Resumen |
"Informed Consent is the decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation."
The Informed consent form must contain adequate information to meet the necessary requirements. In some cases, an information sheet should be attached. A copy of the informed consent form/information sheet must be sent along with the project proposal for the purposes of the scientific evaluation procedure. |