The practice of obtaining informed consent for elective surgery and anesthesia from patients’ perspective: An institutional based cross-sectional study
Research Article
Tadese Tamire, Aragaw Tesfaw
Clinical Ethics, 8 February 2021
Abstract
Introduction
Informed consent is a body of shared decision-making process and voluntary authorization of patients to receive medical or surgical intervention. There are limited studies conducted so far to examine the practice of informed consent in Ethiopia. This study aimed to assess the practice of informed consent process for surgery and Anesthesia.
Method
A cross-sectional study was conducted from March to May 2019. The data were collected using interviewer-administered structured questionnaire and analyzed in SPSS version 23.
Results
A total of 139 patients were interviewed in this study. Most 42(30.2%) of patients were in the age group of 29–38 years. Nearly half 68 (48.9%) of the patients were informed the benefits of the surgical procedure and 78(56.1%) of the patients were informed on the type of anesthesia to be administered while 65 (46.8%) were not informed on any complication related to the anesthesia. About 66 (47.5%) of patients were informed on alternatives to the surgery. Of these patients, 39(59%) were not informed of any benefits and possible risks associated with the alternative modes of treatment. About half (54%) of the patients were reported as they were understood the information provided during the pre-operative informed consent process.
Conclusion
This research revealed that patients were inadequately informed on the complications of proposed procedure, alternative forms of treatment, risks and benefits of the proposed procedure. Therefore, healthcare providers should provide adequate information regarding the proposed procedure and make sure whether patients understood the risks and benefits before the consent.

Decision making and informed consent in uterus transplant recipients: A mixed-methods study of the Dallas uterus transplant study (DUETS) participants
Anji E. Wall, Liza Johannesson, Monica Sok, Ann Marie Warren, Elisa J. Gordon, Giuliano Testaa
The American Journal of Surgery, 4 February 2021
Abstract
Background
Uterus transplantation (Utx) has achieved clinical success but little is known about motivations and experiences of UTx recipients.
Methods
We conducted semi-structured interviews with 20 UTx recipients in addition to collecting quantitative demographic and clinical data. Closed-ended interview questions were treated as categorical variables. Thematic analysis was performed on qualitative data. Bivariate analysis tested associations between categorical variables.
Results
Themes that emerged included: the decision to pursue UTx is a process, primary motivations for UTx are specific to the experience of gestation, and alternative options did not offer the same value as UTx. There was no association between disease etiology, clinical status, or perception of UTx risk with information needs or donor preference.
Conclusions
Our findings suggest that UTx is a unique treatment option that some women with AUFI find preferable to adoption and surrogacy and, as such, should be discussed as a parenthood option with women diagnosed with AUFI.

Understanding Mordel: obtaining informed consent for trisomy screening
Emyr Owain Wile, Alys Einion-Waller
British Journal of Midwifery, 2 February 2021; 29(2)
Abstract
The landmark decision of Montgomery has established that the patient’s right to self-determination and autonomy underpins the doctrine of informed consent. The case of Mordel threw into question the process of obtaining informed consent and whether it was being sufficiently secured in the context of Down’s syndrome screening. This case conveyed a paradigm shift to the role of the midwife and sonographers when obtaining consent for screening and the requisite legal standard of care they owe to expectant parents. However, many key issues remain unanswered from the decision in Mordel, in particular, what steps must healthcare professionals take to discharge their duty of care in the process of securing informed consent from expectant parents for screening.

