# FDA 483 - Mass General Brigham Inc. IRB - May 23, 2017

Source: https://www.globalkeysolutions.net/records/483/mass-general-brigham-inc-irb/a50f07af-054d-49c5-baad-4b9f50992922

> FDA 483 for Mass General Brigham Inc. IRB on May 23, 2017. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mass General Brigham Inc. IRB
- Inspection Date: 2017-05-23
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Partners Human Research Committees in Somerville, MA, revealed a significant issue regarding informed consent. The Institutional Review Board (IRB) failed to ensure that all necessary elements of informed consent were included in information provided to subjects. Specifically, changes to an Informed Consent Form for a protocol were not properly incorporated, leading to subjects re-signing an incomplete form.

## Related Documents

- [483 - 2017-05-23](https://www.globalkeysolutions.net/records/483/mass-general-brigham-inc-irb/a74d922e-fa1e-4e5a-8832-92076a40a9a0)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.globalkeysolutions.net/companies/mass-general-brigham-inc-irb/612e0467-a5d1-45e6-8ff9-90e7807f2ae3

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7