When Understanding Fails: How Diverging Norms in Medicine and Research Led to Informed Consent Failures During the Pandemic
Daniel Pinto
Journal of Medical Ethics, 18 December 2024
Abstract
During the COVID-19 pandemic, there were many vaccine trials which had significant purposes which participants needed to understand to validly consent. For example, participants needed to understand that the purpose of dose-escalation vaccine trials was to give incremental doses of vaccine until participants became ill. Likewise, participants needed to understand that if they received placebos, they could no later take a genuine vaccine to preserve the integrity of the trials. Yet, these intuitive judgements about what participants need to understand to validly consent are rejected by recent accounts of consent. According to these accounts, as long as participants were given a good opportunity to learn these purposes, they do not need to actually understand them to consent. In this paper, I reject this consensus, and I argue that participants who failed to understand these aims associated with vaccine trials failed to provide legitimate consent. I defend this claim by developing and defending a new understanding condition for valid consent. According to this understanding condition, a participant must understand when a consent transaction has features which violate the norms which govern the medical practice with which they are acquainted. I argue that this condition is independently plausible and best explains why participants needed to understand these aims associated with vaccine trials to validly consent.

Medical Ethics and Informed Consent to Treatment: Past, Present and Future
Alan Mordue, Elizabeth A Evans, James T Royle, Clare Craig
Cureus, 9 December 2024; 16(12)
Open Access
Abstract
It has been asserted that there was an erosion of medical ethics during the Covid-19 pandemic and a departure from the principle of obtaining fully informed consent from patients before treatment. In light of these assertions, this article reviews the historical development of medical ethics and the approach to obtaining informed consent and critiques the consent practices before and during the pandemic. It then describes a new tool for displaying key statistics on the benefits and risks of interventions to help explain them to patients and suggests a more rigorous process for seeking fully informed consent in the future.

Care of women and application of the principle of informed consent to interventions during birth in the COVID-19 pandemic period
Research Paper
Alina Liepinaitienė, Izabelė Bujaitė, Aurimas Galkontas, Vaidas Jotautis,Audrius Dėdelė
European Journal of Midwifery, 8 May 2024
Abstract
Introduction
In the early phases of the COVID-19 pandemic, inadequate intrapartum care protocols were in place. Many organizations have responded promptly and recognized the importance of adherence to appropriate guidelines. The International Confederation of Midwives issued an official statement on 29 March 2020, which states that every woman has the right to information, to give consent, to refuse consent, and to have her choices and decisions respected and upheld. No research has been conducted in Lithuania to reveal the care of women who gave birth during the COVID-19 pandemic and the application of informed consent to interventions.
Methods
This study is quantitative of cross-sectional design. An anonymous questionnaire survey method was used. One hundred fifty-two women who gave birth in Lithuania during the COVID-19 pandemic (March 2020 – May 2022) and had COVID-19 infection during childbirth, participated in the study. Statistical data analysis was performed.
Results
During the COVID-19 pandemic, women’s care was characterized by always or almost always adequate information from health professionals on all issues to minimize the stress of new procedures necessitated by the COVID-19 pandemic and allowing them to stay with newborns as long as possible. The application of the principle of informed consent to interventions during the COVID-19 pandemic was not always applied to the performance of transvaginal examination manual compression of the uterine fundus to facilitate the expulsion period.
Conclusions
Most women said that they were properly informed by healthcare professionals about all questions related to the new procedures that became necessary due to the COVID-19 pandemic and felt included in their own choice. However, mothers felt the need of relatives during childbirth, and consent was often not asked for vaginal examination.

Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences and viewpoints
Research Article
Stefanie Weigold, Susanne Gabriele Schorr, Alice Faust, Lena Woydack, Daniel Strech
Plos One, 30 April 2024
Open Access
Abstract
Background
Very little is known about the practice-oriented challenges and potential response strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and potential response strategies for informed consent and study prioritization in a pandemic setting.
Methods
We performed semi-structured interviews with German stakeholders involved in clinical research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and potential response strategies was reached.
Results
We conducted 21 interviews with investigators, oversight bodies, funders and research support units. For the first topic informed consent we identified three main themes: consent challenges, impact of consent challenges on clinical research, and potential strategies for consent challenges. For the second topic prioritization of clinical studies, we identified two main themes: perceived benefit of prioritization and potential strategies for prioritization. All main themes are further specified with subthemes. A supplementary table provides original quotes from the interviews for all subthemes.
Discussion
Potential response strategies for challenges with informed consent and study prioritization partly share common ground. High quality procedures for study prioritization, for example, seem to be a core response strategy in dealing with informed consent challenges. Especially in a research environment with particularly high uncertainty regarding potential treatment effects and further limitations for valid informed consent should the selection of clinical trials be very well justified from a scientific, medical, and ethics viewpoint.

