Proposed Guidelines for the Participation of Persons with Dementia as Research Subjects

Keyserlingk, Edward W.; Glass, Kathleen Cranley; Kogan, Sandra; Gauthier, Serge

doi:10.1353/pbm.1995.0049

Cited by 78 publications

(38 citation statements)

References 6 publications

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“…In the case of patients with clinical conditions that might impede informed consent, the experimenter should consider published guidelines for obtaining substitute consent from family or caretakers~e.g., Keyserlingk, Glass, Kogan, & Gauthier, 1995!. When the subjects are under 18 years old, the investigator should obtain informed consent from the child's guardians and provide information to the child at a level that the child might understand~Van Eys, 1978!. Academic and clinical institutions specify how the rights of human subjects are protected and have committees to approve research protocols and to monitor the research as it proceeds.…”

Section: (I) Informed Consent Must Be Documentedmentioning

confidence: 99%

Guidelines for using human event-related potentials to study cognition: Recording standards and publication criteria

et al. 2000

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Event-related potentials~ERPs! recorded from the human scalp can provide important information about how the human brain normally processes information and about how this processing may go awry in neurological or psychiatric disorders. Scientists using or studying ERPs must strive to overcome the many technical problems that can occur in the recording and analysis of these potentials. The methods and the results of these ERP studies must be published in a way that allows other scientists to understand exactly what was done so that they can, if necessary, replicate the experiments. The data must then be analyzed and presented in a way that allows different studies to be compared readily. This paper presents guidelines for recording ERPs and criteria for publishing the results.Descriptors: Event-related potentials, Methods, Artifacts, Measurement, Statistics Event-related potentials~ERPs! are voltage fluctuations that are associated in time with some physical or mental occurrence. These potentials can be recorded from the human scalp and extracted from the ongoing electroencephalogram~EEG! by means of filtering and signal averaging. Although ERPs can be evaluated in both frequency and time domains, these particular guidelines are concerned with ERPs recorded in the time domain, that is, as waveforms that plot the change in voltage as a function of time. These waveforms contain components that span a continuum between the exogenous potentials~obligatory responses determined by the physical characteristics of the eliciting event in the external world! and the endogenous potentials~manifestations of information processing in the brain that may or may not be invoked by the eliciting event!.1 Because the temporal resolution of these measurements is on the order of milliseconds, ERPs can accurately measure when processing activities take place in the human brain. The spatial resolution of ERP measurements is limited both by theory and by our present technology, but multichannel recordings can allow us to estimate the intracerebral locations of these cerebral processes. The temporal and spatial information provided by ERPs may be used in many different research programs, with goals that range from understanding how the brain implements the mind to making specific diagnoses in medicine or psychology. Data cannot have scientific value unless they are published for evaluation and replication by other scientists. These ERP guidelines are therefore phrased primarily in terms of publication criteria. The scientific endeavor consists of three main steps, and these map well onto the sections of the published paper. The first step is the most important but the least well understood-the discovery of Address reprint requests to: Terence W. Picton, Rotman Research Institute,

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Section: (I) Informed Consent Must Be Documentedmentioning

confidence: 99%

Guidelines for using human event-related potentials to study cognition: Recording standards and publication criteria

et al. 2000

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“…38,39 IRBs, however, tend to see a review of the risk-benefit ratio as one of the most important things they do. 40,41 A persistent controversy exists in interpreting the federal requirement that the risks must be reasonable in relation to anticipated benefits, either to the subject directly or to society in the form of increased knowledge (45CFR46.111a). There are at least three relevant issues for neurotherapeutics research in this regard.…”

Section: Favorable Risk-benefit Ratiomentioning

confidence: 99%

Evidence-based ethics for neurology and psychiatry research

Kim

2004

Neurotherapeutics

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Summary: American bioethics, historically arising out of theology and philosophy, has been dominated by the method of normative analysis. Ethics as policy, however, requires in addition a solid evidence base. This paper discusses the background conditions that make neurotherapeutics research particularly challenging. Three key ethical issues are discussed within an evidence-based ethics framework: the ethical challenges arising from changes in the financial incentive structures for academic researchers and their institutions, the challenges of risk-benefit analysis for neurotherapeutics protocols testing innovative interventions, and the evolving issues surrounding impaired decision-making capacity and surrogate consent for research. For each of these issues, selected empirical data are reviewed, areas for further inquiry are noted, and the need for development of novel methods for bioethics policy research is discussed.

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“…AD research has always presented clinical investigators and research ethics boards (REBs) with difficult ethical challenges in assessing risks and benefits to the research subject (34). Generally, the evaluation of risk centres around the issues of competency of the subject and his or her capacity to provide informed consent (35).…”

Section: Assessment Of Risks and Benefitsmentioning

confidence: 99%

“…Thus, AD patients should be informed ofthe potential risks and benefits of using APO E genotyping for selecting therapy. Consent for participation in research of persons with dementia, however, is complex enough, and other authors have dealt with the difficulties and obstacles in achieving adequate informed consent (34,35,64,65).The dimension of genetic information adds to the complexity! The nature of the relationships that exist in dealing with this disease compounds the challenge further.…”

Section: Consent and Surrogate Decision-makingmentioning

confidence: 99%

Apolipoprotein E Genotyping for Pharmacogenetic Purposes in Alzheimer's Disease: Emerging Ethical Issues

Issa

Keyserlingk

2000

Can J Psychiatry

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lzheimer' s disease (AD) is a progressive neurodegenerative disease and the most common cause ofdementia in the elderly, accounting for about 60% of dementia cases. It is characterized clinically by a decline in cognitive functions, notably memory loss and intellectual faculties. The time from initial diagnosis to death, often with complete dependence on caregivers as the disease progresses, averages between 3 and 15 years. Thus, it exacts enormous pyschosocial costs on afflicted individuals and families, as well as on society as a whole. Demographic projections and prevalence studies indicating a rise in the number of senior citizens in the US and Canada suggest that AD will be one of the primary health problems of the 21st century (1-4).The discovery of genetic susceptibility polymorphisms for AD, such as the association of the apolipoprotein E4 (APO E4) allele with AD risk, along with the increasing availability of therapeutic options in multicentre clinical trials, poses new ethical challenges for both the clinical practice of medicine and the conduct of research with human subjects. Several authors and organizations have expressed concern about the ethical issues related to the use ofAPO E genotyping for predictive purposes (5-9). However, the emerging ethical issues

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Proposed Guidelines for the Participation of Persons with Dementia as Research Subjects

Cited by 78 publications

References 6 publications

Guidelines for using human event-related potentials to study cognition: Recording standards and publication criteria

Guidelines for using human event-related potentials to study cognition: Recording standards and publication criteria

Evidence-based ethics for neurology and psychiatry research

Apolipoprotein E Genotyping for Pharmacogenetic Purposes in Alzheimer's Disease: Emerging Ethical Issues

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