Investigators

Quick guide: Investigators

Individuals who intervene or interact with human subjects, or access subjects' identifiable data, are considered engaged in research and must obtain IRB approval for their participation.

Words to know

  • Investigator: Individual engaged in human subjects research; specifically, an individual who interacts or intervenes with human subjects or accesses subjects’ identifiable information for research purposes.
  • Principal Investigator (PI): Responsible leader of a team of investigators who has the ultimate responsibility for the conduct of the research.
  • Student, Fellow, Resident PI: Student responsible for design and/or conduct of the research under the mentorship of a PI in order to complete an education requirement.
  • Key Personnel: Investigators, other than the PI, who are responsible for the conduct and/or reporting of research. Such individuals may include, among others:
    • Investigators making critical decisions regarding eligibility of subjects
    • Investigators obtaining consent for a study that is greater than minimal risk (Full Board)
    • Investigators listed on Form FDA 1572 or the investigator agreement
  • Non-key personnel: investigators conducting research procedures under the direction of the principal investigator or key personnel but are not considered responsible for the conduct and/or reporting of research.
  • Site-Specific PIs: When the IU IRB is providing review and oversight for an external research site, the responsible leader of a team of investigators at that site who has the ultimate responsibility for the conduct of the research only at that site.

How it works

Individuals who intervene or interact with human subjects, or access subjects' identifiable data, are considered engaged in research and must obtain IRB approval for their participation. See steps below for details.

Who to contact

For questions about investigator engagement or roles, or obtaining IRB review, contact the Human Subjects Office at irb@iu.edu or 317-274-8289.