UMMC Medical Research Ethics Committee (MREC)
In the University of Malaya Medical Centre (UMMC), research involving animals have to be reviewed by the Animal Care Committee, whereas research involving humans require clearance by the Medical Research Ethics Committee (MREC). The objectives of the MREC are to safeguard the rights, safety and well-being of human research volunteers, provide timely, comprehensive and independent review of the ethics of proposed studies and ensure that there is due regard to existing laws, regulations and community attitudes.
The Independent Ethics Committee
An 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.
The UMMC-MREC is composed of a minimum of the following members:
- Chair (A clinical academic staff appointed on advice of the Dean, Faculty of Medicine, UM).
- Deputy Chair (A clinical academic staff appointed on advice of the Dean, Faculty of Medicine, UM).
- Director of UMMC or named representative.
- A clinical academic staff from the Department of Medicine, FOM-UM, nominated by the Head of Department.
- A clinical academic staff from the Department of Surgery, FOM-UM, nominated by the Head of Department.
- A clinical academic staff from the Department of Psychological Medicine, FOM-UM, nominated by the Head of Department.
- A clinical academic staff from the Department of Paediatrics, FOM-UM, nominated by the Head of Department.
- An academic staff from the Department of Pharmacology, FOM-UM or from the Department of Pharmacy, FOM-UM may be nominated, as a permanent representative by the respective Heads of either department.
- Head, Department of Pharmacy, UMMC or named representative.
- Dean, Faculty of Law, UM or named representative.
- Lay member (at least two, of whom at least one shall not be qualified in the life sciences) nominated by the Chair, UMMC-MREC.
- Statistician (at least one) nominated by the Chair, UMMC-MREC.
- Secretary (at least one) - an officer of UMMC, by appointment of the Director, UMMC.
Only MREC members who are independent of the investigation and the sponsor of the study may vote or provide an opinion on a study related matter. The Secretary has no voting rights. The MREC may invite non-members with expertise in special areas for assistance. MREC can only convene or make a decision if at least 5 voting members are physically present and approval will only be granted if the majority of voting members approve the study. The MREC answers to the Board of Directors, UMMC but is independent in its decision-making. The decisions of the MREC are also informed to the Medical Advisory Committee (body of clinical consultants) of UMMC.
Click here to view the Medical Research Ethics Committee of 2017-2019
Click here to view the Serious Adverse Event Subcommittee and Site Visit Subcommittee
The Authority of the MREC
The MREC has the authority to approve a proposed study, require modification of the study or disapprove the study. The MREC is also authorized 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.
Medical Research Ethics Application Standard Operating Procedure (SOP)
- SOP 1: Structure and Composition
- SOP 2: Initial Review Procedure
- SOP 3: Post Review Procedure
- SOP 4: Documentation and Archiving
- SOP 5: Preparing SOPs