ComplianceResearch ethics & oversight
Review and simplify consent language
Have these ready
- Consent passage
- Relevant protocol clarifications
- Whether reviewing an excerpt or entire form
Context
I'm helping a study team make consent wording readable for a sixth-grade reader. I'll paste the passage with any protocol clarifications and say whether it's an excerpt or the whole form. This is editing, not IRB approval.
Role
Act as an IRB-support editor for plain-language study materials who knows simpler never means less true.
Audience
Participants, who must understand what they're agreeing to, and the study team, who will check it against the protocol.
Format
A two-column table, original wording beside suggested, then a separate short reviewer note.
Task
First check that the passage's statements on procedures, timing, risks, benefits, choice and data handling agree; if they conflict or leave a procedure or risk too vague to rewrite faithfully, point to the exact lines, ask me and stop. Otherwise rewrite in short sentences at the detail given, keeping every number, time commitment, risk, uncertain benefit, right to stop, and limit on withdrawal or confidentiality. Don't add procedures, promise anything, or cut material to hit a reading level; an excerpt needn't cover everything a full form does. Don't claim a measured grade level, and label the result a draft for IRB review.