# Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/research-involving-children-as-subjects-and-not-otherwise-approvable-by-an-institutional-review-board-process-for-referrals-to-food-and-drug-administration-and-office-for-human-research-protections-draft-guidance-for-institutional-review-boards-investigators-and-sponsors/26eaec4e-0434-4c59-a182-47818d614186

> FDA guidance document: Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors. Issue date: March 30, 2023. Get complete insights and analysis.

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## Details

- Title: Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2023-03-30
- Comment Close Date: 2023-05-30
- Last Changed: 2024-04-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-0142">FDA-2022-D-0142</a>

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