Event Time: Aug 10th 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
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