You must report planned changes in a study and receive approval from the IRB prior to implementing these changes, except where necessary to eliminate apparent immediate hazards to the subjects. In the case of changes implemented to eliminate immediate hazards to the subjects, the emergency protocol changes must be reported to the IRB using a reportable event submission. See Reportable Event Requirements.

When revising previously approved documents, such as protocols, consent forms, recruitment materials, etc., use a tracked changes feature to denote all revisions (see more information in the Change of Protocol submission guidance). Maintain electronic copies of all documents submitted to the IRB in case revisions are required. Please note that research must continue to be conducted without inclusion of proposed changes until IRB approval of the modification is received unless the changes are necessary to eliminate apparent immediate hazards to subjects.

Depending on the nature of the planned revisions, regulations may require that current and past participants be informed of the revisions. Please review the Reconsenting Participants guidance, and, as necessary, develop a plan for how current and past participants will be informed of the revisions.

The IRB assesses each change to determine whether convened IRB review is required or if the change can be reviewed under expedited procedures (meaning the change can be reviewed by one IRB member apart from an IRB meeting). Typically, changes that can be considered minimal risk (even if the overarching study is more than minimal risk) may be reviewed under expedited procedures. For more information, see HRP 402-CHECKLIST-Non-Committee Review and HRP 313-WORKSHEET-Expedited Review.

For studies funded by NIH, certain modifications will require prior approval by NIH as outlined in NIH’s “Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval: Updated Notice.” Investigators should review this guidance located at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-128.html for information on modifications that require prior approval and the process for submitting prior approval requests.