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Roles and Responsibilities
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Use the links below to access useful information for faculty, staff, and students engaged in human subjects research. These pages include links to guidance documents, training opportunities, and educational tools that researchers can use when designing and conducting human subjects research at the University of Iowa.
The Principal Investigator (PI) of a research project is responsible for all study activities conducted by the PI and research team members. The PI is also responsible for the content of the eResearch (HawkIRB) application. The PI is responsible for submission of a complete HawkIRB New Project form, even when the form is completed by a delegate. Each PI is expected to assure the IRB that they have the expertise and ability to oversee conduct of research exactly as it was approved by the IRB. Student PIs are also required to name a Faculty Advisor to oversee their research and name their advisor as a member of their research team in HawkIRB.
The University of Iowa IRB allows graduate and undergraduate students and trainees in professional programs to serve as the Principal Investigator (PI) of a human subjects research project, provided they have the appropriate knowledge and expertise to oversee the proposed project. Student PIs must have a Faculty Advisor on the research team who agrees to oversee the conduct of the research. Student PIs are required to complete two HawkIRB trainings offered in the IRB ICON Course for Researchers, in addition to CITI human subjects protection trainings appropriate for their discipline.
The Faculty Advisor of a student research project must be a UI faculty or staff member able to provide sufficient time, attention, and guidance to a student PI. Faculty advisors make sure the project design is scientifically sound, the HawkIRB application is thorough and detailed, and the study is conducted in an ethical manner.
For IRB purposes, a research team member is any person in direct contact with research subjects during study procedures and/or has access to subjects' identifiable, private information or biospecimens while working on a research study. While the PI has ultimate responsibility for the conduct of the study, research team members are equally responsible for ensuring that the study is conducted in compliance with all federal, state, institutional and industry regulations.
The eResearch (HawkIRB) system allows Principal Investigators (PIs) name a delegate to act on their behalf to submit forms and respond to HawkIRB workflow. The PI can use the Delegate Permission System to grant and restrict access to delegates on a project-by-project basis. Only the PI can name a HawkIRB Delegate. The HawkIRB Delegates page has instructions for adding/removing a delegate and turning on the Delegate Permission System.
Instructors of research methods courses have a unique opportunity to teach students how to conduct human subjects research. One way to accomplish this is to have students conduct a research project as a course assignment. Instructors must identify when a class research project requires Institutional Review Board (IRB) approval and help students conduct research according to UI IRB policy. This page provides resources and information are available for research methods course instructors.