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# Issues in MIT Institutional Review Board
- URL: https://www.fdaweb.com/issues-in-mit-institutional-review-board/
- Published: 2024-07-16T12:00:00.000Z
- Updated: 2026-09-14T14:35:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157362

CBER says a Bioresearch Monitoring Program remote regulatory assessment of the Massachusetts Institute of Technology Committee on the Use of Humans as Experimental Subjects institutional review board (IRB) conducted between 5/30 and 6/9/2023 found “objectionable conditions” that were repeated observations from previous reviews. A just-released 6/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/massachusetts-institute-technology-mit-663218-06212024?ref=fdaweb.com) says specific violations were:

- failure to ensure that information given to subjects as part of informed consent follows regulations; and
- failure to prepare and maintain adequate documentation of IRB activities.

The letter says that since the observations were repeated from previous reviews, the IRB’s corrective actions were not adequate. The IRB was told to respond with written documentation of additional actions it has taken or will take to correct the violations and prevent their recurrence. “You should investigate and determine the causes of any violations and take prompt actions to correct the violations to prevent the recurrence of similar violations in current and future studies that your IRB oversees,” FDA writes.