《Randomized Trial (SUPPORT)》.pdfVIP

Office of the Secretary DEPARTMENT OF HEALTH HUMAN SERVICES Office of the Assistant Secretary for Health ____________________________________________________________________________________ Office for Human Research Protections The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Telephone: 240-453-6900 FAX: 240-453-6909 June 4, 2013 Richard B. Marchase, Ph.D. V.P. for Research Economic Development University of Alabama at Birmingham AB 720E 701 20th Street South Birmingham, AL 35294-0107 RE: Human Research Protections under Federalwide Assurance (FWA) 5960 Research Project: The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) Principal Investigator: Dr. Waldemar A. Carlo HHS Protocol Number: 2U10HD034216 Dear Dr. Marchase: In the wake of extensive scientific and public discussions since our March 7, 2013, determination letter in the SUPPORT study, OHRP has become aware of widespread misunderstanding about the risks that are required to be disclosed in obtaining informed consent for certain types of clinical trials. Our goal in this letter is to clarify several issues related to our determination. At the outset, we wish to emphasize that OHRP does not