Psychiatric advance directives and consent to electroconvulsive therapy (ECT) in Australia: A legislative review and suggestions for the future
Kay Wilson, Subramanian Purushothaman, Uday Kolur
International Journal of Law and Psychiatry, November–December 2022; 85
Abstract
Psychiatric Advance Directives (PADs) have been adopted in many jurisdictions around the world and in most Australian states and territories. They are seen as a less restrictive and patient-centered approach to the provision of mental health care. Electroconvulsive therapy (ECT) is a restricted treatment in most jurisdictions in Australia and across the world. This paper explores the history, regulation and use of ECT and PADs and the intersections between them. It provides an overview of the legislative framework in each Australian state and territory and explores some of the issues which have arisen such as complexity of the regulatory framework, making PADs binding for refusing and consenting to ECT, involving treating teams in how PADs are made, using restrictive interventions to implement PADs, and the role of the Tribunal. While PADs are often framed as an important legal tool for allowing patients to refuse psychiatric treatment (especially ECT), the paper emphasizes that they can also be an innovative way for people to consent to psychiatric treatment in advance and an empowering option to access mental health care. It then makes some suggestions for future reform.
Month: October 2022
What Cookie Consent Notices Do Users Prefer: A Study In The Wild
What Cookie Consent Notices Do Users Prefer: A Study In The Wild
Ashutosh Kumar Singh, Nisarg Upadhyaya, Arka Seth, Xuehui Hu, Nishanth Sastry, Mainack Mondal
EuroUSEC ’22: Proceedings of the 2022 European Symposium on Usable Security, 29 September 2022; pp 28 – 39
Abstract
Laws like GDPR in the EU mandated all websites operating in their jurisdiction to obtain users’ informed consent before tracking those users and collecting their data. Today, this is achieved by showing users cookie consent notices. These notices are ubiquitous (often permeating the geographical boundaries of GDPR enforcement), even though their exact user interface (UI) designs vary. These designs are provided by Consent Management Platforms (CMPs) to different websites, effectively resulting in a handful of cookie consent notice designs being shown to a majority of internet users. Naturally, not all designs are uniformly liked by the users. Thus the first step of improving cookie consent notice UI design and moving to a better consent mechanism is to understand whether users prefer one design over another in the wild and why. To answer these questions, in this work, we conduct an in the wild comparative survey with 98 participants where 64.3% of the participants were from the EU (i.e., GDPR is applicable), and the rest were self-reported to be located outside of the EU. In this within-subjects study, our participants ranked five different popular cookie consent UI designs (leveraged by CMPs used in Alexa UK Top500 websites) and gave rationale for their choices. Our analysis found that the slider design is statistically significantly better ranked (and thus most liked) than all other designs. Our further qualitative analysis identifies and unpacks five key design factors which impacted our participants’ liking/disliking of consent notice UI designs (as captured by the ranks given to these designs by our participants) – ease of use, amount of information, customisability, decision-making time, and clarity/transparency. We conclude this work by discussing the implications of our findings on future cookie consent notice UI designs.
Physicians’ legal knowledge of informed consent and confidentiality. A cross-sectional study
Physicians’ legal knowledge of informed consent and confidentiality. A cross-sectional study
Research
Maria Cristina Plaiasu, Dragos Ovidiu Alexandru, Codrut Andrei Nanu
BMC Medical Ethics, 16 September 2022; 23(93)
Open Access
Abstract
Background
Only a few studies have been conducted to assess physicians’ knowledge of legal standards. Nevertheless, prior research has demonstrated a dearth of medical law knowledge. Our study explored physicians’ awareness of legal provisions concerning informed consent and confidentiality, which are essential components of the physician-patient relationship of trust.
Methods
A cross-sectional study assessed attending physicians’ legal knowledge of informed consent and confidentiality regulations. The study was conducted in nine hospitals in Dolj County, Romania. Physicians were given a questionnaire with ten scenarios and instructed to select the response that best reflected their practice. We assessed the responses of physicians who claimed their practice to be entirely legal. Their legal knowledge was evaluated by comparing their answers to applicable laws. We also calculated a score for the physicians who admitted to committing a legal breach.
Results
Of the 305 respondents, 275 declared they never committed any law violation. However, their median correct answer score was 5.35 ± 1.66 out of 10. The specialty was the strongest predictor of legal knowledge, with emergency physicians rating the lowest and non-surgical physicians scoring the highest. Physicians who worked in both private and public sectors were better knowledgeable about legal issues than those who worked exclusively in the public sector. Results indicate that physicians are aware of the patient’s right to informed consent but lack comprehensive understanding. While most physicians correctly answered simple questions, only a tiny minority identified the correct solution when confronted with ethical dilemmas. The physicians who acknowledged breaching the law, on the other hand, had a slightly higher knowledge score at 5.45 ± 2.18.
