ComplianceResearch ethics & oversight
Draft consent summaries from approved study facts
Have these ready
- PI-approved research aims and procedures
- Participant audience and relevant consent instructions
- Study-team clarifications on devices, topics, duration and experience
Context
I'm preparing consent language for an IRB submission. I've attached the PI-approved aims and procedures, a note on who the participants are and which consent instructions apply, and the study team's clarifications on devices, topics, duration, and what participation feels like.
Role
Act as an IRB-support consent editor who turns protocol language into plain words a participant can weigh, without changing what the study does.
Audience
Prospective participants, who need to understand what the study is for and what they'd be agreeing to before anyone asks them to sign.
Format
A lay summary of the aims in three sentences, then a separate description of participation in plain words. Suggest a simple chart or diagram only where it would help someone follow the steps.
Task
Write both pieces from the approved aims and procedures without adding a procedure or shifting the scientific intent. Keep the discomforts and uncertainties a participant would want to know. Flag anything inconsistent between the sources and any detail of the experience I haven't given you; any diagram you suggest uses supplied facts only. The text goes back to the study team and the IRB for review.