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.