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Protection of Human Subjects and Standard of Care Research

Wednesday, August 28, 2013
Hubert H. Humphrey Building, Great Hall

9:00 a.m. –  9:15 a.m.                Opening Remarks                                                            
Wanda K. Jones, DrPH                                                         
                                                 Principal Deputy Assistant Secretary for Health                                                    
                                                 U.S. Department of Health and Human Services (HHS)

HHS Panel

Jerry Menikoff, MD, JD
Director, Office for Human Research Protections

Kathy Hudson, PhD
Deputy Director for Science Outreach and Policy
National Institutes of Health                                                                       

Robert Temple, MD
Deputy Center Director for Clinical Science
Center for Drug Evaluation and Research
Food and Drug Administration     


9:15 a.m. – 12:00 p.m.                        Presentations & Panel Questions

                9:15 a.m.         Michael Carome, MD                                    
                                      Public Citizen (Washington, DC)

                9:28 a.m.         Sidney Wolfe, MD                                    
                                      Public Citizen (Washington, DC)

                9:41 a.m.         Alice Dreger, PhD                                    
                                      Northwestern University (Evanston, IL)

                9:54 a.m.         Lois Shepherd, JD                                    
                                      University of Virginia Health System

                10:07 a.m.       George Annas, JD, MPH                                    
                                       Boston University

                10:20 a.m.       Charles Natanson, MD

                10:33 a.m.       Vera Sharav                                    
                                      Alliance for Human Research Protection (New York, NY)

                10:46 a.m.       Elisa Hurley, PhD                                    
                                      Public Responsibility in Medicine and Research (Boston, MA)

                10:59 a.m.       John Lantos, MD                                    
                                      Children’s Mercy Hospital (Kansas City, MO)

                11:12 a.m.       Benjamin Wilfond, MD                                    
                                      Seattle Children’s Research Institute (Seattle, WA)

                11:25 a.m.       Robert Danner, MD

                11:38 a.m.       Nancy Kass, ScD                                    
                                       Johns Hopkins Bloomberg School of Public Health (Baltimore, MD)

                 11:51 a.m.       Session wrap-up

12:00 p.m. – 1:00 p.m.                        Lunch

1:00 p.m. – 4:30 p.m.                          Presentations & Panel Questions

                  1:03 p.m.        Jeffrey Drazen, MD                                    
                                       New England Journal of Medicine & Harvard Medical School

                  1:16 p.m.        Peter Vasilenko, PhD                                    
                                        Alion HRPP (Human Research Protection Program)Accreditation Services (Washington, 

                  1:29 p.m.        Steven Joffe, MD, MPH                                    
                                       University of Pennsylvania

                  1:42 p.m.        David Forster, JD, MA, CIP                                    
                                      WIRB-Copernicus Group (Olympia, WA)

                  1:55 p.m.        David Magnus, PhD                                    
                                       Stanford University (CA)

                  2:08 p.m.        Carl D’Angio, MD                                    
                                       University of Rochester (NY)

                  2:21 p.m.        Jon Tyson, MD, MPH                                    
                                       University of Texas Health Medical School

                  2:34 p.m.        Michele Walsh, MD, MS                                    
                                       Case Western Reserve University (Cleveland, OH)

                  2:47 p.m.        Shawn Pratt                                       
                                        Private Citizen (WV)

                  3:00 p.m.        Sharissa Cook                                     
                                       Private Citizen (AL)

                  3:13 p.m.        Edward Campion, MD                                    
                                       New England Journal of Medicine

                  3:26 p.m.        Michael McGinnis, MD, MPH                                    
                                        Institute of Medicine (Washington, DC)

                  3:39 p.m.        Richard Platt, MD, MSc                                    
                                       Harvard Medical School

                  3:52 p.m.        Ann Bonham, PhD                                    
                                       American Association of Medical Colleges (Washington, DC)

                  4:05 p.m.        Robert Califf, MD
                                       Duke University (Durham, NC)

                  4:18 p.m.        Session wrap-up

4:30 p.m. – 4:45 p.m.       Brief summary of comments submitted by 8/7/2013, by those who did not present today

4:45 p.m. – 5:00 p.m.       Closing Remarks
Wanda K. Jones, DrPH