I am part of a new start-up whose product is a behavioral health software platform. Unlike other entrepreneurial software ventures where a Minimum Viable Product might do, having a great idea for health care software isn't enough to take it to market.
To prove health care products work and do no harm - from medications, to medical devices, to mobile apps - requires clinical trials. (I use "clinical trials" as an umbrella research term to include clinical studies, field studies, pilot studies, etc.) Clinical trials require people. Since start-ups usually don't have, or have access to, lots of people, that means a health care start-up needs to partner with an organization with lots of people. In addition to lots of people, organizations have lots of policies.
I am in the process of following lots of policies.
People are human and, therefore, subject to protection as human research subjects. My first compliance task was to apply as an independent researcher to take an online course from The Collaborative Institutional Training Initiative (CITI). According to CITI's site, "As of May 2010, the CITI Program is used by over 1130 participating institutions and facilities from around the world. Over 1,300,000 people have registered and completed a CITI course since September 2000."
After a month of emails, phone calls and snail mail to receive access to the software, then after what I estimate to be about 80 hours to take and pass the human research course, I am now one of those over 1 million CITI course grads.
I have thought often of the two most important lessons Bob Pack says he has learned about business: "It will cost more than you thought. It will take longer than you thought."
I can't find the source, but I read something like this within the last six months: "Asking an entrepreneur for time is like asking him for blood."
The CITI course was excellent in the way the best courses are - I gained knowledge and my world view was broadened. The course should be a prerequisite for conducting human subjects research. But it took a lot of time...
The next requirement for conducting a clinical trial is to submit an application to an organization's Institutitional Review Board (IRB). When I see a Word doc application, I assume that my long-cultivated, happy, skilled process will kick in and I will just start writing. However, I had no idea of the depth of thinking, concentration and research, and the synthesis of information, knowledge, ideas and concepts that would be required to complete an IRB application.
Two months later, I am almost finished with my part of writing the IRB application. Like the CITI course, the IRB application process is excellent. Our study's research design and its attentiveness to the people involved is profoundly better as a result of having addressed the IRB application's requirements. But the Bob Pack Theorem applies: It has cost more in personal resources and time than I ever could have imagined.
Handshake 2.0 is headquartered in Blacksburg, Virginia, home of Virginia Tech, and I felt immediate empathy and respect for those conducting this research at Virginia Tech when I read, "This study is approved by the VA Tech IRB." Wow, I have an idea of what that took. Awesome.
Photo shows where I have worn the paint off my laptop's touchpad typing IRB applications, posts for Handshake 2.0, Facebook updates about my cats, and other important content.