Question

According to ICH E6, for a clinical trial in which there are no expected benefits to subjects (that is, a non-therapeutic trial), which of the following must apply in regards to informed consent for subjects unable to give their consent personally and must use a legally acceptable representative (LAR)?

1) The LAR must provide informed consent on behalf of the subject
2) The LAR must be a family member of the subject
3) The LAR must have a medical background
4) The LAR must be a legal guardian of the subject

Answer 1

In a non-therapeutic clinical trial, informed consent for subjects unable to give their consent personally must be provided by a legally acceptable representative (LAR), who must be the subject's legal guardian.

Step-by-step explanation:

According to ICH E6, in a non-therapeutic clinical trial where there are no expected benefits to subjects, informed consent for subjects unable to give their consent personally must be provided by a legally acceptable representative (LAR). The LAR does not have to be a family member or have a medical background, but they must be a legal guardian of the subject. This ensures that someone responsible for the subject's well-being and legal decisions is able to provide informed consent on their behalf.