Independent Ethics Committee

Research at SJMC

At SJMC, our experienced investigators explore a diverse range of research, including:

• Clinical Trials of novel drug or medical device therapies in order to further our understanding of their effectiveness in the management of human illnesses. These trials directly involve patients are usually conducted in collaboration with sponsors of novel drug or medical device therapies.
• Registry / Observational studies by conducting analysis of real-world data which provide valuable insights into the natural history of diseases and standard of care treatment effectiveness.
• Health Outcomes Research analysing how healthcare services influence patient well-being and explores ways to improve the overall quality.

We firmly believe that upholding ethical principles is paramount in research and advancing medical knowledge. Under the governance of Independent Ethics Committee (IEC) which was established in 2009, we are fully registered with the Drug Control Authority (DCA) of Malaysia and committed to maintaining ethical standards in research.

The IEC operates in strict adherence to local and international ethics standards and undergoes regulatory inspection as per national guidelines.  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.

Membership

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.

Quorum

• 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
• National Medical Research Register (NMRR)
• Malaysian Code of Responsible Conduct in Research, 2nd Edition 2020
• Health Research Priorities For 12th Malaysia Plan (12MP-HRP) 2021 – 2025
• Guidelines for Application of Clinical Trial Import License And Clinical Trial Exemption In Malaysia, Edition 7.1 2021