Opening and Welcome

Introduction to Conference :: Barbara E. Bierer, M.D., Brigham & Women's Hospital, President, Board of Directors, AAHRPP

Opening Plenary Session

Partnerships in a Global Research Enterprise :: Felix A. Khin-Maung-Gyi, Pharm.D., M.B.A., C.I.P., Chesapeake Research Review Inc.

Breakout Sessions A

A-1. General Accreditation Track: Conducting a self-assessment :: Karen N. Hale, R.Ph., M.P.H., The Ohio State University

A-2. Behavioral/Social Science Accreditation Track: Conducting a self-assessment :: Moira A. Keane, M.A., C.I.P., University of Minnesota

A-3. Institutional Officials Track: Identifying all the organizational components of a HRPP :: Richard W. Bianco, University of Minnesota

A-4. Managing the range of non-compliance :: Jeffrey A. Cooper, M.D., M.M.M., AAHRPP

A-5. Managing continuing review of research :: Daniel K. Nelson, M.S., C.I.P., The University of North Carolina at Chapel Hill

A-6. Industry audits and accreditation: similarities and differences :: Patricia G. Amsler, C.C.R.C., C.C.R.A., Wyeth Pharmaceuticals

Breakout Sessions B

B-1. General Accreditation Track: Domain 1 – Organization :: Karen N. Hale, R.Ph., M.P.H., The Ohio State University

B-2. Behavioral/Social Science Accreditation Track: Domain 1 - Organization :: Moira A. Keane, M.A., C.I.P., University of Minnesota

B-3 . Institutional Officials Track: What is the accreditation process and what am I signing onto? :: David L. Wynes, Ph.D., The University of Iowa

B-4. Defining and Handling Unanticipated Problems :: Jeffrey A. Cooper, M.D., M.M.M., AAHRPP

B-5. Two Types of Emergency Research - Two Sets of Review Issues :: J. Thomas Puglisi, Ph.D., C.I.P., Department of Veterans Affairs

B-6. Negotiating Clinical Trial Agreements :: Linda Strause, Ph.D.

Breakout Sessions C

C-1. General Accreditation Track: Domain 2 - Research Review Unit - Including The IRB :: Karen N. Hale, R.Ph., M.P.H., The Ohio State University

C-2. Behavioral/Social Science Accreditation Track: Domain 2 - Research Review Unit - Including the IRB :: Moira A. Keane, M.A., C.I.P., University of Minnesota

C-3. Institutional Officials Track: What Happens After The Site Visit: The Organizational Response :: Larry D. Milne, Ph.D., University of Arkansas for Medical Sciences

C-4. Managing And Reporting Suspensions And Terminations :: Gary Cseko, M.S.P.H., M.B.A., The University of New Mexico Health Sciences Center

C-5. Ways to streamline the IRB process :: Daniel K. Nelson, M.S., C.I.P., The University of North Carolina at Chapel Hill

C-6. Optimizing Academic And Industry Partnerships :: Mark Crowell, The University of North Carolina at Chapel Hill

Breakout Sessions D

D-1. General Accreditation Track: Domain 3 – Investigator :: Karen N. Hale, R.Ph., M.P.H., The Ohio State University

D-2. Behavioral/Social Science Accreditation Track: Domain 3 – Investigator :: Moira A. Keane, M.A., C.I.P., University of Minnesota

D-3. Institutional Officials Track: What will accreditation mean for the institution? :: Wendy Baldwin, Ph.D., University of Kentucky; Brenda J. Russell, J.D., Baylor Research Institute

D-4. Protecting children who participate in research :: Susan Kornetsky, M.P.H., Children's Hospital Boston

D-5. Putting together the application for accreditation :: Melissa Trumbull, AAHRPP

D-6. International collaborations :: Sujatha Sridhar, Ph.D. National Health Group – Singapore

Plenary - Panel Session

Hot Topics in Human Research Protection :: Debra Aronson, J.D., M.A. Biotechnology Industry Organization ; Richard J. Jacob, Yale University