How to Submit to the IRB

The UC Davis IRB uses an electronic database called IRBNet, which provides a suite of tools accessible via the internet, electronic protocol management, online submission and many other important research oversight features to the research community. IRBNet is hosted at a secure, enterprise-class data center that supports and meets the strict requirements of federal regulations.

Initial Review Application (New Project) Process

The initial review application is required for approval of any research utilizing human participants, regardless of risks imposed by the research. Once received, the IRB begins with a screening process to determine whether the proposal qualifies as research and utilizes human participants. In addition, the screening form will assess whether the submission might qualify for exemption or if expedited/committee review is warranted.

Amendment/Modification Submission Process

All amendments/modifications to currently approved research must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the human subjects.

Reportable New Information Submission Process

During the course of the research, investigators or others may encounter events which are unexpected in nature, potentially adverse, and/or can affect the potential risks or conduct of the research. Such information must be reported to the IRB in the form of a Reportable New Information (HRP-214) submission.

Continuing Review/Study Closure Submission Process

Except for human research studies that have been granted exempt determination, the IRB is required to continually review ongoing research at intervals appropriate to the potential risk to participants. Study closures follow the same submission process as continuing review and must be submitted prior to study approval expiration.

NOTE: If the continuing review application is not received by the administrative due date requested in the approval letter, you will be required to develop and implement a suitable corrective and preventive action plan (CAPA).

Responses

When the IRB requires clarification, justification or modifications to secure approval you will need to submit a response.

Frequent Reasons for Deferral at Initial Review

A list of common reasons why initial review applications to the IRB are delayed or deferred to a later agenda.