NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies for applications submitted prior to January 25, 2023
Note: This policy remains in effect for NHLBI-funded clinical trials and epidemiological studies funded via applications submitted prior to January 25, 2023. Adoption of the new policy is encouraged for those studies and required for applications submitted after that date: NHLBI Supplement to the NIH Policy for Data Management and Sharing (effective May 25, 2023).
The National Heart, Lung, and Blood Institute (NHLBI) has supported data collection from NHLBI-funded awardees for numerous clinical trials and epidemiologic studies. Data from these well-characterized studies constitute an important scientific resource for heart, lung, and blood related research. It is the view of the NHLBI that the full value of data can only be realized if they are made available in a timely manner for use by other researchers. The purpose of this policy is to describe the requirements for data sharing in applicable NHLBI-funded studies.
Refer to NIH Grants & Funding Glossary & Acronym List for additional terms not identified.
The NIH requires applicants/offerors requesting $500,000 or more in direct costs in any given year to submit a plan to share their final research data*. The NHLBI, however, encourages all applicants to include a plan to address data sharing or to state why data sharing is not possible. Exceptions may be considered to safeguard the rights of individuals and communities. These data must only be made available under terms and conditions consistent with the informed consent provided by individual participants, and as approved by the awardees' Institutional Review Board (IRB) and any local, state and Federal laws and regulations. Specific data sharing requirements, as appropriate, will be included in the Funding Opportunity Announcement (FOA), Notice of Award (NoA) or contract terms.
General NHLBI Data Sharing Guidance
This data sharing guidance applies in general to studies meeting at least one of the following:
- research applications/proposals requesting $500,000 direct costs or more in any one year;
- research studies that have 500 or more participants;
- ancillary studies based on NHLBI-funded parent studies;
- applications/proposals submitted in response to FOAs that specify inclusion of data sharing plans; or,
- other research studies deemed appropriate for data sharing by NHLBI Program Official (PO).
For studies meeting at least one of the above criteria, investigators are required to provide a data sharing plan, which will be reviewed and approved by the relevant NHLBI PO. In addition, investigators must address adherence to their approved data sharing plan in the annual progress report, at a minimum. Any changes to the data sharing plan must be discussed in advance with the relevant program official.
DATA SHARING OPTIONS:
When developing data sharing plans, investigators should consider various approaches to sharing data. Although other options are available, the institute recommends sharing NHLBI-funded data through an NHLBI data repository. NHLBI data repositories currently accepting data include the following:
- NHLBI BioData Catalyst® (BDC) is a cloud-based ecosystem that offers data, analytic tools, applications, and workflows in secure workspaces. It is a community where researchers can find, access, share, store, and analyze heart, lung, blood, and sleep data. It is also an NHLBI data repository where researchers share scientific data from NHLBI-funded research so they and others can reproduce findings and reuse data to advance science.
Read more about BDC | Learn how to submit data to BDC
- Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) and (BioLINCC) facilitates and coordinates the sharingactivities of biological specimens and data from NHLBI-the NHLBI Biorepository and its Data Repository. The mission of BioLINCC is to maximize the scientific value of biospecimen and clinical data resources collected by clinical trials and observational studies supported studies. Proceduresby the Institute. BioLINCC promotes the use of and facilitates access to biospecimen and clinical data resources through a single web-based user interface.
Read more about BioLINCC | Learn how to submit data to BioLINCC
- National Sleep Research Resource (NSRR) is an NHLBI-supported repository for sharing sleep data (polysomnography, actigraphy, and questionnaire-based) collected on tens of thousands of individuals from cohort studies, clinical trials, and other data sources. These data can be accessed by the public with the goal of advancing sleep and circadian science as well as signal processing and data analysis techniques.
Read more about NSRR | Learn how to submit data to NSRR
Under this policy (for applications submitted prior to January 25, 2023), data sets stored in an NHLBI data repository have the following data set submission requirements and release schedule:
- Clinical Trials - The data sets must be submitted to the study NHLBI study Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center or principal investigator and sent to the PONHLBI for review prior to release.
- Observational Epidemiology Studies - Epidemiology studies typically have an examination component and a mortality/morbidity follow-up component. Data from each cycle of an examination or follow-up component are prepared by the study coordinating center and sent to the NHLBI PO for distribution as a data set no later than 3 years after the completion of each examination or follow-up cycle or 2 years after the baseline, follow-up, genetic, ancillary study, or other data set is finalized within the study for analysis for use in publication, whichever comes first.
- Ancillary Studies - In those cases in which the timeline for an ancillary study differs from that of its parent study, the release date of data will relate to the timeline of the ancillary study. Requirements will be outlined in the agreement between the parent and respective ancillary study. 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 data sharing.
Data sets can be made available early at the discretion of the study investigator(s).
*Please note that all studies conducting genomic research, regardless of cost, should refer to the NIH Genomic Data Sharing (GDS) Policy for additional requirements.
- NHLBI Supplement to the NIH Policy for Data Management and Sharing for applications received ON/AFTER May 25, 2023
- NIH Data Sharing Policy for applications received BEFORE January 25, 2023
- NIH Data Sharing Policy for applications received ON/AFTER January 25, 2023
For questions and/or concerns regarding the content of this page, please contact the DataSharing@nhlbi.nih.gov
Last Updated: April 2023