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 not an adverse event.

Explanation: The situation mentioned in the question is regarding the lost record of the last three studies that is blood study, history of infectious disease and stress of job. Therefore, important data is lost in this case.

IRB is giving the order of changing the protocol and sending the record electronically because they work for welfare and protecting the rights and information that collected in a research study .By sending data through secure network , losing information case cannot happen and it can remain secure.

They gave this order because the case is an unexpected issue that can result in the harmful effect..Other options are incorrect because  the problem is not expected so it cannot be anticipated and it can possibly have severe effects.Thus,the correct option is option(c).