of Participating Organizations
Office of Extramural Research, Education and Priority Populations (OEREP), (http://www.ahrq.gov)
Title: AHRQ Grants for Health Services Research Dissertation Program (R36)
Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.
Announcement
Type
This Funding Opportunity Announcement (FOA)
is a re-issue of PAR-06-118,
which was previously released January 13, 2006.
Program Announcement (PA) Number: PAR-09-212
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
Catalog
of Federal Domestic Assistance Number(s)
93.226
Key Dates
Release/Posted Date: July 17, 2009
Opening Date: October 1, 2009 (Earliest date an application may be
submitted to Grants.gov)
NOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Due Date(s): February 1, May 1, August 1, and November 1 annually,
beginning November 1, 2009
Peer Review Date(s): Generally two months after receipt date
Earliest Anticipated Start Date(s): Generally two months after peer review date
Expiration Date: August 2, 2012
Due
Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.
Table of Contents
Part
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible
Institutions
B. Eligible
Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an
Application Electronically to AHRQ
C. Application
Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section
VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
Applications for dissertation research grants must be responsive to AHRQ s
mission, which is to improve the quality, safety, efficiency, and effectiveness
of health care for all Americans. The research sponsored and conducted by
the Agency develops and presents scientific evidence regarding all aspects of
health care. It addresses issues of organization, delivery, financing,
utilization, patient and provider behavior, outcomes, effectiveness and
cost. It evaluates both clinical services and the system in which these
services are provided. These scientific results improve the evidence base
to enable better decisions about health care, including such areas as disease
prevention, appropriate use of medical technologies, improving diagnosis and
treatment in cost-effective ways, long-term care, and reducing racial and
ethnic disparities.
AHRQ has identified strategic goals as priority research areas. Research applications must address one of these areas. Applicants are strongly encouraged to focus on topical areas unique to AHRQ, demonstrating how expected results can be used or made available for use to enhance healthcare quality. Results should be directly relevant to customers, such as providers and practitioners, administrators, payers, consumers, policymakers, and insurers. The strategic research goals are:
AHRQ has particular interest in supporting dissertation projects in the following areas: comparative effectiveness, health information technology (health IT), patient safety, prevention and care management, value, and healthcare innovations. To learn more about AHRQ’s focus within these portfolios of work, please visit http://www.ahrq.gov/fund/portfolio.htm
In addition, particular opportunities emphasizing special dissertation areas of interest within AHRQ’s priorities are occasionally posted on AHRQ’s web site at http://www.ahrq.gov/fund/ragendix.htm. Currently, one Special Emphasis Notice is posted which highlights interest in dissertation applications related to use of health IT. The Notice emphasizes an interest in applications focusing on use of health IT to improve the quality and safety of medication management, patient-centered care, and/or health care decision making in one or more of the following care settings: ambulatory setting(s); transitions in care between ambulatory settings; or transitions in care between an ambulatory setting and non-ambulatory setting. A direct link to this Notice can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-HS-08-014.html. This link will be deactivated upon expiration. Applicants are encouraged to access AHRQ’s postings for updates.
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, the elderly; and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care.
This FOA describes the procedures and criteria for the AHRQ dissertation grant program. It updates and supersedes the AHRQ Grants for Health Services Research Dissertation PAR-06-118, published January 13, 2006.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
This FOA will use the research dissertation grant (R36) award mechanism. Applicants will be solely responsible for planning, directing, and executing the proposed project.
AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed. Applicants should use the SF424 (R&R) Budget Component described in the SF424 (R&R) Application Package and Instructions Guide.
2. Funds
Available
The total direct costs awarded under this FOA for dissertation grants must not
exceed $40,000 for the entire project period, which must be a minimum of nine
months and not to exceed 17 months in duration. Individuals supported
under Ruth Kirschstein National Research Service Award (NRSA) mechanisms, including
T32, F31 and F32 research training awards, are eligible to apply for a
dissertation award. However, such individuals may only request up
to $20,000 direct costs for additional, non-salary expenses. A statement
must be provided indicating that the expenses requested under the dissertation
grant application are not supported through the active training grant or
fellowship.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ include support for this program, awards pursuant to this FOA are contingent upon the availability of funds. Facilities and Administrative (F & A) costs (i.e., overhead or indirect costs) are limited to 8% of approved direct costs.