Conclusion
Legal compliance remains relatively low due to insufficient legal awareness. Physicians display limited awareness of legal requirements governing patient autonomy, confidentiality, and access to health data. Law should be taught in all medical schools, including undergraduate programs, to increase physicians’ legal knowledge and compliance.
Evaluate the practice of preoperative informed consent for elective surgical patients at the university hospital, Ethiopia, in 2022
Evaluate the practice of preoperative informed consent for elective surgical patients at the university hospital, Ethiopia, in 2022
Misganaw Terefe Molla, Yosef Belay Bizuneh, Yonas Addisu Nigatu, Debas Yaregal Melesse
International Journal of Surgery Open, 15 September 2022
Abstract
Background
Obtaining preoperative informed consent is considered an integral part of modern clinical practice. It works as a safeguard of the patient’s rights and minimizes the chances of legal action against the surgical team members. This study was to evaluate the practice of informed consent in patients undergoing elective surgery.
Methods
The study was approved by the ethical committee of the school of medicine. The patients were reassured about the anonymity of their information. A study was conducted at different surgical departments of a teaching university hospital for one month. Participants were selected based on consecutive sampling from patients over the age of 18 years who had undergone elective surgery.
Results
The overall adherence of our study to standard guidelines was 48.5%. During informed consent, 51% of patients were informed about their current condition; 49% of patients were informed about the nature and purpose of the proposed surgery; and 25% of patients were informed about the estimated duration of surgery and anesthesia.
Conclusion and recommendation
The overall adherence of our study to standard guidelines was 48.5%. The quality of the makeshift informed consent process in this study is less than the standards. There is a great need to educate the surgical team members regarding the importance of patients’ autonomy and their right to information about the proposed surgical procedure and anesthesia.
Ethically acceptable consent approaches to adolescent research in South Africa
Ethically acceptable consent approaches to adolescent research in South Africa
Marian Loveday, Ameena Goga, Ames Dhai, Melodie Labuschaigne, Theresa Roussouw, Theresa Burgess, Ann Strode, Melissa Wallace, Marc Blockman, Brodie Daniels, Elizabeth Spooner, Linda-Gail Bekker
Southern African Journal of HIV Medicine, 5 September 2022
Open Access
Abstract
Background
Adolescents are a unique population with significant unmet health needs. They are often excluded from research that may benefit them as they are perceived as vulnerable and needing protection from research participation. For Research Ethics Committees, conflicting positions in statutes, regulations and ethical guidelines about who provides informed consent for adolescent involvement in health research can be a significant barrier to approving adolescent research. For researchers, the requirement for parental/guardian proxy consent or prolonged approval processes may potentially result in the exclusion of those adolescents most vulnerable and at risk, particularly if issues such as gender-based violence, gender identity, sexuality and sexual practices are in question.
Objectives
To describe the challenges to adolescent research and suggest strategies to address these.
Method
We consider the legal and ethical framework in South Africa regarding the consenting age for adolescents in research, outline the challenges and, using examples of best practices, suggest strategies to address the current conundrum.
Results
We suggest three principles to guide Research Ethics Committees on their approach to reviewing health research involving adolescents. Strategies to develop ethically acceptable approaches to adolescent research and consent processes are described, which include community involvement. We elaborate on examples of nuanced approaches to adolescent research.
Conclusion
The inclusion of adolescents in research is critical in informing appropriate and effective health services for this vulnerable population, whilst providing an opportunity to link them into care and services where relevant.
The Convolutions of the Concept of Age of Consent amongst Primary School Teachers in Zimbabwe
The Convolutions of the Concept of Age of Consent amongst Primary School Teachers in Zimbabwe
Agnes Pakombwele, Kwashirai Zvokuomba
International Journal of Educational Development in Africa, 30 August 2022; 7(1)
Abstract
The world over the age of consent is used as a child empowerment and protective tool. It has been argued that the age of consent supports teenagers as they negotiate the most profound aspect of childhood transition into adulthood. During this period, children and teenagers face abuse, bodily violence and exploitation. The study sought to analyse the perceptions and views of primary school teachers about age of consent within the educational setting. The study was guided by the interpretivist philosophy and was methodologically underpinned by the qualitative research design, particularly regarding data, which was collected utilising in-depth interviews and focus group discussions to solicit research participants’ opinions, feelings, and thoughts that represent their world views. The study established that teachers had little knowledge about the age of consent due to misrepresentation in the legal frameworks and inconsistencies in the law on the matter. In addition, customary, cultural, and religious practices remain “blind” in the way they approach children’s rights issues. Thus, the article advocates for a child-centred framework when dealing with issues that affect the well-being of children as a way of demystifying the age of consent in the educational sector, which should also be informative not only to teachers but traditional leaders and legal practitioners so as to have a shared understanding of the concept. It is recommended that the age of consent should be the same for both boys and girls just as the age of majority, which is at 18 years.
