Agency for Healthcare Research and Quality (AHRQ) Data Management and Sharing Policy
Notice Number:
NOT-HS-25-010

Key Dates

Release Date:

December 18, 2024

Related Announcements

  • December 18, 2024 - AHRQ Policy for Public Access to AHRQ-Funded Scientific Publications. See Notice NOT-HS-25-011.
  • May 26, 2020 - The Agency for Healthcare Research and Quality Data Management Plan Policy. See NOFO NOT-HS-20-011
  • February 19, 2016 - AHRQ Announces New Policy for Public Access to AHRQ-Funded Scientific Publications. See NOFO NOT-HS-16-008.

Issued by

AGENCY FOR HEALTHCARE RESEARCH & QUALITY (AHRQ)

Purpose

On February 22, 2013, the White House Office of Science and Technology Policy (OSTP) released a memorandum entitled "Increasing Access to the Results of Federally Funded Scientific Research." This memorandum requires federal agencies to make the results of federally funded scientific research available to and useful for the public, industry, and the scientific community. In response, AHRQ published a plan for establishing a policy for public access to scientific publications and scientific data resulting from AHRQ funding (https://www.ahrq.gov/funding/policies/publicaccess/index.html), the Policy for Public Access to AHRQ Funded Scientific Publications (NOT-HS-16-008), and the Data Management Plan Policy (NOT-HS-20-011).

On August 25, 2022, the OSTP released a memorandum entitled “Ensuring Free, Immediate, and Equitable Access to Federally Funded Research” (2022 OSTP Memo). The 2022 OSTP memorandum provides additional policy guidance to federal agencies with research and development expenditures on updating their public access policies to address the public availability of peer reviewed scholarly publications and scientific data. In 2023 AHRQ published a Request for Information seeking public comments on proposed updates to its public access plan for peer reviewed scholarly publications and scientific data resulting from AHRQ funding. This updated AHRQ Data Management and Sharing Policy supersedes the AHRQ Data Management Plan Policy published on May 26, 2020, and provides updated guidance on the management and sharing of scientific data produced in AHRQ-funded research.

Policy

This AHRQ Data Management and Sharing Policy (hereinafter “DMS Policy” or “Policy”) applies to all AHRQ-funded grants and cooperative agreements (hereinafter collectively referred to as “grants”), and research contracts that generate scientific data and metadata as described in this Policy unless otherwise specified in the funding announcement or request for proposal. Conference grants (R13) and Health Services Research Dissertation Program grants (R36) are not subject to this Policy. This Policy also applies to research conducted by AHRQ in its intramural programs.

This policy requires applicants for AHRQ new and non-competing grants and research contracts to include a data management plan and a data sharing plan (DMS Plan) 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, and for sharing data, or state why data management and data sharing is not possible, as a component of their grant application or research contract proposal. AHRQ intramural researchers are expected to submit DMS Plans with their research proposal. Moreover, all new grant applications and research contract proposals are encouraged to include a section detailing the applicants' progress and/or experience to-date with sharing data in digital format arising from previously funded AHRQ projects.

This DMS Policy will be fully effective on the date of publication. Implementation will be prospective. In cases where AHRQ-funded research is administered or performed by a partner agency with a comparable data management and sharing policy, AHRQ will defer to the partner agency’s policies on the management and sharing of scientific data.

The data management component of the DMS Plan must describe the long-term preservation plan for scientific data generated in whole or in part from AHRQ funding. Options of long-term preservations include, but are not limited to the following:

- Submission of data to an appropriate public data repository.

- Submission of data to an existing publicly accessible data server at the recipient institution.

- Establishment of the recipient’s own data hosting capability (which must be described in the grant application or contract proposal).

The data sharing component of the DMS Plan must describe the plan for sharing scientific data generated in whole or in part from AHRQ funding.

Scientific data should be made accessible as soon as possible.

Scientific data underlying peer-reviewed publications should be made accessible no later than the date on which the publication is first made available in print or electronic format. Scientific data underlying findings not disseminated through peer-reviewed publications should be shared by the end of the grant or contract performance period unless the recipient enters into a no-cost extension. If a no-cost extension is permitted, the recipient should share the data by the end of the extended performance period. In addition, researchers should be aware that some preprint servers may require the sharing of data upon preprint posting, and repositories storing data may similarly require public release of data upon preprint posting.

Recipients should take into consideration individual funding agreements or other policies that apply to a specific project and that may have earlier expectations for data sharing timelines.

Recipients are encouraged to consider relevant requirements and expectations (e.g., data repository policies, award record retention requirements, and journal policies) as guidance for the minimum timeframe that scientific data should be made available, which researchers may extend.

