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 Federal-wide Assurance and 45 CFR §46.
Do you need IRB approval for your proposed research activity?
Are you conducting the activity to answer a specific research question or to permit conclusions to be drawn?
Do you have an objective and a set of systematic procedures to reach that objective?
Are you trying to develop or contribute to knowledge that may be applied more broadly?
If you answered “yes” to all three of these questions…
- Are you gathering data about living individuals?
- Are you gathering data through either an intervention or interaction with people?
- Are the data private and identifiable?
If you answered “yes” to questions 1 and 2 OR 1 and 3—your activity is human subjects research and requires IRB approval. If you answered “maybe” to any questions, your activity could be human subjects research and may require IRB approval.
Don’t risk noncompliance with University policy or federal regulations! Contact for guidance and documentation of the determination. Remember, only the IRB can make this determination.
Note: You may not start your human subjects research until your protocol has been officially reviewed and approved by the IRB.
Important Information about the Application Process:
- Complete required CITI training. See Education & Training.
- Request an eIRB user account. See Getting Started in eIRB.
- Review the IRB’s Policies and Investigator’s Guide.
- Apply to the Reynolda Campus IRB via eIRB.
- The study team must address IRB concerns within 60 days (full board) or 30 days (exempt/expedited) to avoid administrative closure of the study.
- Study team members can check on the status of their application 24/7. Researchers receive initial feedback within five (5) business days of submission.
- 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.
- Before the approval term expires, submit a continuing review application or request study closure in eIRB.
- 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.
IRB meetings are held the third Tuesday* of each month, 3:00-4:30 pm, Room 304 Reynolda.
eIRB applications to be reviewed by the Full Board must be submitted at least 1 week before the meeting date to be considered for the agenda. Please note that applications that qualify for Exempt or Expedited level review can be submitted anytime and are reviewed in the order submitted.
Upcoming Meeting Dates:
- 10/14/2014* (second Tuesday)