What information and preparation is required prior to submitting to the IRB?
The level of review for your study or protocol falls under will determine the RCtype of information Information about submitting a new human subjects study for review by the IRB
- Completed application form in the Kuali Protocols system
- If applicable, Study Information Sheet
- Most Exempt research that involves interactions with subjects, including online surveys, should have a study information sheet, but it is not always appropriate for research that is limited to research on normal educational practices when subjects are not asked to perform any extracurricular activities.
- All recruitment materials (advertisements, flyers, phone scripts, etc.)
- All data collection instruments (survey, questionnaires)
For more information on exempt review procedures and requirements, please visit the RCHRPP Policy - Exempt Review Policies and procedures for human subjects research exempt level reviews
- Completed application form in the Kuali Protocols system
- Primary Investigator’s CV
- Informed consent statement or Study Information Sheet (unless a waiver has been requested in the application form)
- Assent (if children capable of assent are being enrolled and a waiver has not been requested in the application form)
- All recruitment materials (advertisements, flyers, phone scripts, etc.)
- All data collection instruments (surveys, questionnaires)
For more information on expedited review procedures and processes, please visit the RCHRPP Policy - Expedited Review HRPP Policy for exempt research policy statements regarding expedited reviews
- Completed application form in the Kuali Protocols system
- Primary Investigator’s CV
- A copy of the protocol
- Informed consent statement or Study Information Sheet (unless a waiver has been requested in the application form)
- Assent (if children capable of assent are being enrolled and a waiver has not been requested in the application form)
- All recruitment materials (advertisements, flyers, phone scripts, etc.)
- All data collection instruments (surveys, questionnaires)