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Consent for critical care research after death from COVID-19 : arguments for a waiver

Moodley, K. ; Rossouw, T.M. ; Allwood, B.W.

SAMJ: South African Medical Journal, 2020-07, Vol.110 (7), p.629-734 [Periódico revisado por pares]

South Africa: South African Medical Association NPC

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Título:
Consent for critical care research after death from COVID-19 : arguments for a waiver
Autor: Moodley, K. ; Rossouw, T.M. ; Allwood, B.W.
Assuntos: Cause of Death ; Coronavirus Infections - epidemiology ; Coronavirus Infections - prevention & control ; COVID-19 ; Critical Care - ethics ; Critical Care - legislation & jurisprudence ; Critical Illness - mortality ; Critical Illness - therapy ; Developing Countries ; Epidemics ; Female ; Health aspects ; Health Care Sciences & Services ; Health Policy & Services ; Hospital Mortality ; Humans ; Infection Control - organization & administration ; Informed Consent - ethics ; Intensive Care Units - ethics ; Intensive Care Units - statistics & numerical data ; Male ; Medical Ethics ; Medical records ; Medical research ; Medicine, Experimental ; Medicine, General & Internal ; Medicine, Legal ; Medicine, Research & Experimental ; Mortality ; Needs Assessment ; Pandemics - prevention & control ; Pandemics - statistics & numerical data ; Pneumonia, Viral - epidemiology ; Pneumonia, Viral - prevention & control ; Research Design ; Risk Assessment ; South Africa ; Vulnerable Populations - statistics & numerical data
É parte de: SAMJ: South African Medical Journal, 2020-07, Vol.110 (7), p.629-734
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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Descrição: 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.
Editor: South Africa: South African Medical Association NPC
Idioma: Inglês;Português

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Consent for critical care research after death from COVID-19 : arguments for a waiver

Moodley, K. ; Rossouw, T.M. ; Allwood, B.W.

South Africa: South African Medical Association NPC

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