Patient consent preferences on sharing personal health information during the COVID-19 pandemic: “the more informed we are, the more likely we are to help”
Research
Sarah Tosoni, Indu Voruganti, Katherine Lajkosz, Shahbano Mustafa, Anne Phillips, S. Joseph Kim, Rebecca K. S. Wong, Donald Willison, Carl Virtanen, Ann Heesters, Fei-Fei Liu
BMC Medical Ethics, 20 May 2022; 23(53)
Open Access
Abstract
Background
Rapid ethical access to personal health information (PHI) to support research is extremely important during pandemics, yet little is known regarding patient preferences for consent during such crises. This follow-up study sought to ascertain whether there were differences in consent preferences between pre-pandemic times compared to during Wave 1 of the COVID-19 global pandemic, and to better understand the reasons behind these preferences.
Methods
A total of 183 patients in the pandemic cohort completed the survey via email, and responses were compared to the distinct pre-pandemic cohort (n = 222); all were patients of a large Canadian cancer center. The survey covered (a) broad versus study-specific consent; (b) opt-in versus opt-out contact approach; (c) levels of comfort sharing with different recipients; (d) perceptions of commercialization; and (e) options to track use of information and be notified of results. Four focus groups (n = 12) were subsequently conducted to elucidate reasons motivating dominant preferences.
Results
Patients in the pandemic cohort were significantly more comfortable with sharing all information and biological samples (90% vs. 79%, p = 0.009), sharing information with the health care institution (97% vs. 83%, p < 0.001), sharing information with researchers at other hospitals (85% vs. 70%, p < 0.001), sharing PHI provincially (69% vs. 53%, p < 0.002), nationally (65% vs. 53%, p = 0.022) and internationally (48% vs. 39%, p = 0.024) compared to the pre-pandemic cohort. Discomfort with sharing information with commercial companies remained unchanged between the two cohorts (50% vs. 51% uncomfortable, p = 0.58). Significantly more pandemic cohort patients expressed a wish to track use of PHI (75% vs. 61%, p = 0.007), and to be notified of results (83% vs. 70%, p = 0.012). Thematic analysis uncovered that transparency was strongly desired on outside PHI use, particularly when commercialization was involved.
Conclusions
In pandemic times, patients were more comfortable sharing information with all parties, except with commercial entities, where levels of discomfort (~ 50%) remained unchanged. Focus groups identified that the ability to track and receive results of studies using one’s PHI is an important way to reduce discomfort and increase trust. These findings meaningfully inform wider discussions on the use of personal health information for research during global crises.

Equipoise, standard of care and consent: responding to the authorisation of new COVID-19 treatments in randomised controlled trials
Current controversy
Soren Holm, Jonathan Lewis, Rafael Dal-Ré
Journal of Medical Ethics, 13 May 2022
Open Access
Abstract
In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well known research ethics issues. In this paper, we identify three such issues by focusing on the authorization of molnupiravir, a novel antiviral medicine aimed at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of molnupiravir through the large-scale Platform Adaptive trial of Novel antivirals for early treatment of COVID-19 In the Community randomized control trial. By analysing the ways in which the authorisation and clinical use of molnupiravir complicate standard approaches to clinical equipoise, standard of care and participant consent in the PANORAMIC randomised control trial, we will explain some ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers.

E-Consent – an innovative solution to maintain recruitment momentum in clinical trials during the COVID-19 pandemic
R Almeida-Magana, J. Grierson, H. Maroof, R. Clow, E. Dineen, T. Al-Hammouri, N. Muirhead, C. Brew-Graves, J. Kelly, G. Shaw
European Urology, 2022
Abstract
Introduction & Objectives
The NeuroSAFE PROOF trial is an ongoing randomized clinical trial evaluating the role of frozen section analysis during robot assisted radical prostatectomy for localized prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this is to describe the implementation, impact on recruitment rate and patient’s experience using e-Consent.
Materials & Methods
To replace in person consent. An email-based PDF Auto-Archiver feature was created within the Research Electronic Data Capture (REDCap®) environment, following the structure and content of the already approved paper consent. Each question was included as a binary (yes/no) field. An electronic signature field allows the participant to sign the document using a mouse, stylus, or their finger. The signature is captured and appended as a PNG image with a timestamp. This allows research staff to review and electronically co-sign and lock the document. This new tool was approved by the Health Research Authority, Research Ethics Committee, Trial Management Group and Sponsor. Owing to the process collecting patient identifiable data, the platform resides within the REDCap service being hosted behind a Data Safe Haven, which conforms to National Health Service Data Security & Protection Toolkit, General Data Protection Regulation and ISO 27001 Information Security standards.
Results
Before recruitment suspension, the trial was recruiting an average of 9 patients per month, with an increasing trend. (Figure 1) After e- Consent implementation in June 2020, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. The use of this pathway eliminates the need to travel and, therefore, the resultant cost and potential risk of infection, while allowing patients to read and understand information in their own time before providing consent. (Figure Presented)
Conclusions
Guidelines for e-Consent implementation are currently lacking. We present the first description of its use for prostate cancer research. This innovation was critical to resume recruitment for the NeuroSAFE PROOF trial and will be essential for planning future research.

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
Abstract
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
H Bookholane, T Du Toit, E Muller, D Thomson
South African Journal of Surgery, 11 April 2022; 60
Abstract
Background
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.
Methods
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).
Results
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.
Conclusion
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
Piergiorgio Fedeli, Roberto Scendoni, Mariano Cingolani, Marcelo Corrales Compagnucci, Roberto Cirocchi, Nunzia Cannovo
Healthcare, 11 February 2022; 10(349)
Open Access
Abstract
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
Original Research
Zorin KV , Gurevich KG
Medical Ethics, 31 March 2021
Open Access
Abstract
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
Indonesian Research
Tiwuk Herawati, Fifik Wiryani, M. Nasser, Mokhammad Najih
Diponegoro Law Review, 2021; 6(2) pp 279-288
Abstract
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
Notebook
Sheila M. Bird
Royal Statistical Society, 25 January 2022
Abstract
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
M. Botes
South African Journal of Bioethics and Law, 2021; 14(3) pp 93-96
Abstract
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.