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We are happy to help you and your organization as you prepare for the "Common Rule" changes. Download the following electronic copies so that you may pass them along to your institution and/or colleagues: Implementing the Revised Common Rule - 10 Ways to Get Started...
On July 24, 2017 the FDA announced a new guidance, effective immediately, which will have significant impacts on industry, IRBs, and investigators. In short, the guidance is being issued to permit IRBs to waive or alter informed consent for minimal risk clinical...