Kafkaesque Research Regulation

From the BMJ:

The local research ethics subcommittee, which comprised a pharmacist and layman with limited clinical experience, had concerns about possible drug interactions between amiloride and other drugs being taken by the study participants and hyperkalaemia and requested resubmission. Although we pointed out that the pilot was identical to one limb of the amendment that it had already approved, in September 2007 the full committee rejected the application for the pilot to be considered as a study amendment. We therefore had to make new submissions to the local ethics committee, Medicines and Healthcare Products Regulatory Agency (MHRA), pharmacy, insurance company, research and development department, and the local (Wellcome Trust) clinical research facility.

In Spain it takes years to get approval. By the time you get approval someone else has published the study you wanted to do. A nightmarish research environment is one more reason that persons with health problems should do their own research: try to find solutions themselves. I started long-term self-experimentation because I knew that conventional sleep research would never — at least, in my lifetime — help me understand why I often woke up too early. A common problem, easy to measure — but conventional sleep research is nearly impossible.

Can it get worse? Yes, in Russia.

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