# Informed Consent:  Guidance for IRBs, Clinical Investigators, and Sponsors - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/informed-consent-guidance-for-irbs-clinical-investigators-and-sponsors/282489cf-c0a6-44c7-acff-58b3373fd179

> FDA guidance document: Informed Consent:  Guidance for IRBs, Clinical Investigators, and Sponsors. Issue date: August 15, 2023. Get complete insights and analysis.

---

## Details

- Title: Informed Consent:  Guidance for IRBs, Clinical 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: 2023-08-15
- Last Changed: 2024-04-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2006-D-0031">FDA-2006-D-0031</a>

## Related Documents

- [Considerations When Transferring Clinical Investigation Oversight to Another IRB:  Guidance for IRBs, Clinical Investigators, and Sponsors](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-when-transferring-clinical-investigation-oversight-to-another-irb-guidance-for-irbs-clinical-investigators-and-sponsors/fe8296e5-3ca7-4209-9920-27aa4635ee35)
- [Principles of Premarket Pathways for Combination Products:  Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/principles-of-premarket-pathways-for-combination-products-guidance-for-industry-and-fda-staff/fef66533-8c76-453a-898c-236775eb59fe)
- [Postmarketing Safety Reporting for Combination Products:  Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/postmarketing-safety-reporting-for-combination-products-guidance-for-industry-and-fda-staff/a8271d36-1dc5-4263-81ed-b9326b983403)