Securing informed consent from clinical trial participants involves more than a signature—you need to ensure participants truly understand what they’re signing. A critical first step, consent has a major impact on regulatory compliance, enrollment rates and expenses across the life of your study.
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.
We’re going through great revolution in clinical trials.
One of the most important things that happens with a patient on our studies is informed consent. It is pivotal.
So informed consent is more than the document, it’s more than getting a signature on a form. It is supporting the patient to make an informed decision.
So if we do that better, we can better support patients and also have better data.
The challenges with the way that informed consent has been done are many.
Once we put all the legal language and the consent and present it on paper, ah, it becomes something that is not that supportive of a patient understanding the information.
One of the biggest challenges with consent is the collaboration that needs to happen between sponsor, the research site, and the ethics committee to get an approved version for the site. So it takes a lot of time, a lot of back and forth communication. So if we could streamline that with an electronic collaboration design, it really could help save time and money.
Electronic consent offers many more features, ah, related to the process of consent than the paper process. So you can have multi-media, so you can be presenting information in different formats. So you can mix video with pictures and text. You also can have the patient pause, go back over information, they can listen to a video as many times as they would like to.
Instead of a linear document, it’s modules or sections of a consent. So we can actually map the sponsor’s procedure for informed consent into the eConsent.
Electronic informed consent can support monitoring of the informed consent process much more efficiently and timely.
We have the ability to allow monitors to remotely review data through different trial management types of systems, where they can, without going to the site, identify if the—what patients have been consented, when they were consented pre—and compare that to procedures that have been performed. And they can verify the process of consent.
So 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.
The thinking is, if we have better informed patients, those that accept our studies will be better patients on our studies.
So when somebody comes in more informed, they are more likely to participate and be compliant with the protocol as instructed.