Informed consent: What risks are material to patients consenting for urological procedures?
Research Article
Nadine McCauley, Siya Lodhia, Andrea Ong, Calum Clark, Tim Lane
Journal of Clinical Urology, 31 March 2021
Abstract
Objective
This study aimed to assess patient recall of the consent discussion for urological procedures and to identify which risks were material to urology patients.
Methods
A total of 102 patients undergoing urological procedures were interviewed in the 24-hour period surrounding the procedure. A self-designed, piloted questionnaire recorded information from the patient’s signed consent form and patient-reported data of the consent discussion.
Results
The mean patient recall was 2.06 risks, whereas the average number of risks listed by the operating surgeon on the consent form was 5.69 risks. The most frequently recalled risk was impotence (91%), followed by urinary incontinence (63%) and haematuria (61%). The risks associated with poorest patient recall were stent symptoms (0%), urethral catheter insertion (5%) and recurrence (8%).
Conclusions
Poor patient recall of the consent discussion has again been demonstrated in this study. However, certain urological procedure risks are better recalled by patients, with impotence, urinary incontinence and haematuria being most frequently recalled. Medical terminology such as stent or catheter may be poorly recalled due to a disparity in understanding between patient and clinician. Clinicians should be aware of poor patient recall when consenting for urology procedures and should ensure precise documentation.
Month: May 2021
Harming one to benefit another: The paradox of autonomy and consent in maternity care
Harming one to benefit another: The paradox of autonomy and consent in maternity care
Original Article
Elselijn Kingma
Bioethics, 11 December 2020
Open Access
Abstract
This paper critically analyses ‘the paradox of autonomy and consent in maternity care’. It argues that maternity care has certain features that increase the need for explicit attention to, and respect for, both autonomy and rigorous informed consent processes. And, moreover, that the resulting need is considerably greater than in almost all other areas of medicine. These features are as follows: (1) maternity care involves particularly socially sensitive body parts that are regularly implicated in consent-centred procedures, as well as in unconsented interventions, in ordinary, non-medical life; and (2) much of maternity care (especially intervening in childbirth) is medically unique, in that it harms one patient (the mother) not primarily for the promotion of her own health but for the benefit of another (the baby). The apt comparison, within medicine, is therefore with non therapeutic research and transplantation medicine—both of which have elevated consent requirements characterized by very rigorous consent processes. At the same time—and this delivers the titular paradox—the importance of autonomy and consent in maternity care is at particular risk of being denied or disregarded. Jointly, these considerations make a very strong case for change: attention to and respect for autonomy and consent should be (1) core values; (2) key points of practical attention in the years ahead; and (3) central quality indicators in maternity care.
Medical images, social media and consent
Medical images, social media and consent
Comment
Jonathan P. Segal, Richard Hansen
Nature Reviews Gastroenterology & Hepatology, 23 April 2021
Excerpt
The popularity of social media amongst medical professionals has led to widespread use for both networking and education. Limited professional guidance exists on the sharing of medical imagery on these platforms. This Comment explores consent and offers reflective advice on the use of medical images on social media…
Meeting Unique Requirements: Community Consultation and Public Disclosure for Research in Emergency Setting Using Exception from Informed Consent
Meeting Unique Requirements: Community Consultation and Public Disclosure for Research in Emergency Setting Using Exception from Informed Consent
Dickert NW, Metz K, Fetters MD, Haggins AN, Harney DK, Speight CD, Silbergleit R
Academic Emergency Medicine, 19 April 2021
Abstract
Background
Exception from informed consent (EFIC) regulations for research in emergency settings contain unique requirements for community consultation and public disclosure. These requirements address ethical challenges intrinsic to this research context. Multiple approaches have evolved to accomplish these activities that may reflect and advance different aims. This scoping review was designed to identify areas of consensus and lingering uncertainty in the literature.
Methods
Scoping review methodology was used. Conceptual and empirical literature related to community consultation and public disclosure for EFIC research was included and identified through a structured search using EMBASE, HEIN Online, PubMed, and Web of Science. Data were extracted using a standardized tool with domains for major literature categories.
Results
Among 84 manuscripts, major domains included: conceptual or policy issues; reports of community consultation processes and results; and reports of public disclosure processes and results. Areas of consensus related to community consultation included the need for a two-way exchange of information and use of multiple methods. Public acceptance of personal EFIC enrollment is commonly 64-85%. There is less consensus regarding how to assess attitudes, what “communities” to prioritize, and how to determine adequacy for individual projects. Core goals of public disclosure are less well-developed, no metrics exist for assessing adequacy.
