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) members | At lease one (1) member who independent of the institutional/trial site | At 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
DRMU 