Nandra Rajpal, Brockie Alan F, Hussain Faisal
Health Education West Midlands, Birmingham, UK.
Academic Department of Military Nursing, Birmingham, UK.
EFORT Open Rev. 2020 Feb 26;5(2):73-79. doi: 10.1302/2058-5241.5.180051. eCollection 2020 Feb.
A vulnerable participant in research lacks capacity to consent or may be exposed to coercion to participate. Capacity may be temporarily impaired due to loss of consciousness, hypoxia, pain and the consumption of alcohol or elicit substances.To advance emergency care, providing life-threatening measures in life-threatening circumstances, vulnerable patients are recruited into research studies. The urgent need for time-critical treatment conflicts with routine informed consent procedures.This article reviews ethical considerations and moral obligations to safeguard these participants and preserve their autonomy.A particular focus is given to research methodology to waive consent, and the role of ethics committees, research audits, research nurses and community engagement.Research on the acutely unwell patient who lacks capacity is possible with well-designed research trials that are led by investigators who are sufficiently trained, engage the community, gain ethical approval to waive consent and continuously audit practice. Cite this article: 2020;5:73-79. DOI: 10.1302/2058-5241.5.180051.
研究中的弱势参与者缺乏同意的能力,或者可能面临参与研究的胁迫。能力可能会因意识丧失、缺氧、疼痛以及饮酒或使用成瘾物质而暂时受损。为了推进急救,在危及生命的情况下提供危及生命的措施,弱势患者被纳入研究。对时间要求紧迫的治疗的迫切需求与常规的知情同意程序相冲突。本文回顾了保护这些参与者并维护其自主性的伦理考量和道德义务。特别关注放弃同意的研究方法,以及伦理委员会、研究审核、研究护士和社区参与的作用。通过精心设计的研究试验,由经过充分培训的研究者牵头,与社区合作,获得放弃同意的伦理批准并持续审核实践,对缺乏能力的急性病患者进行研究是可行的。引用本文:2020;5:73 - 79。DOI:10.1302/2058 - 5241.5.180051。