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1.0 Purpose

Effective data management and sharing is an important pillar of reinforcing the goals established in the Strategic Vision of the National Heart, Lung, and Blood Institute (NHLBI). NHLBI has a long-standing commitment to promoting a culture of data management and sharing and has been in the vanguard of this work for more than 30 years. To further enhance scientific data generated with NHLBI support to be more FAIR (Findable, Accessible, Interoperable, Reusable), this new NHLBI Supplement to the NIH Policy for Data Management and Sharing (NHLBI Supplement) provides updated guidance for data management and sharing for all human and non-human research generating scientific data.

2.0 Background

This NHLBI Supplement replaces the previous NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies. It also harmonizes with the National Institutes of Health (NIH) Final NIH Policy for Data Management and Sharing (NIH DMS Policy), which became effective on January 25, 2023, and applies to research funded or conducted by NIH that results in the generation of scientific data.

Applicants and awardees should refer to NIH DMS Policy (NOT-OD-21-013) for details on its requirements and compliance. Additional guidance and resources are available and continually updated on sharing.nih.gov. Please note that all research subject to the NIH Genomic Data Sharing (GDS) Policy should refer to NOT-OD-22-198 for additional guidance on how to comply with both GDS and DMS policies.

This NHLBI Supplement establishes additional expectations for NHLBI-supported researchers subject to the NIH DMS Policy, including for special compliance timelines, data repositories, and ancillary studies. The NHLBI Supplement may be updated as deemed appropriate by NHLBI to reflect updates to NIH guidance or policy or any significant technological developments that may impact scientific data sharing policies and practices.

3.0 Applicability

This policy is applicable to NHLBI Program staff, NHLBI-supported researchers, and ancillary studies to NHLBI-funded parent studies.

4.0 Roles and Responsibilities

For information on key roles and responsibilities, refer to section 5., Policy.

5.0 Policy

While the effective date of the NIH DMS Policy is January 25, 2023, the effective date of this NHLBI Supplement is May 25, 2023, including for:

  • Competing grant applications that are submitted for NHLBI funding or for ancillary studies to NHLBI parent studies on or after May 25, 2023
  • Proposals for contracts that are submitted for NHLBI funding or for ancillary studies to NHLBI parent studies on or after May 25, 2023
  • NIH Intramural Research Projects conducted on or after May 25, 2023
  • Other funding agreements (e.g., Other Transactions) that are executed on or after May 25, 2023, unless otherwise stipulated by NHLBI

Additionally, on or after May 25, 2023, NHLBI may set the expectations for certain ongoing research that it supports to comply with the updated NHLBI Supplement. This will be done in advance of any renewal as determined by specific programmatic needs and will be communicated to individual awardees.

NHLBI acknowledges that not all research will be immediately subject to the new NHLBI Supplement during the transition period on and after May 25, 2023. Research applications, awards, and intramural research projects not required to comply with the new NHLBI Supplement on and after May 25, 2023, should continue referring to the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies for data sharing expectations and compliance monitoring until notified otherwise.

5.1 Data Repositories

NHLBI-supported researchers are expected to share scientific data through existing NIH-supported Scientific Data Repositories or other repositories that have the desired characteristics described in the Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research. NHLBI encourages submission of data into NHLBI BioData Catalyst (BDC), especially for data from studies that must comply with NHLBI’s Accrual of Human Subjects (Milestones) Policy and for those projects supported by funding opportunity announcements that encourage data deposition into BDC. NHLBI also encourages the submission of data into BDC for NHLBI projects and ancillary studies to NHLBI parent studies subject to the NIH GDS Policy. For data submitted to repositories other than BDC, an appropriate globally-unique, persistent identifier with sufficient metadata should be shared with NHLBI to promote FAIR principles and populate a master index for data generated from all NHLBI-supported research.

NHLBI discourages the deposition of data in multiple places, which may incur issues of version control and excess storage costs. If researchers need to deposit data generated from NHLBI support into more than one repository, the rationale for this need should be provided within the Data Preservation, Access, and Associated Timelines element in DMS Plans. When approved for deposition in multiple repositories by appropriate NHLBI staff, for data deposited in repositories other than BDC, an appropriate globally-unique, persistent identifier for each repository, with sufficient metadata, should be provided to the NHLBI to promote FAIR principles.

5.2 Ancillary Studies

NHLBI defines ancillary studies as studies that collect new data or derive data for purposes that are separate from the main “parent” study. The goal of ancillary studies is to extend scientific knowledge beyond the parent study’s original scope. NHLBI ancillary studies are primarily supported by NIH funds but may also be funded, in part or whole, by other sources such as non-profit and private sector organizations. Studies approved as ancillary, regardless of funding sources, to an NHLBI-funded parent observational study or clinical trial (including studies co-funded by multiple institutes, centers, and offices or to which NHLBI provides administrative oversight) are required to adhere to the parent study’s data sharing policies as a condition of approval. The requirements of data sharing agreements between NHLBI-funded parents and their ancillary studies should be consistent with the principles of the NIH DMS Policy.

Data sharing requirements are outlined in the agreement between the parent and respective ancillary study, and it is the responsibility of the ancillary study principal investigator to state in writing to the parent study steering committee any special circumstances that would preclude or limit data sharing. As specified in contract terms or award terms, designees from the parent studies shall submit updated and new ancillary data to an NHLBI-approved data repository on the same data submission timeline as the parent data (for example, core exam data, annual event surveillance, etc.). Ancillary study principal investigators should get advance approval from the parent study steering committee for any plans to share data with other repositories which have characteristics consistent with those described in the Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research.

For questions and/or concerns regarding the NHLBI Supplement, please contact DataSharing@nhlbi.nih.gov.

6.0 References

The following links highlight NIH DMS Policy and related guidance on sharing research data developed with NIH funding.

Contact

For questions and/or concerns regarding the NHLBI Supplement, please contact DataSharing@nhlbi.nih.gov.