Informed Consent Form
Also written as: ICF — Informed Consent Form
A regulatory and ethical document signed by research participants that confirms they have been given, understood, and agreed to information about a study before enrolment.
Full Definition
The informed consent form (ICF) is a mandatory document in all human dental research, fulfilling requirements set by the Declaration of Helsinki, national ethics regulations, and institutional review boards (IRBs) or ethics committees. In research manuscripts, editors should verify that a statement confirming ethics committee approval and written informed consent appears in the methods section. The term 'informed consent' may also refer to the process, not merely the document; editors should distinguish between 'informed consent was obtained' (process) and 'a completed informed consent form was signed' (document). In dental research involving children, ICFs typically require both parental/guardian consent and child assent documentation.
Usage
Usage note: Confirm that the manuscript includes both ethics approval and informed consent statements. Note that 'assent' (from minors) is distinct from 'consent' (from adults or guardians); both may be required in paediatric dental studies.
In Context
- "Written informed consent was obtained from all participants prior to enrolment, using an ICF approved by the institutional ethics committee." — Ethics statement in a dental clinical study
- "The manuscript states only that 'consent was obtained'; for completeness, add whether a written ICF was used and cite the approving ethics body." — Peer-review editorial suggestion