Multi-site or collaborative research occurs when researchers on KU's Lawrence campus and researchers from another institution both will be engaged in research procedures.
Any KU-Lawrence personnel engaged in non-exempt* human subjects research must have IRB oversight, which can be accomplished in either of the following two ways:
- Receive HRPP approval for the human subjects reseach activities, through a new study submission in eCompliance
- Request KU IRB rely on another institution's IRB review by signing an IRB Authorization Agreement
- HRPP must be contacted in order to initiate an IRB authorization agreement. A researcher cannot sign an agreement on behalf of KU.
- Another institution’s IRB approval does not provide IRB oversight for KU personnel unless an IRB authorization agreement is signed. Contact KU HRPP to discuss signing an IRB authorization agreement.
*Please note that non-exempt determinations should be made by the HRPP office.
An individual is engaged in human subjects research if they are involved in any of the following research procedures, as defined by OHRP guidance:
- Receive an award through a grant, contract or cooperative agreement directly from HHS for non-exempt human subjects research, even where all activities involving human subjects are carried out by employees/agents of another institution
- Intervene with any human subject for research purposes by performing invasive or noninvasive procedures
- Examples: Collecting bodily materials; administering counseling/psychotherapy; administering drugs or treatments; implanting medical devices; utilizing physical sensors; utilizing other measurement procedures
- Intervene with any human subject for research purposes by manipulating the environment
- Examples: Controlling environmental light/sound/temperature; presenting sensory stimuli; orchestrating environmental events or social interactions
- Interact with any human subject for research purposes
- Examples: Asking someone for a specimen; conducting research interviews; administering questionnaires; administering surveys (even if online)
- Obtain identifiable private information OR identifiable biological specimens from any source for research purposes, which include any of the following activities:
- Observing or recording private behavior.
- Using, studying or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution.
- Using, studying or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators.