Ethical frameworks in clinical research processes during COVID-19: a scoping review.

Autor:	Kasherman L; Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.; Department of Medical Oncology, St George Hospital, Kogarah, New South Wales, Australia.; St George and Sutherland Clinical Schools, University of New South Wales, Kogarah, New South Wales, Australia., Madariaga A; Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.; Autonomous University of Barcelona, Barcelona, Spain., Liu Q; Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.; Department of Haematology, St George Hospital, Kogarah, New South Wales, Australia., Bonilla L; Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada., McMullen M; Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.; Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia., Liu SL; Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.; British Columbia Cancer Agency, Surrey, British Columbia, Canada., Wang L; University of Toronto, Toronto, Ontario, Canada., Fazelzad R; Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada., Karakasis K; Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada., Heesters AM; University of Toronto, Toronto, Ontario, Canada.; University Health Network, Toronto, Ontario, Canada., Oza AM; Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada amit.oza@uhn.ca.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2021 Jul 23; Vol. 11 (7), pp. e047076. Date of Electronic Publication: 2021 Jul 23.
DOI:	10.1136/bmjopen-2020-047076
Abstrakt:	Objectives: In response to the COVID-19 pandemic there have been significant developments in research, its conduct and the supporting ethical framework. While many protocols have been delayed, halted or modified, other research efforts have been accelerated, generating controversy. The goal of this paper is to determine the rates of references surrounding the ethical oversight of research as reported in current COVID-19-related research publications. Design: Scoping review. Setting: Population-based observational or interventional studies from December 2019 to May 2020 with sample size of two or more. Studies were searched through electronic databases including Medline, EMBASE, and Cochrane CENTRAL Register of Controlled Trials. Participants: Eligibility criteria included participants within published studies who tested positive for COVID-19. Main Outcomes and Measures: Data were extracted and charting methods included taking note of references to ethical frameworks, institutional review board (IRB), ethics committee (EC) or research ethics board (REB) involvement, consent processes, and other variables. Results: 11 556 articles were screened, with 656 included in the final analysis. References to ethics were present in 530 (80.8%) studies, with 491 (74.8%) involving IRB/ECs/REBs and 126 (19.2%) not referencing ethics. Consent processes were outlined in 201 (30.6%) studies, with 198 (30.2%) reporting that they obtained consent waivers, however, 257 (39.2%) did not mention consent at all. Differences (p<0.001) in ethics-related references were apparent when analysed by continent, publication type, sample size and IF. Conclusions: The majority of published articles pertaining to COVID-19 research made mention of ethical considerations, however, national and regional variations in research ethics review requirements introduce heterogeneity between studies and raise important questions about the conduct of scientific research during global public emergencies. Trial Registration Number: Open Science Framework: https://osfio/z67wb. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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