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,
DC)

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