Research Personnel

Quick guide: Research Personnel

Research personnel, i.e. individuals engaged in human subjects research, specifically, individuals who intervene or interact with human subjects or access identifiable information for research purposes, must obtain IRB approval for their participation.

Words to know

  • Investigator: In research subject to FDA regulations, an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
  • IU-affiliated research personnel: research personnel who are Indiana University faculty, staff, and students or employees and staff of IU affiliate institutions that have contracted with the IU IRBs for review and oversight of human subjects research. IU affiliate institutions include Goodman Campbell Brain & Spine, Eskenazi Health, Indiana State Department of Health, IU Health, Purdue Pharmacy Practice, Regenstrief Institute, Rehabilitation Hospital of Indiana, Roudebush VAMC, and Sigma Theta Tau International.
  • Key Personnel: research personnel, other than the PI, who are responsible for the conduct and/or reporting of research. Such individuals may include, among others:
    • Individuals making critical decisions regarding eligibility of subjects
    • Individuals obtaining consent for a study that is greater than minimal risk (Full Board)
    • Individuals listed on Form FDA 1572 or the investigator agreement
  • Non-key personnel: research personnel conducting research procedures under the direction of the PI or key personnel but are not considered responsible for the conduct and/or reporting of research.
  • non-affiliated research personnel: research personnel who are not faculty, staff, or students of IU, or employees or staff IU affiliate institutions
  • Principal investigator (PI): Responsible leader of a team of research personnel 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.
  • Site-specific PI: When the IU IRB is providing review and oversight for an external research site, the responsible leader of a team of research personnel at that site who has the ultimate responsibility for the conduct of the research only at that site.

How it works

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.