PE Expert E course

Japanese Institute for Public Engagement

PE Expert E course Objectives and Goals

The role of the Research Ethics Review Committee, which examines research from a variety of perspectives, is essential to the development of ethical and scientific medicine and pharmaceuticals. In particular, for research to which the "Ethical Guidelines for Life Science and Medical Research Involving Human Subjects" apply, persons who can express their opinions from a general standpoint, including the viewpoint of the research subjects, are required to participate in the review.
In addition, the Ministerial Ordinance on the Conduct of Clinical Trials of Drugs (GCP Ordinance) also requires that persons other than those with specialized knowledge be included in the review of the clinical trials.
However, there are not many ordinary people who can properly grasp the perspective of research subjects in the process of drug development and medical research, and express their opinions on the plans from a non-expert standpoint.
Therefore, this course will

Basics of research ethics, review systems, and management of conflicts of interest
Ethical validity and subject protection
Research plan, design, analysis, and implementation system

The course aims to develop committee members who can contribute to high-quality ethical review by learning about the basics of research ethics, review systems, management of conflicts of interest, ethical validity and protection of human subjects, etc., and by practically simulating a wide variety of cases as case studies in mock review committees.
In addition, after completing the initial introductory education, students will be able to keep up with the latest review standards through annual continuing education.

Career path

This course is especially recommended for lay members who have no prior experience in ethics review or who have been participating in reviews for less than three years.
Those who complete this course and achieve a certain grade in the evaluation will be issued a certificate of completion and their attributes (anonymous) will be posted on this website. Upon request to participate as a member of the assessment committee, we will refer those who have completed the course to you.

Information for all courses

A course

Introduction to drug development and use in the market

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B course

Leadership training for representatives of patient associations and advocacy groups

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C course

Basic knowledge in drug development, aligned with PharmaTrain Syllabus v2.0

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D course

PharmaTrain’s SMD (Specialist in Medicines Development) program for drug developers

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E course

Educational course for non-scientific members of ECs/IRBs

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