Clinical Research Governance in Malaysian Hospitals: A Maqāsid Al-Sharīʿah Perspective and Comparative Analysis of Bioethical Principlism

Abstract

Clinical research is essential to the progress of modern medicine, especially in developing safe and effective therapies, pharmaceuticals, and health technologies. Ethical oversight of clinical trials is largely shaped by international frameworks such as ICH Good Clinical Practice (E6[R3]) and national standards including the Malaysian Guideline for Good Clinical Practice (4th Edition). Together, these frameworks prioritize participant protection, scientific integrity, informed consent, and institutional accountability. In Muslim-majority settings such as Malaysia, ethical appraisal of hospital-based research may be strengthened by a complementary normative lens grounded in Maqāṣid al-Sharīʿah (the objectives of Islamic law). This article offers a conceptual analysis of clinical research ethics in hospital environments through Maqāṣid reasoning while critically engaging Western bioethical principlism. Using a qualitative, library-based approach, the study synthesizes classical and contemporary Maqāṣid scholarship alongside regulatory and healthcare ethics literature. The analysis indicates that the preservation of life (ḥifẓ al-nafs), intellect (ḥifẓ al-ʿaql), wealth (ḥifẓ al-māl), lineage (ḥifẓ al-nasl), and religion (ḥifẓ al-dīn), supported by the pursuit of maṣlaḥah (public benefit) and the prevention of mafsadah (harm), provides a holistic and purpose-oriented ethical framework. Beyond aligning with global governance standards, the Maqāṣid approach adds ethical depth by emphasizing moral intention, spiritual accountability, and socio-communal welfare. Integrating Maqāṣid into Malaysian clinical research governance may therefore enhance ethical robustness while remaining compatible with international regulatory expectations. This paper proposes a two-layer framework for IRB deliberation that maintains GCP requirements while incorporating Maqāṣid-oriented ethical considerations for Malaysian hospital governance.