Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Components of Participating Organizations
Center for Outcomes and Evidence (COE) (http://www.ahrq.gov/), and its Effective Health Care Program (http://effectivehealthcare.ahrq.gov/)
Title: Recovery Act 2009 Limited Competition: AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) Grants (R01)
Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.
Request for Applications (RFA) Number: RFA-HS-10-003
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
Release/Posted Date: September 25, 2009
Opening Date: November 16, 2009
Letters of Intent Receipt Date(s): November 18, 2009
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): December 16, 2009
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: December 17, 2009
Due Dates for E.O. 12372
Additional Overview Content
Purpose. This AHRQ Funding Opportunity Announcement (FOA), supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5, invites Research Project Grant (R01) applications for large projects in comparative effectiveness aimed at generating new knowledge to help inform decision making in priority areas of clinical care. The impact of these studies should have a high likelihood of creating major advancements in clinical care.
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
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
1. Research Objectives
AHRQ seeks research grant applications for projects in the area of comparative effectiveness research to respond to the American Recovery & Reinvestment Act of 2009. In its Report to the President and Congress, the Federal Coordinating Council for Comparative Effectiveness Research defines comparative effectiveness research (CER) as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in ‘real world’ settings.” Both the Institute of Medicine report on Initial National Priorities on Comparative Effectiveness Research and the earlier Congressional Budget Office report on Research on Comparative Effectiveness of Medical Treatment have adopted similar definitions. These definitions allow comparative effectiveness studies to be approached with the comparison of similar treatments, such as competing drugs, or analyzing very different approaches, such as surgery and drug therapy. In this FOA, AHRQ has operationalized the definition of CER with the additional specification that evaluation of treatments includes any potential medical intervention under consideration, whether prognostic, preventive, diagnostic, therapeutic, or palliative.
In FY 2010, AHRQ intends to support research grants focusing on comparative effectiveness of different clinical treatments and services, as authorized by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), Pub. L. No. 108-173. See 42 U.S.C. 299b-7. The intent of these research project grants is to support research focusing on the generation and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decision-making in the health care system. AHRQ is especially interested in studies that include under represented and AHRQ priority populations such that potential clinical heterogeneities and population subgroups are considered in study design and proposed methodologies, and that subgroup analyses can be performed and research results and findings are relevant for all populations. Applicant’s specific plans for inclusion of priority populations will be evaluated by the scientific review committee and will be a component of the assigned priority score.
Specifically, the goal of this FOA is to request applications for large projects in comparative effectiveness aimed at generating new knowledge to help inform decision making in priority areas of clinical care. The impact of these studies should have a high likelihood of creating major advancements in clinical care. Emphasis will be placed on applications that define important research gaps and design a study to provide actionable results. Applications that include study aims to address the outcomes and effectiveness of assessments across population subgroups often underrepresented in medical research are expected. Priority populations include but are not limited to racial and ethnic minorities, persons with disabilities, children, elderly, patients with multiple and chronic conditions, and disadvantaged and/or under represented populations for the specific condition being studied. Priority conditions important to the Medicare, Medicaid, and CHIP programs and mandated by the MMA section 1013 are of special interest. The current list of priority conditions includes:
The clinical emphasis of the application should be to develop new scientific evidence that fills important knowledge gaps and to generate critical insights on the clinical effectiveness and comparative clinical effectiveness of health care interventions. These interventions could include medical tests, devices, procedures, therapeutics, or behavioral and counseling interventions. For studies in which randomized controlled trials may not be feasible or timely, or would raise ethical concerns that are difficult to address, novel or alternative study designs should be proposed, with the emphasis on prospective data collection as appropriate. Such clinical research projects also need to be informed by the information needs and inputs from various stakeholders (e.g., policy-makers, clinicians, and patients) to ensure the most appropriate outcome measures for assessing the effectiveness of the interventions and outcomes of importance to stakeholders are included in the study.
