Understanding Ethics Committee Frameworks in ASEAN: A Guide for Clinical Trial Professionals

In clinical research, ethics committees play a critical role in safeguarding participant rights, safety, and well-being. Across the ASEAN region, where multi-country trials are increasing in frequency, understanding the structural and procedural variations among national and institutional ethics committees is essential for regulatory success and GCP compliance.

This tutorial offers a deep dive into how ethics committees (ECs) or Institutional Review Boards (IRBs) operate across ASEAN countries. It outlines their responsibilities, standard operating procedures, and how sponsors can harmonize their submission approaches while conducting regional trials.

What is an Ethics Committee in Clinical Trials?

An Ethics Committee is an independent body tasked with reviewing, approving, and monitoring biomedical research involving human subjects. Their goal is to ensure that all ethical and legal aspects of the study are in compliance with the GMP guidelines and the ASEAN GCP framework.

Core Responsibilities of Ethics Committees:

• Review of trial protocols for ethical and scientific soundness
• Assessment of informed consent procedures and documentation
• Oversight of subject safety and risk mitigation plans
• Approval or rejection of trial-related amendments
• Continuous monitoring via progress reports and adverse event summaries

While the functions are similar across regions, the structure and processes differ widely across ASEAN member states.

Country-wise Overview of Ethics Committee Structures:

1. Singapore:

Ethics oversight is coordinated by the Domain-Specific Review Boards (DSRBs) under the Ministry of Health. Singapore’s ECs are highly aligned with international GCP standards and work closely with the HSA for dual ethical and regulatory approvals.

2. Malaysia:

Malaysia utilizes a dual structure comprising the Medical Research and Ethics Committee (MREC) and institutional ECs. For multi-center trials, centralized MREC approval is essential for public hospitals, while private institutions require individual IRB clearance.

3. Thailand:

Ethics reviews are handled by both university-based and hospital-based ECs. Thailand’s Drug Control Division mandates GCP certification and accredited EC approval for trial applications.

4. Indonesia:

Central and regional ECs operate under the supervision of the Ministry of Health. The ECs are often linked to universities and medical faculties. Despite centralized policies, delays and inconsistent SOPs can pose challenges.

5. Philippines:

Ethics Committees are registered with the Philippine Health Research Ethics Board (PHREB). Registration is mandatory, and trials must be approved by accredited ECs before ACTR listing. GCP training is compulsory for all EC members.

6. Vietnam:

MOH-approved ethics boards are required for all clinical trials. Most ethics boards are hospital-based and operate with standard SOPs modeled after ICH-GCP. Some decentralized ECs may require translation of protocols into Vietnamese.

7. Other ASEAN Countries:

• Brunei: Limited clinical trial activity; ECs exist but are not routinely engaged in multinational trials.
• Myanmar and Cambodia: Emerging ethics review frameworks under health ministries with growing capacity-building efforts.
• Laos: Centralized EC under Ministry of Health focusing on public health studies.

The level of maturity and harmonization varies significantly, influencing trial planning, especially for regional submissions.

Harmonization Challenges in ASEAN EC Approvals:

Despite the existence of ASEAN GCP, challenges persist in cross-country EC coordination:

• Inconsistent timelines and review calendars
• Diverse submission formats and language requirements
• Lack of central accreditation systems in several countries
• Manual vs. digital workflows causing administrative delays

Such inconsistencies necessitate buffer timelines, regional submission strategies, and pre-engagement with local EC secretariats.

Submission Process to ASEAN Ethics Committees:

1. Prepare protocol, informed consent forms, IB, and case report forms (CRFs)
2. Translate documents where required (Vietnamese, Bahasa Indonesia, Thai)
3. Submit application form and supporting documents to the designated EC
4. Address queries raised during EC meetings
5. Receive formal approval or request for amendments
6. Submit periodic safety updates and protocol deviations as needed

Templates aligned with Pharma SOP documentation can improve the efficiency and compliance of ethics submissions.

Best Practices for Sponsors and Investigators:

• Engage ECs early during protocol development
• Ensure EC members are GCP trained and recognized by national regulators
• Maintain a master file of EC communications, SOPs, and training logs
• Involve local investigators familiar with EC expectations and language requirements
• Use bilingual consent forms approved by country-specific ECs

Adhering to these practices ensures faster approvals and minimizes protocol compliance issues post-trial initiation.

Future of Ethics Harmonization in ASEAN:

The ASEAN Clinical Research Network (ACRN) is currently exploring centralized ethics review for multicenter studies. Pilot projects are being conducted under the ASEAN Secretariat to streamline mutual recognition of EC approvals.

As per EMA and TGA models, ASEAN nations are working toward shared EC registries, audit trails, and digital application portals.

ACTR integration and standardized GCP inspections may further align national ECs with international expectations, enhancing the global appeal of ASEAN as a trial hub.

Conclusion

The ethics committee landscape in ASEAN is evolving rapidly. While challenges remain in standardization and capacity building, national ECs are increasingly aligning with ASEAN GCP and global norms. Understanding these structures and tailoring submission strategies accordingly is key to successful trial approval and conduct in Southeast Asia.

Whether you are conducting trials in Singapore’s digital environment or navigating decentralized ECs in Indonesia or Vietnam, a clear roadmap built on best practices and local insights will ensure ethical, timely, and compliant trial execution.