Research Risk for Persons With Psychiatric Disorders: A Decisional Framework to Meet the Ethical Challenge

Yanos, Philip T.; Stanley, Bárbara; Greene, Carolyn S.

doi:10.1176/ps.2009.60.3.374

Cited by 12 publications

(7 citation statements)

References 46 publications

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“…This may reflect a difference in the perceived right to choose in the two situations. It is well described that voluntariness is influenced by implicit power in the relationship between participants and investigators in research [4]. Patients not given the opportunity to decline feces sampling might have had difficulties rejecting it when they already were in the study.…”

Section: Discussionmentioning

confidence: 99%

“…The American National Bioethics Advisory Commission views the population with psychiatric disorders as a ‘vulnerable’ one, but also considers that not all people with psychiatric disorders are ‘vulnerable’ at all times and in all areas. Following this argument Yanos et al discusses the vulnerability among persons with psychiatric disorders as a state, rather than a trait, and presents evidence that vulnerability must be evaluated in two dimensions: capacity and voluntariness, which must be considered while designing a study [4]. Capacity is the degree to which participants are able to comprehend informed consent.…”

Section: Introductionmentioning

confidence: 99%

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No regrets: Young adult patients in psychiatry report positive reactions to biobank participation

et al. 2017

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Background: Research in vulnerable individuals must insure voluntariness and minimize negative reactions caused by participation. This study aimed to describe consent and completion rate in young psychiatric patients in relation to study components, degree of disability and to compare response to research participation in patients and controls. Methods: Between 2012 and 2015, 463 patients with psychiatric disorders between the ages of 18-25 from the Dept. of General Psychiatry at Uppsala University Hospital and 105 controls were recruited to donate data and samples to a biobank. Consent and completion in relation to questionnaires, biological sampling of blood, saliva or feces, were monitored. Both groups were also asked about their perceived disability and how research participation affected them. Results: Most patients who participated consented to and completed questionnaires and blood sampling. The majority also consented to saliva sampling, while less than half consented to collect feces. Of those who gave consent to saliva and feces only half completed the sampling. Both patients and controls reported high voluntariness and were positive to research participation. Within the patient group, those with greater perceived disability reported greater distress while participating in research, but there was no difference in consent or completion rates or level of regret. Conclusions: With the described information procedures, psychiatric patients, regardless of perceived disability, reported high voluntariness and did not regret participation in biobanking. Compared to questionnaires and blood sampling, given consent was reduced for feces and completion was lower for both saliva and feces sampling.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

No regrets: Young adult patients in psychiatry report positive reactions to biobank participation

et al. 2017

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“…Two dimensions of vulnerability, capacity and voluntariness, were considered. 35 Patients were invited when they already had an ongoing treatment and were clearly informed that this would not be influenced by their decision. The study received ethical permission from the regional ethics board in Uppsala (Reg.…”

Section: Ethical Permissionmentioning

confidence: 99%

‘Sick and tired’: Patients reported reasons for not participating in clinical psychiatric research

Bixo

Cunningham

Ekselius

et al. 2019

Health Expectations

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Patients' willingness to participate in clinical research is crucial for producing meaningful and generalizable results. 1,2 Today, many studies fail to reach representativeness, 3,4 regardless of study design, country or field of research. 5,6 For example, a review found that only a third of the original target population were recruited in randomized, controlled multicenter studies performed in the UK between 1994 and 2002. 7 In addition to the risk of misleading outcomes, 8 scientists are also often forced to cancel research in advance due to an insufficient number of participants. 6 Participant recruitment in psychiatric research is particularly unsatisfying. 9,10 For example, only

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“…For example, U.S. regulations specifically enumerate only children, prisoners, and pregnant women as vulnerable populations. In practice, however, U.S. institutional review boards frequently consider mentally ill persons, students, non-English speakers, sexual minorities, and HIVinfected persons to be vulnerable (Backlar, 2000;Delano, 2006;Levine, Dubler, & Levine, 2001;Tickle & Heatherton, 2006;Perry, 2011;White, 2007;Yanos, Stanley, & Greene, 2009). Uganda's 2007 National Guidelines for Research Involving Humans as Research Participants enumerates the following additional groups as vulnerable in the context of research: mature and emancipated minors; fetuses; persons who are homeless; and members of the armed forces (Uganda National Council for Science and Technology, 2007).…”

Section: International Constructionsmentioning

confidence: 99%

Is There a Universal Understanding of Vulnerability? Experiences with Russian and Romanian Trainees in Research Ethics

Loue

Loff

2013

Journal of Empirical Research on Human Research Ethics

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Vulnerability of participants in research and the provision of special protections for vulnerable research participants are key concepts in research ethics. Despite international consensus requiring special protections for vulnerable research participants, both the concept of vulnerability and the nature and adequacy of strategies to reduce vulnerability remain vague and, consequently, are subject to varying interpretations. We report on observations of the challenges faced in understanding this key concept by 20 Russian and Romanian trainees participating in a one-year M.A. training program in research ethics from 2000 through 2011. We describe how trainees’ understanding of and appreciation for the need for special protections of vulnerable research participants was nurtured. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.

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Research Risk for Persons With Psychiatric Disorders: A Decisional Framework to Meet the Ethical Challenge

Abstract: Although more research is needed, there is sufficient evidence that many common types of research present minimal risk or only a minor increment over minimal risk for large segments of the population of persons with psychiatric disorders, as they do for persons in the general population.

Cited by 12 publications

References 46 publications

No regrets: Young adult patients in psychiatry report positive reactions to biobank participation

No regrets: Young adult patients in psychiatry report positive reactions to biobank participation

‘Sick and tired’: Patients reported reasons for not participating in clinical psychiatric research

Is There a Universal Understanding of Vulnerability? Experiences with Russian and Romanian Trainees in Research Ethics

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