Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease
Perspective
Timothy Cardozo, Ronald Veazey
The International Journal of Clinical Practice, 28 October 2020
Open Access
Abstract
Aims of the study
Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus.
Methods used to conduct the study
Published literature was reviewed to identify preclinical and clinical evidence that COVID‐19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID‐19 vaccines were reviewed to determine if risks were properly disclosed.
Results of the study
COVID‐19 vaccines designed to elicit neutralizing antibodies may sensitize vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralizing antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID‐19 disease via antibody‐dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID‐19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
Conclusions drawn from the study and clinical implications
The specific and significant COVID‐19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.

Informed consent for Orthopaedic surgeons in the time of COVID-19: Addressing ‘the elephant in the room’
Sohail Yousaf, Syed Hassan, Paul Hamilton, Andrea Sott
BMJ Quality & Safety, 18 June 2020
Open Access
Excerpt
…The doctor-patient conversation that occurs following the diagnosis of such an injury is important to fulfilling ethical and professional responsibilities and reducing medico-legal risk. Understanding the patient’s future goals and expectations influences management and is vital to shared decision-making. Surgeons need to enable patients to be fully informed by giving them high quality information about the current evidence base regarding the proposed treatment and the available alternatives and risks…

Surgical consent during the COVID-19 pandemic
Rotimi, K. Beatson, A. Aderombi, W. Lam, O. Bajomo, N. Kukreja
Annals of Medicine and Surgery, 9 October 2020; 59 pp 229-233
Open Access
Abstract
Background and aims
During the COVID-19 pandemic, surgical practice may deviate with operative and non-operative management considered. Appropriate discussion of options with patients is paramount to quality surgical care. Intercollegiate and EAES guidelines recommend discussing and documenting risk of COVID-19 exposure in the consent process for patients undergoing surgery.
Materials and methods
Closed-loop audit of consent forms for patients undergoing emergency and elective surgical procedures. Interventions implemented included education of wider surgical teams. Data was collected during a one-week period for each cycle and analysed using Chi-squared test.
Results
In cycle 1, 6/17 (35.3%) case notes documented discussion of COVID-19 risk. Following intervention, compliance improved to 23/29 (79.3%) cases in cycle 2 and 33/45 (73.3%) cases in cycle 3.
Conclusion
Pre-intervention, our consenting practice was non-compliant. Our interventions led to significant and sustained improvements in practice. We recommend provision of wider surgical team education to facilitate good consenting practice.

Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
Review Article
Arun Bhatt
Perspectives in Clinical Research, 6 October 2020
Abstract
Obtaining informed consent from vulnerable patients participating in clinical trials of investigational therapies for COVID-19 is a major ethical challenge. Ethical and operational considerations – voluntariness, waiver, timing, time, documentation, and responsibilities of the sponsor, the investigator, and the ethics committee – are discussed briefly.

Consent in the time of COVID-19
Helen Lynne Turnham, Michael Dunn, Elaine Hill, Guy T Thornburn, Dominic Wilkinson
BMJ Medical Ethics, 26 August 2020; 46(9) pp 565-568
Open Access
Abstract
The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.

The ethics of deferred consent in times of pandemics
Rieke van der Graaf, Marie-Astrid Hoogerwerf, Martine C. de Vries
Nature Medicine, 10 July 2020; 26 pp 1328–1330
Open Access
Excerpt
In the current COVID-19 pandemic, many researchers are applying to research ethics committees for deferred-consent procedures for protocols that aim either to test treatments or to obtain tissue or samples from research participants. However, the deferred-consent procedure has not been developed for pandemics. In this Comment, we interpret existing guidance documents and argue when and under which conditions deferred consent can be considered ethically acceptable in a pandemic…

The Use of Electronic Consent for COVID‐19 Clinical Trials: Lessons for Emergency Care research During a Pandemic and Beyond
Eric Jaton, Jamie Stang, Michelle Biros, Abbey Staugaitis, Julie Scherber, Florian Merkle, Nicholas M. Mohr, Christopher Streib, Lauren Klein, Michael A. Puskarich
Academic Emergency Medicine, 24 September 2020
Open Access
Abstract
The novel SARS‐CoV‐2 coronavirus poses many unique challenges to the implementation of clinical research, particularly as it relates to the processes of informed consent. Traditional methods of in‐person informed consent were no longer plausible, as face‐to‐face discussions may expose researchers and patients to increased risk of contracting and spreading the virus. In many circumstances the research personnel obtaining consent were considered non‐essential workers, and thus did not have priority for personal protective equipment in light of national shortages.

