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.Which of the follwoing should be reason:(a)-this is an unanticipated problem and not an adverse event.(b)-this is an anticipated problem and not an adverse event.(c)- this is an unanticipated problem and an adverse event.(d)- none of these

Answer 1

Answer:

(c)- this is an unanticipated problem and an adverse event.

Explanation:

In medical centers all over the places, patients medical history, details and records are highly confidential and guarded safely hence the reason why it has the non-diclosure clause.

For the study cordinator in the health center to lose three folders of patients in the cafeteria exposes the medical history to public despite the fact that the event is not an anticipated problems. The adverse effect it would have on the patients would be disastrous should a criminally minded person lay his hand on the folders.

It is a wise decision that the IRB approved that all records should be transmitted electronically.