and Human Services (HHS)
EXPIRED
Participating
Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
Components of Participating Organizations
Center for Outcomes and Evidence (COE), AHRQ (http://www.ahrq.gov)
Title: ARRA OS Recovery Act 2009 Limited Competition: Enhanced Registries for Quality Improvement and Comparative Effectiveness Research (R01)
Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.
Announcement
Type
This Funding
Opportunity Announcement (FOA) is a new RFA
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-HS-10-020
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)
93.715
Key Dates
Release/Posted Date: January 21, 2010
Opening Date: February 28, 2010 (Earliest
date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not applicable
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): March 29,
2010
Peer Review Date(s): Generally four months after receipt date
Earliest
Anticipated Start Date(s): September,
2010
Additional Information To Be Available Date
(Activation Date): Not Applicable
Expiration Date: March 30, 2010
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Purpose. This AHRQ Funding Opportunity Announcement (FOA), supported by funds provided to AHRQ by the Office of the Secretary (OS) under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5, invites Research Project Grant (R01) applications from organizations that propose to develop the infrastructure and improve the methodology for collecting prospective data from electronic clinical databases to generate new evidence on the comparative effectiveness of healthcare interventions.
The goal of the FOA is to enhance the electronic clinical capability of an existing registry for two purposes: 1) create and analyze valid data for comparative effectiveness research, and 2) enhance the ability to monitor and advance quality improvement of clinical care. Many registries have been created for answering specific clinical and scientific questions in defined populations while others have been developed to improve quality of patient care. However, a variety of limitations have hampered their ability to generate adequate information for decision-making. These include either short-term or no follow-up of patients, low participation rates of patients and providers, limited data quality assurance, data not collected across different care delivery sites, non-representative sampling methods, and lack of clinically-enriched data, use of non-standardized data elements and definitions, lack of full interoperability between registries and electronic health records (EHRs), concerns of complying with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and maintaining the privacy and confidentiality of patient’s information, and lack of scalable and sustainable business models. The applicant will clarify the limitations of the existing registry, specify which limitations will be addressed by the proposal, and how the enhanced registry can rapidly and comprehensively address issues aimed at improving quality of care and the comparative effectiveness of clinical interventions. A secondary goal of this FOA is to address issues relevant to the scalability and sustainability of registries that improve quality of care and that can conduct comparative effectiveness research.
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
Section II. Award Information
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
Section I. Funding Opportunity Description
1. Research Objectives
The Department of Health and Human Services (HHS) will use the definition of comparative effectiveness research used in the Federal Coordinating Council’s Report to Congress to guide the HHS operational plan with regard to OS ARRA funds. The definition is as follows:
Comparative effectiveness research is 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. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs about which interventions are most effective for which patients under specific circumstances.
Priority-Setting Process and Inputs for use of ARRA OS Funds
There were four main inputs for priorities for ARRA OS comparative effectiveness research funds: public input, an internal Departmental workgroup, the Federal Coordinating Council (FCC) for comparative effectiveness research report, and the Institute of Medicine (IOM) report. The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:
1) Included within statutory limits of ARRA and the Council’s definition of comparative effectiveness research;
2) Potential to inform decision-making by patients, clinicians or other stakeholders;
3) Responsiveness to expressed needs of patients, clinicians or other stakeholders;
4) Feasibility of research topic (including time necessary for research).
The Comparative Effectiveness Research-Coordination and Implementation Team will require the use of the FCC’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds. These criteria are:
1) Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),
2) Potential to evaluate comparative effectiveness in diverse populations and patient sub-groups and engage communities in research,
3) Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,
4) Addresses a need or is unlikely to be addressed through other organizations,
5) Potential for multiplicative effect.
Finally, investments funded from this appropriation must address at least one of the following topic areas:
1) One of the 100 IOM topic recommendations;
2) An issue within one the MMA 14 priority conditions identified by AHRQ (pursuant to Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003) which are not currently addressed; and/or
3) Fall into one of the AHRQ identified evidence gaps.
The current list of priority conditions includes:
The primary goal of the FOA is to enhance the electronic clinical capability of an existing registry for two purposes: 1) create and analyze valid data for comparative effectiveness research, and 2) enhance the ability to monitor and advance quality improvement of clinical care. A secondary goal is to address issues relevant to the scalability and sustainability of this enhanced registry.
