9. Subject Considerations

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them?

The methods of advertisement are subject to review and approval by the IRB. 

9.2 Vulnerable Subjects

The Japanese Ethical Guidelines for Medical and Health Research do not include any provisions for the management of vulnerable subjects. 

https://www.mhlw.go.jp/file/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka/0000080278.pdf

9.3 Pediatrics (including whether consent from a single parent is sufficient vs. requiring both parents to sign)

A signature from a single parent is sufficient to support the inclusion of a child in a clinical trial.

9.4 Financial Disclosures

Investigators are required to disclose any real or perceived conflicts of interest, including any financial conflicts.

9.5 ICF translations – Are Certificates Required?

No. Translation certificates are not required.

9.6 Subject Compensation: Is there a need for a local sponsor to be listed on the insurance certificate, the insurance certificate to cover the duration of the study and specific minimum amounts of coverage to be specified, both for individual events occurring and in aggregate?

The person who intends to sponsor a clinical trial shall beforehand take necessary measures such as purchasing insurance in preparation for compensation to the subject in the event of trial-related injuries (including those attributable to the duties performed by the contractor).