Public attitudes towards research participation during an infectious disease pandemic: a qualitative study across four European countries

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].…”

“…It was also emphasised that interventions need to be culturally sensitive [27,29,44,50,51,58] and respond to national as well as global need [36]. Examples of community engagement included regular information sessions [3,5,16,29,34,42,[69][70][71], joint communication plans [20,29], outreach health promotion teams [69] and formation of community advisory boards [69].…”

“…Key actions identifiedDomainKey actions identified Political and economic challenges Establish effective, coordinated, equitable collaborations between international and national organisations involved in public health emergencies at all levels[1,3,7, ,13, 14, 18, 19, 21, 22, 24, 26, 27, 35, 37, 39-41, 51, 52, 54, 57-60] include national stakeholders[26,38] and systems for evaluating the impact, regular reviews and updating[19] Develop pre-designed and pre-approved study protocols and associated tools for different scenarios[1,3,4, 13, 15, 17, 20, 29, 34, 37, 41, 46, 48, 50, 51, 55, 56, 61-63] Establish accelerated pathways for regulatory and ethical joint approvals [1, 2, 6, 7, 13, 18, 20, 21, 32, 34, 37, 40, 41, 45, 49, 51, 53, 56, 64-66] Set up pre-approved site agreements [4, 15, 38, 45, 46, 48, 61] Establish international data and sample sharing agreements and templates [7, 13, 18, 20, 22, 24, 25, 27, 28, 35, 44, 48, 52, 57, 58, 62, 67, 68] Establish coordinated, effective internal and external stakeholder communication and communication plans [3, 5, 14, 16, 18, 20, 23, 25, 29, 32, 34, 42, 46, 58, 65, 69-72] Ethical emergency publication agreements with focus on timely, open data sharing[2,22,38,52,68,73] Ethical and social challenges Explore and trial less complex consent models during emergencies[2,6,15,25,32,37,44,46,48,51,69,70,74] Develop frameworks for ethical and scientifically robust study designs for various epidemic and pandemic scenarios[6, 13, 14, 17-19, 22, 27, 34, 36, 40, 42, 48, 51, 60, 61, 66, 75-77] Develop international guidelines on ethical standards and conduct for emergencies, including inclusion of vulnerable groups[5,18,21,22,27,…”

Pandemics, Public Health and Social Science

“…Such considerations led our research team to look more specifi cally at public involvement and what the public actually thought about giving consent for research during pandemic periods[13,14]. Broad consent was largely regarded by some clinical research physicians as pragmatically important, particularly for emergency situations and crucial to harmonising and streamlining research procedures to facilitate rapid research in times of pandemics.…”