Listing of the 2012 Classes with Brief Descriptions
 

The Eighteenth Convention, Thursday and Friday, May 10-11, 2012

Web page is updated on October 1 of each year.

8:00 a.m. Thursday
2012-01, General Opening

This is a convention opening session for introduction of faculty, announcements, and review of the notebook binder. Thomas E. Ball, M.Div., CIM, Executive Director, NAIL, Atlanta, GA will lead this session.
 
8:30 a.m. Thursday
2012-02, Overview of Tuskegee Syphilis Study Documents

This presenter will discuss his recent examination of original Tuskegee documents to produce a book on "The Ethics of the Syphilis Study." Riggin Earl, Ph.D., Professor of Ethics, the Interdenominational Theological Center, Atlanta, GA will lead this session.
 
9:30 a.m. Thursday
2012-03, Mock Board

This Mock Board will meet for the 14th year to execute a complete agenda that will offer a number of IRB education opportunities. At the end of the meeting, the Board will be open to audience critique. The Board seeks a release from regulatory restriction. Ray R. Maddox, PharmD, a 13th year Mock Board member, Director of Pharmacy and Research at St. Joseph's/Candler Hospital, Savannah, GA will preside over this Mock Board meeting.
 
2012-04, Just New Staff

This is an early IRB career class with enrollment for delegates that are in their first 15 months of human subject protection. Registration for this session is discouraged for delegates with two or more years of experience. After an overview, delegates will select topics and ask questions of choice. Mary C. Barnhart, MA, CIM, CIP, Director, Ethics, Education, Policy and Compliance, Social Sciences Division, University of Chicago, Chicago, IL will lead this session.
 
11:00 a.m. Thursday

2012-05, IRB and Research Structure

This class will address moving IRB's from paper processing to electronic management. The speaker will use examples of one large institution's actual experience. Speaker TBD.

2012-06, Animal Care and Use Committee

This class will focus on the animal lab, care of laboratory animals, and regulation, along with the ACUC and it’s required documentation. Carol L. Clark, DVM, USDA, Washington, DC will lead this session.
12:15 p.m. Thursday

2012-07, Biobanking, Promises and Perils
This will be an introduction to the scientific promise of biobanking as well as its potential hazards for human subjects. Michele Marcus, PhD, MPH, Assistant Program Director, Center for Health Research, Kaiser Permanente and Professor of Epidemiology, Emory University, Atlanta, GA will lead this session.
1:00 p.m. Thursday

2012-08, Commercial vs Central IRB
What is the difference in a central and a commercial IRB? Why might a standing institution select a given central or commercial IRB for a review?

2012-09, IRB Minutes
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 ineffective minutes for reconstructing a meeting.
2:00 p.m. Thursday
2012-10, OHRP-FDA September 2011 Guidance on Exculpatory Language in Informed Consent
Review outcome of data collected. Kristina Borror, Ph.D., Director, Division of Compliance Oversight, OHRP, Rockville, MD will lead this session.
 
2012-11, Institutional Conflict of Interest
What might be an institutional conflict of interest? What are the IRB's options when the institution falls into a full conflict with an active protocol? Sara S. Plaspohl, DrPh, CIM, CIP, Assistant Professor for Health Sciences, Armstrong Atlantic State University, Savannah, GA will lead this session.
 
3:00 p.m. Thursday
2012-12, Communication to Investigator
The mechanics and all parts of a final approval letter will be justified in class. This class will then develop a conditional approval letter for an investigator to begin a social science study. After the conditional approval letter is developed in class, the speaker will share a final version of the letter. Jere Boyer, Ph.D., CIM, CIP, CCRP, Scientific and Human Subjects Protection Consultant, Canton, OH will lead this session.
2012-13, AAHRPP Accreditation
What are the advantages of AAHRPP Accreditation, if any? How does contracted IRB service when it is not accredited impact the accreditation status of a standing institution? What type of programs should seek accreditation? Can a program lose its accreditation? Is the accreditation really worth the money and trouble? Peter Vasilenko, PhD, Chief Education and Evaluation Officer, Association of Accreditation of Human Research Protection Programs, Washington, DC will lead this session.
4:00 p.m. Thursday
2012-14, Informed Consent-Waiver, Alteration, and Documentation

This session will look at when an informed consent is necessary and the required elements, if altered. It will also look at waiver of consent and waivers of documentation of informed consent to determine when it is appropriate for use. Kristina Borror, Ph.D., Director, Division of Compliance Oversight, OHRP, Rockville, MD will lead this session.
2012-15, Review Day 1 Classes With Delegates New to IRB Work

