Informed Consent for Endoscopic Biliary Drainage: Time for a New Paradigm
Marco Spadaccini, Cecilia Binda, Alessandro Fugazza, Alessandro Repici, Ilaria Tarantino, Carlo Fabbri, Luigi Cugia, Andrea Anderloni
Medicina, 22 February 2022; 58(3) pp 331
Open Access
Abstract
Endoscopic retrograde cholangiopancreatography (ERCP) is considered as the first option in the management of malignant biliary obstruction. In case of ERCP failure, percutaneous transhepatic biliary drainage (PTBD) has been conventionally considered as the preferred rescue strategy. However, the use of endoscopic ultrasound (EUS) for biliary drainage (EUS-BD) has proved similarly high rates of technical success, when compared to PTBD. As a matter of fact, biliary drainage is maybe the most evident paradigm of the increasing interconnection between ERCP and EUS, and obtaining an adequate informed consent (IC) is an emerging issue. The aim of this commentary is to discuss the reciprocal roles of ERCP and EUS for malignant biliary obstruction, in order to provide a guide to help in developing an appropriate informed consent reflecting the new biliopancreatic paradigm.

Informed Consent from a Historical, Societal, Ethical, Legal, and Practical Perspective
Original Article
Lee M. Jameson, Sandra K. Al-Tarawneh
Journal of Prosthodontics, 20 February 2022
Abstract
Informed consent is often perceived as a regulatory obligation without recognizing its educational potential in the dynamic provider/patient relationship. This article discusses the complex interaction of ethics, society, and law through a historical and practical perspective. The purpose is to provide the general dentists and specialists with a comprehensive understanding of the complexity and practical dimensions of informed consent.

Consent for Delivery Room Studies: What Can Be Learned from Perceptions of Parents
Original Paper
Maria C. den Boer, Mirjam Houtlosser, Ruben S. G. M. Witlox, Henriëtte A. van Zanten, Martine C. de Vries, Arjan B. te Pas
Neonatology, 18 February 2022
Open Access
Abstract
Background
Obtaining ethically valid consent to participate in delivery room (DR) studies from parents facing an imminent premature birth can be challenging. This study aims to provide insight into parental experiences with and perceptions of consent for DR studies.
Methods
Semistructured interviews were conducted with parents of very and extreme preterm infants. Interviews were audio-recorded, transcribed, and analyzed using the qualitative data analysis software Atlas. ti V.8.4.
Results
Twenty-five parents were interviewed. Despite being in an emotional and stressful situation, most parents considered being approached for DR studies as valuable. According to parents, this was mostly due to appropriate timing and communication, compassion, and investigators not being obtrusive. Interviewed parents generally decided to accept or decline study participation based on perceived risk. Parents differed widely in how risk of specific study interventions was perceived, but agreed on the fact that parental consent is needed for DR studies that involve risk. There was no consensus among parents on deferred consent for DR studies running at our NICU. However, parents considered deferred consent appropriate for observational studies. Furthermore, it became clear that parental misunderstanding of various aspects of DR studies, including aims, the concept of randomization, and risk associated with specific interventions, was common.
Conclusions
Insight into parental perceptions of consent for DR studies allowed us to determine areas where the validity of parental consent can be improved. Further research on parental perspectives for consent for DR studies will allow us to establish consent procedures that are considered both valid and valuable.

Informed consent: perceptions and practice of orthopaedic trainees
Jodie Atkin, Ian W Incoll, John Owen, Chris Conyard
Australian and New Zealand journal of surgery, 4 February 2022
Abstract
Background
The purpose of informed consent is to provide patients with adequate information about a proposed plan or intervention, including the benefits and risks, so that they can make an informed decision about their medical treatment. The literature suggests that trainees are often delegated the task of obtaining consent with inadequate knowledge, skill or experience. The aim of this study is to determine the extent orthopaedic surgical trainees have been exposed to education about the informed consent, their perceived ability to obtain consent effectively and the frequency with which they routinely address elements of the process when consenting patients.
Methods
An eight-item questionnaire assessing trainees’ experience with informed consent was distributed to trainees undertaking Australian orthopaedic surgery training in 2019.
Results
Of the 239 trainees, 102 completed the questionnaire. Although 99% of trainees were confident that they can obtain valid consent from patients, when asked about aspects of the process, many trainees do not address them. Only 29% of trainees always ask patients about goals of care and 21% always advise the patient of who will be performing the procedure. Trainees who indicated that they had received education on informed consent during surgical training are significantly more likely to address key elements.
Conclusion
Trainees’ perceptions of their knowledge and skill in relation to informed consent does not align with their reported practice. Although the majority of trainees had received some education on informed consent, greater emphasis on explicit teaching and formal assessment should be undertaken during surgical training, prior to trainees completing this activity independently.

