In part one of this two-part blog, we went over some of the numerous benefits of eConsent, a term short for electronic informed consent in clinical research. eConsent, which makes several parts of the consent and data collection process within clinical trials far easier and more convenient, has major plusses for not only research trial participants but also researchers and medical professionals alike.
At AGA Clinical Trials, we’ll explain consent and how electronic methods might make your participation in any of our clinical studies simpler and more convenient. In today’s blog, we’ll go over several of the ways researchers and trial sponsors can benefit from eConsent use within clinical research studies.
Research Team Collaboration
The whole purpose of many clinical studies is to produce actionable data on the area being researched, and eConsent offers numerous tools when it comes to the collection and accessing of this data for researchers. Research professionals have options like mobile apps or other connection formats that sync them with eConsent data, allowing them to view everything from informed consent data to study results in many cases. This makes it far easier for researchers to collaborate with one another and advance the studies in question with more robust data streams.
Many of the apps or other programs that can be connected to eConsent formats integrate seamlessly, tying the consent process directly to any other data that’s then gathered on the participant in the future. This allows researchers to update protocol on a per-participant basis, and also to acquire re-consent if needed.
If consent is withdrawn, on the other hand, this system allows researchers to easily note this and discontinue data collection for that individual. In fact, the same individual can actually have multiple consents stored within the system for different studies or different versions of the same study.
One struggle for some researchers, particularly those conducting large-scale studies with many participants, is keeping volunteers engaged and informed. But eConsent helps here as well, sending automatic emails with attachments of documents and signatures. Many connected systems also have trackers that will continue to allow consenting participants access to the platform and sends them updates when needed.
Limiting Regulatory Risks
Finally, researchers always have to be in compliance with regulatory considerations when it comes to consent and their studies, and eConsent makes it much easier to comply with audits or any major needs here. Support from regulatory agencies like the FDA and Office for Human Research Protections (OHRP) is on the rise for eConsent, and standards are being increasingly formatted to fit this approach as well as the traditional on-paper consent format.
For more on eConsent and how it benefits clinical trial participants and researchers alike, or to learn about any of our clinical trials or healthy volunteer needs, speak to the staff at AGA Clinical Trials today.