The IRB evaluates every research protocol according to the ethical principles described in the Belmont Report and according to the specific regulatory criteria outlined in the Common Rule (45 CFR 46) and, when applicable, FDA regulations (21 CFR 50 and 56).
The “Continuing Review Not Required” notification is generated by eIRB when a Minimum Risk, Exempt, or Expedited study that previously had an expiration date in the old IRB system is migrated, and no longer has an IRB approval end date in the new eIRB system. The notification is automated, and you might receive it multiple times; however, no action is required from the Principal Investigator or the study team.
The “Response Time Exceeded’ notification is an auto-generated weekly reminder when a Clarification Request response is pending in eIRB. The notification serves to alert the Principal Investigator and study team that a reply is needed. It does not mean that the response time has expired. The notifications will continue every 7 days until a response is submitted to the IRB.
All investigators and research personnel must complete a Research Certification for each study they are involved with before IRB approval is granted. Note: these study-specific Research Certifications are in addition to the annual conflict of interest (COI) Disclosure Certification.
Research Certifications are integrated with eIRB in two ways:
Only the Principal Investigator (PI) and designated PI Proxies can submit to the IRB. A PI Proxy is someone designated by the PI who can submit on the PI’s behalf in eIRB. PIs can assign any individual listed as a study team member in eIRB as a PI Proxy.
Annual continuing review is generally required for protocols approved by the fully convened IRB committee. An annual continuing review may also be necessary for the following types of protocols:
Typically, U of A researchers must receive U of A IRB approval to conduct research with human subjects, regardless of where the research takes place. When collaborative projects are expected to involve researchers from multiple institutions, contact the HSPP to determine next steps. While in some cases each investigator should work with their own institution’s IRB, in other cases, it might be advisable (or required by a funder) to arrange an IRB reliance/institutional agreement (IAA) to designate one IRB to review and approve the research as a whole.
The HSPP does not accept modifications to determinations of human research as these projects are not overseen by an IRB. Investigators may proceed as long as the intent behind the project remains unchanged. If changes are made affecting whether the activities are human research, a new determination request must be submitted for review in eIRB.
Human subjects training is required for all investigators, faculty, staff, and students conducting research with human subjects at the University of Arizona. There are two CITI training options for investigators to choose from, depending on the type of research:
The IRB must review and approve all changes to previously approved Full Committee or Expedite research prior to implementing the changes. For additional information, see our guidance on Modifying Approved Research.