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| Ethical
Issues in Clinical Research |
| Enhancing
Integrity in Clinical Research
The ethics workshop is organized by
The Endocrine Society’s Advisory
Panel on Ethics and Conflicts of Interest
in collaboration with the International
Congress of Endocrinology (ICE), International
Society or Endocrinology (ISE) and the
Brazilian Society of Endocrinology and
Metabolism (SBEM).
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For
the first time, the International
Congress of Endocrinology Meeting
will be held in beautiful Rio de
Janeiro, Brazil. ICE 2008 promises
to be an exciting venue for the
exchange of cutting edge science.
The Endocrine Society’s Advisory
Panel on Ethics and Conflicts of
Interest has partnered with a renowned
panel of international experts to
present a full day workshop about
the responsible conduct of research
and research ethics in the international
setting. It will be presented in
dynamic, interactive sessions by
prominent researchers and ethicists
from around the world.
Meeting
attendees will come away from this
workshop with a broader understanding
of best practices in clinical research
and how to navigate today’s
complex regulatory environment.
It will help attendees understand
the key pitfalls in the design and
execution of research and how best
to avoid ethical errors, including
research misconduct and malfeasance.
This
program will be invaluable for all
those involved in the research process,
including medical and graduate students,
postdoctoral fellows, clinical fellows,
junior and senior principal investigators,
hospital/institutional ethics committee
members, nurse coordinators, team
members of clinical research trials,
residency program directors, and
training grant directors.
Registration
fee: $25.00
Each attendee will receive a Certificate
of Attendance
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Program |
| 7:30
– 8:30 AM |
Registration
- Continental Breakfast |
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Morning
Session |
| 8:00
– 8:40AM |
Introduction
Speaker: Visiting dignitaries
(Will include representatives
of ISE, TES, Brazilian ES and
Argentinean ES.)
Introduction and welcome, program
outline, goals, historical comments |
| 8:40
– 9:05 AM |
Ethical
issues in global health research:
Overview
Speaker: Paul Komesaroff,
Monash University, Australia
Historical aspects of industry
research in developing countries,
dualities and conflicts of interests,
design and surveillance issues,
relations with national governments
and international requirements
provision of products after conclusion
of studies.
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| 9:05
– 9:35 AM |
Moderated
large group discussion to identify
typical issues
Facilitators: Debora Diniz,
Universidade de Brasília,
Brasília, Brazil; Florencia
Luna, University of Buenos Aires
Example of a case involving research
being conducted by a pharmaceutical
company in a developing country
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| 9:35
– 10 AM |
Ethical
considerations in study design
Speaker: Sergio Rego, Fundação
Oswaldo Cruz, Rio de Janeiro,
Brazil
Research questions, power, populations,
biases, consent issues, risk/benefit
assessment |
| 10
– 10:20 AM |
Break
– Light refreshments |
| 10:20
– 10:45 AM |
Ethical
responsibilities of researchers
Speaker: Dr. Anil Gil Lopes,
National Commission of Ethics
of Research with Human Beings
(CONEP), Brazil
Nature of science, nature of ethics,
historical framework, responsibilities
of researchers, ethical review,
role of international declarations |
| 10:45
– 11:10 AM |
Ethical
issues arising in relation to
clinical trials in developing
countries
Speaker: Dr. Antonio Ugalde,
University of Texas at Austin
Consent issues, relevance of research
to local needs, balancing risks
and benefits, recruitment and
reimbursement, placebo research
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| 11:10
AM – 12:10 PM |
Small
group discussions
Facilitators: Paul Komesaroff;
Sergio Rego; Anil Gil Lopes;
Anthony Ugalde; Debora Diniz;
Florencia Luna; Enrique Guntsche;
Joan Lakoski; Valeria Guimarães
; Judy Botler; Sunil Wimalawansa;
Nuria Homedes; Ursula Kuhnle
Cases will involve some of the
following: cultural issues,
research involving vulnerable
populations, research involving
placebos, ethical oversight
in international research, assessment
of risk and benefit, payment
and reimbursement of participants,
coordination of research between
for profit and not for profit
organisations, management of
adverse events, data and team
relationships, post-trial access
to treatment, monitoring of
research, specific illness categories
such as obesity or diabetes,
conflicts of interest.
