The IRB has updated its basic protocol template, and the new version is now available on the IRB website’s Templates and Training page.
In addition to addressing some issues we’ve noticed ourselves sending a lot of contingencies about, this revised template makes some important updates to the data and specimen handling language. The regulatory oversight of data and specimens just keeps getting more complicated, and failure to meet regulatory requirements can cause really big problems. We revised the template, in part, to get investigators thinking about some of these requirements, and to better document the ways they intend to meet them.
We’ve said it before and we’ll say it again — one of our pet peeves in the IRB office is when investigators, rather than starting from scratch on a clean template, try to adapt a previous study protocol to fit a new study. This template is a prime example of why to always start with a clean template (not to mention that revamping an old protocol is rarely 100 percent successful the first time, as old protocol language often gets left in). We are starting to pay closer attention to issues of data and specimen handling, and you risk getting contingencies if you use old protocol template language to address these issues.