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.

The approach to informed consent in acute care research
Correspondence
Rafael Dal-Ré, Arthur L Caplan
Lancet Respiratory Medicine, 3 November 2022
Open Access
Excerpt
In their discussion of the contrasting responses of the UK and the USA to the unprecedented situation posed by the COVID-19 pandemic—and the urgent need for randomised controlled trials to guide clinical practice—Jonathan D Casey and colleagues state that the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial was approved “with an alteration of informed consent” to facilitate enrolment. We are concerned that this statement could confuse clinical investigators and research ethics committee members…

Editor’s note: The article referenced in this correspondence is Casey JD Beskow LM Brown J et al. Use of pragmatic and explanatory trial designs in acute care research: lessons from COVID-19. Lancet Respir Med. 2022; 10: 700-714.

Community consultation for Exception from Informed Consent (EFIC) before and during the COVID-19 pandemic
Short paper
David J. Gagnon, Richard R. Riker, Frank Chessa, Christine Lord, Ashley Eldridge, Meghan Searight, Sarah Bockian, Barbara McCrum, Teresa L. May, Douglas Sawyer, David B. Seder
Resuscitation Plus, 20 October 2022
Abstract
Aim
Describe community consultation and surrogate consent rates for two Exception From Informed Consent (EFIC) trials for out-of-hospital cardiac arrest (OOHCA) – before and during the COVID-19 pandemic.
Methods
The PEARL study (2016-2018) randomized OOHCA patients without ST-elevation to early cardiac catheterization or not. Community consultation included flyers, radio announcements, newspaper advertisements, mailings, and in-person surveys at basketball games and ED waiting rooms. The PROTECT trial (2021-present) randomizes OOHCA survivors to prophylactic ceftriaxone or placebo; the community consultation plan during the pandemic included city council presentations, social media posts, outpatient flyers, but no in-person encounters. Demographics for PROTECT community consultation were compared to PEARL and INTCAR registry data, with p-value <0.05 considered significant.
Results
PEARL surveyed 1,362 adults, including 64% ≥60 years old, 96% high school graduates or beyond; research acceptance rate was 92% for the community and 76% for personal level. PROTECT initially obtained 221 surveys from electronic media – including fewer males (28% vs 72%,p<0.001) and those >60 years old (14% vs 53%;p<0.001) compared to INTCAR. These differences prompted a revised community consultation plan, targeting 79 adult in-patients with cardiac disease which better matched PEARL and INTCAR data: the majority were ≥60 years old (66%) and male (54%). Both PEARL and PROTECT enrolled more patients using surrogate consent vs EFIC (57%, 61%), including 71% as remote electronic consents during PROTECT.
Conclusions
Community consultation for EFIC studies changed with the COVID-19 pandemic, resulting in different demographic patterns. We describe effective adaptations to community consultation and surrogate consent during the pandemic.

AI Integrated Blockchain Technology for Secure Health Care—Consent-Based Secured Federated Transfer Learning for Predicting COVID-19 on Wearable Devices
Conference paper
T. Ravi Shanker Reddy, B. M. Beena
International Conference on Innovative Computing and Communications, 27 September 2022; Delhi India
Abstract
COVID-19 has been a major global challenge these days. The pandemic has changed human life, attitude, and behavior. This pandemic added a burden to people’s life and health. With the new variants of SARS-CoV-2, a lot of people are even scared of going to the health centers to get the COVID-19 evaluation in fear of contamination and contagious, which caused the surge in the symptoms at later stages. Data collected across various sources can play an important role in predicting and identifying of COVID-19 virus based on the models and the classifications of this data using the most sophisticated machine learning models. The concern here is accessing or transferring an individual’s data from their personal health devices which defers users’ privacy. In the recent past, there are a lot of research that has been done these days on how blockchain can help to securely track and transfer the data across trusted sources. Adding to this, federated learning also is helping on-device data usage without any critical data to be transferred to various external sources. The proposed study directs the stability of frequent health status with the help of wearable devices that capture health metrics like heart rate, blood oxygen levels, breathing rate, muscle activities, stress, emotions, movement patterns, sleep activity, precipitation, and mind/cognitive functions with the introduction of the data streams and models that can seamlessly transfer the data, with the assurance of data integrity, privacy, and control which is the scope of this paper. The usage of both the emerging technologies provides a value addition in terms of health data exchange with effective data distribution with decentralized privacy and computation. We have also introduced a consent-based personal health device registration mechanism on a blockchain consensus network with digital identity to allow and take back controls over who can access their data. We believe that this solution and the implementation would help everyone to predict the possible COVID-19 infections keeping data privacy at the most priority.

Digital Home Health During the COVID-19 Pandemic Challenges to Safety, Liability , and Informed Consent, and the Way to Move Forward
Faculty Books
Sara Gerke
Dickinson Law Idea, 2022
Open Access
Introduction
Artificial intelligence (AI) and other digital health products, such as smart pills, are rapidly entering clinical practice. We live in the age of big data, where massive amounts of data are collected and used to develop or update digital health products and are shared with third parties for research or commercial purposes. Moreover, we can already see a shift in health care from hospitals to people’s homes, for example through the use of medical apps, Fitbits, and other wearables. This line between clinic and home will likely become more and more blurry in the near future. According to one estimate, the smart home health care market size is projected to grow from $6.1 billion in 2018 to over $30 billion in 2025. In particular, the COVID-19 pandemic has propelled the adoption of health AI and digital health across multiple applications. For example, the development and use of digital home health products have been expedited to reduce exposure to the coronavirus SARS-CoV-2, such as through remote patient monitoring, and to better control its spread, such as through exposure-notification apps. At the same time, the regulation of medical devices is more flexible during the public health emergency. However, the acceleration of launching new digital home health devices on the US market combined with less regulatory oversight also raises some challenges, including post-pandemic questions. In this chapter, I will first give an overview of the promise of digital home health. I will then discuss the regulation of digital home health before and during COVID19 in the context of the US Federal Food, Drug, and Cosmetic Act (FDCA). This will be followed by a discussion of three digital home health challenges during the pandemic: 1) safety, 2) liability, and 3) informed consent. In this context, I will also make suggestions on how to move forward.

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
Abstract
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
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
Abstract
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?
Research
Natalie Anne East, Sunitha Ramaiah, Kimberley Morris, Sangeeta Pathak
British Journal of Midwifery, 28 June 2022; 30(7)
Abstract
Background
There is ongoing research on the effects of COVID-19 on pregnancy and whether vertical viral transmission occurs.
Aims
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.
Methods
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.
Results
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.
Conclusion
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.