Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia
Emily A. Largent, Spencer Phillips Hey, Kristin Harkins, Allison K. Hoffman, Steven Joffe, Julie C. Lima, Alex John London, Jason Karlawish
Journal of the American Geriatrics Society, 26 June 2020
Abstract
Embedded pragmatic clinical trials (ePCTs) present an opportunity to improve care for people living with dementia (PLWD) and their care partners, but they also generate a complex constellation of ethical and regulatory challenges. These challenges begin with participant identification. Interventions may be delivered in ways that make it difficult to identify who is a human subject and therefore who needs ethical and regulatory protections. The need for informed consent, a core human subjects protection, must be considered but can be in tension with the goals of pragmatic research design. Thus it is essential to consider whether a waiver or alteration of informed consent is justifiable. If informed consent is needed, the question arises of how it should be obtained because researchers must acknowledge the vulnerability of PLWD due in part to diminished capacity and also to increased dependence on others. Further, researchers should recognize that many sites where ePCTs are conducted will be unfamiliar with human subjects research regulations and ethics. In this report, the Regulation and Ethics Core of the National Institute on Aging Imbedded Pragmatic Alzheimer’s disease (AD) and AD‐related dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory discusses key ethical and regulatory challenges for ePCTs in PLWD. A central thesis is that researchers should strive to anticipate and address these challenges early in the design of their ePCTs as a means of both ensuring compliance and advancing science.

Capacity, consent and compulsion [BOOK CHAPTER]
Margaret Brazier, Emma Cave
Medicine, patients and the law (sixth edition)
Manchester University Press, 29 May 2020; Chapter 6
Abstract/Excerpt
Capacity, Consent and Compulsion examines the Mental Capacity Act 2005 ten years on. This visionary piece of legislation has led to a substantial body of case law. Its rejection of a pure substituted judgement test in favour of a modified best interests test and its adoption of a two part test for (in)capacity have excited much academic debate. In 2007 the Act was amended to introduce new Deprivation of Liberty Safeguards (DoLS). The DoLS have been widely criticised. We consider measures to support those lacking capacity such as advance directives, lasting powers of attorney and court-appointed deputies. Central to the Act is the Court of Protection which adjudicates on disputes in both health care and welfare matters.

Informed Consent in Patients With Frailty Syndrome
Brendan Silbert, David Scott
Anesthesia & Analgesia, June 2020; 130(6) pp 1474–1481
Abstract
Frailty is present in more than 30% of individuals older than 65 years of age presenting for anesthesia and surgery, and poses a number of unique issues in the informed consent process. Much attention has been directed at the increased incidence of poor outcomes in these individuals, including postoperative mortality, complications, and prolonged length of stay. These material risks are not generally factored into conventional risk predictors, so it is likely that individuals with frailty are never fully informed of the true risk for procedures undertaken in the hospital setting. While the term “frailty” has the advantage of alerting to risk and allowing appropriate care and interventions, the term has the social disadvantage of encouraging objectivity to ageism. This may encourage paternalistic behavior from carers and family encroaching on self-determination and, in extreme cases, manifesting as coercion and compromising autonomy. There is a high prevalence of neurocognitive disorder in frail elderly patients, and care must be taken to identify those without capacity to provide informed consent; equally important is to not exclude those with capacity from providing consent. Obtaining consent for research adds an extra onus to that of clinical consent. The informed consent process in the frail elderly poses unique challenges to the busy clinical anesthesiologist. At the very least, an increased time commitment should be recognized. The gap between theoretical goals and actual practice of informed consent should be acknowledged.

Approaches for assessing decision-making capacity in older adults a scoping review protocol
Systematic Review Protocols
Ruth Usher, Tadhg Stapleton
JBI Evidence Synthesis, April 2020; 18(4) pp 832-840
Open Access
Abstract
Objective
This review will identify and map existing evidence on current approaches to determining decision-making capacity in older adults. It will provide a summary of available evidence and policies and identify gaps in research.
Introduction
Assessment of decision-making capacity is emerging as an important issue in society and healthcare. It is considered an ethically challenging area of clinical practice, and issues with implementation have been identified internationally. With the aging population increasing globally, approaches to assess and support decision-making are becoming more pertinent.
Inclusion criteria
This scoping review will consider studies on assessment approaches and procedures that are used to evaluate the decision-making capacity of older adults, aged 60 years and over. It will include those with age-related cognitive impairment, dementia, and neurodegenerative conditions. Quantitative, qualitative, and mixed-methods studies along with gray literature, including expert opinions, policies reports, and practice guides, will be included.
Methods
The JBI scoping review methodological framework will be used. The review will also be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist for scoping reviews. The following major healthcare databases will be searched: MEDLINE, PsycINFO, Embase, CINAHL, Cochrane Databases, Web of Science, and Scopus. The search will cover studies published in English from January 2000 to the present date. Titles and abstracts will be screened against inclusion criteria. Data will be extracted using a form developed for this review. A stakeholder consultation meeting will be held to provide feedback on the findings.

