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2006D-0331: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
C11 11/24/2006 11/21/2006 Private Industry BeneChill, Inc.       pdf  
Signature: Nora K. Hadding
EC62 11/27/2006 11/22/2006 Drug Industry Northfield Laboratories Inc.       pdf  
Signature: Gould, Steven
EC63 11/27/2006 11/26/2006 Health Care Association National Association of EMS Physicians       pdf  
  Signature: O'Connor, Robert
EC64 11/27/2006 11/26/2006 Academia Oregon Health & Science University       pdf  
Signature: Schmidt, Terri
EC65 11/27/2006 11/26/2006 Individual Consumer Law Student       pdf  
Signature: Conrad, Michael
EC66 11/28/2006 11/27/2006 Other Organization Villanova University School of Law -- Student       htm
Attachment
 
Signature: Scarafile, Shevon
EC67 11/28/2006 11/27/2006 Health Professional Wayne State University SOM       htm  
Signature: Dunne, Robert
EC68 11/28/2006 11/27/2006 Academia Baylor College of Medicine       htm  
Signature: Robertson, Claudia
EC69 11/28/2006 11/27/2006 Device Association Medical Device Manufacturers Association       pdf  
Signature: Leahey, Mark
EC70 11/28/2006 11/27/2006 Academia Eastern Association for the Surgery of Trauma       pdf
Attachment
 
Signature: Esposito, Thomas
EMC3 11/06/2006 11/01/2006 Academia University of RI       txt  
Signature: Rev. Dr. Jennifer M Phillips
EC71 11/28/2006 11/27/2006 Other Organization Public Responsibility in Medicine and Research       pdf  
Signature: Davis, Amy
EMC4 11/21/2006 11/21/2006 Federal Government N. I. H.-Office of Biotechnology Activities-Office of Science Policy-Office of the Director       txt
Attachment
 
Signature: Amy P. Patterson, M. D.
EMC5 11/28/2006 11/27/2006 Federal Government N. I. H.-Office of Biotechnology Activities-Office of Science Policy-Office of the Director       txt
Attachment
 
  Signature: Amy P. Patterson, M. D.
C12 11/29/2006 11/28/2006 Health Care Association American Brain Injury Consortium       pdf  
  Signature: Raj K. Narayan, MD, FACS and Antho
C13 12/04/2006 11/28/2006 Private Industry Public Responsibility in Medicine and Research (PRIMER)       pdf  
Signature: Joan Rachlin JD MPH

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Page last updated: January 31, 2007