Question

Which of the following statements about the informed consent form is true according to ISO 14155:2011?

a) It must be written in the local language only
b) It should include only essential information
c) It must be signed by the investigator only
d) It should be easily understandable to the subject

Answer 1

According to ISO 14155:2011, the informed consent form should include only essential information and should be easily understandable to the subject. It should be signed by both the investigator and the subject and outline all the risks and benefits clearly.

Step-by-step explanation:

According to ISO 14155:2011, the informed consent form should include only essential information, not just the local language. It is important for the form to be easily understandable to the subject. The form should be signed by both the investigator and the subject. It should outline all the risks and benefits clearly and provide relevant information about the study so that the subject can give appropriate consent.