We’ve made some important changes to our protocol and consent form templates, and the new versions are now available on the Templates, Training, Tools page on our website.
The revised consent form template revises some language to improve readability, and to correct some inaccurate template language that we’re always sending contingencies about.
The updated protocol template adds some language to the Ethical Considerations section addressing the requirements of IRB Policy 15.5.
As a reminder — always start with a clean template from our webpage when creating protocols or consent forms based off these templates. The temptation to take a previously approved consent or protocol and adapt it to a new study is great, we know. But, you run the risk of accidentally leaving old study language in the new documents if you do that. You also run the risk of not incorporating recent template changes into your new study. Either one of those risks means contingencies get sent back to you.
Also new on the same Templates, Training, Tools page — a checklist for study teams who plan to join a multisite study that is relying on a single, external IRB (or an xIRB study, as we think of them). The checklist is a guide to getting the xIRB process started. We fully expect to update this checklist as we get more practice with xIRB research and learn more about what would be helpful for study teams to know up front. So check back frequently for updates on this checklist too.