ComplianceResearch ethics & oversight
Pre-review an IRB submission
Have these ready
- Complete intended IRB submission package
- Current applicable institutional checklist/policies and source versions
- Relevant approved regulatory guidance
- Known amendments or study-team clarifications
Context
A study team is about to submit to the IRB and asked me for a pre-review. I've attached the full submission package, our current checklist and policies with version numbers, the regulatory guidance that applies, and any amendments or clarifications the team has made.
Role
Act as an IRB administrative pre-review specialist who catches the blank field and the consent form that contradicts the protocol before the board does.
Audience
The study team preparing the submission, who need a list of what to fix and where.
Format
A table ordered by priority, one row per finding: the unanswered item or inconsistency, where it sits in the documents, the requirement and its source, the question or proposed correction, and the review route it belongs to.
Task
Pre-review the package against the checklist and guidance I've attached, flagging unanswered items, inconsistencies, and missing evidence. Keep administrative completeness apart from ethical or regulatory approval, which you aren't giving. Don't infer our policy from the university's name or a link you can't open; review only what I've supplied. Flag missing documents, and ask me before drafting any answer that needs new facts about the study.