This class assures that new human subject protection employees have an opportunity to raise questions about information presented on Thursday with the goal of preparing for the upper level classes on Friday. Speaker TBD.
5:00 p.m. Thursday
2012-16,

(A) Meeting, Top Ten 
(B) Meeting, Re-certification 
(C) Meeting, 2013 Convention
8:00 a.m. Friday
2012-17, International Research, Considerations for Collaborating Institutions
How will U.S. regulations apply to international research, cooperative IRB review and dual regulations when American institutions are conducting joint research with a foreign government or co-investigating with institutions in a foreign country where DHHS funds are used? George Gasparis, BS, CIP, Executive Director, IRBs, Columbia University, New York, NY will lead this session.
2012-18, ANRPM Proposed Change
This will be a legal review of the Common Rule change and how it may impact IRB and/or research work.

9:00 a.m. Friday

2012-19, Continuing Review
What is the minimum, mandatory information required based on regulatory standards for continuing review? What type of institutional requirements differ from government requirements and how are they resolved? How might the regulatory agency expect data to be interpreted and used at the IRB? The FDA Center for Drugs Evaluation and Research has been invited to lead this session.

2012-20, Mock Board's Determination
This will be continuing education from the previous Mock Board meeting. There will be a review of violations from earlier years. The mock review and determination along with lifting or announcing continued mock restrictions is the second and third part of this class. Kristina Borror, Ph.D., Director, Division of Compliance Oversight, OHRP, Rockville, MD will lead this session.
10:00 a.m. Friday
2012-21, Protocol Violation
The speaker will first separate protocol violation from protocol deviation. There will be measurements for the level of risk involved with a violation, be it data reporting, harm to the subject, or both. Quincy J. Byrdsong, EdD, CIM, CIP, CCRP, AVP for Health Sciences-Academic and Research Affairs for the VCU, Richmond, VA will lead this session.
2012-22, Risk Benefit Analysis
When reviewing a protocol, what are the processes that may be used for risk benefit analysis? When given, how might lay members effectively interpret and cast a risk vote? Thomas E. Wasser, PhD, M.Ed., CIM, Biostatistician, Allentown, PA will lead this session.
11:00 a.m. Friday
2012-23, Vendor Presentation

Vendors will present at this hour.
2012-24, Social Media Research

This discussion includes collecting data from online support websites, Facebook, Twitter, and virtual world websites.
12:00 a.m. Friday
2012-25, Putting It All Together

This will be questions, answers, comments, and an evaluation of the two days of classes.
2012-26, IRB and Research Training

Outcome of 2011 Convention Survey on IO's training and support for IRB will be discussed. The goal of this class is training process improvement. Thomas E. Ball, M.Div., CIM, Executive Director, NAIL, Atlanta, GA will lead this session.
2012 FACULTY

Ball, Thomas E., M. Div., CIM, Executive Director, NAIL, Atlanta, GA
Barnhart, Mary C., MA, CIM, CIP, Director, Ethics, Education, Policy and Compliance, Social Sciences Division, University of Chicago, Chicago, IL
Borror, Kristina, Ph.D., Director, Division of Compliance Oversight, OHRP, Rockville, MD
Boyer, Jere,, Ph.D., CIM, CIP, CCRP, Scientific and Human Subjects Protection Consultant, 1232 Lost Free Drive, NW, Canton, OH
Byrdsong, Quincy J., Ed.D. CIM, CIP, CCRP, Assistant Vice President for Health Sciences-Academic and Research Affairs for the Virginia Commonwealth University, Richmond, VA
Earl, Riggin, Ph.D., Professor of Ethics, the Interdenominational Theological Center, Atlanta, GA
Gasparis, George, BS, CIP, Executive Director, IRBs, Columbia University, New York, NY
Maddox, Ray R., PharmD, a 14th year Mock Board member, Director of Pharmacy and Research at St. Joseph’s/Candler Hospital, Savannah, GA
Vasilenko, Peter, PhD, Chief Education and Evaluation Officer, Association of Accreditation of Human Research Protection Programs, Washington, DC.
Wasser, Thomas E., PhD, M.Ed., CIM, Biostatistician, Allentown, PA
Invited but not confirmed September 2011e
Fields, Heather L., JD, a shareholder in Reinhart Boerner Van Deuren, sc., Health Care Department, Milwaukee, WI
Food and Drug Administration
Additional faculty will be announced in January 2012