International course on research ethics 日本語はこちら
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.
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.
Course Coordinators：Reidar Lie (Bergen Univ., NIH), Kenji Matsui (Bergen Univ. Shiga Med.Col), Kenji Hirayama (ITM, Nagasaki Univ.)
Lecturer： Reidar Lie (Bergen Univ. Norway), Juntra Karbwang (WHO/TDR, Geneva), Ezekiel Emanuel (NIH), Benjamin Wilfond (NIH), Hidefumi Nakamura (National Center for Child Health and Development), Eiji Uchida (Showa Univ.), Ock Joo Kim (Seoul National University)
Tutor：Young Moo Koo (Ulsan University), Ki-ichirou Tsutani (Univ Tokyo), Makiko Noguchi (Univ.Tokyo), Toshiyuki Sasaguri (Kyushu Univ), Hitoshi Sasaki (Nagasaki Univ.), Hiroaki Yanagawa (Tokushima Univ.), Hiroshi Satoh (Niigata Univ)
Pompe Hall, Sakamoto Campus, Nagasaki University
1-12-4 Sakamoto, Nagasaki 852-8523
Application to Kenji Hirayama, M.D.,Ph.D.
Department of Molecular Immunogenetics
Institute of Tropical Medicine
Tuition Fee: 20,000JPY (does not include meals, accommodations, and travel)
Send your name, affiliation, address and mail address. We have a special discount fee for student.
July 25, 2005
Introduction to the workshop. Presentation of participants
|9:30||Framework for research ethics
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..
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.
|13:45||Presentation of group work|
|14:30||Evaluation of risks and benefits.
Reidar K. Lie 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.
|16:30||Presentation of group work.|
|17:30||End of day one|
July 26, 2005
|9:00||Research on children: Hidefumi Nakamura|
|9:45||Plenary discussion. Evaluation of risks and benefits in children. Break.|
|11:30||Ezekiel Emanuel: Inducements, exploitation|
|13:00||Eiji Uchida. IRB on clinical trials in Japan.|
|13:45||Ock-Jo Kim. Organization of ethics review and regulations in Korea.|
|14:15||Reidar Lie Policy options for research ethics review|
|15:30||Group work. Break|
|16:00||Presentation of group work|
|16:30||Prof. Shimada. Ethics and field experience|
|17:00||End of day two|
July 27, 2005
|9:00||Issues in international research ethics. Reidar K. Lie.
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
|10:00||Pharmacogenomics genetics and ethics. Benjamin Wilfond/ mock REC|
|12:00||Presentation of certificates End of day three|