Issues of Informed Consent from Persons with Dementia When Employing Assistive Technologies [BOOK CHAPTER]
Peter Novitzky, Cynthia Chen, Alan F. Smeaton, Renaat Verbruggen, Bert Gordijn
Intelligent Assistive Technologies for Dementia, 14 October 2019; Chapter 10
Excerpt
Informed consent is one of the cornerstones and requirements sine qua non of modern medical research and clinical practice. It developed relatively quickly to gain great importance, despite initial setbacks. The requirement of informed consent applies to all subjects of medical research and therapy, including persons with dementia (PwDs), whose impaired competence to provide valid informed consent poses particular challenges…

Differing Understandings of Informed Consent Held by Research Institutions, People with Intellectual Disability, and Guardians: Implications for Inclusive, Ethical Research [BOOK CHAPTER]
Britteny Howell, Karrie Shogren
Research Involving Participants with Cognitive Disability and Differences: Ethics, Autonomy, Inclusion, and Innovation, 5 September 2019; Chapter 3
Excerpt
Approximately 1–3% of the world’s population experiences an intellectual disability (ID)… Despite social and medical gains over the past several decades, people with ID are significantly more likely to experience poorer health and quality of life outcomes than people without… Research participation can play an important role in reducing such persistent disparities; however, people with ID remain under-represented in research for a variety of reasons, including the assumption that they are unable to provide informed consent for participation…

Using Ethnographic Methods to Determine Capacity to Consent amongst Individuals Diagnosed with Chronic Mental Illnesses [BOOK CHAPTER]
Saira A. Mehmood
Research Involving Participants with Cognitive Disability and Differences: Ethics, Autonomy, Inclusion, and Innovation, 5 September 2019; Chapter 14
Introduction
This chapter reports on an ethnographic research project conducted with people diagnosed with chronic mental illnesses and often economic and educational vulnerabilities as well. It focuses particularly on strategies for assessing capacity to consent…

Repurposing Ethnography to Assess Consent Capacity [BOOK CHAPTER]
Megan Wright
Research Involving Participants with Cognitive Disability and Differences: Ethics, Autonomy, Inclusion, and Innovation, 5 September 2019; Chapter 24
Introduction
Saira Mehmood illustrates how participant observation, an ethnographic method, can be applied to asses research consent capacity for persons with chronic mental illness who use mental health services at a non-profit organization. Through observation of and interaction with prospective participants and organization staff members, Mehmood was able to get a sense of a mental health service user’s decisional capacity and vulnerability. While this is a novel and beneficial approach to assessing consent capacity, questions remain about its application, appropriateness, and usefulness in other contexts.

Decisional capacity to consent to treatment and anaesthesia in patients over the age of 60 undergoing major orthopaedic surgery
Research Article 
Gabriele Mandarelli, Giovanna Parmigiani, Felice Carabellese, Silvia Codella, Paolo Roma, Domitilla Brancadoro, Andrea Ferretti, Lucio Alessandro, Giovanni Pinto, Stefano Ferracuti
Medicine Science and the Law, 1 August 2019 
Abstract
Despite growing attention to the ability of patients to provide informed consent to treatment in different medical settings, few studies have dealt with the issue of informed consent to major orthopaedic surgery in those over the age of 60. This population is at risk of impaired decision-making capacity (DMC) because older age is often associated with a decline in cognitive function, and they often present with anxiety and depressive symptoms, which could also affect their capacity to consent to treatment. Consent to major orthopaedic surgery requires the patient to understand, retain and reason about complex procedures. This study was undertaken to extend the literature on decisional capacity to consent to surgery and anaesthesia of patients over the age of 60 undergoing major orthopaedic surgery. Recruited patients (N=83) were evaluated using the Aid to Capacity Evaluation, the Beck Depression Inventory, the State–Trait Anxiety Inventory Y, the Mini-Mental State Examination and a visual analogue scale for measuring pain symptomatology. Impairment of medical DMC was common in the overall sample, with about 50% of the recruited patients showing a doubtful ability, or overt inability, to provide informed consent. Poor cognitive functioning was associated with reduced medical DMC, although no association was found between decisional capacity and depressive, anxiety and pain symptoms. These findings underline the need of an in-depth assessment of capacity in older patients undergoing major orthopaedic surgery.

The Patients Have a Story to Tell: Informed Consent for People who use Illicit Opiates in a Qualitative Research Project
Jane McCall, J. Craig Phillips, Andrew Estefan
Canadian Society of Addiction Medicine, November 2018
Open Access
Abstract
This paper discusses the ethical issues that arise when seeking informed consent from people who use illicit opiates. There is a significant discourse in the literature that opines that people who use illicit opiates are unable to provide informed consent due to withdrawal symptoms and cognitive impairment as a result of opioid use. This paper outlines the ethical issues that have been discussed in relation to this issue, reviews the findings of a study in which staff were asked their opinions about their patients’ ability to provide informed consent and discusses the issues that arise when patients are not allowed to consent to research.

