New Study Personnel and Continuation Review FAQs

1. Do new study personnel added to a protocol have to be HSP trained?

• Yes. Addition of new study personnel to an IRB approved protocol will only be approved if the proposed study personnel have completed the required HSP training.

2. Is training status of study personnel checked at continuation review time?

• Yes. Study personnel listed on the IRB protocol, at continuation review, must have up-to-date HSP training or be removed as study personnel from the IRB protocol.

3. What if an individual listed as study personnel on the continuing review report has not maintained his/her HSP training?

• Upon receipt of a Continuing Review submission, ORI staff screen the submission and promptly notify the investigator regarding any study personnel whose training has or is close to expiring in order for the personnel to complete training while the IRB is conducting the CR review.
• If the listed study personnel have not completed or renewed their HSP training at the time Continuation Review (CR) approval is issued, they will be removed from the protocol and can be added back upon completion of the training via a Modification Request. Automated reminders are sent from CITI to the individual's email listed on the CITI account, approximately 90 days prior to the expiration date.