NIH DATA SHARING POLICY AND IMPLEMENTATION GUIDANCE

(Distributed to Campus Administrators and C&G Representatives 9/4/03)

This email is to advise campus faculty and administrators that NIH has announced a new data sharing policy which will be implemented for NIH applications submitted on or after the October 1st, 2003 deadline. This new policy applies to all investigator-initiated applications with direct costs of $500,000 or more in any single year. As well, in some cases NIH Program Announcements (PAs) or Requests for Applications (RFAs) may request data sharing plans for applications requesting less than $500,000 in direct costs.

This new data sharing requirement is the result of NIH's desire to promote timely release and sharing of final data for use by other researchers in order to advance the research enterprise. NIH has posted a number of resource documents (including Final Implementation Guidance) on its website. Preparation of data sharing plans may be complex, and care should be taken to insure that institutional policies, local IRB rules, and local, state and federal laws and regulations are followed. In particular, investigators should carefully consider the following areas when developing data sharing plans:

• Protecting the Rights and Privacy of Human Subjects: This includes complying with all applicable IRB rules and the federal Health Portability and Accountability Act pertaining to protected health information. In determining how best to make final research data available, investigators must consider the need to protect against disclosure of personally identifiable data (or de-identify data when appropriate). If questions arise concerning HIPAA as it pertains to human research while preparing a data sharing plan contact the UCSF Compliance Specialist, contact the UCSF IRB Education Coordinator Lisa Voss at for general IRB issues relating to data sharing plans; please send your questions via our Contact Us form.



• Meeting the University's Intellectual Property and Third-Party Obligations: This includes complying with the University's obligation under Bayh-Dole to report to federal funding agencies on inventions resulting from federal funds, as well as with third-party obligations resulting from extramural sponsored research agreements or material transfer agreements. In devising a data sharing plan, investigators must consider the need to allow adequate time for review by the UCSF Office of Technology Management (OTM) of intellectual property and/or proprietary information that must be protected prior to release of research data. The NIH Implementation Guidance recognizes the need to protect patentable and other proprietary data (including cases where co-funding is provided by the private sector) and notes reasonable delays in disclosure of research findings may be needed to accomplish this goal. If questions arise when preparing data-sharing plans in the intellectual property arena, the Director of the UCSF OTM should be consulted. It is essential that any inventions be disclosed to the UCSF OTM as soon as they have been invented, which means making the disclosure when the invention is first in hand, no matter how rudimentary, and certainly well in advance of starting to prepare a manuscript or abstract or making any public presentations.

Examples of actual Data Sharing Plans can be found on the NIH web page.

Note: In the NIH Implementation Guidance there is a section entitled "What to Include in an NIH Application" which should be followed closely. When preparing a data sharing plan, sections of the grant application which may be involved are 1) the Data Sharing Plan itself which should follow immediately after the Research Plan Section and which will not count towards the application page limit 2) the Budget and Budget Justification as funds may be requested for implementation of the Data Sharing Plan itself 3) the Background and Significance Section if support is being sought for a large data sharing database, or 4) the Human Subjects Section in order to address issues of confidentiality of data and privacy matters.

NIH has indicated that if an application contains a data-sharing plan, that NIH expects the plan to be implemented and may take various forms of action to protect the government's interest in the case of non-compliance. Therefore, care should be taken to ensure that data-sharing plans are fully enacted if a grant is awarded, and that all plans closely follow the applicable University policies, local IRB rules, local, state and federal laws and regulations and intellectual and third party obligations. Please pass this email on to all applicable administrators and faculty within your department involved in preparation of NIH grant applications. Questions regarding this email can be directed to Joan Kaiser via our Contact Us form.