Regulatory & Compliance
IC
Informed Consent
A participant's voluntary agreement to join a study after understanding its risks and procedures.
Informed consent is the ethical and legal process by which research participants are provided with comprehensive information about a clinical study — including purpose, procedures, potential risks, benefits, alternatives, and their right to withdraw at any time — before voluntarily agreeing to participate. The consent process is overseen by Institutional Review Boards (IRBs) or Ethics Committees. In supplement research, informed consent documents must clearly state that the supplement is investigational, disclose known side effects, and explain data handling procedures. Valid informed consent is a fundamental requirement for ethical human research.