3. Ethics Committee (EC)/Institutional Review Board (IRB)

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. 

The IRB/IEC should be provided with the following documents (one copy of each document translated into the Korean language):

1. Trial protocol(s)/amendment(s)
2. Written informed consent form(s)
3. Written information to be provided to subjects (including information for subjects)
4. Investigator's Brochure (IB)
5. Available safety information
6. Information about payments and compensation available to subjects
7. Investigator’s current curriculum vitae and/or other documentation evidencing the qualifications
8. SOPs and any other documents that the IRB/IEC may need to fulfill its responsibilities

3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process.

The IRB review time is typically 45 days.

https://globalregulatorypartners.com/wp-content/uploads/CLINICAL-TRIAL-APPLICATION-CTA-IN-SOUTH-KOREA-V1.pdf

3.3 Does EC/IRB have any fast-track or expedited review process? 

The IRB/IEC can support an expedited review of the following matters:

1. ADRs.
2. Reporting of Termination Trials.
3. Protocol changes (including protocol amendment) approved by the Commissioner of the Korean Food and Drug Administration.
4. Administrative changes involving the medical monitor, sub-investigator, telephone number for emergencies, and trivial changes of protocol relevant to the addition and/or elimination of a test that does not affect safety and efficacy.
5. Protocol revisions requested by IRB/IEC.
6. Other items that require expedited review related to the conduct of the trial indicated in the SOPs of the IRB/IEC.

3.4 Does EC/IRB need to be registered and/or accredited/approved by RA/CA?

As defined in South Korea’s Bioethics and Safety Act, the establishment of an institutional review board (IRB), is a self-regulatory system. To be considered a functioning IRB, the committee must abide by the below regulations:

1. The IRB/IEC shall consist of at least 5 members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial and include at least one member such as a lawyer and/or religionist, who has not majored in medical, dental, oriental medical science, pharmacy, and nursing and at least one member who is independent of the institution/trial site.
2. The IRB/IEC shall elect the chairman from its own members. Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial shall vote/provide opinions on a trial-related matter.
3. The IRB/IEC shall provide a document on the names and qualifications of the members.
4. The IRB/IEC shall perform its functions according to written operating procedures, shall maintain written records of its activities and minutes of its meetings, and shall comply with KGCP and with the applicable regulatory requirement(s).
5. An IRB/IEC shall make its decisions at announced meetings at which at least a quorum, as stipulated in its written operating procedures, is present.
6. Only members who participate in the IRB/IEC review and discussion shall vote/provide their opinion and/or advise.
7. The investigator may provide information on any aspect of the trial, but shall not participate in the deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC.
8. An IRB/IEC may invite non-members with expertise in special areas for assistance.

3.5 How frequently do EC/IRB meet? 

Each IRB will have a different meeting schedule. However, most IRBs will host a meeting at least once per month.

3.6 Is any additional approval required apart from the EC/IRB (e.g. scientific committee, subject matter expert committee, etc.)? 

No, approval from the EC/IRB is sufficient.

3.7 Process of EC/IRB Submission for Clinical Trial Approval

There is not one process for submission as each IRB will have different requirements. Each committee is required to present the following. The process is typically as follows:

• The Sponsor submits documentation to IRB prior to the targeted meeting.
• IRB meets to discuss the trial and review the documentation.
• IRB requests further information from the Sponsor OR issues a decision to approve or reject.

3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., is the fee different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)? 

The IRB submission fees vary depending on the institution.

3.9 Does EC/IRB accept checks or payment can be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent? 

Payment to the IRB varies for each institution but payment normally takes place electronically.

3.10 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions. 

There is no specific guidance on the application process. Each institution has its own procedure.

3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?

Yes, where patient-facing materials are electronic, screenshots should be provided. They need to be submitted in the Korean language.

3.12 Does the EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?

There is no specific template for Informed Consent. Article 17 of the Korean GCP Guidelines provides some general guidance on Informed Consent.

3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirements?

If required by the applicable regulatory requirement(s), the sponsor shall provide insurance or shall indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence.

The sponsor's policies and procedures shall address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement(s).

When trial subjects receive compensation, the method and manner of compensation shall comply with applicable regulatory requirement(s).

3.14 Are there any specific local safety reporting requirements for clinical studies?

See Section 2.15 of this guidebook.

3.15 Does the EC/IRB require any periodic study reporting?

The IRB/IEC shall conduct a continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year.