Human Research Protection Program & IRB

When is IRB Review Required?

What is a Human subject?

A living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or 

(2) Identifiable private information (45 CFR 46)

What is Research?

Research is defined by the U.S. Department Health and Human Services as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46).

Please refer to the UW Oshkosh IRB Review: Quick Guide for guidance on whether your project will require IRB approval.  When in doubt, contact the IRB Coordinator to help determine whether a particular project is “research” as defined by UW Oshkosh and by federal regulations.

The Role of the IRB

The primary role of the Institutional Review Board (IRB) is to ensure ethical treatment of research participants. While IRB review for protection of human participants in research is a matter of institutional policy and federal law, these policies and law are informed by the ethical principles outlined in the 1979 Belmont Report.

All research involving human participants (subjects) must be reviewed and approved by the University's IRB before you begin collecting data. This peer review ensures that adequate measures are used to protect the individuals who volunteer to participate in your study. All human research must be approved by the IRB. No research is exempt from review.

IRB Submission Process

1. Submit (1)  hard, signed copy of the  IRB Application for new projects, with all required attachments, to the Office of Grants and Faculty Development, Suite 214 Dempsey Hall, and (1) electronic copy to irb@uwosh.edu.
   
2. Prior to receiving IRB approval, Principle Investigators must complete training in human research ethics. 
   

Instructions for Collaborative Institutional Training Initiative (CITI) Training Course:

Principal Investigators must complete a web-based training course in Human Subjects Research sponsored by CITI (Collaborative Institutional Training Initiative).  This training is federally mandated as part of our University’s compliance with our Federal Wide Assurance.  The training is valid for three (3) years.  A refresher training course will be required once the original certificate expires for continuing IRB projects.  Note: The previously required IRB training (NIH Protecting Human Research Participants) will remain valid for 3 years from the date of completion and at the time of their expiration, the CITI training will be required.

• Enter the CITI training website
  

•  Select: New Users Register Here.  You will need to create your profile and affiliate with University of Wisconsin Oshkosh.  You will be prompted by questions that determine what human subjects course and modules you will be required to complete.

• Once your Courses appear on your training page, you may enter the training.  There will be short quizzes at the end of the modules that you will need to take to earn credit for the course.
• The training consists of various modules and may take 2-4 hours to complete, so please plan accordingly.  If you wish to break up the training into shorter sessions, you are free to exit the training at the end of any module (after taking the quiz) and your completed training will be saved.
•    At the completion of the training, a certificate is issued verifying the curriculum completed.  A hard copy of the Training Certificate must be attached to the IRB Application Form.
• For questions about the CITI Program, please contact the IRB Coordinator.

 3.   DO NOT begin recruiting participants or collecting data until IRB review is complete and you have received confirmation of approval. 

 4.   An IRB staff member will perform an initial review to determine that the application is complete and to determine what level of IRB review is required for the project. If the level of risk  is no more than minimal, the proposal can be handled by Exempt or Expedited procedures.  The type of review required is determined by the level of risk participants are asked to assume when engaging in the research. See our Exempt & Expedited Reviews page for more information regarding exempt and expedited reviews.

5.   Review will take approximately 1-2 weeks for an “Exempt” review; 2-3 weeks for an “Expedited” review; and 3-6 weeks for a “Full Board” review.  The Full Board Committee is required to review any research that is more than minimal risk.  The committee meets approximately once a month during the academic school year to conduct IRB business.

6.   If the reviewers determine changes must be made to your research plan, you will be contacted directly.

7.   When your project is approved, you will receive written confirmation from the IRB that you are cleared to proceed with your participant recruitment and data collection.  IRB projects are valid for a period of one year from the approval date.

8.   IRB regulations require at least annual monitoring of all projects.  One year from the date of your IRB approval, you will be required to complete an annual IRB Status Form. On the annual status form,  a brief summary of the project must be provided.  The status form will prompt you to select if your project is completed or if a project extension is requested.  An extension request must be approved by the IRB before continuing the study beyond the project approval period. 

9.   If changes to your research project are requested , you must submit an IRB Modification Request Form. Approval for your modification request must be granted by the IRB before the changes to your protocol can be implemented.

10. Any adverse event or unanticipated problems must be reported to the IRB within 72 hours of the event using the Unanticipated Problem Form or an Adverse Event Form. 

11.  Please direct any questions about the IRB process to Kelly Schill at (920) 424-3375 or irb@uwosh.edu.