Research Ethics: Encouraging a Re-evaluation of Government Guidelines | Shoichi Maeda, Dean of the Graduate School of Health Management
Even in recent years, there are reports of unethical research and 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. That is, 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, researchers may apply for research ethics approval, and the Research Ethics Committee may review the research plan, for example, to meet requirements from journals where the paper is submitted. In such instances, researchers likely prepare their research plans based on the spirit of representative guidelines, including these ones. Similarly, the Research Ethics Committee likely conducts its review based on the spirit 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 committees.
However, as a result of multiple revisions to date—such as responding to 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 reached a point where it requires considerable time and effort for accurate understanding, not only for researchers but also for members of ethics committees. Due to these circumstances, issues that cannot be ignored have arisen, such as points being raised about variations in the quality of reviews by ethics committees.
Many readers have likely experienced the difficulty of understanding these 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 announce the draft of the Administrative Orders, etc. (omitted) and any related materials in advance, and seek opinions (omitted) from the general public, specifying the address to which opinions should be submitted and the period for the submission of opinions (omitted)."
Why not take this opportunity to re-examine 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.