# Presentation: 835385

## Data Sharing and 

**Data Sharing and **
**Intellectual Capital Workspace**
**(DSIC WS)**Status Briefing to the Tissue Banks and
- Pathology Tools Workspace
- April 11, 2006
- Arlington, VA

## Inspirations of the DSIC WS: 

- ...the Beats...

## ...Keats...

- ...Keats...

## ...William Butler Yeats...

- ...William Butler Yeats...

## Slide 5

## “[T]here are known knowns
there are things we know we know.
We also know there are known unknowns
That is to say, we know there are some things we do not know. 
But there are also unknown unknowns
The ones we don't know we don't know."

- there are things we know we know.
- We also know there are **known unknowns**
- That is to say, we know there are some things we do not know.
- But there are also **unknown unknowns**
- The ones we don't know we don't know."

*Laureate Rumsfeld on DSIC WS:*

## Goals of the DSIC WS

- Provided guidance on issues we anticipated at the outset of caBIGTM (“known knowns”)
- Identify and address the requirements and needs of caBIGTM participants (“known unknowns”)
- Conduct research on caBIGTM projects in development and best practices in other initiatives (“unknown unknowns”)

## Current DSIC WS Accomplishments

- Open Source Software (OSS) Licensing Guidelines and Model Agreement
- Source code for all caBIGTM software tools will be available to end-users; no restrictions on how source code modified by end users is distributed
- Use of model agreement is not mandatory; guidance document will assist caBIG institutions in formulating alternatives
- caBIGTM Publication Policy
- Documents process for review and provides guidelines for authorship, attribution, and acknowledgement in caBIGTM Publications

## Current DSIC WS Accomplishments, cont’d

- Conflict of Interest Statement
- Requires disclosure of financial interests in matters under discussion
- Security Administration Recommendation
- Delivered January 2005
- Impetus for the Security Technology Evaluation White Paper and current security program efforts

## DSIC WS projects underway

- Draft Statement on Peer-Reviewed Publications
- Review of OBBR First-Generation Guidelines
- Draft document on data sharing best practices
- Research on other data sharing initiatives (grids, collaborations, etc.)
- Industry Partners Statement
- Restricts activities on teleconferences and at meetings to those related to conducting the mission or business of caBIGTM
- Problem scenarios
- Research on other data sharing initiatives

## 	"As you know, you go to [the genome] with the [caBIGTM] you have, not the [caBIGTM] you might want or wish to have at a later time." 

## Projects slated for Year 3: Security Program

- Security Policy and Procedures for caGRID
- Identify the boundaries of requirements for:
- De-identification
- 21 CFR 11
- Other security requirements
- Policies on authorization, authentication, horizontal trust

## Projects slated for Year 3, cont’d

- Data Sharing Best Practices White Paper
- Develop model patient notification/consent forms
- Additional research on problem scenarios and other initiatives

## "Learn to say 'I don't know.' If used when appropriate, it will be often."

## DSIC WS Methodology: The “Problem Scenario” Approach

- Problem scenarios are solicited from members of the DSIC and throughout the caBIGTM community
- After they submitted, they are fielded by member of the appropriate team (either the Proprietary or Regulatory SIG).

## Problem Scenario Workflow

- Scenario is fielded to subject matter experts
- Proposed solutions submitted; discussed amongst group members
- Adopted as policy/ recommendation

## DSIC WS continues to solicit problem scenarios from development projects in domain workspace

- This includes TBPT WS!

## DSIC Communications:

- Workspace Facilitator (NCI)
- Wendy Patterson, J.D.
- (301) 435-3110
- pattersw@mail.nih.gov
- Workspace Coordinator (BAH)
- Dan Steinberg, J.D.
- (703) 377- 1261
- steinberg_daniel@bah.com

- Regulatory SIG teleconferences are on the 2nd and 4th Thursday of each month, 2 PM EST

## "If I know the answer I'll tell you the answer, and if I don't, I'll just respond, cleverly."

- Questions?