Screen whether a study is described as federally regulated research
Key facts
- Human involvement
- YellowClose supervision
- How AI is used
- From the protocol, list whether it says the research involves human subjects and whether it says a federal department conducts, supports, or regulates it. Do not say an ethics review is required and do not draft the submission.
- What the lawyer must review
- You decide what review is required. Section 46.101(a), except as detailed in § 46.104, applies the policy to human-subjects research conducted, supported, or otherwise subject to regulation by a federal department or agency that makes the policy applicable. Institutions engaged in that research, and institutional review boards reviewing research subject to the policy, must comply with it. Section 46.104 was not opened, so do not list exemptions. Do not recite review criteria. None were opened. Formal Opinion 512 applies to the protocol. You write any submission.
- Written for / version
- United States versionUS
Who does what
| Role | What they do |
|---|---|
| Assistance | Potential support includes organising research leads and preparing preliminary structure or wording. Confirm the tool’s capability and permitted scope. |
| Lawyer | Set the scope, supervise the work closely, verify every part relied on, resolve omissions and exceptions, and approve the exact output. |
Checklist
- Verify the applicable jurisdiction and the version of each relevant law, rule or instrument in force at the material time.
- Confirm the output against the client’s instructions and the complete relevant source material, including omissions or contradictions.
- Resolve exceptions and record the responsible lawyer’s approval of the exact output and intended use.