iium rESEARCH eTHICS cOMMITTEE

The IIUM Research Ethics Committee (IREC) serves as the institutional review board for the International Islamic University Malaysia (IIUM). Formerly known as the Kulliyyah of Medicine Ethics Committee, it was expanded and renamed in 2012 to oversee all research involving human subjects across the university.

Here is an overview of the committee’s Terms of Reference (TOR) based on its mandate and official structure:

1. Core Mandate

IREC’s primary responsibility is to safeguard the rights, dignity, health, safety, and well-being of human participants involved in research conducted under the auspices of the university. The committee ensures that all research is rooted in valid science, prioritizes informed consent, and protects the university against potential legal implications arising from unethical conduct.

2. Committee Composition and Membership

To ensure well-rounded and unbiased reviews, the committee requires a multidisciplinary and diverse membership:

• Size: A minimum of 8 and a maximum of 12 active members.
• Leadership: Headed by a Chairperson (typically an expert in a relevant research area, preferably with a medical background) and an Alternate Chairperson.
• Secretariat: Provided by the Research Management Centre (RMC).
• Representation: Membership must reflect an equitable balance of professional, ethical, legal, cultural, educational, spiritual, and community interests. This includes:
• Academicians, clinicians, and scientists
• Non-scientists and laypersons
• A lawyer or expert in ethics
• A social worker, teacher, or religious scholar
• Community members

3. Key Duties and Functions

IREC operates to maintain ethical integrity in both clinical and social science research through several key functions:

• Review and Approval: Evaluating research protocols to ensure risks are commensurate with the benefits to the individual and humanity.
• Vulnerable Populations: Providing special oversight and care for vulnerable individuals who require additional protection during studies.
• Continuous Monitoring: Conducting annual “continuing reviews” of ongoing research, assessing progress reports, protocol amendments, and reports of Serious Adverse Events (SAEs).
• Compliance: Ensuring that commercial or political influences do not corrupt the progress of research and that the study aligns with local and international legal frameworks.

4. Guiding Principles

The committee bases its reflections, advice, and decisions on established national and international ethical standards, including:

• The Declaration of Helsinki (World Medical Association) regarding the ethical principles for medical research involving human subjects.
• Malaysian Good Clinical Practice (GCP) Guidelines issued by the Ministry of Health, Malaysia.
• CIOMS Guidelines: The International Ethical Guidelines for Health-related Research Involving Humans.
• The overarching vision and mission of IIUM.