In general, it is expected that proposed projects submitted under this FOA will:
When considering potential study designs, topics that address evidence gaps identified for the stated priority conditions are of particular interest to AHRQ. These gaps could be identified from:
1) Research gaps identified in AHRQ comparative effectiveness reviews and evidence reports. A listing of these research reports can be found under the AHRQ’s Effective Health Care program and Evidence-based Practice Centers program web sites at: http://effectivehealthcare.ahrq.gov/ehc/index.cfm/search-for-guides-reviews-and-reports/?category=&search=&trackID=1&trackID=3&methodCategory=&agencyType=2&language=1 and http://www.ahrq.gov/clinic/epcix.htm respectively.
2) Research gaps identified by high quality systematic reviews on clinical and/or comparative effectiveness (e.g. Cochrane Collaboration, Drug Effectiveness Review Project).
3) Evidence gaps identified through a formal process associated with decisional uncertainty within a stakeholder clinician or policy group that have been publically disseminated (e.g. clinical practice guideline developed through expert consensus process secondary to lack of evidence, Centers for Medicare & Medicaid Services evidentiary priority list).
Regardless of topic, the study design should address evidence gaps for AHRQ priority populations and populations under represented in research on the specific condition being studied. Evidence gaps for these populations should be explicitly identified in the application.
Applicants also are encouraged to review the research priorities identified by the Institute of Medicine Report, ”Initial National Priorities for Comparative Effectiveness Research”, for the specific proposed study topics. The proposed comparative effectiveness research projects also may, but are not required to, include methodological inquires as part of the secondary study aims, but the locus of the research projects must focus tightly on the study of comparative effectiveness. While not required in this FOA, AHRQ encourages the inclusion of secondary study aims that develop and validate methods to inform future comparative effectiveness research. These secondary aims could include, for example: a) use and evaluation of novel data collection methods, such as distributed research networks; b) use and comparison of innovative analytic techniques; c) use of modeling to predict longer-term outcomes than the study duration permits; or, d) use of innovative recruitment techniques to assure adequate representation of disadvantaged and/or under represented populations in a prospective sample. For applications that include methodological aims, the goals should be to advance study designs and methods to fill specific knowledge gaps and to enhance the consistency, applicability, and generalizability of the comparative effectiveness study. Innovative study designs with aims related to various fundamental challenges in outcomes and effectiveness research in real world clinical settings, e.g., patients and clinician preferences, integration of research and practice both in terms of workflow and data management in electronic medical records (EMR) as well as non-EMR environment, are also strongly encouraged.
Some examples of potential projects include, but are not limited, to:
Applicants are encouraged to collaborate with institutions well versed in comparative effectiveness methodologies or with research centers and integrated health care delivery systems capable of performing accelerated clinical effectiveness and outcomes research and the translation and dissemination of evidentiary information for health care decision-making. Existing examples of such AHRQ networks include, the Evidence-based Practice Centers (EPCs), the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network, the Centers for Education & Research on Therapeutics (CERTs), the John M. Eisenberg Clinical Decisions and Communications Science Center, Primary Care-Based Research Network (PBRN), Accelerating Change and Transformation in Organizations and Networks (ACTION), and the HIV Research Network. A listing of these research networks can be found at the AHRQ website (http://www.ahrq.gov) and under AHRQ’s Effective Health Care program website (http://effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/).
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
This Funding Opportunity Announcement (FOA) will use the Research Project Grant (R01) award mechanism. The individual researcher sponsored by each organizational grantee will be solely responsible for planning, directing, and executing his or her proposed project.
AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.
2. Funds Available
This initiative is supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. AHRQ has designated $100 million in FY 2010 to fund an anticipated 10 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.
