8th Nagasaki International Course on

Research Ethics
June 29 - July 1, 2009
Institute of Tropical Medicine (NEKKEN), Nagasaki UniversityNagasaki, Japan
Organized byNagasaki Forum on Medical Research Ethics,
In cooperation withThe University of Bergen, National Institutes of Health (NIH) of USA, Nagasaki University,
The University of Tokyo Center for Biomedical Ethics and Law (UT-CBEL), The Forum for
Ethical Review Committees in Asia and the Western Pacific Region (FERCAP), and The
Special Programme for Research and Training 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 bea three day intensive course. English is a common language in the course but all the lecturers
and tutors will take care the communication within the participants whose English is a secondlanguage.
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 Center for Biomedical Ethics and Law), Kenji Hirayama (Nekken, Nagasaki Univ.)
Lecturers：Reidar Lie (Bergen Univ., NIH), Kenji Matsui, Shimon Tashiro (The Universityof Tokyo), Ki-ichirou Tsutani (The University of Tokyo), Hidefumi Nakamura (National
Center for Child Health and Development), Eiji Uchida (Showa Univ.),
Kenji Hirayama(Nekken, Nagasaki Univ.)

Facilitator: Hiroshi Satoh (Niigata University Medical and Dental Hospital), Hiroaki
Yanagawa (Tokushima University Hospital), Hanako Mihara (Center for Cancer Control andInformation Services National Cancer Center), Massie Ikeda (School of Medicine, NagasakiUniversity)
Venue
Pompe Hall in Sakamoto Campus, Nagasaki University
Application:
Please send your name, affiliation, E-mail address, necessity of accommodation arrangementby E-mail to Ms. Junko Hayashima,and CC to Prof. Kenji Hirayama. June 15(Mon), 2009.
Application deadline: June 19(Fri), 2009.
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
Ms. Junko Hayashima
Secretary
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
Tuition Fee: 10,000JPY (does not include meals, accommodations, and travel)
Undergraduate and post-graduate students are free of charge.

COURSE OUTLINE

June 29 (Mon), 2009
9:00-9:30
Inaugural session: Kenji Hirayama
Introduction to the workshop. Presentation of participants
9:30-10:15 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..
10:15-10:45 Coffee/Tea
10:45-11:30 Informed Consent
Kenji 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). Information usually required tobe 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.
11:30-12:30 Group work: informed consent
12:30 -13:30 Lunch
13:30-14:00 Presentation of group work
14:00-14:45 Ethical considerations in the community based study
Kenji Hirayama
14:45-15:15 Coffee/Tea
15:15-16:00 Difference between research and clinical care, ethics of innovative therapy
Shimon Tashiro
16:00-16:45 Placebo and ethics
Ki-ichirou Tsutani
16:45 End of day one

June 30 (Tue), 2009
9:00-9:30
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.
9:30-10:00 Research on children
Hidefumi Nakamura
10:00-10:30 Coffee/Tea
10:30-11:30 Group work: Evaluation of risks and benefits in children
11:30-12:00 Presentation of group work
12:00-13:00 Lunch
13:00-14:00 Ethics on research with stored samples
Kenji Matsui
14:00-15:00 Group work: stored sample
15:00-15:30 Coffee/Tea & group photo
15:30-16:00 Presentation of group work
16:00-16:45 IRB regulations regarding clinical trials in Japan
Eiji Uchida
16:45 End of day two

July 1 (Wed), 2009
9:00-9:45
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?
9:45-10:15
Plenary discussion
10:15-10:45 Coffee/Tea
10:45-12:00 Mock IRB
12:00Presentation of certificates
Reidar K. Lie
End of day three