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 informationInformation about submitting a new human subjects study for review by the IRB RC type of information Information about submitting a new human subjects study for review by the IRBtype of information that you will need to provide. In general, there are three types of reviews used in evaluating research protocols using humans as research subjects - exempted, expedited, and full board.
- Completed application form in the Kuali Protocols system
- If applicable, Study Information Sheet (unless a waiver has been requested in the application form)
- 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 ReviewPolicies and procedures for human subjects research exempt level reviews RC HRPP Policy - Exempt Review Policies and procedures for human subjects research exempt level reviewsHRPP Policy - Exempt Review .
- 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 ReviewHRPP Policy for exempt research policy statements regarding expedited reviews RC HRPP Policy - Expedited Review HRPP Policy for exempt research policy statements regarding expedited reviewsHRPP Policy - Expedited Review (IU HRPP Policy on IRB Review Process, section 2.5).
- 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)