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Faculty of Dentistry, Medical Ethics Committee (FDMEC) undertakes independent ethics review of medical research protocols involving human participants (clinical) that includes funded and unfunded research that is related to dentistry only.
Protocols that involve human subjects but are not medical/health-related studies (non-clinical studies) are referred to the University of Malaya Research Ethics Committee (UMREC). Protocols that involved animals or non-human vertebrates have to be reviewed by the Animal Care Committee of the Faculty of Medicine, UM. Protocols that includes biological agents, living modified organism (LMO), infectious or potentially infectious agents/materials or biological toxins are referred to Biosafety and Biosecurity Committee (IBBC, UM)
Objectives of FDMEC are to safeguard the rights, safety and well-being of human research volunteers, provide timely, comprehensive review of proposed ethical studies, ensuring that there are due regards to existing law, regulations and community attitudes.
Protocols that involve human subjects but are not medical/health-related studies (non-clinical studies) are referred to the University of Malaya Research Ethics Committee (UMREC). Protocols that involved animals or non-human vertebrates have to be reviewed by the Animal Care Committee of the Faculty of Medicine, UM. Protocols that includes biological agents, living modified organism (LMO), infectious or potentially infectious agents/materials or biological toxins are referred to Biosafety and Biosecurity Committee (IBBC, UM)
Objectives of FDMEC are to safeguard the rights, safety and well-being of human research volunteers, provide timely, comprehensive review of proposed ethical studies, ensuring that there are due regards to existing law, 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 as well as the methods and materials to be used in obtaining and documenting consent of the human research subjects. FDMEC also examines the ethics components of the research such as, sound methodology, possible risks to the subjects, confidentiality or anonymity for the subjects, the way in which the data is handled, and how feedback can be provided for the subjects.
Composition of FDMEC Members
- Chair (A clinical academic staff appointed on advice of the Dean, Faculty of Dentistry, UM).
- Deputy Chair (A clinical academic staff appointed on advice of the Dean, Faculty of Dentistry, UM).
- Six (6) academic staff from disciplines of Oral Biology and Biomedical Sciences/ Oro-maxillofacial Surgical and Medical Sciences/ Restorative Dentistry/ Paediatric Dentistry and Orthodontics / Community Oral Health & Clinical Prevention/ Diagnostic and Integrated Dental Practice, Faculty of Dentistry, University of Malaya
- Dean, Faculty of Law, University of Malaya or nominated representative.
- Dean, Faculty of Medicine, University of Malaya or nominated representative.
- Director of Oral Health, Ministry of Health Malaysia or nominated representative.
- Public representative(s): at least one (1) person, by appointment of the Chairperson, as advised by the Deputy Chairperson. As an alternate another one (1) person will be nominated.
- Secretary: An officer of Faculty of Dentistry, appointed by Dean, Faculty of Dentistry
FDMEC answers to the Dean but is independent in its decision-making. Only FDMEC members, who are independent of the investigation and the sponsor of the study, may vote/provide a decision on a study related matter. A member shall not serve when his/ her own research proposal is being considered. Quorum for the full Committee (board) meeting is five (5) voting members including at least one scientific/medical member, at least one non-institutional member and at least one lay member. The Dean shall not approve any study that has been disapproved by FDMEC. FDMEC may further be supported in its deliberations on specific protocols or requests for advice on specific ethical and/or technical issues by independent consultants. The Secretary may provide an opinion on a study related matter but shall be a non-voting member.
Authority of FDMEC
The FDMEC has the authority to approve a proposed study, require modification of the study or disapprove the study. The FDMEC 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 FDMEC such as:
a) Changes to the approved protocol (to reduce/eliminate risk to subjects),
b) All serious adverse events,
c) New information that may adversely affect the safety of subjects or conduct of the trial,
d) When a study is discontinued prematurely, and
e) When a study is completed
a) Changes to the approved protocol (to reduce/eliminate risk to subjects),
b) All serious adverse events,
c) New information that may adversely affect the safety of subjects or conduct of the trial,
d) When a study is discontinued prematurely, and
e) When a study is completed
Dentistry Research Ethics Application Standard Operating Procedure (SOP)
1) SOP I: Structure and Composition
2) SOP II: Initial Review Procedure
3) SOP III: Post Review Procedure
4) SOP IV: Documentation and Archiving
2) SOP II: Initial Review Procedure
3) SOP III: Post Review Procedure
4) SOP IV: Documentation and Archiving
Important information for Ethics Application Process
The FDMEC application forms can be filled up and downloaded directly from this website. Please make sure that you have filled up each section and submission is complete prior to the checklist. Please show proof of payment before submitting your application. The FDMEC will strictly reject and will not entertain any incomplete submissions.
I) Online Application Form (Google Spreadsheet)- To be given later/Screenshot
II) Template for Patient Information Sheet (PIS)
III) Template for Consent Form
IV) Amendment Form
V) Study Progress Report and Closure Report Form
I) Online Application Form (Google Spreadsheet)- To be given later/Screenshot
II) Template for Patient Information Sheet (PIS)
III) Template for Consent Form
IV) Amendment Form
V) Study Progress Report and Closure Report Form
