by Claire Carbary

Draft FDA Guidance: Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors

FDA issued a guidance entitled: “Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors” earlier this week. The draft document consolidates guidance from a number of Information Sheets and other draft and final guidance documents-providing a comprehensive guide to the regulatory requirements for informed consent for research under FDA jurisdiction.  This guidance does not present new information; however, the areas of focus highlight the issue of length and complexity of consent documents. Overall the guidance indicates FDA is focused on enhancing the consent process to help subjects better understand the research. Quorum does not expect any immediate changes to policies due to this draft guidance; however, the suggestions will be taken into consideration as policies and procedures are updated in the future.

For an overview of what’s new in the FDA’s draft guidance, read Jim Gearhart’s blog article.  The guidance is available on FDA’s website.

 

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