FAQ: Research Ethics Approval for Overseas Studies

1. Does the Malaysian Ethics Committee approve research conducted overseas?

No. Our committee’s jurisdiction covers research conducted within Malaysia or involving Malaysian participants, data, resources, or funding. Research done entirely overseas must seek approval from the ethics committee of the host country or institution.

2. Why isn’t overseas research eligible for Malaysian Ethics Committee approval?

Our mandate is governed by Malaysian laws, regulations, and institutional guidelines. Approving overseas research exceeds this mandate and may conflict with host-country governance frameworks and international standards such as the World Medical Association’s Declaration of Helsinki, which requires research ethics oversight by local authorities. [apps.who.int], [who.int]

3. What national references guide our policy?

• Malaysian Code of Responsible Conduct in Research (MCRCR) – states that ethical clearance is required from appropriate authorities, depending on location and involvement of Malaysian entities. [akademisains.gov.my], [rmc.uitm.edu.my]
• NIH Guidelines for Research in MOH Institutions (2021) – clarifies roles of both Malaysian and international ethics committees for studies conducted abroad. [nih.gov.my]
• Malaysian Guideline for Independent Ethics Committee Registration & Inspection (NPRA) – emphasizes committee scope aligned with Malaysian jurisdiction. [npra.gov.my]

4. What international standards support this approach?

• Declaration of Helsinki (World Medical Association) – mandates local ethics review and committee oversight in the research location. [apps.who.int], [who.int]
• CIOMS “International Ethical Guidelines for Health-related Research Involving Humans” (2016) – issued jointly with WHO, it affirms the importance of ethics review by the body in the research locale. [cioms.ch], [cioms.ch]

5. What if my research is overseas but involves Malaysian funding, collaborators, or data?

If any Malaysian entity—be it funding, affiliation, or data—is involved, you must apply for ethics approval here. This is in line with MCRCR, NIH MOH Guidelines, and CIOMS standards. [akademisains.gov.my], [nih.gov.my], [cioms.ch]

6. Who should I contact for overseas ethics approval?

Apply directly to the ethics committee of the host country or institution where the research will take place. Local approval ensures compliance with their regulatory framework, and supports publication and international collaboration.

🛡️ Why Host-Country Ethics Approval Is Mandatory Today

1. Compliance with International Ethical Standards

• Ethical frameworks such as the Declaration of Helsinki, CIOMS, and ICH-GCP require oversight by an independent review body in the country where the research is conducted—not just the sponsor country—ensuring context-sensitive protections for participants. [ummc.edu.my], [hopkinsmedicine.org]

2. Respecting Local Laws, Culture, and Sovereignty

• Requiring local ethics approval underscores respect for the host country’s legal system, cultural norms, and political sovereignty. This is a fundamental principle in international research conduct, reflecting a shift over the past decade. [researchse…ornell.edu], [rochester.edu]

3. Ensuring Appropriate Risk Management and Participant Protection

• Local ethics committees are best positioned to evaluate context-specific risks, consent processes, and participant/community welfare. External committees may overlook cultural nuances that significantly affect ethical validity. [hopkinsmedicine.org], [irb.byu.edu]

4. Alignment with Best Practice and Institutional Guidelines

• Major research institutions like Johns Hopkins, Cornell, and Fordham, as well as UKRIO and COPE, explicitly mandate both sponsor-country and host-country approvals—especially for international social science research. [hopkinsmedicine.org], [link.springer.com], [researchse…ornell.edu], [ukrio.org]

I will be using two or more study site, which one of it is in IIUM and another site at Government Hospital/Clinics (Ministry of Health), could I apply ethical approval to IREC                                                                                                                                                                           

Yes. However, approval from IREC are not accepted by Ministry of Health ( refer to MOH Directive) for MOH facilities. We, recommend you to apply approval from Ministry of Health first prior to IREC. You may submit Approval from Ministry of Health (MREC) together with submission to IREC for IIUM Site.