Enrollment by Surrogate Authorization into Stroke Genetic Research

US Neurology ◽  
2009 ◽  
Vol 05 (01) ◽  
pp. 41 ◽  
Author(s):  
Donna T Chen ◽  
James F Meschia ◽  
Bradford B Worrall ◽  
◽  
◽  
...  
Keyword(s):  
Human Subjects ◽  
Genetic Research ◽  
Minimal Risk ◽  
Scientific Rigor ◽  
Stroke Research ◽  
Current State ◽  
Decision Making Capacity ◽  
Physical Risk ◽  
Therapeutic Research ◽  
Clinical And Translational Research

Continued clinical and translational research is necessary to address unmet clinical needs in stroke and cerebrovascular disease. Ethical and scientific challenges confront these research efforts. Genetic stroke research faces a number of specific challenges related to the legacy of genetic exceptionalism and the reality that stroke frequently impairs decision-making capacity. Maximizing scientific rigor and protecting human subjects have frequently and often erroneously been cast as opposing efforts. In this article, we review the challenges facing stroke genetic research and propose potential approaches given the current state of guidance and regulations. We consider the rationale behind including those with decisional impairment and several options to allow participation of these individuals. Appropriate infrastructure and processes should be established to ensure that genetic information poses minimal risk to individuals, just as has been done to minimize physical risk in non-therapeutic research.

Enrollment by Surrogate Authorization into Stroke Genetic Research

2009 ◽  
Vol 4 (1) ◽  
pp. 64
Author(s):  
Donna T Chen ◽  
James F Meschia ◽  
Bradford B Worrall ◽  
◽  
◽  
...  
Keyword(s):  
Genetic Information ◽  
Human Subjects ◽  
Genetic Research ◽  
Minimal Risk ◽  
Stroke Research ◽  
Current State ◽  
Decision Making Capacity ◽  
Physical Risk ◽  
Therapeutic Research ◽  
Clinical And Translational Research

Continued clinical and translational research is necessary to address unmet clinical needs in stroke and cerebrovascular disease. Ethical and scientific challenges confront these research efforts. Genetic stroke research faces a number of specific challenges related to the legacy of genetic exceptionalism and the reality that stroke frequently impairs decision-making capacity. Maximising scientific rigour and protecting human subjects have frequently and often erroneously been cast as opposing efforts. In this article, we review the challenges facing stroke genetic research and propose potential approaches given the current state of guidance and regulations. We consider the rationale behind including those with decisional impairment and several options to allow participation of these individuals. Appropriate infrastructure and processes should be established to ensure that genetic information poses minimal risk to individuals, just as has been done to minimise physical risk in non-therapeutic research.

Pediatric Participation in Non-Therapeutic Research

2012 ◽  
Vol 40 (3) ◽  
pp. 665-672 ◽  
Author(s):  
Marilyn C. Morris
Keyword(s):  
Medical Condition ◽  
Human Subjects ◽  
National Commission ◽  
Institutional Review Boards ◽  
Minimal Risk ◽  
Research Risks ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
A Minor ◽  
Therapeutic Research

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards (IRBs) to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses (Table 1).

Behavioral Genetics: Concepts for Research and Practice in Language Development and Disorders

1995 ◽  
Vol 38 (5) ◽  
pp. 1126-1142 ◽  
Author(s):  
Jeffrey W. Gilger
Keyword(s):  
Language Development ◽  
Behavioral Genetics ◽  
State Of The Art ◽  
Genetic Research ◽  
Great Promise ◽  
Behavioral Genetic ◽  
Fine Grained ◽  
Future Goals ◽  
Current State ◽  
Research Designs

This paper is an introduction to behavioral genetics for researchers and practioners in language development and disorders. The specific aims are to illustrate some essential concepts and to show how behavioral genetic research can be applied to the language sciences. Past genetic research on language-related traits has tended to focus on simple etiology (i.e., the heritability or familiality of language skills). The current state of the art, however, suggests that great promise lies in addressing more complex questions through behavioral genetic paradigms. In terms of future goals it is suggested that: (a) more behavioral genetic work of all types should be done—including replications and expansions of preliminary studies already in print; (b) work should focus on fine-grained, theory-based phenotypes with research designs that can address complex questions in language development; and (c) work in this area should utilize a variety of samples and methods (e.g., twin and family samples, heritability and segregation analyses, linkage and association tests, etc.).

Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

Cephalalgia ◽  
2021 ◽  
pp. 033310242110299
Author(s):  
Peer Tfelt-Hansen ◽  
Karsten Jørgensen ◽  
Hans-Christoph Diener
Keyword(s):  
Clinical Research ◽  
Migraine Attack ◽  
Human Subjects ◽  
Second Step ◽  
Controlled Trials ◽  
Scientific Rigor ◽  
Protection Of Human Subjects

Purpose In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo. Conclusion To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with “scientific rigor” in the second step of these trials, and this design is not recommended.

Family experiences with non-therapeutic research on dying patients in the intensive care unit

2021 ◽  
pp. medethics-2021-107311
Author(s):  
Amanda van Beinum ◽  
Nick Murphy ◽  
Charles Weijer ◽  
Vanessa Gruben ◽  
Aimee Sarti ◽  
...  
Keyword(s):  
Intensive Care ◽  
Intrinsic Value ◽  
Family Members ◽  
Research Participation ◽  
Decision Makers ◽  
Minimal Risk ◽  
Dying Patients ◽  
Therapeutic Study ◽  
Therapeutic Research ◽  
Work Supports

Experiences of substitute decision-makers with requests for consent to non-therapeutic research participation during the dying process, including to what degree such requests are perceived as burdensome, have not been well described. In this study, we explored the lived experiences of family members who consented to non-therapeutic research participation on behalf of an imminently dying patient.We interviewed 33 family members involved in surrogate research consent decisions for dying patients in intensive care. Non-therapeutic research involved continuous physiological monitoring of dying patients prior to and for 30 min following cessation of circulation. At some study centres participation involved installation of bedside computers. At one centre electroencephalogram monitoring was used with a subset of participants. Aside from additional monitoring, the research protocol did not involve deviations from usual end-of-life care.Thematic analysis of interviews suggests most family members did not perceive this minimal-risk, non-therapeutic study to affect their time with patients during the dying process, nor did they perceive research consent as an additional burden. In our analysis, consenting for participation in perimortem research offered families of the dying an opportunity to affirm the intrinsic value of patients’ lives and contributions. This opportunity may be particularly important for families of patients who consented to organ donation but did not proceed to organ retrieval.Our work supports concerns that traditional models of informed consent fail to account for possible benefits and harms of perimortem research to surviving families. Further research into consent models which integrate patient and family perspectives is needed.

scholarly journals Multifaceted origins of sex differences in the brain

2016 ◽  
Vol 371 (1688) ◽  
pp. 20150106 ◽  
Author(s):  
Margaret M. McCarthy
Keyword(s):  
Sex Differences ◽  
State Of The Art ◽  
Human Subjects ◽  
Special Issue ◽  
Molecular Analyses ◽  
The Past ◽  
Current State ◽  
Biological Variable ◽  
Males And Females ◽  
The Brain

Studies of sex differences in the brain range from reductionistic cell and molecular analyses in animal models to functional imaging in awake human subjects, with many other levels in between. Interpretations and conclusions about the importance of particular differences often vary with differing levels of analyses and can lead to discord and dissent. In the past two decades, the range of neurobiological, psychological and psychiatric endpoints found to differ between males and females has expanded beyond reproduction into every aspect of the healthy and diseased brain, and thereby demands our attention. A greater understanding of all aspects of neural functioning will only be achieved by incorporating sex as a biological variable. The goal of this review is to highlight the current state of the art of the discipline of sex differences research with an emphasis on the brain and to contextualize the articles appearing in the accompanying special issue.

