DHHS


The Children’s Hospital of Philadelphia Department of Anesthesiology and Critical Care Medicine Robert M. Nelson, M.D., Ph.D. 34th Street & Civic Center Boulevard, Rm. 1513 Chair, Committees for the Protection of Human Subjects Philadelphia, Pennsylvania 19104-4399 Associate Professor of Anesthesia and Pediatrics (215) 590-9180 Office (267) 426-5035 Fax November 25, […]

Public Comments Re: Smallpox Vaccine Trial on 2 to 5 ...





THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave, Suite 28P New York, NY 10023 212-595-8974 ahrp@researchprotection.org September 4, 2002 Michael Carome, MD Associate Director for Regulatory Affairs Office for Human Research Protections The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Re: Acute Respiratory Distress […]

ARDSNet – AHRP Reply to OHRP Response



Aug 20, 2002 Medical Science Violating Children – 450 healthy children targeted – Redflagsweekly FYI Redflagsweekly is the first online health news service to pick up on a news item provided in yesterday’s AHRP Infomail about a proposed experiment (whose researcher seeks government funding) to be conducted on 450 children […]

Medical Science Violating Children – 450 healthy children targeted – ...



Federal Investigation of ARDS Study (Accute Respiratory Distress) OHRP conducted a compliance oversight evaluation of the 12 major sites participating in this clinical trial. OHRP’s determination letters documenting the outcomes of these evaluations can be viewed at the OHRP website at the following URLs: Note: OHRP found that federal informed […]

Federal Investigation of ARDS Study (Accute Respiratory Distress)


Is This Permissible Medical Research? Fri, 27 Sep 2002 A federally funded experiment for the treatment of acute respiratory distress (ARDS) conducted at 12 major research centers, 1996-1999, has come under sharp criticism. The ARDS researchers sought to find a method for reducing the death rate among acutely ill patients […]

Is This Permissible Medical Research?


August 26, 2002 OHRP Retreats from Providing Public Info re: Compliance Activities FYI A newly posted announcement by the Office of Human Research Protection (OHRP), dated July 15, rescinds the agency’s announced policy of making public the content of its letters of determination following the agency’s investigation of compliance / […]

OHRP Retreats from Providing Public Info re: Compliance Activities



OHRP Response to AHRP re: Surrogate Consent to Research Office of the Secretary Department of Health & Human Services Office of Public Health and Science Office for Human Research Protections Rockville, Maryland E-mail: mcarome@osophs.dhhs.gov August 28, 2002 Vera Hassner Sharav President, The Alliance for Human Research Protection John H. Noble, […]

OHRP Response to AHRP re: Surrogate Consent to Research