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.

Copies of the following documents must be provided for the Ethics Committee's review:

1. Clinical trial protocol
2. Research brochure
3. Informed consent
4. Application form
5. Information on the test item
6. CoA
7. GMP Certificate
8. Summary batch protocol for three consecutive batches
9. Special lot release (for vaccines only)
10. GCP certificate of the researcher
11. Contract with the ORK
12. Insurance
13. Laboratory certificate
14. CV of the "Main Researcher"

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

It will take 4-6 weeks for a standard approval. If significant queries are raised, then this can delay the approval as the applicant has to wait till the next meeting to have their responses reviewed. 

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

No.

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

No. The ethics committee needs to be an authorized committee within the organization.

3.5 How frequently do EC/IRB meet?

The timelines vary for each individual committee.

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

No.

3.7 Please describe the process of the EC/IRB submission for clinical trial approval.

The process may slightly differ between committees. However, it is generally as follows:

1. The sponsor submits the required documentation to the committee.
2. The committee meets to review and discuss the application.
3. If there are queries, these are sent to the sponsor for consideration. Responses should be submitted for review at the next scheduled meeting.
4. If there are no queries identified, notification of ethics approval is sent to BPOM.

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 fees vary for each institution but are generally nominal and no more than USD500.

3.9 Does EC/IRB accept checks or can payment 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?

This process varies for each committee.

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

Information is available on the website of each institution, but this information is only presented in Bahasa Indonesia.

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 electronic materials are used, screenshots should be provided. All patient-facing materials must be provided in Bahasa Indonesia.

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

No, there is no specific template.

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

No, there is no specific guidance on this matter.

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

Please refer to Section 2.15 of this guidebook.

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

No. Periodic reporting to the ethics committee is not required, but six-monthly reporting to BPOM is mandatory.