News Release

New regulations hinder research

Education & Debate BMJ Volume 329, pp 277-89. Editorial: Clinical research under the cosh again BMJ Volume 329, pp 241-2

Peer-Reviewed Publication


New ethics committee regulations impede and delay clinical research, sometimes to the extent that conclusions are flawed and patients damaged, according to several articles in this week's BMJ.

Hester Ward and colleagues report how data protection rules hampered their study of CJD so much that their results are likely to be unreliable. They call for further debate on how to strike an appropriate balance between an individual's rights and freedoms and the right of the community or society to answer important questions.

Others describe their frustration with the unnecessary bureaucracy of ethics applications. David Wald's application took two weeks and 44 hours to complete, at a cost of £850. "Action is urgently needed to reduce a research bureaucracy that has largely lost sight of the patient, advancing medical knowledge, and improving medical care," he writes.

Konrad Jamrozik also believes that the ethical approval process is too long and cumbersome. He argues for training and certification of research investigators and for simplifying the process of approval of new projects.

Finally, Michael Parker and co-authors describe the difficulties of ethical review of research into rare genetic disorders. "Ethics committees need to take into account the special problems of consent, anonymity, and method in research into rare diseases," they say.

"Rightly or wrongly, clinical researchers are exhausted by the demands of ethics committees who seem more concerned with the science which they cannot necessarily judge, than with ethics," writes Professor Charles Warlow in an accompanying editorial.

He suggests that researchers should make plain which scientifically inappropriate aspects of the methodology were forced on them by ethics committees, and how their findings may be biased as a result. "If nothing is done, clinical research will wither, and that is not to anyone's advantage," he concludes.


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