Shaun Holt: Our ethics system is now so unwieldy, it's unethical

Opinion

Medical research is hugely important to our well-being and many commentators and politicians have stated that scientific and medical research is crucial for New Zealand's economic development.

Despite this, a study from Auckland University showed no clear increase in the number of clinical trials occurring in New Zealand in recent years.

Funding may be contributing to this lack of growth, but a major factor is the system of ethical approval of medical research. Ethics committees were introduced in the 1970s so a further set of eyes could make sure that medical research studies did not cause unnecessary harm or distress to research patients and participants.

This was a sensible step forward after the horrific Nazi medical atrocities in World War II and other medical research scandals in the US and Britain. These committees originally consisted of a brief review by some senior doctors and then, in another sensible step forward, a non-medical layperson was invited on to the committees to make sure that the doctors were not simply rubber-stamping their colleagues' research.

Since then the process has grown into a hugely complicated bureaucracy, which has lost touch with its original aims.

As an experienced medical researcher and an ex-member of an ethics committee, I am likely to know about the ethical requirements of medical research. Last year I submitted an application for a simple study to see if honey could help treat a common skin infection in children that is otherwise very difficult to treat. Only 15 children were required for the study, and all the caregivers had to do was to apply the honey, cover with a dressing and see if it seemed to help.

In order to apply to the ethics committee, I had to consult a Maori health provider to make sure there were no cultural issues if any Maori children took part and see a justice of the peace to sign a statutory declaration.

The application itself needed around 9000 words to complete and over 350 pages had to be submitted. For a study which could not be any simpler and had almost no chance of causing any harm, the application process took longer than doing the study would have.

The study was rejected by the committee and around 40 points were raised, most of which were either wrong or not relevant to the ethics of the study. For example, I was told to consult at least two more Maori health providers and to have systems in place for interpreters, even though the study was to be undertaken by a few GPs who would ask their own patients with this condition if they wanted to take part.

This example demonstrates how the ethics review system is extremely onerous for researchers and not capable of quickly approving simple ethical studies. Rather than the international standard of five committee members of whom one is a lay person, New Zealand requirements are for 12 members of whom at least half are lay people, and a lay person chairs the committee.

Medical researchers are hugely frustrated by the quality of the ethical reviews of their proposals, the work required for an application and the time taken for the responses and approvals. One of our leading orthopaedic surgeons has said the greatest impediment to medical research here is the growth of the ethics committee process.

Since then the process has grown further. The solution is simple. The Minister of Health can approve private fee-paying ethics committees, which can operate according to the international guidelines. There are people ready to run these committees and a one-week simple process, as opposed to the current 10- to 20-week nightmare, would also attract research to this country.

The global clinical trials industry is worth over US$60 billion and is growing rapidly, yet we undertake only around US$10 million here.

Also, clinical trials give participants free access to the latest medications and reduce the burden on the health system.

The New Zealand medical research ethics review system wastes researchers' time and energy and stops good research that can be of huge benefit to our health and economy. This surely is unethical.

* Shaun Holt is a doctor, researcher and author.