Electronic Informed Consent (eConsent) is the equivalent of the paper-based approach of obtaining informed consent from trial participants. It is delivered via electronic media and may contain interactive multi-media functions that can enhance engagement and comprehension by the trial participant.
The process of informing is key and eConsent is not meant to replace the important discussion between site staff and participant. It rather serves as a tool for enhancing the dialogue and documenting the consent from the participant in a compliant manner.
eConsent is rapidly becoming the new consent standard and this trend has been accelerated by the global COVID-19 pandemic as eConsent can help ensure continuation of the informed consent process when face-to-face contact is impossible or undesirable.
Benefits for both sponsors and participants
eConsent can generate valuable benefits for sponsor and sites by:
- Increase comprehension and engagement of the trial participant
- Help the trial staff to monitor comprehension of the trial participant
- Focus the dialog between trial staff and participant on specific question areas
- Allow for remote consents
- Allow for more efficient re-consents
- Facilitate continuous improvement of the consent content
- Reduce administrative work associated with the paper-based forms
- Allow for real-time and remote reviewing of data and consent status across sites
- Allow for easier access to audit trails
- Allow for more accurate, standardized and timely data collection
- Improve recruitment and retention rates
- Increase tracking ability
- Lower the number of transcription errors if integrated with an EDC system
How can we help?
A vendor selection process can be complex, and several aspects must be carefully considered to ensure identification of the best-fit solution. We can ensure that a thorough analysis of the business needs is performed, and that the decision process is made based on actual needs to avoid unnecessary costs and changes.
We recommend running a pilot study before doing the organization wide implementation to help identify strengths and limitations of the eConsent solution and areas of improvement. We can support you in all phases of an eConsent implementation project from the pre-analysis and vendor selection to project closure and handover.
When we support our clients with implementation of eConsent solutions, we usually go through the following phases:
The project is established based on a thorough analysis including roll-out strategy and impact assessment.
The project is executed according to the plan including establishing the new business processes, configuring the new technology and training of study managers and monitors.
The new solution is handed over to Clinical Operations and IT based on developed documentation-
Your next step?
To see how eConsent can be implemented in your trials, the only thing, you need to do, is contact us, and we will help you all the way from a thorough analysis to a successful implementation of eConsent.
We can implement on time and budget and ensure successful adaptation of eConsent by combining a proven Life Science specific project methodology with a “best-in-class” knowledge of the Clinical Development, Regulatory Affairs and Pharmacovigilance business areas.
Sarah Sendrup is a senior Consultant and an expert in eConsent.