Informed consent is as an expression of the individual’s right to self-determination and it plays a key role in the context of clinical trials.
Generally, the duty to obtain patient’s consent for the submission to the experimental protocol belongs to the medical staff of the health facility where the patient is being treated. However, the Sponsor often enters in the trial management, and it could be liable for absent, incomplete or inadequate information.
Given that, when is the Sponsor liable for violation of the patient’s right to self-determination?
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