Major changes are changes that may increase the risk to human subjects or raise new questions concerning risks to human subjects. Examples of major changes that may increase the risk to subjects are: increasing the length of time a subject is exposed to experimental aspects of the study; changing the originally targeted population to include a more at-risk population (e.g., adding children or pregnant women to the study); adding procedures where the risk of the additional procedure is greater than a minimal risk; adding an element that may be the confidentiality of the subject; or increasing the number of participants to be treated by more than 25%, which may affect the study's statistical analyses.
When changing principal investigators, a protocol modification must be submitted to explain who the principal investigator was and who is being appointed the new principal investigator. The original principal investigator completes and submits the request for modification approval form. Changes in principal investigators may qualify for expedited review if no other modification is being pursued.
The IRB may approve, request minor revisions, table or defer, or disapprove modification requests. The OSP staff will notify the researcher in writing of the decision of the IRB and of any changes required. Modification approval is not granted until all required changes have been made and submitted for review and approval. Once approved, the researcher is sent a modification approval letter by OSP staff. Upon receipt of the approval for the modification, the PI may initiate the modification.
The IRB may only approve modifications through the current approval expiration period, unless considered at the time of continuation review. Approval of a modification outside of the continuing review does not extend or otherwise change the expiration date of the IRB's approval for the project. IRB review of a modification outside of a continuing review request does not constitute a continuing review. All researchers are still required to submit research projects for continuing review and approval on an annual basis.
Federal regulations require the prompt reporting by researchers of unanticipated problems that occur in the course of a current IRB approved research project and involve risk to subjects or others. Unanticipated problems may include unexpected adverse events. Unanticipated problems must be reported, within 48 hours, in a written report with a detailed description of the problems by the principal investigator.