The patient suffering from acute respiratory failure COVID-19 related who refuses medical treatment: an emblematic case

The patient suffering from acute respiratory failure COVID-19 related who refuses medical treatment: an emblematic case
Francesca Maghin, Massimo Salvetti, Maria Lorenza Muiesan, Adelaide Conti
Internal and Emergency Medicine, 2 July 2022
Open Access
Respiratory failure related to COVID-19 may evolve into acute respiratory distress syndrome, which may require invasive treatment. Through the analysis of a concrete clinical case, we want to clarify how to manage patients suffering from serious acute pathologies, which require timely intervention, even invasive, but refuse medical treatment. The Italian law 219/2017 states strongly the freedom of the patient to choose, independently whether to start or stop at any time any type of medical treatment through their informed consent. The law, of course, addresses in several parts the problem of the refusal of the subject to certain choices. The law also provides that if the patient refuses therapies or interventions, putting his life at risk, the doctors need to engage in further communication with the support of other professionals, informing the patient of the consequences, promoting every support action, and involving family members. Judgment on the level of impaired capacity, which makes a patient incompetent to make therapeutic decisions, should ideally reflect the balance between respecting patient autonomy and protecting the patient from the consequences of a wrong decision. For the physicians, it is a matter of balancing the need to save the life of the person, or at least to avoid the establishment of permanent damage, with the subject itself expressly stated, including an explicit refusal to carry out maneuvers or therapies or interventions when it is in danger of life, even if such treatments could save it.

Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions

Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions
Julie R Bromberg, Evelyn Nimaja, Andrew W Kiragu, Karla A Lawson, Lois Lee, Isam W Nasr, Charles Pruitt, Stephanie M Ruest, Michael J Mello
Ethics and Human Research, July 2022; 44(4) pp 39-44
The Covid-19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness-implementation trial in 10 pediatric trauma centers. In response to several pandemic-based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in-person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center-based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty-five participants were enrolled in the effectiveness-implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.

A mother’s perspective of consent for maternal and neonatal COVID-19 testing: can we do more?

A mother’s perspective of consent for maternal and neonatal COVID-19 testing: can we do more?
Natalie Anne East, Sunitha Ramaiah, Kimberley Morris, Sangeeta Pathak
British Journal of Midwifery, 28 June 2022; 30(7)
There is ongoing research on the effects of COVID-19 on pregnancy and whether vertical viral transmission occurs.
This study aimed to determine maternal opinions of COVID-19 testing for pregnant women and newborns in order to influence future clinical practice while advancing global knowledge of the impact of testing on patient experiences.
This service evaluation assessed the opinions of 292 pregnant women who were tested for COVID-19 along with their newborn babies using nasopharyngeal swabs and the SARS-CoV-2 reverse transcription polymerase chain reaction test between 28 April and 21 May 2020.
Many women felt their own (60%) and their baby’s (61%) swab was compulsory and did not feel sufficiently informed about the risks and benefits for themselves (43%) or their baby (52%) being tested. Some women did not understand the implications of a positive test for themselves (43%) or their baby (42%). Most participants reported they would agree to themselves (97%) and their baby (86%) being tested in future pregnancies.
Communication to pregnant women regarding the COVID-19 swabbing process is critical and requires improvement. This service evaluation highlighted where women felt under-informed. These areas should be covered in more detail for consenting women for COVID-19 testing in future.

Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable

Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable
Rafael Dal-Ré, Arthur L Caplan, Teck Chuan Voo
European Journal of Internal Medicine, 27 June 2022
Open Access
…Obtaining participants’ informed consent is one of the basic safeguards for ensuring ethically conducted clinical research. Investigators must provide potential participants all reasonable relevant trial information so that they can make an informed decision. How investigators seek participants’ informed consent should be consistent with international ethical standards. First, informed consent must be obtained from patients with capacity. If a patient is incapable of consenting (e.g., intubated patient), the investigator must seek informed consent from their legal representative. During the pandemic, at the trial design stage, investigators of the four aforementioned ad-RCTs (Table 1) decided that deferred consent was an acceptable approach as they realized that many potential trial participants would be incapable of providing consent and having access to the patient’s legal representative could be extremely difficult to obtain. Their decisions were backed by the research ethics committees involved in the review and approval of the ad-RCTs’ protocols. Patients unable to consent were included in the trial and informed consent obtained once they were able to provide it (or when the legally authorized representative became available), rendering the consent deferred. However, deferred consent must fulfil several conditions to be ethically acceptable. Second, trial investigators should seek the informed consent of potential participants before randomization, which ensures that all participants receive the same information on the trial procedures and available treatments in all study arms. This is applicable to any RCT, but it is even more relevant when it is likely that the legal representative of many participants will be involved. The participant’s legal representative should decide considering to what extent study participation promotes the individual’s clinical interests, and to this end should know all the therapies under assessment…

