WELCOME TO UMMC-MREC

OVERVIEW OF
UMMC-MREC

Universiti Malaya Medical Centre-Medical Research Ethics Committee (UMMC-MREC) was formerly known as Medical Ethics Subcommittee (MESC) established under the Medical Advisory Committee of University Hospital in 1970s.

In 2016, the committee was renamed as Medical Research Ethics Committee (MREC). This ethics committee (or institutional review board) is an independent body of medical/scientific professionals and non-medical/non-scientific members that reviews, approves and provides continuing review of human research/trial protocols and amendments, and of the methods and materials to be used in obtaining and documenting consent of the human research subjects.

Click here to view the Medical Research Ethics Committee of 2025-2027

Click here to view the Serious Adverse Event Subcommittee and Site Visit Subcommittee

WHAT IS RESEARCH ETHICS AND
ITS IMPORTANCE?

Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights, and welfare of research participants.

Principles and benchmarks for ethical research are summarised as below:

Respect for persons
Autonomy - Informed consent
Favourable risk-benefit ratio
Fair participant selection
Scientific validity
Social value
Independent review
Collaborative partnership

THE AUTHORITY OF UMMC-MREC

To approve a proposed study, require modification of the study or disapprove the study.

To monitor studies and may suspend or terminate any previously approved study, and approve or disapprove protocol amendments to an approved study.

In accordance with ICH-GCP guidelines, the following must be promptly reported to the MREC:

Changes to the approved protocol (to reduce/ eliminate risk to subjects),
All serious adverse events and serious adverse reactions,
New information that may adversely affect the safety of subjects or conduct of the trial,
When a study is discontinued prematurely, and
When a study is completed.

INVESTIGATOR'S RESPONSIBILITIES

The Investigators are required to:

Follow instructions, guidelines and requirements of the Medical Research Ethics Committee.
Report any protocol deviations/violations and any serious unexpected adverse events related to the conduct of the study or study product to Medical Research Ethics Committee.
Provide annual and closure report to the Medical Research Ethics Committee.
Comply with International Conference on Harmonization – Guidelines for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki.
Obtain permission from the Director of UMMC to conduct research that involves UMMC patient samples or data
Ensure that if the research is sponsored, the usage of consumable items and laboratory tests from UMMC services are not charged in the patient’s hospital bills but are borne by research grant.
Note that he/she can appeal to the Chair of Medical Research Ethics Committee for studies that are rejected.
Note that Medical Research Ethics Committee may audit the approved study.
Ensure that the study does not take precedence over the safety of subjects.

DEADLINE FOR SUBMISSION AND MEETING SCHEDULE 2026

Note :
* The dates of the UMMC-MREC Meetings are subject to change.
*Please note that study applications submitted before the submission deadlines may not necessarily be slotted in for the subsequent month’s meeting as to allow earlier studies submitted to be discussed first.
*Based on our SOP, the review time of a new study from receipt of an application by the secretariat to the UMMC-MREC Chair’s first decision is 60 working days.

Please plan your study submissions based on the turnaround time for study applications.

FLOWCHART PROCESS OF NEW APPLICATION