For grants submitted after January 25, 2018, NIH has instituted significant changes for applications proposing clinical trials and/or work with human subjects.
The new requirements affect how and where information is presented regarding human subjects, enrollment and clinical trial information. This information will now be collected at the “study” level and an individual project may include multiple studies. Any lab performing human genetic studies (including DNA sequencing or utilization of human samples) will be impacted by this new requirement. In the “For Faculty/Staff” section of our department website, you can open the “NIH Grant Templates and Guidance” folder to find a decision tree to determine the applicability of these rules to your study (PrivateInfoORBioSpecimensDecisionChart) as well as an annotated version of the new FORM E (Annotated Forms HumanSubjects FORMS E). Additionally, here is a link to a useful video that will walk you through the new process and a link to the NIH which explains the purpose, changes and provides resources. If you have any questions, please contact Ann Nochlin.