Procedural-based Specialties Benefit from a Formal Informed Consent and Disclosures Educational Program
Original Reports
Valeda Yong, Huaqing Zhao, Kimberly Gilmore, Jane Cripe, Charles Conklin, Elizabeth Dauer
Journal of Surgical Education, 6 January 2022
Abstract
Objective
At our tertiary academic center, residents undergo formalized training in obtaining informed consent and disclosing a complication. The informed consent portion has previously been shown to benefit a group of surgical and emergency medicine residents. We aimed to determine if the benefits from training persist across a larger number of procedural-based specialties and to ascertain the benefit of training in disclosing complications.
Design
This retrospective cohort study examined first-year residents from seven procedural-based specialties who participated in a formal informed consent and disclosures training program, consisting of a didactic lecture and two-part simulation. Two years after the start of the program, the disclosure scenario was added. Participants were given pre- and post-surveys assessing comfort and confidence in the informed consent and disclosure scenarios. Survey results were compared using the signed-rank test and Kruskal-Wallis test as appropriate.
Setting
This study occurred at Temple University Hospital, a tertiary academic institution in Philadelphia, PA.
Participants
First-year residents from 2014 to 2020 in seven procedural-based specialties, including general surgery, orthopedic surgery, otolaryngology, obstetrics and gynecology, emergency medicine, radiology, and anesthesia, participated in this study. One hundred and ninety-three residents completed the program and surveys.
Results
Residents reported improved confidence in filling out an informed consent form (p = 0.036) and more comfortable in obtaining informed consent (p = 0.041), as well as more confidence (p = 0.018) and comfort (p = 0.001) in disclosing a complication. Surgical residents demonstrated greater confidence in obtaining informed consent (p = 0.009) and disclosing a complication (p = 0.0002) after training than non-surgical residents.
Conclusions
Across multiple procedural-based specialties, formal training in informed consent and disclosure of complications increases resident ability to perform these tasks. A formal training program is valuable for residents who are expected to perform these tasks across various specialties.
Is Informed Consent Ever Truly Informed? [BOOK CHAPTER]
Is Informed Consent Ever Truly Informed? [BOOK CHAPTER]
Johelen Carleton, Pringl Miller
Difficult Decisions in Surgical Ethics, 1 January 2022; pp 77-89 [Springer]
Abstract
The clinical ethical imperative to provide patients or their surrogate decision makers with relevant and tailored information is a serious endeavor that has challenged many generations of surgeons. The surgical informed consent process (SIC) is a critical aspect of surgical practice that is especially complex because patients are diverse individuals who do not automatically fit into algorithms. The sensitivity and specificity with which the SIC process must be embraced should be seen through the lens of each autonomous person. During SIC it is vital to understand what matters most to the patient. Only then can a surgeon facilitate a meaningful discussion that will honor a patient’s rights, dignity, preferences, goals and values. This chapter will address the evolution of the medicolegal and ethical aspects of the surgical informed consent process and how to optimally satisfy the communication needs. Additionally, this chapter will explore the adaptations to the surgical informed consent process during the COVID-19 pandemic.
Investigating Key Factors Related to the Decision of a Do-Not-Resuscitate Consent
Investigating Key Factors Related to the Decision of a Do-Not-Resuscitate Consent
Article
Hui-Mei Lin, Chih-Kuang Liu, Yen-Chun Huang, Chieh-Wen Ho, Mingchih Chen
International Journal of Environmental Research and Public Health, 31 December 2021; 19(428)
Open Access
Abstract
Background
The decision to sign a do-not-resuscitate (DNR) consent is critical for patients concerned about their end-of-life medical care. Taiwan’s National Health Insurance Administration (NHIA) introduced a family palliative care consultation fee to encourage family palliative care consultations; since its implementation, identifying which families require such consultations has become more important. In this study, the Taiwanese version of the Palliative Care Screening Tool (TW–PCST) was used to determine each patient’s degree of need for a family palliative care consultation.
Objective
This study analyzed factors associated with signing DNR consents. The results may inform family palliative care consultations for families in need, thereby achieving a higher DNR consent rate and promoting the effective use of medical resources, including time, labor, and funding.
Method
In this retrospective study, logistic regression analysis was conducted to determine which factors affected the DNR decisions of 2144 deceased patients (aged ≥ 20 years), whose records were collected from the Taipei City Hospital health information system from 1 January to 31 December 2018.
