Mbirn: DSTF Mission Statement and Principles

BIRN Data Sharing Mission Statement (approved October 2003)

• 1. To maximize the return on the public investment in the BIRN project, and the studies that utilize its capabilities, by ensuring that BIRN Data Sharing policies and procedures encourage appropriate and widespread dissemination of BIRN data resources with the scientific community.

• 2. To develop, implement and maintain the procedures by which the BIRN project protects the rights and welfare of human subjects who agree to share their information with the scientific community through contributions to the BIRN data resources.

• 3. To ensure that BIRN Data Sharing policies and procedures comply with Federal, State and local regulations.

BIRN Principles for Data Sharing (approved January 2005)

The BIRN is being created to provide a distributed electronic environment that facilitates and promotes large scale sharing of scientific data. To quote from the NIH data-sharing policy guidelines: "…sharing data reinforces open scientific inquiry, encourages diversity of analysis and opinion, promotes new research, makes possible the testing of new or alternative hypotheses and methods of analysis, supports studies on data collection methods and measurement, facilitates the education of new researchers, enables the exploration of topics not envisioned by the initial investigators, and permits the creation of new datasets when data from multiple sources are combined." In recognition of these benefits, BIRN data sharing policies are designed to facilitate access to as much data as possible as freely as possible, while safeguarding human subject data and ensuring proper use and attribution of intellectual property.

Data Sharing is a requirement for use of the BIRN Infrastructure

The BIRN cyber-infrastructure is only to be used for research activities that are in accordance with all applicable BIRN policies; these research activities and their results must be shared with the rest of the scientific community in a timely fashion. A period of one year from the completion of the study or from the point when the study is determined to be inactive is a reasonable criterion for when the data should become available to the scientific community.

What is covered by BIRN Data Sharing Policies?

Any data stored in or made available or processed through the BIRN cyber-infrastructure (herewith known as “BIRN data”) are subject to the BIRN Data Sharing Policies as described in the BIRN Data Use Agreement.

How is the BIRN Data Provenance Handled?

Data submitted to the BIRN should include sufficient information describing the source of the data such that other researchers can accurately attribute these sources for subsequent research and publications. “BIRN data” (as defined above), once made available to the scientific community, cannot be reclassified later as private data or expunged from the BIRN. To ensure safety and consistent access by the scientific community BIRN data will be automatically replicated to a mirror site.

Who must abide by BIRN Data Policies?

Individuals submitting and using BIRN data must sign the BIRN Data Use Agreement indicating they are responsible for protecting, maintaining, sharing and disseminating the data according to BIRN Data Sharing Policies. Each study must designate a responsible person (i.e. the Principle Investigator) that can be contacted regarding shared data.

What are the relations between Institutional and BIRN responsibilities for Data Sharing?

• Each institution that submits, hosts or processes BIRN data will use best practices for data confidentiality and security that are consistent with Federal and other applicable standards.

• Technical and administrative safeguards consistent with these policies will be applied to all person-identifiable BIRN data, regardless of whether that data meets formal criteria as Protected Health Information (PHI).

• Each institution that hosts BIRN data, including the BIRN-CC, will have Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) approval for BIRN Data Sharing Policies and Procedures. This will include IRB and/or IACUC approval of the BIRN database itself at institutions where this is required.

• All BIRN data must have been collected with the originating institution’s IRB or IACUC approval. All BIRN data must have the originating institution’s IRB or IACUC approval for sharing with the scientific community.

• The BIRN will be responsible for verifying the originating institution’s IRB or IACUC to insure compliance with BIRN data sharing policies and procedures prior to inclusion of the data.

Respectfully Submitted by:

Randy Gollub, Chair