It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/foaguidance/index.html.

Applicants who propose the use of identifiable CMS data are advised to review NOT-HS-19-007 (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-007.html) for important changes to how applicants are to budget for the cost of this data.

When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.

2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information
Part 2. Full Text of the 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

Purpose

This Funding Opportunity Announcement (FOA) invites R18 grant applications that disseminate and implement patient-centered outcomes research (PCOR) evidence into clinical practice through clinical decision support (CDS). AHRQ seeks projects that scale interoperable CDS across different health care systems and technologies (e.g., different electronic health records) and that disseminate lessons learned about how to achieve CDS scalability and interoperability.

Definitions of Key Terms

Clinical Decision Support

Clinical decision support (CDS) provides patient-specific information and knowledge, enabled by health information technology (IT), to clinicians, patients, or other individuals to enhance health and health care (Mardon et al., 2014). CDS includes processes and mechanisms that aim to deliver the right information, to the right people, using the right formats, in the right channels, and at the right times during workflow (often referred to as the "5 Rights" framework; Osheroff, 2009). Well-implemented, electronic CDS can improve health care processes (Lobach, 2012). More recently, the Patient-Centered CDS Learning Network highlighted the importance of patients directly participating in the development and implementation of CDS so that the patient perspective can be better incorporated into the design of health IT systems.

Patient-Centered Outcomes Research

Patient-Centered Outcomes Research (PCOR) is comparative clinical effectiveness research of the impact on health outcomes of two or more preventive, diagnostic, treatment, or healthcare delivery approaches. PCOR produces not only clinical findings (e.g., thiazide diuretics are an effective first-line therapy for hypertension), but also evidence about the effectiveness of how healthcare is delivered. There are multiple sources of PCOR findings, including but not limited to those listed below:

• AHRQ Effective Health Care Program (http://www.effectivehealthcare.ahrq.gov/)
• Patient-Centered Outcomes Research Institute (http://www.pcori.org/)
• U.S. Preventive Services Task Force (http://www.uspreventiveservicestaskforce.org/)
• Community Preventive Services Task Force (https://www.thecommunityguide.org/)

Scalability and Interoperability

For the purposes of this FOA, scalability is the concept of growth to accommodate new sites, end users, workflows, and platforms. Projects should focus on how CDS based on the same set of PCOR evidence developed for one setting can be extended to other settings and platforms while still meeting the CDS 5 Rights. Interoperability refers to the secure exchange of health information between systems without special effort on the part of users (see definitions and concepts at https://www.healthit.gov/topic/interoperability). Projects should focus on using health IT standards that promote interoperability and re-use of CDS resources for implementation by other healthcare systems (see AHRQ NOT-HS-19-020 available at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-020.html regarding use of Health Level 7 Fast Healthcare Interoperability Resources or FHIR).

Since 2016, AHRQ has led a multi-component initiative with two broad aims: to advance PCOR evidence into practice through CDS and to make CDS more shareable, standards-based, and publicly available (see https://cds.ahrq.gov). The components of the initiative include:

1. Engaging a stakeholder community, including patients, clinicians, payers, and developers of CDS.

2. Developing prototype infrastructure, called CDS Connect, to author and share interoperable CDS through a publicly-available repository and set of tools.

3. Disseminating evidence into practice through grant-funded CDS demonstrations.

4. Evaluating the overall initiative.

While significant advancement has occurred relative to stakeholder engagement and prototype infrastructure for sharing CDS, CDS development and implementation continue in siloes, leading to redundant effort across healthcare systems that are developing similar CDS from the same set of evidence. This redundant effort has been estimated to cost the U.S. healthcare system $25 billion. (Johnston, 2003)

Health IT standards hold promise for advancing interoperability and re-use of CDS, thus potentially lowering the collective burden on healthcare systems to independently develop CDS. Standards such as HL7 FHIR and Clinical Quality Language (CQL) are gaining momentum and are helping healthcare systems define the data and logic required by CDS systems, which in turn promote interoperability and re-use. However, standards-based CDS still requires local adaptation, as even commonly adopted EHRs are locally customized and unique to each site.

A critical area of research, therefore, is how healthcare systems can effectively share and re-use standards-based CDS where differences exist among EHRs, workflows, and end users. While literature is beginning to grow in this space, showing how best to support adoption and uptake of CDS remains elusive (Mann, 2019). CDS research projects should contextualize dissemination and implementation of CDS accurately and completely.

