09 November 2009

This has the potential to be a really, really good idea...

Every now and then you come across a new development that seems to have potential to change the way clinical trials are conducted.  Today I found another example of this: Consent Solutions.

Here's how it goes:  right now one of the issues in clinical research is the informed consent process is administered by research coordinators with varying degrees of experience and training.  Unfortunately all that technically is required to administer consent is delegation by the principal investigator.  This is where consent solutions comes into play.  Their product is a web-based informed consent discussion that can be tailored to the many individualized needs of not only research sites, but also the participants themselves.  Apparently with this platform, sites (or a sponsor) can submit an informed consent and in return consent solutions produces an integrated, interactive multimedia consent discussion that will ensure consistency across the board.

I think Consent Solutions is a fantastic idea that requires development by a private company because it is likely too technically complex for any one site to build.  I forsee this (if it comes around) to potentially revolutionize the way that clinical trial participants are educated prior to making a decision about jumping on board with a study.  Consent Solutions claims to offer feedback to trial participants in the form of questions to gauge understanding, customization depending on reading level or native language, but most importantly the company standardizes the consent process across sites....something that is clearly absent from clinical trials today.

Just imagine the potential advantage this sort of system: streamlined, consistent consent administration for all sites in a multi-center trial; no qualms from the sponsor/IRB about the quality of consent discussion (presumable, for a site to incorporate Consent Solutions, the finalized product would have to be IRB approved); easy of understanding for subjects; the list goes on and on.  For now though, Consent Solutions seems to be in its relative infancy, but hopefully this idea will catch on and find its niche in clinical research.

Check out Consent Solutions here

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