As clinical trial sites and sponsors consider alternative approaches to conducting research during the coronavirus pandemic, the FDA recommends using electronic consent (e-consent) when possible.
E-consent can help sites provide information to patients and continue enrollment during a time of site closures, quarantines, travel limitations, and more. This is just one of many ways the FDA Guidance recommends anticipating and adapting to these challenges to maintain patient safety and data integrity. Many researchers are already altering study workflows, updating protocol and conducting virtual clinic visits.
Here’s a closer look at what researchers need to consider prior to implementing e-consent.
E-Consent Costs And Requirements
Clinical research is possible because of patients who voluntarily provide their informed consent to participate in trials. The FDA requires a written consent form that is approved by the IRB and signed and dated by the patient or their legally authorized representative at the time of consent (21 CFR 50.27(a)). Remote methods and electronic informed consent (e-consent) have been weighed in recent years to reduce inefficiencies and improve the ability to share new information with currently enrolled patients.
Now more than ever, e-consent could allow for continued enrollment for many trials that have been halted during the pandemic.
E-consent may require up-front costs for design and implementation of a compliant electronic system, plus training study staff and IRB approval. An e-consent must contain all elements required by HHS and/or FDA regulations (45 CFR 46.116 and 21 CFR 50.25). In addition, the e-consent process may include interactive electronic-based technology, diagrams, images or graphics, videos, and possibly narration.
If you are developing an e-consent for your clinical trial, you can find answers in Questions Surrounding Electronic Informed Consents based on the FDA Guidance on the Use of Electronic Informed Consent.
While patients typically experience the informed consent process in-person during discussions with study personnel, e-consent could be obtained through:
- Electronic messaging
- Telephone calls
- Video conferencing
- Live chat with a remotely located investigator or study personnel from a confidential space at home
While in-person visits may be currently restricted due to COVID-19, remote communication with patients at any time can be cost-effective for all parties.
Preparing To Implement E-Consent
For clinical trials not yet open to accrual, consider the following steps:
- Determine if your Electronic Database Capture (EDC) system has the capability of e-consent, or if a separate system is needed.
- Confirm the system and signature process is compliant with 21 CFR Part 11, especially for FDA regulated research. Not all commercially available e-consent solutions are Part 11 compliant.
- Obtain IRB approval for use of e-consent with the specific e-consent system. Of note, some IRBs have preferred vendors.
- Define how the sponsor and its representatives will have access to review the signed e-consent.
- Include e-consent guidance on study training materials and monitoring/data management plans.
For studies currently open to accrual, the above steps still apply. In addition, consider these three questions:
- Will currently enrolled patients be re-consented electronically even if they were initially consented on paper?
- Will e-consent be available for all participating sites or a limited set?
- Will the same language from the original consent be applied, or will there be changes that need to be reviewed and approved by the IRB?
Documentation And Training For E-Consent
When the above steps are complete and questions have been answered, consider the following:
- Document the plan for e-consent implementation in the site and sponsor records.
- Consider noting the relevance to COVID-19 in accordance with the FDA Guidance, similar to how protocol deviations should be explained if they result from the pandemic.
- Determine how consenters should document the process of e-consent in their records.
- Provide clear expectations and training to study staff.
- Paper alternatives should be made available for patients with poor eyesight, limited fine motor skills, or other challenges that could impact the informed consent process.
How IMARC Can Help
Our experienced team has a strong working knowledge of clinical research regulations and best practices. IMARC completes a thorough review of each IRB-approved Informed Consent Form (ICF) and site-specific informed consent process to ensure they are in alignment with the federal regulations, HIPAA, agreements with sponsors, investigational plan, and requirements of the IRB.
We can collaborate with your team to help navigate your next steps in this uncharted territory. Contact us today to talk through e-consent as a possibility for your clinical trial.
Tell Us Your Experience
Have you implemented e-consent for your trial before or during the COVID-19 pandemic? What were some of the challenges you faced? Please let us know your experience and any comments to this post in the comments below.
WIRB Guide for Researchers
WCG Webinar: PART 6: Going Remote During COVID-19: Considerations When Moving Studies Out of the Clinic Setting dated 22 Apr 2020