Bruce Gordon, M.D., associate professor of pediatrics and co-chairman of the Institutional Review Board (IRB) at UNMC, has been named chairman of the newly constituted Pediatric Central Institutional Review Board (PedCIRB). The National Cancer Institute (NCI) made the announcement recently.
“This is a wonderful honor and yet another recognition that UNMC is on the cutting-edge of research ethics and human research subject protection,” Dr. Gordon said.
The 17-member PedCIRB is an expansion of the NCI Central IRB (CIRB) Initiative for the central review of NCI-sponsored Cooperative Group protocols. The CIRB Initiative, which was developed by NCI in consultation with the Department of Health and Human Services Office of Human Research Protections (OHRP), provides an innovative approach to human subject protection through a “facilitated review” process that can streamline local IRB reviews of national multi-center cancer treatment trials and can reduce the administrative burden on local IRBs and clinical investigators.
This is the first centralized IRB for pediatric cancer, Dr. Gordon said. After initial meetings, the group likely will meet twice a month electronically. “We have the benefit of the adult CIRB in knowing what works and what doesn’t, so that will be helpful in developing standard operating procedures for review of pediatric studies.”
With the establishment of the PedCIRB, these objectives are now being extended to children with cancer who participate in NCI-sponsored clinical trials conducted by the Children’s Oncology Group (COG).
PedCIRB board members have a great deal of experience in the review of pediatric clinical trials, especially the special considerations that must be made for the evaluation of research involving children.
“The IRB is such an integral part of any large research institution and certainly having somebody who is among the national leaders in the mechanical workings of the IRB will only enhance our research efforts on campus, ” said Rubens Pamies, M.D., vice chancellor for academic affairs. “By being on the front line, Dr. Gordon will be able to provide educational opportunities to our researchers and keep us as up-to-date as possible on the direction of the IRB. That will be helpful to all of us.”
Dr. Gordon, a pediatric hematologist-oncologist, joined UNMC in July 1989. He became a member of the IRB in 1992 and has served as its chairman for seven years. He is a member of the Public Policy Committee of the Applied Research Ethics National Association (the organization of IRB professionals), an editor of the Collaborative IRB Training Initiative (CITI) Editorial Working Group and author of two modules for the course. He has served as clinical director of the Pediatric Bone Marrow Transplantation Program at UNMC. Dr. Gordon received his undergraduate and medical degrees from The Johns Hopkins University in Baltimore, Md.
Beginning in November, the PedCIRB will review all new NCI-approved COG pilot, phase 2 and phase 3 clinical trials prior to their activation and availability for patient entry. The PedCIRB members provide broad clinical, scientific and ethical expertise for the review of COG treatment protocols. The board consists of 10 physicians, two nurses, one bioethicist, four patient advocates, one pharmacist, and one statistician.
Dr. Gordon is the third UNMC faculty member to serve on a national IRB position. In 2003, Ernest Prentice, Ph.D., associate dean for research and associate vice chancellor for academic affairs, was appointed chairman of the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protection. In 1994, Lois Norris, a community representative on the UNMC IRB, was appointed to President Clinton’s Advisory Committee on Human Radiation Experiments.