The10th Nagasaki International Course

on Research Ethics
July 7 - 9, 2011
Pompe Hall in Sakamoto Campus, Nagasaki University, Nagasaki, Japan
Organized byInstitute of Tropical Medicine (NEKKEN), Nagasaki University
Nagasaki, Japan
In cooperation withThe University of Bergen, National Institutes of Health (NIH) of USA, The University ofToyama Center for Clinical Bioethics, The University of Tokyo, National Center for Child
Health and Development, Showa University, Tokushima University Hospital, The Forum for
Ethical Review Committees in Asia and the Western Pacific Region (FERCAP), The Special
Programme for Research and Training in Tropical Diseases (TDR) andNagasaki University Global COE Program
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 K. Lie (Bergen Univ. & U.S. NIH), Kenji Matsui (Center forClinical Bioethics, Toyama Univ.), Kenji Hirayama (Nekken, Nagasaki Univ.)
Lecturers：Reidar Lie (Bergen Univ. & U.S. NIH), David Wendler (U.S. NIH), Seema Shah(U.S. NIH), Kenji Matsui (Toyama Univ.), Shimon Tashiro (Tokyo Univ.),
Hidefumi Nakamura (National Center for Child Health and Development), Eiji Uchida(Showa Univ.), Kiichiro Tsutani (Tokyo Univ.), Hiroaki Yanagawa (TokushimaUniversity Hospital), Kenji Hirayama (Nekken)
Other Mentors: Hiroshi Sato (Niigata Univ.), Hanako Mihara (Abbott Japan Co., LTD)
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.
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.
DeanInstitute 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: Free of charge (does not include meals, accommodations, and Travel).

COURSE OUTLINE

July 7 (Thu), 2011
9:00-9:30
Inaugural session: Kenji Hirayama & Reidar K. Lie
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. Emphasis will also be on crosscultural concerns.
11:30-12:30 Group work: informed consent
12:30-13:30 Lunch
13:30-14:15 Presentation of group work
14:15-15:00 Distinction between research and practice
Shimon Tashiro
Researchers as well as research subjects often consider research as a part ofclinical care. This misconception sometimes leads to ethical conflicts andproblems. This section will discuss how a research activity is different from aclinical practice, and why understanding of such distinction is ethicallyimportant both for researchers and research subjects.
15:00-15:30 Coffee/Tea
15:30-16:00 IRB regulations concerning clinical trials in Japan
Eiji Uchida
16:00-16:45
Issues on placebo use in clinical trial
Kiichiro Tsutani
16:45 End of the day one

July 8 (Fri), 2011
9:00-9:45
Ethics on research with stored samples
David Wendler & Kenji Matsui
9:45-10:45
Group work: stored sample
10:45-11:00 Coffee/Tea
11:00-11:30 Presentation of group work
11:30-12:20 Evaluation of risks and benefits
David Wendler
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.
12:20-13:10 Lunch
13:10-13:20 Group photo
13:20-13:50 Practical concerns for pediatric research (tentative title)
Hidefumi Nakamura
13:50-14:30 Ethics of research on children
Seema Shah
14:30-15:30 Group work: Evaluation of risks and benefits in children
15:30-15:45 Coffee/Tea
15:45-16:15 Presentation of group work
16:15-16:50 Ethics reviews and education: an example model at Tokushima University
Hospital (tentative title)
Hiroaki Yanagawa
16:50-17:15 Ethical considerations in community based study
Kenji Hirayama
17:15 End of the day twoJuly 9 (Sat), 2011
9:00-9:45Ethical issues in international research
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 best provenand 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
Reidar K. Lie
12:00Presentation of certificates
Reidar K. Lie & Kenji Hirayama
End of the course