About FDMEC

Establishment

An independent body established since 2002


Members

Professionals (medical/dental/scientific) and non-members of medical /dental/scientific to review and approve research protocols involving humans and animals as well as the methods and materials used in obtaining and documenting consent in research involving human


Functions

To review and approve research protocols involving humans and animals as well as the methods and materials used in obtaining and documenting consent in research involving human. For publication purposes


Qourum FDMEC

Should consist of a reasonable number of members. Who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trial


At least five (5) membersAt lease one (1) member who independent of the institutional/trial siteAt least one (1) member whose primary area of interest is a non-scientific area

Responsibility of FDMEC

Qualification
of investigator for the proposed study as documented by CV and/or any other relevant documentation requested the MEC
Duplication
of the projects
Risks
to subjects are minimized and reasonable in relation to anticipated benefits.
Merits
of the proposed project
Informed Consent
related information given to subjects is in accordance with ICH-GCP guidelines. Request for translations if the study population would require that particular language
Review
both amount and methods of payment to subjects to ensure neither presents porblems to coercion or undue influence on the subjects


Who Requires Ethical Approval?

All research projects conducted by lecturers, students and researchers of Faculty of Dentistry
– Researchers from outside dental faculty who want to use the facilities, subjects or data from Faculty of Dentistry