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Principal Investigator (PI) Oversight Responsibilities and Assurances
The Principal Investigator (PI) of a human subjects research project requiring IRB approval has certain responsibilities and makes specific assurances (agreements) with the IRB about oversight of a project. They are outlined in the PI Oversight Responsibilities and Assurances document.
Faculty Advisor Responsibilities for Student Principal Investigators
The University of Iowa IRB has certain expectations of Faculty who oversee students conducting human subjects research requiring IRB approval. These expectations are outlined in the Faculty Advisor Oversight Responsibilities and Assurances document.
For Research Methods Course Instructors
There are various formats for research-oriented UI courses that prepare students to conduct research:
- Research methods course, where students learn about research ethics and study design
- Research seminar, for students to select a research mentor and/or design a research proposal.
Here is a Back to School Reminder which provides a brief snapshot of what to do next if you or one of your students may have projects involving human subjects.
Course-Related Student Project Policy
If your research methods course includes a requirement for students to conduct a research project for educational purposes, please review the IRB policy that allows students to conduct certain types of research as a class assignment without obtaining IRB approval. The instructor is responsible for ensuring that student projects comply with all applicable federal human subjects regulations and University of Iowa policies.
- Policy on Course-Related Student Projects & Human Subjects Research- Located in the IRB Investigator's Guide/Standard Operating Procedure (Section I, Part 12.D)
- Conditions under which IRB approval may not be required for research conducted as a course assignment
- Includes a list of information that must be disclosed to potential subjects
- Checklist for Course-Related Student Projects (download to your desktop for full functionality)
- A tool to help students and course instructors determine if IRB approval may be required
- This checklist is not submitted to the IRB
- Includes a STOP sign and instructions to complete a Human Subjects Research Determination form if the project might require IRB approval
- Human Subjects Research Determination (HSRD) Form – If a determination cannot be made using the checklist above, the student can submit a Human Subjects Research Determination (HSRD) form, through the electronic IRB application system (HawkIRB) to ask whether IRB approval is necessary for a project.
Additional Resource:
- UI Investigator’s Guide\IRB Standard Operating Procedures
- Section II, Part 1.D (Assurances and Responsibilities)