Ageism in Consent? In a decision-making capable geriatric orthopaedic trauma patient population, does increased age impact who physicians consent for surgical fixation?
Madeline M McGovern, Michael F McTague, Marilyn Heng
Jefferson Digital Commons, January 2020
Open Access
Abstract
Introduction
Persistent misconceptions of frailty and dementia in geriatric patients impact physician-patient communication and leave patients vulnerable to disempowerment. Our study examines the consenting process in an orthogeriatric trauma patient population to determine if there is a relationship between increased age at presentation and utilization of health care proxies (HCPs) for surgical procedure consent.
Methods
We retrospectively reviewed medical records of patients aged 65 and older admitted for an operative fracture between 2013 and 2016. Patients were considered decision-making capable if there was absence of history of cognitive impairment prior to surgical consent and if the patients screened negative in a pre-surgical Confusion Assessment Method (CAM) and Mini-Cog Assessment. Data was analyzed via chi-squared and t-test analysis in SPSS.
Results
510 patients were included, and 276 (54.1%) patients were deemed capable of consent. 27 (9.8%) decision-making capable patients had HCPs consent for surgery. 20 of the 27 (74.1%) were 80 years of age or older and 7 patients between 70 and 79 had HCP consent. (p=0.07). HCP consent was significant for age (p<0.001), income level (p=0.03), and HCP physically present at consult (p<0.001). Additionally, language other than English was found to be a significant predictor of HCP consent (p=0.035).
Conclusion
It is concerning that cognitively intact geriatric orthopaedic trauma patients are not always consented for their own surgical procedures. Factors including age, income, and language contribute to increased risk of HCP consent. Increased physician vigilance and adoption of institutional consenting guidelines can reinforce appropriate respect of geriatric patients’ consenting capacity.

Editor’s note: The Jefferson Digital Commons is a service of Thomas Jefferson University’s Center for Teaching and Learning (CTL). The Commons is a showcase for Jefferson books and journals, peer-reviewed scholarly publications, unique historical collections from the University archives, and teaching tools.

Capacity to Consent to Research Participation in Adults with Metastatic Cancer: Comparisons of Brain Metastasis, Non-CNS Metastasis, and Healthy Controls
Kyler Mulhauser, Dario A Marotta, Adam Gerstenecker, Gabrielle Wilhelm, Terina Myers, Meredith Gammon, David E Vance, Burt Nabors, John Fiveash, Kristen Triebel
Neuro-Oncology Practice, 9 March 2020
Abstract
Background
To evaluate the ability of persons with metastatic cancer to provide informed consent to research participation, we used a structured vignette-based interview to measure four consenting standards across three participant groups.
Methods
Participants included 61 persons diagnosed with brain metastasis, 41 persons diagnosed with non-CNS metastasis, and 17 cognitively intact healthy controls. All groups were evaluated using the Capacity to Consent to Research Instrument (CCRI), a performance-based measure of research consent capacity. The ability to provide informed consent to participate in research was evaluated across four consent standards: expressing choice, appreciation, reasoning, and understanding. Capacity performance ratings (intact, mild/moderate impairment, severe impairment) were identified based on control group performance.
Results
Results revealed that the brain metastasis group performed significantly lower than healthy controls on the consent standard of understanding, while both metastatic cancer groups performed below controls on the consent standard of reasoning. Both metastatic cancer groups performed similar to controls on the standards of appreciation and expressing choice. Approximately 60% of the brain metastasis group, 54% of the non-CNS metastasis group, and 18% of healthy controls showed impaired research consent capacity.
Conclusions
Our findings, using a performance-based assessment, are consistent with other research indicating that the research consent process may be overly cumbersome and confusing. This, in turn, may lead to research consent impairment not only in patient groups but also in some healthy adults with intact cognitive ability.

The Patients Have a Story to Tell: Informed Consent for People who use Illicit Opiates
Research Article
Jane McCall, J Craig Phillips, Andrew Estafan, Vera Caine
Nursing Ethics, 26 February 2020
Abstract
Background
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 opiate use.
Aims
This paper discusses the issues related to informed consent for this population.
Ethical considerations
Ethical approval was obtained from both the local REB and the university. Written informed consent was obtained from all participants.
Method
This was a qualitative interpretive descriptive study. 22 participants were interviewed, including 18 nurses, 2 social workers and 2 clinic support workers. The findings were analyzed using thematic analysis, which is a way of systematically reducing the complexity of the information to arrive at generalized explanations.
Results
The staff at the clinic were overwhelming clear in their judgment that people who use opiates can and should be able to participate in research and that their drug use is not a barrier to informed consent.
Conclusions
It is important to involve people who use opiates in research. Protectionist concerns about this population may be overstated. Such concerns do not promote the interests of research participants. People who use heroin need to be able to tell their story.

