A lesson from MMR: is choice of vaccine the missing link in promoting vaccine confidence through informed consent?

A lesson from MMR: is choice of vaccine the missing link in promoting vaccine confidence through informed consent?
Research Article
J O’Neill
Ethics & Behaviour, 20 Apr 2022
A recent study suggests that vaccine hesitancy amongst key demographics – including females, younger individuals, and certain ethnic groups – could undermine the pursuit of herd immunity against COVID-19 in the United Kingdom. At the same time, the UK Joint Committee on Vaccination and Immunization (JVCI) indicated that it will not facilitate the choice between available COVID-19 vaccines. This paper reflects upon lessons from the introduction of the UK’s combined Measles, Mumps and Rubella (MMR) vaccine strategy of the 1980s when Member of Parliament Miss Julie Kirkbride argued that had parents been allowed to choose between vaccine variants, then the crisis of low herd immunity – and subsequent outbreaks – could have been avoided. This paper explores this argument, as applied to the COVID-19 vaccination strategy, by considering how three key elements of informed consent – disclosure of risk, benefit, and reasonable alternatives – may be employed to tackle vaccine hesitancy and build vaccine confidence.

Organ transplantation during the COVID-19 pandemic – impact on deceased organ donor referrals and consent rates in the Western Cape, South Africa

Organ transplantation during the COVID-19 pandemic – impact on deceased organ donor referrals and consent rates in the Western Cape, South Africa
H Bookholane, T Du Toit, E Muller, D Thomson
South African Journal of Surgery, 11 April 2022; 60
The impact of the COVID-19 pandemic on transplantation is multifactorial. This study reports on its influence on deceased donation for transplantation in the Western Cape.
The volume of referrals and those who were consented for organ donation in the province in the pre pandemic period of May 2017 to February 2020 were compared to those of the initial pandemic period (March through December 2020).
Prior to the pandemic, there were 201 deceased donor referrals in the Western Cape province – 152 (75.6%) and 49 (24.4%) in public and private sectors, respectively. The mean referral rates ranged between 59 69 referrals per year, translating into a monthly rate of 4.8 (range 2.8–5.8). During the first 10 months of the pandemic, there were 18 referrals – 12 (66.7%) and six (33.3%) in the public and private sectors; a decrease of 63%, with a mean monthly referral rate of 1.8. The overall consent rate prior to the pandemic in the public and private sectors was 36.6% (38% and 27%, respectively) with an increase to 44.4% (37.5% and 62.5%) during the pandemic.
Despite a 10% increase in consent rate for deceased donation during the COVID-19 pandemic, there was a significant decrease in the number of potential donors referred. Strategies to improve organ donation and transplantation during and after the COVID-19 pandemic are required.

Informed Consent and Protection of Personal Data in Genetic Research on COVID-19

Informed Consent and Protection of Personal Data in Genetic Research on COVID-19
Piergiorgio Fedeli, Roberto Scendoni, Mariano Cingolani, Marcelo Corrales Compagnucci, Roberto Cirocchi, Nunzia Cannovo
Healthcare, 11 February 2022; 10(349)
Open Access
The particular characteristics of COVID-19 demand the careful biomedical study of samples from patients who have shown different symptomatology, in order to understand the genetic foundations of its phenotypic expression. Research on genetic material from COVID-19 patients is indispensable for understanding the biological bases for its varied clinical manifestations. The issue of “informed consent” constitutes the crux of the problem in regulating research biobanks, because it concerns the relationship between the person and the parts separated from the body. There are several consensus models that can be adopted, varying from quite restricted models of specific informed consent to forms that allow very broad authorization (open consent). Our current understanding of COVID-19 is incomplete. Thus, we cannot plan, with precision, the research to be conducted on biological samples that have been, or will be, collected from patients infected by the novel coronavirus. Therefore, we suggest utilizing the “participation pact” between researchers and donors, based on a new form of participation in research, which offers a choice based on the principles of solidarity and reciprocity, which represent the communication of “values”. In the last part of this paper, the general data protection regulation concerning the matter is discussed. The treatment of personal data must be performed with explicit goals, and donors must be provided with a clear, transparent explanation of the methods, goals and time of storage. The data must not be provided to unauthorized subjects. In conclusion, open informed consent forms will be necessary for research on individual patients and on populations.

