Drug Evaluation Committee 2010-41 Inclusion of Persons of Unknown Identity in Clinical Trials
Related classification: Obtaining consent
First published: Jan 2011
Revised release date: Mar. 2021
Question
In emergency situations (e.g., myocardial infarction or cerebral infarction), some patients who are transported to a hospital for life-saving treatment may not be identified at the time of transport. The GCP Article 55 Guidance 3 (Life-saving Clinical Trials under Emergency Situations) states that "subjects whose identity is not known shall not be included in the clinical trial.
What does it mean that this phrase is used instead of saying, "Do not subject (or examine) persons whose identities are not known. Therefore, we are not sure whether this phrase should be interpreted as (1) or (2) below.
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Patients whose identity is not clear" at the time of transport should not be used as subjects (the study drug should not be used on such patients).
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Patients whose identity is not clear" at the time of transport will be excluded from the study if they were once used as subjects in a life-saving clinical trial under emergency circumstances and their identity is not clear thereafter.
Should the phrase "subjects whose identity is not known shall not be subjected to the clinical trial" be interpreted as (1) or (2) above?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 55, Paragraph 1 of the GCP stipulates that only in cases falling under all items of Paragraph 1, a person who is to be a subject and a person who is to be a surrogate may be allowed to participate in a clinical trial without obtaining the consent of the person who is to be a subject and the person who is to be a surrogate. This means that although written consent is required for participation in a clinical trial, if any of the items in Paragraph 1 applies, the patient's life can be given priority for the time being and the person who is to be the subject can be allowed to participate in the clinical trial.
In such cases, as stipulated in Paragraph 2 of the same article, the investigator must promptly provide an appropriate explanation of the matters related to the said clinical trial to the subject or potential surrogate and obtain consent in writing for participation in the said clinical trial after participation in the clinical trial.
In response to this Paragraph 2 regulation, if the "subject's identity is unknown," it is not possible to provide an explanation to the subject or the person who is to be the surrogate after the subject participates in the clinical trial. Therefore, if there is no information on the identity of the patient who was transported to the emergency room (the possibility of obtaining identity information is not considered at all), the patient should not participate in the clinical trial.
Reason for revision of opinion
With the issuance of the GCP guidance (No. 0831-15 issued by the Pharmaceutical Affairs Bureau on August 31, 2020), we have made minor improvements to the questions.