Conclusions
Multiple methods are used to meet community consultation and public disclosure requirements. There remain no settled norms for assessing adequacy of public disclosure, and there is lingering debate about needed breadth and depth of community consultation.
Public Attitudes toward Consent When Research Is Integrated into Care—Any “Ought” from All the “Is”?
Public Attitudes toward Consent When Research Is Integrated into Care—Any “Ought” from All the “Is”?
Article
Stephanie R. Morain, Emily A. Largent
The Hastings Center Report, 11 April 2021
Abstract
Research that is integrated into ongoing clinical activities holds the potential to accelerate the generation of knowledge to improve the health of individuals and populations. Yet integrating research into clinical care presents difficult ethical and regulatory challenges, including how or whether to obtain informed consent. Multiple empirical studies have explored patients’ and the public’s attitudes toward approaches to consent for pragmatic research. Questions remain, however, about how to use the resulting empirical data in resolving normative and policy debates and what kind of data warrants the most consideration. We recommend prioritizing data about what people consider acceptable with respect to consent for pragmatic research and data about people’s informed, rather than initial, preferences on this subject. In addition, we advise caution regarding the weight given to majority viewpoints and identify circumstances when empirical data can be overridden. We argue that empirical data bolster normative arguments that alterations of consent should be the default in pragmatic research; waivers are appropriate only when the pragmatic research would otherwise be impracticable and has sufficiently high social value.
The Consent Continuum: A New Model of Consent, Assent, and Nondissent for Primary Care
The Consent Continuum: A New Model of Consent, Assent, and Nondissent for Primary Care
Article
Marc Tunzi, David J. Satin, Philip G. Day
The Hastings Centre Report, 11 April 2021
Abstract
The practice around informed consent in clinical medicine is both inconsistent and inadequate. Indeed, in busy, contemporary health care settings, getting informed consent looks little like the formal process developed over the past sixty years and presented in medical textbooks, journal articles, and academic lectures. In this article, members of the Society of Teachers of Family Medicine (STFM) Collaborative on Ethics and Humanities review the conventional process of informed consent and its limitations, explore complementary and alternative approaches to doctor‐patient interactions, and propose a new model of consent that integrates these approaches with each other and with clinical practice. The model assigns medical interventions to a consent continuum defined by the discrete categories of traditional informed consent, assent, and nondissent. Narrative descriptions and clinical exemplars are offered for each category. The authors invite colleagues from other disciplines and from the academic ethics community to provide feedback and commentary.
[A few reflective remarks on the notion of consent].
[A few reflective remarks on the notion of consent].
Berard K
Soins Psychiatrie, 23 March 2021; 42(333) pp 12-15
Abstract
Medical paternalism has given way to the autonomy of the patient, who remains master of the decisions he makes concerning his health. His consent, free and informed, has no value unless it is preceded by information adapted to his degree of understanding. The notion of consent raises the question of freedom, and therefore of the autonomy left to patients in their choices. Individual freedom occupies a particular place in psychiatry where it comes into confrontation with constraint. The tensions generated must lead caregivers to ask themselves the right questions in accordance with the principles of medical ethics.
Editor’s note: This is a French language publication
Assessment of the All of Us research program’s informed consent process
Assessment of the All of Us research program’s informed consent process
Megan Doerr, Sarah Moore, Vanessa Barone, Scott Sutherland, Brian M. Bot, Christine Suver, John Wilbanks
American Journal of Bioethics, 4 December 2020; 2 pp 72-83
Abstract
Informed consent is the gateway to research participation. We report on the results of the formative evaluation that follows the electronic informed consent process for the All of Us Research Program. Of the nearly 250,000 participants included in this analysis, more than 95% could correctly answer questions distinguishing the program from medical care, the voluntary nature of participation, and the right to withdraw; comparatively, participants were less sure of privacy risk of the program. We also report on a small mixed-methods study of the experience of persons of very low health literacy with All of Us informed consent materials. Of note, many of the words commonly employed in the consent process were unfamiliar to or differently defined by informants. In combination, these analyses may inform participant-centered development and highlight areas for refinement of informed consent materials for the All of Us Research Program and similar studies.
Center for Informed Consent Integrity 