Informed consent and a risk-based approach to oncologic surgery in a cancer center during the COVID-19 pandemic
de Cássio Zequi S, Franca Silva ILA, Duprat JP, Coimbra FJF, Gross JL, Vartanian JG, Makdissi FBA, Leite FPM, Costa WHD, Yazbek G, Joaquim EHG, Bussolotti RM, Caruso P, de Ávila Lima MC, Nakagawa S, Aguiar S Jr, Baiocchi G, Lopes A, Kowalski LP
Journal of Surgical Oncology, 7 March 2021
Open Access
Abstract
Background
Cancer patients configure a risk group for complications or death by COVID-19. For many of them, postponing or replacing their surgical treatments is not recommended. During this pandemic, surgeons must discuss the risks and benefits of treatment, and patients should sign a specific comprehensive Informed consent (IC).
Objectives
To report an IC and an algorithm developed for oncologic surgery during the COVID-19 outbreak.
Methods
We developed an IC and a process flowchart containing a preoperative symptoms questionnaire and a PCR SARS-CoV-2 test and described all perioperative steps of this program.
Results
Patients with negative questionnaires and tests go to surgery, those with positive ones must wait 21 days and undergo a second test before surgery is scheduled. The IC focused both on risks and benefits inherent each surgery and on the risks of perioperative SARS-CoV-2 infections or related complications. Also, the IC discusses the possibility of sudden replacement of medical staff member(s) due to the pandemic; the possibility of unexpected complications demanding emergency procedures that cannot be specifically discussed in advance is addressed.
Conclusions
During the pandemic, specific tools must be developed to ensure safe experiences for surgical patients and prevent them from having misunderstandings concerning their care.

Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic
Ideas and Opinions
Emily A. Largent, Scott D. Halpern, Holly Fernandez Lynch
Annals of Internal Medicine, March 2021
Open Access
Excerpt
A foundational requirement of ethical research is that persons provide informed consent. Yet, there are exceptions that promote valuable research without unduly compromising participants’ interests. Applicable regulations for federally funded research permit waiver or alteration of consent requirements when certain conditions are met, including that the research poses no more than minimal risk to participants and that it would be impracticable to do without waiver or alteration (1). Determining whether these regulatory standards are met has become increasingly challenging during the coronavirus disease 2019 (COVID-19) pandemic…

Clinical Trial Ethics in the Era of COVID-19 Pandemic
Muhammet Arslan, Nuket Ornek Buken
Journal of Clinical & Experimental Investigations, March 2021; 12(1) pp 1-7
Abstract
The world has been suffering from the deadly effects of coronavirus and seemingly will continue to suffer for quite more time. Humanity has witnessed many kinds of outbreaks that have affected the population endemically or epidemically. Urgent need for treatment of COVID-19 is necessary and essential. In this article the cornerstones of clinical trial ethics, current publications and statements are analyzed to overcome the difficulties of pandemics with an additional focus on Turkey. The researching physician, volunteering patients, industry, institutions, and national/international ethico-legal bodies are playing important role in clinical research. As stated in the Hippocratic Oath, it is a physician’s duty to “first do no harm”. Many international documents also state the fact that preserving the dignity of people and basic rights is the most essential attitude. Clinical trials follow a certain set of principles regulated by legislative bodies. Medical ethics try to establish a common base for all research to fulfill the need for an internationally acceptable standard. Rather than serving the benefit of qualifications, ethical standards preserve qualitative values. It can be said that medical ethics is an appropriate discipline to serve the improvement of both science and morals.

Rethinking Consent for Stroke Trials in Time-Sensitive Situations Insights From the COVID-19 Pandemic
Mayank Goyal, Johanna Maria Ospel, Aravind Ganesh, Martha Marko, Marc Fisher
Stroke, 16 February 2021
Open Access
Abstract
Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.