Informed consent and ethical reporting of research in clinical trials recruiting participants with psychotic disorders
Guy M. Weissinger, Connie M. Ulrich
Contemporary Clinical Trials, 24 June 2019
Abstract
Informed consent is the foundation of modern biomedical research and it is vital for assuring the safety of vulnerable individuals, like those with psychotic disorders (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, etc.). All individuals who are involved in clinical research must have consented to participate or had surrogate consent from a representative. As individuals with psychotic disorders may not always have capacity to consent, assessment of capacity before research participation is vital but there is little research on how these assessments are conducted in clinical research. The authors conducted a systematic review of high-risk trials, defined as randomized medication or device trials that specifically recruited individuals with psychotic disorders, to understand the use of capacity to consent assessment and their reporting. A total of 646 articles, which mostly recruited participants with schizophrenia and were medication trials, were coded using a standardized questionnaire on consent practices and ethical reporting of research. Only 34 (5.3%) of the studies reported an assessment of capacity to provide informed consent and less than half of those used a standardized assessment. Sixty-four (9.9%) of the articles had capacity to provide informed consent in the study inclusion/exclusion criteria. Additionally, 66 (10.2%) of the articles did not have a statement about IRB approval and 134 (20.7%) had no statements about potential conflicts of interest. Though limitations to the review exist, it is clear that both in conducting high-risk research with individuals with psychotic disorders and when reporting research findings, there are ethical issues that must be addressed.

Lack of informed consent for surgical procedures by elderly patients with inability to consent: a retrospective chart review from an academic medical center in Norway
Research
Jorgen Dahlberg, Vegard Dahl, Reidun Forde, Reidar Pedersen
Patient Safety in Surgery, 22 June 2019; 13(24)
Abstract
Background
Respect for patient autonomy and the requirement of informed consent is an essential basic patient right. It is constituted through international conventions and implemented in health law in Norway and most other countries. Healthcare without informed consent is only allowed under specific exceptions, which requires a record in the patient charts. In this study, we investigated how surgeons recorded decisions in situations where the elderly patient’s ability to provide a valid informed consent was questionable or clearly missing.
Method
We investigated all medical records of patients admitted to surgical departments in a Norwegian large academic emergency hospital over a period of 38 days (approximately 5000 patients). We selected records of patients above the age of 70 (570 patients) and searched through these 570 medical records for any noted clear indications of inability to consent such as “do not understand”, “confused” etc. (102 patients). We read through all the medical records on these 102 patients noting any recordings on lack of informed consent, any recordings on reasoning and process hereto. We also took note whether there were clear indications on the use of coercion.
Results
None of the 102 included patients´ charts contained legally valid recorded assessments (for example related to the patients´ competence to consent) when patients without the ability to consent were admitted and provided healthcare. Some charts contained records that the patient resisted treatment, thus indicating treatment with coercion. In these situations, we did not find any documentation related to legal requirements that regulate the use of coercion.
Discussion and conclusion
We found a substantial lack of compliance with the legal requirements that apply when obtaining valid informed consent. There are many possible reasons for this: Lack of knowledge of the legal requirements, disagreement about the rules, or that it is simply not possible to comply with the extensive formal and material legal requirements in clinical practice. The results do not point out whether the appropriate measures are amending the law, educating and requiring more compliance from surgeons, or both.

Questions about informed consent related to the use of haptic suits as assistive technologies for people with intellectual and developmental disabilities
Fiachra O’Brolcháin, Aviva Cohen
International Journal of Applied Ethics, 31 May 2019; 30
Open Access
Abstract
Technological innovation is witnessing the convergence of haptic technologies with real-time 3D virtual environments and / or augmented reality technologies. Among the diverse applications of these innovations is their use as assistive technologies for people with intellectual and developmental disabilities, or people with cognitive deficits, such as dementia.

This article focuses on the issue of informed consent in relation to research and the use of these technologies (hereafter referred to simply as haptic suits). Informed consent is a standard requirement in the ethics of research, as well as in care settings, so it will be necessary for tests with haptic suits in general and, when used as assistive technology. Given the emphasis on the participation of people with intellectual or developmental disabilities in the research and design of assistive technologies for their use, the issue of informed consent is compelling.

Editor’s note: This is a Spanish language publication. In reviewing available definitions for haptic technologies we found the following: “the science of applying touch sensation and control to interact with computer developed applications”.