Problems prompt closer scrutiny of human research

The re-examination is delving into areas such as regulation, accreditation and research integrity.

By Susan J. Landers, AMNews staff. Nov. 19, 2001.

Washington -- Many in the research community took notice when all federally funded biomedical research was suspended at Johns Hopkins University last spring following the death of a young woman who was participating in a clinical trial.

Ultimately, research with human subjects was allowed to go forward at Hopkins -- but only after the university developed a plan to address the violations found by the Food and Drug Administration and the Dept. of Health and Human Services' Office for Human Subject Protections.

And the experience at the Baltimore university has since triggered introspection far beyond this single institution.

The suspension of research at one of the nation's premier research universities was a harsh penalty, but maybe not too harsh, according to Daniel Callahan, PhD, director of international programs at the Hastings Center, an independent institute that conducts research on ethical issues.

"If enough universities get the pants scared off them, they'll say, 'My God, we don't want to lose our NIH grants, let's take this seriously,' " he said.

To address the violations, Johns Hopkins added another Institutional Review Board and intensified the training provided to all IRB members, faculty and staff.

The Hopkins research disaster followed several others, including one involving the death of a teenager who was participating in a gene therapy trial at the University of Pennsylvania in Philadelphia.

The public outcry over what was regarded as lax regulatory oversight in research arises periodically, said Dr. Callahan, who is writing a book on biomedical research. "Practically every six or seven years since the 1970s the issue keeps reappearing," he said. "What we are seeing now is the latest manifestation of this problem." [...]