Results
Among the 1730 patients with a DNR consent, 1298 (75.03%) received family palliative care consultations. The correlation between DNR consent and family palliative care consultations was statistically significant (p < 0.001). Through logistic regression analysis, we determined that participation in family palliative care consultation, TW–PCST score, type of ward, and length of stay were significant variables associated with DNR consent.
Conclusions
This study determined that TW–PCST scores can be used as a measurement standard for the early identification of patients requiring family palliative care consultations. Family palliative care consultations provide opportunities for patients’ family members to participate in discussions about end-of-life care and DNR consent and provide patients and their families with accurate medical information regarding the end-of-life care decision-making process. The present results can serve as a reference to increase the proportion of patients willing to sign DNR consents and reduce the provision of ineffective life-prolonging medical treatment.
Complex surgery and optimal consent: A variety of opinions exist among healthcare professionals
Complex surgery and optimal consent: A variety of opinions exist among healthcare professionals
Cillian Clancy, Niamh McCawley, John P. Burke, Deborah McNamara
The Surgeon, 29 December 2021
Abstract
Background
Establishing healthcare professional’s views on optimal consent in complex surgery could guide tailored consent policy, improving the process in challenging scenarios. To date, no studies have established if professionals of differing specialities agree on major aspects of consent in areas such as emergency surgery and cancer surgery.
Methods
An anonymous web based survey was distributed to a variety of disciplines in a tertiary referral centre. Questions regarding optimal methods and timing of consent in emergency and cancer surgery were posed. Comparative analyses of quantitative data were performed using chi-squared test.
Results
57 responses were received from doctors and nurses of varying disciplines. Differences were found between doctors of separate specialities and nurses in opinion of optimal timing of consent (p = 0.02), consent validity over time (p < 0.001) and the utility of introducing more specific consent policy (p = 0.01). Almost all respondents agreed that healthcare professionals have differing ideas of what consent is.
Conclusions
This study demonstrates differences in opinion regarding optimal consent for cancer and emergency surgery. Consideration should be given to developing consensus among healthcare professionals regarding what consent for complex surgery constitutes.
Automating Cookie Consent and GDPR Violation Detection [CONFERENCE PAPER]
Automating Cookie Consent and GDPR Violation Detection [CONFERENCE PAPER]
Dino Bollinger, Karelcc Kubicek, Carlos Cotrini, Davidcc Basin
USENIX Security Symposium 2022, Boston, MA, USA; 10–12 August 2022
Abstract
The European Union’s General Data Protection Regulation (GDPR) requires websites to inform users about personal data collection and request consent for cookies. Yet the majority of websites do not give users any choices, and others attempt to deceive them into accepting all cookies. We document the severity of this situation through an analysis of potential GDPR violations in cookie banners in almost 30k websites. We identify six novel violation types, such as incorrect category assignments and misleading expiration times, and we find at least one potential violation in a surprising 94.7% of the analyzed websites. We address this issue by giving users the power to protect their privacy. We develop a browser extension, called CookieBlock, that uses machine learning to enforce GDPR cookie consent at the client. It automatically categorizes cookies by usage purpose using only the information provided in the cookie itself. At a mean validation accuracy of 84.4%, our model attains a prediction quality competitive with expert knowledge in the field. Additionally, our approach differs from prior work by not relying on the cooperation of websites themselves. We empirically evaluate CookieBlock on a set of 100 randomly sampled websites, on which it filters roughly 90% of the privacy-invasive cookies without significantly impairing website functionality.
Privacy and Informational Self-determination through Informed Consent: the Way Forward [CONFERENCE PAPER]
Privacy and Informational Self-determination through Informed Consent: the Way Forward [CONFERENCE PAPER]
Mohamad Gharib
International Workshop on SECurity and Privacy Requirements Engineering (SECPRE), 4 January 2022
Open Access
Abstract
“I have read and agree to the Privacy Policy”. This can be described as one of the biggest lies in the current times, and that is all what a service provider needs to acquire what can be called “informed consent”, which allows it to do as it pleases with your Personal Information (PI). Although many developed countries have enacted privacy laws and regulations to govern the collection and use of PI as a response to the increased misuse of PI, these laws and regulations rely heavily on the concept of informational self-determination through the “notice” and “consent/choice” model, which as we will see is deeply flawed. Accordingly, the full potential of these privacy laws and regulations cannot be achieved without tackling these flaws and empowering individuals to take an active role in the protection of their PI. In this paper, we argue that to advance informational self-determination, a new direction should be considered. In particular, we propose a model for informed consent and we introduce a proposed architecture that aims at tackling existing limitations in current approaches.