Whither Psychiatric Diagnosis

1999 ◽  
Vol 33 (2) ◽  
pp. 161-165 ◽  
Author(s):  
Allen J. Frances ◽  
Helen Link Egger
Keyword(s):  
Psychiatric Disorders ◽  
Psychiatric Illness ◽  
Biological Effects ◽  
Genetic Research ◽  
Explanatory Models ◽  
Psychiatric Research ◽  
Diagnostic And Statistical Manual ◽  
Current State ◽  
System Method ◽  
Dsm Iv

Objective: The aim of this paper is to describe the development of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), its purposes and limitations, and the psychiatric nosologies which may emerge from advances in psychiatric research and which may supersede the current classification system. Method: A review of the methodology used to develop DSM-IV, considered in the context of current and future psychiatric, neurobiological, and genetic research, was undertaken. Results: The DSM-IV is a descriptive nosology that has shaped psychiatric research and clinical practice by providing agreed-upon definitions of psychiatric disorders based on the current state of empirical data. Despite the critical importance of the DSM system of classification, this complex yet limited nosology will eventually be replaced by simpler, more incisive explanatory models of psychiatric illness that reflect the interplay of biological, psychological, environmental and social variables affecting the expression and treatment of psychiatric disorders. Conclusions: As we continue to understand the pathophysiology of brain disorders, as well as the biological effects of psychiatric interventions, we will be able to move from a descriptive model to an integrative, explanatory model of psychiatric illness.

scholarly journals Insight and psychosis: the next 30 years

2019 ◽  
Vol 217 (3) ◽  
pp. 521-523 ◽  
Author(s):  
Anthony S. David
Keyword(s):  
Conceptual Development ◽  
State Of The Art ◽  
Involuntary Treatment ◽  
The Past ◽  
Current State ◽  
Decision Making Capacity ◽  
Cognitive Neurosciences ◽  
Clinical Associations ◽  
The Relationship ◽  
Made In

Academic interest in the concept of insight in psychosis has increased markedly over the past 30 years, prompting this selective appraisal of the current state of the art. Considerable progress has been made in terms of measurement and confirming a number of clinical associations. More recently, the relationship between insight and involuntary treatment has been scrutinised more closely alongside the link between decision-making capacity and insight. Advances in the clinical and cognitive neurosciences have influenced conceptual development, particularly the field of ‘metacognition’. New therapies, including those that are psychologically and neurophysiologically based, are being tested as ways to enhance insight.

Risk, double effect and the social benefit requirement

2020 ◽  
pp. medethics-2019-106034
Author(s):  
Robert C Hughes
Keyword(s):  
Medical Research ◽  
Human Subjects ◽  
Double Effect ◽  
Social Benefit ◽  
Social Value ◽  
Doctrine Of Double Effect ◽  
Medical Benefit ◽  
The Social ◽  
Physical Risk ◽  
Research On Human Subjects

Many ethicists maintain that medical research on human subjects that presents no prospect of direct medical benefit must have a prospect of social benefit to be ethical. Payment is not the sort of benefit that justifies exposing subjects to risk. Alan Wertheimer has raised a serious challenge to this view, pointing out that in industry, social value is not considered necessary to make dangerous jobs ethical. This article argues that Wertheimer was correct to think that the ethics of hazard pay should be the same in medical research and in business. Nevertheless, a qualified social benefit requirement should apply in both fields. For a study or a job with significant net physical risk to be ethical, it must have social value beyond the satisfaction of ordinary preferences, including the preference for money. The requirement derives from a non-absolutist version of the doctrine of double effect. If a risky study or a dangerous job has no distinctive social value, and hazard pay is subjects' or workers’ only reason to undergo risks, the very fact that they undergo risk is intended as a means to a financial end. Inviting people to enrol in such a study or to take such a job wrongfully treats people as mere means. By contrast, if a study or a job has social value, people can participate with a primary end other than money, even if they accept compensation. Researchers or employers do not intend but merely foresee risks to subjects or workers.

Theory of Visual Attention (TVA)

2014 ◽  
Author(s):  
Claus Bundesen ◽  
Thomas Habekost
Keyword(s):  
Visual Attention ◽  
Single Cell ◽  
Human Subjects ◽  
Genetic Research ◽  
Reaction Times ◽  
Error Rates ◽  
Healthy Human ◽  
Computational Theory ◽  
Healthy Human Subjects ◽  
Psychological Studies

The theory of visual attention introduced by Bundesen (1990) is reviewed. The authors first describe TVA as a formal computational theory of visual attention and summarize applications of TVA to psychological studies of performance (reaction times and error rates) in healthy human subjects. They then explain their neurophysiological interpretation of TVA, NTVA, and exemplify how NTVA accounts for findings from single-cell studies in primates. Finally the authors review how TVA has been applied to study attentional functions in neuropsychological, pharmacological, and genetic research.

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