NIH Guide: FINAL NIH STATEMENT ON SHARING RESEARCH DATA

"As part of NIH's long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds, NIH announced and invited comments on a draft statement about the sharing of final research data on March 1, 2002. Since that time, NIH has received and reviewed many thoughtful comments from a range of scientific organizations and over 150 individuals. Additionally, during the comment period, HHS published final modifications for the STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION, the "Privacy Rule," of the Health Insurance Portability and Accountability Act (HIPAA), available at http://www.hhs.gov/ocr/. The Privacy Rule is a federal regulation that governs how certain health care providers, health care clearinghouses, and health plans, known as "covered entities," use and disclose identifiable health information. NIH has carefully considered the comments and the Privacy Rule, and issues the following statement on data sharing:

NIH reaffirms its support for the concept of data sharing. We believe that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve human health. The NIH endorses the sharing of final research data to serve these and other important scientific goals. The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers. Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why data sharing is not possible...."