Clinical Research without Consent: Challenges for COVID-19 Research
Ian Freckelton
Journal of Law and Medicine, 28 December 2020; 28(1) pp 90-106
Abstract
The imperatives generated by the need for research into efficacious forms of treatment for COVID-19 have shone a fresh light upon the criteria for inclusion in clinical trials of persons unable to provide informed consent by reason of a number of factors including the seriousness of their illness symptomatology. This column identifies diversity in European, United States and Australian legislative and other guidance on the ethical issues that arise in respect of clinical research to which participants are not able to consent. It reviews the decision-making by the New South Wales Civil and Administrative Tribunal in a 2020 case in which permission was sought to conduct a clinical trial into a drug, STC 3141, designed by researchers as a potential treatment for patients with Adult Respiratory Distress Syndrome arising from COVID-19. It outlines the reasoning of the Tribunal in the context of debates about the balance to be struck between clinically useful medication trials and the need to avoid exploitation of vulnerable persons not able to provide their own consent, be that by virtue of disabilities such as acuteness of illness or dementia symptomatology. It contends that the decision illustrates the potential for research to be undertaken safely and ethically, utilising subjects in an intensive care unit who are unable to provide consent.

Informed Consent for Surgery at Resumption of Elective Activity After the First Wave of COVID-19
Nourelhuda M. Darwish, Muhammad Rafaih Iqbal, Adeel Abbas Dhahri, Neville Jacob, Jennifer
Jebamani, Amy Easthope, Vardhini Vijay
Cureus, 11 December 2020; 12(11)
Open Access
Abstract
Background
The coronavirus disease 2019 (COVID-19) pandemic has changed the dynamics of healthcare, and the elective surgical consent process has also evolved. The Royal College of Surgeons of England published guidance on consent during COVID-19. Through this study, we aimed to assess our local consent adherence to these guidelines on the resumption of elective activity after the first wave of COVID-19.
Methods
This prospective review of consecutive elective surgical consent forms was conducted from 20 July 2020 to 16 August 2020 at the Princess Alexandra Hospital NHS Trust, England. The primary outcome was evidence of COVID-19 risk documentation on the consent forms.
Results
A total of 116 patients’ consent forms were reviewed. Most patients were American Society of Anaesthesiologists (ASA) grade 2 (n=70; 60.34%). Only 25 consent forms (21.55%) had COVID -19 and its associated risks documented, with registrars being the most compliant (19/46; 41.3%) followed by consultants (6/51; 11.7%). With regards to the surgical sub-specialities, general surgery, orthopaedics and ENT had the highest compliance with the guidance.
Conclusions
As the elective activity resumes, peri-operative risks of COVID-19 should be weighted in during the informed consent process, as mentioned in the latest international guidelines on consent to avoid litigation and negligence claims.

Ethical Challenges in Health Care Policy during COVID-19 Pandemic in Italy
Communication
Davide Ferorelli, Gabriele Mandarelli, Biagio Solarino
Medicina, 11 December 2020
Open Access
Abstract
Since the outbreak of the coronavirus disease 2019 (COVID-19) pandemic, Italy has proven to be one of the countries with the highest coronavirus-linked death rate. To reduce the impact of SARS-CoV-2 coronavirus, the Italian Government decision-makers issued a series of law decrees that imposed measures limiting social contacts, stopped non-essential production activities, and restructured public health care in order to privilege assistance to patients infected with SARS-CoV-2. Health care services were substantially limited including planned hospitalization and elective surgeries. These substantial measures were criticized due to their impact on individual rights including freedom and autonomy, but were justified by the awareness that hospitals would have been unable to cope with the surge of infected people who needed treatment for COVID-19. The imbalance between the need to guarantee ordinary care and to deal with the pandemic, in a context of limited health resources, raises ethical concerns as well as clinical management issues. The emergency scenario caused by the COVID-19 pandemic, especially in the lockdown phase, led the Government and health care decision-makers to prioritize community safety above the individuals’ rights. This new community-centered approach to clinical care has created tension among the practitioners and exposed health workers to malpractice claims. Reducing the morbidity and mortality rates of the COVID-19 pandemic is the priority of every government, but the legitimate question remains whether the policy that supports this measure could be less harmful for the health care system.

