UMMC MEDICAL RESEARCH ETHICS COMMITTEE

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: 

  1. Chair (A clinical academic staff appointed on advice of the Dean, Faculty of Medicine, UM).

  2. Deputy Chair (A clinical academic staff appointed on advice of the Dean, Faculty of Medicine, UM).

  3. Director of UMMC or named representative.

  4. A clinical academic staff from the Department of Medicine, FOM-UM, nominated by the Head of Department.

  5. A clinical academic staff from the Department of Surgery, FOM-UM, nominated by the Head of Department.

  6. A clinical academic staff from the Department of Psychological Medicine, FOM-UM, nominated by the Head of Department.

  7. A clinical academic staff from the Department of Paediatrics, FOM-UM, nominated by the Head of Department.

  8. An academic staff from the Department of Pharmacology, FOM- UM, nominated by the Head of Department.

  9. Head, Department of Pharmacy, UMMC or named representative.

  10. Dean, Faculty of Law, UM or named representative.

  11. Lay member (at least two, of whom at least one shall not be qualified in the life sciences) nominated by the Chair, UMMC-MREC.

  12. Statistician (at least one) nominated by the Chair, UMMC-MREC.

  13. Any others with relevant expertise appointed on the advice of the Chair, UMMC-MREC

  14. Secretary and Assistant Secretary (at least one of either) shallbe staff of UMMC or UM, by appointment of the Chair, UMMC-MREC and are non-voting members.

 

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 2021-2023

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

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