Section III. Eligibility Information
1. Eligible Applicants
You may submit an application(s) if your institution/organization has any of the following characteristics:
AHRQ s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to domestic non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
For dissertation grants, the applicant organization must be the doctoral granting institution at which the student is registered and matriculating. Individuals cannot apply directly.
1. B. Eligible Individuals
Eligible individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with his or her 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 programs. Applicants are eligible to apply for this award provided that they:
As noted above, individuals supported under Ruth Kirschstein National Research Service Award mechanisms, including T32, F31 and F32 research training awards, are eligible to apply for a dissertation award, with funding limitations described above. A statement must be provided in the application describing the expenses requested which are not supported through the active training grant or fellowship. The request for support must also satisfy applicant institutional policies. Recipients of mentored career development awards are not eligible for dissertation support.
2. Cost Sharing or Matching
This program does not require cost sharing for applications in response to this FOA.
3.
Other-Special Eligibility Criteria
Number of applications: AHRQ will not accept any application in
response to this FOA that is essentially the same as one currently pending
initial merit review by the Department of Health and Human Services (DHHS)
unless the applicant withdraws the pending application. This does not
preclude the submission of an application already reviewed with substantial
changes, but such application must include an Introduction addressing the
previous critique. Note such an application is considered a
"resubmission" for the SF 424 (R&R).
Resubmissions: Applicants may submit one resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).
Renewals: Renewals will not be allowed for this mechanism.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. AHRQ/NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.
Note: Only
the forms package directly attached to a specific FOA can be used. You will not
be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from
another FOA); although some of the "Attachment" files may be useable
for more than one FOA.
For further assistance, contact GrantsInfo --
Telephone 301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424(R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm)
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required
Components:
SF424 (R&R) (Cover component) PHS398
Cover Letter is optional.
Research & Related Project/Performance
Site Locations
Research & Related Other Project
Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget -- (See Section
IV.6, regarding appropriate required budget component)
Optional
Components:
PHS398 Cover Letter is optional. This does not replace required letters, noted below, which must be
included (Letters of Support).
Applications Involving a Single Institution:
When a single institution is involved, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions:
If multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution must submit its budget using the Research & Related Budget component. All other institutions must have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form in the case of multiple institutions.
3.
Submission Dates and Times
See Section
IV.3.A. For details.
3. A. Submission, Review, and Anticipated Start Dates
Opening Date: October 1, 2009 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): February 1, May 1, August 1, and November 1 annually,
beginning November 1, 2009.
Weekend/Federal Holiday Submission Dates. If a submission date falls on a weekend, it will be extended to the
following Monday; any time the date falls on a Federal holiday, the submission
date will be extended to the following business day. The application will be on
time if it is submitted on or before the following business day.
Peer Review Date(s): Generally two months after receipt date
Earliest Anticipated Start Date(s): Generally two months after peer review date
3. A.1. Letter of Intent
A letter of intent is not required for this FOA. This does not replace required letters, noted above.
3. B.
Submitting an Application Electronically to the AHRQ
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow Steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided
to AHRQ in PDF format, filenames must be included with no spaces or special
characters, and a pdf extension must be used.
3.C.
Application Processing
3.C.1
Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
AHRQ will not accept any application in response to this FOA 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. However, AHRQ will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
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. IRB approval is required prior to award.
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.
Use of CMS Data
Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, must 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 must 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 the confidentiality provision in the AHRQ 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, the DUA will include the requirement that the data 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 must 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 must not include the cost of identifiable 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 initiative is not subject to intergovernmental review.
5. Funding
Restrictions
For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
AHRQ requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Additional Instructions: In preparing the application, the following instructions are to be used in conjunction with the SF424 (R&R) Application Guide:
Research Strategy: Do not exceed 10 pages for the Research Strategy. All tables, graphs, figures, diagrams, and charts must be included within the 10 page limit. Part of the research strategy must describe any potential outcomes, products and/or impact of the proposed research on policy or practice, as well as dissemination plans, which involve traditional academic as well as nontraditional means of communicating relevant research findings to policymakers or health care delivery personnel. A clear description of the unique contribution of this effort must be included, especially if the research builds upon ongoing or previously conducted work by the principal investigator, or other dissertation committee member/faculty.
If the application is a resubmission, an Introduction to the Application for Resubmission must be completed. This section must be limited to one page. This introduction does not count toward the 10 pages limit for the Research Strategy described above.