Improving Surgical Informed Consent, Unanswered Questions
Review Article
Raper, Steven E., Clapp, Justin T., Lee A.
Annals of Surgery, March 2021; 2(1)
Abstract
Objective
This study reviews randomized clinical trials that have attempted to improve the process of informed consent. Consent should be guided by the ethical imperatives of autonomy, beneficence, and social justice.
Summary Background
Informed consent is constantly evolving. Yet our review of the randomized trials done to improve the surgical informed consent process raises a number of questions: How does one define surgical informed consent? What interventions have been tried to measure and improve informed consent? Have the interventions in informed consent actually led to improvements? What efforts have been made to improve informed consent? And what steps can be taken to improve the process further?
Methods
A literature search for randomized controlled trials (RCTs) on informed consent identified 70 trials. Demographics, interventions, assessments, and a semi-quantitative summary of the findings were tabulated. The assessments done in the RCTs, show the surrogate for patient autonomy was comprehension; for beneficence, satisfaction and mental state (anxiety or depression); and, for social justice, language, literacy, learning needs, and cost.
Results
There were 4 basic categories of interventions: printed matter; non-interactive audiovisual tools; interactive multimedia; and a smaller group defying easy description. Improvement was documented in 46 of the 65 trials that studied comprehension. Thirteen of 33 trials showed improved satisfaction. Three of 30 studies showed an increase in anxiety. Few studies tried to assess primary language or literacy, and none looked at learning needs or cost.
Conclusions
No single study improved all 3 principles of informed consent. Validated interventions and assessments were associated with greater impact on outcomes. All 3 ethical principles should be assessed; autonomy (as comprehension), beneficence (as satisfaction, anxiety), and social justice. Not enough consideration has been given to social justice; appropriate language translation, standardized reading levels, assessment of learning needs, and cost to the individual are all important elements worthy of future study.

Informed Consent to Patients in Root Canal Treatment (Case Study: Melati Dental Clinic Jakarta, Indonesia)
Pudentiana Rr RE, Tedi Purnama, Syifa Yulia Lestari, Yulianti
Medico-legal Update, January-March 2021, 21(1)
Open Access
Abstract
Teeth with necrosis require root canal treatment. Before taking any action, the treatment plan that will be carried out along with the risks must be explained clearly to the patient and his family, and then must get informed consent for the treatment plan. The purpose of this study was to the description of informed consent in patients with root canal treatment at the Melati Dental Clinic in Jakarta. Method: This research uses descriptive method with research sample using technique total sampling of 50 respondents. The data used are secondary data taken from the patient’s medical record. Results: Respondents 33 people (66%) provided complete informed consent and 17 people (34%) did not give complete informed consent. Respondents doing root canal treatment caused by caries as many as 38 people (76%) and respondent root canal treatment caused not because of caries as many as 12 people (24%). Respondents provided complete informed consent in patients with root canal treatment because of caries by 27 people (71%) and giving complete informed consent not because of caries by 6 people (50%). Whereas giving informed consent was incomplete because of caries as many as 11 people (29%) and incomplete informed consent was not due to caries as many as 6 people (50%). Conclusion: Management of Informed Consent in Root Canal Treatment patients at Melati Dental Clinic in Jakarta has been carried out well.

Is waiver of consent for the use of health information for research acceptable to emergency department patients?
Perspective
Chase Schultz‐Swarthfigure, Anne‐Maree Kelly
Emergency Medicine Australasia, 27 January 2021
Abstract
Some emergency medicine research, especially retrospective studies using medical records review, rely on waiver of consent for use of personal health information (PHI) contained in clinical records. This is a secondary use of PHI and waiver of consent raises ethical, legal and practical issues. Granting of a waiver of consent is often (but not always) approved by a human research ethics committee and requires separate but inter‐related consideration of the legal and ethical issues. In part, this involves a balancing of the public interest versus the risk to privacy and an evaluation of whether subjects would, mostly likely, have agreed to the use of their PHI had they been asked. To date, there are no robust data about whether use of PHI without consent for research would be acceptable to people who attend Australasian EDs for care.

