Department of Health and Human Services
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Center for Quality Improvement and Patient Safety (CQuIPS), (http://www.ahrq.gov)
Title: Advances in Patient Safety through Simulation Research (R18)
Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.
This Funding Opportunity Announcement (FOA) is a new Program Announcement.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-11-024
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: November 9, 2010
Opening Date: December 25, 2010 (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): Standard dates apply, please see
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: (Now Expired November 23, 2013 per issuance of PA-14-004), Originally January 8, 2014
Due Dates for E.O. 12372
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. Receipt, Review, and Anticipated Start Dates
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
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
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
The Agency for Healthcare Research and Quality (AHRQ) announces the availability of grants to develop, test, and evaluate the impact of various simulation approaches for the purpose of improving the safe delivery of health care. As a training technique, simulation in health care uses a variety of approaches – mannequins, task trainers, virtual reality, in situ scenarios, hybrid configurations, standardized patients – to expose individuals and teams to realistic clinical challenges. A distinguishing feature of simulation is that it allows participants to experience, in real- or near real-time, the consequences of their decisions and actions as they learn new skills and address system anomalies in an environment that does not put patients at risk. Simulation also can be used as a test-bed to identify failure modes and other areas of concern in new clinical processes, procedures, and technologies that might threaten patient safety. AHRQ is seeking applications that address a variety of clinical settings. The projects funded under this funding opportunity announcement (FOA) will inform providers, health educators, payers, policy makers, AHRQ, patients, and the public about the effective use of simulation in improving patient safety.
Applicant institutions are required to describe the simulation, including the expected impact on patient safety outcomes; provide a project design and methodology plan that covers development, test and evaluation activities; specify the simulation methods, equipment, and resources that will be utilized; outline how the simulation will be implemented in the proposed health care setting; describe the metrics to be used to indicate acceptable performance; provide a data analysis and evaluation plan, and address the projected dissemination, adoption, and sustainability issues associated with the particular simulation approach used.
AHRQ encourages a variety of simulation projects from across the health care spectrum which impact diverse patient populations, including priority populations, provider groups, and clinical settings. 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. Diverse settings of care and venues for simulation might include, but are not limited to, hospitals, ambulatory surgery centers, primary care clinics, medical centers, schools of nursing, universities, community colleges, health care provider organizations, health systems, health professional associations, and quality and safety improvement organizations. Projects presented for consideration under this FOA should comply with the Agency’s policy regarding the inclusion of priority populations (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Further information on the requirements is listed in the special requirements section of this FOA.
AHRQ’s Role in Patient Safety
In its release of “To Err is Human: Building a Safer Health System” in November 1999, the Institute of Medicine (IOM) estimated that between 44,000 and 98,000 Americans die each year as a result of medical errors (See ref. 1). The IOM report quickly elevated awareness of patient safety. One of the major take-home messages was that preventable adverse events arise from problems inherent in a complex and fragmented health care system rather than from poor performance by individual providers. Although the United States provides some of the best health care in the world, it isn’t evenly distributed throughout the nation, and the number of patients that are harmed as a result of the process of health care is unacceptably high. The report called for systematic change in health care practice, and cited safety improvements made in other hazardous industries through the use of error reporting systems, information technology, human factors considerations, process redesign, simulation and teamwork, and cultures of open communication and learning. Within weeks of the IOM report's release, congressional hearings were held and AHRQ subsequently was directed to lead a national effort to reduce medical errors and to improve patient safety through appropriately targeted research (See ref. 2).
The initial patient safety grants focused on reporting systems, clinical informatics, the working conditions of providers, Centers of Excellence for multiple, programmatic projects, Developing Centers for new researchers, and education and dissemination efforts. Since these early beginnings, patient safety has continued to be a major portfolio area of AHRQ. A fuller and more detailed account of other patient safety initiatives and activities can be found under the “Medical Errors & Patient Safety” link on AHRQ’s Web site at www.ahrq.gov.
While simulation in health care can be traced to the 1960s with Resusci-Anne used for cardiopulmonary resuscitation (CPR) training (See ref. 3), it was not until the late 1980s that pioneering research efforts started to take hold in anesthesiology with the development of simulation systems that trained participants in clinical management and teamwork.
Traditionally, the education of providers has focused on knowledge acquisition rather than the acquisition of defined levels of acceptable clinical performance. At the same time, it is recognized that many health care procedures are potentially dangerous and very difficult to teach and learn. A troubling paradox of health care delivery is that today's patients can be harmed in the training of tomorrow's practitioners. The apprenticeship model of "see one, do one, teach one" has been reframed as "see one, do many with simulation, teach one" by adopters of simulation techniques. It is increasingly recognized that the education and training of providers is a life-long process, especially as new technology and less invasive procedures make their way into clinical practice. It is reasonable to expect that simulation's benefits accrue not only to inexperienced and vulnerable health care workers at the start of their careers, but also to experienced practitioners learning new procedures.
