Drug Evaluation Committee 2017-28 Obtaining Consent Outside the Investigator Site
Related classification: Obtaining consent
Date of first publication: October 2017
Question
This question is about obtaining consent from a surrogate consentor for a clinical trial involving unconscious patients.
A proxy proposes (consultation) that it is difficult for the patient to visit the Investigator Site, but he/she is willing to give consent if the investigator can explain the clinical trial at home, depending on the content of the explanation. Is it acceptable for the investigator to visit the patient's home to explain the clinical trial and obtain consent from the surrogate?
Also, if the consent would be too coercive at home, would it be possible to obtain consent if the explanation is given in an environment where information is not leaked outside of the home (e.g., in a meeting room)? I know this is a rare case, but I would appreciate it if you could enlighten me.
JPMA's Opinion
The GCP does not indicate where to obtain explanations or consent for participation in a clinical trial. However, GCP Article 52, Paragraph 2, Guidance 1 states, "The investigator, subinvestigator, and collaborator shall not coerce or exert undue influence on a potential subject or a potential surrogate with respect to participation or continued participation in the clinical trial. This is a very important point to keep in mind.
Since this question refers to the location of the explanation requested by the surrogate, we think there is no problem with the investigator or subinvestigator going to that location to explain the trial and obtain consent, even if it is not at the Investigator Site.