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 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.

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.

scholarly journals ‘It’s a tough decision’: a qualitative study of proxy decision-making for research involving adults who lack capacity to consent in UK

2019 ◽  
Vol 48 (6) ◽  
pp. 903-909 ◽  
Author(s):  
Victoria Shepherd ◽  
Kerenza Hood ◽  
Mark Sheehan ◽  
Richard Griffith ◽  
Fiona Wood
Keyword(s):  
Decision Making ◽  
Family Members ◽  
Research Participation ◽  
Structured Interviews ◽  
Number Of Factors ◽  
Complex Process ◽  
Decision Making Capacity ◽  
Supportive Interventions ◽  
Proxy Decision Making ◽  
Conducting Research

Abstract Background Research into dementia and other conditions connected with cognitive impairments is essential but conducting research with populations who lack capacity to provide consent involves a number of ethical, legal and practical challenges. In England and Wales, family members can act as a consultee or legal representative on behalf of someone who lacks capacity. However, there is a paucity of research about how family members make decisions concerning research participation. Objective To explore family members’ experiences of proxy decision-making for research. Understanding how proxy decisions are made could lead to interventions to support greater inclusion of individuals in research who have impaired decision-making capacity. Methods Semi-structured interviews were conducted with a purposive sample of 17 family members who had experience as a proxy for making decisions about participation in research, including those who had agreed to participation and those who declined. Thematic analysis was used to examine experiences and generate findings for research practice and to develop future supportive interventions. Results Proxy decision-making is highly contextualised. Proxies balance a number of factors when deciding about research participation, including the person’s values and preferences, within the specific context of the study, and the practicalities of being involved. Proxies use these factors to construct a decision that is authentic to the person they care for. Conclusions Proxy decision-making for research is a complex process with inter-woven layers of decision-making. Decisions can be problematic for some proxies who may benefit from decision support to make an informed decision about research participation on behalf of a family member.

scholarly journals Decision-making capacity for research participation among addicted people: a cross-sectional study

2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Inés Morán-Sánchez ◽  
Aurelio Luna ◽  
Maria Sánchez-Muñoz ◽  
Beatriz Aguilera-Alcaraz ◽  
Maria D. Pérez-Cárceles
Keyword(s):  
Decision Making ◽  
Research Participation ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Decision Making Capacity

Issues of Capacity and Decision-Making in the Context of Delirium

2015 ◽  
Vol 24 (4) ◽  
pp. 140-145
Author(s):  
Kevin R. Patterson
Keyword(s):  
Decision Making ◽  
Patient Autonomy ◽  
Care Setting ◽  
Cognitive Change ◽  
Treatment Team ◽  
Precipitating Factors ◽  
Term Care ◽  
Decision Making Capacity ◽  
Fundamental Consideration

Decision-making capacity is a fundamental consideration in working with patients in a clinical setting. One of the most common conditions affecting decision-making capacity in patients in the inpatient or long-term care setting is a form of acute, transient cognitive change known as delirium. A thorough understanding of delirium — how it can present, its predisposing and precipitating factors, and how it can be managed — will improve a speech-language pathologist's (SLPs) ability to make treatment recommendations, and to advise the treatment team on issues related to communication and patient autonomy.

Sign in / Sign up

Export Citation Format

Share Document