There will be about five options
of which participants will attend
three. Each group will have
two facilitators who will take
the lead in developing the cases.
Option
#1: Issues involving consent
in culturally and ethnically
different populations
Option
#2: Assessment and acceptance
of risk and benefit
Option
#3: Harmonization of ethics
review
Option
#4: Issues affecting vulnerable
populations
Option
#5: Issues relating to pharmaceutical
research in developing countries |
| 12.10
-1.30PM |
Lunch |
| 12:30
– 1:10 PM |
Lunchtime
address
“Addressing the health needs
of developing countries: the importance
of social , political and economic
factors”
Speaker: Dr. Dirceu Greco.
State University of Minas Gerais,
Brazil |
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Afternoon
Session |
| 1:30
– 1:55 PM |
“Challenges
to ethics oversight in international
research”
Speaker: Prof. Enrique Guntsche,
endocrinologist and bioethicist,
Mendoza, Argentina
International
perspective on ethics review
and history of functions of
the review process, risk vs.
benefit evaluations, management
of clinical research, management
of cross-border issues, including
establishment of appropriate
standards, monitoring and surveillance,
protection of subjects, detection
of and responses to misconduct. |
| 1:55
– 2:55 PM |
Small
group discussions
Facilitators: See above
Attendees to choose another one
of the options |
| 2:55
– 3:15 PM |
Break |
| 3:15
– 4:15 PM |
Small
group discussions
Facilitators: See above
Attendees to choose another one
of the options |
| 4:15
– 4:45 PM |
Case
presentation with discussion to
follow, debate or general discussion
session
Panel: Invited speakers |
| 4:45
– 5:00 PM |
Close |
Online
registration click
here
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New
Strategies for Diagnosis and Treatment
of Diabetes Mellitus in Latin America
Nuevas Estrategias
para el Diagnostico y Tratamiento de la
Diabetes Mellitus en America Latina |
Chairs
| Coordinadores
- Dr.
Marcus Tambasia
- Dr.
Ricardo Meirelles
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Program |
| 14:00-14:30 |
Latin-american
problems and difficulties for the
care of diabetic patients.
Dificuldad
y problematica de atenccion al diabetico
en Latin Americ
Dra. Marilia Brito Gomes
(President SBD) |
| 14:30-15:00 |
Prevention
or delay on starting of Type 2 Diabetes
Mellitus
Prevenir o
Retrazar el inicio de la Diabetes
Mellitus tipo 2
Dr. Juan Rosas Guzmán
(President ALAD)
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| 15:00-15:30 |
Diabetes
and Cardiovascular Disease
Diabetes
y Enfermedad Cardiovascular
Dr. Ruy Lyra (President SBEM) |
| 15:30-15:45 |
Q&A |
| 15:45-16:00 |
Break |
| 16:00:16:45
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“Is
it time for a progressive and intensive
treatment for Type 2 Diabetes Mellitus?”
“¿Es
tiempo de un tratamiento progresivo
e intensivo para la diabetes mellitus
tipo 2?”
Dr Ralph DeFronzo
(Texas University) |
| 16:45-17:30 |
Round
Table with the participants
Mesa Redonda
con los participantes
Coordinator: Dr. Antonio
Chacra
- How to achieve treatment goals
in type 2 diabetes mellitus?
..¿Cómo
lograr objetivos de tratamiento
en la diabetes mellitus tipo 2?
- ALAD, SBEM and SBD actions regarding
diabetes care in Latin America.
..Acciones
de ALAD, SBEM y SBD en la atención
de la diabetes en América
Latina.
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| 18:00 |
Opening
Ceremony |
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Included in the registration fee |
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