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Nature Neuroscience on gaps in ethical oversight of research

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Although institutional review boards are important ethical gatekeepers of human patient research, there is little data to evaluate their effectiveness. More coordination and a more transparent decision-making process is critical if review boards are to make appropriate and consistent decisions – so says the Editorial in this month’s (February) issue of Nature Neuroscience (13, 141; 2010). From the Editorial:

“An ethical overview is meant to be more than just another bureaucratic hurdle in doing research; it is a guarantee that all research is held to certain minimum standards and, particularly for human patient research, it is an assurance that the participants’ welfare is being looked after and that the risk to them is minimized. However, there is very little oversight of how well this overview meets its stated aims, especially for human research. Moreover, what little data exists points to some worrying inconsistencies; a study that submitted a mock functional magnetic resonance imaging human neuroimaging protocol to 43 Canadian review ethics boards found that the protocol was unconditionally approved by 3 boards, approved conditionally by 10 and rejected by 30. Given the increasingly knotty ethical challenges that neuroscience advances present, it is critical that we try to improve this situation by encouraging review boards to make their decision-making process more open and by encouraging greater cross-talk between different ethical review boards……

What is urgently needed is some real data on how the current process is working. Providing a searchable database of current protocols of the sort already provided for clinical studies would be a good first step by providing guidance to local review boards about decisions made on comparable cases, while still retaining the flexibility required to make case-by-case decisions. It would also highlight decisions that differ from the norm. Along with greater cross-talk between local ethical review boards, such publicly available information would also help reassure the public that ethical review is indeed doing what it sets out to do, by ensuring the welfare of subjects while advancing our knowledge of how the human brain works.”

Nature Neuroscience journal website.

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