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Informed consent is mandatory for all clinical trials involving human beings. The consent process must respect the patient's ability to make decisions and adhere the individual hospital rules for clinical studies.
You have a legal informed consent if you have described to your patient the procedure you are going to do in detail. True:informed consent means a decision made by or for a patient after being informed about the proposed procedures, risks, benefits, and alternatives to the proposed treatment.
Informed consent may not be necessary when: an emergency situation exists in which the patient cannot give consent but will be harmed without the procedure.
Informed Consent Checklist (1998).
A statement that the study involves research..
An explanation of the purposes of the research..
The expected duration of the subject's participation..
A description of the procedures to be followed..
Identification of any procedures which are experimental..