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# No Informed Consent in 2 Clinical Investigations: FDA
- URL: https://www.fdaweb.com/no-informed-consent-in-2-clinical-investigations-fda/
- Published: 2026-02-10T12:00:00.000Z
- Updated: 2026-09-14T13:33:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160639

An FDA Bioresearch Monitoring Program 10/23-11/8/2024 inspection of two clinical investigations conducted by **Mark Dacey** in Denver, CO, found that Dacey failed to obtain informed consent for the investigations. A 2/2 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mark-s-dacey-md-722942-02022026?ref=fdaweb.com) acknowledges the corrective and preventive actions the site has taken and plans to take, but says Dacey’s response is inadequate because he did not provide sufficient details about how he, as the clinical investigator, would ensure adequate oversight of study procedures.

Dacey was told to respond with a list of specific actions he has taken to prevent similar violations in the future.