Assessing comprehension of clinical research

Lipton, Lianna R.; Santoro, Nanette; Taylor, Hugh S.; Kidwai, Neiha; Isaac, Barbara; Magnani, Maureen; Pal, Lubna

doi:10.1016/j.cct.2011.04.014

Cited by 8 publications

(5 citation statements)

References 14 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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“…There is a chasm between the theoretical ideals of informed consent and what it accomplishes in actual practice ( 46 , 53 , 55 ). Empirical research has amply shown that consent forms are too long and written at too high a grade level ( 1 , 4 , 19 , 29 , 76 , 84 , 85 , 105 , 106 , 125 ) and, not surprisingly, many participants do not understand the information disclosed ( 4 – 6 , 70 , 71 , 83 , 87 , 97 ), including biobank participants ( 93 , 104 , 114 ). This situation has led commentators to note that consent forms are “growing in length and complexity, becoming ever more intimidating, and perhaps inhibiting rather than enhancing participants’ understanding.…”

Section: Eliciting and Using Public Opinionmentioning

confidence: 99%

Lessons from HeLa Cells: The Ethics and Policy of Biospecimens

Beskow

2016

Annu. Rev. Genom. Hum. Genet.

100

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Human biospecimens have played a crucial role in scientific and medical advances. Although the ethical and policy issues associated with biospecimen research have long been the subject of scholarly debate, the story of attention of a much broader audience. The story has been a catalyst for policy change, including major regulatory changes proposed in the United States surrounding informed consent. These proposals are premised in part on public opinion data, necessitating a closer look at what such data tell us. The development of biospecimen policy should be informed by many considerations—one of which is public input, robustly gathered, on acceptable approaches that optimize shared interests, including access for all to the benefits of research. There is a need for consent approaches that are guided by realistic aspirations and a balanced view of autonomy within an expanded ethical framework.

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“…As they acknowledge, Beskow and Weinfurt are in good company in finding empirically that participants often do not understand components of the research they are looking to participate in, even when various interventions are deployed to improve understanding (Beardsley et al 2007;Bergenmar et al 2011;Bergenmar et al 2008;Jefford et al 2011;Joffe et al 2001;Koh et al 2012;Lipton et al 2011;McCarty et al 2007;Montalvo and Larson 2014;Ormond et al 2009;Rahm et al 2013).…”

Section: Editorialmentioning

confidence: 99%