Implications and advice on getting COVID-19 vaccine consent

Implications and advice on getting COVID-19 vaccine consent
Jonathan Beebee
Learning Disability Practice, 1 April 2021; 24(2) pp 10-12
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

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
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.
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.
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).
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

COVID-19 vaccination: your guide to consent
Erin Dean
Nursing Standard (2014+), 3 March 2021; 36(3)pp 42-43
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

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
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

Consent in covid: A researcher’s dilemma
Trends in Anaesthesia and Critical Care, 3 April 2021
Heena Garg, Puneet Khanna
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

Global Ethical Considerations Regarding Mandatory Vaccination in Children
Julian Savulescu, Alberto Giubilini, Margie Danchin
The Journal of Pediatrics, 20 January 2021
Open Access
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.

Informed consent and a risk-based approach to oncologic surgery in a cancer center during the COVID-19 pandemic

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
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).
To report an IC and an algorithm developed for oncologic surgery during the COVID-19 outbreak.
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.
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.
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

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
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

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
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

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
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.