Van Westendorp Mathijs, Lierman Steven
Leuven Institute for Healthcare Policy, University of Leuven, Leuven, Belgium.
Leuven Centre for Public Law, University of Leuven, Leuven, Belgium.
Med Law Rev. 2020 Feb 1;28(1):65-92. doi: 10.1093/medlaw/fwy041.
Prisoners are often excluded from participating in clinical research (ie clinical trials and clinical investigations related to medicinal products and medical devices) due to the historical precedent of their abuse and exploitation. The exclusion of prisoners from clinical research is often deemed necessary to guarantee their protection from such abuse and exploitation. However, in this article, we argue that the right to science, which encompasses the right to access the benefits of science and research participation, is an emerging human right that is applicable to prisoners and may only be limited when this is necessary and proportionate. Whether this is necessary depends in part on the validity of a prisoner's informed consent. We discuss the importance of prison conditions for voluntary consent and examine the relationship between prison overcrowding and sub-par prison conditions by analysing the jurisprudence of the European Court of Human Rights on Article 3 of the European Convention on Human Rights on the prohibition of torture and inhuman treatment. We contend that the special circumstances of being in prison warrant additional protective measures, concurring with the Belgian Advisory Committee on Bioethics that research without the explicit aim of improving the situation of the individual prisoner or the prison community should be excluded. Given the complexity of the question of whether prisoners can give valid informed consent, rigorous oversight by an ethics committee with expertise concerning the prison system is necessary to provide a proportional balance between offering prisoners access to research and protection from abuse and exploitation.
由于历史上存在对囚犯的虐待和剥削先例，囚犯往往被排除在参与临床研究（即与药品和医疗器械相关的临床试验及临床调查）之外。将囚犯排除在临床研究之外通常被认为是必要的，以确保他们免受此类虐待和剥削。然而，在本文中，我们认为，科学权，包括获得科学利益和参与研究的权利，是一项适用于囚犯的新兴人权，只有在必要且相称的情况下才可能受到限制。这是否必要部分取决于囚犯知情同意的有效性。我们讨论了监狱条件对自愿同意的重要性，并通过分析欧洲人权法院关于《欧洲人权公约》第三条禁止酷刑和不人道待遇的判例，研究了监狱过度拥挤与低于标准的监狱条件之间的关系。我们认为，身处监狱的特殊情况需要额外的保护措施，这与比利时生物伦理咨询委员会的观点一致，即应排除那些并非明确旨在改善个别囚犯或监狱社区状况的研究。鉴于囚犯能否给出有效的知情同意这一问题的复杂性，由具有监狱系统专业知识的伦理委员会进行严格监督，对于在让囚犯参与研究与保护他们免受虐待和剥削之间实现相称的平衡是必要的。
