Ongoing Consent in Situations of Cognitive Vulnerability

2019 ◽  
pp. 3-14 ◽  
Author(s):  
Lauren R. Sankary ◽  
Paul J. Ford
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Ethical Issues ◽  
Cognitive Vulnerability ◽  
Research Participation ◽  
Proxy Consent ◽  
Decision Making Capacity ◽  
Research Oversight ◽  
Vulnerable Patient ◽  
Study Participants

This chapter explores ethical issues in obtaining ongoing consent for clinical research involving cognitively vulnerable patient populations. Stakeholders in these challenges include researchers, sponsors, study participants, caregivers and other legally authorized representatives, and research oversight boards. First, this chapter examines existing conceptual frameworks and proposed safeguards for the protection of cognitively vulnerable research participants, including double consent, proxy consent with participant assent, advance consent, and process consent. This chapter then proposes an inclusionary approach to obtaining ongoing consent to research participation when cognition could fluctuate over the course of research participation. Proposed safeguards and modifications to the consent process should address duration of research participation, the nature and timing of research-related risks, expected and unexpected fluctuations in decision-making capacity, and the process of exiting a clinical trial. The proposed framework is then applied to the specific context of implanted neural device trials, with special attention to considerations for device explant.

Ethical issues in palliative care research

2021 ◽  
pp. 1312-1317
Author(s):  
Tyler Tate ◽  
David Casarett
Keyword(s):  
Decision Making ◽  
Palliative Care ◽  
End Of Life ◽  
Ethical Issues ◽  
Research Participation ◽  
Ethical Aspects ◽  
Care Research ◽  
Qualitative And Quantitative ◽  
Decision Making Capacity ◽  
Potential Benefits

Recent growth in palliative care research has created a heterogeneous field that encompasses both qualitative and quantitative techniques, and descriptive as well as interventional studies. Despite the valuable knowledge that has been produced by this research, and the promise of future important advances, its progress has been impeded by a persistent uncertainty about the ethics of these studies. For instance, there have been concerns raised about whether patients near the end of life should ever be asked to participate in research, although others have objected to this extreme position. Nevertheless, the combination of ethical and practical issues can create substantial barriers to palliative care research. This chapter discusses five ethical aspects of palliative care research that investigators and clinicians should consider in designing and conducting palliative care research. These include (1) the study’s potential benefits to future patients, (2) the study’s potential benefits to subjects, (3) the study’s risks to subjects, (4) subjects’ decision-making capacity, and (5) the voluntariness of subjects’ choices about research participation.

scholarly journals Older Persons’ and Their Caregivers’ Perspectives and Experiences of Research Participation With Impaired Decision-Making Capacity: A Scoping Review

2020 ◽  
Author(s):  
Annmarie Hosie ◽  
Slavica Kochovska ◽  
Nola Ries ◽  
Imelda Gilmore ◽  
Deborah Parker ◽  
...  
Keyword(s):  
Decision Making ◽  
Cognitive Impairment ◽  
Scoping Review ◽  
Older Persons ◽  
English Language ◽  
Research Participation ◽  
Proxy Consent ◽  
Willingness To Participate ◽  
Decision Making Capacity ◽  
Scoping Reviews

Abstract Background and Objectives Human research ethics statements support equitable inclusion of diverse groups. Yet older people are under-represented in clinical research, especially those with impaired decision-making capacity. The aim of this study was to identify perspectives and experiences of older persons and their caregivers of research participation with impaired decision-making capacity. Research Design and Methods Scoping review of literature and online sources in January-February 2019 (updated June 2020) according to Joanna Briggs Institute methodology and PRISMA Extension for Scoping Reviews. English-language peer-reviewed research articles and Australian online narratives were included. Data were tabulated and narratively synthesized. Results From 4171 database records and 93 online resources, 22 articles (2000-2019, 82% United States, 16 first authors) and one YouTube webinar (2018) were initially included; updated searches yielded an additional article (2020) and YouTube webinar (2020). Studies were heterogeneous in terminology, methods and foci, with hypothetical scenarios, quantitative analyses and examination of proxy consent predominating. Participants (n=7331) were older persons (71%), caregivers of older persons with dementia/cognitive impairment (23%) and older persons with dementia/cognitive impairment (6%). Synthesis identified two themes: willingness to participate and decision-making approaches. Discussion and Implications Research participation by older persons with dementia may be optimized through reducing risks and burdens and increasing benefits for participants, greater consumer input into study development, and shared and supported decision-making. Older persons’ and caregivers’ perspectives and experiences of research participation with impaired decision-making capacity require investigation in a greater range of countries and conditions other than dementia, and dissemination through more varied media.