Budget proposals are limited to $10 million in total costs over the maximum 3-year project period. Applicants are encouraged to accelerate and complete work in less than 3 years, when appropriate. However, the total costs in any one year of the project may not exceed $4 million and the total cost budget for the entire project period cannot exceed $10 million. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 3 years, $4 million total costs in any one year, or budgets that exceed $10 million in total costs over the project period will not be reviewed. Funding beyond the first year will be contingent upon a review by Agency staff of the non-competing continuation report.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Contingent upon the availability of funds, a limited competition solicitation may be announced in fiscal year 2012 for selected projects awarded under this current FOA to support follow-up studies, e.g., longitudinal outcomes.
Funding for this program is provided under the American Recovery and Reinvestment Act of 2009 (Recovery Act). The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, eligible domestic (United States) institutions/organizations who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested total costs or $25,000 (aggregate total for a foreign component or multiple foreign components), whichever is less. AHRQ awards under the Recovery Act will be for up to three years.
The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization of one of the types listed below. The United States institution/organization must be located in the 50 states, or in the territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. Foreign organizations/institutions are not permitted as the applicant organization.
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 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.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.
A minimum time commitment of 25% annual effort is expected from the PD/PI.
2. Cost Sharing or Matching
This program does not require cost sharing for applications in response to this FOA.
While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions that plan to provide support should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.
3. Other-Special Eligibility Criteria
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
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:
A PD/PI should work with his/her institution/organization to make sure he/she is 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
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. The NIH and AHRQ 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 301-435-0714; Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
The SF424 (R&R) application has several components. 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:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Research & Related Budget
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: November 16, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 18, 2009
Application Due Date(s): December 16, 2009
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date
3.A.1. Letter of Intent
To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions. Please include the name and email address of the Principal Investigator.
This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application. However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.
The letter of intent should be sent electronically, with a subject line of “Letter of Intent CHOICEgrants, to:
Letter of Intent CHOICEgrants
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
The letter of intent is to be sent by the date listed in Section IV.3.A
3.A.2. Technical Assistance
3.B. Submitting an Application Electronically to AHRQ
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
3.C. Application Processing
Applications 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.
Once an application package has been successfully submitted through Grants.gov, any 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 application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete or non-responsive 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 the application status in the Commons.
AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
Use of CMS Data
Purchase of Centers for Medicare & 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 the confidentiality provision in the AHRQ statute, 42 USC 299c-3(c); the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule 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 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 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
Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.
6. Other Submission Requirements
The PD/PI must have demonstrated successful leadership of a multi-disciplinary project team and must commit a minimum effort of 25% annually (3.0 calendar months per year) to the project.
The PD/PI and up to two other members of the project team must attend the AHRQ annual meeting and one other site visit to AHRQ each year. The time of the second site visit will be determined in consultation with the AHRQ project officer. The travel costs for these two yearly visits should be included in the budget.
While there is not a specific dollar limit on budgeted equipment and supplies, any funds requested for equipment, hardware, software, and supplies should be uniquely required to support study aims and should be well justified. A personal computer on which to collect and archive study data would not meet this criterion.
The budget should also include a plan to disseminate the results of the research to health care decision makers, including disparate groups.
Letters of support are expected from the PD/PI’s institution, as well as from key stakeholder groups in the topic of study.
PD/PI Credential (e.g., Agency Login)
The NIH 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.
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
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.
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:
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Special Instructions for Modular Grant applications
AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.
No supplemental/update information will be accepted.
The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. This authority is found at 42 USC 299(c). To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.
Applicants will be required to include in their applications a narrative describing the inclusion of AHRQ priority populations or other under-represented populations in the proposed project or providing a rationale for exclusion of priority populations when the requirement for inclusion would be inappropriate with respect to the purpose of the study. Thus, in addition to the requirement to include women and members of minority groups as subjects in all studies involving human subjects, investigators should also consider including subjects from one or more AHRQ priority populations and populations under represented in research on the specific condition being studied within the context of developing a research design appropriate to the scientific objectives of the planned study. The proposed priority populations to be included in the study should be discussed within the research plan section of the SF #424 (R&R) grant application. The narrative should also contain a description of the proposed outreach activities for recruiting and retaining priority populations as research participants. Applicants should assess the feasibility of subgroup analyses to provide specific research results relevant to one or more priority populations and include this assessment with the research application. There is no pre-specified format for the narrative.
