How do dementia researchers view support tools for informed consent procedures of persons with dementia?
Original Contributions
Theresa S. Wied, Aoife Poth, Johannes Pantel, Frank Oswald, Julia Haberstroh
Zeitschrift für Gerontologie und Geriatrie, 19 September 2020
Open Access
Abstract
The study aimed to assess how dementia researchers view eight support tools that have been defined to enhance informed consent (IC) procedures for people with dementia (PwD). In an online survey, 19 dementia researchers from Germany and Portugal evaluated the tools in terms of 4 implementation criteria. Overall, they all had a very positive attitude towards the support tools, whereby the tools person-centered attitude of the researcher and elaborated plain language were the most highly rated of the eight tools. Our findings also indicated that familiar support tools were assessed more favorably than those that were previously unknown. Overall, the results of this study showed that the participating dementia researchers were open to the use of decision support measures in PwD and were willing to apply the support tools in practice.

Awareness and Understanding of Decision-Making Capacity and Its Relationship to Legally Valid Consent for Older Patients in Dentistry
Research Article
Amardeep Singh Dhadwal, Lwazi Sibanda, Igor R. Blum
Primary Dental Journal, 17 September 2020
Abstract
With a growing ageing population and increased life expectancy in the UK, oral healthcare professionals will be exposed to a greater number of patients with health conditions which may affect cognitive function, communication and capacity to consent to treatment. This often gives rise to a conundrum which clinicians may face when considering capacity, consent and the legal implications and frameworks surrounding this. Assessing patient capacity is encountered routinely in dental practice and so oral healthcare professionals should be well informed of their responsibilities in this context. This article summarises and introduces readers to key concepts regarding consent and capacity with reference to relevant cross-jurisdictional legislation.

Constructing authentic decisions: proxy decision-making for research involving adults who lack capacity to consent
Victoria Shepherd, Mark Sheehan, Kerenza Hood, Richard Griffith, Fiona Wood
BMJ Medical Ethics, 2 September 2020
Open Access
Abstract
Research involving adults who lack capacity to consent relies on proxy (or surrogate) decision-making. Proxy decisions about participation are ethically complex, with a disparity between normative accounts and empirical evidence. Concerns about the accuracy of proxies’ decisions arise, in part, from the lack of an ethical framework which takes account of the complex and morally pluralistic world in which proxy decisions are situated. This qualitative study explored the experiences of family members who have acted as a research proxy in order to develop an understanding of the ethical concepts involved, and the interactions between those concepts. Proxies described a complex process of respecting the wishes and preferences of the person they represented, whist integrating preferences with what they viewed as being in the interests of the person. They aimed to make a decision that was ‘best’ for the person and protected them from harm; they also aimed to make the ‘right’ decision, viewed as being authentic to the person’s values and life. Decisions were underpinned by the relationship between the person and their proxy, in which both trust and trustworthiness were key. Proxies’ decisions, based both on respect for the person and the need to protect their interests, arose out of their dual role as both proxy and carer. The findings raise questions about accounts which rely on existing normative assumptions with a focus on accuracy and discrepancy, and which fail to take account of the requirement for proxies to make authentic decisions that arise out of their caring obligations.

POLST Signature Requirements: Responding With Compassion While Ensuring Informed Consent
Research Article
Robert Macauley, Susan Tolle
American Journal of Hospice and Palliative Medicine, 1 September 2020
Open Access
Abstract
The majority of states require the signature of a surrogate decision maker on a POLST form for a patient who lacks decisional capacity. While commendable in its intention to ensure informed consent, in some cases this may lead the surrogate to feel that they are signing their loved one’s “death warrant,” adding to their emotional and spiritual distress. In this paper we argue that such a signature should be recommended rather than required, as it is neither a sufficient nor necessary condition of informed consent. Additional steps—such as requiring the attestation and documentation of the signing health care professional that verbal consent was fully informed and voluntary—can achieve the ultimate goal of respecting patient autonomy without adding to the surrogate’s burden.

