An examination of the moral conundrum of informed consent within the framework of African values and belief systems : a case study
Jamila Kathoon Adam, Francis Fabian Akpa-Inyang
Interdisciplinary Journal of Economics and Business Law, 2023; 12(1)
Abstract
The notion of bio-medical ethics, which places a strong focus on individual autonomy when considering informed consent, is mostly inspired by western European medical and moral traditions, leaving African traditions and values out of the practice of medical ethics. This is due to the fact that African customs and values favour communitarianism above individualism. In African culture, your strong relationships with people in the community which include sharing everything, including decision-making are what define you as a human being. As a result, it is clear that when applied to the majority of Africans, the idea of individual liberty in informed consent is inapplicable. This is because African communitarian ethics focuses on the interests of the family, community and society and not the individual. Thus, there might be a conflict in the application of the western principle of medical ethics in the general population in Africa. This review paper intends to use published articles, reports, case studies, and ethical principles to explore this potential conflict.
Accessibility of the consent form in Brazilian clinical research
Accessibility of the consent form in Brazilian clinical research
Research
Renan Emilio Kintopp, Sergio Surugi de Siqueira, José Eduardo de Siqueira, José Humberto Guerreiro Tavares Fregnani
Revista Bioética, 2023
Abstract
The informed consent form informs clinical research patients about the nature of the research and their rights, formalizing their decision to participate; however, studies show that this document is written in a complex manner, compromising patient autonomy. Two consent forms from the same hypothetical research were developed with different writing styles and analyzed by the Coh-Metrix Port tool, which evaluates linguistic metrics and textual accessibility. Results showed that both texts were complex and required high schooling level to be understood. These findings reinforce the perception that consent forms may have their real function compromised and point to the importance of changing its elaboration.
Consent for Medical Treatment: What is ‘Reasonable’?
Consent for Medical Treatment: What is ‘Reasonable’?
Original Article
Abeezar Ismail Sarela
Health Care Analysis, 19 August 2023
Open Access
Abstract
The General Medical Council (GMC) instructs doctors to act ‘reasonably’ in obtaining consent from patients. However, the GMC does not explain what it means to be reasonable: it is left to doctors to figure out the substance of this instruction. The GMC relies on the Supreme Court’s judgment in Montgomery v Lanarkshire Health Board; and it can be assumed that the judges’ idea of reasonability is adopted. The aim of this paper is to flesh out this idea of reasonability. This idea is commonly personified as the audience that has to be satisfied by the doctor’s justification for offering, or withholding, certain treatments and related information. In case law, this audience shifted from a reasonable doctor to a ‘reasonable person in the patient’s position’; and Montgomery expands the audience to include ‘particular’ patients, too. Senior judges have clarified that the reasonable person is a normative ideal, and not a sociological construct; but they do not set out the characteristics of this ideal. John Rawls has conceived the reasonable person-ideal as one that pursues fair terms of co-operation with other members of society. An alternative ideal can be inferred from the feminist ethic of care. However, the reasonable patient from Montgomery does not align with either theoretical ideal; but, instead, is an entirely rational being. Such a conception conflicts with both real-life constraints on rationality and the doctor’s duty to care for the patient, and it challenges the practice of medicine.
A Systematic Review Of Patient Perspective On The Informed Consent Doctrine: Ethical And Legal Reflections
A Systematic Review Of Patient Perspective On The Informed Consent Doctrine: Ethical And Legal Reflections
Alexander Fiifi Ghartey
UCC Law Journal, July 2023; 3(1) pp 32-56
Abstract
Informed consent is an ethical and legal doctrine of patients’ right of acquiescence to treatment and the disclosure of adequate information by the physician to facilitate patients’ medical decisions. The doctrine seeks to expand the scope of potential legal liabilities of medical practitioners and to promote patients’ rights to medical care. A breach of the informed consent doctrine could be actionable in battery or assault when there is bodily trespass without consent and the tort of clinical negligence when there are inadequate disclosures. This article is a desk-top systematic review of primary data from seven independent empirical studies on informed consent from the perspective of the patient in five common law African countries. The publications which were purposively searched and extracted from Google Scholar reveal that though majority of patients (at least 79 percent) granted consent for treatment, there was insufficient disclosure of material complications or risks, treatment alternatives or the right of patients to refuse medical treatment if they so wished. Disclosures on material risks were as low as 21.2 percent of patients. The physician’s competence in providing adequate information disclosure demands continual medical training in the practice of the informed consent doctrine. The application of communication strategies that could enhance patients’ capacity to understand the informed consent process is recommended. Additionally, clear guidelines from relevant regulatory bodies are recommended to promote patient rights to informed consent and to protect medical practitioners from potential legal liabilities.
