The KUMC Human Research Protection Program is responsible to the federal government for all human subjects research conducted by our faculty, staff or students, regardless of whether it is on our campus or in collaboration with another institution.
Faculty who are collaborating on research outside KUMC must obtain approval for their activities before starting work on the project. In times past, IRB approval from each involved institution was required. Recently, however, the federal government has been encouraging arrangements by which collaborative research can be reviewed and approved by one lead IRB when the proper legal agreements are in place. Investigators are encouraged to contact the HSC Office early in the process of establishing their collaboration.
We are committed to working with investigators to negotiate a single IRB review whenever feasible.
Listed below are examples of current IRB reliance arrangements:
KUMC will rely on the NCI Central IRB for Phase 3 adult cooperative group trials.
(includes collaborative research with UMKC/Truman Medical Center, Children's Mercy Hospital, St. Luke's Hospital, KCUMB)
The CTSA Partners are entering into an umbrella IRB reciprocity agreement that will streamline the approval process for joint research. While the umbrella agreement is under development, study-specific agreements are being negotiated. The CTSA Partners have established an algorithm to determine which IRB will be the IRB of record. CTSA investigators are encouraged to contact their home institution to request a single IRB review for their collaborations.
Collaborations involving investigators from KUMC and KULC require approval from only one IRB. Administrators from the two IRBs will determine which IRB conducts the review, based upon the location of the research activities and the location of the subject population.
KUMC is responsible for research conducted by our graduate students regardless of where it takes place. KUMC distance learners who conduct their master's or doctoral research at their home institution should consult with their advisors and with the HSC Office as the project is being developed. Single IRB review is generally feasible.
KUMC investigators have the option of using Western IRB for Phase III or Phase IV multi-center, industry-sponsored drug or biologic trials. Additional information is available from the HSC Office.
When individuals from non-profit organizations, school districts or community groups serve as study personnel on KUMC research, their employers may not typically conduct research and may not have their own IRB. KUMC often serves as the IRB in these circumstances. KUMC investigators should contact the HSC Office to determine how best to meet the regulatory requirements for our community partners.
Also, please refer to the following topical guidance: