Frequently Asked Questions about Sharing Data from NHLBI Funded Studies

Where can I find basic information on data sharing?

• NIH Data Sharing Policy
• NHLBI Data Sharing Policy
• Data Sharing Workbook and Testimonials
• Frequently Asked Questions about Data Sharing
• Key Elements to Consider in Preparing a Data Sharing Plan Under NIH Extramural Support
• Guidelines for NHLBI Data Set Preparation
• NIH Data Sharing Policy Training Resource(Internal Use Only)

What is the data sharing policy?

NIH requires researchers requesting $500,000 or more in direct costs in a year to include a plan to share their final research data in their applications or proposals or explain why data sharing is not possible.

NIH's genome-wide association studies (GWAS) policy is part of this requirement; however for GWAS, you need to share the data regardless of the proposed budget. See NIH GWAS Page

NHLBI encourages all applicants to include a plan to address data sharing.

Must all applicants and offerors include a plan for sharing data?

No. 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.

Am I required to submit share my data in BioLINCC, the NHLBI data repository?

NHLBI strongly encourages applicants/offerors to share data in BioLINCC and the National Center for Biotechnology Information (NCBI) Database (e.g. dbGAP, dbSNP, etc.) as appropriate.

What are the submission requirements for sharing data in BioLINCC?

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.

For additional questions the Office of Extramural page: Frequently Asked Questions about Data Sharing

For questions and/or concerns regarding the content of this page, please contact the
Clinical Research Policy Manager

Last Updated: April 2011