Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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Appendix I: Discussion Paper: Health Research as a Public Good
Appendix I: Discussion Paper: Health Research as a Public Good
Pages 207-210
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From page 207... ...
Each individual measure was introduced with the best of intentions, but the law of unintended consequences has meant that the regulatory and governance framework for health research is now dysfunctional, uncoordinated, and no longer "fit for purpose." The EU directive regulating clinical trials places unnecessary and unreasonable burdens on investigators; there are at least a dozen bodies involved in granting ethical approval for health research; and each National Health Service (NHS) hospital involved in a study insists on re-examining the ethical, legal, and financial arrangements that have already been largely scrutinised by one (and often more)
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From page 208... ...
First, it will bring together the current disparate arrangements for pro viding ethics approvals for health research. The National Research Ethics Service has already moved into the HRA and other bodies will do so shortly.
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From page 209... ...
As a member state of the European Union, the United Kingdom has no alternative but to subscribe to the provisions of the EU Clinical Trials Directive. Nevertheless, the UK government is committed to re-negotiating the provisions of the directive to ensure that, in revised form, it is less burdensome, appropriately proportionate, and applied evenly across the European Union.
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