The 12th Nagasaki International Course on Research Ethics
Pompe Hall in Sakamoto Campus, Nagasaki University, Nagasaki, Japan
7-9 July 2013
Organized and supported byInstitute of Tropical Medicine (NEKKEN), Nagasaki UniversityNagasaki, Japan
In cooperation withThe Tropical Disease Research (WHO/TDR), University of Tokyo, National Center for Child Healthand Development, Tokushima University Hospital, Forum for Ethical Review Committees in Asiaand the Western Pacific Region (FERCAP), Strategic Initiative for Developing Capacity in Ethical
Review (SIDCER), and Nagasaki University Program for Nurturing Global Leaders in TECD.
Course description
This international course is an overview of research ethics, focusing on the ethics of healthresearch. This course will cover the following: a) historical background, principles, andguidelines of research ethics; b) structure, roles, and functions of research ethics committees; c)
ethical considerations in health research such as those related to informed consent, conflict ofinterest, and risk and benefit evaluation; and d) ethical issues and methodologies in different
health research fields (genetics research, epidemiological and social research, pediatricresearch; and traditional medicine research) in the context of national, regional, andinternational collaborative research.
Course objectives
The general objectives of this course are: a) demonstrate a common understanding of theethical principles in health research and b) utilize the ethical principles in reviewing different
considerations and issues related to various health research fields.
Course format
This course will to a large extent be organized as interactive learning where the students will
work on a number of problem cases which illustrate the main points made in the lectures andpresentations. It will be a three-day intensive course. English is a common language in thecourse, however, the lecturers and mentors are able to communicate in other 5 languages, i.e.
Japanese, Filipino, Thai, Korean and Spanish. Comprehensive background materials will be
provided to the participants.
Course participants

Version 1.14-1-The target participants for this course are postgraduate students and researchers in biomedicalsciences (including health social sciences) and members of research ethics committees.
Course organizers
Prof. Dr. Juntra Karbwang
Professor and Head, Product Development, NEKKEN, Nagasaki University
Prof. Dr. Hitoshi SasakiProfessor and Head, Nagasaki University Hospital Pharmacy
Prof. Dr. Kenji Hirayama
Professor and Head, Immunogenetics, NEKKEN, Nagasaki University
Faculty
Lecturers: Fabio Zicker (WHO/TDR, Geneva, Switzerland), Kiichiro Tsutani (University of Tokyo),
Cristina Torres (FERCAP-Philippines), Young- Mo Koo (FERCAP-South Korea), Nao Tsuchida(National Center for Child Health and Development), Hiroaki Yanagawa (Tokushima University
Hospital), Akiko Matsuyama (Nagasaki University), Kenji Hirayama (Nagasaki University) andJuntra Karbwang (Nagasaki University)
Other Mentors: Hiroshi Sato (Niigata University), Hanako Mihara ( Sanofi Pasteur KK)
Course venue
Pompe Hall in Sakamoto Campus, Nagasaki University
Course fee
Free to all participants (meals, accommodation, travel are not included).
The course is financially supported by National Program to support the specific academic
community of the Institute of Tropical Medicine (NEKKEN), Nagasaki University program for
nurturing global leaders in tropical and emerging infectious diseases and SIDCER to facilitate theethical conduct of research for health.
Application
Please send your name, affiliation, e-mail address, accommodation arrangement by e-mail toMs. Junko Hayashima and cc to Prof. Dr. Kenji Hirayama.
Registration deadline: June 21 (Fri), 2013
Ms. Junko Hayashima
Course Office Staff
Department of Immnogenetics, Institute of Tropical Medicine (NEKKEN), 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
Prof. Dr. Kenji Hirayama
Professor and Head
Department of Immunogenetics, Institute of Tropical Medicine (NEKKEN), Nagasaki University
Tel: +81-95-819-7818 | Fax +81-95-819-7821
E-mail: hiraken@nagasaki-u.ac.jp
Version 1.14-2-Course outline
First Day
July 7 (Sunday)
08:45

Inaugural session
Facilitators: Juntra Karbwang, Hitoshi Sasaki, Kenji Hirayama
Introduction to the workshop
Presentation of participants

09:15

Introduction to research ethics:
History and the need of ethical review system
Fabio Zicker (WHO/TDR, Switzerland)

10:00

Coffee/Tea break

10:30

Roles and functions of research ethics committees
Cristina Torres (FERCAP-Philippines)

11:15

Informed consent
Cristina Torres (FERCAP-Philippines)

12:00

Lunch

13:00

Conflict of interest
Young Mo Koo (FERCAP-South Korea)

13:30

Risks and benefits evaluation
Hiroaki Yanagawa (Tokushima University Hospital)

14:15

Coffee/Tea break

14:30

Case Study 1: Group discussion

Facilitators: Fabio Zicker, Cristina Torres, Young Mo Koo, Hanako Mihara, Akiko Matsuyama,
Kenji Hirayama, Juntra Karbwang
15:30

Case Study 1: Reporting and Plenary discussion
Moderators: Fabio Zicker, Cristina Torres

17:00

End of day one*******Version 1.14-3-

Second Day
July 8 (Monday)
09:00

Ethical issues in human genome research
Kenji Hirayama (Nagasaki University Japan)

09:45

Ethical issues in pediatric research
Nao Tsuchida (National Center for Child Health and Development, Japan)

10:30

Coffee/Tea break

11:00

Ethical issues in traditional medicine research
Kiichiro Tsutani (University of Tokyo, Japan)

12:00

Lunch

13:00

Ethical issues in epidemiological and social research
Cristina Torres (FERCAP-Philippines)

14:00

Case Study 2: Group discussion

Facilitators: Kiichiro Tsutani, Cristina Torres, Kenji Hirayama, Akiko Matsuyama, Fabio Zicker,
Young Mo Koo, Hiroshi Sato, Hanako Mihara, Juntra Karbwang
15:00

Coffee/Tea break

15:30

Case Study 2: Reporting and Plenary discussion
Moderators: Akiko Matsuyama, Cristina Torres

17:00

End of day two

Third DayJuly 9 (Tuesday)
09:00

Ethical issues in international health research:
Study design, informed consent, level of care, post trial benefit
Akiko Matsuyama (Nagasaki University)
Cristina Torres (FERCAP-Philippines)

10:15

Quality improvement in Ethical Review
Juntra Karbwang (Nagasaki University, Japan)

10:30

Coffee/Tea break

11:00

Plenary discussion
Moderators: Akiko Matsuyama, Cristina Torres, Juntra Karbwang

12:00

Presentation of certificate
Juntra Karbwang, Kenji Hirayama
End of the course

Version 1.14-4-