4/2/2018
Informed Consent is the process of ensuring the subject’s understanding of the study prior to enrollment, and eConsent may be one step in that process. Not only is Informed Consent a regulatory requirement for subject safety, but well-informed subjects are more likely to enroll and remain compliant, positively affecting enrollment numbers, reducing study costs, and protecting data integrity. eConsent supports the site’s efforts in fully informing subjects. As eConsent gains in popularity, it is important to understand some key benefits and considerations prior to adoption.
Benefits to subjects:
- Ability to review the eConsent at a more relaxing location
- More time to consider the options and request input from friends or family
- Links to additional resources explain study procedures, disease process, definitions, etc.
- Interactive process allows subjects to mark where they have questions
- More engaging digital interface improves attention to the content
Benefits to clinical research stakeholders:
- Better informed subjects are more compliant and less likely to withdraw from the study
- Greater understanding of the study increases enrollment
- Improved comprehension of the study through interactive information delivery, including rich media and knowledge checks
- Direct interactions through the eConsent interface between study staff and subject
- Better documentation of the consent process including version control and audit trail
- Ability to consent subjects at a greater distance from the study site
Due to key differences in utilizing an electronic format, some considerations should be addressed prior to adopting eConsent. eConsent must comply with all regulations regarding Informed Consent, human subject protections, and electronic systems.
Considerations for eConsent Adoption:
- What procedures will be in place to protect data integrity and security?
- How will eConsent integrate into the current Informed Consent process?
- What information does the eConsent automatically document versus what data should the site manually document?
- What training of site study staff needs to be completed and documented?
- How will direct access to the eConsent information be provided in case of inspections / audit?
Although paper-based consent forms have been the standard, interest in eConsent adoption is increasing. The paper-based Informed Consent process is a frequently cited regulatory deficiency. Supporting stakeholders in clinical trials interested in switching to eConsent, the 2016 FDA Final Guidance: Use of Electronic Informed Consent Questions and Answers describes procedures that strengthen subject protections and reduce regulatory burdens. Due to better informed subjects, eConsent promotes human subject protections and cost savings due to increased enrollment and improved subject retention. Automatic eConsent version control, audit trail records, and documentation of the consent process support regulatory risk management and data integrity.
- The Clinical Pathways Team
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