Drug Evaluation Committee 2017-28 Obtaining Informed Consent Outside the Investigator Site
Related Category: Obtaining Informed Consent
Initial Publication Date: October 2017
Question
This is a question regarding obtaining consent from a surrogate for a clinical trial involving an unconscious patient.
A surrogate has suggested that, while it is difficult for the patient to visit the Investigator Site, they might give consent depending on the details if the clinical trial is explained at home. Would it be acceptable for the principal investigator or another authorized person to visit the patient’s home to explain the clinical trial and obtain consent from the surrogate?
Additionally, if the patient might feel pressured at home, would it be possible to obtain consent by providing the explanation in a setting where information cannot be overheard by others (such as a conference room)? I realize this is a rare case, but I would appreciate your guidance.
JPMA's view
GCP does not specify requirements regarding the location where explanations are provided or consent is obtained for participation in a clinical trial.However, Guidance Note 1 for Article 52, Paragraph 2 of GCP states: “The principal investigator, sub-investigator, and study staff shall not coerce or unduly influence a prospective subject or a prospective surrogate regarding participation in or continuation of participation in a clinical trial.”Therefore, it is important to bear this point in mind.
Since your question concerns a location requested by the proxy, I believe it is acceptable for the principal investigator or a sub-investigator to travel to that location—even if it is not an Investigator Site—to provide the explanation and obtain consent.