The 13th Nagasaki International Course on Research Ethics
Pompe Hall in Sakamoto Campus, Nagasaki University, Nagasaki, Japan
8-10 May 2014
Organized and supported byInstitute of Tropical Medicine (NEKKEN), Nagasaki UniversityNagasaki, Japan
In cooperation withNational Cerebral and Cardiovascular Center, University of Tokyo, National Center for Child
Health and Development, Showa University, Tokushima University Hospital, Forum for EthicalReview Committees in Asia and the Western Pacific Region (FERCAP), Strategic Initiative forDeveloping Capacity in Ethical Review (SIDCER), and Nagasaki University Leadership Program.
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 the
ethical 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.
Version 8-1-Course participants
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 Sasaki
Professor and Head, Nagasaki University Hospital Pharmacy
Prof. Dr. Kenji Hirayama
Professor and Head, Immunogenetics, NEKKEN, Nagasaki University
Faculty
Lecturers: Chitr Sitthi-amorn, (Chulalongkorn University), Kiichiro Tsutani (University of Tokyo),
Cristina Torres (FERCAP-Philippines), Nao Tsuchida (National Center for Child Health) andDevelopment), Akiko Matsuyama (Nagasaki University), Kenji Hirayama (Nagasaki University) andJuntra Karbwang (Nagasaki University)
Other Mentor: Nguyen Tien Huy (Nagasaki University)
Course venue
Pompe Hall in Sakamoto Campus, Nagasaki University
Course fee
Free to all participants (meals, accommodation, and travel are not included).
The course is financially supported by the Institute of Tropical Medicine (NEKKEN) and SIDCER tofacilitate the ethical 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.
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 8-2-Course outline
First Day
May 8 (Thursday)
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
Chitr Sitthi-amorn (Chulalongkorn University)

10:00

Coffee/Tea break10:30

Roles and functions of research ethics committees
Juntra Karbwang (Nagasaki University, Japan)

11:15

Informed consent
Cristina Torres (FERCAP-Philippines)

12:00

Lunch

13:00

Conflict of interest
Juntra Karbwang (Nagasaki University, Japan)

13:30

Risks and benefits evaluation
Cristina Torres (FERCAP-Philippines)

14:15

Coffee/Tea break

14:30

Case Study 1: Group discussion

Facilitators: Chitr Sitthi-amorn, Cristina Torres, Akiko Matsuyama, Kenji Hirayama, Juntra
Karbwang
15:30

Case Study 1: Reporting and Plenary discussion
Moderators: Chitr Sitthi-amorn, Cristina Torres

17:00

Version 8End of day one-3-Second Day
May 9 (Friday)
09:00

Ethical issues in pharmacogenomics research
Kenji Hirayama (Nagasaki University Japan)

09:45

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

10:30

Coffee/Tea break

11:00

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

12:00

Lunch

13:00

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

14:00

Case Study 2: Group discussion

Facilitators: Kiichiro Tsutani, Nao Tsuchida, Cristina Torres, Kenji Hirayama, Akiko
Matsuyama, Chitr Sitthi-amorn, 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 twoThird Day
May 10 (Saturday)
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)

1015

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 8-4-