7th Nagasaki International Course on

Research Ethics
June 30 - July 2, 2008
Institute of Tropical Medicine (NEKKEN), Nagasaki University
Nagasaki, Japan
Organized byNagasaki Forum on Medical Research Ethics,
In cooperation withUniversity of Bergen, National Institutes of Health (NIH) of USA, Nagasaki University, The
University of Tokyo, National Center for Child Health and Development, Showa University,
Ulsan University, Tohoku University, The Forum for Ethical Review Committees in Asia andthe Western Pacific Region (FERCAP), and The Special Programme for Research andTraining in Tropical Diseases (TDR)

Objectives
The course participants will be provided with an overview of current research ethics, focusing
on the ethics of clinical research. Topics to be covered include the structure, roles andfunctions of research ethics committees, informed consent, evaluation of risks and benefits,inducements, and the special issues in research in developing countries. The course will also
cover behavioral and epidemiological research. The course participants will learn about where
there is consensus and where there is controversy in today’s research ethics, and will learn
how to handle areas of controversy.
Course format
The course is organized as interactive learning, where the students will work on a number ofproblem cases which illustrate the main points made in a few introductory lectures. It will
be a three day intensive course. English is a common language in the course but all thelecturers and tutors will take care the communication within the participants whose English isa second language.
Target groups
Ph.D. students in health sciences, researchers, members of research ethics committees,
Undergraduate students at medical and health sciences.
Teaching Staffs
Course Coordinators：Reidar Lie (Bergen Univ., NIH), Kenji Matsui (The University ofTokyo), Kenji Hirayama (Nekken, Nagasaki Univ.)
Lecturers： Reidar Lie (Bergen Univ. Norway), Hidefumi Nakamura (National Center forChild Health and Development), Eiji Uchida (Showa Univ.), Young Mo Koo (UlsanUniversity), Ki-ichirou Tsutani (The University of Tokyo), Kenji Matsui (The University ofTokyo), David Wendler (NIH), Shimon Tashiro (Tohoku University).

VenuePompe Hall in Sakamoto Campus, Nagasaki University
Application:
We have closed the application.Thank you so much for many applications.
Please send your name, affiliation, E-mail address, necessity of accommodation arrangementby E-mail to Ms. Junko Hayashima,and CC to Prof. Kenji Hirayama.
Ms. Junko Hayashima
Course Office
Department of Immnogenetics, Institute of Tropical Medicine, Nagasaki University
1-12-4 Sakamoto, Nagasaki 852-8523, Japan
TEL: +81-95-819-7820
FAX: +81-95-819-7821
E-mail: j-haya@nagasaki-u.ac.jp
Kenji Hirayama, M.D.,Ph.D.
Dean
Institute of Tropical Medicine (NEKKEN)
Nagasaki University
Tel: +81-95-819-7818
Fax +81-95-819-7821
E-mail: hiraken@nagasaki-u.ac.jp
Tuition Fee: 10,000JPY (does not include meals, accommodations, and travel)
Undergraduate and post-graduate students are free of charge.

COURSE OUTLINE
June 30, 2008
9:00 Inaugural session:
Kenji Hirayama
Introduction to the workshop. Presentation of participants
9:30
Framework for research ethics
Reidar K. Lie
One could argue that modern research ethics started in the mid 1960s with thedocumentation of some serious cases of research abuse in the US and othercountries. A classic article is the one published by Beecher in 1966, although
this article was in part based on cases brought forward by Pappworth in the UK.
The public discussion following these publications led to the introduction ofresearch ethics committees in the US and the UK, and subsequently in othercountries. The aim of this section is to let the participants get a feel for thetypes of cases that led to the development of current research ethics guidelines,
such as the Helsinki Declaration and the CIOMS guidelines..
10:15 Coffee/Tea
10:45 Informed ConsentKenji Matsui
This section will discuss what is informed consent, why it is needed. It will
make a distinction between the informed consent process and the signature on
the informed consent form. Examples of deficiencies in informed consent
forms (incomplete, misleading, too technical). Informations usually required to11:30
13:00
13:45
14:30

be covered in the informed consent process. Overviews will be provided on
exceptions to informed consent requirements, and how to deal with persons
with limited capacity to consent. Emphasis will also be on cross-culturalconcerns.
Group work
Lunch
Presentation of group work
Research on stored tissue samples
David Wendler, Kenji Matsui

15:30
Group work
16:30 Presentation of group work.
17:00 End of day one

July 1, 2008
9:00 Evaluation of risks and benefits.
Reidar K. Lie
Types of risks and benefits. Inconvenience vs. risk. Benefits to participants vs.
benefits to others. Evaluations of risks and benefits when starting a study vs.
evaluation of risks and benefits during the study. Reasons for discontinuationof a study.
9:30 Research on children or vulnerable persons: Hidefumi Nakamura. David Wendler
10:45 Group work
Coffee/Tea
Evaluation of risks and benefits in children. .
12:00 Presentation of group work
12:30 Lunch
13:15 Shimon Tashiro. Research vs. clinical care
13:45 Eiji Uchida. IRB regulations regarding clinical trials in Japan.
14:15 Young Mo Koo: Payments and inducements
14:45 Coffee/Tea
15:15 Kiichiro Tsutani. Pharmacogenetics and ethics.
16:00 Kenji Hirayama. Ethical considerations in the community based study
16:45 End of day two

July 2, 2008
9:00 Issues in international research ethics. Reidar K. Lie.
Is it permissible to carry out a trial in a developing country, but not in adeveloped country, or can one permit differences in trial design. Specifically,
the controversy over level of care will be discussed, as well as the the best
proven and highest attainable standards. Is there a responsibility to ensure theavailability of the product being tested after the trial? What options are there
for facilitating access to the investigational drugs and vaccines after the trial?
What are the strengths and weaknesses of the various options?
10:00 Plenary discussion
10:30 Coffee/Tea
11:00 Mock IRB
12:00 Presentation of certificates
Reidar K. Lie & Kenji Hirayama
End of day three