Project Narrative: within the Research Strategy, include a brief description of the Relevance and Impact of the proposed research on policy or health practice. Use no more than two to three sentences for the narrative.
Letters of Support and Appendix materials: The only acceptable Appendix materials are (a) a required copy of the scanned official transcript from the current institution granting the Ph.D.; and (b) copies of any survey instrument(s) to be used in the proposed research, if applicable (See below for details for including the required Letters of Support and appendix materials).
Research & Related Senior/Key Person Profile: The dissertation candidate, who must be matriculated in an accredited doctoral program, will be the designated PD/PI. The mentor for the PD/PI must be listed as a key person. Other key persons are the other members of the dissertation committee, as well as any other consultants involved in the research project. Attach a biographical sketch for the PD/PI, mentor, and all other key personnel. It is strongly encouraged that the doctoral dissertation committee includes recognized health services researchers with appropriate interdisciplinary or multidisciplinary expertise necessary to fully support the research activities.
Budget: AHRQ does not accept modular budgets. Below is a further description of the budget component.
Allowable Costs: The Senior/Key Person is the applicant (the person completing the dissertation). Stipend/salary compensation can be requested for the applicant up to the current fiscal year NRSA pre-doctoral stipend level (in FY 2009 this is $20,976, see http://grants.nih.gov/training/nrsa.htm#policy).
Include equipment and travel costs as appropriate. General purpose equipment items, such as personal computers, must be separately listed and estimated under equipment costs. The applicant must provide justification for each budget item requested in the detailed budget for the total period of support being requested. In particular, proposed computer-related purchases need to be fully justified in terms of not being readily available to the student for the conduct of the research. Applicants can request up to $1500 in travel costs to attend appropriate scientific meetings.
The only allowable tuition-related costs are those associated with dissertation credits and matriculation fees. Health insurance fees should also be listed, as well as other direct costs associated with completing the dissertation, such as materials, supplies and ADP services.
Unallowable Costs: Specific costs not allowed on dissertation research grants include: alterations/renovations, space rental, contracting or consortium costs, dissertation defense or deposit fees, membership fees and costs associated with faculty/advisor mentor supervision. This list is not all inclusive, and the applicant should contact AHRQ staff regarding any other items being considered for which there are questions regarding whether or not the items are allowed to be included.
Level of Effort: Students must devote at least 40 hours per week on the dissertation for a minimum of nine months beginning at the time of award. The requested start date of award must be estimated to begin no less than four months from the submission date. Receipt of additional compensation (e.g., pay) for performance of work that is distinctly separate from the actual work involved in the conduct of the dissertation is allowable, but cannot exceed a paid level of effort greater than 20 hours per week.
Facilities and Administrative Costs: (i.e., overhead or indirect costs) are limited to eight percent of approved direct costs less tuition-related costs.
Protection of Human Subjects: A discussion of human subjects protection must be included if the proposed research involves any contact with or data on humans (e.g., patients, providers, administrators); including data obtained from secondary publicly or privately available data sources. This section does not count toward the 10 page limitation. If human subjects are involved, the applicant must also check yes in the appropriate box described in the Other Project Information Component Section of the SF 424 R&R application form.
Targeted/Planned Enrollment: AHRQ does not require completion of targeted/planned enrollment.
Letters of Support: The following two letters are required (NOTE: these differ in content from the optional Cover Letter described in the SF 424 (R&R) instructions. Applicants must follow the specific instructions on Letters of Support as described in SF424 (R&R) Application Guide.
Warning: Be sure that the direct cost, project period, and page number limitations specified for this FOA are observed. Any application not in compliance with the requirements will not be reviewed.
Appendix Materials: The only acceptable appendix materials are (a) a required copy of the scanned official transcript from the current institution granting the Ph.D.; and (b) copies of any survey instrument(s) to be used in the proposed research, if applicable. Do not mail transcripts to the AHRQ.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. Any application that does not comply with this requirement will not be reviewed.
Priority Populations
The Healthcare Research and Quality Act of 1999, in amending the Public Health Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. This authority is found at 42 USC 299(c). To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.
Publication Transmittal: General AHRQ Requirements
In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.
Assessment of AHRQ Grant Programs
In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.
AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.
