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# ‘Objectionable Conditions’ in Med School Pediatric Trials
- URL: https://www.fdaweb.com/objectionable-conditions-in-med-school-pediatric-trials/
- Published: 2023-03-29T12:00:00.000Z
- Updated: 2026-09-14T18:22:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154089

A 6/23/22-7/8/22 FDA inspection of two pediatric clinical trials conducted by Dr. **Robert Hayashi** at the Washington University School of Medicine in St. Louis, MO, found objectionable conditions that indicated Hayashi did not adhere to the applicable legal requirements and regulations governing the conduct of clinical investigations and the protection of human subjects. A 3/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/robert-j-hayashi-mdwashington-university-school-medicine-department-pediatrics-654873-03142023?ref=fdaweb.com) emphasized that Hayashi failed to ensure that the investigation was conducted according to the investigational plan.

The letter says Hayashi acknowledged the findings and took complete responsibility for them. FDA acknowledges the corrective and preventive actions the site has taken and plans to take. “However,” it says, “given the significance of the protocol deviations involving pediatric subjects, we request documentation following up on some of the trainings listed in your Corrective and Preventive Action Plan.”

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