Human Subjects Research

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…

  1. Are you gathering data about living individuals?
  2. Are you gathering data through either an intervention or interaction with people?
  3. 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

To watch a quick instructional power point, click here.  Getting My Research Started

  • Complete required CITI training. See Education & Training.
  • Request an eIRB user account. See Getting Started in eIRB.
  • Review the IRB’s Policies, Investigator’s Guide, and Data Classification Definitions.
  • Apply to the Reynolda Campus IRB 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. Apply to the medical school 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.
  • Any substantive changes to the original application must be made via an application amendment. Changes to personnel are also made via amendment–use application amendment to change the Principal Investigator and/or non-WFU collaborators; use personnel amendment to change all others.
  • Before the approval term expires, submit a continuing review application or request study closure in eIRB. Don’t forget to complete the final report.
  • 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 second Tuesday of each month, 3:30-5:00 pm, Room 304 Reynolda Hall.

Please note that most applications (those that qualify for Exempt or Expedited level review) can be submitted anytime and are reviewed in the order submitted.  Applications to be reviewed by the Full Board must be submitted at least one week before the meeting date to be considered for the agenda.

IRB meetings are routinely scheduled for the second Tuesday of each month, 3:30-5:00 pm, Room 304 Reynolda Hall.  If there are no agenda items requiring Full Board review, the meeting may be cancelled.

Upcoming Meeting Dates

  • September 11
  • October 9
  • November 13
  • December 11
  • January 8
  • February 12
  • March 19 (third Tuesday)
  • April 9
  • May 14
  • June 11
Contact IRB

John V. Petrocelli, Chair 
Department of Psychology

Pam Moser, CIP
Associate Director for Human Research Protection and Human Protections Administrator

Jeanie Baird, CIP
Human Subjects Protection Specialist    

306 Reynolda Hall
Wake Forest University-Reynolda Campus
PO Box 7528
Winston-Salem, NC 27109-7528