montreal

The Medical Research Council of Canada (MRC) is to attempt to broaden the ethical code of conduct for research involving humans that it published in September (see Nature 395, 420; 1998). The decision follows a dispute between a clinical researcher, the pharmaceutical company funding her research, and the hospital where the research took place.

At present, the MRC code covers only research funded by itself and the two other principal fund-granting agencies, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council. It now wants the code to cover all research involving humans, regardless of who funds it. This is becoming increasingly important as government funding for research is being replaced by funding from industry.

The move follows a request for help from Toronto's Hospital for Sick Children to Henry Friesen, president of the MRC, following the release of a report about the activities of Nancy Olivieri, a researcher who had been carrying out clinical studies of the drug deferiprone in the treatment of thalassaemia.

When Olivieri went public with warnings that the drug could cause liver fibrosis, Apotex, the drug's manufacturer which was paying for the research, disagreed with her findings and threatened her with legal action because she had signed a confidentiality agreement.

Olivieri claims that the hospital refused her legal aid to defend herself, a charge the hospital denies. When her research colleagues backed her, a public furore erupted. Olivieri and her supporters called for an independent inquiry into the affair but the hospital refused, agreeing only to set up an investigation of hospital policies and practices in general.

The hospital later changed its mind, and agreed to set up an inquiry into the affair itself. But Olivieri and her supporters refused to participate, claiming that the panel leader, Arnold Naimark, professor of medicine and physiology at the University of Manitoba, had previous links with Apotex funds and so was not impartial.

On 9 December, the hospital released the panel's report, which exonerated the hospital from improper conduct, and said that patient safety was not compromised and that there were no conflicts of interest. But the report acknowledged the need to improve some hospital policies.

The report also criticized Olivieri for failing to report her concern about liver toxicity promptly to its Research Ethics Board. But Olivieri calls the report a whitewash.

Olivieri says that she and her colleagues refused to participate in the inquiry because of conflicts of interest on Naimark's part that she says are a matter of public record. “All the people with intimate knowledge of what happened were never questioned,” she said.

She and her colleagues are determined to get an independent investigation into the matter. Observers say the affair illustrates the dangers of increasing industrial support for research in Canada.