Patient Registry:
A patient registry can be defined as an organized system that uses observational study methods to collect uniform data to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s) (http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=nr&ProcessID=21&DocID=12). The registry database is the file(s) derived from the registry. A registry can serve many purposes such as understanding the natural history of a disease, evaluating the clinical effectiveness of therapies, measuring and monitoring harm associated with clinical interventions, measuring quality of care, etc.
Many registries have been created for answering specific clinical and scientific questions in defined populations while others have been developed for purposes of quality improvement of patient care. However, a variety of limitations in their design and implementation have hampered their ability to generate valid and adequate information (such as health outcomes, and appropriate utilization of clinical interventions) that is necessary for decision-making at various levels: patient-provider shared decision-making, formulation of clinical guidelines, reimbursement and coverage, and regulatory decisions. The limitations include either no or short-term follow-up of patients, low participation rates of patients and providers, limited data quality assurance, data not collected across different care delivery sites, non-representative sampling methods, and lack of clinically-enriched data. Additional limitations include the use of non-standardized data elements and definitions, lack of full interoperability between registries and EHRs, concerns of complying with HIPAA and maintaining the privacy and confidentiality of patients information, and lack of scalable and sustainable business models that are also affected by concerns of potential medical malpractice.
The Health Information Technology expert panels (HITEP) I and II have addressed the issues of electronic exchange of health information to improve quality of care, such as promoting care coordination and creating a standardized quality data set (http://www.qualityforum.org/projects/hitep2.aspx). HITEP I identified several gaps in the ability to automate quality measurement: quality measurement specifications are not designed to leverage EHR systems, the specifications rely heavily on administrative data rather than clinical data, and clinical information required for quality measurement is not adequately captured in EHRs. Further, HITEP I identified 84 high priority performance measures to enhance capabilities for the electronic capture of data for quality measurement. HITEP II and its two workgroups are focusing on recommendations for a standardized Quality Data Set (QDS) and more meaningful quality measurement through improved clinical data flows within and across care settings.The HITEP work is expected to inform and provide a foundation for the enhanced patient registries projects.
The primary goal of the enhanced patient registries projects is to enhance the capability of existing registries to rapidly answer two types of questions: those aimed at improving quality of care and those aimed at determining the comparative effectiveness of clinical interventions. The secondary goal is to explore issues relevant to the scalability and sustainability of registries that meet these purposes.
Requirements for Projects
1) All enhanced registries must establish a link to EHRs and be able to evaluate data collected across at least two categories of care delivery sites such as ambulatory clinics, hospitals, and long-term care facilities.
2) The enhanced registries projects must build on an existing registry. The timeline and resources of the FOA are not compatible with the development of a de-novo registry.
3) The proposal must identify current limitations in the capabilities of the existing registry to provide valid and generalizable information on comparative effectiveness and quality improvement of care. The applicant must propose solutions to overcome as many of these limitations as possible, i.e., commensurate with the available resources and timeline. The solutions must include enhancements of IT capability such that information collected in an EHR is part of the registry. The intent is to create a dynamic registry where the data are easily and quickly updated with near real-time information. A solution proposing to link old, static databases into a flat file that cannot be updated, other than starting from scratch, is not acceptable.
4) The proposal must ensure the collection of high quality and clinically-rich data by the registry. The proposal must ensure appropriate procedures are in place to maintain privacy and confidentiality of a patient’s information. Please see Plan for Privacy and Security Protections in the Development and Implementation of Health IT Systems in Section IV-6 of PAR-08-270: http://grants.nih.gov/grants/guide/pa-files/PAR-08-270.html. The proposal must also ensure maximal efficiency in data collection and minimize duplicate data entry such that clinical workflow is minimally disrupted. The proposal must clearly specify the approach to collecting data for measuring and improving quality of care. The approach to specifying and collecting measures must use a consensus-based process such that the measures are not only valid and useful for the clinical issue at hand but are also generalizable to other data systems and clinical organizations addressing the same clinical issue. The work done by HITEP and other relevant national health IT projects must be considered in developing or modifying the measures.
5) The proposal must explore issues relevant to the scalability and sustainability of the registry as well as improving participation rates of patients and providers.