Liminal spaces in neurosurgery – tensions between expectations of the patient and their surgeon at the threshold of informed consent
Original Article
Nicole C. Keong
British Journal of Neurosurgery, 19 January 2021
Abstract
Purpose
The concept of ‘liminality’, describing the universal human experience of transition in status, has been shown to be relevant in addressing the provision of healthcare needs within clinical medicine. Consent may be viewed as a threshold which patients must cross between a state of integration of information to a state of transformation into knowledge. This article reframes gaps in the modern surgical approach to the process of ‘informed consent’ via the lens of liminality, drawing on key illustrative cases from the medicolegal evolution in the UK and Commonwealth.
Materials and methods
A focused literature search was performed for informative medical legal cases addressing or contributing to the understanding of “informed consent”. Searches and references to sources of case law were performed using Westlaw and Hein Online databases. Searches for secondary sources for interpretation and discussions of case law and concepts, as well as topics of liminality and autonomy, were performed via PubMed and Academia databases and relevant online resources.
Results
The paper organizes the illustrative material using the following approach: a discussion and dissection of the i) evolution of consent as a duty to warn, comprising a summary of landmark cases, ii) materiality of risks and what a particular patient would wish to know and iii) conceptual relevance of troublesome knowledge, relational autonomy and threshold concepts in learning to key examples in case law and the process of informed consent.
Conclusions
Modern surgical practice of informed consent must strive for clarity of mutual understanding. The framework of liminality allows us to understand the in-between states encountered during the patient’s journey. An ability to recognize such gaps in expectations, and develop tools to promote transformational learning, would allow the surgeon to evolve from prudent practitioner to patient mentor at the threshold of informed consent.

Consent in Surgical Practice
Review Article
Bindey Kumar, Mokarram Ali, Manish Kumar, Amit Kumar Sinha, Anil Kumar, Utpal Anand
Indian Journal of Surgery, 15 January 2021
Abstract
Informed consent addresses core principles of medical ethics—beneficence, nonmaleficence and autonomy. In this era of ever-increasing legal and social scrutiny of complex surgical procedures, informed consent is not just an ethical debate but a legal requirement. Unfortunately, many surgeons, to their own peril, still see it as a mere formality. This article deliberates upon informed consent process in surgical practice with emphasis on Indian perspectives and discusses common scenarios and special situations through legal citations in order to sensitize surgeons regarding their obligations pertaining to informed consent.

Failed consent in spinal surgery again. Minimum standards for consent must be adopted by all surgeons
Original Article
Nicholas V. Todd
British Journal of Neurosurgery, 11 January 2021
Abstract
Aim
To report another case of failed consent in spinal surgery leading to an award in damages of £4.4 million and to suggest an improved method of recording discussions in respect of consent.
Methods
A recent Court Judgment, previous Judgments and the relevant medical law were reviewed.
Results
A standardised proforma recording the necessary preoperative discussions that must be had with our patients is described.
Conclusions
Spinal surgeons must adhere to new standards in respect of the consenting process and, crucially, in recording the dialogue that has occurred between the patient and the surgeon.

Regional anaesthesia: risk, consent and complications
K McCombe, D Bogod
Anaesthesia, 10 January 2021; 76(Suppl 1) pp 18-26
Open Access
Abstract
The risks of regional anaesthesia relate primarily to the technical nature of the procedure, chief among them being neurological. While rare, the direct relationship between nerve damage and the procedure itself means that patients need to be aware of this complication when consent is sought. In order to give valid consent, a patient must be informed. The extent of the information required has been defined by a 2015 legal ruling which established that the standard is the expectation of a reasonable patient, rather than the information deemed consequential by a reasonable doctor. The implications of this for clinicians are profound, and mean that the process of consent must, for example, include alternatives to the proposed treatment. Additionally, patients must have capacity and give their consent without coercion. Effective communication of risk can be challenging. As well as the barriers to comprehension that can result from language, literacy and numeracy, clinicians need to be aware of their own biases, often in favour of a regional anaesthetic approach. Patients also have biases, and doctors must be aware of these in order to best target their provision of information. Careful use of language and employing adjuncts such as information leaflets and visual aids can help to maximise the individual’s autonomy. Particular care must be taken in special situations such as where patients have capacity issues or time is limited by the emergency nature of the intervention.