# FDA WARNING_LETTER - Massachusetts Institute of Technology MIT - June 09, 2023

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> FDA WARNING_LETTER for Massachusetts Institute of Technology MIT on June 09, 2023. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Massachusetts Institute of Technology MIT
- Inspection Date: 2023-06-09
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: This Warning Letter details objectionable conditions observed during an FDA Remote Regulatory Assessment (RRA) of the Massachusetts Institute of Technology (MIT) Committee on the Use of Humans as Experimental Subjects (COUHES) Institutional Review Board (IRB) from May 30 to June 9, 2023. The RRA assessed compliance with 21 CFR Parts 50, 56, and 812.

The FDA identified violations of 21 CFR Part 56, including:

1.  **Failure to ensure informed consent information is in accordance with 21 CFR 50.25 [21 CFR § 56.109(b)]**:
    *   IRB-approved informed consent forms (ICFs) for Protocols #211100051 and #2211000807 lacked disclosure of appropriate alternative procedures or treatments (21 CFR 50.25(a)(4)). The IRB's response was inadequate as it didn't describe the standard of care to be added.
    *   The ICF for Protocol #2201000535 (more than minimal risk) did not explain compensation for injury or where to obtain information (21 CFR 50.25(a)(6)). The IRB's justification regarding collaborative research was inadequate, lacking documentation of IRB responsibilities.

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