Medication Safety: Advancing the Development of Improvement Strategies and Tools (R18)

Medication Safety: Advancing the Development of Improvement Strategies and Tools (R18) is sponsored by Agency for Healthcare Research and Quality (AHRQ). This funding opportunity supports investigator-initiated research projects focused on medication safety.

Expired PA-20-028: Medication Safety: Advancing the Development of Improvement Strategies and Tools (R18) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) Agency for Healthcare Research and Quality ( AHRQ ) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

of Participating Organizations Agency for Healthcare Research Funding Opportunity Title Medication Safety: Advancing the Development of Improvement Strategies and Tools (R18) R18 Research Demonstration and Dissemination Projects that resubmissions of applications originally submitted to PA-16-421 will not be accepted under the current PA, only new applications, or applications originally submitted under this FOA October 3, 2022 - Notice to Extend PA-20-028, Medication Safety: Advancing the Development of Improvement Strategies and Tools (R18).

See Notice NOT-HS-22-024 NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 July 26, 2022 - Notice to Extend PA-20-028, Medication Safety: Advancing the Development of Improvement Strategies and Tools (R18).

See Notice NOT-HS-22-020 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018 . August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

See Notice NOT-OD-21-169 . August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 .

April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 . March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available.

See Notice NOT-OD-20-077 . January 10, 2020 - AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46. 114 (b).

See Notice NOT-HS-20-005 . November 22, 2019 - New NIH "FORMS-F" Grant Application Forms and Instructions Coming for Due Dates on or after May 25, 2020. See Notice NOT-OD-20-026 .

January 11, 2019 - AHRQ Implementation of Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule). See Notice NOT-HS-19-008 . January 11, 2019 - AHRQ Announces Change in Grant Recipient Purchasing of Identifiable CMS Data, effective FY2019.

See Notice NOT-HS-19-007 . January 11, 2019 - AHRQ Announces Change in Grant Recipient Purchasing of Identifiable CMS Data, effective FY2019. See Notice NOT-HS-19-007 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose Despite some progress and improvement, medication errors continue to occur at an alarming rate. The U.S. Food and Drug Administration receives more than 100,000 U.S. reports each year associated with a suspected medication error.

Adverse drug events (ADEs) are estimated to account for more than 3. 5 million physician office visits and 1 million emergency department visits each year. It is believed that preventable medication errors impact more than 7 million patients and cost almost $21 billion annually across all care settings.

Medication errors and ADEs continue to adversely affect patients, providers, and the economy. This funding opportunity continues AHRQ's support of medication safety investigator-initiated research projects. Medication safety research should not only address the prevention of harm, but also promote standardized and optimized practices and behaviors.

AHRQ will focus on funding grants that have strong patient safety impact potential and address significant patient safety problems that result in patient harm or mortality, occur with high frequency, and entail a high cost burden.

It is further emphasized that AHRQ is interested in funding grants that will create additional sustainable tools or resources for healthcare providers that can be widely disseminated to promote processes and behaviors that address medication safety events. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) dates apply By 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) Generally, four months after receipt date. Generally, four months after peer review date.

New Date - January 27, 2023 per issuance of NOT-HS-22-024 (Original Date: September 26, 2022) 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 . 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 Part 1.

Overview Information Part 2. Full Text of the Announcement I. Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Full Text of Announcement I. Funding Opportunity Description In fiscal year 2013, AHRQ launched a multi-year initiative to expand the scientific evidence, strategies, and tools that are available for improving medication safety in all health care settings. (see https://grants.

nih. gov/grants/guide/pa-files/PA-14-002. html ).

This Program Announcement (PA) was extended in fiscal year 2015 as PA 16-421 (see https://qrants. nih. qov/grants/quide/pa-files/pa-16-421.

html ) Through the PA-16-421 (R18) grant program, AHRQ addressed "patient safety and medication research by focusing on the safe usage of medications". This perspective centers on how medications move through the health care system and how this systemic process can be improved so that patients are not harmed, while health care delivery is improved.

In addition, this program encouraged "the involvement of all members of the health care team, especially patients and families; nurses, pharmacists, technicians (pharmacy and medication administration technicians), health care administrators, risk managers, and physicians across all settings of care (including in the home)".

Through this mechanism, AHRQ funded "investigative research demonstration projects that examine the effective implementation of processes, policies, and behaviors that support safe use of medication as well as its sustainment and dissemination."

The value added from research projects funded under PA-16-421 was the development and improvement of metrics, tools and practices derived from new and existing data sources that are accurate and feasible for broad dissemination.

The findings and new knowledge that have been generated create the potential to enhance the identification and prevention of medication safety adverse events that occur in the acute, ambulatory, and long term care setting. The findings also serve as prototypes of the types of tools and practices necessary to prevent harm in these settings.

Funding Opportunity Announcement (FOA) (PA 16-421) AHRQ Health Services Research Projects: Advancing Patient Safety Implementation through Safe Medication Use Research (R18) expired on September 26, 2019. This This PA will continue to support medication safety investigator-initiated research projects. Medication safety research needs to not only address the prevention of harm, but also promote standard optimized practices and behaviors.

