From paper to screen: regulatory and operational considerations for modernizing the informed consent process

Cobb, Nichelle; Farrar-Edwards, Dorothy; Chin, Erin; Lah, James J.; Goldstein, Felicia C.; Manzanares, C; Suver, Christine

doi:10.1017/cts.2022.379

Cited by 2 publications

(1 citation statement)

References 24 publications

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“…At the center of the informed consent process is the agreement between the researcher and the individual being studied. More research is needed to understand the process an individual undergoes when making the decision to participate or not and how to best inform potential participants [ 16 ]. It is likely that some combination of MRL and trust in, past experiences with, and perceptions of medical research moderates the decision-making process.…”

Section: Introductionmentioning

confidence: 99%

Exploring the Relationship between Medical Research Literacy and Respondents’ Expressed Likelihood to Participate in a Clinical Trial

Dykema

Jones

Garbarski

et al. 2022

IJERPH

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Medical research literacy (MRL) is a facet of health literacy that measures a person’s understanding of informed consent and other aspects of participation in medical research. While existing research on MRL is limited, there are reasons to believe MRL may be associated with a willingness to participate in medical research. We use data from a racially balanced sample of survey respondents (n = 410): (1) to analyze how MRL scores vary by respondents’ socio-demographic characteristics; (2) to examine how MRL relates to respondents’ expressed likelihood to participate in a clinical trial; and (3) to provide considerations on the measurement of MRL. The results indicate no differences in MRL scores by race or gender; younger (p < 0.05) and more educated (p < 0.001) individuals have significantly higher MRL scores. Further, higher MRL scores are associated with significantly lower levels of expressed likelihood to participate in a clinical trial. Additionally, the MRL scale included both true and false statements, and analyses demonstrate significant differences in how these relate to outcomes. Altogether, the results signal that further research is needed to understand MRL and how it relates to socio-demographic characteristics associated with research participation and can be measured effectively.

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Section: Introductionmentioning

confidence: 99%

Exploring the Relationship between Medical Research Literacy and Respondents’ Expressed Likelihood to Participate in a Clinical Trial

Dykema

Jones

Garbarski

et al. 2022

IJERPH

View full text Add to dashboard Cite

show abstract

e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence

Mitchell,

Appelbe,

Bravery

et al. 2023

Trials

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Background During the COVID-19 pandemic, in-person healthcare visits were reduced. Consequently, trial teams needed to consider implementing remote methods for conducting clinical trials, including e-Consent. Although some clinical trials may have implemented e-Consent prior to the pandemic, anecdotes of uptake for this method increased within academic-led trials. When the increased use of this process emerged, representatives from several large academic clinical trial groups within the UK collaborated to discuss ways in which trialists can learn from one another when implementing e-Consent. Methods A survey of UKCRC-registered Clinical Trials Units (CTUs) was undertaken in April–June 2021 to understand the implementation of and their views on the use of e-Consent and experiences from the perspectives of systems programmers and quality assurance staff on the use of e-Consent. CTUs not using e-Consent were asked to provide any reasons/barriers (including no suitable trials) and any plans for implementing it in the future. Two events for trialists and patient and public involvement (PPI) representatives were then held to disseminate findings, foster discussion, share experiences and aid in the identification of areas that the academic CTU community felt required more research. Results Thirty-four (64%) of 53 CTUs responded to the survey, with good geographical representation across the UK. Twenty-one (62%) of the responding CTUs had implemented e-Consent in at least one of their trials, across different types of trials, including CTIMPs (Clinical Trial of Investigational Medicinal Product), ATIMPs (Advanced Therapy Medicinal Products) and non-CTIMPs. One hundred ninety-seven participants attended the two workshops for wide-ranging discussions. Conclusion e-Consent is increasingly used in academic-led trials, yet uncertainties remain amongst trialists, patients and members of the public. Uncertainties include a lack of formal, practical guidance and a lack of evidence to demonstrate optimal or appropriate methods to use. We strongly encourage trialists to continue to share their own experiences of the implementation of e-Consent.

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From paper to screen: regulatory and operational considerations for modernizing the informed consent process

Cited by 2 publications

References 24 publications

Exploring the Relationship between Medical Research Literacy and Respondents’ Expressed Likelihood to Participate in a Clinical Trial

Exploring the Relationship between Medical Research Literacy and Respondents’ Expressed Likelihood to Participate in a Clinical Trial

e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence

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