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Dear Researchers,

Welcome to the online application platform for ethical review and approval by the Jawatankuasa Etika Penyelidikan Manusia (JEPeM). To ensure that USM meet international standards, the university has made JEPeM approval is required in the following conditions:

• Whenever a USM staff or student is the principal investigator of the research and/or
• Data are collected from participants within or from USM and/or
• USM is the main funding body for the research

For the following types of projects:

• Research involving human subjects
• Research involving human samples
• Research involving data derived from humans
• Research involving products [biological or non-biological] which will be tested on humans

Researchers can expect the first decision within 4-6 weeks for low-risk non-interventional studies and 4-8 weeks for interventional studies exceeding low risk, calculated from the date of complete submission to the relevant JEPeM-USM meeting. It is advisable to schedule submissions with these timelines in mind.

JEPeM Processing Fee

Commencing January 2021, JEPeM has implemented processing fees which must be paid in full upon submission of the application in order for the application to be processed. The fees are as follows:

1. For Industry Sponsor Clinical Trials, the fee is RM 3000. This is a one-off payment which covers the entirety of the EC approval of the same application (amendment, continuing review, SAE, protocol deviation, etc).

2. For other sponsor (foreign university, private institution, etc) the fee is RM 750. This is a one-off payment which covers the entirety of the EC approval of the same application (amendment, continuing review, SAE, protocol deviation, etc).

3. For non-USM independent researchers (staff/student), the fee is RM 750. This is a one-off payment which covers the entirety of the EC approval of the same application (amendment, continuing review, SAE, protocol deviation, etc).

Registration with National Medical Research Registry (NMRR)

All medical research involving humans are encouraged to be registered with National Medical Research Registry (NMRR). However, for research involving drugs (interventional and observational), NMRR registration is mandatory effective from 1 January 2014.

MREC review and approval is only required for the studies that involve Ministry of Health (MOH) personnel or that is conducted in MOH facility or funded by MOH research grant.

JEPeM Online Initial Application Registration

Click E-JEPeM button below to proceed with the application process. Once the submission has been registered, all the communication with the JEPeM Secretariat will be via email. Kindly please check your registered EMAIL frequently (within 1 weeks upon submission) for the additional required documents. If there is no feedback from secretariat, the application is well received and ready to be processed.