Drug Evaluation Committee (4) Scope of Substitute Consentor
Related classification: Obtaining consent
First published: December 2004
Revised publication date: December 2021
Question
What is a "surrogate" in a clinical trial?
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1.GCP states that "In this Ministerial Ordinance, "surrogate" means a person who exercises parental authority over the subject, spouse, guardian, or other equivalent person." The GCP states that "a surrogate" is defined as "a person who has parental authority over the subject, spouse, guardian, or other equivalent person. What is the position of the "other equivalent person" mentioned here?
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2.In cases where a person is unconscious or disoriented due to an injury or illness, is a relative included as a surrogate?
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3.If so, should a spouse, parent, or other high ranking person be given priority, or is it necessary to strictly confirm the wishes of the high ranking person?
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4.Is a relative who has heard the doctor's explanation sufficient?
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5.Are those in a common-law relationship included as surrogates?
I believe the interpretation of custodians, guardians, relatives, and in-laws is as follows.
Person with parental authority
(1) Person who exercises parental authority During the marriage of the parents, both parents have parental authority, but when the parents are divorced, only one of them has parental authority.
Guardian
(Law) A person who should be in charge of property management and personal custody for a minor who is incontinent or lacks parental authority. Also a legal representative.
Relative
Under the Civil Code, blood relatives within the sixth degree of kinship, spouse and in-laws within the third degree.
Relative by marriage
A relative created by marriage. Blood relatives of a spouse. In other words, the wife's parents and siblings in terms of the husband.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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1.According to GCP Article 2 Guidance 14, a "person who is justified in giving consent with or on behalf of the subject, and who has custody of the subject, spouse, guardian, or other similar person who can serve the best interests of the subject in view of the substance of their lives and their common psychological relationship. If a person can be regarded as a surrogate, he or she can be considered a surrogate. In the case of an emergency, there is an argument that a friend who accompanies the subject may be considered as a surrogate. However, in this case, it should be handled in accordance with Article 55 of GCP (Life-saving Clinical Trials under Emergency Situations), and it would be appropriate not to consider them as a surrogate consentor.
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2.Even a relative cannot be a surrogate consentor unless the conditions in 1) are met.
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3.In general, the intention of a surrogate who is in a closer (higher) position to the subject should be given priority. However, since this is not stipulated in GCP, we do not think it is necessary to adhere to this rule. In this case, again, we believe that the criterion for judgment should be whether or not the condition in 1) is met. In the case where there are multiple qualified surrogates who express conflicting views, the following actions may be taken: (1) adopt the view of the (higher-ranking) surrogate who has a closer relationship with the subject, (2) deem that consent was not obtained, or (3) make a judgment based on the opinion of a third party. Therefore, it would be better to obtain the opinion of the Clinical Trial Review Committee on the appropriateness of the decision beforehand, so that you can take appropriate measures without being panicked at that time.
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4.It does not mean that any relative who has heard the explanation is acceptable. The criteria for judgment should be based on whether or not the conditions in 1) are met. Conversely, it is essential to confirm that the condition 1) is met before providing an explanation.
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5.Even if you are in a common-law relationship, you can be a surrogate if you meet the condition 1).
Reason for revision of opinion
The referenced clause has been changed in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).