Informing children citizens efficiently to better engage them in the fight against COVID-19 pandemic
Viewpoints
Jean-Eric Ghia, Sophie Gaulin, Laure Ghia, Laure Garancher, Claude Flamand
Neglected Tropical Diseases, 4 November 2020
Open Access
Abstract
Since the beginning of the year, the world’s attention has rightly been focused on the spread of the Coronavirus Disease 2019 (COVID-19) pandemic and the implementation of drastic mitigation strategies to limit disease transmission. However, public health information campaigns tailored to children are very rare. Now more than ever, at a time when some governments are taking populations out of lockdown and youth are returning to schools, children around the world need to fully grasp the modes of transmission of the disease, the health risks, the scientific notions of the immune system, the value of barrier measures, and the progress of scientific research. In the context of the COVID-19 pandemic, comics can be very useful for communicating quickly and effectively abstract and important information to children who might be under the influence of a large amount of sometimes contradictory information. Conveying precise, reliable, and accessible information to children is key in a world overwhelmingly impacted by the outbreak. This should be the role and the responsibility of world health official leaders and governments in compliance with the United Nations Convention on the Rights of the Child. In partnership with mainstream medias, consortia of scientists, communication experts, and education specialists, it is urgent that world leaders engage children in this worldwide public health fight.

COVID-19 and consent for research: Navigating during a global pandemic
Research Article
Ran D Goldman, Luke Gelinas
Clinical Ethics, 5 November 2020
Open Access
Abstract
The modern ethical framework demands informed consent for research participation that includes disclosure of material information, as well as alternatives. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic (COVID-19) results in illness that often involves rapid deterioration. Despite the urgent need to find therapy, obtaining informed consent for COVID-19 research is needed. The current pandemic presents three types of challenges for investigators faced with obtaining informed consent for research participation: (1) uncertainty over key information to informed consent, (2) time and pressure constraints, and (3) obligations regarding disclosure of new alternative therapies and re-consent. To mitigate consenting challenges, primary investigators need to work together to jointly promote urgent care and research into COVID-19. Actions they can take include (1) prior plan addressing ways to incorporate clinical research into clinical practice in emergency, (2) consider patients vulnerable with early deliberation on the consent process, (3) seek Legally Authorized Representatives (LARs), (4) create a collaborative research teams, (5) aim to consent once, despite evolving information during the pandemic, and (6) aim to match patients to a trial that will most benefit them. The COVID-19 pandemic both exacerbates existing challenges and raises unique obstacles for consent that require forethought and mindfulness to overcome. While research teams and clinician-investigators will need to be sensitive to their own contexts and adapt solutions accordingly, they can meet the challenge of obtaining genuinely informed consent during the current pandemic.

COVID-19 Trial Enrollment for Those Who Cannot Consent: Ethical Challenges Posed by a Pandemic
Samantha A. House, Catherine D. Shubkin, Tim Lahey, Jeffrey P. Brosco, John Lantos
Pediatrics, November 2020, 146(5)
Abstract
The current coronavirus disease 2019 (COVID-19) pandemic has triggered an intense global research effort to inform the life-saving work of frontline clinicians who need reliable information as soon as possible. Yet research done in pressured circumstances can lead to ethical dilemmas, especially for vulnerable research subjects. We present the case of a child with neurocognitive impairment who is diagnosed with COVID-19 infection after presenting with fever and a seizure. The child lives in a group home and is in the custody of the state; her parents lost parental rights many years ago. Some members of the health care team want to enroll her in a randomized clinical trial evaluating an experimental treatment of COVID-19. For minor patients to enroll in this clinical trial, the institutional review board requires assent of patients and consent of guardians. An ethics consult is called to help identify relevant concerns in enrollment. In the accompanying case discussion, we address historical perspectives on research involving people with disabilities; proper management of research participation for people with disabilities including consent by proxy, therapeutic misconception, and other threats to the ethical validity of clinical trials; and the potentially conflicting obligations of researchers and clinicians.