In addition to their promising potential of reducing risk to patients, simulations are valued for their ability to create conditions that optimize learning. Limited performance repertoires of novices and practitioners learning new procedures can be expanded with a graduated crawl-walk-run approach. Intricate elements of a difficult procedure can be selectively rehearsed again and again. Simulations can be programmed to provide training on patient complications and equipment malfunctions that occur infrequently in practice, but that require decisive action and skilled performance when they do occur. Simulations enable a complex mosaic of multiple skills – cognitive, perceptual-motor, and affective – to be simultaneously exercised (See ref. 4). When fluid team performance is the goal, simulations provide a venue for technical skills, decision-making, communication and leadership skills to be exercised together.
In contrast to training-based applications, simulations also can serve as evaluation and usability test-beds to work out the unanticipated wrinkles of new emerging technologies. Changes to the clinical workflow and potential treats to patient safety can be identified as Health IT and new electronic display and tracking systems are tested or modeled in a simulated environment.
Within the past decade, there has been a progressively increasing interest in a broad array of simulation applications to health care. Advances in medical simulation technology, a progressive lowering of associated costs, a national focus on patient safety, greater recognition of the performance-based component of clinical competency, shortening of hours for residents thereby reducing exposure to less common procedures, and a greater willingness to incorporate lessons learned from other high-risk industries are a few of the factors that help to account for this heightened interest. Other indicators of the heightened interest can be found in the impressive growth of simulation centers in medical and nursing schools, and the Society for Simulation in Healthcare with its own journal and well attended annual conferences. It also is noteworthy that the Accreditation Council for Graduate Medical Education (ACGME), the governing body for post-graduate medical education in the US, has been exploring the educational implications for the inclusion of simulation in medical education and accreditation.
AHRQ-Funded Simulation Grants
In keeping with its focus on patient safety, AHRQ, in fiscal years 2006 and 2007, awarded approximately $10 million to 19 investigators to advance knowledge in how simulation can improve patient safety across diverse healthcare disciplines, settings and populations (See ref 5). The grants were 2-year cooperative agreements and covered a diverse range of simulated clinical applications. Representative of the diversity were simulations that focused on central venous catheter insertion, diagnosis of melanoma, obstetric emergency response drills, pediatric airway management, rapid response teams, acute coronary syndrome management in rural settings, patient care hand-offs, virtual reality team training, and disclosure of medical error. In 2008, AHRQ, along with other organizations, supported an academic emergency medicine consensus conference that was organized to help define a national research agenda for maximizing effective use of simulation across undergraduate, graduate, and continuous medical education (See ref. 6,7). In 2010, AHRQ released a Request for Applications (RFA), entitled Improving Patient Safety through Simulation Research, for which it received a high volume response. Those applications, at the time of writing, are undergoing the review process.
To make the same advances in healthcare with simulation that other hazardous industries have made will take an expanded, programmatic effort. There remain a vast number of research challenges that need to be addressed for simulation in healthcare to reach its full potential. In responding to these challenges on a more steady and on-going basis, AHRQ is releasing this new program announcement (PA). Provided below is a partial list of research challenges and issues to stimulate ideas and about potential projects. It by no means exhausts the range of simulation issues which are of interest to AHRQ, and applications addressing relevant simulation challenges and issues not stated below are welcomed.
Educational and Training Issues
See Section VIII, Other Information - Required Federal
policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the AHRQ Research Demonstration and Dissemination Projects Grant (R18) award mechanism. The individual researcher sponsored by each organizational applicant will be solely responsible for planning, directing, and executing his or her proposed projects.
AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.
Applications may be up to three years in duration with a budget supported by AHRQ not to exceed $350,000 per year in total costs to the government. Applications with project periods that exceed the duration or $350,000 total costs in any given year will not be reviewed.
Funding beyond the first year will be contingent upon a review by Agency staff of the annual non-competing continuation progress report.
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 apply as the primary organization or to be the lead on projects 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 be returned without review. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.
Because the FOA is intended to support the safe delivery of health care, organizational entities that are not health care provider organizations must have a provider organization that is actively engaged in the delivery of health care as a participating partner in the proposed project. For purposes of this FOA, a health care provider organization is defined as any organization engaged in the direct delivery of care to patients in any setting, including but not limited to, in-patient, out-patient or ambulatory centers, community health centers, emergency medical centers, laboratories, diagnostic centers, pharmacies, blood centers, long term care, and/or home care.
