Wednesday, November 03, 2010

Informed consent, teenage girls, medical ethics.

Set aside for a minute the fact that these girls are sexually active - that's to say having sex,usually with older boys or men who are thus committing statutory rape. Set aside the fact that parents seem to have lost control of what their children do - or can't be arsed finding out and where necessary intervening (no, that's the job of the State, innit?)

It is reported that children as young as 13 will be allowed to obtain oral contraceptives without either seeing a doctor or obtaining the knowledge or consent of their parent or guardian.

The 'pilot scheme', is described as an 'enhancement of services' however in truth it is a clinical trial in all but name. NHS Isle of Wight let the cat out of the bag by announcing on their website that the aim of the project is to reduce the number unwanted pregnacies. This is a hypothesis and the testing ground is this 'pilot scheme'. There will be 'real-time data-reporting'. The subjects of what is effectively a community-based trial will be prescribed - without medical supervision - medication with potentially serious adverse effects. As I understand it, neither they nor their parents will be asked for their informed consent. If it looks like a clinical trial and it sounds like a clinical trial - it is a clinical trial.

The conduct of clinical trials in this country is governed by statute in The Medicines For Human Use (Clinical Trials) Regulations 2004 and related legislation. Unless this case has not been properly reported in the press, it would seem that NHS Isle of Wight is conducting a clinical trial on vulnerable subjects involving medication with serious adverse effects, without informed consent. If this is the case, how and why have the law and the ethical principles of the Declaration of Helsinki been so flagrantly ignored?

Were I to conduct a clinical trial in which no informed consent was given (I had to get written, informed consent in one of my recent studies to ask people about their faith in the context of a qualitative study), my feet would not touch the ground on the way to the GMC. I would be out of a job before you could say 'Andrew Wakefield'.

How come NHS Isle of Wight get a free pass?


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