There are some exciting things happening in clinical research; one of which is patient centric focused trials and improvements in informed consent. Electronic Informed Consent (eConsent) is here to help. One of the goals of eConsent is to support a subject become a successful participant leading to better patients and better data. Through a variety of new consent approaches, eConsent can:
- Enhanced understanding and comprehension – with the eConsent design having an age appropriate design to support the learner and include a variety of media to help present and transmit information to the patient. Therefore, supporting a variety of learning styles and learning level to provide the best experience available to the patient.
- Reduced patient burden with remote consenting – easy access to comprehensive consent, not limited to a paper form.
- Customized consent for diverse participants – The delivery of consent can be done in multiple ways depending on patient needs such as a recording being available to support the visual material and more.
All of the elements described above are referred to in the finalized joint FDA and OHRP Guidance on eConsent. The final FDA guidance emphasizes interactivity and support of flexibility in design and features offered by eConsent. Specifically, the guidance notes that integrating eConsent can help facilitate the subject’s comprehension of the information presented during the consent process.
Thinking about electronic informed consent? SAM Sather discusses the three key benefits of adopting electronic Informed Consent (eConsent) in your clinical trial in this short CRF Health’s video:
-The Clinical Pathways team