Follow-up Visits, etc.
IRB Tackles Re-Reviews
Sharon Krag, PhD, hefts a green expandable folder crammed five
inches thick with human research protocol paperwork that will be
reviewed this August afternoon by a newly created third Institutional
Review Board (IRB) at the School.
She sets it on a table in her office. "This is what five
inches of paper? And in two days, they'll get another five inches
of paper. That's the challenge," says Krag, associate dean for graduate
education and research, and professor, Biochemistry and Molecular
Members of the new IRB face a difficult task: conducting thorough
reviews of 105 protocols at the School so that investigators can
restart their research projects.
The reviews follow a July 19 federal Office for Human Research
Protections (OHRP) suspension of federally supported human subjects
research that had been approved by the School of Medicine's Joint
Committee on Clinical Investigation (JCCI) or the Bayview Medical
The OHRP ordered the suspension after its investigation of procedures
following the June 2 death of Ellen Roche, a 24-year-old technician
at the Johns Hopkins Asthma and Allergy Center who had volunteered
for an asthma research study at Bayview.
The July 19 announcement by the OHRP shut down virtually all human
subject research across the University about 2,400 studies.
For the most part, however, the School of Public Health was spared
from the suspension because the School operates under its own research
agreement (called an assurance) with the federal government. The
Krieger School of Arts and Sciences is also under a separate assurance,
and work there was not shut down.
The OHRP announced on July 23 that it would suspend its funding
ban, on the condition that the University re-review most of its
protocols, including 105 protocols led by investigators with primary
appointments at the School of Public Health. These 105 protocols
had initially been reviewed by IRBs at Medicine and Bayview because
they involved new drugs or devices, or patient populations from
The School operates two IRBs, each composed of about 15 faculty
members. One IRB is charged with approving new protocols within
the School, while the second IRB focuses on doing continuing reviews
of the 1,000 studies already in progress at the School. The second
IRB is co-chaired by Ron Gray, MD, professor of Population and Family
Health Sciences, and Ann Skinner, MSW, associate scientist in Health
Policy and Management.
School of Public Health administrators decided to create a third
IRB at the School, also led by Gray and Skinner, to re-review the
The investigators whose studies are on hold until they are re-reviewed
want the reviews done quickly because effects of the delay are rippling
through their research groups. Layoffs are possible because there
is nothing for research staff to do, students need research results
in order to graduate on time, and grant and contract deadlines necessary
for continued funding are in danger of being missed.
"We have taken the position that this is going to be a very thorough
review," says Gray. "We're not rushing it I guess that's
not the right word. We are rushing it, but we're doing it damn carefully."
Gray says he is working three and four nights per week just to
keep up with the workload for IRB3, part of the School's Committee
on Human Research (CHR). "We're not cutting corners because of the
pressure of the number of projects," he says. "We take this very
seriously. We have to protect the reputation of the CHR and the
A typical protocol review done by IRB3 involves an administrative
re-view to ensure that all necessary paperwork is present, a thorough
review of the entire research project by the board's members, and
a vote on whether it should be approved or not. (IRB1 sends back
80 percent of protocol applications for revisions before they can
be approved, according to Krag.) Krag estimates that the 105 protocol
re-reviews being done by IRB3 will be finished by the end of the
Reviewing protocols, however, is not always a straightforward process.
"Human subject research regulations constantly change, and interpretations
constantly change," says Krag. She notes that at a recent OHRP workshop
on the IRB process, the OHRP presenter had to defer answering several
questions because they were about issues that haven't yet been resolved
by the agency.
"It's a very complicated process, and it's complicated because
you want to do the right thing by each subject," says Krag.
Brian W. Simpson
Obesity Proves Tenacious
Results from the three-year Pathways program aimed at reducing
childhood obesity in American Indian communities led School researchers
to two conclusions: The program improved children's diets and increased
physical activity at school, and these successes weren't enough
to reduce students' body fat.
The school-based program attacked the obesity problem from several
angles, says Benjamin Caballero, a professor in International Health
and chair of the Pathways steering committee. Classroom curricula
emphasized healthy eating and physical activity, while the school
cafeteria served more fruits and vegetables and provided reduced
fat milk. Surveys showed that the amount of fat that children consumed
during the school day fell from 33 to 27 percent. The program also
scheduled physical exercise into the school day, with Native American
games such as "Crows and Cranes" and "Chase the Lizard." (See "Healthy
Traditions," Johns Hopkins Public Health, Spring 2000.)
Pathways improved kids'
diets and increased their physical activity. Why didn't their
body fat decrease?
"The question is then, why did it not have an effect on children's
body weight and body composition?" says Caballero, MD, PhD. He notes
several reasons. Pathways only changed children's diet for breakfast
and lunch during the nine-month school year. "It's possible children
eat differently outside of school and some might have compensated
for whatever reduction in calorie intake," says Caballero, director
of the School's Center for Human Nutrition.
While Pathways sponsored informational events for families, the
goal was to make parents and siblings more amenable to healthy choices
that a child learned in the program. "We focused on the piece of
the problem at the school where children spend two-thirds of their
day and consume 65 percent of their calories," Caballero says. Other
studies are looking specifically at the family's role in the nutrition
Another obstacle to reducing children's body fat was age-related:
7- to 10-year-olds are primed for gaining weight and fat. In addition,
the program, which involved 21 intervention and 20 control schools
in the western United States, wasn't helped by mainstream American
advertising that relentlessly hawks fast food, sweets, and sodas
to children. Pathways was designed in response to an epidemic of
obesity among the nation's children, particularly on American Indian
reservations. At one reservation, the rate of obesity in children
quadrupled from 1976 to 1991, leaping from 9 percent to 38 percent.
With obesity now considered an early symptom of diabetes and other
illnesses, communities must prevent it now or pay for a lifetime
of health problems, according to Caballero. "Really there is no
possibility to treat all the symptoms that emerge when 60 to 70
percent of people are obese," he says.
Caballero sees the Pathways results as the foundation for more
research in reducing childhood obesity. Another project is already
under way to collect data on 3- to 5-year-olds in the White Mountain
Apache reservation. Ultimately, the plan is to introduce a program
similar to Pathways for children at a younger age before
they become obese.
"I'm optimistic," Caballero says. "I think our experience from
Pathways is there is a very strong commitment to change things from
everybody, from tribal leaders, teachers, parents, and health administrators.
They really want to change."