COVID-19 Vaccination of Minors Without Parental Consent; Respecting Emerging Autonomy and Advancing Public Health
Viewpoint
Larissa Morgan, Jason L. Schwartz, Dominic A. Sisti
JAMA Pediatrics, 12 July 2021
Excerpt
In May 2021, the Pfizer-BioNTech COVID-19 vaccine received emergency use authorization from the US Food and Drug Administration in adolescents aged 12 to 15 years, with authorization for younger children expected later this year.1 Despite reported clinical trial data indicating that the vaccine is safe and 100% efficacious for this age range, some parents and guardians may remain hesitant or outright opposed to vaccinating their children, particularly in politically and culturally conservative communities… Children and adolescents have the capacity to understand and reason about low-risk and high-benefit health care interventions. State laws should therefore authorize minors to consent to COVID-19 vaccination without parental permission…

Implications and advice on getting COVID-19 vaccine consent: How to support people with learning disabilities to get vaccinated
Jonathan Beebee
Learning Disability Practice, 2021; 10-12
Abstract
Vaccinations against COVID-19 are not mandatory and where people can give or refuse consent we have a responsibility to ensure consent is sought. Many people with learning disabilities will be unable to consent, but others will be able to consent if given the right support. Nurses, carers and families should begin planning as soon as possible, so they are prepared when the invitation to receive the vaccine arrives.

Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial
Patricia Woods, Maura Flynn, Paul Monach, Karen Visnaw, Sara Schiller, Erika Holmberg, Sarah Leatherman, Ryan Ferguson, Westyn Branch-Elliman
Contemporary Clinical Trials Communications, September 2021, 23
Abstract
Background and objective
The communicable nature of many infectious diseases, including SARS-CoV-2, creates challenges for implementing and obtaining regulatory-compliant written informed consent. The goal of this project was to identify and evaluate processes that address these barriers while maintaining clinical and research staff safety.
Methods
We reviewed Federal Drug Administration (FDA), World Health Organization (WHO), and VA Office of Research and Development (ORD) guidance about informed consent during the COVID-19 pandemic, and identified and pilot-tested several mechanisms for obtaining regulatory-compliant consent during our COVID-19 therapeutics clinical trial.
Results
Several processes were identified. These included a standard face-to-face consent with a plan for maintaining a paper copy of the signed consent form, a phone or video chat consent process that included taking a picture of the signed consent form or a screen shot of the signed document during a video chat, integration of the consent forms into software embedded within the electronic health record, and secure software programs with electronic signature. These processes are FDA-compliant but time-intensive, often requiring four or more hours of coordination between the clinical team, research staff, patients, and legally authorized representatives.
Conclusions
Future studies could evaluate how to improve efficiency, and whether some elements of the consenting process, such as the requirement for documented written signed consent, rather than a witnessed oral consent, is an acceptable standard for research participants with communicable diseases.

Ethical and legal requirements for biomedical research involving health data in the context of the Covid-19 pandemic: is informed consent still playing the leading role?
Federico de Montalvo Jääskeläinen
BioLaw Journal, February 2021
Open Access
Abstract
The current pandemic could have accelerated a change of the traditional paradigm about the secondary use of health data. The traditional one has been based on the faculty of the individuals about accepting or not that use of their health data through the main role of informed consent. The new paradigm considers the current value of that secondary use for the improvement of the health of community and its individuals, through the possibilities offered by Big Data and AI. Therefore, the need of a balance between individual rights and the common good is indispensable. Pseudonymization could be the way to find this balance.

Editor’s note: This article notes that pseudonymization is understood as the processing of personal data in such a way that they can no longer be attributed to an interested party without using additional information.

Implications and advice on getting COVID-19 vaccine consent
Feature
Jonathan Beebee
Learning Disability Practice, 1 April 2021; 24(2) pp 10-12
Abstract
How to support people with learning disabilities to get vaccinated. Vaccinations against COVID-19 are not mandatory and where people can give or refuse consent we have a responsibility to ensure consent is sought. Many people with learning disabilities will be unable to consent, but others will be able to consent if given the right support. Nurses, carers and families should begin planning as soon as possible, so they are prepared when the invitation to receive the vaccine arrives.

Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19
Research Article
Dennis M. Bierle, Ravindra Ganesh, Caroline G. Wilker, Sara N. Hanson, Darcie E. Moehnke, Tammy A. Jackson, Priya Ramar, Jordan K. Rosedahl, Lindsey M. Philpot, Raymund R. Razonable
Journal of Primary Care & Community Health, 25 May 2021
Open Access
Abstract
Background
The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal antibody therapies are not established. This study aimed to identify factors impacting the decision to consent for monoclonal antibody therapies and assess the differences in clinical outcomes of patients who accepted compared to those who declined these therapies.
Methods
This retrospective cohort study enrolled 2820 adult patients who were offered monoclonal antibody therapies, bamlanivimab and casirivimab-imdevimab, for COVID-19 at Mayo Clinic in the Midwest between 11/19/2020 and 12/31/2020. The primary endpoint is the decision to accept or decline monoclonal antibody treatment. Secondary endpoints were patient-level factors that could have impacted the decision to accept treatment (age, gender, race, ethnicity, primary language spoken, and medical comorbidities). The main clinical endpoint was hospitalization within 28 days of COVID-19 diagnosis.
Results
59.1% (n = 1669) chose to accept monoclonal antibody therapy, and 40.9% (n = 1151) chose to decline the offer for treatment. Patients were more likely to accept treatment if they were non-Hispanic White, English speaking, identified a spouse or life partner, had a religious affiliation, and possessed more medical comorbidities. Overall, 28-day hospitalization rate was 2.6% (n = 72/2820) and was higher among those who declined (3.3%) than those who accepted monoclonal antibody therapy (2.0%; Rate Ratio = 0.62, 95% Confidence Interval, 0.39-0.98).
Conclusions
Despite having more comorbidities, patients who accepted monoclonal antibody treatments had a lower rate of hospitalization compared to patients who declined treatment. Several social and cultural factors were associated with the decision to decline therapy, including race, language, ethnicity, and lack of social support. These findings can inform public health efforts to reduce social disparities in the treatment of COVID-19 and increase utilization of monoclonal antibody therapies in high risk populations.

COVID-19 vaccination: your guide to consent
Erin Dean
Nursing Standard (2014+), 3 March 2021; 36(3)pp 42-43
Excerpt
The COVID-19 vaccination campaign is the biggest in the history of the NHS, with millions of people being offered the vaccine. Consent must be obtained before starting any treatment or investigation or providing personal care. This includes the administration of all vaccines.

For many, the idea of consent is inextricably linked to signing a form, and the government has introduced a number of consent forms specifically for the COVID-19 vaccine programme, including forms for adults and care home residents.

Yet RCN and government guidance is clear: consent should be a process rather than a single event and a signature alone does not demonstrate that the consent process has been followed.

Here, we look at the key issues surrounding consent, and the implications for nursing staff who are involved in the COVID-19 vaccine programme…

Nursing Home and Vaccination Consent: The Italian Perspective
Nunzia Cannovo, Roberto Scendoni, Marzia Maria Fede, Federico Siotto, Piergiorgio Fedeli, Mariano Cingolani
Vaccines, 24 April 2021; 4(429)
Open Access
Abstract
Since the beginning of the Covid-19 pandemic, many countries have begun vaccination campaigns, with different methods and timelines, with the goal of vaccinating over 75% of the population and thus achieving herd immunity. Initially it was necessary to identity the categories of citizens who should be the first to receive the vaccines, on the basis of scientific evidence. On the basis of this information, elderly residents in nursing homes and the staff who care for them should be the highest priority subjects for vaccination. In this context, obtaining informed consent to Covid-19 vaccination presents a considerable challenge, as the advanced age and frequent comorbidities of a significant number of the residents may mean that they are incapable of expressing consent themselves. The legislation of various Western nations substantially agrees on the general principle that those capable of judgement must be asked for their consent for healthcare services, and that even those with psychological weaknesses that limit their full ability to decide must be involved in these decision-making processes. The article can help systematize the processes to be implemented to protect the health of individuals as members of a close and fragile community.

Consent in covid: A researcher’s dilemma
Review
Trends in Anaesthesia and Critical Care, 3 April 2021
Heena Garg, Puneet Khanna
Abstract
An informed consent is a vital component of health care and forms an important component of any research study. Informed consent is the process where a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. A proper consent is imperative to ensure safety of the patients. However, obtaining a consent in the hospital settings has become a matter of concern in the times of this coronavirus-19 (COVID-19) pandemic. This brief review describes the additional complexities added to the consent for research and the various modifications needed in view of this pandemic. The current consent proformas need to be modified and individualised to the patient ensuring patient safety during research in the ongoing pandemic. We need to become more familiar with the technology and electronic tools as the acceptable alternative tools of communication in the current scenario. There is a need to incorporate a separate covid consent with due consideration to deferred consent, pre-emptive consent or waiver of a consent.

Global Ethical Considerations Regarding Mandatory Vaccination in Children
Julian Savulescu, Alberto Giubilini, Margie Danchin
The Journal of Pediatrics, 20 January 2021
Open Access
Abstract
Whether children should be vaccinated against coronavirus disease-2019 (COVID-19) (or other infectious diseases such as influenza) and whether some degree of coercion should be exercised by the state to ensure high uptake depends, among other things, on the safety and efficacy of the vaccine. For COVID-19, these factors are currently unknown for children, with unanswered questions also on children’s role in the transmission of the virus, the extent to which the vaccine will decrease transmission, and the expected benefit (if any) to the child. Ultimately, deciding whether to recommend that children receive a novel vaccine for a disease that is not a major threat to them, or to mandate the vaccine, requires precise information on the risks, including disease severity and vaccine safety and effectiveness, a comparative evaluation of the alternatives, and the levels of coercion associated with each. However, the decision also requires balancing self-interest with duty to others, and liberty with usefulness. Separate to ensuring vaccine supply and access, we outline 3 requirements for mandatory vaccination from an ethical perspective: (1) whether the disease is a grave threat to the health of children and to public health, (2) positive comparative expected usefulness of mandatory vaccination, and (3) proportionate coercion. We also suggest that the case for mandatory vaccine in children may be strong in the case of influenza vaccination during the COVID-19 pandemic.