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. The PD/PI must devote a minimum level of effort of 15% annually (1.8 calendar months) to the project.
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.
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct. AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.
Resubmissions. Applicants may submit a resubmission application, but such applications must include an introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).
Renewals. Applicants may not submit a renewal application.
Special Requirements. The applicant must address the following eight project requirements in their application. Applications that do not address all eight project requirements will not undergo peer review.
1. The applicant, or at least one of its partner(s), must be a health care provider organization. The applicant must specify the chosen simulation and justify its selection. The application must provide supporting evidence as to how the simulation potentially impacts the safe delivery of health care.
2. The applicant must further identify the issues addressed by the simulation, the setting of care where the simulation will be conducted, the health professional groups involved in the simulation, and the anticipated patient population impacted by the simulation.
3. The applicant must describe in sufficient detail to render a complete understanding the nature of the clinical performance problem that is addressed by the proposed simulation. This includes not only a brief review of the salient literature with respect to the problem area, but also the anticipated benefits, limitations, and scientific, clinical or performance-based significance of the proposed research. The applicant should demonstrate an understanding of the problem (past trends, need for improvement), the purpose of the evaluation, the supporting theoretical or conceptual framework, underlying assumptions, and scope or boundary conditions of the proposed research.
4. The applicant must provide clear articulation of the research objectives, the methodology or research design that will be enable the research objectives to be realized, and any associated practical considerations. Where appropriate, the applicant should include specification of outcome measures, process measures, and formative measures for pilot testing, implementation, adoption, and sustainability, where appropriate. Measures that would be of interest to decision- and policy-makers (e.g., return on investment, cost-effectiveness) also should be considered. The evaluation should focus not only on the anticipated benefits to the simulation participants, but also to the clinical practice to which the newly acquired skills and knowledge are expected to transfer. This section should specify the sampling strategy that identifies the target audience to be sampled, the type of sampling, sample sizes, and any priority populations, conditions, or characteristics that require discussion. The design should include milestones and timelines covering all major phases of the project.
5. The applicant must describe all the functions that the simulation performs and the system components and features that will enable realization of the functions. Where appropriate, the applicant should describe all the clinical, physiological, behavioral, cognitive, visual, auditory, tactile or otherwise unique features that are simulated. Since simulations often make unique demands on the parent organization, the applicant should describe the full complement of support requirements for effective and efficient deployment of the simulation, such as space and facilities; computer and technical support; specialized equipment; maintenance; and instructors, schedulers, researchers and training development personnel.
6. The applicant must provide a simulation implementation plan which includes the necessary steps, preparations, permissions, approvals, and rehearsals for conducting the simulation. The plan should include information on scenario generation, pilot-testing, scheduling of participants, assignment of participants to groups in accordance with the research design, preparation of materials, orientation of participants, briefing and de-briefing procedures, data collection procedures and instruments, training of personnel and data collectors, and any specialized device, mannequin, or ancillary equipment considerations. The plan should describe quality control procedures for ensuring that all components function well together in achieving a smooth implementation of the simulation.
7. Applicants must describe how their procedures for collecting data are derived from the research objectives. Where appropriate, describe how the data are to be collected, coded, stored, and analyzed in terms of descriptive or inferential methods. Any potential limitations, concerns, or anticipated contingency planning with respect to data collection procedures also should be noted.
8. The applicant must describe how the project potentially could be integrated
into the mainstream clinical or educational environment of their own or tested organizations. The applicant must also discuss the necessary steps and resource requirements for effective and efficient deployment of the simulation, as well as for its longer term sustainability.
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.
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
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 AHRQ (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
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
Research & Related Budget
(See Section IV.6., “Special Instructions,” regarding appropriate required budget component.)
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Applications Involving a Single Institution
When a single institution is involved, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a 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.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: December 25, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): Standard dates apply, please see
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
A letter of intent is not required for this funding opportunity.
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/web/grants/applicants/apply-for-grants.html 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.
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 Viewing 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 and AHRQ for further processing.
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 FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. However, a previously unfunded application, originally submitted in response to RFA-HS-10-018 (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-10-018.html) can be revised and submitted to the current FOA. Such an application MUST be initially prepared and submitted as a NEW application versus a resubmission; i.e., it MUST NOT include an “Introduction” to indicate changes made to the previously unfunded version of the application. All NEW applications submitted for this FOA that are not funded may be revised and resubmitted once. These resubmissions 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.
