---
title: "Screen whether a study is described as federally regulated research"
url: "https://ailawframework.com/practice/health-and-medical-law/prepare-the-ethics-review-submission-for-a-human-research-project/united-states"
type: "task_jurisdiction_version"
site: "AI Law Framework"
id: "A32-R20261018-5-US"
practice_area: "Health & Medical Law"
tier: "yellow"
lawyer_review: "required"
jurisdictions: ["US"]
last_reviewed: "2026-10-22"
---

# Screen whether a study is described as federally regulated research

> From the protocol, list whether it says the research involves human subjects and whether it says a federal department conducts, supports, or regulates it.…

Canonical page: https://ailawframework.com/practice/health-and-medical-law/prepare-the-ethics-review-submission-for-a-human-research-project/united-states  
Last reviewed: 2026-10-22

Site index for agents: https://ailawframework.com/llms.txt

## Key facts

| Fact | Value |
| --- | --- |
| Practice area | [Health & Medical Law](https://ailawframework.com/practice/health-and-medical-law.md) |
| Human involvement | Yellow: Lawyer and AI draft together |
| 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 | United States |
| Applies to | [Prepare the ethics review submission for a human research project](https://ailawframework.com/practice/health-and-medical-law/prepare-the-ethics-review-submission-for-a-human-research-project.md) |

## Checking plan

- What the AI does: 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.
- Basis: Checked against the linked sources on 22 October 2026. Confirm the current instrument before reliance.

## Notes

- A study that is not federally conducted, supported, or regulated is not, on this section alone, inside the policy.
- Do not invent consent elements. They were not opened.

## Sources

- [45 CFR § 46.101 (to what the human-subjects policy applies)](https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.101) (checked 2026-10-22)
- [ABA Formal Opinion 512, Generative Artificial Intelligence Tools (29 July 2024)](https://www.americanbar.org/content/dam/aba/administrative/professional_responsibility/ethics-opinions/aba-formal-opinion-512.pdf) (checked 2026-10-22)
- [ABA Model Rule 1.1, Comment 8 (competence includes technology)](https://www.americanbar.org/groups/professional_responsibility/publications/model_rules_of_professional_conduct/rule_1_1_competence/comment_on_rule_1_1/) (checked 2026-10-22)

## Forms and precedents for this task

| Form or precedent | Kind | AI level | Summary |
| --- | --- | --- | --- |
| [Human research ethics submission readiness checklist](https://ailawframework.com/precedents/health-and-medical-law/human-research-ethics-readiness.md) | Checklist | Yellow | Readiness checklist for a human research ethics submission, limited to what the NHMRC publication page says about the 2025 National Statement. It is not the submission. |

Signed-in accounts can read the full text of each one.

*Practice guidance for planning and review. Confirm current primary sources and the requirements of the actual matter. This is general information, not legal advice.*