Initial Intake and Verification of Training Requirements
Once a new study is submitted by the investigator and enters the Pre-Review state, it is triaged to the appropriate IRB Coordinator based on the type of review:
- Administrative reviews (no human subject, exempt, expedited) and committee meeting reviews are assigned to the IRB Coordinator based on the last name of the principal investigator
- sIRB arrangements are assigned to the Reliance Team
- Reportable New Information and Expanded Access submissions are assigned to the Regulatory Affairs Specialist
Modification and continuing review submissions are automatically assigned by the system to the IRB Coordinator listed as the owner.
A comprehensive pre-review of all applications is conducted to ensure completeness and to identify areas where changes are required to meet regulatory requirements, state and local law, and University policies. Once the review is complete, the IRB coordinator will execute the Pre-Review activity which moves the study into the next phase of review. For procedures specific to applications deemed “not research” or determinations of “no human subjects” , see Chapter 9. For procedures specific to exempt determinations, see Chapter 10. For procedures specific to expedited review, see Chapter 11. For procedures specific to convened committee review, see Chapter 12.
Verification of Training Requirements
All investigators and key personnel involved in Human Subject Research (including Faculty Mentors) are required to complete specific research ethic courses using the CITI training program. Only those individuals who have completed the required training are permitted to conduct human subject research or to access PittPRO. At a minimum, all users must complete courses in Human Subjects Research and Responsible Conduct of Research. Depending on the nature of the study, other courses may be required. See Chapter 22 for additional information. The CITI program can be accessed through www.citi.pitt.edu. IRB Coordinators will verify completion of training for all new submissions as well as when a modification is submitted to add new personnel.