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Principal Investigator Statement of Assurance
Description
By submitting a study application via IRBOnline, the Principal Investigator agrees to comply with all University of Illinois Urbana-Champaign policies and procedures, as well as with all applicable federal, state, and local laws regarding the protection of human participants in research, including, but not limited to:
- Ensuring all investigators and key study personnel have completed the University of Illinois Urbana-Champaign IRB approved human subjects training program and declared all significant financial conflicts of interest;
- Ensuring the project is conducted with adequate resources to protect participants including but not limited to time, equipment, space, and by qualified personnel following the approved IRB application and study protocol;
- Implementing no changes in the approved IRB application, study protocol, or informed consent document without prior IRB approval in accordance with University of Illinois Urbana-Champaign IRB policy (except in an emergency, if necessary to safeguard the well-being of a human participant, and will report to the IRB within 5 days of such change);
- Obtaining the legally effective informed consent from human participants or their legally responsible representative, using only the currently approved date-stamped informed consent documents prior to that participant’s involvement in the research, and providing a copy to the participant, if applicable;
- Promptly report to the IRB, Data Safety and Monitoring Boards, sponsors and appropriate federal agencies any adverse experiences and all unanticipated problems involving risks to human subjects or others that occur in the course of the research in accordance with University of Illinois Urbana-Champaign IRB Policies and Procedures;
- If unavailable to conduct this research personally, as when on sabbatical leave or vacation, the Principal Investigator will arrange for another investigator to assume direct responsibility for the study. Either this person is named as another investigator in this application, or the PI will notify the IRB of such arrangements;
- Promptly and completely complying with an IRB decision to place an administrative hold suspend or withdraw approval for the project;
- Obtaining Continuing Review approval prior to the date the approval for the study expires. If the Principal Investigator fails to apply for continuing review, IRB approval for the study will automatically expire, and all study activity must cease until IRB approval is granted;
- Fully informing the University of Illinois Urbana-Champaign IRB of all locations in which human participants will be recruited for this project and being responsible for obtaining and maintaining current IRB approvals/letters of cooperation when applicable.