Government cool on clinical research

Tony Ryall
Tony Ryall
The Government is not keen to fund district health boards to undertake clinical research as a frontline activity.

In its response to the Health Committee's report on how to improve New Zealand's clinical trials environment released recently, the Government suggested to support trials as a frontline activity as recommended would be beyond the scope of district health board objectives.

These objectives included improvement, promotion and protection of the health of people and communities, the reduction of health disparities and the promotion of care and support for people with disabilities.

While clinical research might play some role in achieving these objectives, its effectiveness would be "case and location specific", so could not be thought of as front-line activity.

In its response to the 54 recommendations of the committee, the Government has agreed to streamline and simplify the process.

Health Minister Tony Ryall said the inquiry into the approvals process found it was robust, but it could take months and sometimes years.

"Applicants need electronic filing, they want much tougher time limits and they need the ethics committees working in a more effective way."

The Government has agreed international times for health and disability ethics committee reviews should be introduced and monitored.

Full reviews should take 35 days and expedited reviews 15 days, times shorter than those recommended by the health committee.

Membership of ethics committees will be reduced from the existing 12 to eight, with at least three lay members on each committee.

The number of committees will also be reduced from seven to four by next July. The response document does not give details about the areas the committees will cover.

Clarifying and reducing the scope of the ethics committees' reviews would result in fewer applications being received by them and the reduction in committees would bring New Zealand into line with countries such as France, Germany, Sweden and Japan, the report said.

The Government did not go along with chairmen having power to co-opt, saying that because the committees would not be expected to conduct peer review themselves, their members would not be expected to be experts in the technical detail of the research they reviewed.

Rather than technical or clinical matters, training for committee members would focus on the ethical standards applying to health and disability research and the process that must be followed checking these standards have been met.

"The Government is committed to improving New Zealand's clinical trials environment, and has accepted many of the Health Committee's recommendations on how that should be achieved," Mr Ryall said.

The ethics committee approval process would be streamlined and simplified over the next 10 months.

This work would ensure ethics committees were more efficient and transparent and focusing more clearly on protecting participants in higher-risk research, he said.

Mr Ryall says the Ministry of Health is also looking with other agencies at developing a national health research strategy.

"We are missing out on things, so that's why we need to speed the process up."

- elspeth.mclean@odt.co.nz

 

 

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