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.

Referenced forms can be accessed and completed by logging into GW iRIS.

Exempt Studies

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

Expedited and Full Board Studies

A Modification form is required to be completed for both minimal and major modifications. You will be responsible for completion of a Modification form, in addition to submitting any revised research documents or tools. This includes, but is not limited to, the synopsis form, consent forms, surveys, flyers, and interview questions. The Modification form can be initiated via GW iRIS.

Changes in research team members

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

*Changes to PI: Both the PI to be removed and the PI to be added must approve the Modification form. 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 (available in GW iRIS) 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 can be found in GW iRIS.

 

IRB Forms

Electronic Submission and Tracking of IRB Applications and Studies