Institutional Review Boards (IRB), or ethical review boards, approve, monitor and review biomedical and behavioral research involving humans. The reviews, presented in the form of studies or protocols, can be long and arduous and demand an enormous dedication of resources including time-management, reams after ream of paper (the eco-impact alone is daunting), and coordinating board members, investigators and researchers who all have hectic schedules of their own! Compound that in the United States with heavy Federal regulation by the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) and you have a process that can be unwieldy at best.
Syync was approached by an IRB looking for help managing the studies, the paper, the individuals and the board. A way to easily maintain massive amounts of information, documentation and decision letters centralized and digitally accessible while automating as much as possible.
First we needed to understand the process. They were the experts, but we needed an education. We attended Ethics conferences and months of workflow and procedural meetings that followed the process from concept to board meeting to approved study. We developed a framework based in Ruby on Rails to give us a solid code base that would scale with demand. We identified both core and possible future modules within the system, developed methods for account holders to modify or create their own digital forms and a digital workflow to encompass the various types of review in our 1.0 release (full board, expedited, exempt, amendments, continuing and adverse event). The meetings module alone had to let the board members meet in real-time, online, and interact with each other while yielding control of the meeting to that particular board's administrator. Details down to automating meeting minutes, pre-populating study information and recording the vote once a motion had been accepted offer a glimpse into to sheer size of the application.
Iritzi, a name we chose rooted in Basque (a region between France and Spain) which translates to opinion, synonym: to review, is becoming the industry tool to manage IRB members, studies from submission to IRB decision, all the forms any institution would want (or can input), minutes, agendas and real-time meetings. Members and researchers can login from anywhere to keep their research moving forward.