6) The enhanced registry must have the capability of collecting health-related quality of life and other patient reported outcomes at the point-of-care to evaluate quality of care and also to compare effectiveness of interventions.
7) All proposals must include an AHRQ priority population: http://www.ahrq.gov/qual/nhdr07/Chap4.htm. Data collected from priority populations must be adequate to perform rigorous analysis and support conclusions generalizable to the priority population group. The study population is not limited to a priority population but it must include one. In particular, projects that design the electronic data infrastructure such that it can be used to ascertain evidence of comparative effectiveness pertinent or unique to the underserved in healthcare or underrepresented patient populations in clinical trials are strongly encouraged.
8) All proposals must collect data within one of the AHRQ priority conditions or one of IOM priority topics for comparative effectiveness research. The lists are available at: http://effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics-chosen/; and http://www.iom.edu/~/media/Files/Report%20Files/2009/ComparativeEffectivenessResearchPriorities/Stand%20Alone%20List%20of%20100%20CER%20Priorities%20-%20for%20web.ashx
9) The proposal must clearly demonstrate the link between the enhanced capabilities of the registry to the research project on comparative effectiveness and quality improvement. This includes specifying the enhancements to the registry, the rationale for choosing them, and how these will be tested and used in conducting the research project.
10) Clinical informatics: The design of the clinical informatics infrastructure must ensure the infrastructure is readily scalable and inter-operable across a variety of software platforms and IT architectures. The use of open-source software-based data platforms and linkages is strongly encouraged. The applications need to provide details on their approach to linking data and ensure this is consistent with ongoing national efforts to harmonize health IT standards.
11) Governance: The applications must provide adequate details of a governance plan for project oversight, especially on issues related to data linkage, access, and privacy and confidentiality of patient information. In addition, the governance plan should describe provisions for oversight and responsibility concerning operational issues and scientific and technical concerns related to study design, implementation and data analysis. The plan must address potential solutions to barriers raised by organizational, business or other considerations that will impede collaboration and sharing of data between the partner organizations of the network. Provisions to review conflict of interest of investigators and center personnel on an ongoing and regular basis must be included. The governance plan must also describe provisions for obtaining input and feedback concerning important aspects of the design of data collection infrastructure as well as on the comparative research undertaken. End-user feedback will be important in designing the infrastructure so that the data are efficiently collected and clinical workflow is minimally impacted. Patient participation is an essential component of the governance plan.
12) Scientific collaboration: Applications must budget to travel at least two, preferably three, persons to AHRQ for an annual program meeting and at least one person for three in-person meetings annually that are convened by the Electronic Data Methods (EDM) forum. [See related FOA: ARRA-AHRQ Recovery Act 2009 Limited Competition: Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (U13) (RFA-HS-10-006)]. Most meetings are expected to last for two days.
13) Minimum effort of personnel: The PD/PI must budget for at least 20% effort annually (2.4 calendar months). There must also be a program manager/coordinator who must budget for 100% effort annually (12 calendar months) to manage the project. There must be an appropriate mix of time allocated for senior and junior scientists to ensure the successful conduct of the study as well as training of new investigators. Budgeted effort of other personnel must be appropriate to the needs of the project.
14) Reporting: ARRA-specific reporting requirements are described in Section VI of this FOA. 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.
It is anticipated that the details of the approach used to build the clinical informatics infrastructure as well as the results of comparative effectiveness studies will be published in peer-reviewed literature as well as reported to AHRQ. Quarterly conference calls with the AHRQ program officer, and other individuals deemed necessary by the program officer, are required. These calls will review the progress on all aspects of the project and collaboratively discuss any challenges affecting the project and potential solutions to the challenges. Annual progress reports will detail the progress on all scientific, technical and programmatic aspects of the project.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
This Funding Opportunity Announcement (FOA) will use the Research Project Grant (RO1) 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 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 $24 million total costs to fund up to two research project grant applications under this FOA, contingent upon the submission of a sufficient number of scientifically meritorious applications.
Budget applications are limited to $4 million in total costs per year for a total of $12 million over 3 years. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 3 years or budgets that exceed $4 million total costs in any given year or $12 million total costs over the course of the three year project period will not be reviewed.
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.
