| 2001-01, Establishing a New IRB, Thursday,
9:00 a.m.- 10:00 a.m. |
In this session, delegates will look briefly at historical
information and relevant findings that predate the existence of IRB, for
example, the Belmont Report. Then, there will be limited dialogue on
development over the life of IRB. Institutional policy and necessary
board members’ skills, strengths, and potential weaknesses will be
determined. With an institutional profile model, the delegates will
determine credentials and experience needed for 12 board members. This
practical session was last offered in 1996 and will be facilitated by Thomas
E. Ball, M.Div., CIM
| 2001-02, Drug Protocol Design and Review
Strategy,
Thursday, 10:00 a.m.- 11:00 a.m. |
In this session, delegates will be able to recognize common
elements of a new drug protocol. An overview of the drug development
process and types of clinical trial designs will be presented. The delegates
will examine and evaluate standard elements of clinical protocols that must be
considered in IRB review. This session will be facilitated by Daniel W.
Krichbaum, Pharm.D., BCPS, Pfizer Pharmaceutical, Medical Research Department,
Granger, IN.
| 2001-03, IRB Policies and Procedures,
Thursday, 10:00 a.m.- 11:00 a.m. |
This is an open dialogue session. The writing (or rewriting)
of policies and procedures will be considered. Policies that work best
in certain types of institutions will be explored. The process also
calls for identifying policies that will not be effective in certain settings.
This session will be facilitated by Virginia (Ginger) Farley French, Pharm.D.,
CIM, Wesley Medical Research Institute, Wichita, KS.
| 2001-04, Recruitment and Retention of Effective
IRB Members,
Thursday, 11:00 a.m.- 12:00 p.m. |
In this session, a systematic method of recruiting effective
volunteer board members will be introduced. There also will be emphasis
on retention of effective board members. Some class time will be spent
in dialogue with delegates who are in the process of re-organizing or
improving their board. This session will be facilitated by Anne S.
Wimberly, Ph.D., Professor, Interdenominational Theological Center in Atlanta.
Dr. Wimberly’s main teaching emphasis is on organizing and developing
successful programs.
| 2001-05, Educating and Training IRB Members and
Investigators,
Thursday,
11:00 a.m.-
12:00 p.m.
|
| 2001-06, Investigator’s Conflict of Interest,
Thursday,
1:30
p.m.- 2:30 p.m.
|
What constitutes a conflict of interest for a clinical
investigator? What checks and balances must IRB administration put in
place to manage investigator’s conflicts of interests? What are the
obligations of the IRB when allegations of conflict of interest arise in
connection with a clinical study? What are the relevant regulatory and
legal provisions for handling these situations? This session will be
facilitated by Thomas J. Babbo, J.D., Assistant General Counsel,
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois.
| 2001-07, Development of Pre-Submission and Review
Package, Thursday,
1:30 p.m.- 2:30 p.m.
|
In this session, the delegates will review protocol checklist
models, then develop two different checklists that may be used to assure that
incoming protocols have the proper elements and materials necessary for a
thorough review. Needs for both an academic medical research facility
and a non-medical setting will be addressed. This session will be
facilitated by Pam Fowler, RN, CIM, and Doug Sinclair, CIM.
| 2001-08, The Mock Board,
Thursday, 2:30 p.m.- 4:00 p.m. |
At the delegates’ request, the Mock Board is in its third
year of continuous service. It will follow up on its Denver 2000
minutes, review its bylaws and evaluate two protocols. The first
protocol will be a social science study followed by an oncology study.
After deliberation, the Board will take questions and justify its actions in
open forum. W. Barton Campbell, M.D., is the Mock Board Chairperson.
Dr. Campbell is Chairperson of St. Thomas Hospital IRB, Nashville, TN.
He is or has served on the faculty at both Maharry Medical College and
Vanderbilt University in Nashville.
| 2001-09, Special Category, Vulnerable Populations,
Thursday, 4:15 p.m.- 5:00 p.m. |
This session will deal with special circumstances, e/g/.
minors, foreign language, terminally ill or, cognitively impaired patients,
and others with special needs. A method of well documented review and
protection of vulnerable populations will be introduced.
| 2001-10, Round Table, Thursday,
4:15 p.m.- 5:00 p.m. |
This is an open forum dialogue session designed to provide
delegates the opportunity to raise and discuss any issues or problems they see
facing IRBs today. Delegates themselves will raise issues for public
discussion and/or resolution on the floor. This session will be
facilitated by Leigh Pruneau, RN, Ph.D., Alta Bates Medical Center, Berkeley,
CA.
| 2001-11, FDA Overview,
Friday, 7:00 a.m.- 8:00 a.m. |
This
session will focus on preparing IRBs for a systematic FDA inspection.
The facilitator will review sections of FDA's IRB Compliance Program
and will discuss with the delegates specific inspectional elements used to
determine the IRB's level of compliance with Parts 50 and 56.
This session will be facilitated by Marian Linde, R.N., Nurse
Consultant at CDRH, FDA, Rockville, MD.
| 2001-12, Financial Aspects of IRB
Management, Friday, 8:00 a.m.- 9:30 a.m. |
This session will be presented in three parts: Part I will
look at a model of conversion from free IRB service to a system of IRB reimbursement
for protocol review and research related duties. Part II of the session will
examine an established program where there is a reimbursement system for
reviewing protocols, revenue budget and accounting for IRB income. Part III
will be spent in rebuttal dialogue about financial disclosure and other
related topics. This session will be facilitated by Ray Maddox, Pharm.D.,
St.Joseph's/Candler Health System, Savannah, GA.
| 2001-13, OPHS Overview of Changes: Question and
Answer Session, Friday,
9:50 a.m.- 11:15 a.m. |
After an overview of restructuring and changes in the agency,
the facilitator will offer a model problem with a regulation approach for
solving it. Much of the time will be spent in question and answer
dialogue. The speaker for this session will be Jeff Cohen, Ph.D., Director of
Education, Office of Human Research Protection, Rockville, MD.
| 2000-14, Interpreting Informed Consent Documents,
The IRB’s Perspective, Friday,
1:00 p.m.- 2:00 p.m. |
This session will intentionally examine consent forms from an
IRB defensive position. Local, regional and national trends on this
subject will be explored. The facilitator writes hospital based informed
consent documents on a regular basis. The class will be taught by
Catherine Butler, J.D., M.P.H., CIM, Associate Corporate Counsel, Northside
Hospital, Atlanta, GA. Ms. Butler led highly rated sessions at the NAIM
Conventions in 1996, 1997, and 1998.
| 2001-15, Evaluating Informed Consent Documents,
The Sponsor’s Perspective, Friday,
1:00 p.m.- 2:00 p.m. |
In this session, delegates will be exposed to a method of
evaluating informed consent documents from the sponsor’s perspective.
The facilitator, a writer of informed consent documents for investigational
drug and device protocols, will provide the philosophical foundation on which
certain statements are a part of the initial consent that comes to the IRB.
This session will be facilitated by Linda Apholz, CIM, Critikon, LLC., Tampa,
FL.
| 2001-16, The Ethical Challenge of IRB Deception, Friday,
2:00 p.m.- 3:30 p.m. |
In this session, delegates will face the dilemma where a
board member’s hidden involvement with a study and her subsequent deception
places both the institution and the investigator at risk. After didactic
information is offered, the facilitator will moderate an ethical discussion
that will lead to gaining local problem solving skills. This session
will be facilitated by Riggins Earl, Jr., Ph.D., Professor of Ethics, The
Interdenominational Theological Center, Atlanta, GA. This is the third
year the delegates have requested Dr. Earl’s return.