“ EVERY INDIVIDUAL HAS THE RIGHT TO KNOW WHAT RISKS ARE INVOLVED IN UNDERGOING OR FOREGONIG MEDICAL TREATMENT (research) AND CONCOMMITTANT RIGHT TO MAKE MEANINGFUL DECISIONS BASES ON A FULL UNDERSTANDING OF THOSE RISKS ….. JUDICIAL ATTEMPT TO REDRESS THE INEQUALITIES OF DOCTOR-PATIENT RELATIONSHIP.”
" Disclosure " refers to the provision of relevant information by the clinician (researcher) and its comprehension by the patient (participant).
" Capacity " refers to the patient's/participant’s ability to understand the relevant information and to appreciate those consequences of his or her decision that might reasonably be foreseen.
" Voluntariness " refers to the patient's right to come to a decision freely, without force, coercion or manipulation.
Normally, should be provided by participants themselves.
• Deferred consent is where the subject is entered into a research study and consent is gained from surrogates after a specified period of time for continuation of the subject’s inclusion in the trial.
• Prospective informed consent represents an attempt to canvass support in advance from a population considered at risk of developing a serious illness.
• Surrogate consent (SDM): ideally a substituted judgment made by a person responsible for health care decision-making for a particular patient under the relevant legislation
Ghaiath Research Ethics, Dec. 08.
Practical challenges to a "Fully Informed Consent"
Complexity of medical information
Linguistic and cultural differences
Overworked health personnel
Paternalistic approach in doctor-patient (researcher-participant) relationship in developing countries.