Published 6 January 2009, doi:10.1136/bmj.a3141
Cite this as: BMJ 2009;338:a3141

Letters

Regulation’s threat to research

Over-regulation, Russian style

The first 150 words of the full text of this article appear below.

Bureaucratic and ethical control that damages research is not limited to the United Kingdom.1

When ethical control of applications for clinical trials was introduced in Russia many years ago, the federal law on drugs stated that only drug developers can initiate trials. To my knowledge, Russia is the only country where state or academic or non-industrial organisations are barred from initiating clinical research. This tool is systematically used to block any independent drug research.

The requirement to insure participants of clinical research against possible harm has also recently been hijacked by industry. Although some clinical studies are connected with minuscule risks from experimental procedures (such as the risk from interview or donating a urine sample), ethics committees demand the full scale insurance, which makes a study impossible without generous external support.

This situation results in poor quality clinical research in Russia, limited to case series and convenience sample cohort studies. . . . [Full text of this article]

Vasiliy V Vlassov, professor1

1 Moscow Medical Academy, Trubetskaya 8, Moscow, 101000 Russia

vlassov@cochrane.ru


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