Rationale

While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials has been historically paper-based.  Given the inefficiencies in the traditional process and the increasing complexity of clinical studies, the current approach at times may raise challenges with respect to quality, compliance, patient understanding and trial retention.

The development of enabling technologies are ongoing to address these issues; however, there is limited guidance currently available to facilitate effective implementation. The eConsent Initiative will develop practical guidance on efficient processes and potential multimedia components that are available to sponsors to facilitate broad, voluntary adoption of patient eConsent. Successful industry adoption of eConsent will transform the informed consent process by using an array of patient-focused multi-media components to empower patients and their caregivers to make better, informed decisions and create process efficiencies for sites, Health Authorities, IECs/IRBs and sponsors.

Benefits

  • Provide patients clear and easy-to-understand clinical trial information so that they are truly informed when making a decision to participate
  • Improve patient compliance by offering sites the tools to get insight into patient’s understanding and reduce complex and time-consuming explanations, paperwork and quality risks
  • Reduce inspection findings and establish submission considerations for Health Authorities and Ethics Committees to improve review/approval process
  • Enable process efficiencies (e.g., re-consent, remote monitoring, integration with other eClinical systems), reduce corrective actions for audit/inspection consent findings, improve patient recruitment process and reduce dropout rates

Available Assets

The eConsent team plans to collaborate with Patient and Site Advocates, Health Authorities and institutional review boards (IRBs)/independent ethics committees (IECs) to develop the following assets:

  • A framework that describes the potential multi-media components available to sponsors for use in implementing eConsent.
  • A toolkit to aid sponsors by identifying potential processes that may facilitate more efficient and effective implementation of eConsent

Please check back for more information.

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