Study Personnel Process Change
COMIRB Aug 25, 2017
As part of ongoing efforts to increase efficiency and improve turnaround times in the COMIRB Office, the COMIRB will no longer review and approve personnel beyond Principal Investigator, Co-investigators and Primary Contact.
Effective Monday, September 5, 2017, COMIRB will only review and approve updates or changes to individuals in the roles of: Principal Investigator, Co-investigator, Primary Contact, or Faculty Mentor.
There is no regulatory requirement for COMIRB to review such changes and the extra work this process has made for study teams and IRB staff will be reduced with this new process.
For personnel who need administrative access to eRA(InfoEd) for COMIRB submissions, COMIRB communications, or study documents, the PI can:
1) Assign these individuals as a “Delegate” within eRA(InfoEd) via “My Profile” (click here for instructions), or
2) Submit a change form allowing access for a specific study.
This process change does not change the requirement for research personnel to maintain all of the required COI disclosures and CITI education courses as outlined in the COMIRB Policy and Procedures (Section 25.3) and the COMIRB website, This change in process will move the responsibility for oversight and compliance to the Principal Investigator.
Effective Monday, September 5, 2017, COMIRB will only review and approve updates or changes to individuals in the roles of: Principal Investigator, Co-investigator, Primary Contact, or Faculty Mentor.
There is no regulatory requirement for COMIRB to review such changes and the extra work this process has made for study teams and IRB staff will be reduced with this new process.
For personnel who need administrative access to eRA(InfoEd) for COMIRB submissions, COMIRB communications, or study documents, the PI can:
1) Assign these individuals as a “Delegate” within eRA(InfoEd) via “My Profile” (click here for instructions), or
2) Submit a change form allowing access for a specific study.
This process change does not change the requirement for research personnel to maintain all of the required COI disclosures and CITI education courses as outlined in the COMIRB Policy and Procedures (Section 25.3) and the COMIRB website, This change in process will move the responsibility for oversight and compliance to the Principal Investigator.
