Drug Evaluation Committee 2017-60 Participation in Clinical Trials by Employees, etc. of the Performing Medical Institution as Subjects

Is it possible to introduce the clinical trial to the following persons involved in the clinical trial, and if there are any who wish to participate, can they participate in the clinical trial?

If the above is possible, but the introduction does not exceed the information available on JAPIC and ClinicalTrials.gov, is IRB deliberation required as part of the procedure for recruiting subjects?

When selecting persons who may suffer unjustified disadvantages by not participating in a clinical trial (hereinafter referred to as "socially vulnerable persons"), investigators must give sufficient consideration to ensure that such persons voluntarily give their consent to participate in the clinical trial (GCP Article 44). A "socially vulnerable individual" is an individual whose willingness to voluntarily participate in a clinical trial may be unduly influenced by the anticipation of benefits associated with participation in the trial or retaliation by a superior due to refusal to participate, including lower-level employees of hospitals and laboratories and employees of pharmaceutical companies (GCP Article 44 Guidance 3). However, the investigator must consider the dependency of the potential participant on the sponsor, the investigational site, and the investigator, and ensure that the potential participant does not influence the individual's free expression of will and is qualified to participate in the clinical trial (Article 44, Guidance 3). The investigator must carefully consider whether or not the candidate is eligible as a subject, taking into account the dependency of the candidate on the sponsor, the clinical trial site, and the investigator, etc. Obtaining the opinion of the Clinical Trial Review Committee may be one way.

When recruiting subjects for a specific clinical trial, even if it is based on information that is not beyond the scope of publicly available information, the procedure must be reviewed by a clinical trial review committee (GCP Article 32, Paragraph 1, Item 2).