Changes to Approved Studies

Modifications

Submission of changes or modifications to IRB-approved studies are required to maintain compliance with IRB and federal requirements. It is recommended that one modification be approved by the IRB before another modification for the same study is submitted.

Exempt Studies

If the modification will increase or possibly increase the risk level to the study a Modification form (HRP-203) is required. You should also contact the OHR if significant changes are planned that may change the category of review. Generally, changes to the research team only do not require a modification for Exempt Studies, however, if the *PI changes, a Modification form (HRP-203) is needed. 

Expedited and Full Board Studies

A Modification form (HRP-203) is required to be completed for both minimal and major modifications. You will be responsible for completion of a Modification form (HRP-203), in addition to submitting any revised research documents or tools. This includes, but is not limited to the Synposis Form, consent forms, surveys, flyers, and interview questions. The Modification form HRP-203 can be found on the Forms page.

Changes research team members

*Exempt studies do not submit research team roster changes unless the change is a change in PI.

*Changes to PI: Please have the PI to be removed and the PI to be added sign the Modification form (HRP-203). An updated Application Form listing the new PI's information must be included and signed by the new PI and the new PI's Department Chair (as a reminder all studies with a PI with an appointment in the MFA must have either Dr. Simon or Dr. Wasserman sign as department chair, please see Donna Embersit for one of their signatures).

If you are only updating the research team roster (adding or removing personnel), a modification form is no longer required. Please update the Research Team Personnel form (HRP-201) to reflect the current research team and all the personnel changes and submit to OHR with the new team members required training completion report(s). Once OHR has received and acknowledged the updated roster, team members may begin working on the study. 

The Research Team Personnel form must be maintained throughout the life of the study. The Research team personnel form HRP-201 can be found on the Forms page.

See an example of the Research Team Personnel form: Example Research Team Form


 

IRB Forms

Please find the New Chart Review Application Form with New Application Forms below.


Always check the website for latest versions of IRB forms.​