HCUP & MEPS
Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS),the Kids Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS) and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). The NEDS, the newest addition to the HCUP databases, is the largest all-payer ED database in the United States and contains over 25 million (unweighted) records for ED visits at about 1,000 hospitals. More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.
The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.
Applicants use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.
Plan for Sharing Research Data
Data sharing is not required for this FOA.
Section V. Application Review Information
1. Criteria
Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.
Merit Review Criteria are described below. The review criteria described below will be considered in the review process.
2.
Review and Selection Process
Review Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications, or applications not following instructions given in this FOA, will not be reviewed.
As part of the initial merit review, all applications will:
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Does the proposed dissertation project address an important problem that is within the mission and priorities of AHRQ as described above? If the aims of the project are achieved, how do they advance scientific knowledge or how usable are they to decision makers or consumers? What will be the effect of this research project on the concepts or methods that drive the field of study?
Investigators: Does the candidate have the potential for a promising career in health services research? Does the mentor have the appropriate background and expertise in health services research? Is there adequate demonstration of the mentor’s commitment to the student? Is sufficient multidisciplinary expertise encompassed on the dissertation committee?
Innovation: Does the project contribute to existing literature? For example, does the project address an innovative hypothesis?
Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Are potential problem areas acknowledged and alternative tactics considered?
Environment: Does the scientific environment in which the student’s work will be done contribute to the probability of success? Does the proposed project take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support in the form of adequate office, computer, methodological, and statistical support?
2. A. Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).
Inclusion: Adequacy of plans to address the needs of genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below.
Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?
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.
Dissemination Plans: Does the applicant describe plans to disseminate the results of the dissertation research? If appropriate, do the plans include dissemination strategies which avail policymakers, consumers, providers or other users of the results?
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
2. B.
Additional Review Considerations
Not Applicable.
2. C. Resource Sharing Plan(s)
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 civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with 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 for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/
The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.
Sharing
Research Resources:
Rights in Data
AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. 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. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
Generally, applicants must anticipate a minimum of four months between the application submission date and the earliest possible start date.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the
application is under consideration for funding, AHRQ will request
"Just-In-Time" information from the applicant. Just-In-Time
information generally consists of information on other support and
certification of IRB approval of the project's proposed use of human subjects.
For details, applicants may refer to the "AHRQ Revised Policy for
Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant
Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).
A formal notification in the form of a Notice of Award (NOA) will be
provided to the applicant organization. Once all administrative and
programmatic issues have been resolved, the Notice of Award will be
generated via email notification from the awarding component to the grantee
business official. The NOA 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 NOA are at the recipient’s risk. 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 the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).
The dissertation award terminates once the requirements for the doctoral degree are met. Should the award terminate before the reflected project period end date, submit a letter to AHRQ, counter-signed by an administrative official, indicating the expected end date. Unexpended funds are to be reported on the financial status report (FSR) and returned to the AHRQ within 90 days of the expiration date.
As necessary, Terms and Conditions will be incorporated into the award statement.
A final Progress Report and Financial Status Report are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.
Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). 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 assigned grants management specialist.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.
1. Scientific/Research Contact(s):
Direct inquiries about general FOA issues to:
Brenda A.
Harding, M.A.
Division of Research Education
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1527
FAX: (301) 427-1562
Email: [email protected]
2. Peer Review Contact(s):
Direct inquiries about peer review issues toissues to:
Ali
Azadegan, D.V.M., Ph.D.
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) 427-1689
Fax: (301) 427-1562
E-mail address: [email protected]
3. Financial/Grants Management Contact(s):
Direct inquiries regarding fiscal matters to:
Anna
Caponiti
Division of Grants Management
Office of Performance Accountability, Resources and Technology
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1402
Fax: (301) 427- 1462
E-mail address: [email protected]
Section VIII. Other Information
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 at 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 at 45 CFR Part 46 require that applications and proposals involving
human subjects research must be evaluated in accordance with those regulations,
with reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.
Access to Research Data through the Freedom of Information Act:
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 is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption in FOIA, 5 USC 552(b)(3). 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", 5 USC 552(b) (4) for example, if it constitutes 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 confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.
Healthy People 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. Awards are made under the authority of 42 USC 299 et seq. and,
42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other
referenced applicable statutes and regulations. All awards are subject to
the terms and conditions, cost principles, and other considerations described
in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be
found at http://www.ahrq.gov/fund/hhspolicy.htm.
The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.
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NIH Funding Opportunities and Notices
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