Consent or Public Reason? Legitimacy of Norms Applied in ASPD and COVID-19 Situations
Original Article
Elvio Baccarini
Philosophy and Society, 30 November 2021; 32(4) pp 674–694
Open Access
Abstract
This paper extends Alan John Simmons’s conceptual distinction between Lockean (or consent) and Kantian (or justificatory) conceptions of legitimacy that he applied to the question of the legitimacy of states, to the issue of legitimacy of public decisions. I criticise the consent conception of legitimacy defended by Simmons, and I defend the Rawlsian version of the justificatory conception of legitimacy from his objection. The approach of this paper is distinctive because the two conceptions are assessed by investigating, using the method of reflective equilibrium, their respective prescriptions concerning the treatment of antisocial personality disorder (ASPD) and epidemiologic measures. I argue that the method of reflective equilibrium does not support the consent conception. Considering the issues of treatment of ASPD and of epidemiologic measures, I argue that the consent conception of legitimacy is not well-equipped for the evaluation of norms that are not strictly self-regarding. This causes a deficit of prescriptions for relevant social responses. Further, by considering the case of responses to epidemics, I argue that such a conception can avoid harmful consequences only by recurring to additional, and independent, premises. This does not cause incoherence but reduces the coherence of a normative system. Finally, the consent conception is not equipped to support social cooperation in an optimal way, which has proved to be necessary in critical conditions, like a pandemic. On the other hand, I argue that the method of reflective equilibrium supports the Rawlsian version of justificatory conception of legitimacy, because of its advantages in handling the indicated issues. In addition, I maintain that this justificatory conception is respectful of freedom and equality of agents as moral self-legislators, and, thus, it is not vulnerable to Simmons’s main criticism.

Surgery during the COVID-19 pandemic: Are we obtaining informed consent?
Emily Robinson, Joseph Ayathamattam, Holly Harris, Malcolm McFall
British Journal of Surgery, 28 October 2021; 108(Supplement 7)
Abstract
Background
It was estimated that 1 in 4 inpatients with COVID-19 acquired the virus whilst admitted in December 2020. Surgical patients that contract COVID-19 have poor outcomes, with mortality rates as high as 24% and risk of pulmonary complications as high as 50%. The Royal College of Surgeons of England published COVID-19 consenting guidelines in June 2020.
Aims
To identify the proportion of surgical patients who were informed of the risk of acquiring COVID-19 during the consenting process at two District General Hospitals.
Methods
The consent forms of 220 surgical patients who had either elective or emergency surgery during the second COVID-19 lockdown were reviewed retrospectively (1/11/2020-20/11/2020). This included General Surgery, Trauma and Orthopaedics and Urology. Patients with incomplete notes or who lacked capacity were excluded.
Results
In total, 193 patients were included. We found that 41.5% of patients were consented for the risk of acquiring COVID-19 peri-operatively. This did not vary significantly between elective and non-elective patients.
Conclusions
Our study shows that current practice does not meet national recommendations. In order to provide informed consent, surgeons must engage in emerging research regarding the local prevalence of COVID-19 and the implications of infection during the peri-operative period. Only with this knowledge, will surgeons be able to balance the risks and benefits on a case by case basis, to provide the patient with necessary information for consent. We recommend that trusts adopt a COVID-19 consenting policy, as part of the pre-operative assessment.

Parental consent for vaccination of minors against COVID-19
Nina Shevzov-Zebrun, Arthur Caplan
Vaccine, October 2021; 39(44) pp 6451–6453
Introduction
As of May 2021, emergency use authorization (EUA) for Pfizer’s COVID-19 (COVID) vaccine applies to minors at least 12 years of age—some 25 million adolescents across the United States [1], [2]. While this change marks a critical step towards herd immunity and return to normality in everyday life, it also raises a host of questions concerning parental consent for vaccination of minors in pandemic times, most notably: should parental consent be required for COVID vaccine administration?

