Quorum Review IRB is launching a cloud-based and secure electronic informed consent (eConsent) solution that simplifies research studies, accelerates study startup and improves participant engagement. Developed by Kinetiq, the technology and consulting division of Quorum, Q Consent is the first and only IRB-integrated eConsent solution.
“Our mission at Quorum is to move research forward together, and our Q Consent tool will help researchers and sponsors move forward with a new standard in consenting,” said Cami Gearhart, CEO of Quorum. “The result of our in-house development effort by Kinetiq is a game-changer. Q Consent turns current market perceptions—that eConsent is too slow and too expensive—upside down.”
The New Standard in Consenting
With Q Consent, Quorum identified a need to build a revolutionary, cloud-based solution that removes study startup hurdles by integrating electronic consent with the IRB process. This eConsent solution engages participants more meaningfully in the informed consent process, improves the communication between sites and participants, and greatly reduces the likelihood of consent documentation errors within studies. Plus, Q Consent can be accessed through any desktop, laptop or tablet computer.
“There are good reasons why electronic informed consent technology hasn’t taken off up to this point,” said Tom Favillo, president and COO of Quorum. “Paper-based informed consent has remained entrenched because the cost of implementing eConsent solutions has outweighed the benefits. Q Consent bridges almost every gap that sponsors, CROs, and sites have identified in their analyses of electronic informed consent solutions. Beyond the participant engagement features of most solutions in the marketplace, Q Consent provides an easy and secure way to improve compliance, accuracy, and study startup timelines—activating studies in days instead of weeks.”
Highest Level of Compliance and Security
Q Consent achieves the highest level of compliance available. This solution meets or exceeds the most stringent privacy and security requirements, including HIPAA, HITECH and 21 CFR Part 11. Plus, this is the only electronic consent solution that complies with the Children’s Online Privacy and Protection Act (COPPA) and the Canadian Personal Information Protection and Electronic Documents Act (PIPEDA).
All eConsent Tools Reviewed
Quorum Review IRB will continue to review eConsent-enabled studies that use eConsent solutions from other vendors. Quorum has developed a practical approach to eConsent review that fits any eConsent tool. Quorum has incorporated its years of experience, industry considerations, and the FDA’s final eConsent guidance to develop what is elusive in the industry—a submission process that provides clear direction on what and how to submit to ensure appropriate IRB review.