Material risk: a review of informed consent in the UK
Thomas Walton
Orthopaedics and Trauma, 24 April 2020
Abstract
Consent is a requirement for any medical or surgical intervention to be deemed appropriate. For such consent to be considered valid, it must be given voluntarily, by an individual with capacity, who has the appropriate information available to make an informed decision in line with their values. Following the Montgomery vs. Lanarkshire ruling in 2015, the legal basis from which informed consent is measured has changed. The law now reflects pre-existing professional guidelines, and advocates a patient-centred approach to informed consent. The previously paternalistic focus of informed consent, whereby it was deemed a matter for clinical judgement, has been firmly abandoned in favour of the provision of information pertaining to ‘material risks’, as determined by the significance attached to these risks by the patient themselves. This paper serves to provide an overview of consent within the medical profession, and gives an account of the implications of this landmark ruling.
Month: May 2020
A Review of Socio-Cultural Factors Affecting Patients’ Right to Informed Consent and Autonomy in Medical Practice in Nigeria
A Review of Socio-Cultural Factors Affecting Patients’ Right to Informed Consent and Autonomy in Medical Practice in Nigeria
Chinemelum Nelson Arinze-Umobi, Godwin N Okeke
African Journal Of Law And Human Rights, 2020; 4(1)
Open Access
Abstract
Today, the fundamental principle of medical law and ethics is that a medical professional should obtain the informed consent of a competent patient before administering any form of treatment on such a patient. This is in tandem with the principle of autonomy (self-determination) which is intrinsic in every individual save for circumstances wherein the observance of this principle can legally be departed from. In clinical context, ‘autonomy’ connotes a patient’s ‘right to refuse and right to participate in every decision regarding medical treatment’. This study reviewed the socio-cultural factors inhibiting patients’ right to autonomy in medical practice in Nigeria. The study found that striking a balance between the opposing interests may be a difficult tasks as patients’ right to autonomy is case-specific and that a whole lot of factors operate in the social space and as a result, alter, from time to time, the standard, such that it becomes nearly impossible to apply the same standard in all instances. The study found that certain circumstances exist in the doctor-patient relationship wherein a patient lacks capacity to grant such consent to the medical professional – hence the need for such consent to be given on his/her behalf towards his/her best interests.
Informed Consent For Surgery On Neck Of Femur Fracture: A Multi-Loop Clinical Audit
Informed Consent For Surgery On Neck Of Femur Fracture: A Multi-Loop Clinical Audit
Rohi Shah, Sharan Sambhwani, Awf Al-Shawani, Christos Plakogiannis
Annals of Medicine and Surgery, 8 April 2020
Open Access
Abstract
Background
The Montgomery case in 2015 resulted in a pivotal change in practice, leading to a patient-centric approach for informed consent. Neck of femur fractures are associated with a high rates perioperative morbidity and mortality. Using guidelines highlighted by the British Orthopaedic Association we performed a multi-loop audit within our department to assess the adequacy of informed consent for NOF fractures.
Methods
Two prior cycles had been performed utilising a similar framework. Prior interventions included ward posters, verbal dissemination of information at Doctor’s induction and amendments to the JD handbook. For the latest audit loop, a retrospective analysis of 100 patients was performed. Risk factors were classified as common, less common, rare and ‘other’. The adequacy of informed consent was evaluated by assessing the quality and accuracy of documentation in the signed Consent Form-1s.
Results
Infection, bleeding risks, clots and anaesthetic risks were documented in all patients(100%). Areas of improvement included documentation of neurovascular injuries(98%), pain(75%) and altered wound healing(69%). There was no significant change in the documentation of failure of surgery(83%) neurovascular injuries(98%). Poorly documented risk factors included mortality(21%), prosthetic dislocation(14%) and limb length discrepancy(6%).
Conclusion
Following the latest cycle, the trust has now approved the use of 2 consent-specific stickers(arthroplasty/fixation), amendable on a patient-to-patient basis. As part of the multi-loop process, the cycle will be repeated every year-in line with Junior Doctor rotations. Medical professionals have an ethical, moral and legal obligation to ensure they provide all information regarding surgical interventions to aid patients in making an informed decision.
