The Understanding of Informed Consent Information—Definitions and Measurements in Empirical Studies

Sand, Kari; Kaasa, Stein; Loge, Jon Håvard

doi:10.1080/21507711003771405

Cited by 33 publications

(35 citation statements)

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“…Previous reviews have either concentrated on informed consent comprehension in developed countries (Sand et al . ) or compared the quality of informed consent between Western and developing countries in Africa and Asia (Mandava et al . ).…”

Section: Discussionmentioning

confidence: 99%

“…A previous review of studies conducted in developed countries reported a lack of consensus definition of comprehension and an absence of a standardised tool to measure objectively the adequacy of participants' comprehension (Sand et al . ). The authors concluded that a contextual definition of comprehension and systematic design of an instrument could guarantee adequate measurement of participants' comprehension (Sand et al .…”

Section: Introductionmentioning

confidence: 97%

“…The authors concluded that a contextual definition of comprehension and systematic design of an instrument could guarantee adequate measurement of participants' comprehension (Sand et al . ; Mandava et al . ).…”

Section: Introductionmentioning

confidence: 99%

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Informed consent comprehension in African research settings

Afolabi

Okebe

McGrath

et al. 2014

Tropical Med Int Health

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Abstractobjective Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings.methods We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies.results Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants.conclusions Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for informed consent comprehension in low literacy research settings in Africa. This will be an essential step towards developing appropriate tools that can adequately measure informed consent comprehension. This may consequently suggest adequate measures to improve the informed consent procedure.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 97%

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Informed consent comprehension in African research settings

Afolabi

Okebe

McGrath

et al. 2014

Tropical Med Int Health

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“…Despite the apparent consensus in the literature concerning the patients’ lack of comprehension of the essential aspects and features of being enrolled in a clinical trial, what ‘patient comprehension’ actually refers to may vary substantially between studies, as shown in recent papers 7 8. According to these studies, this confusion is mainly due to two related factors: (1) a variety of terms has been used—comprehension, understanding, recall—to define what the specific study aims at measuring; (2) different criteria have been considered for assessing comprehension.…”

Section: Discussionmentioning

confidence: 99%

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension

et al. 2013

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We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

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“…Men som Kari Sand avdekket i sitt doktorgradsarbeid, finnes det ingen enhetlig definisjon av forståelse og derfor heller ingen felles instrumenter som gjør målinger sammenlignbare (Sand 2012, Sand et al 2010. Det underliggende problemet er at forståelse i hovedsak anses for bare å vaere en intellektuell og rasjonell ferdighet, basert på tanke og fornuft, saerlig for å vurdere og overskue konsekvenser av alternative valg.…”

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Ruyter¹

2015

Etisk Skjønn I Forskning

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This work is licensed under the Creative Commons Attribution 4.0 International (CC-BY 4.0).To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/. SAMMENDRAG Stadig flere reguleringer bidrar til å minske rommet for skjønn i forskningsetikken. Det kan vaere behagelig for forskeren å forholde seg til gitte krav og etablere strategier for å unngå å utøve skjønn. Denne artikkelen fremhever at skjønn like fullt er en avgjørende egenskap for at forskere skal kunne utføre forskning på mennesker på en forsvarlig måte. Samtidig vektlegges at det er viktige grenser for skjønnsutøvelse og at skjønnet kan ta feil.NØKKELORD forskningsetikk, samtykke, skjønn, forsvarlighet, tillit ABSTRACT An increasing number of regulations are diminishing the space for discretionary judgement in research ethics. Following requirements thus set out and establishing strategies for avoiding the exercise of discretionary judgement can also be temptingly convenient for the researcher. This article highlights the fact that discretionary judgement is nonetheless an essential quality for researchers, enabling them to conduct research on humans in an appropriate manner. At the same time, the article emphasises that the exercise of discretionary judgement has important boundaries, and such judgement can sometimes be wrong.

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The Understanding of Informed Consent Information—Definitions and Measurements in Empirical Studies

Cited by 33 publications

References 41 publications

Informed consent comprehension in African research settings

Informed consent comprehension in African research settings

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension

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