# FDA WARNING_LETTER - Essex Institutional Review Board, Inc - March 21, 2011

Source: https://www.globalkeysolutions.net/records/warning_letter/essex-institutional-review-board-inc/615b5298-e4c2-46ee-8a93-3028ea778c80

> FDA WARNING_LETTER for Essex Institutional Review Board, Inc on March 21, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Essex Institutional Review Board, Inc
- Inspection Date: 2011-03-21
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspected Essex Institutional Review Board (IRB), Inc. from March 14-21, 2011, to assess compliance with human subject protection regulations (21 CFR parts 50 and 56). The inspection was prompted by a fictitious research submission.

The FDA identified several violations:
1.  **Failure to minimize risks (21 CFR 56.111(a)(1)):** The IRB approved a protocol for a drug with known cardiovascular risks without documenting consideration of these risks in meeting minutes or including them in the informed consent form. The IRB also incorrectly classified two studies involving investigational articles as "minimal risk," failing to apply the regulatory definition (21 CFR 56.102(i)) correctly.
2.  **Failure to ascertain research acceptability (21 CFR 56.107(a)):** The IRB did not adequately verify the qualifications of a clinical investigator, specifically failing to check the validity of a medical license.
3.  **Failure to comply with safeguards for children (21 CFR 56.109(h) and 21 CFR Part 50, Subpart D):** For a pediatric study, the IRB failed to document whether the research met the criteria of 21 CFR 50.51, 50.52, or 50.53. Inaccurate regulatory references were also noted

## Related Officers

- [Leslie K. Ball](https://www.globalkeysolutions.net/people/leslie-k-ball/8306ea83-6a4c-4f2f-9527-9d22e58b5378)

Company: https://www.globalkeysolutions.net/companies/essex-institutional-review-board-inc/a09e4ad7-9e8a-4f93-9688-db45f75b4856

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c