University of California

Office of the President

 

Senior Vice President—

Business and Finance

Memo

Operating

Guidance

 

Costing Policy & Analysis

Research Administration Office

No. 03-05

 

August 11, 2003

 

CONTRACT AND GRANT OFFICERS (CAMPUS AND LAB)*

Subject:  NIH Data Sharing Policy and Implementation Guidance

The attached letter from Lawrence Coleman, Vice Provost for Research, provided campus Vice

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

 
 
 
   

David Mears

Director, Research Administration

 

Attachments

nihimpguide.pdf

 

Cc:  Campus Patent Coordinators

       Campus Copyright Coordinators

       Campus HIPAA Privacy Officers