Scope of Digital Scientific Data

Digital scientific data that are covered by this policy include:

  • Field data
  • Lab data
  • Other data (e.g., quality control samples, sample identification (ID) data, and instrument calibration data
  • Digital scientific, clinical, or institutional data that can be in scope at the discretion of the program or in an appropriate context: models and model-related content, including parameters and outputs, including models of public health emergencies; command files, such as SAS or STATA files created from secondary sources (typically referred to as secondary or outside data); de-identified Electronic Health Record (EHR) patient treatment records; and nonproprietary records and data collected as part of the National Hospital Preparedness Program.

Digital scientific data that are not in scope for this policy include:

  • Proprietary trade data
  • Personally identifiable data
  • Data related to protecting critical infrastructure
  • Other data whose release is limited by law, including the AHRQ confidentiality statute, regulation, security requirements, or policy[1]

AHRQ is exploring ways to make all research data available to the public by creating de-identified public use data files.

AHRQ will consider open-source formats to promote free and equitable public access.

Consistent with the OSTP Memorandum, the following are not considered research data and therefore, not subject to this policy:

  • preliminary analyses
  • drafts of scientific papers
  • plans for future research, peer reviews, communications with colleagues
  • physical objects, such as laboratory specimens

Investigators are, however, encouraged to include relevant content from laboratory or field notebooks in their published datasets if that information provides documentation that would help future users successfully re-use the data. (i.e., lab and field notebooks are not themselves scientific data, but may contain relevant metadata to be included in the published dataset).

Review of public access resources developed by the National Institutes of Health (NIH) is encouraged at https://publicaccess.nih.gov/.

Definitions

Refer to AHRQ plan for establishing a policy for public access to scientific publications and scientific data in digital format resulting from AHRQ funding at

https://www.ahrq.gov/funding/policies/publicaccess/index.html

Implementation

The DMS Plan should be submitted under the Resource Sharing Plan section of a grant application or as an appendix for a research contract proposal. The plan will not count toward the page limit for grant applications or contract proposals.

Applicants are encouraged to discuss their proposed DMS Plan with the AHRQ Program Officials named in the grant funding announcement or the research contract proposal at the time of the application preparation.

The DMS Plan will undergo review by AHRQ program staff for acceptability who may request modifications prior to award as appropriate, while considering the associated cost and administrative burden. The scientific peer reviewers will not review DMS Plans as part of the application review process but may consider any related budget items as part of the budget for the overall application. Note that a DMS Plan is not a scored peer review criterion unless specifically stated as such in the funding announcement. Review of the DMS Plan will not usually count toward the objective review score.  Program staff will, however, assess the adequacy of the DMS Plan for specific funding announcements where data sharing is integral to the project design and tied to a scored review criterion. In these cases, scientific peer reviewers will be able to review DMS Plans and may factor that information into the score as outlined in the review criteria.

AHRQ program staff will assess the DMS Plan to ensure the elements of the DMS Plan have been adequately addressed and to assess the reasonableness of those responses, including assertions that either data management or data sharing is impossible.

Applications selected for funding will only be funded if the DMS Plan is complete and acceptable.  If the DMS Plan provided in the application cannot be approved based on the information provided, applicants will be notified that additional information is needed. This will occur through the Just-in-Time (JIT) process. Applicants will be expected to communicate with their Program Official, grants management specialist, or contracting officer’s representative to resolve any issues that prevent AHRQ from approving the DMS Plan, including submitting a revised Plan if requested. AHRQ may delay processing of non-competing continuation awards until such awards are deemed to be in compliance with this Policy.

Recipients are expected to carry out data management and sharing as outlined in the approved DMS Plan, and as a term and condition of the award. Compliance with the approved DMS Plan will be evaluated through project monitoring by AHRQ Program Officials or contracting officer’s representatives, as appropriate. The approved DMS Plan will become part of the terms and conditions of award for grants and contracts.

Post-Award Plan Revisions and Submission Process

Following the award, recipients are required to comply with the version of the DMS Plan that was approved by AHRQ. DMS Plans may be updated during regular reporting intervals as part of the annual Research Performance Progress Report (RPPR) process for grants. Changes to the DMS Plan must be approved by the AHRQ Program Official or Contracting Officer’s Representatives overseeing the award.

Program Officials or Contracting Officer’s Representatives overseeing awards will also review progress reports carefully for adherence to the DMS Plan. Under the intramural research program, AHRQ will be responsible for ensuring intramural researchers are in compliance with the DMS Policy. AHRQ will conduct an audit of its intramural research program to monitor overall compliance with the DMS Policy.

AHRQ requires a recipient to comply with the DMS Plan as approved by AHRQ Program Official or Contracting Officer’s Representatives. Recipients may revise an approved DMS Plan only after consulting with AHRQ Program Official or Contracting Officer’s Representatives and obtaining prior approval. All requests for prior approval must be submitted by the Authorized Organization Representative (Signing Official (SO) role in eRA Commons) at least 30 days in advance of the requested change. The approved DMS Plan remains in effect for the award until the revision request is approved by the AHRQ Program Official or Contracting Officer’s Representatives.

