Human Research Protection Program & 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 Process

1. Submit your completed IRB application, with all required attachments, to the Office of Grants and Faculty Development, Suite 214 Dempsey Hall.
   
2. Follow these instructions for NIH web-based training course:
1. Prior to receiving IRB Approval, Principle Investigators must complete a web-based training course sponsored by the National Institutes of Health. This training is federally mandated as part of our University's compliance with our Federal-Wide Assurance.
2. The training is found at http://phrp.nihtraining.com/users/login.php.
3. The training consists of seven (7) sections and takes approximately three (3) hours to complete.
4. At the completion of the training, a certificate is issued with the date of completion. The certificate is valid for a period of three years. A hard copy of the Training Certificate must be attached to the IRB Application Form.
5. For more information or questions about the NIH web-based training requirement, please contact Research Administration Manager, Kelly Schill at (920) 424-3375 or schillk@uwosh.edu.
3. DO NOT begin recruiting participants or collecting data until IRB review is complete and you have received confirmation of approval.
   
4. A staff member will perform an initial review to determine that the application is complete and what level of review is required for the project. The level of review 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 1-2 weeks for an “exempt” review; 2-5 weeks for an “expedited” review; 3-6 weeks for a “full board” review.
6. For inquiries regarding the status of your review, contact Kelly Schill, or (920) 424-3375.
7. If the reviewers determine changes must be made to your research plan, you will be contacted directly.
8. 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.
   
9. If changes to your research project are requested, you must submit a 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. One year from the date of your original IRB approval, you will be required to complete the annual IRB Status Form. On the annual status form, you will indicate if your project is completed or if a continuation is requested. This is required per federal IRB regulations.