Ethics changes may be threat to patients, say critics

The Government said it would streamline the clinical trial application process. Photo / Sarah Ivey

The health of patients who take part in treatment trials may be put in danger by Government changes to ethics committees, says a group of academics.

After a health select committee inquiry last year into making New Zealand more attractive to companies wanting to run clinical trials, the Government said it would streamline the trial application process, making it simpler and more internationally competitive.

Health Minister Tony Ryall said last night that the safety of participants remained paramount.

The changes include reducing the number and size of the regional health and disability ethics committees, and restricting some trials, based on their expected level of risk, to consideration solely by a committee chairman.

The head of Otago University's bioethics centre, Professor Gareth Jones, said in a letter to the Herald that he and Professors Donald Evans, John McCall and Charlotte Paul (Otago) and Professor Tim Dare (Auckland University), believed the changes would "undermine the current safeguards for research participants".

"The reduction in the number of ethics committees from seven to four will significantly increase the workload of each committee. To meet that workload, the committees are expected to reduce the level of scrutiny of clinical trials, provide expedited review by the chair, and not review some research.

"... many studies will not receive full ethical review and some will not be reviewed at all."

Some trials considered low risk would receive only the "expedited review" by the chairman, which was sometimes likely to prove hazardous.

Professor Jones cited the example of a trial of probiotic use in serious illness as one that would not, under the new system, require full review.

"Yet one such trial published in the Lancet in 2008 reported on a case in the Netherlands where a major excess of deaths in the probiotic group and subsequent investigation showed that the monitoring arrangements for adverse events were insufficient; hence some deaths may have been avoidable."

Professor Paul said yesterday there had been some problems with the ethics committees, but they had been resolved and the new scheme, to be implemented by mid-year, was a backward step.

"I can't see how you can - you couldn't - distinguish high and low risk trials. All trials should go for full review," said Professor Paul, who was a medical adviser to the Cartwright inquiry in the 1980s into the "unfortunate experiment" at National Women's Hospital.

Professor Paul said the group of academics was writing to the minister, appealing for a re-think on the ethics committee changes.

But Mr Ryall said, "We are providing a more streamlined process without affecting quality ... we are confident that quality review will not be adversely affected and that participant safety remains paramount."