Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members

Koonrungsesomboon, Nut; Laothavorn, Junjira; Karbwang, Juntra

doi:10.2149/tmh.2014-36

Cited by 15 publications

(19 citation statements)

References 2 publications

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“…Autonomy, also known as respect for persons, is a fundamental ethical principle in healthcare 3 Autonomy is "a person's ability and opportunity to make decisions relating to his/her own wishes" 4 , or "an act of self-determination exercised by a competent person" 5 . As determined by the Belmont's report, the autonomy principle requires three elements to validate the process of informed consent (IC): (1) disclosure of su cient relevant information for decision-making, (2) patient's comprehension, and (3) voluntariness 3 .…”

Section: Introductionmentioning

confidence: 99%

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Geriatricians’ Standpoint of the Informed Consent Process among Patients with Alzheimer's Disease: The Lebanese Context

Fakhro¹,

Dpt²

2020

Preprint

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BackgroundDespite the existence of laws that ensure that patients’ capacity to consent is assessed systematically, many gray areas remain with that regard. As dementia progresses, some patients lose their capacity to make decisions. The aim was to characterize Lebanese geriatricians’ perspectives about decision-making capacity (DMC) of their patients with Alzheimer’s disease (AD). Moreover, to propose an algorithm for a reliable, comprehensive, and valid assessment of DMC. MethodsA cross-sectional descriptive study was designed to empirically collect data via an e-survey. Accordingly, a comprehensive list of geriatricians was provided by the Lebanese Order of Physicians. Geriatricians were approached via a phone call, to provide them with study-specific information. Those who accepted to participate received a link to the study’s survey via an e-mail.ResultsAmong the eligible geriatricians, 75% had successfully completed the e-survey, with a mean of 14.7 ± 9.6 years of experience. More than half of the geriatricians failed to recognize that assessing the patients’ DMC is an integral component of the informed consent (IC) process. Yet, 88.9% assessed the DMC of their patients with AD using different modalities. However, the majority were unable to clearly justify their judgment of DMC based on the tools they have selected.ConclusionLebanese geriatricians have demonstrated a poor understanding of the concept of autonomy and the need for the DMC assessment as part of the IC’s process. Moreover, they were unable to select adequate tools to assess and judge the DMC of their patients with AD.

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Section: Introductionmentioning

confidence: 99%

“…The "comprehension" element of the informed consent, requires an adequate understanding of the provided information 3, and a capacity to make a decision 9 . It is noteworthy that even though capacity is dependent on cognition, it is not the same as cognition 10 .…”

Section: Introductionmentioning

confidence: 99%

Geriatricians’ Standpoint of the Informed Consent Process among Patients with Alzheimer's Disease: The Lebanese Context

Fakhro¹,

Dpt²

2020

Preprint

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“…Moreover, these ethical dilemmas are magni ed when the research is invasive, burdensome, and with unexpectable risks 2,3. "Respect for Persons" is one of the principles de ned by the report of Belmont in 1979, for biomedical research. This principle identi es three elements to validate the informed consent (IC) process: (1) disclose su cient relevant information for decisionmaking, (2) patient's comprehension, and (3) voluntariness 4 . Voluntariness means that the patient should take a decision without being subjected to coercion or undue in uence 4 .…”

Section: Introductionmentioning

confidence: 99%

“…This principle identi es three elements to validate the informed consent (IC) process: (1) disclose su cient relevant information for decisionmaking, (2) patient's comprehension, and (3) voluntariness 4 . Voluntariness means that the patient should take a decision without being subjected to coercion or undue in uence 4 . This re ects the principle of autonomy which is de ned in the literature as "a person's ability and opportunity to make decisions relating to his/her own wishes" 5 , or as "an act of self-determination exercised by a competent person" 3 .…”

Section: Introductionmentioning

confidence: 99%

“…On the other hand, comprehension concept of the IC process, require that the person understand adequately the information provided 4 , and has the capacity to make the decision in question 6 . Capacity evaluation is a two-step process, where the clinician starts by assessing a person's decisional abilities, followed by a judgment regarding the patient's capacity to make a particular decision (e.g., consent) 7 .…”

Section: Introductionmentioning

confidence: 99%

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Geriatricians’ Standpoint Regarding the Informed Consent Process among Patients with Alzheimer's Disease: The Lebanese Context

