The IRB is changing the way study personnel Roles function in eRA. Starting Wednesday, July 25, 2016, the following changes will take effect:
- Individuals listed on studies in eRA with Co-Investigator with Edit and Research Coordinator roles will have the ability to view study documents and to create and submit study submissions such as Amendments and Continuing Reviews on behalf of a PI.
- A new role, Research Assistant, will be included in eRA. Personnel who may not have a direct role in the science of a research study but need to access and download documents from eRA for study activities can be assigned this role (Undergraduate and Graduate Research Assistants, etc.).
Why are you making this change?
Updating these roles helps the you more clearly define the activities that are being undertaken by the personnel on your Protocol. Giving the Co-Investigator with Edit and Research Coordinator roles the ability to submit on your behalf allows you to delegate some of these more administrative tasks to others. This also allows the IRB greater oversight of these roles for investigators who currently utilize Delegates in the eRA system.
How do I update my Co-Investigator's roles for my study?
Submit an Amendment to any study where you would like to update the roles of your Co-Investigators to allow them to submit Amendments or Continuing Reviews on your behalf. These changes will only take effect once the IRB has reviewed and Approved this change, and updated their role in the system. Note that these roles are protocol-specific, so if you need to make this change on several studies, separate submissions will be needed. Note that if you already have personnel with these roles assigned, these changes will take place automatically and no action need be taken unless you wish to revoke these permissions.
Can my Research Coordinator or Co-Investigator with Edit submit my Initial Application?
No. The Principal Investigator of a study will be required to complete the Initial Application process. Part of the submission process is a certification that the investigator will abide by the rules and requirements of CU Human Subjects Research Policy outlined in the Investigator Manual. This certification must be completed by the PI for the Initial Application, and would not be recorded if submitted by another study staff member.
Do I need to make these changes if I have Delegates?
Delegate permissions, which allow an individual to fully act on behalf of a PI in the eRA system for any study, whether listed on that study or not, are being phased out. The IRB is no longer assigning new Delegates. Existing Delegates will continue to be active until this transition is complete. Look for an email in the coming months requesting you update the IRB with your delegate's information in order to ensure they have the appropriate Research Coordinator or Co-Investigator with Edit role in the necessary Protocols.
More information about study personnel roles can be found on the IRB's website, here: http://www.colorado.edu/vcr/irb/getting-started/roles-responsibilities.