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 documents required may vary for each Committee. The standard EC submission package includes:

1. EC application form
2. Submission checklist
3. Cover Letter
4. Study Protocol
5. Investigators Brochure
6. Subject Information Sheet and Informed Consent Form in English, Malay, Simplified Chinese, and Tamil (if requested), site-specific version
7. Insurance Certificate + Physician Indemnity Letter (if applicable)
8. CV of all investigators + GCP Certificates (if required by EC)
9. Any patient-related materials (i.e. advertisement, patient diary, etc.)
10. Financial contract (if applicable)
11. Statement of publication rights (if applicable). This can be obtained from the protocol, usually under the Publication Policy.

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 vary depending on the ethics committee, but this is typically around 50 business days. The timeline will be extended if there are queries from the committee.

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?

Yes, all ECs that approve drug-related trials MUST be registered with DCA. A list of approved ECs is provided on the NPRA website.

The Ethics Committee shall seek approval from the NCCR prior to applying to the NPCB for inclusion in the NPCB. The IEC is required to complete the application form as described in 4.2.4 and submit the application in hardcopy to NPCB. Links to the application form and instructions to complete it can be downloaded from the NPCB official website. The application shall be made and signed by the chairperson of the IEC.

3.5 How frequently do EC/IRB meet?

The schedule of each EC varies. Some committees meet weekly and others only monthly.

The 2021 meeting schedule for the MREC can be found here.

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

No.

3.7 Process of EC/IRB Submission for Clinical Trial Approval

The process may vary depending on the EC. The process for submission to the MREC (the national body for trials involving Ministry of Health sites) is described below:

• The application process for the MREC is an online submission using the National Medical Research Register (NMRR) website. Users are required to register with the NMRR website and obtain a user account that can be used for all submissions thereafter. All relevant information is available under the User Manual/Documents section on the NMRR website (https://www.nmrr.gov.my).
• NMRR is a web-based tool designed to support the implementation of the National Institute of Health (NIH) guidelines on the conduct of research in the Ministry of Health Malaysia (MOH). NMRR enables online research registration and online submission, as well as ethical review and approval of MOH research.
• Before the submission process is started, the Corresponding Principal Investigator (for studies with more than one MOH site) needs to be appointed to act as the main investigator in the study. S/he is responsible for submitting the relevant study documents in NMRR.
• As per the NIH Guidelines for Conducting Research in Ministry of Health Institutions and Facilities (October 2015), if the study registered is an Investigator Initiated Research and does not involve international collaboration, the study would be reviewed by a research review panel prior to MREC’s review.
• Studies that are forwarded to MREC are initially accessed to determine the type of review. In the case of clinical research, most of the studies would need to undergo MREC full-board review.
• The PI or corresponding Principal Investigator is no longer required to attend MREC full-board review meetings unless specific requests are made by the MREC reviewers. If needed, the Secretariat will be communicating with the PI or correspondence Principal Investigator at least 2 working days prior to the meeting. If the PI or corresponding Principal Investigator is unable to attend, the Secretariat would make arrangements for SKYPE/teleconference.
• The PI or Corresponding Principal Investigator will be informed of the decision within 10 working days after the meeting. Should there be a delay (due to the need for added review/clarifications after the meeting), the MREC Secretary will be communicating with the PI or Corresponding Principal Investigator on the matter.
• The scheduled panel meeting dates are published on the NMRR website. In general, MREC meetings are on the 2^nd and 4^th Tuesday of each month. The cut-off date (the date the study package is forwarded to MREC) is 10 working days before the meeting date.
• Please refer to the User Manual/Documents on the NMRR websitefor:
  • Investigator Registration - New User Account Creation (this is to briefly explain how to create a user account in NMRR).
  • Step-by-Step Research Registration & Submission using NMRR (this is a comprehensive guide to demonstrate how to navigate and complete submission in NMRR).

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.)?

At present, there is no fee required for an Ethics Committee (EC) review. The processing fee per product is RM500 (equivalent to ~USD110).

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?

The payment method depends on each individual committee’s arrangements.

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

For submission to the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, there are guidance tools available such as a Step-by-Step Research Registration & Submission using NMRR. This is a comprehensive guide to demonstrate how to navigate and complete submission in NMRR.

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 patient-facing materials are used, screenshots should be provided (also in the local language as appropriate).

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

NRPB makes reference to the WHO template for Informed Consent.

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

According to Section 5.8.1 in the Malaysian Guideline for Good Clinical Practice:

“If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should 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.”

It is a requirement by the Independent Ethics Committee (IEC)/Medical Research & Ethics Committee (MREC), Ministry of Health Malaysia, that all ethics submissions for clinical trials must include proof of trial indemnification either by insurance certificate or letter of indemnity. These documents should indicate the protocol title and number, period of coverage, and list of coverage for Malaysia sites among others. Insurance certificates that are renewed should be duly submitted to the ethics committee on an ongoing basis.

Any institution/center or investigator involved in a clinical trial should be indemnified or insured for claims arising from:

1. Use of investigational medicinal product (IMP)
2. Procedures/activities performed for clinical trial
3. Malpractice/negligence

For more information regarding insurance in Malaysian clinical trials: https://hpupm.upm.edu.my/upload/dokumen/20220324164152A._iii._Summary_of_clinical_trials_insurance_services_(Great_Eastern,_Allianz_and_Chubb).pdf

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

No, there are no safety reporting requirements other than what has been previously mentioned in Section 2.15 of this guidebook. See the below link for more information regarding safety reporting in Malaysia.

Useful Guideline for Safety Reporting of Investigational Products

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

This varies depending on the committee, but at least annual reporting is normally required.