Human Research Protection Program & IRB
Information about research with human subjects and the Institutional Review Board (IRB).
When is IRB Review Required?
(1) Intervention or interaction with human subjects
(2) Collection of identifiable private data on living individuals and/or
(3) Data analysis of identifiable private information on living individuals
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.
In general, the secondary analysis of existing data only requires IRB review when it falls under the regulatory definition of research and human subjects. Please refer to the IRB Policy on Analysis of Secondary Data for further information.
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.
The Office for Human Research Protections (OHRP) has posted on its website a new set of Frequently Asked Questions (FAQs) on informed consent. In its announcements, OHRP noted that this and all of its FAQs should be viewed as recommendations unless specific regulatory requirements are cited. View the OHRP Informed Consent FAQs here
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
- Submit (1) hard, signed copy of the IRB Application Form for new projects, with all required attachments, to the
Office of Grants and Faculty Development, Suite 214 Dempsey Hall, and (1) electronic copy with attachments as a single word or pdf document to email@example.com. If you will be working with an existing human subjects dataset only, please complete an IRB Existing Data Form instead of the IRB Application Form.
- Prior to receiving IRB approval, Principle Investigators (and Advisors for student projects) must complete training in human research ethics through CITI Program.
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.
- 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. Faculty and staff are required to complete the Social and Behavioral Science Module. Student s are required to complete the Students Conducting No More than Minimal Risk Research Module.
- 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. During the summer months, the IRB doesn't have scheduled meetings, but continuously reviews applications that qualify for exempt status or expedited review.
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, although the IRB may prescribe more frequent monitoring based on risk assessment. One year from the date of your IRB approval, you will be required to complete an annual IRB Continuing Review Form. On the continuing review form, a brief summary of the project must be provided and the 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. The IRB requests that these continuing review forms be submitted 30 days prior to protocol expiration. Submitting an extension request in sufficient time is the responsibility of the PI. If you allow your protocol to expire, all data collection must stop and a new application must be submitted to continue the human subjects research.
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.
11. Please direct any questions about the IRB process to IRB Chair Anca Miron at (920) 424-2328 or IRB Administration at 424-3215 or firstname.lastname@example.org.