Fakhro

2019

Preprint

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Background Alzheimer’s disease (AD) is a degenerative brain disease and the most common cause of dementia among older adults. Moreover, as the disease progress, patients lose their capacity to make important decisions as related to their wishes. The primary objective was to characterize the Lebanese Geriatricians’ standpoint regarding the decision-making capacity (DMC) to consent to research and/or treatment participation among their patients with Alzheimer Disease (AD). The secondary objective was to propose an algorithm for a reliable, comprehensive, and valid assessment of the DMC. Methods A cross-sectional descriptive study was designed, where a list of active members of the Lebanese Society for Geriatric Medicine was obtained, and participants were contacted via a phone call, to explain the study purpose, and send them thereafter the survey link. Results Nine Geriatricians with a mean of 14.7 ± 9.6 years of experience completed the survey. Moreover, 66.67 % of the Geriatricians failed to recognize the need to confirm the patient's capacity to make decisions as related to her/his own wishes as related to the process of informed consent (IC). Despite that, 88.9 % of them stated that they tested for DMC among their patients with AD. Conclusion This study finding revealed that Lebanese Geriatricians had a poor understanding of both the concept of autonomy and the criteria needed for the IC process. Moreover, they were unable to select adequate tools to assess and judge the DMC.

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Comparison of Audiovisual and Paper-Based Materials for 1-Time Informed Consent for Research in Prison

et al. 2022

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ImportanceFew studies are available on informed consent (IC) among detained persons, even with ethics being a critical aspect of prison research. In IC research, audiovisual material seems to improve understanding and satisfaction compared with conventional paper-based material, but findings remain unclear.ObjectiveTo compare audiovisual and paper-based materials for 1-time general IC for research in prisons.Design, Setting, and ParticipantsThis cross-sectional randomized clinical trial was conducted in 2 corrections facilities in Switzerland (an adult prison and a juvenile detention center). The study was conducted from December 14, 2019, to December 2, 2020, in the adult prison and from January 15, 2020, to September 9, 2021, in the juvenile detention center. In the adult prison, study participation was offered to detained persons visiting the medical unit (response rate, 84.7%). In the juvenile detention center, all newly incarcerated adolescents were invited to participate (response rate, 98.0%).InterventionsParticipants were randomized to receive paper-based conventional material or to watch a 4-minute video. Materials included the same legal information, as required by the Swiss Federal Act on Research Involving Human Beings.Main Outcomes and MeasuresThe main outcome was acceptance to sign the IC form. Secondary outcomes included understanding, evaluation, and time to read or watch the IC material.ResultsThe study included 190 adults (mean [SD] age, 35.0 [11.8] years; 190 [100%] male) and 100 adolescents (mean [SD] age, 16.0 [1.1] years; 83 [83.0%] male). In the adult prison, no significant differences were found between groups in acceptance to sign the IC form (77 [81.1%] for paper-based material and 81 [85.3%] for audiovisual material; P = .39) and to evaluate it (mean [SD] correct responses, 5.09 [1.13] for paper-based material and 5.01 [1.07] for audiovisual material; P = .81). Understanding was significantly higher in the audiovisual material group (mean [SD] correct responses, 5.09 [1.84]) compared with the paper-based material group (mean [SD] correct responses, 4.61 [1.70]; P = .04). In the juvenile detention center, individuals in the audiovisual material group were more likely to sign the IC form (44 [89.8%]) than the paper-based material group (35 [68.6%], P = .006). No significant difference was found between groups for understanding and evaluation. Adults took a mean (SD) of 5 (2) minutes to read the paper material, and adolescents took 7 (3) minutes.Conclusions and RelevanceGiven the small benefit of audiovisual material, these findings suggest that giving detained adults and prison health care staff a choice regarding IC material is best. For adolescents, audiovisual material should be provided. Future studies should focus on increasing understanding of the IC process.Trial RegistrationClinicalTrials.gov Identifier: NCT05505058

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Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members

Cited by 15 publications

References 2 publications

Geriatricians’ Standpoint of the Informed Consent Process among Patients with Alzheimer's Disease: The Lebanese Context

Geriatricians’ Standpoint of the Informed Consent Process among Patients with Alzheimer's Disease: The Lebanese Context

Geriatricians’ Standpoint Regarding the Informed Consent Process among Patients with Alzheimer's Disease: The Lebanese Context

Comparison of Audiovisual and Paper-Based Materials for 1-Time Informed Consent for Research in Prison

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