An article full of revelations appeared on Monday by Shaun Holt on medical ethics in NZ. He explains:
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.
Sounds about as simple as you can get. It is 1,000 miles away from let’s not treat this women for cervical cancer so we can see how effective the treatment is.
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.
This is the first stage of distress. Consulting a Maori health provider should not be mandatory – common sense should apply. And God forbid how you need 350 pages for such a simple study. Think of not only the cost to the healthcare system, but also the research that never happens due to such bureaucracy.
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.
Almost enough to make you weep.
It is no surprise he writes:
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.
We owe Dr Holt our thanks for speaking up. Hopefully the powers that be will take note.
Hat Tip: MacDoctorTags: Health, political corectness