Unethical research undertaken by a single handed GP

Case number:
98-03

Case text (Anonymised)

We have received a paper from a GP testing the hypotheses that because 24,25 cholecalciferol has a similar structure to commercially available statins, it may act as an inhibitor of HMA co-reductase. He screened 350 patients in his practice and identified 77 who had a cholesterol concentration above 6.5 mmol per litre. Thirty-three of them agreed to return for a second test 2 weeks later. They then agreed to take calcium and ergocalciferol tablets for 2 weeks and to return for a further estimate of their cholesterol. The author observed that their cholesterol concentration decreased, and he observes that the reduction in cholesterol is similar to that published in large studies on the effects of statins. This is a scientifically meaningless paper, and there is no evidence that the GP got consent from an ethics committee. Indeed, I don’t see how he could possibly have got consent for such a study. I have written to ask him if he has got such consent and I’m waiting to hear from him. The patients clearly agreed to take the tablets, but I worry that they were misled over the scientific value of the study. What should I do, if as I suspect, I discover that the GP did not have ethical approval? Should I report him to the GMC?

Advice: 

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Reject the paper.

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There is no obligation on a GP to get ethics committee approval (they are not employees).

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The GP would need a DDX certificate if using a drug for an unlicensed use.

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If a journal states that it requires ethics committee approval then that journal could reject the paper on those grounds.

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The journal could ask him whether he obtained a DDX.

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The journal could seek the GMC’s advice on GP research. Conclusion The journal should be advised in future to require ethics committee approval for all submitted research. The editor should tell the GP that it would be good practice to get ethics committee research and warn him to do so in future.

Follow up: 

The GP did not have ethics committee approval, nor did he have informed consent from his patients.

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