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.

Who Has the Ability to Consent?
La Vonne Ann Downey, Les Zun
Primary Care Companion for Central Nervous System Disorders, 20 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.

The capacity to consent to treatment in amyotrophic lateral sclerosis: a preliminary report
Original Communication
Rossella Spataro, Vincenzo La Bella
Journal of Neurology, 6 August 2020
Abstract
Background
Facing the relentless worsening of their condition, ALS patients are required to make decisions on treatments and end-of-life care. A cognitive impairment showed to be a negative prognostic factor in ALS patients, perhaps affecting the ability to make informed decisions. Notwithstanding its crucial role, the capacity to consent to treatment (CCT) has never been evaluated in these patients.
Objectives
To assess the CCT in an ALS cohort in comparison to a control group, and to study the effects of demographic and clinical variables on this high-level cognitive function.
Methods
102 ALS patients and 106 healthy controls (HC) were enrolled. CCT was assessed using the MacArthur Competence Assessment Tool for Treatment (MAC-CAT-T) and the performance was classified into the three CCT outcomes (full credit, partial credit, no credit). Cognitive and psychological variables were assessed by MMSE, phonemic fluencies, Frontal System Behavioural Scale (FrSBe), and ALS Depression Inventory (ADI). Clinical and demographic variables were analyzed as possible predictors of the MAC-CAT-T outcomes. After a 1-year follow-up, CCT and neuropsychological assessments were repeated.
Results
Most ALS patients (i.e., from 75 to 83% according to the different sub-items) retain full CCT. However, a subpopulation of the ALS patients showed a reduced CCT with respect to the HC. Age, education, phonemic fluency, and depression appeared related to the CCT outcomes. After 1 year, only the reasoning items worsened.
Conclusions
This is a preliminary report suggesting that the large majority of ALS patients can retain full ability to choose between treatment options. However, demographic and neuropsychological variables may affect CCT, pointing to the need for special attention to the consent disclosure in this disease.

Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review
Victoria Shepherd
Contemporary Clinical Trials, August 2020; 95
Abstract
Informed consent is an essential requirement prior to clinical trial participation, however some ‘vulnerable’ groups, such as people with cognitive impairments and those in medical emergency situations, may lack decisional capacity to consent. This raises ethical and practical challenges when designing and conducting clinical trials involving these populations, who are frequently excluded as a result. Despite recent advances in improving informed consent processes, there has been far less attention paid to the enrolment of adults lacking capacity.

Exclusion criteria are an important determinant of the external validity of clinical trial results. The exclusion of these populations, and consent-based recruitment biases which arise from the challenges of identifying and involving surrogate decision-makers, leads to trials which are not representative of the clinical population.

This article discusses the involvement of adults who lack decisional capacity to consent in clinical trials and presents the advances over the previous decade and the remaining ethical challenges for the inclusion of this under-represented population in research.

Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)
Research Article
J. Evans, E. Yorganci, P. Lewis, J. Koffman, K. Stone, I. Tunnard, B. Wee, W. Bernal, M. Hotopf, I. J. Higginson, Deborah Tanner, Claire Henry, Gunn Grande, Steve Dewar, Gareth Owen, Rachel Burman, Dimitrios Adamis, Michael Dunn, Scott Kim, Simon Woods & Rowena Vohora
BMC Medicine, 22 July 2020; 18(221)
Open Access
Abstract
Background
Involving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum.
Methods
Methods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert ‘think-tank’ to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.
Results
Of the 5539 articles identified, 91 met eligibility. The studies encompassed people with dementia (27%) and in palliative care (18%). Seventy-five percent used observational designs. Studies on research methods (37 studies) focused on processes of proxy decision-making, advance consent, and deferred consent. Studies implementing research methods (30 studies) demonstrated the role of family members as both proxy decision-makers and supporting decision-making for the person with impaired capacity. The TEC involved 43 participants who generated 29 recommendations, with consensus that indicated. Key areas were the timeliness of the consent process and maximising an individual’s decisional capacity. The think-tank (n = 19) refined equivocal recommendations including supporting proxy decision-makers, training practitioners, and incorporating legislative frameworks.
Conclusions
The MORECare_C statement details 20 solutions to recruit ALC nearing the EoL in research. The statement provides much needed guidance to enroll individuals with serious illness in research. Key is involving family members early and designing study procedures to accommodate variable and changeable levels of capacity. The statement demonstrates the ethical imperative and processes of recruiting adults across the capacity spectrum in varying populations and settings.