Current Edition

Paving the Way for a Robust Research Ethics Review Structure in Malaysia

Introduction

The foundation of good research is built on sound ethical principles, which require a good rationale, a solid methodology and proper consideration of the important ethical issues that may arise from the research. The main task of research ethics committees is to ensure the above principles, so all research involving human subjects will have adequate protection of their dignity, rights, and safety.

With over 30 years of experience in clinical research, Malaysia has a well-established and experienced ethics and regulatory infrastructure. There are 13 recognised research ethics committees/institutional review boards (RECs/IRBs) in Malaysia, each responsible for the ethical review of research proposals involving human participants conducted at their respective institutions. The Medical Research Ethics Committee (MREC) within the National Institutes of Health (NIH), which is part of the Ministry of Health (MOH) Malaysia, reviews all clinical research protocols involving any MOH facility. The majority of public universities and a few private institutions have their own REC/IRB and for institutions that do not have their own REC/IRB, the ethics application is sent to any of the recognised RECs/IRBs. In the case of multicentre research proposals, making use of facilities of different institutions, ethical approval is obtained from each of the institutions involved in the research.

In an attempt to increase the capacity and quality of ethical review of research proposals involving humans, and to streamline and harmonise the processes of the various IRBs/IECs in Malaysia, the Network of Ethical Review Committees in Malaysia (NERCIM) was established in 2015. This article aims to lay out the current challenges faced by various research ethics committees in the region, detailing the current Malaysian ethical and review landscape, and present NERCIM as a proposed way forward to address these issues.

Challenges Faced with Research Ethics Committees in the Asia-Pacific Region

While ethics review and all processes involved in it seem to be quite uniformed and harmonised for many of the high-income countries, it is just not feasible to adopt all of their processes especially, when factoring in the protection of populations in many low- and middle-income countries in our region. Basic differences in accessibility to healthcare facilities and drugs are quite notable between countries, and even between provinces within many countries. There are also significant gaps in education, let alone health awareness and commitment to a healthy lifestyle.

On top of the difference in needs between the low- and middle-income countries versus the high-income countries, many of the countries in the region still experience a certain lack of capacity to conduct high-quality ethical review of complex research proposals, often causing unnecessary delays in the start of international projects and sometimes depriving their institutions of good research opportunities.