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NIH Spending clinical trials

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.

POLICY DETAILS

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).

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