Informed consent for medical student involvement in patient care: an updated consensus statement
Informed consent for medical student involvement in patient care: an updated consensus statement
Walker S, Reid P, Anderson L, Bull S, Jonas M, Manning J, Merry A, Pitama S, Rennie S, Snelling J, Wilkinson T, Bagg W
The New Zealand Medical Journal, 21 July 2023; 136(1579) pp 86-95
Abstract
Enabling patients to consent to or decline involvement of medical students in their care is an essential aspect of ethically sound, patient-centred, mana-enhancing healthcare. It is required by Aotearoa New Zealand law and Te Kaunihera Rata o Aotearoa Medical Council of New Zealand policy. This requirement was affirmed and explored in a 2015 Consensus Statement jointly authored by the Auckland and Otago Medical Schools. Student reporting through published studies, reflective assignments and anecdotal experiences of students and teachers indicate procedures for obtaining patient consent to student involvement in care remain substandard at times. Between 2020 and 2023 senior leaders of Aotearoa New Zealand’s two medical schools, and faculty involved with teaching ethics and professionalism, met to discuss these challenges and reflect on ways they could be addressed. Key stakeholders were engaged to inform proposed responses. This updated consensus statement is the result. It does not establish new standards but outlines Aotearoa New Zealand’s existing cultural, ethical, legal and regulatory requirements, and considers how these may be reasonably and feasibly met using some examples.
Autonomy with responsibility: is informed consent just a signature on a paper? Evaluation in patients who underwent spine surgery
Autonomy with responsibility: is informed consent just a signature on a paper? Evaluation in patients who underwent spine surgery
Jorge H. Nuñez Camarena, David Bosch Garcia, Berta Escudero
The Spine Journal, September 2023; 23(9)
Abstract
Background Context
Despite the relevance of informed consent in spine surgery, and all type of surgeries, and its daily use, there are very few studies that have checked if this document really accomplishes its duty.
Purpose
The aim of this study is to evaluate the real information that patients who went under spine surgery receive and know, after signing the informed consent.
Study Design/Setting
Retrospective study.
Patient Sample
Patients who underwent spine arthrodesis or spine discectomy between 2017 and 2019 were analyzed. Surgical technique and risks were explained before they were accepted to be on the surgery waiting list. They were given a copy of the informed consent.
Outcome Measures
Within the studied variables, we have asked patients if they have read the informed consent before surgery, if they could recall the surgical technique, spinal segment operated (cervical, thoracic, or lumbar) and vertebral levels operated. We added if they knew about surgical risks and if they looked for information about their procedure from other sources.
Methods
Answers were analyzed by age and educational level.
Results
From 458 total patients, only 51.9% of them answered all the questions. Also, 63% of patients agreed to have read the informed consent before surgery; 91.6% of patients knew about the spine segment operated; however, only 73.5% of patients remembered the surgical technique and 63.9% of patients could recall the vertebral levels. In addition, 39.1% of patients did not know about surgical risks and only 16.0% of patients mentioned to have looked for additional information using other sources. A significant statistical result was obtained between the search of additional information and younger patients (p < 0.001) and superior educational formation (p = 0.023).
Conclusions
Even though informed consent is an important procedure to get patients informed before spinal surgery, almost 40% of our patients underwent surgery without reading this document and not being aware of surgical risks.
Can we do it better? Consent in dentoalveolar surgery
Can we do it better? Consent in dentoalveolar surgery
Short Communication
Jai Parkash Ramchandani, Miss Alice Cameron, Montey Garg, Laurence Newman
British Journal of Oral and Maxillofacial Surgery, 19 August 2023
Open Access
Abstract
Obtaining informed consent is essential for any medical or dental procedure. Dentoalveolar surgery poses numerous risks due to the complex environment and anatomy of the oral cavity. Failure to seek and correctly document consent may lead to claims in negligence, as demonstrated by the increasing litigation in OMFS. We audited dentoalveolar surgery consent forms at two different UK OMFS units and found that many forms failed to document important material risks associated with procedures. In attempt to improve the consent process, we developed a standardised form containing a list of risks for dentoalveolar surgery that can be affixed to the consent form. We suggest other OMFS units adopt this form to standardise the consent process and optimise patient care while protecting clinicians from medico-legal claims.
