To bring you up to speed, the use of OnCore is School of Medicine policy on all studies with human subjects. It’s canon. We need to see that you’ve accounted for this in your submissions. The use of OnCore is mandated to help track human subjects populations here at Wayne State and, until recently, OnCore fees were to be budgeted into all studies with human subjects. While a good portion of budgets still need to reflect this, the mandate has been altered slightly.
Going forward, investigators applying for funding from non-corporate (i.e., federal and foundation) sources no longer need to include OnCore fees in their budget. They DO, however, need to ensure that their protocol and human subjects populations are registered in the OnCore database at time of award. Please note that proposals and contracts with corporate entities (i.e. pharmaceuticals, biomarkers, and devices) that exceed $50,000 in total direct costs WILL still need to include OnCore fees in their budgets. For all funded studies (corporate and non-corporate) that wish to use OnCore as their Clinical Research Management tool, respective OnCore fees will apply.
This should bring some relief to federal and foundational proposal budgets that are often subject to caps. To reiterate, however: your human subjects populations must still be registered with OnCore (this includes non-clinical trial populations). Please be sure to contact the Clinical Research Services Center (CRSC) for assistance in registering your population, or for questions regarding study management capabilities.
May your June submissions be fruitful!