Talking to the people that really matter about their participation in pandemic clinical research: A qualitative study in four European countries

Abstract

BackgroundPandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza‐like illness pandemic.MethodsDescriptive‐interpretive qualitative study, using focus groups (n = 10) and semi‐structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario‐based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis.ResultsPublic understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life‐threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low‐risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain.ConclusionsThis bottom‐up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low‐risk studies.

Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review

“…Ethical issues also arose around equity in access to health care for participants and nonparticipants [44,50,59]. There were calls for international standards for the conduct of emergency research [21,51,60,62], [51], acceptable study designs [14] and simplified consent methods [2,3,6,25,37,46,51,70,74]. Some studies explored waivered consent [2,25,69,70,74] and/or proxy consent [69].…”

“…However, gaining proxy consent was also found to be challenging during emergencies [15]. A qualitative study set in Europe found public support for consent waiver for publicly funded, low-risk studies and routinely collected anonymised biological samples for research, and for advanced or verbal consent models for pandemics [70,74]. An interventional Ebola study set in Guinea reported patient preference for verbal consent [69].…”

Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic

“…Patients agree with this approach, as shown by a number of studies conducted before the current pandemic. 7,8 Canada's clinical research infrastructure is being scaled quickly to meet these scientific and ethical imperatives, similar to trials that were conducted during the Ebola epidemic. 9 The Canadian Institutes of Health Research and its partners launched a rapid research funding opportunity on COVID-19 in February 2020, completing applications, submissions, peer review and initial funding decisions within 18 days.…”

Participant and Caregiver Perspectives on Clinical Research During Covid‐19 Pandemic

“…Historically, low and middle income countries have borne the burden of infectious disease outbreaks, but more recently pandemics have exposed the lack of preparedness in well‐connected, economically‐stable, developed countries. Although patient‐centered research is critical during pandemics, each pandemic brings huge disruptions in essential clinical research . Coronavirus Disease (COVID‐19), with its asymptomatic transmission, symptoms mimicking those of influenza, and a human‐to‐human transmission rate of 4, has attained a pandemic state and exposed the vulnerability of our clinical research enterprise …”