The 15th Nagasaki International Course on Research Ethics
Pompe Hall in Sakamoto Campus, Nagasaki University, Nagasaki, Japan
16-18 May 2016
Organized and supported byInstitute of Tropical Medicine (NEKKEN), Nagasaki UniversityNagasaki, Japan
In cooperation withForum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP), Strategic
Initiative for Developing Capacity in Ethical Review (SIDCER).
Course description
This international course is an overview of research ethics, focusing on the ethics of health research.
This course will cover the following: a) historical background, principles, and guidelines ofresearch ethics; b) structure, roles, and functions of research ethics committees; c) ethicalconsiderations in health research such as those related to informed consent, conflict of interest, andrisk and benefit evaluation; and d) ethical issues and methodologies in different health research fields(genetics research, epidemiological and social research and pediatric research) in the context ofnational, regional, and international collaborative research.
Course objectives
The general objectives of this course are: a) To demonstrate a common understanding of the ethicalprinciples in health research and b) To 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 participants will workon a number of problem cases. The case studies will illustrate the main points made in the lecturesand presentations. 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 4 languages, i.e.
Japanese, Filipino, Thai and Vietnam. Comprehensive background materials will be provided to theparticipants.

Version 4-1-Course participants
The target participants for this course are postgraduate students , researchers in biomedical sciences(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: Cristina Torres (FERCAP-Philippines), Jarupim Soongswang (Mahidol University,Thailand),
Kwanchanok Yimtae (Khon Khen University), Hitoshi Sasaki (Nagasaki University),Akiko Matsuyama(Nagasaki University), Kenji Hirayama (Nagasaki University) and Juntra 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. Sayuri Delaney and cc to Prof. Dr. Kenji Hirayama.
Ms. Sayuri Delaney
Course Office Staff
Department of Clinical Product Development, Institute of Tropical Medicine (NEKKEN), Nagasaki
University
1-12-4 Sakamoto, Nagasaki 852-8523, Japan
Tel: +81-95-819-7558| Fax: +81-95-819-7821
E-mail: delaney@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 4-2-Course outline (draft agenda)
First DayMay 16 (Monday)
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
Juntra Karbwang (Nagasaki University, Japan)

10:00

Coffee/Tea break

10:30

Roles and functions of research ethics committees
Jarupim Soongswang (Mahidol University,Thailand)

11:15

Informed consent
Cristina Torres (FERCAP-Philippines)

12:00

Lunch

13:00

Conflict of interest
Kwanchanok Yimtae (Khon Khen University,Thailand)

13:30

Risks and benefits evaluation
Cristina Torres (FERCAP-Philippines)

14:15

Coffee/Tea break

14:30

Case Study 1: Group discussion

Facilitators: Kwanchanok Yimtae, Cristina Torres, Jarupim Soongswang, Hiroshi Sasaki, Akiko
Matsuyama, Kenji Hirayama, Juntra Karbwang, Nguyen Tien Huy
15:30

Case Study 1: Reporting and Plenary discussion
Moderators: Kwanchanok Yimtae , Cristina Torres

17:00

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End of day one-3-Second Day
May 17 (Tuesday)
08:30

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

09:00

Ethical issues in Emergency Medicine Research
Kwanchanok Yimtae (Khon Khen University,Thailand)

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
Jarupim Soongswang (Mahidol University,Thailand)

12:00

Lunch

13:00

Case Study 2: Group discussion

Facilitators: Kwanchanok Yimtae, Jarupim Soongswang, Cristina Torres, Hitoshi Sasaki, Kenji
Hirayama, Akiko Matsuyama, Juntra Karbwang15:00

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 18(Wednesday)
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)

10:30

Coffee/Tea break

11:00

Plenary discussion
Moderators: Akiko Matsuyama, Cristina Torres

12:00

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

Version 4-4-