Publication Transmittal: General AHRQ Requirements
In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.
Assessment of AHRQ Grant Programs
In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.
AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.
HCUP & MEPS
Applicants are encouraged to make use of AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids’ Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS); and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.
The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.
Applicants’ use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
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
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:
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 research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
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 meritorious 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 study address an important problem (e.g., areas of crucial evidence gaps, or areas of controversy of high variation in clinical care)? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the population selected for study important and will disproportionately affected subpopulations or previously under-represented populations be included in sufficient numbers to allow subpopulation analysis? If the aims of the application are achieved, how will it fill an important gap in scientific knowledge or clinical practice? How will important health care decision-making be better informed? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive 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 project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the selected study outcomes appropriate and do they include relevant patient-centered outcomes? Are the interventions selected for comparison the most appropriate and relevant to decision makers? Will the study design provide sufficiently strong evidence to achieve the study aims and adequately inform clinical decision making?
Innovation: Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?
Investigators: Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Does the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? Are excess funds requested for equipment that has broad use at the institution beyond the proposed study?
2.A. Additional Review Criteria
In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:
Stakeholder Involvement: Has the PD/PI consulted with or described a plan to involve key stakeholders in the research? Stakeholders may include decision makers such as the public, patients, providers, policy makers, and groups that are traditionally under-represented in the research enterprise. Has the PD/PI demonstrated that the project is applicable to problems important to stakeholders? This evidence may include specific and detailed plans to solicit stakeholder input during the research process or letters of support from stakeholder groups representing multiple perspectives.
Translation: Has the PD/PI described a plan to disseminate the results of the study? Do these plans consider targeted dissemination plans to reach racial and ethnic minorities as well as other groups where there are disparities in health care and for whom the results are directly applicable? How will the results of the work be presented to stakeholders in a structure that can be immediately incorporated to inform their health care decision making? How will successful implementation be measured?
Degree of responsiveness: How well does the application address the purpose and objectives of this FOA? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?
Is the proposed condition to be studied a priority condition of the Effective Healthcare Program (see http://effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics-chosen/?keywords=priority%20conditions)? If not, has evidence been provided to demonstrate that the topic is of high importance for study? Factors to consider include: 1) burden of disease, including severity, incidence and/or prevalence, or relevance of organizational/financial suggestions of research to the general population and/or AHRQ's priority populations including racial and ethnic minority populations; 2) controversy or uncertainty about the topic or limited scientific data to support clinical decision making; 3) total costs associated with a condition, procedure, treatment, or technology, whether due to the number of people needing care, the unit cost of care, or indirect costs; 4) potential impact for reducing clinically significant variations in the prevention, diagnosis, treatment, or management of a disease or condition, or in the use of a procedure or technology; 5) potential impact for informing and for improving patient and/or professional decision-making, improving health outcomes, and/or reducing costs; 6) relevance to the needs of the Medicare, Medicaid, CHIP, and other Federal health care programs; 7) addresses need or gap unlikely to be addresses through other organizations; and 8) potential for multiplicative effect (e.g., lays foundation for future CER such as data infrastructure and methods development and training, or generates additional investment outside government).
Inclusion: Adequacy of plans to address the needs of genders, racial and ethnic minorities, socioeconomic position, elderly, others with special health care needs (and subgroups) and others that are not adequately represented in clinical studies in the research area. Are both genders and racial and ethnic minorities, socioeconomic position, elderly, others with special health care needs (and subgroups) included and are subgroup analyses planned? Are special populations under represented in research on the condition of interest identified, included, and are subgroup analyses planned? Adequacy of attention to under represented and AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements,” and inclusion criteria included in section VIII of Required Federal Citations, below.)
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).
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.
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:
Appeals will not be permitted. See Recovery Act of 2009: AHRQ Announces Suspension of Grants Funding Appeals Process (see NOT-HS-09-011, http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-011.html).
