IRB Process in a Nutshell

The Reynolda Campus Institutional Review Board (IRB) protects the rights and welfare of human participants involved in research conducted under the auspices of Wake Forest University, in accordance with its Federalwide Assurance and 45 CFR §46.

Note: You may not start your research until your protocol has been officially reviewed and approved by the IRB.

1. Complete required CITI training. See Education & Training.

2. Request an eIRB user account. See Getting Started in eIRB
   

3. Review the IRB’s Policies and Investigator’s Guide.
   
   
4. Apply via eIRB.
   • Researchers should check the resources available at Getting Started in eIRB for guidance.
   • Investigators whose research requires the review and approval of the WFUHS's IRB should select the medical school IRB when completing their application in eIRB.

     
     

5. 2009-10 meeting schedule
   
   

Meeting dates:
9/21/09
10/19/09
11/23/09
12/14/09
1/11/10
2/15/10
3/15/10
4/19/10
5/10/10
6/21/10*
7/19/10*
8/16/10*

*meeting convened only if full board review is required


6. The study team must address IRB concerns within 60 days (full board) or 30 days (exempt/expedited) to avoid administrative closure of the study.
   
   
7. Study team members can check on the status of their application 24/7. Researchers receive initial feedback within five (5) business days of submission.
   
   
8. Amendments or modifications to an approved protocol should be submitted on paper, using an amendment request form, if the original protocol was submitted on paper. Amendments for protocols that were originally submitted via eIRB should be submitted through eIRB.
   
   
9. Approvals are usually valid for 1 year. Before the approval term expires, submit a continuation or closure form to the IRB. For protocols submitted via eIRB, use eIRB for Continuing Review or Closure.
   
   
10. Retain IRB records and accompanying documentation for as long as they are scientifically useful or three years after study closure, whichever is longer, before destroying them.