Informed Consent
How can we meaningfully communicate and be transparent about research methods that involve deep, complex, often passive and continuous data collection, machine-learning analysis, and interpretation?
1. Have we appropriately adapted our informed consent procedures to our specific study population, including possible use of surrogate consent?
2. Will we provide background education on relevant technologies, such as explaining what social media companies may already be doing with the participant’s data?
3. Have we determined what a reasonable person would want to know, and explained in our IRB proposal the evidence on which we reached that determination?
Resources:
Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4344220/
Informed Consent Workshop – Informed consent: content, communications & emerging technologies
https://www.hhs.gov/ohrp/sites/default/files/informed-consent-agenda-as-of-3-9-18.pdf
Individual Autonomy
“Third-party directive” within the individual right of access vacated by a federal court
https://www.hhs.gov/hipaa/court-order-right-of-access/index.html