The Forgotten Element in the Resumption of Elective Bariatric Surgery During the COVID-19 Pandemic: the Patient Consent!
Brief Communication
Mohammed Said, Hosam Hamed
Obesity Surgery, 19 September 2020
Abstract
Safety comes first, and the sympathy with the postponed bariatric patients should not come at the expense of the proper standard of care. This study presents a survey of 266 bariatric candidates who were rescheduled for bariatric surgery after postponement during the COVID-19 pandemic. The aim was to assess their knowledge and expectations regarding bariatric surgery and the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. A total of 233 (87.6%) candidates believed that they were prone to a higher risk of severe SARS-CoV-2 infection, and 24.4% of them believed that bariatric surgery, during the pandemic, would improve their immunity. A total of 27.8% of candidates attributed the responsibility regarding potential perioperative SARS-CoV-2 infection to the medical personnel, and 10.7% of them believed it to be the surgeon’s responsibility.

COVID-19 consent and return to elective orthopaedic surgery allowing a true patient choice?
Timothy M. Clough, Nikhil Shah, Hiren Divecha, Sumedh Talwalkar
Bone Joint Open 2020, 14 September 2020; 1(9) pp 556–561
Abstract
Aims
The exact risk to patients undergoing surgery who develop COVID-19 is not yet fully known. This study aims to provide the current data to allow adequate consent regarding the risks of post-surgery COVID-19 infection and subsequent COVID-19-related mortality.
Methods
All orthopaedic trauma cases at the Wrightington Wigan and Leigh NHS Foundation Trust from ‘lockdown’ (23 March 2020) to date (15 June 2020) were collated and split into three groups. Adult ambulatory trauma surgeries (upper limb trauma, ankle fracture, tibial plateau fracture) and regional-specific referrals (periprosthetic hip fracture) were performed at a stand-alone elective site that accepted COVID-19-negative patients. Neck of femur fractures (NOFF) and all remaining non-NOFF (paediatric trauma, long bone injury) surgeries were performed at an acute site hospital (mixed green/blue site). Patients were swabbed for COVID-19 before surgery on both sites. Age, sex, nature of surgery, American Society of Anaesthesiologists (ASA) grade, associated comorbidity, length of stay, development of post-surgical COVID-19 infection, and post-surgical COVID-19-related deaths were collected.
Results
At the elective site, 225 patients underwent orthopaedic trauma surgery; two became COVID-19-positive (0.9%) in the immediate perioperative period, neither of which was fatal. At the acute site, 93 patients underwent non-NOFF trauma surgery, of whom six became COVID-19-positive (6.5%) and three died. A further 84 patients underwent NOFF surgery, seven becoming COVID-19 positive (8.3%) and five died.
Conclusion
At the elective site, the rate of COVID-19 infection following orthopaedic trauma surgery was low, at 0.9%. At the acute mixed site (typical district general hospital), for non-NOFF surgery there was a 6.5% incidence of post-surgical COVID-19 infection (seven-fold higher risk) with 50% COVID-19 mortality; for NOFF surgery, there was an 8.3% incidence of post-surgical COVID-19 infection, with 71% COVID-19 mortality. This is likely to have significance when planning a resumption of elective orthopaedic surgery and for consent to the patient.

Allocation of Resources and Health Professionals’ Burden During the Covid-19 Pandemic: Reflection on Advanced Directives, Informed Consent, And Social Perception in Mexico
Karen Herrera-Ferrá, Leonardo Souza-García, Antonio Muñoz-Torres
Online Journal of Health Ethics, 11 August 2020; 16(2)
Open Access
Abstract
One of the main problems in the COVID-19 pandemic is the insufficient availability of resources. This deficiency has resulted in emotional and moral burdens of health professionals. Decisions are having to be made as to who will live and who will die. Moreover, given the global impact of this pandemic, negative impacts are heightened in low and middle-income countries such as Mexico. Authors focus on two issues related to, but not exclusive, to the Mexican healthcare system in an attempt to partially address scarce resources and health professionals’ burden. First, is the empowerment of patients’ autonomy through the incorporation of advanced directives (i.e. nonresuscitate order, the use of intensive care unit and/or ventilator) within informed consent. And second, the socio-cultural perception of risk as relevant for public engagement on protective behavioral patterns. We argue that addressing these issues could possibly lessen the burden of healthcare professionals and bring about greater autonomy among the public.