Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations

Gupta, Umesh C.; Kharawala, Saifuddin

doi:10.4103/2229-3485.92301

Cited by 26 publications

(25 citation statements)

References 49 publications

(65 reference statements)

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“…Psychiatric research must include vulnerable individuals in order to be valid and this involves ethical risks [3]. Young adult psychiatric patients who participated in psychiatric biobank sampling reported high voluntariness and did not regret participation.…”

Section: Discussionmentioning

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%

“…To provide a valid basis for psychiatric research, sample collection must reflect the population and include patients with significant deficits in executive function, cognitive abilities and emotional regulation. Complicated ethical aspects are a central factor contributing to the slow development within this area [3]. …”

Section: Introductionmentioning

confidence: 99%

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

et al. 2017

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“…Ethical complexity associated with proxy and surrogate consent is of special importance for research involving patients with mental disorders. [2021]…”

Section: Obtaining Informed Consentmentioning

confidence: 99%

“…Gupta et al .,[2021] has provided a comprehensive review and guidance on various ethical issues and recommendations related to informed consent in psychiatry clinical research.…”

Section: Informed Consent: An Ongoing Processmentioning

confidence: 99%

Informed consent in clinical research: Revisiting few concepts and areas

Gupta

2013

Perspect Clin Res

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116

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“…dikkat, bellek, kavrama) uygun olarak, onamın sunumu sırasında bilgilerin parçalı olarak verilmesi, basitleştirilmiş bir dilin kullanımı, bilgilerin tartışılması, gerekli görüldüğünde tekrar edilmesi önem kazanmaktadır. [59] Pope ve Vazquez'in de vurguladığı üzere, onam alma müdahale içeriğinin zaman içerisinde yeniden tartışılarak, evrilen bir akışganlığa sahip olmalıdır. [5] Hughes'a göre hasta-doktor ilişkisi hastanın özerkliği kadar bağımlılığıyla da ilgilidir ki bu durum psikoterapist-danışan ilişkisine de genellenebilir.…”

Section: Discussionunclassified

Informed Consent and Capacity to Give Consent in Mental Disorders

Maçkalı¹

2014

Psikiyatride Guncel Yaklasimlar - Current Approaches in Psychia

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ÖzetSağlık alanında etik davranışları belirleyen dört temel ilke (özerkliğe saygı, faydalı olma, zarar vermeme ve adalet) içinde en çok 'özerkliğe saygı' prensibiyle ilişkili olan bilgilendirilmiş onam aynı zamanda danışanın karar verme hakkı ve hastaya/danışana ve özerkliğine verilen değeri de yansıtır. Bilgilendirilmiş onam, bireyin pek çok farklı seçenek içinden kendisi için en uygun yöntemi seçmek üzere mantıklı bir karar almasını ve klinisyen ile etkileşimi de kapsayan bilgi paylaşım sürecidir. Bu kavram gizliliğin sınırlarına, yetkinliğe, uygun ve yeterli bilgi paylaşımına, gönüllülüğe dair ölçütle-rin neler olduğuna ilişkin klinisyenlere ışık tutmaktadır. Bir kuramsal derleme olan bu çalışmada bilgilendirilmiş onam kavramının tanımları ve içeriği paylaşıldıktan sonra, psikoterapistlerin psikoterapi sürecinde kullanacakları onam formunun neleri kapsaması, bilgilendirilmiş onam bileşenleri irdelenmiştir. Ardından yukarıda belirtilen tanı grupları kapsamında ruhsal bozukluklar ve onam verme kapasitesi ilişkisi incelenmiştir. AbstractAmong four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice) which determine ethical behaviors in healthcare, informed consent is mostly related to 'respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interaction between the clinician and the client. This concept sheds light on criteria regarding the limits of confidentiality, competency, appropriate and sufficient information sharing and voluntariness. In this theoretical review, the definitions and the content of informed consent were shared, and then a section regarding the required content of informed consent for psychotherapy process was provided. Then, the components of informed consent were discussed and the relationship between capacity to consent and mental disorders in terms of aforementioned diagnostic groups was examined.

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Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations

Cited by 26 publications

References 49 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

Informed consent in clinical research: Revisiting few concepts and areas

Informed Consent and Capacity to Give Consent in Mental Disorders

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