The purpose of the Informed Consent Process is to ensure the subject’s understanding of the study prior to enrollment, to protect data integrity and the subject’s safety and rights, and to reduce noncompliance and study drop-outs. Paper consent forms have been used traditionally, but due to more complex clinical trials and longer, more complicated consent forms, they may not be the best option moving forward.
Some challenges paper consent forms present:
- Long forms containing medical and legal terminology
- Barriers to gauging subject understanding
- Difficult to track amount of time spent on comprehension or the consent process
- Accidental use of wrong version of consent form
Our own SAM Sather and Mika Lindroos from CRF Health co-authored an article, “Using eConsent in Clinical Research to Support Patient Understanding and Welfare,” that describes the benefits of Electronic Informed Consent (eConsent).
Some key benefits include:
- Improved comprehension for subjects
- Ease of documenting
- Topics where subjects had questions
- Questions were adequately answered
- Accessibility for subjects’ future reference
- Facilitates prompt form updating
- Support of the continual consent process
- More efficient use of study teams’ time
Due to its distinctive characteristics, eConsent is uniquely able to facilitate the Informed Consent Process. Utilizing an electronic format allows for a more interactive and informative consent form.
Some key attributes are:
- Displaying the most current version of the consent form
- Imbedded audio and video capabilities for improved comprehension
- Interactive confirmation of comprehension
- Hyperlinks to definitions of medical / legal terminology
- Tracking of subject questions
- Automatic dating of signatures
- Remote monitoring of progress
- Defensible data in case of audit
Supporting stakeholders in clinical trials interested in switching to eConsent, the FDA Final Guidance document on eConsent describes procedures to uphold subject protections and reduce regulatory burdens. Additionally, the TransCelerate eConsent Assets released in October 2017 contain an array of tools and guidelines designed to assist stakeholders in widespread adoption of eConsent.
Eliminating many of the deficiencies of paper format, eConsent offers improvements and benefits to the Informed Consent Process. Utilization of eConsent in clinical trials may enhance subject comprehension and welfare. Better informed subjects result in improved quality of data and subject retention.
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-The Clinical Pathways Team