The KUMC Human Research Protection Program is accountable 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 IRB Office early in the process of establishing their collaboration. We are committed to working with investigators to negotiate a single IRB review whenever feasible.
Collaborations involving investigators from KUMC and KU - Lawrence 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 relies on the NCI Central IRB for adult cooperative group trials.
The University of Kansas Cancer Center participates in selected clinical trials offered by US Oncology. Request for oversight by the US Oncology IRB is submitted through the KUMC electronic IRB system.
The CTSA regional partners (UMKC/Truman Medical Center, Children's Mercy Hospital, St. Luke's Hospital, KCUMB) have signed an umbrella IRB reciprocity agreement that will streamline the approval process for joint research. One only IRB review will be needed for projects involving these institutions. The partners have established an algorithm to determine which IRB will be the IRB of record. Investigators from these institutions are encouraged to contact their home IRB office to request a single IRB review for their collaboration.
KUMC sponsors the Greater Plains Collaborative (GPC), a network of ten leading medical centers in seven states. The GPC is funded by the Patient-Centered Outcomes Research Institute (PCORI) to improve healthcare delivery through community-based participatory research and the adoption of evidence-based practices. All ten sites have entered into an IRB reliance agreement so that one institution's IRB can review GPC studies on behalf of all sites.
KUMC investigators have the option of using Western / Copernicus IRB for Phase III or Phase IV multi-center, industry-sponsored drug or biologic trials. Other tirals may be reviewed by this group on a case-by-case basis. Additional information is available from the IRB Office.
KUMC is a member of Neuronext which is an NIH initiative to conduct exploratory trials in neurological conditions. All Neuronext studies are overseen by a central IRB at Partners Healthcare System. Request for oversight by the Neuronext IRB is submitted through the KUMC electronic IRB system.
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 IRB Office as the project is being developed. Single IRB review is generally feasible.
The KUMC IRB will work collaboratively with other IRBs as needed to develop protocol-specific reliance agreements. Please consult with the IRB office as soon as you identify a need to engage an external IRB.
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 / IRB Office to determine how best to meet the regulatory requirements for our community partners.