Chadly Ali
Service de Médecine Légale, Hôpital Universitaire Fattouma Bourguiba, Monastir, Tunisie.
Tunis Med. 2004 Nov;82(11):985-9.
Clinical trials are necessary for medical advancement. They must respect legal obligations. Ethical questions related to protection of the human being's rights are yielded by these trials. Joining research to medical core is problematical in consideration of patient's consent to clinical trial. Exclusion by the Tunisian law of persons under age, pregnant or breast-feeding women from medical experimentation in the aim of protecting them against clinical research adverse events or abuses is ethically questionable since it deprives them from a possible medical progress. So why not to involve them in clinical research when there is an expected benefit, after bringing them protection as vulnerable persons like we should do for instance for the elderly, handicapped persons or prisoners. Legal creation of research ethics committees is important for the respect of experimentation rules on human beings.
临床试验对于医学进步是必要的。它们必须遵守法律义务。这些试验引发了与保护人权相关的伦理问题。考虑到患者对临床试验的同意,将研究与医学核心相结合存在问题。突尼斯法律将未成年人、孕妇或哺乳期妇女排除在医学实验之外,旨在保护他们免受临床研究不良事件或滥用的影响,但从伦理角度来看这是有问题的,因为这使他们无法获得可能的医学进步。那么,当存在预期益处时,为什么不像我们对待老年人、残疾人或囚犯等弱势群体那样给予他们保护后,不让他们参与临床研究呢?合法设立研究伦理委员会对于遵守人体实验规则很重要。