The Agency for Healthcare Research and Quality Data Management Plan Policy

Notice Number: NOT-HS-20-011

Key Dates
Release Date: May 26, 2020

Related Announcements
NOT-HS-16-008

Issued by
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)

Purpose

Policy

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. AHRQ intramural researchers are also expected to submit a DMP with their research proposal. Moreover, all new grant and cooperative agreement applications, and 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 previous AHRQ funding.

This policy applies to AHRQ intramural researchers and extramural recipients of AHRQ grants and research contracts, unless otherwise specified in the funding opportunity announcement or request for proposals.This policy applies to all scientific metadata in digital format arising from AHRQ funding.

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

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

- Submission of data to appropriate public data repository

- Submission of data to existing publicly accessible data server at the grantee institution; and

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

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 covered by for this policy include:

  • Proprietary trade data;
  • Personally identifiable data*;
  • Data related to protecting critical infrastructure; and
  • Other data whose release is limited by law, regulation, security requirements, or policy.

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

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, or
  • 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 Public Access to Federally Funded Research at https://www.ahrq.gov/funding/policies/publicaccess/index.html

Implementation

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

The DMP will undergo objective review by AHRQ's scientific peer review groups to assess its merits, while considering the associated cost, and administrative burden. The scientific peer reviewers may provide constructive comments, but the review of the DMP will not be counted towards the objective review score. If applicable the applicant must explain why data management is not possible.

Compliance with the proposed DMP will be evaluated through project monitoring by AHRQ Program Officials or Contracting Officer Representatives, as appropriate. The DMP will become part of the terms and conditions of award as appropriate for grants and contracts.

AHRQ makes awards to institutions and not to individuals. The institution may have policies and procedures regarding the custody, distribution, and required retention period for data produced under research awards. Grant and contract recipients need to comply with institutional and federal requirements.

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

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

Content of the Data Management Plan

The DMP 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.), which are produced during the project; necessary data flow, and produces the data entry/tracking plan.

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, e.g., a template that will be employed to capture metadata consistently through the search.

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 and other researchers.

15. The plan for addressing the study 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 DMP 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 DMP. 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 additional considerations are needed to preserve and make accessible implement the scientific data. Plan (e.g., prior permission to use a specific repository

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 study 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. The appropriateness of requested funding levels for DMPs 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 federal and institutional policy.

Post-Award Monitoring

AHRQ-funded extramural and intramural 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, and will develop mechanisms to monitor such compliance.

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

In final reports, grantees and contractors are required to discuss execution and any updating of the original DMP included in the original grant applications or contract research proposals. 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:
stablish, 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 this policy;
  • Coordinate the collaboration and cooperation of public access with other federal agencies;
  • Develop criteria for the conduct of periodic reviews to identify gaps in preservation coverage and respond to changing needs arising from new data types.

AHRQ’s DMP policy recognizes proprietary interests, business confidential information, and intellectual property rights and avoids significant negative impact on intellectual property rights, innovation, and U.S. competitive research grants and cooperative agreements and a requirement of appropriate contracts.

Grant, Cooperative Agreement, and Research Contract 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 DMPs in quarterly (if applicable), annual, and final reports;
  • Where necessary, include reasonable cost for public access to digital data as a component of grant or cooperative agreement 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 DMP 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 plan for public access to scientific data.

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 (AHRQ)

Inquiries

Please direct all inquiries to:

Hope Hongzhu He, JD, MPA, MA

AHRQ Human Protections Administrator

Office for Extramural Research, Education, and Priority Populations

Agency for Healthcare Research and Quality (AHRQ)

Telephone: 301-427-1905

Email: PublicAccess@ahrq.hhs.gov