Informed consent and good clinical practice go hand in hand. GCP Clinical Research is a set standard that includes informed consent, as the function of GCP is to protect the participants. Informed consent consists of the 20 ICH-required elements.
Informed consent is a legal document that entails all the information regarding the clinical trial. It involves educating the participants about the risks and benefits of the trial. Informed consent helps the individual to make an informed decision by providing them with all the necessary information regarding the trial to protect them from any harm, as per the GCP Good Clinical Practice guidelines.
A person who willingly consents to participate in a GCP Clinical Research study after being fully educated about it verbally with study staff and after receiving written, signed, and dated documentation is considered to have provided their informed agreement. Throughout the study, a participant’s consent will be repeatedly requested. They will also be informed of any modifications to the study and any other relevant details that might affect their decision to continue participating.