Transformative experience and the principle of informed consent in medicine
Transformative experience and the principle of informed consent in medicine
Original Research
Karl Egerton, Helen Capitelli-McMahon
Synthese, 18 August 2023; 202(65)
Open Access
Abstract
This paper explores how transformative experience generates decision-making problems of particular seriousness in medical settings. Potentially transformative experiences are especially likely to be encountered in medicine, and the associated decisions are confronted jointly by patients and clinicians in the context of an imbalance of power and expertise. However in such scenarios the principle of informed consent, which plays a central role in guiding clinicians, is unequal to the task. We detail how the principle’s assumptions about autonomy, rationality and information handle transformative experiences poorly, appealing to several difficult cases for medical decision-making to illustrate the resulting problem, and we consider how the existing literature on complications with consent fails to offer a resolution. We argue that recognition of the problem has a role to play in achieving a more effective response to transformative decisions. In Sect. 1 we introduce several representative cases of challenging patient decision-making that clinicians might face. In Sect. 2 we detail how transformative experience has been analysed in the recent literature, before outlining in Sect. 3 the theoretical basis of the principle of informed consent, which plays a central role in how clinicians are expected to support decision-making. In Sect. 4, having laid the groundwork for a clear description, we return to the cases given in Sect. 1 to confirm how their transformative nature presents a problem: either clinicians treat the decisions faced by these patients as ‘normal’, encouraging them to focus on information provision that patients may be unable to act on, or they treat them as transformative, in which case they lack the resources to recognise whether they are helping patients make (subjectively) good decisions. In Sect. 5 we argue that the existing literature does not offer any escape from this problem. We close in Sect. 6 by noting the significant impact that appreciating the problem of transformative experience could have on supporting transformative decisions in medicine and briefly suggesting how we might aim to develop new approaches to dealing with these.
Establishing an Ethics for Psychedelic Psychiatry
Establishing an Ethics for Psychedelic Psychiatry
Brian Holoyda, Cameron Kiani
Psychiatric Services, 1 August 2023
Excerpt
…Informed consent, a cornerstone of ethical clinical practice, is particularly challenging in the context of psychedelic-assisted psychotherapy. The authors aptly point out that the potent effects of psychedelics necessitate an enhanced consent process to ensure understanding of risks and potential treatment outcomes. Patients should understand that acute and long-term emotional, cognitive, and perceptual changes may occur with psychedelic use. Although psychedelic journeys are positively transformative for many people, these journeys are not beneficial for everyone. Barber and Dike also note that psychedelics not only may be used to treat some mental disorders but also may lead to changes in personality and beliefs. Eliciting such changes could be outside the scope of psychiatric treatment; therefore, practitioners need to ensure that their patients’ understanding of the goals of treatment align with their own…
Ethical and Psychosocial Factors in the Decision-Making and Informed Consent Process for Upper Extremity Vascularized Composite Allotransplantation: A Mixed-Methods Study
Ethical and Psychosocial Factors in the Decision-Making and Informed Consent Process for Upper Extremity Vascularized Composite Allotransplantation: A Mixed-Methods Study
Elisa J. Gordon, Jessica Gacki-Smith, Brianna R. Kuramitsu, Max Downey, Karen B. Vanterpool, Michelle J. Nordstrom, Tiffany Riggleman, Carisa M. Cooney, Sally Jensen, Gregory Dumanian, Scott Tintle, Macey Levan, Gerald Brandacher
Transplantation Direct, August 2023; 9(8)
Abstract
Background
Although upper extremity (UE) vascularized composite allotransplantation (VCA) aims to improve quality of life, relatively few have been performed worldwide to support evidence-based treatment and informed decision-making.
Methods
We qualitatively examined factors contributing to anticipated and actual decision-making about UE VCA and perceptions of the elements of informed consent among people with UE amputations, and UE VCA candidates, participants, and recipients through in-depth interviews. Thematic analysis was used to analyze qualitative data.
Results
Fifty individuals participated; most were male (78%) and had a mean age of 45 y and a unilateral amputation (84%). One-third (35%) were “a lot” or “completely” willing to pursue UE VCA. UE VCA decision-making themes included the utility of UE VCA, psychosocial impact of UE VCA and amputation on individuals’ lives, altruism, and anticipated burden of UE VCA on lifestyle. Most respondents who underwent UE VCA evaluation (n = 8/10) perceived having no reasonable treatment alternatives. Generally, respondents (n = 50) recognized the potential for familial, societal, cultural, medical, and self-driven pressures to pursue UE VCA among individuals with amputations. Some (n = 9/50, 18%) reported personally feeling “a little,” “somewhat,” “a lot,” or “completely” pressured to pursue UE VCA. Respondents recommended that individuals be informed about the option of UE VCA near the amputation date.
Conclusions
Our study identified psychosocial and other factors affecting decision-making about UE VCA, which should be addressed to enhance informed consent. Study participants’ perceptions and preferences about UE VCA suggest re-examination of assumptions guiding the UE VCA clinical evaluation process.
Center for Informed Consent Integrity 