2.B. Additional Review Considerations
Applications that include a significant focus on under represented and priority populations such that these populations are included in primary analyses will undergo discussion at scientific peer review and will be assigned a priority score. Special consideration will be applied to those applications whose plans on inclusion of priority populations are deemed acceptable by the scientific review committee (25 priority score points will be adjusted from the final average priority score).2.C. Resource Sharing Plan(s)
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 the HIPAA Privacy Rule 45 CFR Parts 160 and 164. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/
The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.
Sharing Research Resources:
Rights in Data
Unless otherwise provided in grant awards, AHRQ grantees may copyright or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ 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).
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects. For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).
Once all administrative and programmatic issues have been resolved, a formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. The NOA 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.
The terms of the NoA will reference the requirements of the Recovery Act.
In addition to the standard AHRQ terms of award, all funding provided under the Recovery Act will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA). The full text of these terms approved for AHRQ awards can be found in the following document: Department of Health and Human Services Standard Terms and Conditions American Recovery and Reinvestment Act of 2009. (see http://www.ahrq.gov/fund/arraterms.htm).
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., “Funding Restrictions.”
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).
As necessary, additional Terms and Conditions will be incorporated into the award statement.
When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.
The annual progress report summary must include Section 2.2.6 items A through F as described in the general PHS form 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.
The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable for these progress reports.
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.
Section 1512 of The American Reinvestment and Recovery Act of 2009 (ARRA) requires prime recipients of the ARRA funds to submit quarterly reports, due no later than 10 calendar days after each calendar quarter in which the recipient receives the award (January 10, April 10, July 10, and October 10). Accordingly, in addition to the standard AHRQ terms of award, all funding provided under the Recovery Act must comply with the statutory reporting requirements and will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the AHRQ Website at http://www.ahrq.gov/fund/arraterms.htm.
In addition, AHRQ is currently developing AHRQ-specific reporting requirements. Detailed information and requirements on the specific AHRQ reporting venues and reporting timeline will be included in the Notice of Grant Award and incorporated into AHRQ Terms and Conditions of Award.
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.
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 (program), peer review, and financial or grants management issues.
1. Scientific/Research Contact(s):
Direct your questions about general FOA issues, including information on the inclusion of priority populations to CHOICEgrants@ahrq.hhs.gov. Due to staffing resource constraints, all scientific/research (program related) inquiries pertaining to general FOA issues must be submitted, and will only be answered, via email. A compilation of frequently asked questions and answers will be posted at http://www.ahrq.gov/fund/grantix.htm on November 2, 2009 and will include replies to inquiries received on or before October 23, 2009.
Center for Outcomes and Evidences
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1600
Fax: (301) 427-1639
E-mail address: CHOICEgrants@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:
Kishena Wadhwani, Ph.D., M.P.H.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427-1562
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov
3. Financial/Grants Management Contact(s):
Direct inquiries regarding fiscal matters to:
Office of Performance Accountability, Resources and Technology
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1450
Fax: (301) 427-1462
E-mail address: George.Gardner@ahrq.hhs.gov
Office of Performance Accountability, Resources and Technology
Division of Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1451
Fax: (301) 427-1462
E-mail address: Michelle.Burr@ahrq.hhs.gov
Required Federal Citations
The American Recovery and Reinvestment Act of 2009: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf
Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for AHRQ awards can be found in the following document: http://www.ahrq.gov/fund/arraterms.htm
Funding under this program is subject to the “Updated Guidance Regarding Communications with Registered Lobbyists About Recovery Act Funds” that was issued by the Office of Management and Budget on July 24, 2009 to implement section 3 of the President’s March 20, 2009 Memorandum entitled “Ensuring Responsible Spending of Recovery Act Funds.” Many of the restrictions described in the guidance also apply to non-lobbyists after the submission of competitive applications for Recovery Act funds and before awards are made. The guidance is available at http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf.
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:
OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552 in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 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 PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.
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