Subjects Agree to Participate in Environmental Health Studies without Fully Comprehending the Associated Risk

Lee, Robin; Lampert, Samantha; Wilder, Lynn; Sowell, Anne L.

doi:10.3390/ijerph8030830

Cited by 11 publications

(15 citation statements)

References 35 publications

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“…They knew that comprehension was going to be tested after a time delay. This likely added to the length of time spent reviewing the consent form compared to the earlier studies of Baren, McNutt, and Lee [3]–[5]. Among both research professionals and patients, next-day comprehension was better in subjects randomized to the interactive iPad consent form.…”

Section: Discussionmentioning

confidence: 94%

“…After providing information verbally to two samples of women, research assistants observed that over half of the women read their consent forms in thirty seconds or less before signing. Lee and colleagues gave 73 subjects a comprehension quiz right after the consent form was signed [5]. Of six elements of the form, about half the subjects were not aware of two or more study-related risks.…”

Section: Discussionmentioning

confidence: 99%

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Interactive Informed Consent: Randomized Comparison with Paper Consents

et al. 2013

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Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject’s own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session). Among research professionals (n = 14), there was a trend (p = .07) in the direction of iPad subjects testing better on the online test (mean correct = 77%) compared with paper subjects (mean correct = 57%). Among patients (n = 55), iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001). For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz). Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 99%

Interactive Informed Consent: Randomized Comparison with Paper Consents

et al. 2013

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“…Clinicians have raised the alarm that the consent process is “broken” (Hayden, 2012). For example, research has shown that patients have great difficulty understanding and recounting the research to which they have consented (Brehaut et al, 2012; Ghandour, Yasmine, & El-Kak, 2013; Lee, Lampert, Wilder, & Sowell, 2011; Tamariz, Palacio, Robert, & Marcus, 2013). In other words, clinicians are concerned that the informed consent process leaves research participants and patients not informed about how their data will be used.…”

Section: Introductionmentioning

confidence: 99%

Did I Tell You That? Ethical Issues Related to Using Computational Methods to Discover Non-Disclosed Patient Characteristics

Cato

Bockting

Larson

2016

Journal of Empirical Research on Human Research Ethics

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Background Widespread availability of large data sets through warehousing of electronic health records coupled with increasingly sophisticated information technology and related statistical methods offer great potential for a variety of applications for health and disease surveillance, developing predictive models and advancing decision support for clinicians. However, use of such ‘big data’ mining and discovery techniques has also raised ethical issues such as how to balance privacy and autonomy with the wider public benefits of data sharing. More specifically, electronic data are being increasingly used to identify individual characteristics which can be useful for clinical prediction and management, but that were not previously disclosed to a clinician. This process in computer parlance is called electronic phenotyping, and has a number of ethical implications. Approach Using the Belmont Report’s principles of respect for persons, beneficence, and justice as a framework, we examined the ethical issues posed by electronic phenotyping. Findings Ethical issues identified include the ability of the patient to consent for the use of their information, the ability to suppress pediatric information, ensuring that the potential benefits justify the risks of harm to patients, and acknowledging that the clinician’s biases or stereotypes, conscious or unintended, may also become a factor in the therapeutic interaction. We illustrate these issues with two vignettes, using the person characteristic of gender minority status (i.e., transgender identity) and the health history characteristic of substance abuse. Conclusion Big data mining has the potential to uncover patient characteristics previously obscured which can provide clinicians with beneficial clinical information. Hence, ethical guidelines must be updated to ensure that electronic phenotyping supports the principles of respect for persons, beneficence, and justice.

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“…Studies of the consent process have likewise demonstrated poor participant understanding of study procedures and outcomes. 4,5 Further complicating the challenges to achieving informed consent, clinical studies and their accompanying consent processes have grown in complexity, particularly for multisite clinical trials.…”

mentioning

confidence: 99%