Drug Evaluation Committee 2004-13 "Fair Witness" Conditions
Related classification: Obtaining consent
First published: December 2004
Revised publication date: December 2021
Question
Please tell me about the explanation of consent for subjects with visual impairment.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding your question, I would like to express my opinion in the context of a person who is unable to read the explanatory documents due to visual impairment.
1. regarding the condition of "fair witness
An "impartial witness" is defined as a person who is independent of the clinical trial and not under undue influence from any person involved in the clinical trial (GCP Article 2 Guidance 18 (5)). In addition, according to ICH GCP 1.26, a "fair witness" is a person who is present when consent is obtained and reads the explanatory document to the patient, so we believe that a person who is not involved in the conduct of the clinical trial and can take a third-party position (i.e., excluding the investigator, subinvestigator and collaborator who are in the position to explain the clinical trial) may be a staff member of the site of the medical institution. We think that it is acceptable for them to be staff members of the site. Currently, we think it is preferable that the potential subject be a trusted person (e.g., family member, friend, social worker, etc.).
2) "Fair Witness" in the case where a substitute is not provided
A surrogate is a person who gives consent on behalf of a potential subject when that person is incapable of consenting, and if that person is capable of consenting, a witness will be appointed instead of a surrogate. However, even if a substitute consensor is appointed due to lack of capacity to consent, if the substitute consensor is unable to read the explanatory document for some reason, a further witness should be appointed (GCP Article 52, Paragraph 3, Guidance 1).
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Bureau of Japan, No. 0831-15), some of the statements in the Opinion have been changed.