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.

Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable
Commentary
Rafael Dal-Ré, Arthur L Caplan, Teck Chuan Voo
European Journal of Internal Medicine, 27 June 2022
Open Access
Excerpt
…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
Selmi H, Davies A, Walker J, Heaton T, Sabharwal S, Dani M, Fertleman M, Reilly P
BMJ Open Quality, 1 June 2022, 11(2)
Abstract
Introduction
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.
Aim
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.
Methods
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.
Results
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.
Conclusion
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.