Duly accomplished Informed Consent Document Review form
Procedures primarily intended for research are stated
Appropriate procedure for obtaining informed consent
There is adequate provision for the protection of vulnerable participants
Names and contact details of the investigators are found in the ICF
Explicit statement regarding privacy and confidentiality
Information contained should be comprehensive and relevant
Consistency in the information provided in the protocol or research proposal with those in the ICF
Study-related risks are mentioned in the ICF
Language in the ICF is understandable
ICF is translated into the local dialect
Consent form is appropriate for the type of study participants
Provisions for medical/psychosocial support when needed
Provisions for treatment of study-related injuries
Provisions for compensation