Mbirn: DSTF Action Plan 2005

DSTF Proposed Action Plan with Timeline

All work in the next block of time will focus on the implementation of the BIRN infrastructure necessary to enable sharing of existing BIRN data with the scientific community. We propose to:

Complete by June 2005

1) Prepare the following documents for submission to BEC and BIRN community for final ratification:

a) Data Use Agreement(*)

b) Template IRB language for subject consent and IRB protocol documents for submitting data to BIRN.

c) Template IRB language for obtaining Protected Health Information from the BIRN.

d) Text required for submission of IRB applications for each BIRN site, including the CC, to obtain institutional approval of BIRN data sharing policies and procedures per se.

(*)There are several unresolved issues requiring decisions about how to treat Intellectual Property. Either the mandate of the DSTF should be expanded and its membership augmented with individuals possessing additional experience in this domain or this should be a joint project with the IP Task Force. BEC must tell to us how to proceed on this point.

Complete by October 2005

2) Prepare a draft of a Data Sharing Policies and Procedures manual relevant to the existing BIRN data (e.g. that collected by the consortium investigators) that:

a) Delineates classes of data, classes of users, and levels of privacy.

b) Delineates policies for each of the classes of users for each interface with the BIRN data.

c) Describes mechanism by which the link table linking the unique BIRN ID to PHI will be held at the institution where the data were acquired.

d) Provides guidelines for how data can be de-identified and un-linked (i.e. anonymized) such that it does not require any additional approvals in order to be shared with the scientific community.

e) Provides guidelines for how de-identified data can be shared with any member of the scientific community who has executed the BIRN Data Use Agreement that stipulates that they will not attempt to re-identify the data.

Complete by December 2005

3) Revise the above documents pending input from the BEC and BIRN community.

Looking ahead to 2006

The Data Sharing Task Force will codify in policy form the decisions developed by the BIRN community on issues related to managing the BIRN data resources such as data provenance and curation, user policies, testing and auditing of procedures. This must include development and Implementation of a plan for how BIRN resources will be shared outside the test beds including preparation of the following text:

a) Template language to go into a grant that proposes to use the BIRN infrastructure to meet the NIH Data Sharing requirement.

b) Template language to go into the Resources and Environment section of a grant that uses the BIRN.

Respectfully Submitted by:

Randy Gollub, Chair