Consent for orthopaedic trauma surgery during the COVID-19 pandemic

Consent for orthopaedic trauma surgery during the COVID-19 pandemic
Selmi H, Davies A, Walker J, Heaton T, Sabharwal S, Dani M, Fertleman M, Reilly P
BMJ Open Quality, 1 June 2022, 11(2)
The COVID-19 pandemic has brought a series of new challenges to the management of surgical patients. The consent process relies on a foundation of open and non-coerced discussion between clinician and patient, which includes all the potential risks of surgery. This must be updated to incorporate the additional risks of surgery during the pandemic including infection with the SARS-CoV-2 and increased risks of complications with the potential requirement for intensive care support.
The aim of this multi-cycle quality improvement project was to ensure all patients were fully informed of the risks of developing COVID-19 and the possible need for intensive care unit (ICU) support.
We investigated the quality of the consent process for patients undergoing surgery for trauma at our major trauma centre. Our baseline data collection included a review of all orthopaedic trauma consent forms over a 4-week period in March 2020. We subsequently undertook three further Plan-Do-Study-Act (PDSA) cycles over separate 4-week periods. First, in June 2020, after education measures and presentation of baseline data, second in July 2020 after further education and regular digital reminders were sent to staff, and third in September 2021 after the implementation of an electronic consent form.
At baseline, only 2.6% of consent forms mentioned the risk of COVID-19 and none mentioned the risk of requiring ITU support. Through three PDSA cycles this increased to 97% of cases where consent forms displayed the additional risks of COVID-19 and the potential need for ITU admission.
Our quality improvement project improved the informed consent procedure at our trust. By incorporating these additional risks into the template of an electronic consent form, we hope to achieve sustained improvement in practice.

Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives

Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives
Gonasagrie Nair, Siti M. Kabanda, Meagan M.M. Jacobs-Alfred, Adetayo E.A. Obasa, Michael G. McCaul, Keymanthri Moodley
South African Journal of Science, 31 May 2022; 5
Open Access
The COVID-19 pandemic has warranted modifications to clinical research implementation to ensure adherence to public health and safety measures. Often, this modification has necessitated a deviation from the traditional face-to-face approach to an electronic or hybrid consent process. We assessed the acceptability and preference for electronic consent and explored understanding of the electronic consent information – an outcome which is vital in providing reassurance that consent is provided with full appreciation of the risks and benefits of study participation. In this descriptive study, healthcare professionals (HCPs) were invited, through a database of HCP contacts, snowball sampling and advertisement, to participate in an online survey between 14 July 2021 and 17 September 2021, to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa (SISONKE Trial). Descriptive analysis was used to characterise respondents and categorical data were expressed as frequencies. The prevalence of recurring responses to open-ended questions allowed for the identification of themes. A total of 1025 HCPs completed the online survey. Access to a COVID-19 vaccine was the strongest motivating factor for enrolment (82.3%) into the SISONKE Trial. Over a third of participants (38.6%) were not able to discuss the study with research staff. While the majority of participants (85.2%) indicated that online consent was acceptable, it was recognised that acceptability was context specific. Although 64% indicated awareness that reporting both a positive COVID test and adverse events were requirements, a significant percentage (32%) did not recall that the reporting period was 2 years. The electronic consent process was easily navigated by educated HCPs with access to electronic devices and data. Vaccine access was the most important motivation for participation, thus raising questions about how voluntary the consent process was and the role of desperation in deciding to participate.

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”

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”
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
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.
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.
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.
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

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
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

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
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.
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)
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?

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.