Commentary 1: Research with Persons Under Involuntary Commitment—Ethical Issues Surrounding Competence and Voluntariness

2019 ◽  
Vol 14 (5) ◽  
pp. 475-478
Author(s):  
Matthé Scholten ◽  
Jochen Vollmann
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Research Participation ◽  
Research Participant ◽  
Involuntary Commitment ◽  
Proxy Consent ◽  
Undue Influence ◽  
Research Participants ◽  
Manic Symptoms ◽  
Prospective Research

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants’ decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial

2005 ◽  
Vol 80 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Scott Stroup ◽  
Paul Appelbaum ◽  
Marvin Swartz ◽  
Mukesh Patel ◽  
Sonia Davis ◽  
...  
Keyword(s):  
Decision Making ◽  
Research Participation ◽  
Decision Making Capacity

scholarly journals INFORMED CONSENT IN CLINICAL TRIALS FOR PERSONS WITH DEMENTIA

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S28-S28 ◽  
Author(s):  
Joan G Carpenter
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Nursing Homes ◽  
Decision Maker ◽  
Surrogate Decision Maker ◽  
Decision Making Capacity ◽  
Consent Document ◽  
Surrogate Decision

Abstract Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were required by the IRB; (3) the required legal wording was difficult to understand and deterred potential participants; and (4) the primary mode of communication was via phone. We tailored assent and informed consent procedures to persons with dementia and their legally authorized representative/surrogate decision maker to avoid risking an incomplete trial and to improve generalizability of trial results to all persons with dementia.

Ethical issues in palliative care research

2015 ◽  
Author(s):  
David Casarett
Keyword(s):  
Palliative Care ◽  
Ethical Issues ◽  
Research Participation ◽  
Ethical Aspects ◽  
Interventional Study ◽  
Care Research ◽  
Qualitative And Quantitative ◽  
Decision Making Capacity ◽  
Potential Benefits ◽  
Study Designs

Recent growth in palliative care research has created a heterogeneous field that encompasses both qualitative and quantitative techniques, and descriptive as well as interventional study designs. Despite the valuable knowledge that has been produced by this research, and the promise of future important advances, its progress has been impeded by a persistent uncertainty about the ethics of these studies. For instance, there have been concerns raised about whether patients near the end of life should ever be asked to participate in research, although others have objected to this extreme position. Nevertheless, the combination of ethical and practical issues can create substantial barriers to palliative care research. This chapter discusses five ethical aspects of palliative care research that investigators and clinicians should consider in designing and conducting palliative care research. These include (1) the study’s potential benefits to future patients, (2) the study’s potential benefits to subjects, (3) the study’s risks to subjects, (4) subjects’ decision-making capacity, and (5) the voluntariness of subjects’ choices about research participation.

scholarly journals Diversity or disarray? A systematic review of decision-making capacity for treatment and research in schizophrenia and other non-affective psychoses

2017 ◽  
Vol 47 (11) ◽  
pp. 1906-1922 ◽  
Author(s):  
B. W. J. Spencer ◽  
G. Shields ◽  
T. Gergel ◽  
M. Hotopf ◽  
G. S. Owen
Keyword(s):  
Systematic Review ◽  
Decision Making ◽  
Wide Spectrum ◽  
Meta Analysis ◽  
Research Participation ◽  
Demographic Factors ◽  
Neurocognitive Deficits ◽  
Ovid Medline ◽  
Decision Making Capacity ◽  
Socio Demographic Factors

BackgroundValid consent for treatment or research participation requires that an individual has decision-making capacity (DMC), which is the ability to make a specific decision. There is evidence that the psychopathology of schizophrenia can compromise DMC. The objective of this review was to examine the presence or absence of DMC in schizophrenia and the socio-demographic/psychopathological factors associated.MethodsWe searched three databases Embase, Ovid MEDLINE(R), and PsycINFO for studies reporting data on the proportion of DMC for treatment and research (DMC-T and DMC-R), and/or socio-demographic/psychopathological associations with ability to make such decisions, in people with schizophrenia and related illnesses.ResultsA total of 40 studies were identified. While high levels of heterogeneity limited direct comparison, meta-analysis of inpatient data showed that DMC-T was present in 48% of people. Insight was strongly associated with DMC-T. Neurocognitive deficits were strongly associated with lack of DMC-R and to a lesser extent DMC-T. With the exception of years of education, there was no evidence for an association with socio-demographic factors.ConclusionsInsight and neurocognitive deficits are most closely associated with DMC in schizophrenia. The lack of an association with socio-demographic factors dispels common misperceptions regarding DMC and characteristics such as age. Although our results reveal a wide spectrum of DMC-T and DMC-R in schizophrenia, this could be partly due to the complexity of the DMC construct and the heterogeneity of existing studies. To facilitate systematic review research, there is a need for improvement within research study design and increased consistency of concepts and tools.

Ethics

Oncology ◽  
2017 ◽  
pp. 728-738
Author(s):  
Natalia S. Ivascu ◽  
Sheida Tabaie ◽  
Ellen C. Meltzer
Keyword(s):  
Decision Making ◽  
Critical Care ◽  
Informed Consent ◽  
Ethical Issues ◽  
Surrogate Decision Making ◽  
Ethical Problems ◽  
Decision Making Capacity ◽  
Surgical Critical Care ◽  
Surrogate Decision ◽  
Special Circumstances

In all areas of medicine physicians are confronted with a myriad ethical problems. It is important that intensivists are well versed on ethical issues that commonly arise in the critical care setting. This chapter will serve to provide a review of common topics, including informed consent, decision-making capacity, and surrogate decision-making. It will also highlight special circumstances related to cardiac surgical critical care, including ethical concerns associated with emerging technologies in cardiac care.

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