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, 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. The applicant should obtain an estimate for the costs of the requested data, if possible. 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, 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.
Applications must use the detailed budget format.
The budget must include funding to allow the PI/PD and at least one key program staff member of the project to attend at least 3 days of an annual AHRQ-sponsored meeting in the Washington, DC area for each year of funding.
Applicant institutions may use no more than a total of 15% of the Federal grant funds for purchasing equipment, hardware, or software. Applications which propose more than 15% for such purchases will not be reviewed.
Note: It is assumed that the applicant institution has sufficient facilities and simulation equipment for the proposed research and that this will preclude the need for acquisition of major equipment or supply items.
The PD/PI must devote a minimum level of effort of 15% annually (1.8 calendar months) to the project.
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
PD/PI Credential (e.g., Agency Login)
AHRQ requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.
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 that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional 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).
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.
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.
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.
AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants’ understanding.
IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.
All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
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: Merit Review Criteria, as described below, will
be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will be returned to the applicant without further consideration.
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.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does this study address an important patient safety problem? If the aims of the application are achieved, does it have the potential to make a difference in patient care and improved patient safety? What will be the effect of the project on the concepts, methods, technologies, treatments, services, or interventions that drive this field? What is the potential for the adoption and diffusion of the simulation into practice?
Investigators. What are the qualifications of the PI and other key personnel to lead the development, testing, and evaluation of the simulation? Is the work proposed appropriate to the experience levels of the PI and other key researchers? Does the PI and investigative team bring complementary and integrated expertise to the project?
Innovation. Is the project original and innovative? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area? Are there aspects to the simulation that have not been widely explored or implemented before?
Approach. Is there a clear articulation of the research objectives and a methodology, research design, or management plan that will enable the research objectives to be tested and evaluated. Is there sufficient and detailed discussion regarding the major components and elements of the research design so that the reviewer has a full understanding of the project that is being proposed? Does the design include milestones and timelines covering all major phases of the project? Is there acknowledgement of potential difficulties in implementing aspects of the project as intended and evidence of considering alternative approaches?
Environment. Does the scientific and organizational environment in which the project will be conducted contribute to the probability of success? Does the proposed project benefit from unique features of the scientific or organizational environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Additional Review Criteria
In addition to the above criteria, the following items will be addressed and considered in the determination of scientific merit and the rating.
Degree of Responsiveness. How well does the application address the purpose and objectives of this FOA? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?
Budget and Period of Support. Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed simulation research? Are dedicated grantee resources sufficient to ensure commitment on the part of key personnel? Is there effective and efficient use of project resources? Is there specific evidence of the nature and extent of the applicant institution resource contribution? Does the budget include support for the PI/PD and at least one other key personnel for travel to an annual AHRQ-sponsored meeting? Note: It is assumed that the applicant institution has sufficient facilities and simulation equipment for the proposed research and that this will preclude the need for acquisition of major equipment or supply items.
Inclusion. Are plans adequate to address the needs of both genders, racial and ethnic minorities (and subgroups), and children? Is there adequacy attention in the project given to AHRQ priority populations?
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. How adequate are the resources and processes to be used for addressing privacy and security issues, given the design and implementation features of the proposed simulation project?
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?
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:
Additional Review Considerations
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).
3. Anticipated Announcement and
Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
AHRQ will request "Just-In-Time" information from the
applicant. Just-In-Time information generally consists of information on
other support, any additional information necessary to address administrative
issues, and certification of IRB approval of the project's proposed use of
human subjects. For details, applicants may refer to the "AHRQ
Revised Policy for Institutional Review Board (IRB) Review of Human Subjects
Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).
Once all administrative and programmatic issues have been resolved, a formal notification in the form of the Notice of Award (NoA) will be generated via email notification from the awarding component to the grantee business official at the applicant organization. The NOA signed by the AHRQ grants management officer is the authorizing document.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., “Funding Restrictions.”
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.
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).
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 reports 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.
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.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the AHRQ Grants Process web site at http://www.ahrq.gov/fund/postawrd.htm#terms for additional information on this reporting requirement.
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 your questions about general FOA issues, including information on the inclusion of priority populations to:
Center for Quality Improvement and Patient Safety (CQuIPS)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1331
Fax: (301) 427-1341
E-mail address: Kerm.Henriksen@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:
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) 427-1457
Fax: (301) 427-1462
E-mail address: Galen.Gregor@ahrq.hhs.gov
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 HIPAA Privacy Rule, 45 CFR Parts 160 and 164, 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 may 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 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.
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