Drug Evaluation Committee 2017-25 Handling of cases in which the surrogate is an employee of the implementing medical institution
Related classification: Obtaining consent
Date of first publication: October 2017
Question
Question 1
Please let me know if there are any GCP issues regarding the inclusion of subjects.
The exclusion criteria for this study include "staff and relatives of the investigational site who are directly involved in the conduct of this study, staff of the investigational site who receive instructions from the investigator, or employees and relatives of XX company who are directly involved in the conduct of this study. However, since it is difficult to obtain consent from the patient himself/herself in this study, consent will be obtained from a surrogate consentor. The substitute consentor is a head nurse who is a member of the ward staff at the institution and works in the same department as the principal investigator (their affiliations are different, and there appears to be no direct hierarchical relationship between them. They are not directly involved in the clinical trial.) The head nurse is not directly involved in the clinical trial. In this case, is it possible to be included in the trial?
In addition, I have read about efforts at other facilities, and if inclusion is possible, I would like to explain in the medical record that "In consideration of the fact that his surrogate is an employee of this hospital, we will take great care to avoid unfair inducement or coercion, explain the details of the clinical trial based on the consent document, and explain that he will never be treated unfairly or disadvantageously if he refuses to participate in the trial. The staff explained that they would never be treated unfairly or disadvantageously if they refused to participate in a clinical trial. He also explained that no special benefits would be provided by participating in the clinical trial. He explained that the decision to participate was made freely and of his own volition, and that the trial would be conducted in the same manner and by the same means as any other participant in the trial, with respect for his wishes and workplace duties." Is it preferable to include comments such as the following?
Question 2
Our hospital has a standardized consent document format, and we ask the sponsor to use it as much as possible. We received a request from one of the sponsors to delete the section for a substitute consentor because there is no substitute consentor in this study. Since a surrogate is also a subject's right, we would like to keep that field, but if there is no field for a surrogate, how should it be stated in the consent document?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Answer 1
According to Article 44 Guidance 3 of the GCP, a "socially vulnerable individual" is an individual whose willingness to participate voluntarily in a clinical trial may be unjustly influenced by anticipation of benefits associated with participation in the trial or retaliation by a superior due to refusal to participate, and examples of such individuals include medical and dental students as members of hierarchical groups Examples include medical and dental students, pharmacy students, nursing students, and lower level employees of hospitals and laboratories as members of a hierarchical group. Particular care must be taken when using these individuals as subjects, not only as subjects but also as surrogates.
In the case of your question, we believe it is necessary to carefully consider whether the consent is voluntary, given the relationship between the subject and the surrogate and the investigator. Also, if the investigator deems it necessary, it would be one way to ask for an opinion from the Clinical Trial Review Committee. Since the protocol stipulates exclusion criteria such as the one in your question, we believe that the final decision must be made after consultation with the sponsor.
Answer 2
In the case of a clinical trial in which it is impossible to obtain consent from a surrogate (consent can only be obtained from the subject himself/herself), we do not see any particular problem even if the consent document does not include a section for a surrogate consentor.