In addition, the recently funded Patient-Centered CDS Learning Network identified patient perspective as important to include during CDS design and implementation. CDS projects should incorporate patient perspective in meaningful ways to ensure that CDS systems support patient-clinician relationships and shared decision-making.

The ultimate goal of this FOA is to disseminate and implement PCOR evidence in clinical practice by scaling shared, interoperable CDS. To meet this goal, applicants must describe the following:

Demonstrating scalability: How the project extends existing CDS beyond the initial clinical setting or institution that initially developed the CDS to other sites with different EHRs, end users, work flows, and/or health IT platforms.

Promoting interoperability: How the project uses standards such as Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR), Clinical Quality Language (CQL), FHIR Clinical Guidelines (also known as ClinicalPracticeGuidelinesOnFHIR or CPGonFHIR), and others to facilitate consistent and replicable implementation of the CDS across different healthcare systems. Applicants are highly encouraged to use open source authoring (https://cds.ahrq.gov/cdsconnect/authoring) and testing tools (https://cds.ahrq.gov/cdsconnect/community/tech_resources) available through AHRQ’s CDS Connect project (https://cds.ahrq.gov/cdsconnect).

Disseminating CDS knowledge artifacts: How the project will develop and disseminate interoperable CDS knowledge resources ( artifacts ) for potential re-use by others, including how those resources will be FAIR (Findable, Accessible, Interoperable, and Re-usable). Examples of CDS knowledge resources include CQL code, Level 2 and Level 3 representations of the CDS (Boxwala, 2011), and value sets. Applicants must also describe any supporting material appropriate for public dissemination, e.g., implementation guides and reports about pilot testing and evaluation. At a minimum, grantees will be required to use the CDS Connect repository to disseminate CDS artifacts and any supporting material, though grantees may decide to disseminate further, e.g., through other websites, peer-reviewed publications, scientific meetings, in addition to using CDS Connect. The CDS Connect repository has become essential to AHRQ's efforts to disseminate PCOR evidence into practice through CDS and has become the central location for disseminating AHRQ-funded, PCOR-based CDS. Further, the repository is supported by a diverse public work group that provides feedback on CDS Connect activities, resources, and infrastructure.

Incorporating patient perspective: How the project will incorporate patient perspective during the design and implementation of the CDS, including evaluating how the CDS was changed or improved because of patient input.

Contributing to a collaborative community of CDS developers and implementers: How the project will participate and contribute to a growing CDS community aimed at helping to share and re-use interoperable, patient-centered CDS. Examples of collaborative activities include: participating in the CDS Connect Work Group, actively reaching out to other grantees (once identified) to share lessons learned over the course of the projects, and collaborating on abstracts submitted to research meetings and conferences.

Choosing important clinical domains: How and why the particular CDS and clinical domain(s) were chosen. For example, what gap(s) in care are being addressed? How will the CDS impact patient outcomes? Why would the new settings receiving the scaled CDS want to use it? Applicants must describe the evidence-based practice that the CDS is meant to disseminate and implement (including the strength of recommendation and level of evidence, if applicable, and appropriate citations). At least one government-funded PCOR finding or study (e.g., PCORI, NIH, AHRQ Effective Health Care Program, U.S. Preventive Services Task Force) must be among the citations.

Using the Five Rights framework: How the CDS being developed and scaled meets the Five Rights framework. For example, how will the CDS be incorporated into workflow for clinical teams and for patient-facing applications, "life flow" for patients and caregivers? What aspects of user-centered design have been incorporated and adjusted to reflect the scaling effort to new users and settings?

Evaluating impact: How the project will frame and conduct an evaluation of the dissemination and implementation of interoperable CDS, including the hypotheses to be tested and measures to be used.

In addition, applications must include a detailed project timeline that shows major milestones.