If a proposed grant, research contract, or intramural research project is expected to transform or link datasets, rather than producing a new set of data, the researchers are expected to submit a DMS Plan. If there are limitations associated with the data sharing agreements for the original data that preclude subsequent sharing, the grant application or contract proposal must explain these limitations.

Content of the DMS Plan

The data management component of the DMS Plan should describe what data will be generated and how the recipient will manage, store, and disseminate data generated, which may include, but is not limited to the following descriptions or explanations:

1. Types of primary data, samples, physical collections, software, curriculum materials, etc., (e.g., digital numeric data, photographs, video, acoustic records, database tables, spreadsheets, paper records, physical samples, etc.).

2. What metadata the proposed research will generate and how the metadata will be captured and structured (e.g., in Word document, tab, on data spreadsheet).

3. Tools, such as a template that will be employed to capture metadata consistently through the research.

4. The metadata standard(s) or formats to be used or considered to represent data and metadata elements in the data collection, including any modifications of the standard(s).

5. The volume of data that is anticipated to be collected and growth to help understand the amount of digital storage space required during the course of the research.

6. The anticipated time frame of the research effort in relation to the duration when digital storage space will be required.

7. Indicate how the scientific data will be made discoverable and whether a persistent unique identifier or other standard indexing tools will be used, and whether the data contain Personally Identifiable Information or any information whose distribution may be restricted by law or national security.

8. Indicate whether scientific data generated from humans or human biospecimens will be available through unrestricted (made publicly available to anyone) or restricted access (made available after the requestor has received approval to use the requested scientific data for a particular project or projects). If the scientific data will be shared through a restricted access mechanism, describe the terms of access for the data.

9. If applicable, any documentation on specific terminology or guidance on valid values (e.g., t = time), and include or reference that documentation.

10. Where and how the data will be stored initially (i.e., prior to being sent to a long-term archive facility), such as the use of data repositories.

11. The minimum preservation time afforded by the proposed budget.

12. Describe any future decision points regarding continued preservation, archiving, or retiring the data.

13. Describe any provisions for maintaining the security and integrity of the scientific data (e.g., encryption and backups, how the data will be protected from accidental or malicious modification or deletion, including data back-up, disaster recovery/contingency planning, and off-site storage relevant to the data collection).

14. The quality control procedures, and the overall lifecycle of the data from collection or acquisition to making it available to the public.

15. The plan for addressing the research participants consent process to enable the de-identified data to be shared broadly for future research.

16. The copyright and the intellectual property rights of the data. If applicable, indicate how intellectual property, including invention or other proprietary rights, will be managed in a way to maximize sharing of scientific data. Include any information relevant to the intellectual property rights associated with the scientific data, such as whether the intellectual property stems from an existing agreement or is anticipated to arise from the proposed research project itself.

17. An estimated cost to implement the data management plan. This cost is allowable as part of the grant award direct costs or contract award price. Any costs associated with implementing the Plan should be explained in the budget justification.

18. Address the roles and responsibilities of all parties with respect to the management of the data (including contingency plans for the departure of key personnel from the project) after the grant or research contract ends.

19. Explain how the recipient plans to manage and disseminate data generated by the project.

20. Describe how you will check for adherence to this DMS Policy. Indicate the party responsible for managing the data.

21. If data will not be available to the public, describe why data will be closed or limited. Note any ethical or legal reasons for limited public access.

22. Describe any existing data sharing agreement(s), outlining the responsibilities of each party, as well as how scientific data can and cannot be used.

23. Describe any existing general licensing terms, and any limitations on the scientific data use and reuse based on these terms. Describe whether the licensing is imposed by the applicant institution or whether it comes from any existing agreement(s).

24. Describe alternative plans for maintaining, preserving, and providing access to scientific data should the original Plan not be achieved.

25. Other Considerations: Indicate whether there are additional considerations involved in the implementation of the DMS Plan (e.g., prior permission to use a specific repository).

The data sharing component of the DMS Plan may include, but is not limited to the following descriptions or explanations:

1. Briefly describe the expected schedule for data sharing;

2.Briefly describe the format of the final dataset and the documentation to be provided;

3. Briefly describe whether or not any analytic tools also will be provided;

4. Briefly describe whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave).

Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Investigators are encouraged to select a data repository that is appropriate for the data generated from the research project and is in accordance with the desired characteristics reflected in “Desirable characteristics of data repositories for Federally Funded research” (https://www.whitehouse.gov/wp-content/uploads/2022/05/05-2022-Desirable-Characteristics-of-Data-Repositories.pdf). These desired characteristics aim to ensure that data are managed and shared in ways that are consistent with FAIR data principles.

