Challenges and practices arising during public health emergencies: A qualitative survey on ethics committees

Ekmekçi, Perihan Elif; Güner, Müberra Devrim; Buruk, Banu; Güneş, Begüm; Arda, Berna; Görkey, Şefik

doi:10.1111/dewb.12345

Cited by 7 publications

(7 citation statements)

References 8 publications

(10 reference statements)

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“…However, a study among EC members in China 13 recorded that although the risks were perceived to be potentially more to the individual participants, the long-term benefits to the society at large were considered greater. Although the pressure for issuance of quick approvals was felt and expressed as a need of the pandemic time, it was not perceived as political pressure as reported in the investigations conducted in other countries 14 15 .…”

Section: Discussionmentioning

confidence: 97%

Challenges faced by ethics committee members in India during COVID-19 pandemic

Kadam

Patil

Sane

et al. 2022

Indian Journal of Medical Research

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Background & objectives: The COVID-19 pandemic had a distinct impact on scientific research and Ethics Committees (ECs). We conducted a mixed-methods investigation to understand the issues faced and solutions identified by ECs during this pandemic in India. Methods: A quantitative online survey form (30 members) and qualitative in-depth interviews (10 members) from various ECs were conducted. Thematic content analysis for qualitative and proportion analysis for quantitative data was carried out. Results: During the online survey, an average difficulty score, which was measured using the Visual Analogue Scale, was 5.3 (SD 2.1). Pressure for expedited approvals was felt by EC members with a drastic increase in the number of submission of research projects. The scarcity of information on investigational products (IPs) and requisite consent process posed major hurdles. Ongoing non-COVID studies and post-graduate dissertations were badly hit due to the shift in attention towards COVID-related research. Non-familiarity with virtual technology and lack of face-to-face interactions were highlighted as demerits. However, a few of the EC members welcomed newer methods, being time-saving, convenient and reducing travel hassles. Site monitoring and severe adverse event-related analyses were also negatively impacted upon. Solutions included the alternate methods of consenting (virtual, abbreviated), a detailed explanation of the protocol and IPs and benefits versus risk assessment. Interpretation & conclusions: Despite various challenges posed by the COVID-19 pandemic, the ECs in India steered well through the hurdles. Moreover, adapting a hybrid mode, technical training and updating guidelines were perceived as urgent by EC members.

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Section: Discussionmentioning

confidence: 97%

Challenges faced by ethics committee members in India during COVID-19 pandemic

Kadam

Patil

Sane

et al. 2022

Indian Journal of Medical Research

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“…Several of these contributions focus exclusively on one ERC, usually associated with an academic or health care institution. The literature includes descriptions of ERC operations during the pandemic in Central America and the Dominican Republic [17], China [18], Ecuador [19], Egypt [20], Germany [21], India [22–24], Iran [10], Ireland [25], Kenya [26], Kyrgyzstan [27], Latin America [28], the Netherlands [29], Pakistan [30], South Africa [31,32], Turkey [33], and the United States [34–36]. Most of these studies reported results from surveys, interviews, focus groups, and documentary analysis, including review of research protocols, ERC meeting minutes, and existing SOPs.…”

Section: Discussionmentioning

confidence: 99%

Research ethics review during the COVID-19 pandemic: An international study

Salamanca-Buentello,

Katz,

Silva

et al. 2023

Preprint

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Research ethics review committees (ERCs) worldwide faced daunting challenges during the COVID-19 pandemic. There was a need to balance rapid turnaround with rigorous evaluation of high-risk research protocols in the context of considerable uncertainty. This study explored the experiences and performance of ERCs during the pandemic.We conducted an anonymous, cross-sectional, global online survey of chairs (or their delegates) of ERCs who were involved in the review of COVID-19-related research protocols after March 2020. The survey ran from October 2022 to February 2023 and consisted of 50 items, with opportunities for open text responses.Two hundred and three participants [130 from high-income countries (HICs) and 73 from low-and middle-income countries (LMICs)] completed our survey. Respondents came from diverse entities and organizations from 48 countries (19 HICs and 29 LMICs) in all World Health Organization regions. Responses show little of the increased global funding for COVID-19 research was allotted to the operation of ERCs. Few ERCs had pre-existing internal policies to address operation during public health emergencies, but almost half used existing guidelines. Most ERCs modified existing procedures or designed and implemented new ones but had not evaluated the success of these changes. Participants overwhelmingly endorsed permanently implementing several of them. Few ERCs added new members but non-member experts were consulted; quorum was generally achieved. Collaboration among ERCs was infrequent, but reviews conducted by external ERCs were recognized and validated. Review volume increased during the pandemic, with COVID-19-related studies being prioritized. Most protocol reviews were reported as taking less than three weeks. One-third of respondents reported external pressure on their ERCs from different stakeholders to approve or reject specific COVID-19-related protocols.ERC members faced significant challenges to keep their committees functioning during the pandemic. Our findings can inform ERC approaches towards future public health emergencies. To our knowledge, this is the first international, COVID-19-related study of its kind.

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“…El trabajo de los comités de ética, tanto de investigación como de asistencia, se vio entorpecido por las incertidumbres, la falta de precedentes y la desorientación frente a dificultades de recursos materiales y humanos 22 . Primeros estudios empíricos confirman la disposición a aplicar evaluaciones rigurosamente médicas en situaciones de emergencia pandémica, a pesar de que en toda otra situación priman valores relevados por la bioética y los criterios personales de los cuidadores, sobre lo cual será necesario reflexionar una vez superada la urgencia actual, pues todos los criterios valóricos tienden a discriminar contra los desfavorecidos.…”

Section: Atualizaçãounclassified

Dos conflictos en la salud pública en pandemia

Kottow

2022

Rev. Bioét.

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Resumen La pandemia del covid-19 ha respondido de forma inédita a la asignación de recursos escasos e insuficientes en emergencia (triage) y a las dificultades de establecer medidas de contención que fluctuaban entre ser sugerentes, persuasivas y coercitivas. Criterios clásicos de triage fueron reemplazados por un utilitarismo extremo basado en criterios médicos objetivamente evaluados para privilegiar personas gravemente enfermas con pronóstico recuperable al aplicar medidas extremas de soporte y tratamiento. Las medidas obligatorias de contención y el llamado a la vacunación no lograron respaldo científico convincente; aplicadas en forma irregular y plagada de incertidumbres e inseguridades, afectaron a los más desaventajados y causaron protestas públicas y desacatos. El triage basado en criterios médicos utilitaristas provocó desazones y serias tensiones mentales en los decidores médicos y miembros de comités ad hoc. Estas experiencias sugieren renovar el discurso bioético individualista y elitista en busca de privilegiar el bien común por sobre intereses individuales.

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Challenges and practices arising during public health emergencies: A qualitative survey on ethics committees

Cited by 7 publications

References 8 publications

Challenges faced by ethics committee members in India during COVID-19 pandemic

Challenges faced by ethics committee members in India during COVID-19 pandemic

Research ethics review during the COVID-19 pandemic: An international study

Dos conflictos en la salud pública en pandemia

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