Follow-up Visits, etc.

New 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 Biology.

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 Center IRB.

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 those institutions.

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 105 protocols.

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 School."

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 year.

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

Childhood 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.)

"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 equation.

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."

—BWS