# FDA 483 - Rush University Medical Center IRB - December 21, 2005

Source: https://www.globalkeysolutions.net/records/483/rush-university-medical-center-irb/1bbc2de8-128b-4863-a723-1e386e4c393e

> FDA 483 for Rush University Medical Center IRB on December 21, 2005. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rush University Medical Center IRB
- Inspection Date: 2005-12-21
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Rush University Medical Center IRB in Chicago revealed several deficiencies in its oversight of human subject research. The IRB failed to follow its own written procedures for continuing review, maintained inadequate meeting minutes, and approved research without ensuring proper informed consent. These findings indicate a need for improved controls in protecting human subjects.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/lisa-hayka/a8ca35f8-88e2-4dfb-9881-82f0ac7db8bf)

Company: https://www.globalkeysolutions.net/companies/rush-university-medical-center-irb/b9bb7c92-cb60-474d-822d-9eedaef36d40

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