NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies
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 NHLBI Clinical Research Guide Glossary 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. Examples can be found in the NIH Data Sharing Workbook
. Another option is to share data through the NHLBI data repository. The NHLBI data repository is managed by the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) and facilitates the sharing of biological specimens and data from NHLBI-supported studies. Procedures for preparing NHLBI data sets for submission to BioLINCC can be found in the Guidelines for NHLBI Data Set Preparation.
Of note, data sets stored in the 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 and sent to the PO 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.
The following links highlight NIH policy and related guidance on sharing of research data developed with NIH funding.
- NIH Data Sharing Policy
- Data Sharing Workbook
- Frequently Asked Questions about Data Sharing
- Key Elements to Consider in Preparing a Data Sharing Plan Under NIH Extramural Support
For questions and/or concerns regarding the content of this page, please contact the Clinical Research Policy Manager
Last Updated: September 2014