Patient-Consent Disconnects in Clinical Research

Dickert, Neal W.; Brabson, JoAnne M.; Hunter, Rodney J.; Riedford, Michele

doi:10.1007/s40271-018-0331-7

Cited by 5 publications

(2 citation statements)

References 7 publications

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“…Location of information in consent forms is important, as it has been shown that patients tend to read certain sections of consent forms more attentively than others [ 27 , 28 ], though the impact of the location of information on the comprehensibility of key ideas in consent forms needs to be studied further [ 27 ]. Douglas et al [ 28 ] demonstrated that the first two sections of a consent form are the most thoroughly read.…”

Section: Discussionmentioning

confidence: 99%

Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback

et al. 2023

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Background Although patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation of important information in consent forms for these trials. Methods The study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial’s consent form. The location of information in the consent forms was compared to the participants’ suggestions for placement. Results 34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the “Risks” section. 3/5(60%) consents did this. Conclusions Designing consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding.

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Section: Discussionmentioning

confidence: 99%

Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback

et al. 2023

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“… 36 – 37 Dickert and colleagues argue that de-emphasizing a study’s benefits, while intended to protect participants, may actually reduce understanding and foster mistrust. 38 In the setting of efforts to reduce health disparities, positive framing can encourage uptake of recommended clinical interventions 39 and recruitment of diverse research populations. 36 Emphasizing study benefits does not seem to threaten the voluntariness of an individual’s decision through either undue inducement (i.e., participating because of an improper offer) or coercion (i.e., participating due to a threat of material or physical loss).…”

Section: Discussionmentioning

confidence: 99%

Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol’s evolution

Kraft

McMullen

Lindberg

et al. 2020

Genetics in Medicine

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Purpose This study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations. Methods We conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials. Results Our analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations. Conclusion While involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.

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The Importance of Listening to Patients and to Evidence Regarding Consent for Research

Dickert

2019

The American Journal of Bioethics

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Patient-Consent Disconnects in Clinical Research

Cited by 5 publications

References 7 publications

Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback

Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback

Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol’s evolution

The Importance of Listening to Patients and to Evidence Regarding Consent for Research

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