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?

There is no specific guidance on this matter. This is subject to ethics approval.

9.2 Vulnerable Subjects

Vulnerable subjects should be managed in accordance with the GCP guidelines. These include children, the disabled, and prison inmates.

Vulnerable Subjects are governed by Section 1.61 of the ICH GCP.

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

In the Indonesian context, there is no specific national regulation for obtaining informed consent in research involving children. 

Most studies that involve children as informants apply a process of dual consent by seeking informed consent from both children and their parents, caregivers, or guardians.

Law No. 35 of 2014 on Child Protection stipulates protection against medical research that involves children without parental consent and without consideration of the child’s best interest (article 47).

9.4 Financial Disclosures

The Main Investigator is required to disclose any financial conflicts of interest.

9.5 ICF translations – Are Certificates Required?

Yes, translation certificates should be provided.

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?

Yes, the sponsor should be listed. There is no guidance on minimum amounts.