There is an ongoing need for the clinical research enterprise to address the challenges raised in relation to eConsent, genomics, vulnerable populations, and other aspects of the business. As things evolve, everyone involved needs to have a clear understanding of what’s involved and how to give (or deny) their informed consent.

However, it still requires a human being, well informed and experienced in these matters, to decide whether or not the program is up to the required standards. Firm relationships don’t appear overnight and it takes time to build the cornerstones of a correctly performed informed consent process. Experienced clinical research coordinators (CRCs) as well as new hires with no or little experience are not fully equipped to understand all that’s involved, and that’s concerning since it can lead to sub par standards.

Let’s look at an example of how this problem might arise. A young medical student who is unaware of the importance of the consent signature directs the subject to sign the form and then take it home to read it. The lack of awareness combined with haste can result in this kind of, “It’s just a formality. It’s not important.” attitude. What the student should do is ask the subject to read the form thoroughly and only sign it when they are satisfied that they understand its contents and the implications of agreeing to it. This same lack of attention to detail can result in important information being overlooked by the student.

We know how easily such mistakes can occur which is why our team strives to ensure that all subjects fully understand what they are consenting to. Our teams ask subjects to:

Explain how they would describe the trial to their family.
Complete some short quizzes to test and confirm their understanding.
Confirm their understanding of eConsent.

Another important point to consider is how easy it is to understand the consent forms. These forms can be large, up to 60 pages in length in some cases, so it’s vital that they are written and presented in a format that subjects can comprehend. This is not difficult and only requires some thought and design. For example:

Use simple, straightforward terminology that subjects can understand without having to refer to legal or medical dictionaries.
Use clear headings, and space out the text and paragraphs in such a way that they are easy to read and understand. This is a lesson that online newspapers have already absorbed.