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. 

Each EC has its own application form and clearance requirements that can differ significantly regarding the number of copies to be supplied and application format requirements.

The following list is considered to cover all of the common elements required by an EC:

• Application for Human Research Ethics Review
• Protocol
• Sample ICF
• Case Report Form
• Principal investigator(s) CV(s)
• NMPA approval letter (if available)
• Certificate of Analysis for the drug issued by the National Institutes for Food and Drug Control (NIFDC) or corresponding provincial, autonomous region, or municipal institutes
• IB
• Any additional feedback from other ECs participating in the protocol
• Statement of planned tasks
• Letter of intent for cooperation
• Site list
• Site profile(s)
• Product Literature
• Insurance policy (if any)
• Materials provided to participants
• Information on the lead research investigator; the legal qualification certificate of the institution; and the source of research funding
• Other relevant materials that the EC believes need to be submitted

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

The timelines differ for different ethics committees. Typically the EC must give written notice of its decision to the applicant within 10 working days after the review. Approval is valid for no more than 12 months, at which point the EC will conduct a follow-up review.

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

Some institutions offer a fast-track review. For example, in the Third Affiliated Hospital, Sun Yat-Sen University, the routine EC meeting is held monthly. For fast-track applications, a decision is available within 11 working days after submission. Please find the link below in Chinese:

https://www.zssy.com.cn/cat/547

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

Yes. The EC has to be established and approved by the hospital management team and timely inspected by both the National Health Commission of the People’s Republic of China and the National Medical Products Administration.

3.5 How frequently do EC/IRB meet?

There are different schedules at each institution.

Some ECs meet weekly, such as at Peking University First Hospital where the EC meeting is held each Wednesday afternoon. Please find detailed information below in Chinese:

https://www.pkufh.com/Html/News/Articles/30135.html

Some ECs meet every 2 weeks, such as at the First Affiliated Hospital, Zhejiang University School of Medicine. The EC meeting is held on the 2nd Thursday and the last Thursday of each month.

https://zy.runtrial.net/public/content/detail.htm?cid=821

Some sites have ECs meet each month, such as the Third Affiliated Hospital Peking University.

https://www.puh3.net.cn/llwyh/index.shtml

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

Where there is the intention to ship biospecimens outside of China for analysis, then approval from the OHGRA is needed. See Section 2.7.

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

There are five steps to the submission process as outlined below:

1. Account application or project code application.
2. Compile dossiers and submit them to the EC office.
3. Format review by EC office, additional dossiers may be requested.
4. Technical review by EC office.
5. Admin approval.

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 fee varies at different sites: Some examples are below:

Some sites are 5,885 RMB (720 USD) for initial submission and 2,140 RMB (280 USD) for amendment, such as the Third Affiliated Hospital Sun Yat-Sen University.

https://www.zssy.com.cn/cat/547

Some sites are 10,000 RMB (1,400 USD) for initial submission and 2,000 RMB (280 USD) for amendment, such as Jiangsu Taizhou People’s Hospital. 

http://www.jstzhospital.com/

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?

Fees are paid directly to the institution by electronic transfer.

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 guidance tool available. This differs for every institution.

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?

Screenshots are not normally required.

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

The required information varies by site. Some sites have special requirements/templates, such as Beijing Cancer Hospital:

https://www.bjcancer.org/Html/News/Articles/4816.html

Other sites have no special requirements and only follow ICH requirements.

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

The sponsor must take appropriate measures to ensure that the participants and researchers can be compensated. The sponsor must bear the costs of diagnosis and treatment for the damage or death of the participant related to the clinical trial, as well as the corresponding compensation. Further, the sponsor must provide free trial drugs to participants and pay for medical testing related to clinical trials.

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

In general, China follows five key ICH guidance related to clinical pharmacovigilance, including M4, E2A, E2D, M1/MedDRA, and E2b(R3).

Local agency-issued local GVP has been carried out since 01 Dec 2021.

Some sites have special SUSAR report templates, such as Third Affiliated Hospital Sun Yat-Sen University, https://www.zssy.com.cn/article/16267.

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

See Section 2.15.