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. 

As outlined in the "Ministerial Ordinance on Good Clinical Practice for Drugs (2012)", the following documents should be submitted to the IRB: 

Article 10. Prior Submission of Documents to the Head of Medical Institution 

The person who intends to sponsor a clinical trial shall beforehand submit the following documents to the head of the medical institution: 

(1) Protocol (including its amendments pursuant to Article 7, Paragraph 5) 

(2) Investigator’s Brochure (including its amendments pursuant to Article 8, Paragraph 2) 

(3) Sample of the case report form 

(4) Written information 

(5) List of prospective investigators and sub-investigators (hereinafter collectively referred to as “investigators etc.”)

(6) Documents on the burden of expenses for the clinical trial 

(7) Document explaining compensation to the subject in the event of trial-related injuries

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

Ethics approval typically takes between 4 – 8 weeks. This time may be extended by 2- 4 weeks if queries are raised by the EC.

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

Some commercial ethics committees may offer a fast-track process for an additional fee.

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

Yes, ethics committees are now governed by the MHLW. An accreditation process was implemented in 2018.

3.5 How frequently do EC/IRB meet?

It varies depending on the institution, but most committees meet at least monthly. Some committees will meet more often. Submissions are due 2 weeks (14 days) prior to the committee's meeting. 

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

No, once ethics approval has been gained, the clinical trial application may be made to PMDA.

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

• The Application must be submitted to the IRB at least 14 days prior to the meeting. Most ECs allow online submissions.
• The ethics committee will review the application at the designated meeting.
• If further information is required, a request will be made to the sponsor.
• Once all information has been submitted, the ethics committee will either approve or reject the application.

The process takes around 4 – 8 weeks.

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 cost varies for each institution. The costs are typically low (less than USD 1000) and normally only cover the expenses of the committee. Commercial IRB fees may be higher. 

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?

Payments are normally made electronically. The process differs for each institution.

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

Guidelines are normally available on the institution’s website.

An example is provided: https://www.ut-crescent.jp/makers/shinkishinsei/

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?

Whenever patient-facing materials are provided electronically, a screenshot should be provided.

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 for the Informed Consent form. The "Ministerial Ordinance on Good Clinical Practice for Drugs (2012)" states the following regarding Informed Consent: 

Section 4.  Informed Consent of Subjects

Article 50.  Providing Written Information for Explanation and Obtaining Written Informed Consent

1. Prior to a subject’s participation in the clinical trial, the investigators, etc. shall obtain written informed consent from the subject by appropriately explaining in writing the trial-related information, such as the content of the clinical trial, to the subject so that he or she will understand the information.
2. Notwithstanding the provisions of the preceding paragraph, a subject who is incapable of giving consent may be enrolled in a trial on the consent given by the subject’s legally acceptable representative.
3. When the consent of the subject’s legally acceptable representative is obtained pursuant to the preceding paragraph, the investigators, etc. shall prepare records of the consent and the relationship of the legally acceptable representative to the subject.
4. Notwithstanding the provisions of Paragraph 2, the investigator, etc. shall not enroll any subject who is incapable of giving consent to participation in a clinical trial in which no clinical benefit of the investigational product to the subject is anticipated, excluding the cases stated in Article 7, Paragraph 2 or Article 15-4, Paragraph 2. 
5. The investigators, etc. shall give the prospective subject (or the legally acceptable representative if applicable; the same shall apply in Articles 51 though 53) the opportunity to make inquiries about the content of the written information and other trial-related matters. All inquiries should be answered to the satisfaction of the subject.

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

There is no specific guidance on the value of insurance required. The "Ministerial Ordinance on Good Clinical Practice for Drugs (2012)" states the following regarding Informed Consent: 

Article 14. Compensation to Subjects 

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).

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

Please refer to Section 2.15.

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

There is no specific reporting period, but reporting is normally conducted annually.