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 are no specific guidelines on this matter. Marketing materials are the subject of review by the IRB.

9.2 Vulnerable Subjects 

Vulnerable Subjects are Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. 

Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

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

There is no specific guidance around Informed Consent for pediatric patients.

The Personal Information Protection Act states:

When notifying children aged under 14 of matters relating to the processing of PI, ICSPs must also use understandable forms and plain and readily comprehensible language.

The PIPA also permits the PIPC to take measures to protect the PI of children under the age of 14 who may not clearly understand matters such as the risks and results of PI processing and users’ rights.

https://fpf.org/wp-content/uploads/2022/06/ABLI-FPF-Consent-Project-South-Korea-Jurisdiction-Report.pdf

9.4 Financial Disclosures

Personnel involved in clinical trials must disclose any real or perceived conflicts of interest, including any financial matters.

9.5 ICF translations – Are certificates required? 

Translation certificates are not mandatory but may be beneficial if available.

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, any insurance should be specific to the local environment.