Protocols involving clinical audit, literature review, systematic review and meta-analysis and lab-based biomaterials DO NOT need ethics application.
Clinical research protocols involving human participants; as well as methods and materials used in obtaining and documenting consent in research includes the following: a. Biological samples e.g. blood, saliva etc b.Archived data e.g. radiographs, biopsy reports, archival tissues etc. c.Paraffin-embedded tissue d.Survey using questionnaires (physical or online survey) e.Cell line/ stem cell f.Extracted teeth
All human studies require ‘Participant Information Sheet (PIS)’ and Consent form EXCEPT for online questionnaires/surveys.
A copy of the approval letter / agreement from the relevant organization / agency shall be attached together with the application for ethics approval, in the following situations: i) UMMC MREC - For research involving University Malaya Medical Centre (UMMC). ii) University of Malaya Institutional Animal Care and Use Committee (UMIACUC) - For research involving animals iii) Senior Principal Director (Oral Health), Oral Health Division, Ministry of Health Malaysia - For research involving the Oral Health Division in the Ministry of Health (MOH) iv) National Medical Research Registry (NMRR) - For research conducted in public hospital and clinic iv) Institutional Biosafety and Biosecurity Committee (IBBC) - For research involving infectious and potentially infectious agents/ materials and biological toxins.
Elements in reviewing the FDMEC application
In the consideration of a study, the FDMEC requires that it be conducted in accordance with ICH Harmonized 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. FDMEC may request for translations if they think the study population would require that particular language. The review process may (and often does) involve an interview of the Principal Investigator.
The elements of the FDMEC 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.
FDMEC Ethics Review Assessment Form (RAF) and Checklist