Research Ethics

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 Composition of the Medical Research Ethics Committee (MREC)

Chairman:
A clinical academic staff appointed by the Board of Management, University Malaya Medical Centre, on advice of the Dean Faculty of Medicine
Deputy Chairman:
A clinical academic staff appointed by the Board of Management, University Malaya Medical Centre, on advice of the Dean Faculty of Medicine
Members:

  1. Director, University Malaya Medical Centre or nominated representative
  2. Head, Department of Medicine or nominated representative
  3. Head, Department of Psychological Medicine or nominated representative
  4. Head, Department of Surgery or nominated representative
  5. Dean, Faculty of Law, University of Malaya or nominated representative
  6. Head, Department of Pharmacy / Pharmacology, Faculty of Medicine, University of Malaya, or nominated representative, on rotation through a two yearly term
  7. Head of Pharmacy, Department of Pharmacy, UMMC or nominated representative
  8. Public representative(s): at least two (2) persons, by appointment of the Chairman, Board of Management of UMMC, as advised by the Director, UMMC
  9. Secretary: An administrative 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 2017-2018

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:

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

Click here to view the Medical Research Ethics Application Standard Operating Procedure (SOP)

Studies that require MREC Approval

Clearance from the MREC is required for all health-related studies involving human participants (including patients), their medical records and tissues under the aegis of the University of Malaya Medical Centre or Faculty of Medicine, University of Malaya. These include:

  1. studies requiring extra procedures to be carried out on subjects i.e. any procedure which would not have been normally carried out in the course of the subject's stay/visit to the medical centre and which is proposed to be carried out because of the study,
  2. clinical trials,
  3. studies, whether retrospective or prospective, using patient data outside of the researcher's Department,
  4. questionnaire or surveys or qualitative interviews involving human participants and/or their relatives,

Special attention should be given to projects involving:

  1. research with children, prisoners and adults not competent to give consent,
  2. research involving the use of genetic material, and
  3. research that may impose an undue disadvantage upon participants.

For studies that are conducted outside UMMC/FOM, researchers can also apply for UMMC MREC ethics approval, if the researchers are from UMMC/FOM staff.

UMMC MREC will consider application for studies that are conducted outside UMMC/FOM if the researchers are from UMMC/FOM. However, the researchers should also seek ethics approval from the respective institution (eg. National Medical Research Registry for public hospital and clinic) before conducting the studies.

Elements in reviewing the MREC application

In the consideration of a study, particularly clinical trials, the MREC requires that it be conducted in accordance with ICH Harmonised Tripartite Guidelines for Good Clinical Practice (ICH-GCP). In principle, there should be respect for the dignity of the person (the right to information, informed consent and the right to refuse or withdraw from the study) and the research should not over-ride the health, well-being and care of the subject. In this regard, the information given to subjects in the obtaining of informed consent should be in simple layman language. The MREC may request for translations if they think the study population would require that particular language.
The elements of the MREC review would also encompass:

  1. the scientific worth of the study, as it would be unethical to inconvenience subjects for a futile study,
  2. the capability and suitability of the investigators to undertake the study,
  3. the criteria for recruitment of study subjects including the means of contact and recruitment, to ensure no undue coercion or inducement,
  4. care and protection of subjects, especially that risks to subjects are minimized and also that risks are reasonable in relation to anticipated benefits,
  5. special safeguards to protect vulnerable subjects, such as children, pregnant women, the mentally disabled and prisoners,
  6. provisions for privacy and confidentiality of data obtained,
  7. cost considerations including coverage of inconvenience, adverse reactions and injuries to subjects, and special sensitivities of the community.

Click here to download the UMMC-MREC Ethics Review Assessment Form and Checklist

The review process may (and often does) involve an interview of the Principal Investigator.

Relevant Guidelines and Acts (Click on the title below to download the file)

  1. Malaysian Guideline for Good Clinical Practice 2011
  2. Declaration of Helsinki
  3. Guidance Document and Guidelines for Vaccines Lot Release in Malaysia
  4. Guideline for Stem Cell Research and Therapy
  5. Guidelines for Good Clinical Practice (GCP) Inspection
  6. Guidelines on Good Distribution Practice (GDP)
  7. Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption
  8. Malaysian Guideline for Bioequivalence Inspection
  9. Malaysian Guideline for Ethics Committee Registration and Inspection
  10. Malaysian Guideline for Safety Reporting of Investigational Products
  11. Malaysian Guidelines on the Use of Human Biological Samples for Research
  12. Medical Device Act 2012
  13. National Guidelines for Haemopoietic Stem Cell Therapy
  14. National Standards for Stem Cell Transplantation - Collection, Processing and Infusion of HSC and Therapeutic Cell
  15. Personal Data Protection Act 2010

The MREC meets regularly once a month, except in December. Meetings are usually on the third Wednesday of each month, to review proposals received by the first week of that month.

Click here to view the submission dateline and the meeting schedule in 2016

Click here to view the submission dateline and the meeting schedule in 2017

The review timeline:

  1. For MREC's first decision to the new study, review timeline is within 1 month from receipt of application by the Secretariat.
  2. For modification to the new study, the cut-off date is within 2 months from request for modification. Otherwise, the study will be archived and new application required.
  3. For amendment, notification or other revision to approved study, the review timeline is within 1 month from the date of receipt by the Secretariat.

Please read through all of the information in the sections above before applying.

Consider applying to the UMMC MREC only if one of the investigators in your study is from University of Malaya Medical Centre (UMMC) or Faculty of Medicine (FOM), University of Malaya. Investigators who are NOT from UMMC/FOM must appoint one investigator from UMMC/FOM to apply for the research ethics approval. The applying investigator as well as all investigators are accountable for the research conducted in UMMC.

  1. For a UMMC/FOM investigator who has a Single Sign On (SSO) account, please apply via the UMMC Staff Portal (http://my2.ummc.edu.my/loginntv2.asp) at e-servis > iResearch.
  2. For a UMMC/FOM investigator who does NOT have a Single Sign On (SSO) account, please apply at the UMMC eservices portal (https://eservices.ummc.edu.my/iresearch/login.asp).

Students from FOM can apply for the UMMC Research Ethics Approval but he/she must include his/her supervisor's name (who are from UMMC/FOM) when applying. Students who are not from FOM should appoint one lecturer from UMMC/FOM to apply for the Ethics Approval.

Research Assistant (RA), Study Coordinator (SC), Clinical Research Officer (CRO) or any personnel from the pharmaceutical company are not allowed to apply for UMMC research ethics approval instead the UMMC/FOM investigator who is in the same team should apply for the ethics approval.



Click here to download the template of the MREC Online Application Form .
*Note: The MREC only accepts online submission. This template is just for reference and discussion with co-investigators before submission.

Click here to view the flow chart of the process of the Research Ethics Application.



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