Prepare the ethics review submission for a human research project
Key facts
- Human involvement
- YellowClose supervision
- How AI is used
- From the protocol, participant information and consent forms, recruitment material and data management plan, map each document against the National Statement chapters relevant to the project’s risk level and participants, and list gaps (consent pathway, data sharing, vulnerable participants, return of results).
- What the lawyer must review
- The lawyer or research governance adviser decides the risk level and review pathway, settles the participant information and consent wording, confirms data and privacy arrangements, and checks that the submission is complete for the reviewing committee.
- Written for / version
- US
Open a jurisdiction version of this task to see which instruments apply: US
Who does what
| Role | What they do |
|---|---|
| Assistance | From the protocol, participant information and consent forms, recruitment material and data management plan, map each document against the National Statement chapters relevant to the project’s risk level and participants, and list gaps (consent pathway, data sharing, vulnerable participants, return of results). |
| Lawyer | Set the scope, supervise the work closely, verify every part relied on, resolve omissions and exceptions, and approve the exact output. |
Checklist
- Confirm patient health information goes only into a tool the practice has approved for health records, de-identified where the task allows, and that the output discloses no patient detail beyond what the recipient needs.
- Confirm which edition of the National Statement the reviewing committee applies.
- Check the consent pathway against the participant groups, including any vulnerable participants.
- Check data sharing and privacy statements against the data management plan.
Forms and precedents for this task
| Form or precedent | Kind | AI use | Summary |
|---|---|---|---|
| Human research ethics submission readiness checklist | Checklist | AI use Yellow | Readiness checklist for a human research ethics submission, limited to what the NHMRC publication page says about the 2025 National Statement. |
Signed-in accounts can read the full text of each one. All precedents.
Sources
These are suggested working checks. Confirm the required checking with the responsible lawyer before work starts; the checking approach does not establish permission to use AI.