Eliciting consent from patients with dementia in general X-ray departments: Law, ethics and interpretation of context [CONFERENCE PAPER]
Katie Kelly, Lisa Booth, Paul K. Miller
United Kingdom Imaging and Oncology Congress 2020: Pathways and Communication, 1-3 June 2020; ACC, Liverpool
Open Access
Abstract
Background
While the numbers of individuals suffering from dementia syndromes in the UK steadily increase, many practitioners in the allied healthcare professions, and particularly junior staff, still feel ill-equipped for face-to-face communicative encounters with such individuals (Miller et al., 2019; Tullo et al., 2016). An elemental feature of effective communication in healthcare contexts is the seeking of proper consent to perform given procedures. The propositions above, however, raise questions regarding how ‘properly’ consent is being acquired when dementia is at stake. This paper, thus, reports findings from a qualitative study of general radiographers’ experiences of acquiring consent from patients with dementia, specifically exploring participants’ interpretations of correct legal and ethical practice therein.
Methods
With institutional ethical approval, N=6 general radiographers with less than ten years of clinical experience were recruited to sit for extended interviews. Verbatim transcripts were analysed using the domain-established techniques of Interpretative Phenomenological Analysis (Miller et al., 2017).
Results
Four key areas of extremely variable interpretation and practice were identified. (1) How to assess capacity for informed consent; (2) How to effectively modify communication when gaining consent; (3) Managing carer involvement during consent-acquisition and; (4) Constituting the ‘best interest’ of the patient.
Conclusion
Participants’ own accounts often indicated that they were often not lawfully implementing the Mental Capacity Act (MCA) when acquiring consent. Moreover, as previously identified by Miller et al. (2019), the situational confusion did little for participants’ confidence, with prospectively damaging import for future encounters. Stronger training in practical application of the MCA is recommended.

Consent conundrums: patient consent in neuroscience nursing
John Finch
British Journal of Neuroscience Nursing, 25 February 2020; 16(1)
Abstract
In BJNN 15(4) and BJNN 15(5), John Finch looked in detail at the role of the Mental Capacity Act 2005 and its accompanying Code in the practice of neuroscience nurses. He concluded, as have others, that the guidance offered by the Act and the Code falls short of what neuroscience nurses need in their practice. In this article, he turns his attention to the treatment of patients who can and do consent to proposed treatment. The law relating to such patients in this matter offers neither an act nor a code. The law is to be found in court decisions. It might, at first sight, appear that a practice situation in which a patient with undoubted mental capacity or, at least, sufficient mental capacity to understand and accept what is proposed, presents no legal problem. But a closer examination of mental processes encountered in patients who may be in pain, distress and pressing need reveals that communication between the treater and the treated may be subtle and complex, and that the meeting of minds required in law to ensure that a patient has genuinely agreed to a detailed proposal is anything but simple.

‘Delusional’ consent in somatic treatment: the emblematic case of electroconvulsive therapy
Original Research
Giuseppe Bersani, Francesca Pacitti, Angela Iannitelli
Journal of Medical Ethics, 13 February 2020
Abstract
Even more than for other treatments, great importance must be given to informed consent in the case of electroconvulsive therapy (ECT). In a percentage of cases, the symbolic connotation of the treatment, even if mostly and intrinsically negative, may actually be a determining factor in the patient’s motives for giving consent. On an ethical and medicolegal level, the most critical point is that concerning consent to the treatment by a psychotic subject with a severely compromised ability to comprehend the nature and objective of the proposed therapy, but who nonetheless expresses his consent, for reasons derived from delusional thoughts. In fact, this situation necessarily brings to light the contradiction between an explicit expression of consent, a necessary formality for the commencement of therapy, and the validity of this consent, which may be severely compromised due to the patient’s inability to comprehend reality and therefore to accept the proposal of treatment, which is intrinsic to this reality. With the use of an electric current, the symbolic experience associated with anaesthesia, and the connection to convulsions, ECT enters the collective consciousness. In relation to this, ECT is symbolic of these three factors and hooks on to the thoughts, fears, feelings and expectations of delusional patients. These are often exemplified in the violent intervention of the persecutor in the patient with schizophrenia, the expected punishment for the ’error’ committed for which the depressed patient blames himself and the social repression of the maniacal patient’s affirmation of his inflated self-esteem.