Clinical Development

Informed Consent(ICF)

The process by which a research participant learns about and agrees to participate in a clinical trial after understanding the risks, benefits, and alternatives.

Usage Examples

All subjects provided written informed consent before enrollment.
The ICF was updated to include newly identified risks.
Translation of informed consent documents is required for non-English speakers.

What is ICF?

Informed consent is an ongoing process of communication between researcher and participant, documented through the Informed Consent Form (ICF). It ensures participants understand what the study involves before agreeing to participate.

Required elements include: purpose of research, expected duration, procedures, risks, benefits, alternatives, confidentiality protections, compensation/treatment for injury, contacts for questions, and statement of voluntary participation.

Consent must be obtained before any study procedures and may need updates if significant new information emerges. Special protections apply for vulnerable populations including children, prisoners, and cognitively impaired individuals.

Regulatory Context

This term appears most often in clinical development workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 50, 45 CFR 46, ICH E6.

FDAEMAPMDA

When This Matters

All subjects provided written informed consent before enrollment.
The ICF was updated to include newly identified risks.
Translation of informed consent documents is required for non-English speakers.

Common Mistakes

Applying one-region clinical assumptions to global submission strategies.
Missing protocol-to-regulation traceability for pivotal studies.
Underestimating how regional guidance updates impact trial documentation.

Related Regulations

21 CFR 5045 CFR 46ICH E6

Frequently Asked Questions

Yes, FDA and IRBs permit electronic consent (eConsent) when done properly with appropriate security measures and ensuring participant comprehension.

Assent is agreement from a child (typically 7+ years) to participate in research. It's obtained in addition to parental/guardian consent for pediatric studies.