Ethics
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Psychiatr. Mar 19, 2021; 11(3): 58-62
Published online Mar 19, 2021. doi: 10.5498/wjp.v11.i3.58
Rapid commentary: Ethical implications for clinical trialists and patients associated with COVID-19 research
Gayathri Delanerolle, Shanaya Rathod, Kathryn Elliot, Rema Ramakrishnan, Tony Thayanandan, Natasha Sandle, Nyla Haque, Vanessa Raymont, Peter Phiri
Gayathri Delanerolle, Tony Thayanandan, Natasha Sandle, Nyla Haque, Vanessa Raymont, Department of Psychiatry, University of Oxford, Oxford OX3 7JX, United Kingdom
Shanaya Rathod, Kathryn Elliot, Peter Phiri, Research and Development Department, Southern Health NHS Foundation Trust, Southampton SO30 3JB, United Kingdom
Rema Ramakrishnan, Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford OX3 7JX, United Kingdom
Peter Phiri, Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton SO16 5ST, United Kingdom
Author contributions: Delanerolle G, Phiri P and Raymont V made significant contribution to the development of the draft; Delanerolle G, Phiri P, Raymont V, Elliot K, Ramakrishnan R, Rathod S, Thayanandan T, Sandle N and Haque N contributed to the manuscript revisions and approved the final version.
Conflict-of-interest statement: Phiri P has received research grant from Novo Nordisk, and other, educational from Queen Mary University of London, other from John Wiley & Sons, other from Otsuka, outside the submitted work. Rathod S reports other from Janssen, Lundbeck and Otsuka outside the submitted work. All other authors report no conflict of interests for this article. The views expressed are those of the authors and not necessarily those of the NHS, the National Institute for Health Research, the Department of Health and Social Care or the Academic institutions.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Peter Phiri, BSc, PhD, RN, Academic Fellow, Nurse, Department of Research and Development, Southern Health NHS Foundation Trust, Tom Rudd Unit, Botley Road, West End, Southampton SO30 3JB, United Kingdom. p.phiri@soton.ac.uk
Received: December 15, 2020
Peer-review started: December 15, 2020
First decision: January 7, 2021
Revised: January 28, 2021
Accepted: March 8, 2021
Article in press: March 8, 2021
Published online: March 19, 2021
Processing time: 85 Days and 22 Hours
Abstract

Pandemics disrupt clinical trials worldwide, with lasting effects on research. It can severely impact clinical trialists ability to conduct safe and ethically uncompromised trials. Hence, the mounting pressure results in ethically and morally distressing decisions faced by clinical trial professionals during pandemic situations. Whilst clinical trialists attempt to think about preparedness and responses during a pandemic, the need to have an ethical framework that has real-world applicability is imperative. Pandemics are a challenging time for all, however, the safety and access to support for clinical trialists and patients within clinical trials should be at the forefront for their organisations and the government.

Keywords: COVID-19; Pandemic; Ethics; Clinical trials; Patients; Trialists

Core Tip: This commentary provides an important facet and argues the ethical implications surrounding clinical research practices and staff during pandemic situations. Clinical trial professionals face ethical dilemmas whilst conducting trials safely at an unprecedented rate given the clinical urgency. This commentary highlights the detrimental impact of not having a protocol for pandemic-driven clinical research, as well the lack of an ethical framework with real-world applicability to support the clinical trial workforce. Unethical behaviours and practices could be introduced in the current pressurised climate in order to rapidly respond to coronavirus disease 2019 research in particular.