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.

Concepts in Emergency Research Exception from Informed Consent

Concepts in Emergency Research Exception from Informed Consent
Book Chapter
Christine S. Cocanour, Isabelle A. Struve
The Acute Management of Surgical Disease, 16 September 2022; pp 113–123 [Springer]
Abstract
Informed consent is an ethical concept, codified in the law, and is in daily practice at every healthcare institution. It is the process of communication between patients and treating physicians that results in an agreement that allows the treating physician to perform a specific medical intervention. A valid informed consent requires disclosure, capacity, and voluntariness. In the emergency setting this consent process is not possible. Ethical concerns involving subjects who cannot provide consent was a barricade to emergency research. Standard, accepted medical therapy was not tested for either safety or efficacy in the emergency setting. In recognition of this potential harm, the government eventually permitted exception from informed consent in certain emergency research trials in order to (1) provide individuals in life-threatening situations access to potentially life-saving therapies, (2) advance knowledge through collection of information about effectiveness and safety, and (3) improve therapies used in emergency medical situations that currently have poor clinical outcomes. This chapter will explore the history behind informed consent, informed consent for human subject research, and exception from informed consent (EFIC)/waiver of informed consent (WIC).

An evaluation of patient informed consent for dental extractions

An evaluation of patient informed consent for dental extractions
Richa Arya, Sarah Jadun, Aneesha Shah
Primary Dental Surgery, 7 September 2022; 11(3)
Abstract
Dental practitioners are well versed in informing patients of the risks and benefits associated with dental extractions. The purpose of this service evaluation was to determine whether patients understood and recalled information relevant to their planned oral surgery procedure, prior to second stage consent. A questionnaire was distributed to patients who were attending for their elective treatment appointment. This explored their ability to recall the planned intervention, the modality of treatment (local anaesthetic, intravenous sedation, or general anaesthetic), understanding of alternative treatment options and the risks associated with the procedure. Completed responses were received from 29 of the distributed questionnaires (response rate=58%). The majority of patients were not aware of the following risks with their procedure: pain, bleeding, bruising, swelling, infection, damage to adjacent structures. Despite a well-documented consent form and comprehensive discussion, we identified that patients may not comprehend or recollect the risks associated with their dental extraction. As dental professionals we have a duty to seek ways to facilitate patient understanding and maximise their autonomy.

Fertility clinic consent forms and the disposition of reproductive material upon a fertility patient’s death

Fertility clinic consent forms and the disposition of reproductive material upon a fertility patient’s death
Legal reflections
D W Thaldar
South African Medical Journal, September 2022; 112(9) pp 744-746
Open Access
Abstract
South African fertility clinics often include a provision in their consent forms that deals with the disposition of reproductive material (gametes and embryos) after a fertility patient’s death. This practice is problematic as such a provision is not legally valid. If the clinic acts in pursuance of such a provision upon a fertility patient’s death, the fertility clinic may be committing a civil wrong and a crime. Accordingly, consent forms should not include any provision that deals with the disposition of reproductive material after a fertility patient’s death. Instead, to address the practical concern of keeping reproductive material cryopreserved without receiving payment, fertility clinics’ storage agreements should use non-payment by fertility patients (or their successors in title) as the trigger event for the disposition of reproductive material. The importance of dealing with reproductive material in both its property rights dimension and its personality rights dimension is highlighted.