Beshir Lamis
Department of Clinical Immunology, Sudan Medical Specialization Board, Khartoum, Sudan.
On behalf of the IFCC Task Force on Ethics (TF-E).
EJIFCC. 2020 Nov 20;31(4):282-291. eCollection 2020 Nov.
Biomedical research that involves human subjects requires compliance with ethical principles and guidelines. The ethical and scientific standards of research have been thoroughly discussed by international ethical guidelines and declarations. Compliance with these ensures the autonomy, dignity and well-being of research subjects; as well as the integrity and credibility of research results. Research ethics committees (RECs) are mandated to ensure that research proposals are scientifically sound and ethical. In this review, we define RECs in laboratory medicine and describe their role based on the examination of the requirements of ethical research; discuss particular ethical issues that arise in laboratory medicine research using biological samples, what challenges they face and how they can ensure the quality of their review. RECs need to be put into a broader framework that ensures institutional governance with continuous evaluation and auditing that ensure the quality of ethical review.
涉及人类受试者的生物医学研究需要遵循伦理原则和准则。国际伦理准则和宣言已对研究的伦理和科学标准进行了全面讨论。遵守这些准则可确保研究受试者的自主性、尊严和福祉，以及研究结果的完整性和可信度。研究伦理委员会（RECs）的职责是确保研究提案在科学上合理且符合伦理。在本综述中，我们界定了检验医学中的研究伦理委员会，并根据对伦理研究要求的审视描述了它们的作用；讨论了使用生物样本的检验医学研究中出现的特定伦理问题、它们面临的挑战以及如何确保其审查质量。研究伦理委员会需要置于一个更广泛的框架中，该框架确保通过持续评估和审计进行机构治理，以确保伦理审查的质量。
