Six essential conditions for achieving free and informed consent
According to Sonya Audy (2005), six conditions must be met before obtaining the free and informed consent of clinical trail participants.
1. The potential participant must possess all information that is relevant to his decision-making process.
2. The potential participant must fully understand the information provided.
3. Consent must be voluntary.
4. The potential participant must be capable of understanding and making decisions.
5. The potential participant must be given sufficient time to consider his decision.
6. The potential participant's ongoing freedom must be guaranteed.
Interview with Jean-Pierre Bélisle on the subject of clinical trials
What does someone who is asked to participate in a clinical trial need to know before signing on?
This is not a decision to be taken lightly, but only after a period of reflection. The person needs to take his time and also take the time to consult someone else in order to better understand all of the issues.
He should receive a copy of all the documents, including the consent form, before signing and have the opportunity to consult someone with the documents in hand.