Acceptable options may include

  • A repository curated by the grantee institution
  • A central public repository
  • A repository maintained by grantee and made available upon request

Primary consideration should be given to data repositories that are discipline or data-type specific to support effective data discovery and reuse. Researchers are encouraged to review NIH compiled list of such data repositories available (https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html).

Funds for Data Sharing

AHRQ recognizes that it takes time and money to prepare data for sharing. Recipients who incorporate data sharing in the initial design of the research may more readily and economically establish adequate procedures for protecting the identities of participants and share a useful dataset with appropriate documentation. AHRQ will allow the inclusion of appropriate costs for data management and access in grant applications and research contract proposals. The appropriateness of requested funding levels for DMS Plans will be assessed on a case-by-case basis through scientific peer review, and by program and grants or contracts management staff. Only costs that will be incurred while the award is active can be requested. Applicants must categorize these costs as either direct costs or as indirect costs, as appropriate in accordance with HHS grants policy.

Reasonable, allowable costs may be included in AHRQ budget requests when associated with preserving and sharing data through established repositories, such as data deposit fees necessary for making data available and accessible. For example, if a DMS Plan proposes preserving and sharing scientific data for 10 years in an established repository with a deposition fee, the cost for the entire 10-year period must be paid prior to the end of the period of performance. If the DMS Plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included.

Post-Award Monitoring

AHRQ-funded researchers will be expected to include updates on publicly released data in digital format resulting from their research in quarterly reports (if applicable), annual progress reports, and final reports. AHRQ will develop mechanisms to monitor such compliance.

Annual progress reports, or quarterly reports should provide information on the progress on data management and sharing, including the public release of the research products. This information could include citations to relevant publications, conference proceedings, and descriptions of other types of data sharing and dissemination of results.

In the final report, recipients are required to discuss execution and any updating of the original DMS Plan included in the original grant application or research contract proposal. This discussion must describe:

  • How the data were produced during the award;
  • How the data will be retained after the award expires;
  • How data will be made available for sharing;
  • How community standards for data format will be communicated;
  • How data will be disseminated;
  • The format data will be made available to others; and
  • How and for how long the data will be housed and archived.

Roles and Responsibilities

AHRQ will:
 Establish, implement, manage, and evaluate this policy;

  • Ensure compliance with this policy;
  • If appropriately requested in a grant application or contract proposal selected for funding, provide funding to foster successful implementation of the recipient’s DMS Plan;
  • Develop criteria for the conduct of periodic reviews to identify gaps in preservation coverage and respond to changing needs arising from new data types.

Recipients and their institutions will:

  • Ensure that researchers are aware of and comply with the AHRQ policy;
  • Provide periodic reporting on progress and compliance with the proposed DMS Plan in quarterly (if applicable), annual, and final reports;
  • Where necessary, include reasonable costs for public access to digital data as a component of grant applications or research contract proposals, in accordance with applicable cost principles; and
  • Ensure that the final project reports discuss the execution and any updating of the original DMS Plan included in the original grant application and research contract proposal.

AHRQ may issue additional guidance in specific areas as needed to support the implementation of its DMS Policy.

Investigators

Prior Awards

  • Determine if proposed research is subject to the DMS Policy.
  • Identify appropriate methods/approaches and repositories for managing and sharing scientific data.
  • Develop a DMS Plan for managing and sharing scientific data and submit this plan within the funding application or proposal.
  • Estimate and request funds for data management and sharing activities if not already covered by institution or other sources.

* Note that applications subject to this DMS Policy will submit a single DMS Plan that includes a data management plan and a data sharing plan.

Post Awards

  • Manage and share data as described in the approved DMS Plan.
  • Provide updates on data management and sharing activities in annual progress reports.
  • If plans change over the course of the project, work proactively with AHRQ program staff to obtain review and approval of modifications.

Legal Authorities
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a)
Section 944(a) of the Public Health Service Act, 42 U.S.C. 299c -3(a)
42 C.F.R. Part 67
45 C.F.R. Part 75

Disclaimer

This policy is subject to applicable statutory and regulatory requirements, the availability of agency appropriations, and resource constraints. Nothing in this policy shall be construed to undermine any right under provisions of Title 17 or 35, United States Code. This policy is not intended to, and does not create any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the United States or the Agency for Healthcare Research and Quality.

[1] For information concerning the AHRQ Confidentiality Statute, see Confidentiality in AHRQ Supported Research, NOT-HS-18-012: https://grants.nih.gov/grants/guide/notice-files/NOT-HS-18-012.html.

Inquiries

Please direct all inquiries to:

Office for Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1905
Email: [email protected]