Informing MS Patients on Treatment Options: A Consensus on the Process of Consent Taking
Informing MS Patients on Treatment Options: A Consensus on the Process of Consent Taking
Brief Communication
C Tortorella, C Solaro, P Annovazzi, L Boffa, M C Buscarinu, F Buttari, M Calabrese, P Cavalla, E Cocco, C Cordioli, G De Luca, M Di Filippo, R Fantozzi, D Ferraro, A Gajofatto, A Gallo, R Lanzillo, A Laroni, S Lo Fermo, S Malucchi, G T Maniscalco, M Moccia, V Nociti, D Paolicelli, I Pesci, L Prosperini, P Ragonese, V Tomassini, V L A Torri Clerici, M Rodegher, M Gherardi, C Gasperini, RIReMS Group
Neurological sciences, 2 Apr 2020
Abstract
In the last years, change in multiple sclerosis (MS) therapeutic scenario has highlighted the need for an improved doctor-patient communication in advance of treatment initiation in order to allow patient’s empowerment in the decision-making process. AIMS: The aims of our project were to review the strategies used by Italian MS specialists to inform patients about treatment options and to design a multicentre shared document that homogenizes the information about disease-modifying treatment (DMTs) and the procedure of taking informed consent in clinical practice. RESULTS: The new resource, obtained by consensus among 31 neurologists from 27 MS Centres in Italy with the supervision of a medico-legal advisor, received the aegis of Italian Neurological Society (SIN) and constitutes a step toward a standardized decision process around DMTs in MS.
Mainstream consent programs for genetic counseling in cancer patients: A systematic review
Mainstream consent programs for genetic counseling in cancer patients: A systematic review
Review
Tahlia Scheinberg, Alison Young, Henry Woo, Annabel Goodwin, Kate L. Mahon, Lisa G. Horvath
Asia-Pacific Journal of Clinical Oncology, 29 February 2020; pp 1–15
Open Access
Abstract
As demand for germline genetic testing for cancer patients increases, novel methods of genetic counseling are required. One such method is the mainstream consent pathway, whereby a member of the oncology team (rather than a genetic specialist) is responsible for counseling, consenting, and arranging genetic testing for cancer patients. We systematically reviewed the literature for evidence evaluating mainstream pathways for patients with breast, ovarian, colorectal, and prostate cancer. Medline, EMBASE, and Cochrane Library were searched for studies that met inclusion and exclusion criteria. Article references were checked for additional studies. Trial databases were searched for ongoing studies. Of the 13 papers that met inclusion criteria, 11 individual study groups were identified (two study groups had two publications each). Ten of the 11 studies evaluated the acceptability, feasibility, and impact of BRCA testing for patients and/or clinicians in different clinical settings in breast and ovarian cancer, while the final study explored the attitudes of colorectal specialists toward genetic testing for colorectal cancer. None involved prostate cancer. Overall, mainstream pathways were acceptable and feasible. Medical oncologist and nurse-driven pathways were particularly successful, with both patients and clinicians satisfied with this process. Although the content of pretest counseling was less consistent compared with counseling via the traditional model, patients were largely satisfied with the education they received. Further research is required to evaluate the mainstream pathway for men with prostate cancer.
The Importance of Physician Directed Informed Consent
The Importance of Physician Directed Informed Consent
Neena Oza
Journal of Health Care Finance, 2020
Open Access
Abstract
The process and scope of procedural/surgical informed consent has changed dramatically with emerging technologies, expanding medical knowledge, updated outcomes data and increased recognition of patient autonomy. With the paradigm shifting towards ethical considerations of patient care and active involvement of patient’s in their treatment, medical practices and laws have evolved to guide communication standards between the patient and physician. The delivery of all relevant information should enable the patient to make an informed decision regarding the procedure, while preserving the core principles of patient understanding and free consent, devoid of coercion or manipulation.[1],3 Additionally, education and counseling delivered during the informed consent should relieve the patient’s safety concerns related to procedures and to address patient knowledge deficiencies, present other alternative plans or procedures, as well as any possible perceived coercion related to noninvasive and invasive procedures. The intent of this article will be to further explain the rationale for the performing provider, attending physician or surgeon, to be the sole person ultimately responsible for providing the patient with the goals, risks and benefits of the proposed treatment or intervention; and for the words and actions of any other medical team member (such as medical students or residents) that may assisting during the informed consent process.
