As a former site research coordinator, when I think about the process of informed consent, my mind immediately flashes back almost 15 years to a large room with me standing at the podium. As I finish reading the interminable document aloud, I ask in my perky, fresh-out-of-college voice, “Okay, any questions?” Twenty pairs of glazed over eyes look up from the papers, and shake their heads “no” in unison. I then walk around the room signing the document over and over, in duplicate. “Oh no sir, please don’t scribble out the date – just a single line through, initial and date.” I could recite the speech in my sleep.
Fast-forward to today. Through technological advancements in our industry, we now have the ability to hand our volunteers a tablet that contains the informed consent document, explanations of medical jargon, video clips, and quizzes to ensure that they actually understand. The benefits for the site and participants abound: better patient understanding, E-signatures with time and date stamps, medical terminology explained consistently in easy to understand terms – Oh my! Sounds fabulous, right? Well, not so fast – there are plenty of things to consider before implementing eIC on your trial.
In December, the FDA issued new guidance on the use of e-consent, endorsing the practice. Clearly, this is component that more trials will be implementing in the future. As with any new technology or process, there are always points to consider and limitations. The guidance lists several areas that investigators and research sites should be aware of when using eIC.
- Every element that is in your written IC document, must be in the eIC.
- Have a paper copy ready for individuals with poor eyesight, impaired motor skills, or that lack skills in electronics.
- Additional advantages can be seen if you can integrate your e-consent technology into your CTMS, eTMF or EDC technology. A prime example of such is our ClinPlus® eClinical Platform which is unified platform. The addition of this information into our system can provide multiple levels of deeper insights to our trials.
- Since eIC may occur remotely, ensure privacy for your volunteers if your process involves video conferencing or chat.
- How will your site ensure the integrity of e-signatures? Multiple methods of verification are acceptable under 21 CFR part 11 including computer-readable ID cards, biometrics, digital signatures, and combinations of user names and passwords. Similar methods can be utilized to prevent fraudulent use.
- Be prepared to provide a paper copy of the e-signed document for the participant’s records.
- If your site is covered under HIPAA, those authorizations may also be completed electronically.
- You must submit all forms of your consent to the IRB, including any videos and web based presentations that the volunteer may view during the consent process. Note: the additional complexity and new technology may add time to the overall review process.
- Under certain circumstances, the Center for Drug Evaluation and Research, as well as the Center for Biologics Evaluation and Research may request all consent materials for review.
- E-consent materials and documentation of the same, must be archived in a manner that is easily retrieved.
Does eIC present the risk of doubling your work load? Yes, at least with your initial forays into the realm. But, does eIC have the capability to make your life easier, and provide a better overall experience for your trial participants easier? Absolutely.
For more information, ACRP is hosting a one hour webinar on February 28th discussing these recommendations. The webinar is available for $25 for members and $75 for non-members.