Monday, October 09, 2006

Watchdogs and Fig Leaves

Many government, professional and private organizations claim to support ethical conduct in research.

Some of these organizations pontificate and write guidelines, but remain completely silent and unsupportive when those guidelines are breached.

Others are used as a smokescreen allowing "virtuous protestations from those whose success is based upon systemic failures" (1).

They can also be used to create a false impression that "all is well", that "there are safeguards" out there, and that "whistleblowers are supported" - when no plausible safeguards exist.

Sometimes these organizations are completely subverted by those with different aims, and used as a Fig-Leaf to hide systemic failures.

A report in The Times describes just such a Fig-Leaf (Drug trials and errors : An expert watchdog is disbanding in protest. The Times. 7 Oct 2006 Link).

"an expert watchdog has announced that it is to disband, claiming it has been used as a fig leaf for the Government’s failure to provide volunteers with independent advice or support. The watchdog CERES (consumers for ethics in research) launched itself as “the voice of the guinea-pig” in 1989. For the past three years this group of academics and health service experts has lobbied for funding to run helplines for drug-test volunteers. But it is to disband on December 31, claiming that the Government’s clinical ethics committee has been advising drug-trial researchers that simply showing volunteers a leaflet from CERES will satisfy the EU requirement. CERES says this has been done “without our permission or recognition"

Here is how CERES was represented in the Consent form for the ill-fated TGN1412 trial. I hadn't read this consent form before, and I am shocked by it's complacent and misleading content.

It remains to be seen whether the new UK Panel for Research Integrity will turn out to be any less of a Fig Leaf for research misconduct.

Girard,M. (2005) Reformulating the principles of Hippocrates. Medical Veritas 2:682.

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