COVID-19 Vaccination and the Role of Informed Consent: England as a Case Study
Caterina Milo
European Journal of Health Law, 22 May 2023
Abstract
Informed consent (IC), following the Supreme Court judgment in Montgomery v Lanarkshire Health Board, [2015] UKSC 11, constitutes a key patients’ right. There is a vast literature exploring the significance of this right, while an analysis of the role that this has played in England during the COVID-19 vaccine distribution has been under-explored. Using England as a case study, this paper argues that IC has received limited protection in the COVID-19 vaccination context of the adult population, upholding at its best only a minimalistic approach where mere ‘consent’ has been safeguarded. It suggests that new approaches should be brainstormed so as to more properly safeguard IC in a Montgomery-compliant-approach, namely in a way that enhances patients’ autonomy and medical partnership, and also to better prepare and respond to future pandemics.

Adaptive, platform trials assessing therapies for hospitalized COVID-19 patients: Informed consent forms omitted a few important elements of information
Rafael Dal-Ré, Teck Chuan Voo, Søren Holm
Journal of Global Health, 12 May 2023
Abstract
Background
The information provided to participants of adaptive platform trials assessing therapies for COVID-19 inpatients is unknown. We aim to evaluate it by reviewing participant information sheets/informed consent forms (PIS/ICFs).
Methods
We searched the Cochrane COVID-19 Study Register and ClinicalTrials.gov (28 March 2022) to identify non-industry-sponsored adaptive platform phase 2+ trials with publicly available protocols and PIS/ICFs, selecting versions closest to the initial one. We assessed the elements of information included in the Good Clinical Practice guidelines and the Declaration of Helsinki as present, absent, or deficient (incompletely described).
Results
We included PIS/ICFs of 11 trials (ACCORD-2, ACTIV-1IM, Bari-SolidAct, CATALYST, Discovery, HEAL-COVID, ITAC, RECOVERY, REMAP-COVID, Solidarity and TACTIC-R), which were 4-32 pages long (median (md) = 11). Between two and 11 (md = 6) of the 25 different elements of information assessed were omitted or deficiently described in the PIS/ICFs of the 11 trials. Information about providing trial results, investigators’ conflicts of interest, post-study provisions, payment to and anticipated expenses for participants, number of participants, and on whether participants will receive new information that could impact their decision on staying in the trial, were omitted or deficiently described in at least five PIS/ICFs.
Conclusions
Investigators failed to include a few important elements of information in the trial’s PIS/ICF deemed relevant by international standards. In protocols of future trials, investigators should explain why elements of information specified in the Good Clinical Practice guidelines and/or by the Declaration of Helsinki were omitted from the PIS/ICFs.

Research recruitment and consent methods in a pandemic: a qualitative study of COVID-19 patients’ perspectives
Research
Serena S Small, Erica Lau, Kassandra McFarlane, Patrick M Archambault, Holly Longstaff, Corinne M Hohl
BMC Medical Research Methodology, 11 May 2023
Open Access
Abstract
Background
Virtual data collection methods and consent procedures adopted in response to the COVID-19 pandemic enabled continued research activities, but also introduced concerns about equity, inclusivity, representation, and privacy. Recent studies have explored these issues from institutional and researcher perspectives, but there is a need to explore patient perspectives and preferences. This study aims to explore COVID-19 patients’ perspectives about research recruitment and consent for research studies about COVID-19.
Methods
We conducted an exploratory qualitative focus group and interview study among British Columbian adults who self-identified as having had COVID-19. We recruited participants through personal contacts, social media, and REACH BC, an online platform that connects researchers and patients in British Columbia. We analyzed transcripts inductively and developed thematic summaries of each coding element.
Results
Of the 22 individuals recruited, 16 attended a focus group or interview. We found that autonomy and the feasibility of participation, attitudes toward research about COVID-19, and privacy concerns are key factors that influence participants’ willingness to participate in research. We also found that participants preferred remote and virtual approaches for contact, consent, and delivery of research on COVID-19.
Conclusions
Individuals who had COVID-19 are motivated to participate in research studies and value autonomy in their decision to participate, but researchers must be sensitive and considerate toward patient preferences and concerns, particularly as researchers adopt virtual recruitment and data collection methods. Such awareness may increase research participation and engagement.