The total costs across the three years of support for individual grants awarded under this FOA will not exceed $12 million.
Grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.
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 total costs (aggregate total for a subcontract or multiple subcontracts), whichever is less. AHRQ awards under the Recovery Act will be for up to three years.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible Institutions
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. The PI/PD must devote a minimum level of effort of 20% annually (2.4 calendar months) to the project.
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 information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be 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.
Research on Humans:
All Federal regulations on research on human subjects will apply. Successful applicants will be required to have IRB approval prior to commencing research.
Applications must specify a data safety and monitoring plan that provides for the appropriate level of oversight and monitoring of the conduct of research to ensure the safety of participants, and the validity and integrity of the data. The method and degree of monitoring must be commensurate with the degree of risk involved for participating subjects and the size and complexity of the research. Applications that do not include a data and safety monitoring plan will not undergo peer review or consideration for funding.
Data and safety monitoring involving some level of independent monitoring, generally in the form of a Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC), is required for research studies involving interventions that entail significant potential health risk to research participants due to the nature of the intervention. A committee will also be needed to coordinate collection of valid data across multiple sites.
Section IV. Application and Submission Information
To download a SF424 (R&R)
Application Package and SF424 (R&R) Application Guide for completing the
SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically
button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Registration:
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
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PI(s) 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
one FOA.
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. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Research & Related
Budget
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
SPECIAL INSTRUCTIONS
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: February 28, 2010 (Earliest date an
application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not applicable
Application
Due Date(s): March 29, 2010
Peer Review
Date(s): Generally four months after receipt date
Earliest
Anticipated Start Date(s): September 2010
3.A.1. Letter of Intent
Not applicable.
3.A.2. Technical Assistance
Applicants may submit questions
to AHRQ via email at EnhancedRegistrygrants@ahrq.hhs.gov
AHRQ will respond to questions via email only.
In addition, based on inquiries received, AHRQ will post a list of Frequently
Asked Questions (FAQs) and responses to these questions approximately 4
weeks after the release of this FOA at http://www.AHRQ.gov/fund/grantix.htm.
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. 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.
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
3.C.1 Submitting
On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 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 for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. AHRQ will not accept any application that is essentially the same as one already reviewed. However, AHRQ will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.
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 PI/PD must devote a minimum level of effort of 20% annually (2.4 calendar months) to the project. A program manager/coordinator must devote a level of effort of 100% annually (12 calendar months) to manage the project.
Applications must budget to travel at least two, preferably three persons (at a minimum the project PI and program manager must travel) to AHRQ for an annual Enhanced Registries program meeting. In addition, at least one project personnel will be required to attend three in-person meetings convened by the Electronic Data Methods (EDM) Forum annually. Most meetings are expected to last two days. [See related FOA: ARRA-AHRQ Recovery Act 2009 Limited Competition: Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (U13)--RFA-HS-10-006].
The PI and other key personnel of the Enhanced Registries study are expected to contribute to the activities of the EDM Forum [see related FOA; ARRA-AHRQ Recovery Act 2009 Limited Competition: Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (U13)--RFA-HS-10-006], on a regular basis. Participation may involve activities such as meetings, teleconferences, participation in working groups, or other similar activities.
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.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
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.
Appendix Materials
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. 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.
Priority Populations
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), the Kids Inpatient Database (KID), and the Nationwide Emergency Department Sample, 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.
Health Literacy
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.
Consumer Products
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.
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.
Section V. Application Review Information
1. Criteria
Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.
Merit Review Criteria are described below.
The review criteria described below will be considered in the review
process.
2. Review and Selection Process
Review Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed. .
As part of the initial merit review, all applications will:
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five 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 the application address all requirements for enhanced registry projects? Does this study address an important problem? 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 preventive interventions that drive this field? How will the infrastructure developed through this project advance our ability to collect meaningful data for studies on the comparative effectiveness of healthcare interventions and to improve quality of care? How will the information from the enhanced registry inform important healthcare decisions?
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? Do the PD/PI and investigative team bring complementary and integrated expertise to the project?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms; 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?
Approach: Are the conceptual, informatics and 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?
Environment: Does 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?
2.A. Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).
Inclusion: Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below.)
Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?
Privacy and Security Protections for Patients: The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.
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?
