Yale ethicist defends safeguards in human investigations

Is the pace of medical advances moving beyond existing safeguards regarding the use of human subjects in experimentation? A series of recent federal reports to the U.S. Congress asserted just that. Responding to the reports, Yale faculty member Robert J. Levine, M.D., told Congress in June that the present methods and guidelines employed by medical schools to assure the safe and ethical use of humans in investigations are “working very well.”

According to four reports recently issued by the inspector general’s office of the Department of Health and Human Services, the system designed to protect human subjects in clinical trials has failed to keep pace with advances in medicine such as gene therapy. “Our total effort reveals a brittle system and even a few cracks,” George Grob, deputy inspector general for evaluations and inspections, testified in June on his office’s year-long inquiry before the House Government Reform and Oversight Subcommittee on Human Resources.

Not so, said Dr. Levine, a professor of medicine and lecturer in pharmacology, who testified in rebuttal on behalf of the Association of American Medical Colleges. Dr. Levine, who chairs the Human Investigation Committee at the School of Medicine, said, the reports “created the impression that the IRB [Institutional Review Board] system is a disaster just looking for a place to happen.

“It would be easy to infer there is a systemic threat to patients,” Dr. Levine testified. “Yet, quite to the contrary, the report acknowledges the study yielded no evidence of harm or abuse to patients.”

For the past two decades, medical schools have been required to follow federal regulations for in-house institutional review boards. Any federally funded research involving human subjects must pass through several layers of review by the school’s board.

While Dr. Levine disagreed with many of the reports’ findings, he did agree with some recommendations for improving the existing system. He concurred that IRBs, in which participation is voluntary, face tremendous workloads and would benefit from greater resources. Requiring IRB review after funding has been approved would reduce the workload, he said, and ensure that research involving humans has been reviewed. He also agreed that training for investigators and IRB members is essential.

Although he described IRBs as overworked and short of resources, he said, “By any standards of realistic performance the IRB system works very well.”