Moodley K, Allwood B W, Rossouw T M
Centre for Medical Ethics and Law, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
S Afr Med J. 2020 May 26;110(7):629-634.
Pandemics challenge clinicians and scientists in many ways, especially when the virus is novel and disease expression becomes variable or unpredictable. Under such circumstances, research becomes critical to inform clinical care and protect future patients. Given that severely ill patients admitted to intensive care units are at high risk of mortality, establishing the cause of death at a histopathological level could prove invaluable in contributing to the understanding of COVID-19. Postmortem examination including autopsies would be optimal. However, in the context of high contagion and limited personal protective equipment, full autopsies are not being conducted in South Africa (SA). A compromise would require tissue biopsies and samples to be taken immediately after death to obtain diagnostic information, which could potentially guide care of future patients, or generate hypotheses for finding needed solutions. In the absence of an advance written directive (including a will or medical record) providing consent for postmortem research, proxy consent is the next best option. However, obtaining consent from distraught family members, under circumstances of legally mandated lockdown when strict infection control measures limit visitors in hospitals, is challenging. Their extreme vulnerability and emotional distress make full understanding of the rationale and consent process difficult either before or upon death of a family member. While it is morally distressing to convey a message of death telephonically, it is inhumane to request consent for urgent research in the same conversation. Careful balancing of the principles of autonomy, non-maleficence and justice becomes an ethical imperative. Under such circumstances, a waiver of consent, preferably followed by deferred proxy consent, granted by a research ethics committee in keeping with national ethics guidance and legislation, would fulfil the basic premise of care and research: first do no harm. This article examines the SA research ethics framework, guidance and legislation to justify support for a waiver of consent followed by deferred proxy consent, when possible, in urgent research after death to inform current and future care to contain the pandemic in the public interest.
大流行在许多方面给临床医生和科学家带来了挑战，尤其是当病毒是新型病毒且疾病表现变得多变或不可预测时。在这种情况下，开展研究对于指导临床护理和保护未来患者至关重要。鉴于入住重症监护病房的重症患者死亡风险很高，在组织病理学层面确定死亡原因对于增进对新冠病毒的了解可能具有极高价值。包括尸检在内的死后检查将是最佳选择。然而，在高传染性和个人防护装备有限的情况下，南非并未进行全面尸检。一种折中的办法是在患者死亡后立即进行组织活检并采集样本，以获取诊断信息，这有可能为未来患者的护理提供指导，或为找到所需解决方案提出假设。在没有预先书面指示（包括遗嘱或病历）同意进行死后研究的情况下，替代同意是次优选择。然而，在法律规定的封锁期间，严格的感染控制措施限制了医院访客，要从心烦意乱的家庭成员那里获得同意具有挑战性。他们极度脆弱且情绪痛苦，使得在家庭成员死亡之前或之时充分理解研究的基本原理和同意程序都很困难。虽然通过电话传达死亡消息在道义上令人痛苦，但在同一通电话中要求同意进行紧急研究是不人道的。认真权衡自主、不伤害和公正原则成为一项伦理要求。在这种情况下，研究伦理委员会根据国家伦理指南和立法批准豁免同意，最好随后获得延期替代同意，将满足护理和研究的基本前提：首先不造成伤害。本文探讨了南非的研究伦理框架、指南和立法，以论证在死后紧急研究中支持豁免同意并在可能的情况下随后获得延期替代同意的合理性，以便为当前和未来的护理提供信息，从公共利益出发控制疫情。
