Ethics

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BioethicsWatch

Do We Have a Problem Here? Federal oversight agencies regularly complain about objectionable conduct in human research. These are some favorite extracts from warning letters issued by the US Food and Drug Administration.

Scientific Misconduct

There were no source documents regarding drug disposition for subject 1156 [redacted]. In addition, it is obvious that any drug accountability records for the four subjects who were fabricated are false.

The signed consent forms for subjects 1157 [redacted] 1159 [redacted] and 1337 [redacted] were not the latest version approved by the IRB. It is obvious that valid informed consent to participate could not have been obtained from subjects 1014 [redacted] 1101 [redacted] 1154 [redacted] and 1158 [redacted] whose signatures were forged on informed consent documents.

Read more FDA warning letters issued to clinical investigators

Imbecility

The practice of recording data for study subjects prior to their actual study visits is unacceptable.

Browse the collection of documents from human subject research released under FOIA

Indifference

During the inspection, records for the study [redacted] were examined. This study had been ongoing for 24 years, having been approved in 1974 and closed in 1999. There was no evidence that the COMIRB ever re-evaluated this study to ensure consideration of current technology or changes in the COMIRB procedures for approval or review.

Indifference and Ineptitude

During the inspection conducted in 1997, the continuing review of studies was found to be severely inadequate with approximately 758 studies overdue for continuing review …

Employees have not been fully trained in the use of the database. Employees were not able to sort or print certain databases and did not know what all the database fields were even though they were responsible for entering data into those fields. It was necessary to utilize a former employee to obtain printouts of open and closed studies.

Read more FDA warning letters issued to Institutional Review Boards


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