Informed Consent to Online Standard Form Agreements
Informed Consent to Online Standard Form Agreements
Rob Nicholls
Global Privacy Law Review, 2022; 3(3) pp 163-176
Abstract
This article examines the issues associated with online consent to ‘take it or leave it’ contracts, also known as standard form agreements. It does this by describing the concepts of standard form agreement and their deviations from bilateral contracts. It also sets out the meaning of informed consent. With these concepts established, the article analyses informed consent in online standard form agreements and provides an analysis of the factors impacting informed consent. The article also draws a distinction between unfairness and unconscionability. The article demonstrates that courts and regulators look the other way when it comes to recognizing substantive unfairness and unconscionability in online standard form agreements. It discusses the legal, economic, behavioural and social dynamics of informed consent in the context of the Australian marketplace. The article demonstrates that, in Australia, the focus on procedural unfairness and procedural unconscionability as threshold requirements have prevented the notion of informed consent from voiding particular terms. That is, as long as there was notice and an opportunity to read, in Australia the actual content of the terms seems to have limited importance.
Reform in Australia: A Focus on Informed Consent
Reform in Australia: A Focus on Informed Consent
Rob Nicholls
Global Privacy Law Review, 2022; 3(3) pp 177-189
Abstract
This article analyses the Australian privacy framework in the context of both the Australian Competition and Consumer Commission’s Digital Platforms Inquiry (DPI) and the Consumer Data Right (CDR). This analysis extends to informed consent and attitudes to unfairness and unconscionability. The article offers potential solutions to the current patchwork approach which go further than the Government response to the DPI. It argues that the Australian Government’s response is not an adequate response nor a set of suitable solutions to the problem. The article proposes a two-pronged approach that recognizes the urgency of the issue through the suggestion of a series of ‘quick policy wins’ that will result in more meaningful and effective protection for consumers and further systemic, long-term recommendations for change that can be achieved through policy development, further consultation and integration with other existing legislation. The quick policy wins centre on three specific changes, including definitional updates, content and structure of online standard form agreements and enforcement, penalties and sanctions, and long-term solutions. The long-term solutions are proposed to include regulation of website design, better integration of the laws, regulators and enforcement bodies, a faster, more consistent pace of policy review and recognition of the societal and human benefit of informed consent to online standard form agreements.
Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations’ policies in England and Wales
Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations’ policies in England and Wales
Original research
Cynthia A Ochieng, Hollie Richards, Jesmond Zahra, Sian Cousins, Daisy Elliott, Nicholas Wilson, Sangeetha Paramasivan, Kerry N L Avery, Johnny Mathews, Barry G Main, Robert Hinchliffe, Natalie S Blencowe, Jane M Blazeby
BMJ Open, 1 September 2022
Open Access
Abstract
Objective
To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds).
Design
A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales.
Setting
NHS trusts in England and health boards in Wales, UK.
Participants
Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review.
Results
From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure’s novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon’s experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included.
Conclusions
Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients’ and clinicians’ views is required to address variability around information provision/consent for innovative procedures.
How readable are orthognathic surgery consent forms?
How readable are orthognathic surgery consent forms?
Original Article
Maurice J.Meade, Craig W. Dreyer
International Orthodontics, 16 September 2022
Summary
Background/objective
The valid consent process for medical intervention requires the disclosure of information in a format that is easily understandable by the patient. The aim of this investigation was to assess the readability of orthognathic surgery informed consent forms (OSICFs).
Methods
An online search methodology was conducted to identify OSICFs for analysis. The forms that satisfied inclusion/exclusion criteria were evaluated according to a standardised protocol. The readability of the content was assessed using three validated tools: the Simple Measure of Gobbledegook (SMOG) score, Flesch-Kincaid Grade-Level (FKGL) score and Flesch Reading Ease (FRE) score.
Results
Most of the 26 evaluated OSICFs were sourced from websites within the United States (69.2%) and from oral and maxillo-facial surgery practices (76.9%). Two of the assessed forms were template OSICFs available from oral and maxillo-facial professional societies to its members. The scores from the three tools found that the content of 84.6% to 92.3% of the forms were “difficult” to read. The mean (SD) SMOG score for all evaluated OSICFs was 12.31(2.22) [95% CI: 11.42 to 13.21]. The SMOG and FKGL scores were closely correlated (r = 0.99, P < 0.0001; 95% CI: 0.9864 to 0.9973). There was no association between SMOG scores and the number of words contained within each consent form (r = −0.047;95% CI: −0.44 to 0.36).
Conclusions
The OSICFs surveyed in this investigation failed to meet recommended readability levels. A significant number of patients are not likely to understand the information contained within the forms. Orthodontists are advised that poor literacy skills of their patients may preclude them from validly consenting to orthognathic surgery treatment procedures.
Center for Informed Consent Integrity 