Drug Evaluation Committee 2017-28 Obtaining Consent Outside the Performing Medical Institution
Related classification: Obtaining consent
Date of first publication: October 2017
Question
This question is about obtaining consent from a surrogate in a clinical trial for patients who are not conscious.
A surrogate consents to a clinical trial for patients who are not conscious, but is unable to come to the site. 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 the home (e.g., in a conference room)? I know this is a rare case, but I would appreciate it if you could enlighten me.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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 your question refers to the place requested by the surrogate, we think there is no problem for the investigator or subinvestigator to visit the place to explain the trial and obtain consent, even if it is not at the site of the site of the study.