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
- 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.
- Not all individuals involved in research are engaged in the human subjects portion of research. These individuals do not need to obtain IRB approval for activities related to the research. For more information, please contact HSO or see the OHRP Guidance on Engagement.
- Individuals who are receiving only deidentified samples or data
- Individuals who access identifiable data for auditing or monitoring
- Individuals who facilitate recruitment by informing potential subjects about the research, sharing recruitment materials or other information about the research with potential subjects, direct potential subjects to the study team, or seek or obtain potential subjects' permission for the study team to contact them.
- Individuals who perform commercial or other services for investigators, when (1) services performed do not merit professional recognition or publication privileges, (2) services performed are typically performed by those institutions/individuals for non-research purposes; and (3) the individuals do not administer the study intervention being tested or evaluated under the protocol.
- Individuals at an institution not selected as a research site who perform protocol-dictated services/procedures which would typically be performed as part of routine clinical monitoring or follow-up of subjects enrolled at a study site. Please contact HSO for details and specific requirements.
- Investigator(s) at an institution not selected as a research site who administer the study interventions being evaluated under the protocol on a one-time or short-term basis. Please contact HSO for details and specific requirements.
- Research personnel should be listed on the KC IRB Personnel Tab and assigned the appropriate role as defined above: PI; Student, Fellow, Resident PI, Key Personnel, Non-key Personnel. The study team determines the most appropriate role based on the individual’s protocol-specific responsibilities.
- If you need to make changes to PI; Student, Fellow, Resident PI; Key Personnel; or Site-Specific PI, an amendment must be submitted to and approved by the IRB prior to participation in research. For instructions on Amending a Protocol or Adding or Removing Research Personnel, see the KC IRB Instructional Guides.
- Changes to Non-key Personnel should be reported to the HSO; however, prior approval is not required, and the personnel can begin work as soon as the notification has been submitted. For instructions on Amendment for Non-Key Personnel, see the KC IRB Instructional Guides.
- Adding non-affiliated research personnel or external sites must be done by submitting an amendment. When IU is providing approval for an external site, only the Site-specific PI should be listed on the KC IRB Personnel Tab. For more information, see the Quick Guide on IU IRB Review for Non-Affiliated Research Personnel or External Sites.
- If IU-affiliated research personnel wish to obtain approval from an external IRB, see the Quick Guide on Reliance on external IRBs.
Who to contact
For questions about investigator engagement or roles, or obtaining IRB review, contact the Human Subjects Office at firstname.lastname@example.org or 317-274-8289.