Workshop Groupings

1
Workshop Groupings

• Group 1 North Hall
• (Chair Doug Fridsma, Scribe Fiona)
• Group 2 Garden Room
• (Chair Monica Jones, Scribe Peter)
• Group 3 Committee Room
• (Chair Peter MacCallum, Scribe Max)

2
What are the burning issues?

• Data Governance responsibility
• Research governance patient involvement/contract
  s
• IP, contracts, data ownership
• Existing data
• Prospective data
• Open source vs propietary software
• Costing / funding (additional problem)
• Involvement of regulators
• International trials special data issues
• Data Quality control analysis qc
• What would we need to do as NCRI to advance the
  issues
• How do we measure success of this?
• How many standards do we need?
• How do we communicate to the public the
  importance od data sharing?
• Who is going to support/provide service of
  vocabs/ontologies and how do we do it?
• Is there a tipping point for this activity?
• Incentives/who are the people on the ground we
  need to convince?
• How flexible does the system need to be for the
  future?

3
Group 1 Feedback

• Consent
• Need option to opt out of secondary usage of
  non-trial data (prospective trials vs existing
  data)
• Transparency about what will happen to the data
  but may not yet know all the questions we want to
  ask
• A CONSORT statement for consent?
• Need to clearly explain to patients that the
  accumulation of data is powerful

4
Feedback (2)

• Anonymisation
• How does it affect the issue?
• Issues of re-identification and disclosure
• Need to balance risk of participation with
  benefit (e.g. Tamoxifen)

5
Feedback (3)

• Data
• Need to tool-up data for sharing (meta-data)
  and need preferred formats
• Need to know what is out there we may want to
  analyse (register?)
• Need to know which groups sign-up to comply and
  meet requirements
• Need to monitor re-use of data, quality of
  studies and where published (oversight committees)

6
Feedback (4)

• Who will pay for what we need?
• 4 pillars of semantic interoperability
• Make it easier to comply than not
• Those who do the work need appropriate funding
  and recognition
• CFH should provide some funding to research
  community if to be of the greatest benefit