Patient attitudes towards side effect information: An important foundation for the ethical discussion of the nocebo effect of informed consent
Research Article
Mette Sieg, Lene Vase
Clinical Ethics, 1 February 2022
Abstract
A growing body of evidence suggests that the informed consent process, in which patients are warned about potential side effects of a treatment, can trigger a nocebo effect where expectations about side effects increase side effect occurrence. This has sparked an ethical debate about how much information patients ought to receive before a treatment while trying to balance the moral principles of patient autonomy and nonmaleficence. In keeping with the principle of patient autonomy, the opinion of patients themselves in relation to how much information they want about side effects is of utmost relevance in this debate. The literature was searched to identify surveys assessing patient attitudes towards side effect information. Across a broad variety of patient populations, treatment types, and countries, the majority of patients wished to be fully informed of potential side effects, particularly in relation to frequent and severe side effects, while only a small minority wanted minimal or no information at all. Results from this review suggest that nocebo research should focus on methods of avoiding nocebo effects of informed consent while ensuring that patients are well-informed about potential side effects.

Adults with capacity – a practical guide to gaining consent
Katie Crawley
Nature; BDJ Student, 31 January 2022; 29 pp 10
Introduction
Consent is an essential component of dentistry. Dental students often have very good theoretical knowledge of the consent process, but they may struggle to apply this knowledge practically within dental school. This article therefore presents a practical guide to obtaining valid consent from adults with capacity.

Living Kidney Donor Knowledge of Provided Information and Informed Consent: The PRINCE Study
Article
Emerentia Q. W. Spoon, Kirsten Kortram, Sohal Y. Ismail, Daan Nieboer, Frank C. H. d’Ancona, Maarten H. L. Christiaans, Ruth E. Dam, Hendrik Sijbrand Hofker, Arjan W. J. Hoksbergen, Karlijn Ami van der Pant, Raechel J. Toorop, Jacqueline van de Wetering, Jan N. M. Ijzermans, Frank J. M. F. Dor
Journal of Clinical Medicine, 28 January 2022; 11(698)
Open Access
Abstract
Background
Informed consent for living kidney donation is paramount, as donors are healthy individuals undergoing surgery for the benefit of others. The informed consent process for living kidney donors is heterogenous, and the question concerns how well they are actually informed. Knowledge assessments, before and after donor education, can form the basis for a standardized informed consent procedure for live kidney donation.
Methods
In this prospective, a multicenter national cohort study conducted in all eight kidney transplant centers in The Netherlands, we assessed the current status of the informed consent practice for live donor nephrectomy. All of the potential living kidney donors in the participating centers were invited to participate. They completed a pop quiz during their first outpatient appointment (Cohort A). Living kidney donors completed the same pop quiz upon admission for donor nephrectomy (Cohort B).
Results
In total, 656 pop quizzes were completed (417 in Cohort A, and 239 in Cohort B). The average donor knowledge score was 7.0/25.0 (±3.9, range 0–18) in Cohort A, and 10.5/25.0 (±2.8, range 0–17.5) in Cohort B. Cohort B scored significantly higher on overall knowledge, preparedness, and the individual item scores (p < 0.0001), except for the long-term complications (p = 0.91).
Conclusions
Donor knowledge generally improves during the live donor workup, but it is still quite disappointing. Long-term complications, especially, deserve more attention during living kidney donor education.

Respecting Patient Autonomy: Voluntary Informed Consent in Modern Medicine
Original Research
Grebenshchikova EG, Chuchalin AG
Medical Ethics, January 2021
Open Access
Abstract
The article reveals the most influential in modern bioethics approach to understanding voluntary informed consent as a way to implement the principle of respect for patient autonomy, which is determined by both legal regulation and socio-cultural factors. The authors discuss the main elements of informed consent, its specificity in clinical trials, and criteria for autonomous choice.

Types of Off-Label Drug Use and Informed Consent Doctrine When Prescribing Them
M. Drogovoz, V. M. Khomenko, V. V. Krynychko, M. Barus, A. Kovpak, M. O. Ostapets, T. O. Artiukh
Pharmacology Online, 2021; 3
Open Access
Abstract
Today, medicine does not have a sufficient arsenal of drugs for the personalized treatment of cancer, neurological, psychiatric, pediatric patients, HIV-infected patients. An important aspect of informed consent when prescribing drugs off label is informing patients about potentially unknown risks, as well as about the existence of a rationale for such prescription of the drug. Thus, the doctrine of informed consent means, on the one hand, the doctor provides the patient with complete information about the use of an off label drug, an alternative method of treatment, the risks and potential benefits of such an alternative, and on the other hand, the patient decides whether he is ready to be treated with a drug that will be used off label, and confirms this with informed consent. In modern good medical practice, the patient’s rights take precedence over the opinion of the medical practitioner. Informed consent is an integral component of the modern relationship between doctors and their patients and a means of ensuring that the doctor’s beliefs do not override the patient’s right to self-determination and personal integrity.