Question

Principal investigators are encouraged, but not required, to conduct research in compliance with the study protocol. Occasionally, they may deviate from the protocol as needed for certain participants.

A) Principal investigators must strictly adhere to the study protocol.
B) Principal investigators are prohibited from deviating from the protocol.
C) Principal investigators may choose to follow or not follow the study protocol.
D) Principal investigators are obligated to deviate from the protocol for all participants.

Answer 1

Principal investigators may need to follow IRB-approved research protocols, but they can deviate for participant safety or unforeseen circumstances with proper oversight and ethical consideration. Option number C is correct.

Step-by-step explanation:

Principal investigators in research studies have an ethical and sometimes legal obligation to follow the study protocol as approved by Institutional Review Boards (IRBs). However, there may be instances where they can deviate from it. Research ethics, consent, and participant safety are paramount. If a protocol deviation is necessary, it must be done with careful consideration and IRB approval, with transparency to participants.

Deviations might occur for participants' safety or based on specific circumstances that were not foreseen in the initial protocol. Consistency with the ethical framework and federal regulations overseen by the U.S. Department of Health and Human Services is crucial.