Bruce
Gordon, M.D., associate
professor of pediatrics and co-chairman of the Institutional Review
Board (IRB)
at the University of Nebraska Medical Center, 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.