In addition to the above criteria, the
following items will be considered in the determination of scientific merit for
enhanced registries:
a. Applicant must
arrange for partnership with multiple clinical organizations and
must document commitments from those sites.
b. Proposed project must involve data collection from more than one type of care delivery site (e.g., hospital, long-term care facility, ambulatory clinic etc.).
c. Applicant must provide explanation and detail on how proposed infrastructure will support the collection of improved data, i.e. clinically-enriched patient-specific data that will allow for better, timely and more valid (both internally and externally valid) comparative effectiveness research and for improved quality of care.
d. Applicant must describe the collection of new point-of-care clinical data relevant to the proposed study and steps taken to minimize burden and clinical workflow for the data collection
e. Applicant must describe how the proposed infrastructure will be leveraged or modified to address the evidentiary needs for underserved or underrepresented patient population groups.
f. Application must include technical detail on the clinical informatics approach adequate to assess its feasibility, including consideration of issues related to interoperability and scalability, and the design of a dynamic system that allows frequent and relatively easy and quick updating of the database with near real-time information.
g. Applicant must demonstrate a track record of successfully collecting and managing electronic health care data, preferably from disparate sources. This includes a successful track record in protecting privacy and confidentiality of data. To address this criterion, applicant should submit letters from previous partner organizations, attesting to the usability and positive contribution of data collected and to the applicant’s ability to work cooperatively with partner facilities.
h. Application must include scientific team with expertise in comparative effectiveness research and in quality improvement.
i Application must demonstrate that the applicant’s comparative effectiveness research and quality improvement team is involved with the infrastructure development aspects of the project as well as the specification and design of comparative effectiveness studies included in the application.
j. Application must focus on at least one priority condition
k. Application must address a priority patient population that is under-represented in randomized controlled clinical trials or with limited access to healthcare, or both, such as elderly, pediatric, patients of different race/ethnicity and socioeconomic status, multiple co-morbidities, etc.
l. Application must reflect real-world populations,
m. Application must focus on health outcomes,
n. Application must describe how the proposed research will yield internally valid as well as generalizable conclusions.
o. Application must describe a governance plan meeting all the requirements laid out in the FOA.
p. Application must specify the method to link patient-level information
q. Application must specify a plan for privacy and security protections independent of the plan for human subject protection from research risk
In addition, the review criteria listed in the Priority-Setting Process and Inputs for Use of ARRA OS Funds section (Part II-Section 1) will also be used.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
Appeals will not be permitted. See http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-011.html, Recovery Act of 2009: AHRQ Announces Suspension of Grants Funding Appeals Process.
2.B. Additional Review Considerations
Not Applicable
2.C. Resource Sharing Plan(s)Data Confidentiality
Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with 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 HHS 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 Award Dates
Not applicable
Section
VI. Award Administration Information
1.
Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
AHRQ will request "Just-In-Time" information from the
applicant. Just-In-Time
information generally consists of information on other support, 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 any/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.
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.
The awardees are required to have a quarterly teleconference call with the AHRQ program officer to update progress on the project and to collaboratively discuss any challenges or problems affecting the project and the potential solutions to these challenges or problems.
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.
Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.
Section 1512 of the Recovery Act requires prime recipients of the ARRA funds submit quarterly report, 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 ARHQ 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, Final Invention Statement, 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.
This FOA is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application (also including submission of a letter of intent), by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:
For additional information see: http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf
Please note, the President’s memorandum applies to communications prior to the award of a grant or other Recovery Act funding; it does not apply to communications with officials regarding the administration of a grant that has already been awarded.
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: EnhancedRegistrygrants@ahrq.hhs.gov.
Due to staffing resource constraints, all scientific/research (program-related) inquiries pertaining to general FOA issues must be submitted by e-mail and will only receive an e-mail reply.
Amy Lindinha
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1600
E-mail address: EnhancedRegistrygrants@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:
George Gardner
Office of Performance Accountability, Resources and Technology
Grants Management
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
Michelle Burr
Office of Performance Accountability, Resources and Technology
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.
Section VIII. Other Information
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
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 HHS "Standards for Privacy of Individually Identifiable Health Information" regulation was mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) which governs the protection of individually identifiable health information. It is administered and enforced by the HHS 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(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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