Plenary - Panel Session

Ask Legal Counsel :: Theresa J. Colecchia, Esq., University of Pittsburgh; Patrick Taylor, J.D., Children’s Hospital Boston

Breakout Sessions E

E-1. General Accreditation Track: Domain 4 - Sponsored research :: Karen N. Hale, R.Ph., M.P.H., The Ohio State University

E-2. Behavioral/Social Science Accreditation Track: Domain 4 - Sponsored research :: Moira A. Keane, M.A., C.I.P., University of Minnesota

E-3. Institutional Officials Track: Managing conflict of interest in a changing business environment :: Harry B. Greenberg, M.D., Stanford University

E-4. Enrolling the decisionally impaired and LARs :: Lynn E. Smith, J.D., C.I.M., C.I.P., AAHRPP

E-5. HRPPs for research sites – What Do They Look Like? :: Jan Holladay, M.P.H., Rx Trials, Inc.

E-6. Navigating all the Regulations and Guidance: ICH-GCPs, FDA, and DHHS Regulations :: Roxanne Loomis, M.S., Eli Lilly and Company

Panel Session

The Role of Voluntary Health Agencies in Protecting Research Participants :: Louis J. DeGennaro, Ph.D., The Leukemia & Lymphoma Society; Eric Juengst, Ph.D., Case Western Reserve University; John Walsh, Alpha-1 Foundation

Breakout Sessions F

F-1. General Accreditation Track: Domain 5 - Participant Outreach :: Karen N. Hale, R.Ph., M.P.H., The Ohio State University

F-2. Behavioral/Social Science Accreditation Track: Domain 5 - Participant Outreach :: Moira A. Keane, M.A., C.I.P., University of Minnesota

F-3. I nstitutional Officials Track: Reporting To Regulatory Authorities – Dos and Donts :: David L. Wynes, Ph.D., The University of Iowa

F-4. Accrediting the HRPP of CROs :: Marjorie A. Speers, Ph.D., AAHRPP

F-5. Managing Scientific Review For Biomedical And Social Science Research :: John M. Falletta, M.D., Duke University Medical Center; Theodore J. Glattke, Ph.D., The University of Arizona

F-6. Protecting Research Participants Through Safety Monitoring :: Elizabeth H. Cothran, M.S., C.I.P., Baylor Research Institute

Closing Plenary Session

Regulation and Guidance: A Discussion with FDA and OHRP :: Bernard A. Schwetz, D.V.M., Ph.D., Office for Human Research Protections, DHHS; Steve Gutman, M.D., Center for Devices and Radiological Health, FDA