Ariz. Doctor Banned From Human Research

TUCSON, Ariz. – A cardiologist has been banned from conducting research on humans after federal regulators cited him for violating scientific and safety rules during a nationwide study of heart patients.

The University of Arizona issued the ban against Dr. Paul Fenster after he helped test an experimental pacemaker on patients with moderate to severe heart failure.

The Food and Drug Administration cited Fenster for nine violations, including failure to follow safety rules, failure to obtain informed consent from patients, and maintaining incomplete or accurate records.

In his response, Fenster said the violations involved only clerical mistakes and that the errors had “absolutely no impact on patient safety or well-being and did not compromise the scientific validity of the data.”

University officials said it remains unclear whether the violations caused harm because patients in the study were already extremely ill.

Problems with the research were uncovered last summer during a routine university audit. The school then contacted the FDA, said George Humphrey, spokesman for the Arizona Health Sciences Center.

The FDA is reviewing the case before deciding on any final action against Fenster.