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The Life Cycle of Informed Consent in Clinical Trials

Graphic showing informed consent form being signed, beign sent to phones and computers, and being stored in binders

by Kathryn Meagley, Senior Product Manager at Florence and former Clinical Research Manager at the Atlanta Veterans Affairs Medical Center

Historically, informed consent in clinical trials has consisted of excessive, time-consuming paperwork. I became a clinical research coordinator and manager because I wanted to serve patients. But I spent much of the consent process copying, scanning, and filing documents instead. 

The traditional informed consent process can also frustrate participants, who must come to the site and quickly read detailed, 15-20 page documents

Electronic informed consent, or eConsent, can make this process more patient-friendly and help clinical research coordinators get back to our top priority: serving participants. The right eConsent software will follow all ICH E6 guidelines and protect participants’ privacy. But it will also provide a more patient-friendly experience and give clinical research coordinators back the time we would otherwise spend buried in paperwork. 

Here’s how eConsent can transform the traditional life cycle of the consent form into a process that’s easier and more efficient for both staff and participants. 

Creating the Consent Form 

Informed consent in clinical trials begins with creating a compliant consent document. Here’s a quick description of how most sites, including mine, used to create a form, and how we could improve our process with eConsent. 

The Traditional Method

When creating a consent form, sites need to ensure that all of the content aligns with 21 CFR Part 50 and 56 and 45 CFR Part 46. Consent forms go through multiple rounds of revisions to make them thorough but understandable to people who don’t have a background in healthcare or medicine.

All of these approvals used to mean sending emails back and forth with sponsors, IRBs, and regulatory teams. We needed to know that we were working with the most up-to-date version of the consent form as we made edits, but this was hard to track. 

Like many research coordinators and managers, my team relied heavily on tracked changes in Word. This meant downloading, editing, saving, and reuploading forms multiple times. We then had to trust that the person we were emailing would use the newest version instead of a version from two or three revisions ago.

With eConsent 

With eConsent software, clinical research coordinators, IRB members, and regulatory staff will all upload the latest version of the informed consent document in the same location. Good eConsent programs will also offer version tracking, so you can instantly see which version of the document is the most recent. 

Using the Latest Version of Updated Consent Forms

Once you identify an eligible participant who wants to join the study, you need to retrieve the latest consent form and bring it to them. Historically, this process could open up multiple opportunities for protocol deviations, especially if consent documents were being stored in multiple locations, like binders or local drives. 

The Traditional Method

When I worked at a research site, my team relied on manual processes, as many sites still do. I remember emailing my team every time an amendment had been submitted to the IRB so they could be on the lookout for new forms. 

Once the IRB reviewed and stamped the form with their approval, we had to be careful to file that form in the correct binder and pull the latest version of the form every time a participant needed to sign. It was a protocol deviation if a participant signed an outdated form, and that deviation required notifying multiple regulatory authorities.

With eConsent

eConsent would eliminate many of these steps, which may be why so many sites are interested in it. Research coordinators would no longer need to worry about sending manual reminders of form changes or filing new forms. 

eConsent platforms would let us log in, see the newest version of a consent document, and automatically send that document to participants. The chance of protocol deviations because a participant received an old form would almost disappear. 

Ensuring Participant Comprehension

Research staff don’t hand a participant a consent document and walk away. To perform informed consent in clinical trials properly, we have to make sure patients understand the study’s procedures, risks, and benefits. 

The Traditional Method

Some participants want time to review the consent form independently with their family, while others are willing to sign at the clinic. With paper forms, the former process requires two trips. The latter can lead to participants feeling overwhelmed by the length of the form and the amount of information contained on each page. 

Research coordinators also have to make sure the participant reviews all sub-forms. If we forget a sub-form, a signature, or part of a form, that constitutes a protocol deviation. So the manual consent process looks something like this:

  1. The participant receives the form. If they want to share it with their family, they often have to leave the site and then return with the form. 
  2. When they return, they sign the form and so does the research coordinator. If the participant or licensed representative signs on the wrong line or misses a line, that’s a protocol deviation. 
  3. The patient has to review all relevant subforms. Missing one is a protocol deviation. 
  4. The clinical research coordinator makes copies of the form, gives one to the participant, and files the other in the participant binder. 
  5. If the participant leaves their copy of the form at the site, the CRC has to mail it to them. 
  6. The CRC manually notes which version of the consent form the participant signed. If the form changes in the future, the CRC might need to ask the participant to come back in to sign a new consent form, and the process will repeat. 

With eConsent

With an eConsent solution, research sites can not only streamline this process but also recruit more patients. For example, I worked on an acute gastroenteritis surveillance study where it was possible for participants to leave the hospital or clinic before we had the chance to approach them to see if they were interested in participating in the study. 

This problem often happened over the weekend, when a patient was admitted into the hospital after hours. The patient might only stay for 1-2 days and would be discharged prior to Monday morning. However, their biological sample that was collected for clinical testing would still be at the hospital. 

We often tried to contact the patient to see if they could come back in to sign the consent form, but we were rarely successful. Who could blame them? Staying in the hospital is never fun. With an eConsent solution, we could have consented them into our study from a remote location. This would have improved our enrollment numbers and the quality of the study. 

eConsent can also ensure that the patient receives the correct form and subforms, automatically signs on all of the correct lines, and has copies of all forms. The participant won’t always have to make an extra trip to the site, and clinical research coordinators won’t have to waste time at the copy machine or post office. 

If participants want time at home to read the document slowly or discuss it with loved ones, eConsent will ensure they have that time. Patients can even enlarge the document on their phone, tablet, or computer to make it easier to read. 

Auditing Informed Consent in Clinical Trials

In order to ensure that we were in compliance, my research site conducted internal audits and double-checked that our consent forms were filled out correctly. This is a regular part of life for any research site–we all want to make sure the safety and rights of our participants are protected. 

The Traditional Method

During a traditional audit, clinical research coordinators have to go through dozens of binders and look at hundreds of forms one by one. I used to find mistakes like participants signing on the line for legally authorized representatives instead of the participant line, or participants signing an outdated version of a form. I’d then have to track down the participants so we could correct the errors.

With eConsent

eConsent software can prevent a number of these mistakes before you even perform an audit. Most eConsent platforms won’t let participants sign on the incorrect line or skip a line. They also won’t give participants access to an outdated form. 

With an eConsent solution, clinical research coordinators don’t have to be on-site and dig out binders to perform audits. Instead, you can conduct audits from any secure location using your laptop or tablet. This makes teams more efficient and allows clinical research staff to spend more time with participants. 

How eConsent helps with the lifecycle of consent forms

As a clinical research coordinator or manager, you’re responsible for managing the long and complex life cycle of informed consent in clinical trials. eConsent can make this life cycle faster and more compliant by eliminating mundane activities like copying and scanning and improving participants’ understanding of the forms. 

When the field made the switch from paper medical records to electronic medical records, the industry went through massive process changes. The same thoughtful evolution will need to occur to bring the informed consent portion of research out of paper. But as more research sites embrace eConsent, we’ll see the entire informed consent process become more efficient, more compliant, and more patient-friendly.