When effective patient safety improvements are discovered, it is important that investigators consider how best to disseminate and spread these results so that more organizations and individuals will experience better care. This FOA is focused on tool development and dissemination.

AHRQ is focusing grant funding support further down the "research to practice continuum" and closer to the points of care delivery by supporting projects that will generate information and scientific evidence that could enable improvement on a larger scale.

AHRQ is interested in funding projects that have patient safety impact potential and focus on significant patient safety problems that result in patient harm or mortality, occur with high frequency, or entail a high cost burden. Results of these projects should provide healthcare providers additional sustainable tools or resources that can be widely disseminated.

This area is relevant to AHRQ’s priority to support research to improve health care patient safety by improving the safety of health care delivery. Medication safety grants supported through this FOA must develop, test and disseminate new tools and/or further refine and spread existing tools that have previously been used in limited settings.

This FOA also supports HHS's National Action Plan for Adverse Drug Event Prevention’s approach to reduce patient harms from adverse drug events through research. Grant applications that develop tools and resources to address the opioid crisis are encouraged.

When effective patient safety improvements are discovered, it is important that investigators consider how best to disseminate and spread these results so that more organizations and individuals will experience better care. All applications must include a dissemination plan which A detailed dissemination plan that includes options for scaling the dissemination of research outputs at various organizational levels.

These organizational levels will likely vary based on each project’s focus and may include scaling within a health care organization’s units or departments. It may also include spread of a successful project's output for use in local, state, and federal entities.

Consideration of multiple methods for effective dissemination For applications that will produce resources and tools that are intended for patient, family, or provider use, a plan for potential use among populations with varying health literacy levels and English proficiency. Project Impact Statement: Applicants are required to include a section titled "Predicted Project Impact Statement".

External stakeholders often ask about the impact that AHRQ's funded research is having in terms of making health care safer, higher quality, and less costly.

Given increasing use of data visualization, infographic, extrapolation, modeling, and predictive and sensitivity analytic techniques in moving from the known to the unknown and to better portray the potential value and benefit resulting from research findings, applicants must describe - recognizing the necessary precautions and the early stage nature of the request - the techniques that could be used to best show the impact their proposed research aims could have.

Applicants are to include in this statement a quantifiable estimate of potential impact based upon identified techniques. Quantifiable estimates include data that can be measured or counted, such as, but not limited to: X% improvement in A , X% decrease of errors in B , etc. The Predicted Project Impact Statement will be evaluated as part of the determination of scientific merit in terms of the proposed project's significance.

Please note that this scored review criterion is different from the "Overall Impact" in Section V. Applications that fail to include a Predicted Project Impact Statement will not be accepted VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed (originally submitted under this FOA only).

Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards The number of awards is contingent upon the submission of a sufficient number of meritorious applications and the availability of funds. Future year funding will depend on funding availability. The total costs (direct and indirect) for a project awarded under this FOA will not exceed $500,000 in any given year and $1.

5 million for the entire project period. Funds may be used only for those expenses that are directly related and necessary to the project and must be expended in compliance with applicable OMB Uniform Administrative Requirements, Cost Principles, and Audit Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and the HHS Grants Policy Statement .

The project period may not These projects are authorized by 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

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.

Section III.

Eligibility Information 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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based 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 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 Non-domestic (non-U.S.) components of U.S. Organizations are not eligible 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 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.

Management (https://www. sam. gov/portal/SAM/#1) (formerly CCR) 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. Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration.

Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration. 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.

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 a 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. Eligible Individuals (Program Director/Principal 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.

See also AHRQ's NOT-HS-16-018 related to Multiple PD/PI via https://grants. nih. gov/grants/guide/notice-files/NOT-HS-16-018.

html . 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. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

AHRQ will not accept duplicate or highly overlapping applications under review at the same time. This means that AHRQ will not A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission 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-14-074 ). Application and Submission Information Buttons to access the online ASSIST system or to download application forms 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.

2. Content and Form of Application Submission It is critical that applicants follow the Research (R) Instructions (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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the SF424 Application Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide Budget Component: Special Instructions for AHRQ 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 All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 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 Predicted Project Impact Statement must be submitted in the Appendix Section.

The Predicted Project Impact Statement shall not exceed two Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application 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 PHS Human Subjects and Clinical Trials Information 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 Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions: 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 PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide 3. Unique Entity Identifier and System for Award Management (SAM) 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 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 holiday , the application deadline is automatically extended to the next 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.

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. 5.

Intergovernmental Review This initiative is not subject to intergovernmental 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.

Requirements and Information 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 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 .

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 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 by the Center for Scientific Review, NIH and for responsiveness by AHRQ.

Applications that are incomplete 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. Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in see NOT-OD-19-083 . Any instructions provided here are in addition to the instructions in the policy.

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. 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 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 should 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