Consent, capacity and the law [BOOK CHAPTER]
Jonathan Waite
The ECT Handbook, Online 2018; chapter 22
Summary
All medical procedures, be they therapeutic or investigative, touch on the issue of consent – that is a measure of willingness on the part of the patient to undertake the procedure proposed. In this, ECT is no different to other therapeutic interventions. However, ECT has a particular status both within psychiatry and within the law that makes specific discussion of issues with regard to consent necessary.
Month: July 2019
Reconsidering Dynamic Consent in Biobanking: Ethical and Political Consequences of Transforming Research Participants Into ICT Users
Reconsidering Dynamic Consent in Biobanking: Ethical and Political Consequences of Transforming Research Participants Into ICT Users
Alexandra Soulier
IEEE Technology and Society Magazine, 10 June 2019; 38(2) pp 62-70
Abstract
Biobanks are not new. However, the scope of their application is growing, especially in genomics. Biobanks are also currently being reorganized to enable more genomic samples to be made available for different types of studies. Some future uses of the biobanks cannot be anticipated.
‘I haven’t met them, I don’t have any trust in them. It just feels like a big unknown’: a qualitative study exploring the determinants of consent to use Human Fertilisation and Embryology Authority registry data in research
‘I haven’t met them, I don’t have any trust in them. It just feels like a big unknown’: a qualitative study exploring the determinants of consent to use Human Fertilisation and Embryology Authority registry data in research
Qualitative research
Claire Carson, Lisa Hinton, Jenny Kurinczuk, Maria Quigley
BMJ, 30 May 2019; 9(5)
Abstract
Objectives
To explore why and how fertility patients decide to allow (or deny) the use of personal data held in the Human Fertilisation and Embryology Authority registry for linkage and research.
Design
A qualitative study was conducted using in-depth face-to-face interviews and an online survey to garner information on experience and opinions from fertility clinic patients and staff. Verbatim transcripts were analysed using the ‘one sheet of paper’ method to identify themes.
Setting
Women and men were recruited between September 2015 and December 2017, via fertility clinics across England and online advertising, then interviewed at a location convenient to them.
Participants
20 patients and 9 staff were interviewed, 40 patients completed the online survey.
Results
Consent for disclosure (CD) forms are completed at a stressful time, when patients often feel overwhelmed; these forms were considered a low priority. Perceptions of benefit (to individuals, to wider society) and harm (misuse of data, impact of disclosure on child) influenced consent. Important themes included: understanding of the forms; trust in those asking, in researchers, in the Human Fertilisation and Embryology Authority (HFEA); and wider attitudes to data use. Issues influencing response, and thus the representativeness of the HFEA data set, were highlighted.
Conclusions
Understanding what is being asked, and trust in those organisations keeping and using personal data, affects individual decisions to consent to disclosure. Patients were influenced by the wider context of infertility, as well as general concerns about data sharing and security. Low consent rates, which vary by clinic and likely also by patients’ characteristics, have adverse implications for research conducted using HFEA data collected after 2008. Public understanding of data use and security is relatively poor; increased public trust in, and awareness of, research based on routine data could improve consent to data use and reduce the risk of bias.
Consent and Autonomy in the Genomics Era
Consent and Autonomy in the Genomics Era
Rachel Horton, Anneke Lucassen
Current Genetic Medicine Reports, 2 May 2019; 7(2) pp 85–91
Abstract
Purpose of Review
Genomic tests offer increased opportunity for diagnosis, but their outputs are often uncertain and complex; results may need to be revised and/or may not be relevant until some future time. We discuss the challenges that this presents for consent and autonomy.
Recent Findings
Popular discourse around genomic testing tends to be strongly deterministic and optimistic, yet many findings from genomic tests are uncertain or unclear. Clinical conversations need to anticipate and potentially challenge unrealistic expectations of what a genomic test can deliver in order to enhance autonomy and ensure that consent to genomic testing is valid.
Summary
We conclude that ‘fully informed’ consent is often not possible in the context of genomic testing, but that an open-ended approach is appropriate. We consider that such broad consent can only work if located within systems or organisations that are trustworthy and that have measures in place to ensure that such open-ended agreements are not abused. We suggest that a relational concept of autonomy has benefits in encouraging focus on the networks and relationships that allow decision making to flourish.
Concise Consent Forms Appreciated—Still Not Comprehended: Applying Revised Common Rule Guidelines in Online Studies
Concise Consent Forms Appreciated—Still Not Comprehended: Applying Revised Common Rule Guidelines in Online Studies
Research Article
Evan K. Perrault, Seth P. McCullock
Journal of Empirical Research on Human Research Ethics, 6 June 2019
Abstract
As informed consent documents have historically gotten lengthier, recent revisions to federal Common Rule guidelines now require consent forms that are “concise” and presented in ways that “facilitate comprehension.” The current research sought to apply these guidelines by developing a consent process for an online study that was only 71 words and also allowed participants a choice to either continue directly to the study or learn more about the study to which they were consenting. All participants (100%, N = 429) decided to continue directly to the study, choosing to forgo additional information about the study and the institutional review board (IRB) approval process. Participants indicated they liked this streamlined consent process, even though on average they only comprehended about half of the information this streamlined process contained. A plurality of participants indicated they would like to see this style of streamlined consent continued in future online studies. However, if we want to continue referring to informed consent as informed, future research should be welcomed and supported by IRBs to seek ways to apply the newest Common Rule guidelines while increasing comprehension; otherwise, informed consent will likely always remain an oxymoron.
Hormone replacement therapy: informed consent without assessment?
Hormone replacement therapy: informed consent without assessment?
