Question

Housekeeping employees of the medical center were recruited for a federally funded study of blood pressure, blood count levels, infectious disease history, and job stress. The interviews and blood tests were conducted in a private location not affiliated with the study center. Follow-up interviews were conducted in the same location. The study coordinator stopped at the cafeteria on her way back to the study office after the second study visit for the last three study subjects and lost the three file folders. Records of one subject indicated he had a history of a sexually transmitted disease and another had recently been treated for tuberculosis. The subjects were notified of the loss. Following this event, the IRB approved a protocol change requiring that all records be transmitted electronically to the study office using the medical center’s secure network.

Answer 1

Answer:  The correct answer is; This was an unanticipated problem and not an adverse event of the study. The people who were recruited did not think that their files would be misplaced or lost. The study coordinator should have never taken the files out of the office and had them out to leave them. The IRB was correct by implementing and only transmitting the files electronically on a secure network for all future studies. This was a violation of the participant's HIPPA rights.

Explanation: