Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders

Dunn, Laura B.; Jeste, Dilip V.

doi:10.1007/s00213-003-1501-3

Cited by 32 publications

(21 citation statements)

References 17 publications

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“…We have previously found that persons with schizophrenia have greater difficulty with openended questions than with those requiring answers of the yes or no type. 9 This issue may arise in part from the patient's inability to adequately articulate responses to open-ended queries (which puts the subjects at an unnecessary disadvantage) and in part from the fact that there is a 50% chance of the subject's giving a correct yes or no answer without comprehending the topic (which may lead to missed opportunities to clarify initially misunderstood information). For that reason, we decided to use a combination of open-ended and true or false questions.…”

Section: Item Generation and Selectionmentioning

confidence: 99%

A New Brief Instrument for Assessing Decisional Capacity for Clinical Research

Jeste¹,

Palmer²,

Appelbaum³

et al. 2007

Arch Gen Psychiatry

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357

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Context: There is a critical need for practical measures for screening and documenting decisional capacity in people participating in different types of clinical research. However, there are few reliable and validated brief tools that could be used routinely to evaluate individuals' capacity to consent to a research protocol.Objective: To describe the development, testing, and proposed use of a new practical instrument to assess decision-making capacity: the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). The UBACC is intended to help investigators identify research participants who warrant more thorough decisional capacity assessment and/or remediation efforts prior to enrollment.Design, Setting, and Participants: We developed the UBACC as a 10-item scale that included questions focusing on understanding and appreciation of the information concerning a research protocol. It was developed and tested among middle-aged and older outpatients with schizophrenia and healthy comparison subjects participating in research on informed consent. In an investigation of reliability and validity, we studied 127 outpatients with schizophrenia or schizoaffective disorder and 30 healthy comparison subjects who received information about a simulated clinical drug trial. Internal consistency, interrater reliability, and concurrent (criterion) validity (including correlations with an established instrument as well as sensitivity and specificity relative to 2 potential "gold standard" criteria) were measured. Main Outcome Measures:Reliability and validity of the UBACC. Results:The UBACC was found to have good internal consistency, interrater reliability, concurrent validity, high sensitivity, and acceptable specificity. It typically took less than 5 minutes to administer, was easy to use and reliably score, and could be used to identify subjects with questionable capacity to consent to the specific research project. Conclusion:The UBACC is a potentially useful instrument for screening large numbers of subjects to identify those needing more comprehensive decisional capacity assessment and/or remediation efforts. Psychiatry. 2007;64(8):966-974 Arch Gen

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Section: Item Generation and Selectionmentioning

confidence: 99%

A New Brief Instrument for Assessing Decisional Capacity for Clinical Research

Jeste¹,

Palmer²,

Appelbaum³

et al. 2007

Arch Gen Psychiatry

Self Cite

453

357

View full text Add to dashboard Cite

show abstract

“…For example, in a relatively low-risk protocol, researchers found that, compared with healthy controls, middle-aged and older patients with schizophrenia had more difficulty responding to an open-ended question about the potential risks of enrolling. 167 In this same study it was found that a computer-based, enhanced consent procedure was associated with better performance on the question. 167 Further studies will be needed to clarify the dimensions of nonbiological risk (eg, psychosocial, economic, anxiety-related) that are associated with taking part in psychosocial or survey research.…”

Section: Understanding/perceptions Of Riskmentioning

confidence: 87%

“…167 In this same study it was found that a computer-based, enhanced consent procedure was associated with better performance on the question. 167 Further studies will be needed to clarify the dimensions of nonbiological risk (eg, psychosocial, economic, anxiety-related) that are associated with taking part in psychosocial or survey research. 47,96,168,169 In biologically oriented research as well, the phenomenon of ''respondent burden'' (eg, time, energy, and emotional expenditures by participants) has received only passing interest.…”

Section: Understanding/perceptions Of Riskmentioning

confidence: 87%

Reviews: Emerging Empirical Evidence on the Ethics of Schizophrenia Research

Dunn

Candilis

Roberts

2005

Schizophrenia Bulletin

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Many challenging ethical questions come with the scientific efforts to understand the nature and treatment of schizophrenia. The empirical study of ethical aspects of schizophrenia research has sought to clarify and resolve many of these questions. In this article we provide an overview of the existing data-based literature on schizophrenia research ethics and outline directions for future inquiry. We examine 5 broad categories of inquiry into the ethics of schizophrenia research: (1) Scientific designs (eg, placebo-controlled studies and medication-free intervals, prodromal and high-risk research, and genetics research); (2) informed consent and decision-making capacity, including assessment of decisional abilities, as well as intervention studies; (3) understanding and perceptions of risk and benefit (including the therapeutic misconception); (4) influences on research participation (including voluntarism, altruism, and other motivations); and (5) key participant safeguards, such as protocol review and participant advocates. We discuss how empirical work in each of these areas answers certain questions and raises new ones. Finally, we highlight important gaps in our understanding of ethically relevant aspects of schizophrenia research and offer a specific research agenda for empirical ethics.

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“…This is somewhat surprising, insofar as considerable energy in bioethics has been devoted in recent years to issues of decisional capacity-specifically, treatment consent capacity and research consent capacity--in individuals with dementia, schizophrenia and other severe neuropsychiatric disorders [8][9][10][11][12] . In its report Research Involving Persons with Mental Disorders That May Affect Decision-Making Capacity, the National Bioethics Advisory Commission focused attention on, and made substantive recommendations regarding, informed consent procedures in research with persons with mental disorders such as schizophrenia and dementia 13 .…”

Section: Ethical Aspectsmentioning

confidence: 99%

Clinical and Ethical Aspects of Financial Capacity in Dementia: A Commentary

Marson

2013

The American Journal of Geriatric Psychiatry

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In contrast to issues like treatment and research consent capacity, financial capacity has received relatively little clinical and ethical attention in the dementia literature. Yet issues of financial capacity emerge frequently in patients with Alzheimer's disease (AD), Parkinson's disease (PD) and related dementias, and commonly present ethical and clinical challenges for clinicians treating these patients. These issues include whether a patient with possible dementia has sufficient capacity independently to manage their financial affairs, needs referral for financial capacity assessment, and/or is being financially exploited or abused by others. The accurate identification, assessment and successful handling of such financial capacity issues can have a substantial impact on the financial and psychological well-being of patients and their family members. The present commentary presents an overview of financial capacity and associated clinical and ethical issues in dementia, and describes a set of possible clinician roles regarding these issues as they arise in clinical practice. The commentary concludes with a section describing educational resources available to clinicians and bioethicists seeking additional guidance in handling financial capacity issues. The ultimate goal of the paper is to focus clinical and ethical attention on a neglected capacity that is of fundamental importance for patients, families, and health care and legal professionals.

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Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders

Cited by 32 publications

References 17 publications

A New Brief Instrument for Assessing Decisional Capacity for Clinical Research

A New Brief Instrument for Assessing Decisional Capacity for Clinical Research

Reviews: Emerging Empirical Evidence on the Ethics of Schizophrenia Research

Clinical and Ethical Aspects of Financial Capacity in Dementia: A Commentary

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