Investigating demographic differences in patients’ decisions to consent to COVID-19 research
Research Article
Kelly Robertson, Kimberly Reimold, Ann M. Moormann, Raquel Binder, Kristen A. Matteson, Heidi K. Leftwich
The Journal of Maternal-Fetal & Neonatal Medicine, 7 November 2022; 36
Open Access
Abstract
Objective
COVID-19 disease severely impacted pregnant persons, resulting in a significant increase in poor maternal health outcomes, with a disproportionate impact on minority populations and individuals with low socioeconomic status. We sought to determine demographic differences between birthing parents with SARS-CoV-2 infections who consented to research study participation versus those who declined. By analyzing demographic differences, we are able to ensure the generalizability of study outcomes and to aid in future prospective research design, with the ultimate goal of recognizing and ameliorating research disparities.
Methods
We conducted a secondary analysis to investigate demographic differences in patients who consented to versus declined study participation, in an effort to confirm the external validity of the study results and ensure minority populations most affected by SARS-CoV-2 infection were accurately represented. An IRB waiver was obtained to conduct retrospective chart review for demographic data collection of all patients approached for the COVID-19 Analysis on Perinatal Specimens Related to ExpoSure (CARES) research study. Pregnant patients with SARS-CoV-2 infection were identified at a single hospital center and approached either in person or via phone, with a translator if primary language listed as non-English. Demographic variables including race, ethnicity, primary language, and insurance type were obtained from the electronic medical record and analyzed via Chi-square to determine significant differences between individuals who consented to participation and those who declined participation.
Results
One hundred and fifty-eight pregnant patients with SARS-CoV-2 infection were approached for CARES study participation. Eighty-nine patients consented to study participation, while 69 declined study participation. A retrospective chart review was conducted on all 158 patients. Patients who identified as Black race or non-White race were more likely to decline participation (23.2%, p = .031, 68.1%, p = .026), compared to patients who identified as White (31.9%) (Table 1). Patients with public insurance were also more likely to decline study participation (72.5%, p = .049) compared to those with private insurance (27.5%). There was no significant difference between primary language spoken or ethnicity in patients who participated or declined. There was no difference in study participation between patients who identified as Asian race or Other race, compared to patients who identified as White race.
Conclusions
We found significant differences in race and insurance type between pregnant patients with SARS-CoV-2 infection who consented versus declined research study participation. Our study showed that patients who identify as Black race or have public insurance are less likely to consent to research study participation. However, when demographics of consented patients are compared to county, state, and national demographics of female patients age 18–49 with confirmed SARS-CoV-2 infection obtained from a dataset collected by the Center for Disease Control and Prevention (CDC), there was no significant difference between race representation of patients who consented to study participation. This suggests that though the external validity of the CARES study is confirmed, more efforts need to be made to address racial and socioeconomic disparities in research participation.

Informed Consent for Risk of COVID-19 in Preoperative Trauma Patients
Harvey, A. Sheokand, R. Rambani
Orthopaedic Proceedings, 14 November 2022; 104
Open Access
Abstract
Introduction
The risk of Covid-19 community and hospital acquired infection (HAI) on patient outcomes in trauma is still relevant. Patient’s should be routinely consented for this risk to ensure informed consent for perioperative contraction.
Method
A prospective audit was completed from December-March 2022 examining a consecutive series of patient admissions with capacity to consent. The standards for compliance was RCOS Toolkit 5#3 stating the importance of enhanced consent for risk of contraction, in operating and changes to care pathways. The target was 95% compliance. 2/2 contingency tables were generated to determine odds ratio for compliance versus Covid+ rate.
Results
This audit generated 80 consecutive patients from which 28 were excluded as non-operative or lacking capacity. It was found that 25% (13/52) had been specifically consented for risks of Covid-19. The rate of PCR-positive results was 15% (8/52) with a mortality of 25%. Approximately 2% of patients in this series were informed of the risk and had a positive Covid-PCR. An odds ratio of 0.38 indicates that being informed of the risk is not associated with rate of infection e.g by adopting enhanced personal protective measures.
Conclusions
The pandemic recovery has not removed this substantial community and nosocomial risk. Our results demonstrate poor compliance with RCS guidance despite ongoing relevance to care. Consent includes the counselling of a patient to specific Covid-related risks including thrombosis & death. Dissemination of these results will be followed by completion of the audit cycle to look for improvements in compliance.

Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management
Sînziana-Elena Bîrsanu, Maria Cristina Plaiasu, Codrut Andrei Nanu
Vaccines, 5 November 2022; 10(11)
Abstract
Informing patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was evident when the medical personnel at the vaccination centers were provided with informed consent forms that did not respect the existing legal requirements. In addition, the protocol for persons seeking vaccination stated that the patient was supposed to receive the informed consent form from the receptionist in order to read and sign it. We analyzed the legal implications and the malpractice litigation risk associated with this practice. Due to essential deficiencies and in the absence of an official enactment of new regulations, we conclude that the vaccination consent process did not comply with the legal requirements. Implications include medical personnel’s legal liability, loss of malpractice insurance coverage, and public mistrust that may have contributed to a low vaccination rate. Given the potential of future pandemics or other health crises, this may be a valuable lesson for developing better legal strategies.