Information Disclosure in Informed Consent
Information Disclosure in Informed Consent
Review Article
Lydia Aiseah Ariffin
Malaysian Journal of Medicine and Health Sciences, May 2020
Open Access
Abstract
Informed consent has been recognised as an essential part of clinical practice, giving ethical and legal legitimacy to medical intervention. There is no universal standard on the amount and type of information that a patient is entitled to and needs to be adequately disclosed. This article proposes nine information that will assist the doctor in providing adequate information for a patient to evaluate whether to authorise medical intervention. The recommended information are: (i) diagnosis, prognosis and its uncertainties; (ii) nature of proposed medical intervention; (iii) the expected benefit of proposed medical intervention; (iv) the potential risk of proposed medical intervention; (v) alternative to proposed medical intervention; (vi) progress of proposed medical intervention; (vii) opportunity for a second medical opinion and to seek further details; (viii) costs of proposed and alternative medical intervention; and (ix) the person responsible for implementing medical intervention.
Exploring solutions to the privacy paradox in the context of e‑assessment: informed consent revisited
Exploring solutions to the privacy paradox in the context of e‑assessment: informed consent revisited
Original Paper
Ekaterina Muravyeva, José Janssen, Marcus Specht, Bart Custers
Ethics and Information Technology, 24 April 2020
Open Access
Abstract
Personal data use is increasingly permeating our everyday life. Informed consent for personal data use is a central instrument for ensuring the protection of personal data. However, current informed consent practices often fail to actually inform data subjects about the use of personal data. This article presents the results of a requirements analysis for informed consent from both a legal and usability perspective, considering the application context of educational assessment. The requirements analysis is based on European Union (EU) law and a review of current practices. As the main outcome, the article presents a blueprint which will be the basis for the development of an informed consent template that supports data controllers in establishing an efective and efcient informed consent form. Because the blueprint, and subsequently, the template, distinguishes between legal and usability requirements, it also provides the basis for the mapping of legal requirements in other (non-European) contexts
The myth about consent forms
The myth about consent forms
Advice
Russell Heathcote-Curtis
BDJ In Practice, 6 April 2020
Open Access
Excerpt
…The consent process is not about creating legal protection for the clinical team that will be providing treatment. It is a communication process that reflects the autonomy of the patient who will be receiving that treatment. Any consent form that you have asked the patient to sign, should be regarded as just one small part of the overall record of the communication that has taken place between patient and clinician in advance of treatment being provided. The larger part of the record needs to capture the essence of the information provided to the patient, the issues raised by any of the treatment options and the clinician’s response along with the patient’s final decision about their preferred choice from the options discussed…
Rethinking consent in mHealth: (A) moment to process [BOOK CHAPTER]
Rethinking consent in mHealth: (A) moment to process [BOOK CHAPTER]
Iris Loosman
Aging between Participation and Simulation
Walter de Gruyter GmbH, 6 April 2020; Chapter 10
Abstract
The field of mobile health promises a transformation of the healthcare industry, by providing health-related information and services directly to individuals, through digital mobile devices. This presents society with new platforms for persuasive systems for healthy behavior change. Before such systems’ full potential can be utilized, however, the question of how to consent to their use needs to be addressed. In this paper, I argue that one-off all-encompassing consent moments at the start of use of persuasive mobile health services do not suffice, given the functions they present, and the context in which they are used. Persuasive mobile health services are not only data-intensive, they are also designed to influence the user’s behavior and health. Informed consent should be temporally distributed, in order to improve the quality of the user’s autonomous authorization, that this context requires.
Center for Informed Consent Integrity 