NATIONAL CANCER INSTITUTE CENTRAL IRB
Louisiana State University Health Sciences Center – New Orleans and the National Cancer Institute have entered into an agreement whereby LSUHSC-NO will defer to the Adult and Pediatric NCI Central IRBs (CIRBs) on certain national multi-center cancer treatment trials. The NCI CIRB is dedicated to protecting the rights and welfare of participants in cancer clinical trials. Institutions across the country rely on their expertise to ensure that clinical trials are reviewed efficiently and with the highest ethical and quality standards.
Studies reviewed by the Adult CIRB include all Phase III Adult Cooperative Group treatment trials approved by CTEP (Cancer Therapy Evaluation Program). The Adult CIRB may review other CTEP-approved Phase III clinical trials, even if the sponsor is not a Cooperative Group. The Board may also review Phase II studies for rare tumors that appear on the Cancer Trials Support Unit menu. Studies reviewed by the Pediatric CIRB include all Pilot, Phase II, and Phase III Children’s Oncology Group treatment trials approved by CTEP and/or the Division of Cancer Prevention (DCP). The Pediatric CIRB may review other trials approved by DCP and other federally-funded trials (i.e., R01 grants). The Board may review other CTEP-approved clinical trials as directed by CTEP, even if the sponsor is not a Cooperative Group.
LSUHSC-NO investigators planning to conduct a study for which the NCI CIRB can serve as the IRB of record must also undergo review by the LSUHSC-NO human research protection program (HRPP) to ensure compliance with local institutional requirements as outlined in the CIRB Standard Operating Procedures. The NCI CIRB is responsible for the regulatory IRB review of studies. LSUHSC-NO is responsible for oversight of studies and local monitoring, which will be accomplished by LSUHSC-NO HRPP staff, the Clinical Trials Review Committee in the Stanley S. Scott Cancer Center, and the Pediatric Review Committee in Children’s Hospital. This oversight is not an IRB review, but it does involve in part reviewing proposed research to ensure:
- investigators and research staff are appropriately qualified and resourced;
- mechanisms are in place to receive and address concerns from local study participants and others about the conduct of the research;
- the research is being conducted at sites where appropriate research agreements are in place; and
- Institutional concerns, including biological safety and risk management, are being addressed.
The below form and guidance describe LSUHSC-NO requirements and procedures for conducting applicable NCI–sponsored studies.
For additional information, please contact:
LSUHSC’s CIRB Administrator/Liaison
Jennifer Caldwell, PhD, CIP
Office: (504) 568-4372