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. 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.

If revisions to a consent document are needed, the revised consent incorporating the new information must be submitted. Depending on the type of new information, a consent form addendum may be appropriate for informing currently enrolled subjects of significant new findings that may have a bearing on their willingness to continue participation in the study. The addendum to consent focuses on the new information subjects need to consider when making a decision about their continued participation in the study but avoids them having to reassess the entire consent when much of it may not be relevant to the change(s). Depending on the nature of the changes, study teams should consider whether subjects should be informed of the change orally prior to consent.

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.