Ethical Aspects of the Informed Consent During COVID-19 Vaccination

Ethical Aspects of the Informed Consent During COVID-19 Vaccination
Original Research
Zorin KV , Gurevich KG
Medical Ethics, 31 March 2021
Open Access
The main tactics used for COVID-19 prevention should be both quarantine measures and the large scale vaccination of the population. This does raise many ethical issues related to obtaining informed consent in biomedical research and clinical practice. The full and adequate ethical review of vaccination against the novel coronavirus infection can be provided only subject to ethical aspects of voluntary informed consent. Without that, it would be impossible to control the quality, efficiency and safety of the vaccine, and, consequently, the patients’ vaccination and its results.

Transparency informed consent related to patient dishonesty amid COVID-19 pandemic in Indonesia: In law perspective

Transparency informed consent related to patient dishonesty amid COVID-19 pandemic in Indonesia: In law perspective
Indonesian Research
Tiwuk Herawati, Fifik Wiryani, M. Nasser, Mokhammad Najih
Diponegoro Law Review, 2021; 6(2) pp 279-288
To break the chain of transmission of COVID-19 outbreak, the public is expected to be honest in explaining chronological physical contact when treating to health facilities, especially if the patient experiences symptoms of COVID-19. Honesty of patients indicated by COVID-19 is very important so that the chain of transmission of COVID-19 does not expand and facilitate health workers in data collection. Denial, lies, even like the refusal of COVID-19 corpses if it continues to be left, does not mean the countermeasures of COVID-19 are increasingly stretched. This article tries to review the transparency of informed consent in relation to patient dishonesty, where transparent communication is expected by the patient to be honest and not to cover the perceived symptoms or various things related to COVID-19. This research is normative juridical research. In normative legal research, library material is the basic data that in research science is classified as secondary data.

Editor’s note: Diponegoro Law Review is published by the Faculty of Law, Diponegoro University, Indonesia.

Medical research, data sharing, and properly informed consent

Medical research, data sharing, and properly informed consent
Sheila M. Bird
Royal Statistical Society, 25 January 2022
When Sheila M. Bird agreed to participate in a Covid surveillance study, she did not realise her negative test result and personal details would be passed to NHS Test and Trace. Here, she calls for closer scrutiny of privacy policies by research ethics committees, and clearer communication with study participants

Informed consent during pandemics: Experimental medicine, experienced consent

Informed consent during pandemics: Experimental medicine, experienced consent
M. Botes
South African Journal of Bioethics and Law, 2021; 14(3) pp 93-96
No known cure exists for COVID-19, and medical practitioners are exhausted and at their wits’ end trying to find treatments that prevent patients from ending up in hospital or intensive care, or even dying. A variety of treatments tried by medical practitioners include standard registered medicine, investigational or so-called experimental, unapproved or preapproved medicines, emergency or compassionate-use authorised medicine and pre-market approved medicine. However, the medicines that can be accessed via each of these categories are at different stages of efficacy testing and knowledge about adverse effects, dosages and risks. To obtain ethical and legal informed consent, medical practitioners must deal with a lot of medical uncertainty, and care must be taken to ensure that the patient understands the difference in risks they may be willing to take depending on the medicine’s stage of development. Often additional information is required to obtain ethical consent as opposed to legal consent. A purely legal approach to informed consent, especially when dealing with the medical uncertainties of health emergencies and pandemics, may lead to patients’ consent lacking in enough substance to be truly considered legal and ethical. Informed consent as respect for autonomy in this sense requires more than the patient’s explicit agreement or compliance with a certain treatment proposal. This article explains the difference in consent content attached to each different stage of a medicine’s development, especially considering the additional difficulties posed by obtaining truly informed consent during a pandemic with uncertain characteristics, treatment and solutions.

Consent or Public Reason? Legitimacy of Norms Applied in ASPD and COVID-19 Situations

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
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?

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)
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.
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.
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.
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.
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

Parental consent for vaccination of minors against COVID-19
Nina Shevzov-Zebrun, Arthur Caplan
Vaccine, October 2021; 39(44) pp 6451–6453
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?