Urological surgery in the COVID-19 era: Patient counselling and informed consent

Urological surgery in the COVID-19 era: Patient counselling and informed consent
Elsayed Desouky
Arab Journal of Urology, 17 May 2020; 18(2) pp 62-64
Open Access
Abstract
The current coronavirus disease 2019 (COVID-19) pandemic is massively affecting our daily practice. Elective surgical service has been significantly altered, i.e. reduced overall service provision, special operating theatres’ precautions, as well as considerations for testing patients before surgery. The process of counselling patients and obtaining their consent is a must before any surgical intervention. Several factors can affect this process particularly amid the current pandemic crisis. Only with a full understanding of all the relevant facts, including risks and available alternatives, can patients give an ‘informed consent’. Therefore, we urologists need to be aware of the impact of the current COVID-19 situation on how to consent our patients.

COVID-19 and its impact on informed consent: What should health professionals tell their patients or their proxies?

COVID-19 and its impact on informed consent: What should health professionals tell their patients or their proxies?
D J McQuoid-Mason
South African Journal of Bioethics Law, 13 May 2020; 13(1)
Open Access
Abstract
Given the increasing number of ethical and legal issues arising from the impact of the COVID-19 epidemic on informed consent by patients, it is necessary for health professionals to explain to patients how the measures taken to combat the spread of the virus impact on their right to give informed consent. Patients need to be reassured that wherever possible, health professionals are ethically bound to obtain informed consent from patients before they subject them to diagnostic testing and treatment, but at the same time, have to comply with the demands of the law. While the South African Constitution, statutory law and the common law all recognise a person’s right to consent before being subjected to treatment or surgical operations, it is necessary to take remedial steps, because of the dangers of spreading the potentially fatal COVID-19 virus, to prevent this. Such steps may involve compelling patients to be screened, tested and treated – sometimes without their consent. Guidance is given to healthcare professionals on how they should counsel their patients, and what they should tell patients about the impact of the COVID-19 regulations on healthcare professionals’ ethical and legal duties regarding the obtaining of informed consent, as well as on whether, if asked, employers can compel their employees to undergo testing without consent, and what to tell patients about this.

Modelling Consent in the Time of COVID-19

Modelling Consent in the Time of COVID-19
Bartha Maria Knoppers, Michael J S Beauvais, Yann Joly, Ma’n H Zawati, Simon Rousseau, Michaël Chassé, Vincent Mooser
Journal of Law and the Biosciences, 8 May 2020
Open Access
Abstract
Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patient, respiratory/infectious disease patients, and longitudinal study participants. We explore the potential approaches that can be taken to consent processes with these three participant groups. We furthermore describe an access model for both single-site and multi-site data and sample storage. Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science.

A rationale and framework for seeking remote electronic or phone consent approval in endovascular stroke trials – special relevance in the COVID-19 environment and beyond

A rationale and framework for seeking remote electronic or phone consent approval in endovascular stroke trials – special relevance in the COVID-19 environment and beyond
Original Research
Ansaar T Rai, Donald Frei
Journal of NeuroInterventional Surgery, 28 April 2020
Open Access
Abstract
Background
Enrollment in time-sensitive endovascular stroke trials can be challenging because of an inability to consent a debilitated patient. Often the legally authorized representative is not on site. Remote consent procedures in the US are inconsistent with the majority of sites shunning these approaches. The current pandemic with visitor restrictions highlights the need for enhancing these options.
Methods
Remote electronic and phone consent procedures specifically for endovascular stroke trials from two comprehensive stroke centers (CSC) are presented. An overview of the genesis of informed consent procedures in the US is also included. Results The two CSCs identified as Institution-1 and Institution-2 are large tertiary systems. Institution-1 is a non-profit university-affiliated academic medical center in rural geography. Institution-2 is an HCA hospital in an urban environment. Both serve patients through a spoke-and-hub network, have participated in multiple randomized endovascular stroke trials, and have successfully used these remote options for enrollment. A tiered approach is employed at both institutions with an emphasis on obtaining informed consent in person and resorting to alternatives methods when efforts to that are unsuccessful. A rationale for electronic and phone consent is included, followed by step-by-step illustration of the process at each institution.
Conclusion
Two examples of remote electronic or phone consent procedures from institutions in different geographic environments and organization structures demonstrate that these options can be successfully used for enrollment in stroke trials. The current pandemic highlights the need to enhance these approaches while maintaining appropriate adherence to ethical and legal frameworks.

Informed Consent for Surgery During COVID-19

Informed Consent for Surgery During COVID-19
Indian Journal of Surgery, 24 April 2020
Open Access
Abstract
Informed consent has become a challenging issue when surgery at the time of novel corona virus disease 2019 (COVID-19) is to be performed, in view of increased risk of the need of intensive care unit (ICU) in the post-operative period and the associated high mortality if a patient exhibits COVID-19 symptoms in the post-operative period. We have devised a new informed consent format for all patients undergoing surgery incorporating a few points specific for the disease.