This is the general opening, recognition of faculty, other introductions and notebook binder overview. Thomas E. Ball, MDiv, CIM, Executive Director, NAIL, Atlanta, GA, will facilitate this session.
 

Respect for and Protection of the Most Vulnerable Populations. Speaker: David Satcher, MD, PhD, former Director, Centers for Disease Control and Prevention and former Surgeon General Director, Satcher Research Institute, Morehouse School of Medicine, Atlanta, GA.
 

This workshop offers a career introduction and it will give an overview of what the new IRB employer or leader may expect over the period of employment. Speaker: Quincy J. Byrdsong, EdD, CIM, CIP, CCRP, Vice President, Academic Administration, Atlanta, GA.

This Mock Board will meet for the 15th year. It will execute a complete agenda and offer a number of IRB education opportunities. It is open to critique. The Board seeks release from regulatory restriction. Ray R. Maddox, PharmD, a 14-year Mock Board member, will preside over the meeting. He is Director of Pharmacy and Research at St. Joseph’s/Candler Hospital, Savannah, GA.
 

This class will address differences and similarities with the U.S. Federal Regulations and with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance. The discussion will focus on issues created by the various differences and how these may be addressed. Jere Boyer, Ph.D., CIM, CIP, CCRP, Scientific and Human Subjects Protection Consultant, Clinical Research Management, Hinckley, OH will lead this session.

This class will offer a method for various auditing and monitoring systems. Speaker: Marjorie Speers, PhD, Executive Director, AAHRPP, Washington, DC.

This session will look closely at the continuing review process and sponsor amendments, along with actions the IRB may take

This class will provide IRBs with a case study for identifying clues that a Phase IV Post Market study is in fact a seeding trial and how the IRB may manage its submission. Speaker: John Ponzillo, PharmD., Chair, IRB, Mercy Medical Center, St. Louis, MO

This discussion will compare the duties of the IACUC to those of the IRB and briefly discuss the animal foundation of human clinical trials. Carol Clarke, DVM, DACLAM; US Department of Agriculture, Riverdale, MD is the speaker.

The FDA will review its 2012 guidance on drug investigation. Speaker: Marie Mathews, Compliance Officer, FDA District Office, Atlanta, GA.

There are approximately 4,000 institutional IRBs in the US plus a few hundred independent programs sometimes called central. This speaker will discuss how the drive to accelerate research, together with a renewed effort to rationalize the system of protecting human research subjects, are leading to the emergence of IRBs serving regional and functional networks. The speaker will review the evolution of IRBs and describe the emerging models that exist. Speaker: Stuart Horowitz, PhD MBA, President, Institutions & Institutional Services, WIRB-Copernicus Group, Seattle, WA.

The speaker will look at passive ways of coercing subjects to participate in research

A retention model will be taken from the Mock Board and NAIL’s faculty for recruitment and retention of IRB members at the delegate’s home institution.