Examples of highly responsive applications include but are not limited to:

• Scaling previously developed and validated CDS from the grantee s healthcare system to a different healthcare system that uses a different EHR
• Using the CDS Connect Authoring Tool (or similar technology) to engineer new, standards-based CDS and demonstrating implementation in more than one channel (e.g., different EHR platforms, EHR platform plus mobile app)
• Re-using CDS developed outside a grantee’s healthcare system (e.g., CDS developed elsewhere and publicly available on CDS Connect or another platform) and adapting the CDS to work within the grantee’s own healthcare system

References:

Boxwala AA, Rocha BH, Maviglia S, Kashyap V, Meltzer S, Kim J, Tsurikova R, Wright A, Paterno MD, Fairbanks A, Middleton B. A multi-layered framework for disseminating knowledge for computer-base decision support. J Am Med Inform Assoc 2011:18(Suppl 1):i132-i139.

Johnston D, Pan E, Walker J, Bates DW, Middleton B. The value of computerized provider order entry in ambulatory settings. Center for Information Technology Leadership, 2003.

Lobach D, Sanders GD, Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux R, Samsa G, Hasselblad V, Williams JW, Wing L, Musty M, Kendrick AS. Enabling Health Care Decisionmaking Through Clinical Decision Support and Knowledge Management. Evidence Report No. 203. (Prepared by the Duke Evidence-based Practice Center under Contract No. 290-2007-10066-I.) AHRQ Publication No. 12-E001-EF. Rockville, MD: Agency for Healthcare Research and Quality. April 2012.

Mann D, Hess R, McGinn T, Mishuris R, Chokshi S, McCullagh L, Smith PD, Palmisano J, Richardson S, Feldstein DA. Adaptive design of a clinical decision support tool: what the impact on utilization rates means for future CDS research. Digit Health. 2019;5:2055207619827716. Published 2019 Feb 6. doi:10.1177/2055207619827716.

Mardon R, Mercincavage L, Johnson M, Finley S, Pan E, Arora D. Findings and Lessons From AHRQ’s Clinical Decision Support Demonstration Projects. (Prepared by Westat under Contract No. HHSA 290-2009-00023I). AHRQ Publication No. 14-0047-EF. Rockville, MD: Agency for Healthcare Research and Quality. June 2014.

Osheroff JA, ed. Improving medication use and outcomes with clinical decision support: a step-by-step guide. Chicago, IL: HIMSS, 2009.

See Section VIII. Other Information for award authorities and regulations.

42 U.S.C. 299b-37(b) authorizes AHRQ to make these awards to assist users of health information technology focused on clinical decision support to promote the timely incorporation of government-funded PCOR research findings into clinical practice and to promote the ease of use of such incorporation.

All applications submitted and AHRQ grants made in response to this FOA are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

AHRQ's authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. 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.

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.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. The AHRQ multiple PDs/PIs policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote a minimum of 20% full-time effort (i.e. at least 8 hours per week) in each given year of the project.

This FOA does not require cost sharing.

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 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 shown/included in the detailed budget request.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The AHRQ will not accept duplicate or highly overlapping applications under review at the same time. This means that the AHRQ will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-18-197). If the sentence above is not true, and the Number of Applications field in the first table states that only one application is allowed, IC must insert a comment to change the sentence above to Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Not applicable

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Budget Component: Special Instructions for AHRQ applications

AHRQ is NOT using the Modular Grant Application and Award Process. Applicants applying for funding from AHRQ are to 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.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• Introduction (not required) is limited to 1 page.
• Specific Aims section is limited to 1 page.
• Research Strategy section, including tables, graphs, figures, diagrams, charts, the dissemination plan, and the timeline is limited to 12 pages.

Applicants must describe their approach to using shared, interoperable CDS resources as a means of disseminating and implementing evidence into clinical practice. Specifically, applicants must address the following elements:

