Event Time: Aug 10^th 2016 13:47

Video Session

Content

Notable Issues

• Particularly sensitive information being collected
• Names of devices (e.g., via Bluetooth)
• Geographic information
• Network recruitment requires blinded referrals
• Collectively identifiable information
• Notifiable behavior
• Lawbreaking activities
• Smartphone use in vehicles
• Special ethics handling required in context of clinician-patient relationship
• Advised: separate notification or study personnel to approach
• Tighter scrutiny over intervention studies

Tips

• Engage early, engage often with IRB/REB
  • Develop a relationship with the IRB/REB
• Point IRBs/REB to precedent (EULAs, published work, …)
• Warn in consent form about legal obligations wrt subpoenas
• Refer IRBs/REB to other IRBs/REBs with history of handling
• Reuse earlier documentation
• Use pilots and feasibility studies prior to large-scale studies
• Be patient (IRBs/REB learn over time)
• Err on side of complying with concerns
• Consider tiered opt-in strategies

Some Points for Discussion with IRBs

• Precedent with other studies
• Public nature of much visible information
• Capacity to opt out
• Commercial exploitation of such information

Support for ongoing and retroactive participant opt-out

• Opting out from a specific data source
• Pausing data collection
• Dropping out of study
• Option to deleting the data anytime after the study: (Data ownership: Data is generated by participants and owned by them, and they should always have a way to access it, and delete it if needed.)

Data Escrow-Based Studies: Addressing Concerns via Contingent Use

• Some potential participants
• May be uncomfortable with providing sensor and self-reported data in general
• May be comfortable with data being used in urgent contexts
• One option is to guarantee participants that
• Data will not be examined except in stated contingencies
• Data that is not analyzed will be deleted after a specified period of time