Informed Consent (IC)
ICA process by which a potential clinical trial participant voluntarily confirms their willingness to participate after being fully informed about the study's purpose, procedures, risks, benefits, alternatives, and rights to withdraw. Informed consent is an ethical and legal requirement derived from the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The consent document must be written in lay language and approved by the institutional review board (IRB).
Ejemplos
- Phase I oncology trials: detailed explanation of dose-escalation risks, including unknown toxicities
- Pediatric assent: simplified consent process for children aged 7-17 alongside parental permission
- Emergency exception from informed consent (EFIC) for acute stroke or cardiac arrest trials
¿Sabías que...?
A process by which a potential clinical trial participant voluntarily confirms their willingness to participate after being fully informed about the study's purpose, procedures, risks, benefits, alternatives, and rights to …