What Should I Do if I Want to Make Changes to Approved Research?

If a research proposal receives expedited IRB approval or approval by the full committee, it is approved for implementation exactly as it was submitted to the IRB.  All documents (informed consent forms, recruitment materials, survey tools, etc.) are approved for use in the version that was reviewed by the IRB. All procedures are approved as described in the study protocol and IRB application reviewed by the IRB. Any changes that you wish to make to approved documents or procedures must be reviewed and approved by the IRB before implementation unless the change is necessary to eliminate an apparent immediate hazard to a research subject (in which case the IRB should be notified of the revision as soon as possible after the action has been taken).

 

 

To have revisions to approved research reviewed by the MDHHS IRB, the investigator and Responsible MDHHS Employee should complete the MDHHS IRB Research Revision Request (DCH-1478) and e-mail the completed form with any attachments to MDHHS-IRB@michigan.gov. If the change you have requested represents only a minor adjustment that does not increase the risks to study subjects, it will likely be reviewed by the IRB Chair or other IRB members on an expedited basis. Expedited review should be completed in a few days or up to a few weeks. If the revision proposed is more than a minor change to research that was approved by the full committee, or if the revision might increase risks to participants, the revision request will need to be reviewed at a convened meeting of the IRB.  The IRB meets monthly (generally the first Tuesday of each month) and requires no fewer than 10 business days of notice prior to reviewing a revision request or other IRB application.

 

You will receive a determination notice regarding your revision request and if approved, you can implement the proposed change effective the date of IRB approval.

 

Please note: for research that is approved under an exemption, revision requests only require IRB review if they may have an impact on the exempt status of the research. Similarly, activities approved as not research involving human subjects require revision requests only if the revision may cause the activity to include research, or to involve human subjects in research. We encourage you to contact the MDHHS IRB or to speak with a member of the IRB in your work area if you ever have a question on whether or not a change may impact an exempt or non-research determination.