What is an ICF?
ICF - Informed Consent Form
An ICF is a document that provides clear, detailed information about the clinical trial to potential participants.
It allows them to make a voluntary and informed decision about whether they wish to participate.
Key Contents of an ICF:
Purpose of the clinical trial
Description of the study (drug/device/intervention, Procedures involved and duration of participation)
Potential risks and discomforts
Possible benefits (it any)
Alternative treatments available
Confidentiality of participant data
Right to withdraw at any time without penalty
Contact information for queries and emergencies
Patient Information Sheet (PIS):
The PIS is often attached to the ICF and explains trial details in simpler, more patient-friendly language to help participants better understand the study.
- ICF and PIS should be provided to both participants in clinical trials and patients in clinics. While some clinics already do this, it is essential that all clinics adopt this practice.