Who Has the Ability to Consent?
Downey VA, Zun L
The Primary Care Companion for CNS Disorders, 19 August 2020; 22(4)
Abstract
Objective
Previous studies have shown no consistent examinations for testing the ability of patients to consent in hospital emergency departments (EDs). The primary objective of this study was to compare providers’ opinions with 3 capacity assessment tools to determine the ability of medical and psychiatric patients to consent in the ED.
Method
The study was conducted at a level 1 inner-city general hospital ED from June 2016 to October 2017. The study participants comprised a random sample of English-speaking patients aged ≥ 18 years who presented with any medical or psychiatric complaint. Each patient was administered 3 tools: the standard ED consent form, the Aid to Capacity Evaluation (ACE), and the Mini-Mental State Examination. The results of these assessments were then compared to the provider’s opinion of the patient’s ability to provide consent.
Results
A total of 283 patients participated in the study, and 84.4% were able to consent according to providers. There was a high level of consistency with the provider’s assessment and the other assessment tools on the patient’s ability to consent. Most patients, both medical and psychiatric, showed the ability to consent. However, this was less true for psychiatric patients with schizophrenia, as 32.6% (n = 14) were unable to consent.
Conclusions
The study revealed that the ACE capacity assessment was highly consistent with the providers’ assessment for medical (88.3%) and psychiatric patients (80.3%), but not for psychiatric patients with schizophrenia. Using the ACE, patients with schizophrenia presenting to the ED were significantly less able to understand their illnesses (0.01) and treatments (0.04) and thus were less able to give consent.

Investigating assumptions of vulnerability: A case study of the exclusion of psychiatric inpatients as participants in genetic research in low‐ and middle‐income contexts
Andrea C. Palk, Mary Bitta, Eunice Kamaara, Dan J. Stein, Ilina Singh
Bioethics, 14 January 2020
Abstract
Psychiatric genetic research investigates the genetic basis of psychiatric disorders with the aim of more effectively understanding, treating, or, ultimately, preventing such disorders. Given the challenges of recruiting research participants into such studies, the potential for long‐term benefits of such research, and seemingly minimal risk, a strong claim could be made that all non‐acute psychiatric inpatients, including forensic and involuntary patients, should be included in such research, provided they have capacity to consent. There are tensions, however, regarding the ethics of recruiting psychiatric inpatients into such studies. In this paper our intention is to elucidate the source of these tensions from the perspective of research ethics committee interests and decision‐making. We begin by defining inpatient status and outline some of the assumptions surrounding the structures of inpatient care. We then introduce contemporary conceptions of vulnerability, including Florencia Luna’s account of vulnerability which we use as a framework for our analysis. While psychiatric inpatients could be subject to consent‐related vulnerabilities, we suggest that a particular kind of exploitation‐related vulnerability comes to the fore in the context of our case study. Moreover, a subset of these ethical concerns takes on particular weight in the context of genetic research in low‐ and middle‐income countries. At the same time, the automatic exclusion of inpatients from research elicits justice‐related vulnerabilities.

Prevalence of the Inability to Give Informed Consent in the Elderly Orthopaedic Trauma Population [DISSERTATION]
David G. Clossey
Harvard Medical School Doctoral Dissertation, 2020
Abstract
Purpose
Despite the fact that fractures are a leading cause of morbidity in the elderly, a study of the prevalence of the inability to give informed consent in the elderly orthopaedic trauma population has, to the best of our knowledge, not been performed. In addition, the condition of mild cognitive impairment (MCI) has become increasingly recognized since the introduction of the Montreal Cognitive Assessment (MoCA). By simultaneously determining capacity for consent (by clinician gestalt – the gold standard) and degree of cognitive impairment (by utilizing the MoCA), we hope to better understand the relationship between the ability to consent and MCI as well as the specific components of cognition that may allow for decision-making capacity (DMC).
Methods
This prospective study was carried out at Brigham and Women’s Hospital (BWH). English and Spanish speaking patients older than 65 who were admitted for orthopaedic injury requiring surgical management were included in the study. Those who had previously known dementia and delirium were excluded from the study, as well as those who were unable to communicate. (NB: A recent IRB amendment has now allowed us going forward to approach certain patients with known dementia and delirium). Attending physicians determined whether or not a patient had DMC. Independently, a research staff member administered the confusion assessment method (CAM) short form to screen for delirium and the MoCA to screen for cognitive impairment. Various other background data were obtained retrospectively.
Results
While the prevalence of the inability to give informed consent cannot be determined since the project is still actively recruiting patients, we hypothesize that this prevalence is at least 15.6%. While patients with DMC had various demographic data characteristic of the elderly orthopaedic trauma population, 81.8% had an abnormal total MoCA score. Participants generally scored worse on tasks assessing for certain cognitive domains, such as visuospatial/executive function tasks (mean score: 46.7%) and the delayed recall task (mean score: 40%). The vast majority of participants (90.5%) who struggled with the delayed recall task were, however, able to remember additional words with category and/or multiple choice clues. None of the participants had a positive screen for delirium.
Conclusions
Mild cognitive impairment at the time of consent appears not to preclude a patient from having DMC. Although the relationship between cognitive ability and DMC remains not well understood, further conclusions regarding early cases of dementia should be studied going forward. Deficits in certain domains of cognitive thinking may be correlated with an inability to give informed consent, although a comparison of testing results between patients with versus without DMC will be required to further understand this idea.