• Demonstrating scalability: How the project extends existing CDS beyond the initial clinical setting or institution that initially developed the CDS to other sites with different EHRs, end users, workflows, and/or health IT platforms.
• Promoting interoperability: How the project uses standards such as Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR), Clinical Quality Language (CQL), FHIR Clinical Guidelines (also known as ClinicalPracticeGuidelinesOnFHIR or CPGonFHIR), and others to facilitate consistent and replicable implementation of the CDS across different healthcare systems. Applicants are highly encouraged to use open source authoring and testing tools available through AHRQ’s CDS Connect project (https://cds.ahrq.gov/cdsconnect).
• Disseminating CDS knowledge artifacts: How the project will develop and disseminate interoperable CDS knowledge resources ( artifacts ) for potential re-use by others, including how those resources will be FAIR (Findable, Accessible, Interoperable, and Re-usable). Examples of CDS knowledge resources include CQL code, Level 2 and Level 3 representations of the CDS (Boxwala, 2011), and value sets. Applicants must also describe any supporting material appropriate for public dissemination, e.g., implementation guides and reports about pilot testing and evaluation. At a minimum, grantees will be required to use the CDS Connect repository to disseminate CDS artifacts and any supporting material, though grantees may decide to disseminate further, e.g., through other websites, peer-reviewed publications, scientific meetings, in addition to using CDS Connect. Current information about contributing to the CDS Connect repository can be found at https://cds.ahrq.gov/cdsconnect/governance and https://cds.ahrq.gov/cdsconnect/faq.
• Incorporating patient perspective: How the project will incorporate patient perspective during the design and implementation of the CDS, including evaluating how the CDS was changed or improved because of patient input.
• Contributing to a collaborative community of CDS developers and implementers: How the project will participate and contribute to a growing CDS community aimed at helping to share and re-use interoperable, patient-centered CDS. Examples of collaborative activities include: participating in the CDS Connect Work Group, actively reaching out to other grantees (once identified) to share lessons learned over the course of the projects, and collaborating on abstracts submitted to research meetings and conferences.
• Choosing important clinical domains: How and why the particular CDS and clinical domain(s) were chosen. For example, what gap(s) in care are being addressed? How will the CDS impact patient outcomes? Why would the new settings receiving the scaled CDS want to use it? Applicants must describe the evidence-based practice that the CDS is meant to disseminate and implement (including the strength of recommendation and level of evidence, if applicable, and appropriate citations). At least one government-funded PCOR finding or study (e.g., PCORI, AHRQ Effective Health Care Program, U.S. Preventive Services Task Force) must be among the citations.
• Using the Five Rights framework: How the CDS being developed and scaled meets the Five Rights framework. For example, how will the CDS be incorporated into workflow for clinical teams and for patient-facing applications, "life flow" for patients and caregivers? What aspects of user-centered design have been incorporated and adjusted to reflect the scaling effort to new users and settings?
• Evaluating impact: How the project will frame and conduct an evaluation of the dissemination and implementation of interoperable CDS, including the hypotheses to be tested and measures to be used.
• In addition, applications must include a detailed project timeline that shows major milestones.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. See NIH/NIOSH/AHRQ New Policy Appendix Guide located at NOT-OD-18-126.

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. AHRQ and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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 HHS Grants Policy Statement can be found at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

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 be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to AHRQ. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

The applicant should pay particular attention to the SF424 (R&R) application guide instructions (https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf) concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH and responsiveness by AHRQ. Applications that are incomplete or non-compliant will not be reviewed.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://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.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Priority Populations

AHRQ supports research, evaluations, and demonstration projects concerning 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. 42 USC 299(c). 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 is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at https://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.

Public Access to AHRQ-Funded Scientific Publications

Investigators should review the document titled AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications , which is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html). For all research arising from AHRQ support, this policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) to be made publicly available within 12 months of the publisher’s date of publication.

AHRQ Data Management Plan Policy

Investigators should review the document titled AHRQ Data Management Plan (DMP) Policy, which is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html). This policy requires applicants for AHRQ new/competing grants and research contracts to include a DMP for managing, storing and disseminating the primary data, samples, physical collections and other supporting materials created or gathered in the course of research funded by AHRQ, or state why data management is not possible, as a component of their grant application or research contract proposal.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. 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 (see NOT-HS-18-012: Confidentiality in AHRQ-Supported Research). The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

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 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 support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. 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 requests that grantees notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to [email protected] at least four to six weeks in advance of the journal’s expected publication date.

Regulations applicable to AHRQ grantees concerning intangible rights and copyright can be found at 45 CFR 75.322.

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.

AHRQ's priority areas of focus are available at: https://www.ahrq.gov/funding/policies/foaguidance/index.html.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate objective 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. Only the review criteria described below will be considered in the review process.

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, National Institutes of Health, and for responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific 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.

• To what extent will the project increase our knowledge about the interoperability and scalability of CDS across healthcare systems?
• To what extent will the project increase our knowledge about the use of CDS-related standards in operational settings?
• To what extent does the CDS address an important gap in quality of care? Will the CDS impact patient outcomes, improve patient-centeredness of care, and/or reduce clinical burden?
• If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
• To what extent will the project advance our knowledge about how to meaningfully incorporate patient perspective early in CDS development and implementation (e.g., during design)?

• Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project?
• If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?
• If the project is collaborative or includes multi-PDs/PIs, do the investigators have complementary and integrated expertise; are their leadership approaches, governance and organizational structures appropriate for the project?
• Does the team have specific expertise in standards that support CDS specification (e.g., CQL) and services (e.g., FHIR)?
• A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote a minimum of 20% full-time effort (i.e. at least 8 hours per week) in each given year of the project.
• Is the minimum effort level requirement of the PD(s)/PI(s) being met?

Are the proposed levels of effort for all key personnel appropriate for carrying out the project successfully?

• To what extent will the project include new and innovative methods for scaling CDS implementations? Are the methods themselves scalable and repeatable?
• To what extent will the project include new technologies (e.g., channels, formats) to deliver the CDS?
• To what degree (i.e., level of effort) are patients included in the design and implementation of the CDS?
• To what extent will the project disseminate CDS resources that are FAIR (Findable, Accessible, Interoperable, and Re-usable)?

• Does the approach build on the 5 Rights of CDS framework, including attention to workflow and user-centered design? How well does the approach balance the needs of patients, clinicians, and others when applying the 5 Rights framework?
• How will the project document and disseminate lessons learned about any gaps in relevant health IT standards and the use of standards by commercial EHRs in operational settings?
• Does the dissemination plan include posting CDS artifacts and any supporting material to the CDS Connect repository as required?
• To what extent will the project leverage and adhere to appropriate health IT standards (e.g., HL7 FHIR R4 and CQL)?
• Are the proposed framework and metrics for evaluating impact appropriate?
• To what extent are users engaged in the adaptation and design of the scaled CDS?
• Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
• Are potential problems and alternative strategies presented?
• Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in human subjects?

• Will the proposed organizational structure support scaling the CDS to new settings, sites, or systems that are different from where the CDS was originally developed, currently implemented, or being used?
• If the application indicates partnering organizations, is there a history of successfully working together?
• Is there evidence of institutional commitment and support from all proposed organizations?
• Will the scientific environment in which the work will be done contribute to the probability of success?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Degree of Responsiveness

Reviewers will assess how well the application addresses 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?

When the proposed project involves human subjects the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Budget and Period of Support

Reviewers will evaluate whether the proposed budget is reasonable, and whether the requested period of support is appropriate in relation to the proposed research.

Inclusion of Priority Populations

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.7 Other Submission Requirements ).

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

N/A

N/A

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

N/A

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate Scientific 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 scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA.

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the FOA.
• Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities.

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 eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement (see https://www.ahrq.gov/funding/policies/hhspolicy/index.html).

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 and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

If all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the e-mail address designated by the recipient organization during the eRA Commons registration process.

Awardees must comply with any funding restrictions described in Section IV.6. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at https://www.ahrq.gov/funding/grant-mgmt/index.html.

All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that grantees inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

As necessary, additional Terms and Conditions will be incorporated into the NoA.

Accessibility Provisions for All Grant Application Packages and Funding Opportunity Announcements.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all AHRQ grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award. Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Annual progress reports are due 3 months before the start date of the next budget period of the award.

In addition to the annual progress report, recipients will be required to submit quarterly progress reports to AHRQ. Detailed instructions on additional reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2020, the annual FFR is due 9/30/2020 (90 days after the end of the calendar quarter of 6/30/2020).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer https://www.ahrq.gov/funding/grant-mgmt/closeout.html.

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 NIH 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 HHS Grants Policy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html) for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Mario Ter n, MD, MSc
Physician Clinical Informatics
Division of Digital Healthcare Research (DDHR)
Center for Evidence and Practice Improvement (CEPI)
Agency for Healthcare Research and Quality (AHRQ)
Email: [email protected]

Priti Mehrotra, Ph.D.
Agency for Healthcare Research and Quality
Telephone: (301) 427-1556
Email Address: [email protected]

Office of Management Services
Division of Grants Management
Agency for Healthcare Research and Quality
Email: [email protected]

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices. All awards are subject to the terms and conditions, cost principles, and other considerations in the HHS Grants Policy Statement.

This program is described in the Assistance Listings (formerly called 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 in accordance with 45 CFR Part 75 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.html.