The need to tighten research oversight

Hopkins study: Outside panel finds institutional fault, but sees hope for new national model.

September 01, 2001

THE BLUNT CRITICISM of Johns Hopkins University's medical research program by an outside panel of experts is a renewed call for the institution to overhaul its safety procedures.

While detailing lapses previously reported by Hopkins and federal investigators after the June death of a human research subject, the panel was most critical of an institutional environment and culture that gave inadequate attention to safety.

Changing that attitude, evident even after a four-day suspension of human research by the federal government in July, will be the biggest challenge for the institution, which gets the most federal grant money of any medical school.

Johns Hopkins has taken strong steps to improve its oversight of clinical research, the panel noted. The five-member external review committee recruited by Hopkins expressed the hope that the university's corrective actions will serve as a national model.

To heighten the scrutiny of medical studies using humans, the university has increased the number of its institutional review boards and is intensifying training for board members. Review boards will fully discuss and examine each study, rather than signing off on subcommittee approvals.

Researchers will receive more training and librarian assistance in searching medical databases on the safety of chemicals. Instruction on the safety of humans in research projects will be intensified.

The panel also criticized the adversarial approach of university researchers toward federal regulators, which leads to resistance to important procedural safeguards.

And panelists challenged Hopkins' repeated assertion that its employees did not feel pressure to volunteer as medical research subjects. A university committee is to reexamine the institution's policies, and consent forms for volunteers will be reviewed.

Ellen Roche, a lab technician at the Hopkins asthma center, died of lung failure after participating in an asthma study. Probable cause of death was inhalation of a chemical, which was not approved by the Food and Drug Administration, given to her in the study.

Strengthening oversight of human research projects, giving the fullest scrutiny to the growing number of such studies, must be the primary goal for this world-renowned medical institution.

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