Discrepancy between participants' understanding and desire to know in informed consent: are they informed about what they really want to know?

Koh, Jiwon; Goh, Eurah; Yu, Kyung‐Sang; Cho, Belong; Yang, Jason

doi:10.1136/jme.2010.040972

Cited by 27 publications

(23 citation statements)

References 19 publications

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“…Our study was initially motivated by the goal of testing the effectiveness of a simplified biobanking consent form and thus the need to develop a measure of "adequate" comprehension. Over the course of this research, however, we realized that implementing such a measure brings into stark relief the question of what should happen when prospective participants fail to grasp the requisite information-a phenomenon that has been amply documented in many research contexts (Beardsley, Jefford, and Mileshkin 2007;Bergenmar et al 2008;Bergenmar, Johansson, and Wilking 2011;Jefford et al 2011;Joffe et al 2001;Koh et al 2012;Lipton et al 2011;Montalvo andLarson 2014), including biobanking (McCarty et al 2007;Ormond et al 2009;Rahm et al 2013). In further exploring this question, we discovered fundamental discord both within and between nationally recognized experts regarding the role and implications of consent comprehension.…”

Section: Discussionmentioning

confidence: 88%

Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension

Beskow

Weinfurt

2019

The American Journal of Bioethics

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Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant's consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked to evaluate the importance of the information again, panelists' opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether consent comprehension is an ethical requirement or an ethical aspiration.

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Section: Discussionmentioning

confidence: 88%

Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension

Beskow

Weinfurt

2019

The American Journal of Bioethics

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“…For example, the high rates of illiteracy make understanding of research concepts challenging; the superior societal status of physicians can deter patients from questioning their doctors; poor access to medical services increases the likelihood of coercion; patients may be suspicious of signing anything other than vital documents such as a marriage license or property transactions; and physicians may be unaware of the procedural details of obtaining informed consent (5). While research participants’ views of the informed consent process have been investigated elsewhere (6,7), little is known about the views of research participants in the EMR. A detailed understanding of the impediments to obtaining a valid informed consent can aid researchers in improving the consent process.…”

Section: Introductionmentioning

confidence: 99%

155 Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study

Mansour¹,

Zaki²,

Abdelhai³

et al. 2015

Easter Mediterr Health J

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Few studies have explored the informed consent process among research participants in developing countries. This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. Over 90% agreed they had time to ask questions and received adequate information about the risks prior to consenting. All participants thought the research and the drug would improve their condition; only 46.1% were aware of receiving a non-approved experimental drug and 21.3% of being randomized. Reasons for participation included: better treatment (100%), to benefit society & advance science (85.4%), to receive free drugs (42.6%) and medical care (43.6%), to get hospitalized (15.8%) and to receive money or gifts (4.9%). Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception.

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“…Limited research has been conducted on the burden aspect of informed consent. At least one study has demonstrated discrepancies between participants' subjective understandings of informed consent elements and what they desire to know with regard to those elements, suggesting that informed consent could be improved by placing more emphasis on elements where participants perceive they are under-informed [20]. However, an earlier study indicated that perceived comprehension may in fact overestimate what research participants understand [15].…”

Section: Introductionmentioning

confidence: 99%

Comparison of Closed-Ended, Open-Ended, and Perceived Informed Consent Comprehension Measures for a Mock HIV Prevention Trial among Women in Tanzania

et al. 2014

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Verifying participant comprehension continues to be a difficult ethical and regulatory challenge for clinical research. An increasing number of articles assessing methods to improve comprehension have been published, but they use a wide range of outcome measures including open-ended, closed-ended, and self-perceived measures of comprehension. Systematic comparisons of different measures have rarely been reported. This study evaluated the likely direction of bias observed when using open-ended, closed-ended, and perceived ease of comprehension measures among women administered a mock informed consent process in Mwanza, Tanzania. Participants were randomized to either a closed-ended or an open-ended assessment of comprehension, administered the consent process for a hypothetical HIV prevention trial in Kiswahili, and then administered a comprehension assessment, per their randomization. They were then asked how easy or hard it was to understand each of the informed consent components measured in the comprehension assessment. Women in the closed-ended arm had significantly higher overall comprehension scores than in the open-ended arm. Perceived scores were significantly higher when compared to both open-ended and close-ended scores within arms but were similar between arms. Findings highlight the importance of comprehension assessments in complex clinical trials that go beyond asking participants if they understand or have any questions. They also indicate the need for continued exploration of objective measures of comprehension in international clinical research settings, so that points in need of clarification can be efficiently and effectively identified and addressed. Such measures would reduce burdens on both staff and participants that result from well-intentioned but potentially unnecessary time spent explaining in unwarranted detail things already understood.

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Discrepancy between participants' understanding and desire to know in informed consent: are they informed about what they really want to know?

Abstract: An information discrepancy was observed between the participants' understanding and their desire to know. By putting more emphasis on under-informed elements, the quality of informed consent could be improved.

Cited by 27 publications

References 19 publications

Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension

Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension

155 Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study

Comparison of Closed-Ended, Open-Ended, and Perceived Informed Consent Comprehension Measures for a Mock HIV Prevention Trial among Women in Tanzania

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