Response
Toni C Saad, Bruce Philip Blackshaw, Daniel Rodger
Journal of Medical Ethics, 22 June 2019
Abstract
Florence Ashley has argued that requiring patients with gender dysphoria to undergo an assessment and referral from a mental health professional before undergoing hormone replacement therapy (HRT) is unethical and may represent an unconscious hostility towards transgender people. We respond, first, by showing that Ashley has conflated the self-reporting of symptoms with self-diagnosis, and that this is not consistent with the standard model of informed consent to medical treatment. Second, we note that the model of informed consent involved in cosmetic surgery resembles the model Ashley defends, and that psychological assessment and referral is recognised as an important aspect of such a model. Third, we suggest that the increased prevalence of psychiatric morbidity in the transgender population arguably supports the requirement of assessment and referral from a mental health professional prior to undergoing HRT.
Editor’s note: This article is a response to the viewpoint article which can be found at this link
Complexity of Clinical Decision Making: Consent, Capacity, and Ethics
Complexity of Clinical Decision Making: Consent, Capacity, and Ethics
Review Article
Annette Askren, Paula Leslie
Seminars in Speech and Language, June 2019; 40(03) pp 162-169
Abstract
Speech–language pathologists (SLPs), and really their patients, are often faced with challenging clinical decisions to be made. Patients may decline interventions recommended by the SLP and are often inappropriately labeled “noncompliant.” The inappropriateness of this label extends beyond the negative charge; the patient’s right to refuse is, in fact, protected by law. Anecdotal exchanges, social media platforms, and American Speech-Language-Hearing Association forums have recently revealed that many SLPs are struggling with the patient’s right to decline. Many are not comfortable with the informed consent process and what entails patients’ capacity to make their own medical decisions. Here, we discuss the basics of clinical decision-making ethics with intent to minimize the clinician’s discomfort with the right to refuse those thickened liquids and eliminate the practice of defensive medicine.
Moving Beyond Informed Consent to Dynamic or Shared Consent: The Clinical and Legal Framework of a More Patient-Centred Approach [MA DISSERTATION]
Moving Beyond Informed Consent to Dynamic or Shared Consent: The Clinical and Legal Framework of a More Patient-Centred Approach [MA DISSIERTATION]
Thandi S Mabeba
University of Pretoria; Faculty of Law, 28 October 2018
Abstract
Obtaining the consent of a patient is at the centre of medical practice and as such medical practitioners need to ensure proper patient’s approval in the administration of medical services or prescription of medical products. Informing a patient about the medical implications involved in the procedure they are about to undergo is not sufficient as patient needs to be fully engaged. The transcendence beyond informed consent to shared or dynamic consent is the core focus of discussion in this work. It is argued in this work, that there has to be policy that deals with specifically with consent across a broader spectrum of the provision healthcare goods and services.
Consent in gastrointestinal endoscopy: valid, informed and nurse-led
Consent in gastrointestinal endoscopy: valid, informed and nurse-led
Christine Metcalf
Gastrointestinal Nursing, 19 Jun 2019; 17(5)
Abstract
Gastrointestinal endoscopy is generally safe, but these diagnostic and therapeutic interventions come with potential risks and thus require written, valid and informed consent, except in emergencies. Informed consent requires patients to receive and discuss information on the benefits, risks and nature of the procedure, as well as any alternatives. To consent, a patient must have the mental capacity to understand the information and use it to make and communicate a decision. Consent is a multi-stage procedure, beginning when endoscopy is first proposed and continuing into the intervention, as patients can withdraw consent during the procedure, whether sedated or not. For high-volume, low-risk procedures, the consent process can be safely delegated to qualified endoscopy nurses, with sufficient and relevant training, knowledge and support from the trust. Nurses competencies and other elements of the consent process should be regularly audited.
The Reading Level of Surgical Consent Forms in Hand Surgery
The Reading Level of Surgical Consent Forms in Hand Surgery
Original Research
Kevin Mertz, Matthew B. Burn, Sara L. Eppler, Robin N. Kamal
Journal of Hand Surgery Global Online, 19 June 2019
Abstract
Purpose
The average United States adult reads at an eighth-grade reading level. In an effort to ensure that patients understand written medical information, the National Institutes of Health and American Medical Association suggest that patient-directed material be written at a sixth- to eighth-grade reading level. We hypothesized that the mean reading level of surgical consent forms for hand surgery is not at or below an eighth-grade reading level (the suggested maximum from the National Institutes of Health).
Methods
We conducted a retrospective review of consecutive consent forms used for hand surgery patients from 7 hand surgeons at our institution from June, 2017 to October, 2017. Consent forms were reviewed to collect the hand-written portion describing the procedure. We also assessed our institution’s consent form template. This text was assessed for readability and reading level with the following tools: Flesch-Kincaid Grade Level and Flesch Reading Ease. We categorized the procedures written on each consent form by procedure type and then created simplified language for the same procedure below an eighth-grade reading level.
Results
Mean Flesch-Kincaid grade level of all consent forms was 10.5 (SD, 5.8) and mean Flesch readability was 33.6 (SD, 38.8), or difficult to read. A total of 78% and 58% of forms were written above the sixth- and eighth-grade reading levels, respectively. Readability was remarkedly poor; 94% and 88% of consent forms were written above sixth- and eighth-grade readability, respectively. The grade level of the consent form template was 17.1.
Conclusions
Most consent forms were written above a sixth- to eighth-grade reading level and may not have been well-understood by patients. It is possible for physicians to write on surgical consent forms at a reading level that patients are more likely to understand by opting for less specialty-specific words and writing in shorter sentences. Improving the readability of patient-directed materials is an approach to improving patient-centered care.
Center for Informed Consent Integrity 