A Listing of the 2010 Classes with Brief  Descriptions
 
The New Orleans Convention, Thursday and Friday, May 6-7, 2010
8:00 a.m. Thursday
2010-01, General Opening Session

This is the general opening, and recognition of Top Ten IRBs for Human Subject Protection Education, faculty and other introduction, along with notebook binder overview. This is not a class but an hour for getting acquainted. Thomas E. Ball, Executive Director, NAIM, Atlanta, GA will facilitate this session.
 
9:00 a.m. Thursday
2010-02, Special Population, 45 CFR 46, Subparts B and C

This is a general review of the regulation dealing with special categories. Emphases will be on properly identifying and protecting vulnerable populations. This session will be led by Kristina Borror, Ph.D., Director, Division of Compliance Oversight, OHRP, Rockville, MD.
 
2010-03, Seminar for New IRB Leadership

This session will be facilitated by Mary C. Barnhart, MA, CIM, CIP, Director, Ethics, Education, Policy and Compliance, Social Sciences Division, University of Chicago, Chicago, IL.
10:00 a.m. Thursday

2010-04, New IRB Coordinator/Administrator’s Workshop

This two-hours workshop will be divided into four parts 1) orientation and what to expect over the career, 2) introduction to forms and information flow, 3) leadership with emphases on consistency and 4) decision making and career tracks for IRB personnel. This session will be led by Quincy J. Byrdsong, Executive Director of Research Administration, EdS, CIM, CIP, CCRP, Virginia Commonwealth University, Richmond, VA.

2010-05, Mock Board

This Mock Board will meet for the 12th year. It will execute a full agenda. It offers a number of IRB education opportunities. It is a highly respected practice that is open to critique. The Board seeks release from regulatory restriction. Ray R. Maddox, PharmD, an eleventh year Mock Board member will preside over the meeting. He is Director of Pharmacy and Research at St. Joseph’s/Candler Hospital, Savannah, GA.
12:00 p.m. Thursday

2010-06, Pediatric Assent and Permission for Homeless Minor to be in Research
This will be the working lunch case study topic. The class will determine who among a list is most warranted to give permission. This same discussion may change its regulation paragraph and be used for a mentally challenged subject. This is usually a case study with a dramatic skit.
1:00 p.m. Thursday
2010-07, Networking Hour
The convention will be divided into about four groups. During this hour, delegates may move from one room to the next, they may negotiate in the hall, or in the restaurant station..
 
2:00 p.m. Thursday
2010-08, Amendment and the IRB
How might non-clinicians interpret amendments?  How does one justify or not justify full board approval of amendments?  The Speaker is TBD.
2010-09, Pediatric Research Review
This session will deal with the special populations and problems posed in pediatric research as well as the IRB’s role in reviewing it.  The speaker is to be determined.  The speaker is to be determined.
3:00 p.m. Thursday
2010-10, Review of New AAHRPP Standards and Procedures

The speaker will introduce the revised while highlighting new accreditation standards and change.  About one-half of the class time will be devoted to individual questions and answers about accreditation change.  The session will be led by Marjorie Speers, Ph.D., former Assistant Director for Science at CDC, now Executive Director, AAHRPP, Washington, DC.
2010-11, Communication in the IRB Office

How might communication from the IRB coordinator/administrator flow to the PI, sponsor, FDA, OHRP, and the administration? What provisions should be in the policies and procedures? Where are the checks and balances for a given case? This session will be led by Jere M. Boyer, Ph.D., CIM, CIP, CCRP, Director, Clinical Research Management, Inc., Hinckley, OH.
4:00 p.m. Thursday
2010-12, Data Safety Monitoring Board’s Impact

Which institutions may need a DSMB? Who should serve on the Board and what should be its mission? How might its mission meet local IRB needs? This session will be led by Richard D’Augusta, R.Ph., MPA, Regional Director, ORO, VA Health System, Bedford, MA.
2010-13, HIPAA Privacy Rule Beyond the 2009 Report
This speaker will examine the privacy rule that Congress introduced in the 1990s, and includes a discussion of the 2009 privacy update as well. This session will be facilitated by Heather L. Fields, JD, Shareholder, Reinhart, Boerner, Van Deuren, s.c., Milwaukee, WI.
2010-14, Manual of Mandatory Reading for New IRB Personnel
This will be instruction for people with two or fewer years in IRB work. Mock Board and speaker documents in the binder will be used to critique-teach: minutes, membership list, letters, and the regulations. This session also prepares new IRB officers for higher issues on the second day.
7:15 a.m. Friday

2010-15A, Committee Meeting
Committees will meet during this hour.
7:30 a.m. Friday

2010-15B, Developing a Disaster Plan
How does the IRB prepare for disaster, hurricane or a paper loss from fire or other reasons? How does one reconstruct processes, build replacement files, and make investigator determinations under such conditions? This session will be led by Laura Orem, CIP, CIM, IRB Program Manager, Florida Hospital, Orlando, FL.
8:00 a.m. Friday
2010-16, Oversight and Adherence to Federal Regulation
The speaker will review the regulation with focus on compliance in the areas selected for review. This session will be led by Kristina Borror, Ph.D., Director, Division of Compliance Oversight, OHRP, Rockville, MD.
2010-17, Research Measurement Method
Where does QI end and research begin? Whose measuring stick is used to make the determination? This session will be led by Thomas E. Wasser, Ph.D., CIM, Bio-statistician, Macungie, PA.
9:00 a.m. Friday
2010-18, FDA vs HHS Regulations, 21 CFR Parts 50 and 56 vs 45 CFR 46

The two regulations will identify how they differ. This class will examine which regulations apply to given situations and the circumstances when both may apply. This session will be led by George Gasparis, CIP, Executive Director, Columbia University Medical Center's IRB, New York, NY.
2010-19, Training IRB Members and Staff

The facilitator will use a number of methods and experiences to discuss information gathered during the convention that may be used for local training.  Appropriate methods to be used at the local institution will be shared.  Kevin L. Nellis, MS, MT, (ASCP), Program Analyst, Research Integrity Development, Department of Veterans Affairs, Washington, DC, former employer, OHRP, Education.
10:00 a.m. Friday
2010-20, Mock Board Exit Report

This will be continuing 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. This session will be led by Kristina Borror, Ph.D., Director, Division of Compliance Oversight, OHRP, Rockville, MD.
2010-21 Eliminating the Paper Research File

This is a vendor session. Vendor (A) ProIRB, Vendor (B) IRBNet, (C) TBD.
11:00 a.m. Friday
2010-22, "Findings in IRB Warning Letters and What IRB Administrators can do to Avoid Problems During an Inspection."

This session will be led by Kevin Prohaska, DO, MPH, Captain, U.S. Public Health Service Corps, Medical Officer, FDA, Division of Scientific Investigations, Silver Spring, MD.
2010-23, Developing a Disaster Plan

How does the IRB prepare for disaster, hurricane or a paper loss from fire or other reasons? How does one reconstruct processes, build replacement files, and make investigator determinations under such conditions? This session will be led by Laura Orem, CIP, CIM, IRB Program Manager, Florida Hospital, Orlando, FL.
12:30 p.m. Friday
2010-24, Close Out Session

This is the session where delegates will plan for 2011 Convention.