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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:
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:
Data sets can be made available early at the discretion of the study investigator(s).
*Please note that all studies conducting GWAS, regardless of cost, should refer to the NIH GWAS Policy for additional requirements.
The following links highlight NIH policy and related guidance on sharing of research data developed with NIH funding.
For questions and/or concerns regarding the content of this page, please contact the Clinical Research Policy Manager
Last Updated: April 2011