Shepherd Victoria
South East Wales Trials Unit, Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Room 406, 4th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
BMC Med Ethics. 2016 Sep 8;17(1):55. doi: 10.1186/s12910-016-0138-9.
Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals' exclusion from research as a result of such regulation risks condemning such populations to poor quality care as a result of 'evidence biased' medicine.
This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs.
The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented.
社会未能履行其道德义务，未能通过一种被误导的家长式作风来提高为弱势群体（如缺乏决策能力的人）提供的医疗保健标准。这种家长式作风试图通过将他们排除在医学研究之外来保护他们。在双重监管制度下，关于研究参与决策的依据存在不确定性，这进一步增加了复杂性。由于这种监管，弱势群体被排除在研究之外，这有可能使这些人群因“证据有偏差”的医学而陷入低质量的医疗护理中。
本文探讨了针对那些无法自行提供知情同意的人的代理决策的研究监管规定，以及决策者随后面临的法律和实际困难。在英格兰和威尔士，有两种独立的监管制度来管理涉及缺乏同意能力的成年人的研究。2005年《精神能力法案》规定了无行为能力的成年人如何参与研究，然而，药品临床试验则由2004年《人用药品（临床试验）条例》另行监管。在这两种制度下，对于缺乏参与医学研究能力的人的规定存在显著差异。允许的风险水平不同，参与临床试验比其他类型的研究需要更多的参与理由。谁担任代理决策者、向无行为能力的人提供多少信息以及他们是否保留否决权也有很大差异。
两种独立监管制度的发展导致了临床试验规定与其他形式研究规定之间以及与常规医疗实践之间的显著差异。由此产生的不确定性强化了那些批准和进行研究的人排除无行为能力成年人的倾向，以避免就他们参与研究寻求同意做出艰难决策。未来的发展，如即将出台的欧盟法规，可能会解决其中一些差异，然而，允许的理由和风险水平需要审查，以确保要求适当且与个人的负担和风险以及更广泛人群所代表的利益相称。