Informed Consent: A Monthly Review
___________________________
January 2022
This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_January 2022
Consent or Public Reason? Legitimacy of Norms Applied in ASPD and COVID-19 Situations
Consent or Public Reason? Legitimacy of Norms Applied in ASPD and COVID-19 Situations
Original Article
Elvio Baccarini
Philosophy and Society, 30 November 2021; 32(4) pp 674–694
Open Access
Abstract
This paper extends Alan John Simmons’s conceptual distinction between Lockean (or consent) and Kantian (or justificatory) conceptions of legitimacy that he applied to the question of the legitimacy of states, to the issue of legitimacy of public decisions. I criticise the consent conception of legitimacy defended by Simmons, and I defend the Rawlsian version of the justificatory conception of legitimacy from his objection. The approach of this paper is distinctive because the two conceptions are assessed by investigating, using the method of reflective equilibrium, their respective prescriptions concerning the treatment of antisocial personality disorder (ASPD) and epidemiologic measures. I argue that the method of reflective equilibrium does not support the consent conception. Considering the issues of treatment of ASPD and of epidemiologic measures, I argue that the consent conception of legitimacy is not well-equipped for the evaluation of norms that are not strictly self-regarding. This causes a deficit of prescriptions for relevant social responses. Further, by considering the case of responses to epidemics, I argue that such a conception can avoid harmful consequences only by recurring to additional, and independent, premises. This does not cause incoherence but reduces the coherence of a normative system. Finally, the consent conception is not equipped to support social cooperation in an optimal way, which has proved to be necessary in critical conditions, like a pandemic. On the other hand, I argue that the method of reflective equilibrium supports the Rawlsian version of justificatory conception of legitimacy, because of its advantages in handling the indicated issues. In addition, I maintain that this justificatory conception is respectful of freedom and equality of agents as moral self-legislators, and, thus, it is not vulnerable to Simmons’s main criticism.
Implementing two-stage consent pathway in neonatal trials
Implementing two-stage consent pathway in neonatal trials
Short Report
Eleanor Mitchell, Sam J Oddie, Jon Dorling, Chris Gale, Mark John Johnson, William McGuire, Shalini Ojha
Archives of Disease in Childhood – Fetal and Neonatal Edition, 23 December 2021
Abstract
Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway…
Informed consent and assent guide for paediatric clinical trials in Europe
Informed consent and assent guide for paediatric clinical trials in Europe
Original Research
Pirkko Lepola, Maxine Kindred, Viviana Giannuzzi, Heidi Glosli, Martine Dehlinger-Kremer, Harris Dalrymple, David Neubauer, Geraldine B Boylan, Jean Conway, Jo Dewhurst, Diane Hoffman
Archives of Disease in Childhood, 1 December 2021
Abstract
Objective
Clinical trial sponsors spend considerable resources preparing informed consent (IC) and assent documentation for multinational paediatric clinical trial applications in Europe due to the limited and dispersed patient populations, the variation of national legal and ethical requirements, and the lack of detailed guidance. The aim of this study was to design new easy-to-use guide publicly available on European Medicines Agency’s, Enpr-EMA website for all stakeholders.
Methods
Current EU legal, ethical and regulatory guidance for paediatric clinical trials were collated, analysed and divided into 30 subject elements in two tables. The European Network of Young Person’s Advisory Group reviewed the data and provided specific comments. A three-level recommendation using ‘traffic light’ symbols was designed for four age groups of children, according to relevance and the requirements.
Results
A single guide document includes two tables: (1) general information and (2) trial-specific information. In the age group of 6–9 years old, 92% of the trial-specific subject elements can be or should be included in the IC discussion. Even in the youngest possible age group (2–5 years old children), the number of elements considered was, on average, 52%.
Conclusion
The EU Clinical Trial Regulation (2014) does not contain specific requirements exclusively for paediatric clinical trials. This work is the first to extensively collate all the current legal, regulatory and ethical documentation on the IC process, together with input from adolescents. This guide may increase the ethical standards in paediatric clinical trials.
Center for Informed Consent Integrity 