The informed consent process intends to ensure trial participants understand the risks and benefits of joining your trial, but a poor experience leads to low recruitment rates and costly drop-outs.
Electronic Informed Consent (eConsent) improves recruitment and retention of participants by developing better comprehension of consent materials and improving engagement for the full duration of your study.
In this short video, industry expert Sandra "Sam" Sather, reviews the ways that eConsent supports and adds value to the recruitment process.
Sandra "SAM" Sather’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 30 years of clinical experience, has a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. SAM has been dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years as a CCRA and CCRC. She is a current member of the ACRP Academy Board of Trustees, and ACRP Regulatory Affairs Committee (RAC); SAM has been a clinical research coordinator, site manager, sponsor and CRO monitor, auditor, trainer and quality manager. She has multiple training, monitoring and project management experiences of diverse size, and objectives with a variety of global clients. She is a frequent speaker at industry conferences and has authored dozens of courses for clinical research training programs. In 2002 she co-founded Clinical Pathways (CP), LLC.
Informed consent is pivotal to a patient’s experience on a trial.
It helps in our retention, it helps in the quality of our data.
Recruiting patients is—the process can be extremely overwhelming, so when they’re looking at 30 pages, either they’re gonna consent not being totally informed, many times, or they’re going to be overwhelmed and not want to move forward. So having the ability to present the information in different medias and different formats can help support that process of information.
Think about a piece of paper listing 20, 30 risks, 25 benefits. But in electronic informed consent, those risks can be stated but the most major ones first, and maybe explained with a link, ah, presented with ah, a picture or video.
How I go through an electronic consent, can be different from patient to patient, and we can map that.
So eConsent supports recruitment by being able to present the information in a way that is more related to and more supportive of how adults or children, depending on who is being consented, ah, process information.
Another reason it’s much more supportive is that when they’re at home, they would have access to their consent remotely, to be able to look back at certain sections. So designing the consent where they can easily manoeuvre between different sections of the consent, not flipping through 20, 30 pages like they do in paper.
The informed consent process is to ensure someone has had enough information presented that they can process, saying yes or no, coming onto the study.
Electronic informed consent can support the presentation of the information in a way that we can actually test comprehension by asking questions throughout the consent process, especially in those critical things related to ah, understanding the purpose of the study, or understanding what the risks are for the study. So if the person consenting someone sees that they missed those questions in an electronic consent environment, they can spend more time with that patient.
Our goal is that they really understand what they’re committing to, and that they have the ability to understand what might be the—the risks and benefits and make an informed decision. So when somebody comes in more informed, they are more likely to participate and be compliant with the protocol as instructed.
So electronic informed consent can better support retaining our patients on studies, by supporting them being better informed patients. So they’re making a better informed decision coming onto the trial.