Question Detail

MIC 121 LaboratorySafety andEthicsin Microbiology Objective Question

Question

What is required for the 'Documentation' aspect of informed consent?
Options
A Oral consent is sufficient for minor studies.
B Consent must be reviewed by the participant only.
C Consent must be recorded in writing and archived, and reviewed by a research ethics committee.
Correct Answer
D Consent is only needed for studies with significant risks.
Correct Answer

Option C is the correct answer.

Detailed Explanation

The 'Documentation' principle states: 'Consent must be recorded in writing and archived. A research ethics committee (IRB/REC) must review and approve all human subjects research before it begins.'

Hint

Recall the formal requirements for recording and approving informed consent.

Question Info