Human Testing Draws Researcher a Sanction

Johns Hopkins University sanctioned a researcher who tested experimental cancer drugs on patients in India without the approval of a university review board, the school said Monday.

The sanctions, the latest in a series of embarrassments for the university involving human subjects, were based on the findings of a faculty committee appointed in July. It investigated Ru Chih C. Huang, a biology professor in the Krieger School of Arts and Sciences, which is separate from the medical school.

The committee did not find any evidence that patients were harmed. It also found that Huang did not conduct adequate preliminary tests of the drugs on animals.

The university said it has barred Huang from serving as lead investigator on future research involving human subjects and mandated that a senior faculty member supervise her if she participates in studies on humans led by other researchers.

The committee’s report was not made public, university spokesman Dennis O’Shea said, and Huang was not named in university statements due to a confidentiality policy.

Huang’s study was conducted with collaborators at the Regional Cancer Centre in the southern India state of Kerala. The study, involving 26 oral cancer patients, ran from November 1999 to April 2000. Researchers tested whether a chemical from the creosote plant could stop the cancer’s growth.

In July 2001, reports appeared in Indian news media of complaints by physicians that the trial had been improperly conducted.

The doctors reportedly questioned whether researchers had received proper permission from patients, whether surgery or other treatments were delayed, and whether the drug had been screened for toxicity.

Huang said all the patients consented, and she blamed the dispute on confusion between the chemical used, M4N, and NDGA, a toxic derivative of the creosote plant. M4N is not toxic, Huang said.

She said she did not submit her study to a Hopkins review board because the research was approved by a Regional Cancer Centre panel. Huang said she was not aware that Hopkins requires internal approval for studies conducted abroad.

Huang, a faculty member since 1965, can appeal the decision.

In July, federal regulators halted most human research at the university for five days after a healthy 24-year-old volunteer died after participating in an asthma study.