National Health Research Act and Regulatory Framework

This topic examines the National Health Research Act of Zambia (2013), a critical legislative framework for tertiary students in health policy, law, and public health. It covers the establishment and functions of the National Health Research Authority (NHRA) and the National Health Research Ethics Board (NHREC). Students will learn about the regulatory processes for approving, monitoring, and accrediting health research, research institutions, and ethics committees within Zambia. The module addresses key provisions regarding ethical approval, informed consent (including for minors and vulnerable groups), handling of biological materials, clinical trials regulation, and intellectual property rights. For university and college students, understanding this Act is essential for conducting legally compliant research in Zambia, serving on ethics review boards, or engaging in health policy analysis. It provides the legal and ethical groundwork for ensuring that health research in Zambia is conducted responsibly, prioritizes national needs, and protects the rights and welfare of all participants.