Griffith Richard, Tengnah Cassam
School of Health Science, Swansea University.
Br J Community Nurs. 2010 Oct;15(10):508-9, 511-2. doi: 10.12968/bjcn.2010.15.10.78763.
In keeping with the Declaration of Helsinki, health-care research generally requires the informed consent of those who participate in the study. This approach upholds the autonomy of the participants but restricts research to subjects who have decision-making capacity. In order that people who lack decision making capacity can benefit from properly conducted research, the Mental Capacity Act 2005 introduced safeguards that enable researchers to investigate the care and treatment of people with incapacity while protecting this vulnerable patient group. This article outlines the requirements that must be met when conducting research with subjects who lack decision-making capacity.
根据《赫尔辛基宣言》，医疗保健研究通常需要研究参与者的知情同意。这种做法维护了参与者的自主权，但将研究限制在具有决策能力的受试者范围内。为了使缺乏决策能力的人能够从妥善开展的研究中受益，2005年的《精神能力法案》引入了保障措施，使研究人员能够在保护这一弱势群体的同时，对无行为能力者的护理和治疗进行研究。本文概述了在对缺乏决策能力的受试者进行研究时必须满足的要求。
