Good Clinical Practice (GCP) Practice Exam

Informed consent is a fundamental ethical and legal requirement in clinical research. It ensures that participants are fully aware of the study's purpose, procedures, risks, and benefits before agreeing to participate. Obtaining informed consent occurs before any study procedures are initiated, as this allows participants to make an informed choice about their involvement.

This process involves providing potential participants with comprehensive information about the trial, which they can review and ask questions about, ensuring they understand what participation entails. The emphasis is placed on respecting autonomy and protecting the rights of participants, making it crucial that consent is secured prior to any involvement in the study.

Obtaining consent after the trial has concluded or at any point post-participation would undermine the participant's ability to make an informed decision, violating ethical standards of conducting research. Similarly, waiting until the results are published would not allow individuals to understand and consider the implications of joining the study beforehand.