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Even in recent years, there are reports of unethical research or research with problematic scientific validity. To prevent such situations, laws and various government guidelines regarding research ethics have been formulated in Japan.

Currently, a government committee is considering a revision of the "Ethical Guidelines for Medical and Biological Research Involving Human Subjects." In connection with this, a call for opinions (so-called public comments) is being conducted from the end of last year until the 25th of this month.

These guidelines are representative government guidelines regarding research ethics and are directly or indirectly related to research conducted at SFC. Specifically, when conducting research subject to these guidelines, researchers formulate research plans based on them. Furthermore, the Research Ethics Committee reviews submitted research based on the content of these guidelines if the research falls under their application.

However, depending on the content of the research, there may be cases where no applicable government guidelines exist. Even in such cases, a researcher may apply for research ethics review, and the Research Ethics Committee may review the research plan, for example, to meet requirements from a journal where the paper is being submitted. In such instances, the researcher likely creates the research plan based on the intent of representative guidelines, including these ones. Similarly, the Research Ethics Committee likely conducts the review based on the intent of those same representative guidelines.

From the above, it can be said that these guidelines are important ones that should be fully grasped and understood in advance by researchers (especially those involved in life sciences and medical sciences research), as well as by members and administrative staff of the ethics review committee.

However, as a result of multiple revisions to date—such as to accommodate amendments to the Act on the Protection of Personal Information—the content of these guidelines has become complex and difficult to understand. Consequently, it has become a situation that requires considerable time and effort for accurate understanding, not only for researchers but also for members of the ethics review committee. Due to these circumstances, non-negligible issues have arisen, such as points being raised about variations in the quality of reviews by ethics review committees.

Many readers have likely experienced the difficulty of understanding the guidelines firsthand. I myself often struggle with the interpretation and understanding of the guidelines while being involved in research ethics reviews and the formulation and revision of government guidelines.

The current call for opinions is an important procedure toward revising the guidelines with these issues in mind. Incidentally, the so-called public comment system is based on the Administrative Procedure Act; for example, Article 39, Paragraph 1 of the Act stipulates that "When Organs Establishing Administrative Orders, etc. intend to establish Administrative Orders, etc., they shall publicly notice the draft of the Administrative Orders, etc. (omitted) and any related materials in advance, and designate the address to which opinions (omitted) should be submitted and the period for the submission of opinions (omitted), and seek opinions from the public at large."

Why not take this opportunity to reconfirm these guidelines from your standpoint as someone involved in research? Furthermore, if you have any opinions or insights, submitting them as public comments can be considered one of the important activities of a researcher.