The committee is an independent body comprised of medical and scientific professionals, and non-medical members, whose ultimate responsibility it is to:
- Ensure the protection of the rights, safety and well-being of human subjects involved in a trial
- Provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Clinical trials must be conducted in accordance with the ethical principles that originate in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s) of the country in which they are undertaken.
This committee is an independent body constituted of medical, scientific and lay members. It consists of nine members who collectively have the qualifications and experience to review and evaluate the scientific, medical and ethical aspects of a proposed research project.
- A minimum of five (5) members are required to form the quorum, without which a decision regarding the project should not be taken.
- The quorum must include at least one member whose primary area of interest/specialisation is non-scientific and at least one member who is independent of the institution/site of the trial.
Research Resources / Useful Links
- Malaysian Guideline for Good Clinical Practice 4th Edition 2018
- Belmont’s Report
- The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
- Research guidelines information from Clinical Research Centre Malaysia
- MOH Checklist For Research On Stem Cell And Cell-Based Therapies
- Malaysia Guidelines on the use of Human Biological Samples for Research