This is the general opening, recognition of Top Ten IRBs for Human Subject Protection Education, faculty and other introduction, along with notebook overview. This is not a class, but an hour to get acquainted. Thomas E. Ball, Executive Director, NAIM, Atlanta, GA, will facilitate this session.
 

This is an introduction to IRB work.  First, there will be the community hospital’s approach followed by the academic medical center’s approach, then a combined view of starting to work in a busy IRB office.
 

This session will include a discussion about the differences between Significant Risk Device Studies vs. Non-significant Risk Devices vs. Exempt Devices.  Fabienne Santel, MD, FDA, Center for Devices and Radiological Health, Rockville, MD, will facilitate this session.
 

This session will look at review elements of a biomedical and a social science protocol.  The advantage/disadvantage of both primary and a full board review will be explored.  This session will be facilitated by Richard D’Augusta, R.Ph., MPA, ORO, VA Regional Director, Bedford, MA.

This 10 year-old Mock Board offers a number of IRB education methods.  It is a practice that is open to critique.  It executes a full agenda with long-term Mock Board members.  It seeks to be released from mock regulatory restrictions.  This session will be facilitated by Ray R. Maddox, Pharm.D., Director, Research, St. Joseph’s/Candler Hospital, Savannah, GA.

What AE responsibility does the investigator have to the local IRB?  There will be examples of local AE’s that may cause the IRB to have concern.  The data safety monitoring board will be introduced.  FDA’s Center for Drug Evaluation and Research has been invited to lead this session.

In this session, the speaker will review FDA’s guidance on the use of unapproved devices and HUDs. Marian Serge, RN, CIM, Nurse Consultant, CDRH, FDA, Rockville, MD, will lead this session.

This is an open dialogue session. The writing (or rewriting) of policies and procedures will be considered, with focus on a methodological approach to satisfy regulatory requirements and institutional needs.  Sara S. Plaspohl, MHS, CIM, CIP, Research Ethics Officer, Memorial Health University Medical Center, Savannah, GA, will facilitate this session.

The facilitator will share a concept that allows regulatory as well as institutional officials to reconstruct an IRB meeting from its minutes.  There will be examples of effective and less than effective minutes for reconstructing a meeting.  This session will be lead by a staff member from OHRP, Rockville, MD.

This session will focus on human subject protection in a large academic research institution.  Internal structure, staff, and reporting that meet the expectation of regulatory agencies will be shared.

This class will examine the safety pre-test of the sponsor’s hypotheses as part of the review.  The pre-test finding will be weighed against the sponsor’s stated belief in the hypotheses.  Thomas E. Wasser, Ph.D., CIM, HealthCore, Inc., Wilmington, DE, will facilitate this session.

Andrew Olmsted, IRBNet, Cambridge, MA, will lead this session.

This will be continuous education from the previous day’s Mock Board meeting.  There will be a review of violations from earlier years.  The mock review and regulatory finding along with lifting or announcing continued mock restrictions is the third part of this class.

Delegates will share three systems of IRB software and state future needs for consideration.  Two different IRB software design teams will review the information and give probability of future need.

The facilitator will bring a discussion approach that leads to successful recruiting and maintaining IRB staff and Board members.

The IRB finds challenge with a given sponsor who is also the only investigator for the activity.  The potential conflict is the investigator/sponsor in question sits in a well-represented seat at the IRB table.

2009-31, Mental Health Research

2009-33, Open Meeting for Planning the 2010 Convention in New Orleans, LA.