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          Informed ConsentSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Informed Consent
					Guidance for IRBs, Clinical Investigators, and Sponsors
		
		August 2023


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2006-D-0031
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice
          Center for Drug Evaluation and Research
          Center for Devices and Radiological Health
          Center for Biologics Evaluation and Research


This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This guidance supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued in September 1998, and finalizes FDA’s draft guidance entitled “Informed Consent Information Sheet,” issued in July 2014. This document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions.


 
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					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2006-D-0031.

                                                                                  Content current as of:
      08/15/2023
         
                  
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