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University
of California Office
of the President Senior
Vice President— Business and Finance |
Memo Operating Guidance |
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Research Administration Office |
No. 03-05
August
11, 2003 |
CONTRACT AND
GRANT OFFICERS (CAMPUS AND LAB)*
Subject: NIH Data Sharing Policy and Implementation Guidance
Chancellors for Research with information about the new National Institutions of Health (NIH)
Statement on Sharing Research Data and NIH Data Sharing Policy and Implementation Guidance,
also attached.
The letter advises Vice Chancellors of this new policy which will be implemented by NIH for
applications submitted on or after October 1, 2003. While it will be required for “all
investigator-initiated applications with direct costs greater than $500,000 in any single year”,
in some cases, NIH program announcements may request data sharing plans for applications
requesting less than $500,000 in a single year.
The letter provides an outline of some of the federal requirements and University policies which
must be considered in the development of a data sharing plan. These include:
• The federal Health Insurance Portability and Accountability Act’s (HIPAA) Privacy Rule
• Institutional Review Board rules
• Protection of confidential and proprietary data
• Compliance with third party obligations
• Publication of findings
The NIH Data Sharing Policy and Implantation Guidance (Updated: March 5, 2003) provides
guidance on methods of data sharing as well as examples of data sharing plans. The attached
document is also available on-line at:
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm .
The NIH website for its Data Sharing Policy (http://grants.nih.gov/grants/policy/data_sharing/)
also provides links for:
• Frequently Asked Questions - Data Sharing (03/05/2003) - Listing of Frequently Asked Questions
that will be updated as new questions are received. Please check back periodically for new questions
and answers. http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm
• Data Sharing Workbook (PDF or MS Word) - (03/04/2003) - Workbook to show how investigators
working in a variety of scientific areas have shared their data. http://grants.nih.gov/grants/policy/data_sharing/data_sharing_workbook.pdf
• Other Data Sharing Documents and Resources (03/05/2003) - Additional resources relating to
data sharing. http://grants.nih.gov/grants/policy/data_sharing/data_sharing_resources.htm
Campus Principal Investigators may need to consult with a variety of campus offices for assistance
in the development or review of proposed data sharing plans. In addition to the Contract and Grant
Office, these may include IRB staff, HIPAA Privacy Officers, and technology transfer officers. The
development of a web-based data sharing plan, particularly one that requires secure or password
access, could involve campus computing services as well.
Campus Contract and Grant Offices may want to implement a procedure for assuring that data sharing
plans are appropriately included in NIH proposals when required and that they have been reviewed
by the appropriate campus oversight office(s) for any specific issues in the proposed plan as part of
the campus proposal review and submission process.
| Refer: Samuela A. Evans (510) 987-9849 Samuela.Evans@ucop.edu |
Subject: 11 Organization: F-350 |
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David Mears Director, Research Administration |
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Attachments
Cc: Campus Patent Coordinators
Campus Copyright Coordinators
Campus HIPAA Privacy Officers