Informed Consent for Neck of Femur Fracture Surgery During the Covid-19 Pandemic: An Evidence-Based Approach
R Cuthbert, D Ferguson, B Kayani, S Haque, A Ali, A Parkar, P Bates, K Vemulapalli
British Journal of Surgery, 12 October 2021; 108 (Supplement 6)
Abstract
Background
Surgical intervention for neck of femur fractures continues to be prioritised during the Covid-19 pandemic. However, there remains a lack of clarity for clinicians during the consent process. This study quantifies additional perioperative risks for Covid-19 positive patients undergoing neck of femur fracture surgery and establishes an evidence-based framework for facilitating informed consent during the Covid-19 pandemic.
Method
259 patients undergoing neck of femur fracture surgery in four hospitals at the epicentre of the United Kingdom’s first wave of Covid-19 were recruited. 51 patients were positive for Covid-19. Predefined outcomes were recorded in a 30-day postoperative period.
Results
Odds of intensive care admission were 4.64 times higher (95% CI 1.59-13.50, p = 0.005) and odds of 30-day mortality were 3 times higher (95% CI 1.22-7.40, p = 0.02) in Covid-19 positive patients. 74.5% of Covid-19 positive patients suffered post-operative complications. 35.3% of Covid-19 positive patients developed lower respiratory tract infection with 13.7% progressing to acute respiratory distress syndrome. 9.8% of Covid-19 positive patients experienced symptomatic thromboembolic events with a 3.9% incidence of pulmonary emboli.
Conclusions
The implications of Covid-19 on the informed consent process for neck of femur fracture surgery are profound. Covid-19 positive patients should be consented for increased risk of postoperative complications (including lower respiratory tract infection, acute respiratory distress syndrome and thromboembolic events), longer inpatient stay, increased frequency of intensive care admission and higher risk of mortality.

The Implication of Telephone Consultations During COVID-19 Pandemic on Informed Consent
N Ayoub, F Gareb, M Akhtar
British Journal of Surgery, 12 October 2021; 108 (Supplement 6)
Abstract
Aim
Is to find whether telephone consultations have affected patient’s comprehension of the proposed surgical management and possible risks until the day of surgery and accordingly ability for informed consent.
Method
This study included a sample of patients admitted to QEQM hospital for elective day case surgery during November 2020 and had only telephone consultation when referred for surgery. A feedback survey assessing quality of information given to patients before and on day of surgery was filled by the patients after the procedure.
Results
The sample included 40 patients undergoing different procedures [cholecystectomy (25), inguinal hernia repair (25), rectal examination under anaesthesia (5), ventral hernia repair (2), incisional hernia (2), inguinal lymph node biopsy (1)]. It was found that 27.5% of patients didn’t have thorough explanation of possible risks and no explanation about postoperative care in 35%.20% were not provided a leaflet about procedure, 57.5% had concerns before surgery and 75% of patients wished for a leaflet with illustrative diagrams, explanation of risks with their management to be able to take the right decision and majority of these patients were from cholecystectomy subgroup.
Conclusions
The lack of face-face appointment affected greatly the informed consent process resulting in patient dissatisfaction which raised the need for new leaflets containing diagrammatic explanation of procedures and possible risks with their management to ensure fulfilment of autonomy principle.

The right to respect for family life, consent, minors and Gillick competence
Richard Griffith
British Journal of Nursing, 2 October 2021; 30(17)
Abstract
Richard Griffith, Senior Lecturer in Health Law at Swansea University, discusses the statement made by the UK vaccines minister that healthy 12–15-year-olds could override their parents’ decision on coronavirus vaccination.

