Professional Documents
Culture Documents
Patient Information and Informed Consent Process
Patient Information and Informed Consent Process
participation,
No.of patients to be enrolled
procedures to be followed,
Information exchange
Investigator/IRB approved
designee explains the
study,purpose,procedure, risks and
benefits,alternatives.
Investigator
Witness
with date
UNDERSTANDING
Patients comprehension depends
on the intelligence
APPROACHES TO ENSURE
UNDERSTANDING
Individualised approach
Audiovisual aids
UNDERSTANDING
Giving appropriate time
Questionnaires
VOLUNTARINESS
Not coerced or unduly influenced
Interferences?
Social
Economical influences
FORMAL CONSENT: THE
SIGNATURE
INVESTIGATOR ,date
FORMAL CONSENT: THE
SIGNATURE
UNCONCIOUS PATIENTS