# FDA 483 - Copley Memorial Hospital IRB - February 10, 2020

Source: https://www.keypedia.com/records/483/copley-memorial-hospital-irb/ff74c3e2-d709-4c0e-9343-14eaa2b98032

> FDA 483 for Copley Memorial Hospital IRB on February 10, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Copley Memorial Hospital IRB
- Inspection Date: 2020-02-10
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection conducted from February 4-10, 2020, at Copley Memorial Hospital IRB identified significant deficiencies in its operations. The Institutional Review Board frequently failed to conduct research reviews at properly convened meetings, instead utilizing electronic or email-based processes without live discussion or simultaneous voting, thereby not ensuring the required majority and nonscientific member presence. A critical issue was the absence of a comprehensive and maintained list of IRB members detailing their affiliations, making it impossible to verify quorum at past meetings.

Furthermore, meeting minutes were found to be inadequately detailed, lacking clear records of attendance, precise voting results, or summaries of discussions on contentious matters. The FDA also observed a conflict of interest where an IRB member participated in the initial review of a project. Procedurally, Copley Memorial Hospital IRB did not maintain all required written procedures, particularly for reporting unanticipated problems, noncompliance, or study suspensions, as mandated by 21 CFR 56.108(a) and (b). The IRB also failed to adhere to its own written procedures for closing studies, neglecting to verify closure letters or notify principal investigators. These observations necessitate prompt corrective actions to ensure full compliance with regulatory requirements for the protection of human subjects in research.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/jennifer-c-adams/85608566-bd13-41d8-b86e-cc9111c7dfe5)
- [issuing_officer](https://www.keypedia.com/people/shalonda-clifford/b6d67ba0-e40e-4347-9b58-a2bddc6983e3)

Company: https://www.keypedia.com/companies/copley-memorial-hospital-irb/feb23575-a643-449f-af2a-e675fb07a880

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669