An audit on our procedural consent forms for complication of covid-19 during the pandemic
C. Chaudhary, A. N. Najdawi, K. N. Noureldin, M. D. Dworkin
Colorectal Disease, 2021; 23(supplement 1) pp 78-79
Abstract
Aims
COVID-19 has had a global impact over the last 12 months Currently there have been over 2 millions deaths from close to 100 millions infected patients. With the changes from face to face consultations to remote virtual/phone/video consultations the consent process for common procedures both elective and emergency have been affected RCSE have produced a document published 30 June 2020 setting out the main principles of the consent process and providing advice on what additional information should be included in conversations with patients while COVID-19 is still prevalent in society
Method
During 1st November to 28th November all patients in Southend University Hospital undergoing an operation were identified on a near daily basis. Wards reviewed Castlepoint -Orthopaedic Princess Anne -Elective Windsor -General Surgery/Urology Eastwood -Gynaecology Hockley -Acute surgical admissions
Discussion and Conclusion
Operation notes were reviewed and patients with COVID-19 complications mentioned were identified and recorded in an excel spreadsheet Only 72% of consent forms mentioned COVID-19 as a recognised complication 92% of consultants (n = 14) mentioned COVID-19 compared to 60% (n = 30) for registrars and 78% (n = 9) for SHOs There was no obvious difference between elective and emergency consenting process.

Parental consent for the Covid-19 vaccine in children
Andrew Power
Practice Management, 17 September 2021; 31(8)
Abstract
Parents may not always agree on childhood immunisation and this may also apply to the Covid-19 vaccination. Dr Andrew Power, Medicolegal Consultant at Medical Protection, discusses how to resolve parental disagreement.

COVID-19 Vaccines and their Pitfalls in Informed Consent
Yousef Haik, Eleni Polymenopoulou
Hastings Science and Technology Law Journal, Summer 2021; 12(2)
Abstract
The World Health Organization declared the coronavirus (COVID-19) pandemic as a global health crisis. The search for a coronavirus vaccine escalated to a global competition. Drugs for other diseases as well as new formulations are proposed as potential candidates for the treatment or intervention of coronavirus. Almost all pharmaceutically able countries are pursuing potential vaccines. At the time of writing this article, two vaccines are already marketed and tested with promising interim results. Both vaccines use messenger RNA (mRNA) encapsulated in a lipid nanocarrier. Under ordinary circumstances, clinical trial authorizations oblige sponsors to disclose all risks to volunteers in order to formulate an informed knowledgeable decision. This however has been subject to exceptions during the pandemic. The mRNA-based vaccine has been rushed in unprecedented record speed to human clinical efficacy evaluation. This raises a number of questions related to the validity of volunteers’ free and informed consent. The present article argues that informed consent of all risks as well as the protection of volunteers’ personal data constitute concrete obligations under human rights law that cannot be derogated from in times of emergency – such as the COVID-19 pandemic. Furthermore, it suggests a risk governance framework through blockchain for international vaccine testing clinical trials.

Legal and Ethical Issues Around COVID-19 Vaccination Consent in Italian Children From 12 Years of Age
Roberto Scendoni, Nunzia Cannovo, Piergiorgio Fedeli, Mariano Cingolani
Journal of Legal, Ethical and Regulatory Issues, 2021; 24(Special Issue 1)
Open Access
Introduction
    In Europe, there are currently two vaccines against COVID-19 recommended by the European Medicines Agency (EMA) for children aged 12 and older: Spikevax (Moderna) and Comirnaty (Pfizer-BioNTech). At the moment, about half of European countries have decided to age 12 as the minimum age for vaccination against COVID-19. In addition to Italy, France, Spain, Austria, Slovenia, Hungary, Czechia, Slovakia, Denmark, Switzerland, Romania, Bulgaria, Lithuania, Latvia and Estonia. Others (Germany, UK, Netherlands, Belgium, Sweden, Finland) recommend vaccination only for children in textual conditions facing COVID-19 or living with frail people. The Italian Medicines Agency (AIFA) has approved the extension of the therapeutic indications for Comirnaty on May 31 and for Spikevax on July 29, 2021.

The various scientific societies in Italy (SIPPS, SIP) agreed in favor of vaccinating children from 12 years old. However the problem of informed consent to COVID-19 vaccination in minors is absolutely emerging, in Italy as well as in other countries (Heuerman, 2021). According to national and international conventions, he should be informed, listened to and must participate in the co-decision process regarding medical treatment. Achieving a “triple” medical-parent-child therapeutic alliance is the main goal at this time of the pandemic, but this is not always possible (Morgan, 2021). The main key legal and ethical issues on the matter are represented below.