Step 1: What is Good Clinical Practice (GCP)?
GCP is an international ethical and scientific standard for designing, conducting, and reporting clinical trials. It protects the rights, safety, and wellbeing of trial participants.
Step 2: What does informed consent mean under GCP?
Informed consent is the process by which a person voluntarily agrees to participate in a trial after being fully explained its purpose, risks, benefits, and alternatives. GCP requires this consent to be documented in writing.
Step 3: Evaluate the wrong options.
Option 1 is wrong because consent must be obtained BEFORE participation, not after. Option 3 is wrong because consent is required in ALL phases, not just Phase III. Option 4 is wrong because a researcher can never waive consent based on personal opinion about safety.
Step 4: Confirm the correct answer.
Under ICH-GCP guidelines, informed consent must be written, freely given (voluntary), and obtained from the participant BEFORE they join any trial procedure. This applies universally across all phases and settings.
Step 5: Key memory point.
Think of the three W's: Written, Willing (voluntary), and Before the trial. All three must be present.
Answer: Option (2) — Written, voluntary and obtained before trial participation