Informed consent
In Running the trial
Informed consent is the process by which a person voluntarily agrees to take part in a trial after being given, and understanding, the information they need to decide. It is a conversation and a decision, not just a signature on a form. Consent must be obtained before any study-specific procedure, and it continues throughout the trial.
Why it matters
It is the practical expression of respect for persons — the single most fundamental protection in human research, and the most closely inspected process at any site.
Example
A coordinator gives the participant the information sheet, allows time to read it and ask questions, checks understanding, and only then has the participant and the delegated staff member sign and date the form personally.
Common questions
- Can a participant withdraw consent after signing?
- Yes. A participant may withdraw at any time, for any reason or none, without their care being affected. Data already collected up to that point is normally kept, and the consent form explains this in advance.
- Who is allowed to take informed consent?
- Only staff qualified and specifically delegated for it by the principal investigator, and in many regions the discussion must involve a suitably qualified clinician. The delegation log must show the authority was in place on the date consent was taken.
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