International course on research ethics

Nagasaki, Japan, July 31- August 2, 2003


Organized by

Nagasaki University, NIH (USA), Bergen University (Norway)


Co-sponsored by

Federation of Ethical Review Committee members in Asia and Pacific regions (FERCAP),


Association of Alumni of Institute of Tropical Medicine  and Hojinnkai, Nagasaki University


Venue: Institute of Tropical Medicine, Nagasaki university

Tution fee: 10,000 JPN or 80 USD

We will help you to reserve your accommodations


Tutors and fascilitators

Reidar Lie (Professor of Philosophy, Bergen University, and NIH, USA),

Juntra Karbwang (Clinical coordinator, TDR/WHO, Geneva, Switzerland),

and other international experts


Secretary general: Kenji Hirayama, M.D.Ph.D.

Department of Molecular Immunogenetics,

Institute of Tropical Medicine, Nagasaki University

1-12-4 Sakamoto, Nagasaki852-8523, Japan

Tel: +81-95-849-7820, Fax: +81-95-849-7821, Mail:



Course format

The course is organized as interactive learning, where the students will work on a number of problem cases which illustrate the main points made in a few introductory lectures.  It will be a three day intensive course.


Target groups

Ph.D. students in health sciences, researchers, members of research ethics committees, senior medical and health sciences students.



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 and functions 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 as well as issues of research integrity. 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.





July 31, 2003

9:00      Inaugural session:

                    Introduction to the workshop. Presentation of participants

9:45     Introduction to research ethics. Historical background. Ethical principles

One could argue that modern research ethics started in the mid 1960s with the documentation of some serious cases of research abuse in the US and other countries. 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 of research ethics committees in the US and the UK, and subsequently in other countries.  The aim of this section is to let the participants get a feel for the types of cases that led to the development of current research ethics guidelines, such as the Helsinki Declaration and the CIOMS guidelines..

10:30         Coffee/Tea

11:00   Informed decision making

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). Informations usually required to be 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-cultural concerns.

12:00         Lunch

13:00   Group work: Informed decision making

14:30         Coffee/Tea

15:00   Plenary discussion of informed consent

16:00   Roles and functions of research ethics committees

17:00         End of day one



Agust 1, 2003

9:00      Evaluation of risks and benefits.

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 discontinuation of a study.

9:30      Case discussion: Evaluation of risks and benefits

10:30         Coffee/Tea

11:00   Plenary: Evaluation of risks and benefits

12:00         Lunch

13:00   Inducements and financial incentives

Can one pay research subjects? Difference between reimbursements of expenses and payments. Payments to researchers. Different ways of paying researchers such as per capita reimbursements.


13:30   Case discussion

15:00         Coffee/Tea

15:30   Plenary

16:30         End of day two



August 2, 2003

9:00     Ethical issues in collaborative research. Standards of care. Benefits after research is over

Is it permissible to carry out a trial in a developing country, but not in a developed 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 the availability 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?  In particular, the Thai experience with the phase III HIV vaccine trial will be examined

9:30      Case discussion

10:30         Coffee/Tea

11:00   Plenary

12:00         Lunch

13:00   Ethical issues in social science research/Research integrity

13:30   Case discussion

15:00         Coffee/Tea

15:30   Plenary

16:30         End of day three



International course on research ethics











講師:Reidar Lie (Professor of Philosophy, Bergen University, and NIH, USA),

Juntra Karbwang (Clinical coordinator, TDR/WHO, Geneva, Switzerland),

and other international experts




852−8523 長崎市坂本1−12−4

電話:095-849-7820, FAX: 095-849-7821, Mail:














午前9時              開講のあいさつ


午前9時45分  医学研究の倫理とは。その歴史的背景と原理



午前10時30分        コーヒーブレーク


午前11時          研究への参加の意志決定



12時                  昼食1

午後1時              インフォームド・コンセントに関するグループ討論

午後2時30分  コーヒーブレーク

午後3時              グループ討論のまとめ

午後4時              倫理委員会の役割と機能

午後5時              第1日目の終了




午前9時              リスクと利益の評価




午前9時30分  リスクと利益の評価に関するケーススタデイ

午前10時30分        コーヒーブレーク

午前11時          ケーススタデイの討論のまとめ

12時                 昼食

午後1時              勧誘と金銭による誘導



午後1時30分  症例検討

午後3時              コーヒーブレーク

午後3時30分  討論のまとめ

午後4時30分  第2日の終了



午前9時              共同研究における倫理問題、標準的な治療、研究が終わった後の利益。


午前9時30分  症例検討

午前10時30分        コーヒーブレーク

午前11時          症例検討のまとめ

12時                 昼食

午後1時              社会科学研究における倫理・研究における道徳

午後1時30分  症例検討

午後3時              コーヒーブレーク

午後3時30分  討論のまとめ

午後4時30分  修了式