IRB Education Website: This link contains the following and more!

• Pre-Review/Self-Assessment Tool helps to determine the level of risk, type of review, and documents required for the IRB review of your study.

• Easy to read guidance documents to simplify complex policy

• Decision tools

• Informed Consent Templates

• Schedule of upcoming training events

Pre-Review/Self-Assessment Tool:

The IRB has a decision tool to help determine if the human subject research regulations and IRB policy apply to individual proposals- Human Participant Research (HPR) Determination Tool . This is a good place to start. Reviewing the IRB Education On Demand videos (available in the links below) before completing the tool is recommended.  

• If by the use of this tool, you have determined that the project does not require IRB review:  

  • You do not need to submit this form to the IRB office unless you need documentation from the IRB to concur with your self-determination.  

• If assistance is needed, or you require documentation from the IRB office:  

  • Complete the entire form and email it to IRBQuestions@wayne.edu Include any relevant supporting documents (e.g., grant, protocol, data collection tools)

• If you determine that IRB review is required:

  • If you have determined that IRB review is required, IRB approval must be obtained before conducting any human participant research activities. Visit the WSU IRB website for additional information and the forms required for a new submission: www.research.wayne.edu/irb . E-mail irbquestions@wayne.edu with any questions that come up along the way 

Note about what the IRB's HPR Determination is and what it is not:   

• An IRB Human Participant Research (HPR) Determination is not IRB review.  

  • Investigators can request an HPR Determination from the IRB if assistance is needed to determine if a proposed project requires IRB review, or if IRB documentation is required.   

  • When an HPR determination is requested from the IRB, a designated representative from the IRB Administration Office will review information provided to determine if the proposed project falls within the purview of human subject/participant research regulations and the IRB's oversight.   

  • If the IRB determines during this review that IRB review and approval is required, instructions will be provided to help get started with the process of submitting a study for IRB review and approval.  

• An IRB HPR Determination is different from an IRB Exempt review.  

  • An exempt study is human subject/research that is such minimal risk that it is exempt from some regulatory requirements such as signed informed consent. IRB review and approval is required for all human subject/participant research that fits one or more exempt review category.     

HPR Determination Tool: Instructions and guidance:  

• • Note: the intent to publish a project that would not otherwise meet the regulatory definition of human subject/participant research does not automatically mean that the project requires IRB review.   

Links to relevant IRB guidance:   

• • IRB Education On-Demand: Does My Study Need IRB Review- Part 1   

  • IRB Education On-Demand: Does My Study Need IRB Review Part 2    

Need more assistance? Reach out to one of the following emails:

Email irbquestions@wayne.edu for:

• Asking questions about preparing your IRB documents, IRB policies, and Human Research Regulations

• On-Demand education available

• Pre-Review service for full board studies

Email wsuirbinfo@wayne.edu for:

• Requests to be added to IRB listserv

• Technical questions about eProtocol submission system

Email irbstatus@wayne.edu for:

• Status update requests for any reviews in progress *You must be listed as Key Personnel on the study to receive status updates

• Check your CITI training status

Email relyirb@wayne.edu for:

• Questions on collaborative research external IRB reviews

• Submit external IRB requests