Human Subjects Protection (IRB)

 

Federalwide Assurance Number: FWA#00000737

NOTE: The IRB now requires that all investigators take the CITI course on-line. Please contact Dr. Christopher Leone with any questions.

Meeting Schedules

The IRB meets on a monthly basis. The fall 2009 schedule is available here.

PLEASE NOTE: Projects that require full-board review (those that are not eligible for "exempt" or "expedited" review) need to be submitted at least 2 weeks prior to the monthly IRB meeting.

New Protocol Submission

Do I Need IRB Approval?

Does My Project Require Exempt, Expedited, or Full Board Review?

What Forms Do I Need to Fill Out?

Special Circumstances

Once you have completed the required forms, new submissions may be forwarded to IRB administrative staff electronically at dawn.oconnor@unf.edu.

Changes to Existing Protocols

In order to implement changes to a previously approved protocol, you must submit an Amendment Request to the IRB. To complete this request you will need to forward the following documents to ORSP:

  • Amendment Request
  • Revised documents (Informed consent forms, instruments, etc.), where applicable.
  • Additional documents as necessary

All documents may be submitted electronically to IRB administrative staff at dawn.oconnor@unf.edu.

Principal Investigator Responsibilities

The principal investigator must maintain a file of human subjects research project documents. This file must include the following items:

  • a copy of the original proposal sent to the IRB for review
  • a copy of all correspondence to and from the IRB regarding the proposal
  • a copy of the IRB stamped approved proposal
  • a copy of the IRB stamped approved consent form(s)
  • a copy of the IRB stamped approved data collection instruments (surveys, tests, questionnaires, etc.)
  • a copy of the IRB stamped approved recruitiment flyers, notices, advertisments, etc.
  • a copy of all IRB stamped approval of revisions (modifications) to any part of the research (proposal, consent form, instruments, etc.)
  • the original signed consent form for each participant
  • a copy of all data derived from the study

Quality Assurance Audits

In accordance with the University of North Florida's assurance agreement with the Office of Human Research Protections (OHRP) and 45 CFR 46.108 of the Code of Federal Regulations for the Protection of Human Subjects in Research, the IRB will perform random and for-cause audits of research projects conducted by UNF researchers.

Policy and Procedures

The IRB and the Research Integrity staff of ORSP are currently in the process of revising their Policies and Procedures. The documents provided below are the most current complete versions. However, if you have a specific question regarding IRB Policy and Procedure, contact IRB administrative staff at dawn.oconnor@unf.edu.

Forms

As you complete the forms below, do not delete questions or sections. If a question or section is not applicable to your research project indicate such with a "not applicable" response. Forms other than those revised in May 2009 will not be accepted after June 1, 2009.

Special Circumstances

Are you:

  • releasing or receiving confidential information pertaining to human subjects? If so, complete the Confidential Control Form.
  • including children in your study? If so, create an Assent Procedure.
  • including children or other vulnerable populations in your study? If so, see the appropriate guidance from the Office of Human Research Protection

IRB Committee

Institutional Review Board

Compliance Links