Making Clinical Trials More Patient-Centered Using Digital Interactive E-Consent Tools

Abstract

International is an independent, nonprofit research organization dedicated to improving the human condition. The RTI Press mission is to disseminate information about RTI research, analytic tools, and technical expertise to a national and international audience. RTI Press publications are peer-reviewed by at least two independent substantive experts and one or more Press editors.

Education and Consent for Population-Based DNA Screening: A Mixed-Methods Evaluation of the Early Check Newborn Screening Pilot Study

“…The U.S. Food and Drug Administration (2015) defines this as “the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive, and interactive Web sites …. to convey information related to the study and to obtain and document informed consent.” Electronic consent may enhance knowledge and engagement of study participants in comparison to traditional informed consent, and improve quality and consistency of the consent process ( Rowbotham et al, 2013 ; Rothwell et al, 2014 ; Simon et al, 2016 ; Cadigan et al, 2017 ; Buckley et al, 2018 ; Biesecker et al, 2019 ). Additionally, electronic consent leverages digital tools to improve visual clarity and focus on content most important to decision making and reduces the length, complexity, and literacy demand of consent materials.…”

“…Additionally, electronic consent leverages digital tools to improve visual clarity and focus on content most important to decision making and reduces the length, complexity, and literacy demand of consent materials. Such approaches may be more engaging, participant-centered, and help address long-reported issues with standard informed consent ( Biesecker et al, 2019 ; Grant, 2021 ).…”

Shining a spotlight on the inclusion of disabled participants in clinical trials: a mixed methods study

“…Exclusion criteria related to potential participants' ability to consent, including the type/degree of disability of disabled people, remain ambiguous. Although some studies have proposed the consideration of alternative methods such as electronic consent forms or proxy consent or the use of assessment tools at the individual level, there are only a few reports of their implementation in clinical trials [50][51] [52]. No clear measures on this topic have yet been presented, so there is an urgent need for consensus on workable strategies, such as standardised guidelines and criteria on disability to be applied to all studies.…”

Use of Communication Technology to Improve Clinical Trial Participation in Adolescents and Young Adults With Cancer: Consensus Statement From the Children's Oncology Group Adolescent and Young Adult Responsible Investigator Network

“…It can also be more difficult to verify the identity and capacity of consenting individuals. 24,30 The use of multimedia resources may also result in a lengthier consent process. 24 Most physicians in small community practices may not receive training for these processes and these services may not be reimbursed by insurances depending on the location and policy.…”

“…[27][28][29] There is also evidence suggesting the e-Consent process is more effective than paper consents for helping potential trial participants understand the procedures and risks of the trial. 30 Moreover, electronic processes enable more straightforward translation into multiple languages. 31 For CROs, e-Consent increases the efficiency of obtaining patient consent for trials.…”