129

Advanced Clinical Research Center

Division of Bioethics
生命倫理研究分野
Associate Professor

Ayako Kamisato, Ph.D.

准教授

博士（法学）

神里

彩子

Medical research has high expectations from society, however, it imposes burdens
and risks on subjects. Also, research using advanced medical technology may
raise new ethical, legal and social issues (ELSI). For these reasons, certain rules
are required for medical research. In our laboratory, we consider what kind of rules
are necessary for protecting subjects and responding to the new ELSI.

1. Survey on Public Awareness of Medical Research Terminology and the Accuracy of Physicians’ Predictions regarding that Awarenessin Japan
Ayako Kamisato, Hong Hyunsoo
One of the ethical principles of medical research
involving human subjects is obtaining proper informed consent (IC). However, if the participants’ actual awareness of medical research terminology islower than the researchers’ prediction of that awareness, it may cause difficulty obtaining proper IC.
Therefore, this study aims to clarify the presence of“perception gaps” and then discuss IC-related issues
and measures based on the insights obtained. We conducted two online surveys: a “public survey” to understand the Japanese public’s awareness of 11 medical research terms and a “physicians’ survey” toinvestigate physicians’ predictions regarding publicawareness. In the “public survey,” for each term, respondents were instructed to select their situationfrom “understand,” “have heard,” or “have neverheard.” In the “physicians’ survey,” respondents
were asked to estimate the proportions of the generalpublic who would “have understood,” “have heard,”
or “have never heard” by using an 11-step scale. We
analyzed separately in two age groups to understandthe age-related difference. We received 1002 valid re-sponses for the “public survey” and 275 for the “physicians’ survey.” Of the public respondents, morethan 80% had never heard of terms such as interventional study, prospective clinical study, cohort study, Phase
I clinical trial, or double-blind study. Concurrently, physicians overestimated general public awareness of theterms placebo, cohort study, double-blind study, and randomized clinical trial (in the group of people under 60).
The results revealed the perception gap between thegeneral public and physicians which raises serious
concerns about obtaining proper IC from clinical research participants.
2. Research on the Japan’s clinical research review system
Ayako Kamisato
As of the end of 2023, clinical research is being
conducted under four laws, orders based on them,and eight guidelines. All of these laws and guidelines
have in common that they require researchers to create a research protocol and get it reviewed by a review body established at the research institution(hereinafter referred to as a local committee). However, on the other hand, there are many differences on
the review system between laws and guidelines, suchas whether additional review is required by a review
body set up by the government or whether there is a130
local committee certification system. Therefore, we
examined the examination system of all laws andguidelines and considered the issues that emerged
from this and the future system design.
3. Ethical support for “The Center of Well-being
Regional Society Innovation project.”Ayako Kamisato, Kazuyo Arisawa, Yoshiko Takahashi“The Center of Well-being Regional Society Innovation project,” promoted by Hirosaki University(Hirosaki COI-NEXT), is one of the projects of the JST
Program on Open Innovation Platform for Industry-Academia Co-Creation. The goal of this project isto build and utilize a big data platform on medicaland health. To achieve this goal, one of the wide-ranging efforts of Hirosaki COI-NEXT is the implementation of a large-scale health survey called the “Iwaki
Health Checkup Project” (hereinafter referred to as“Iwaki Health Checkup”), targeting residents of theIwaki district of Hirosaki City. In this checkup, Hirosaki University collaborates with companies andresearch institutes to collect 2,000 to 3,000 items ofhealth and medical data per person. The aim is toquickly find preventive and therapeutic methods fordementia and lifestyle-related diseases by analyzing
such big data from multiple angles. Our laboratory is

in charge of ethical support for the Iwaki healthcheckup. As part of our support, in 2023, we established an ethics review committee dedicated to thisproject. We began reviewing it to promote the use ofhealth checkup data for research and development.
4. The REC Education program (RECs) for Research Ethics Committees (REC) members
and researchers
Ayako Kamisato, Kazuyo Arisawa, Hong Hyunsoo,
Yoshiko Takahashi
We have constructed the REC Education programfor Research Ethics Committees (REC) members withsupport from the Japan Agency for Medical Researchand Development (AMED) since FY 2016. So far, wehave produced fifteen video programs and released
them on our website. Two thousand two hundred fifty-two members and 778 institutions have registeredwith our program as of 31 May 2022. Also, we haveconstructed the REC Education program for researchers and produced five video programs with support
from the AMED since FY 2019. Currently, we have
2,939 members registered with this program as of 31
May 2022.
In 2023, we revised the video programs following
revisions of the “Ethical Guidelines for Medical andBiological Research Involving Human Subjects.”

出版物
・神里彩子「第8章 個人情報の取扱いに関する基礎知識」飯嶋久志、氏原淳、内田直樹、神里彩子、
佐藤愛美『超簡単！！研究倫理審査と申請 第2版～適正な臨床・疫学研究の推進に向けて～ 』（薬事日報社、2023年）
・神里彩子「第5章 臨床研究の審査体制－現状と今後の在り方」甲斐克則編『臨床研究と医事法（医事法講座 第13巻）』（信山社、2023年）
・神里彩子・武藤香織編『医学・生命科学の研究倫理ハンドブック第2版』（東京大学出版会、2023年）
・Hideki Yui, Ayako Kamisato, Kaori Muto, Yoshimi
Yashiro, Saori Watanabe, Yukitaka Kiya, KumikoFujisawa, Yusuke Inoue, Zentaro Yamagata. Attitudes towards human fetal tissue research: Surveyof researchers and the public in Japan. Regenerative Therapy,Volume 24,2023,Pages 78-84, https://doi.org/10.1016/j.reth.2023.05.007.
・Kamisato, A., Hong, H. & Okubo, S. Public Aware-ness of Medical Research Terminology in Japan,
and the Accuracy of Physicians’ Predictions regarding that Awareness. ABR (2023). https://doi.
org/10.1007/s41649-023-00247-4
・Iimura, Yohei & Nakazawa, Mitsuko & Tsuru,Yukari & Togashi, Hitomi & Honda, Tomoe &Baba, Keisuke & Ishibashi, Masaaki & Sasuga,
Chieko & Furukawa, Naoki & Sato, Tomoko & Matsubara, Yasuo & Kamisato, Ayako & Yoshii, Eiko &Kuroda, Seiichiro & Boku, Narikazu. Evaluation ofclinical effects of a multidisciplinary-collaborated
cancer support team for gastrointestinal cancer
chemotherapy: prospective observational study
protocol of M-CAST study. Research Square; 2023.
DOI: 10.21203/rs.3.rs-2529768/v1.10.21203/rs.3.rs-25
29768/v1.
・神里彩子「生殖技術に関する倫理的・法的・社会的課題（ELSI）の全体」医事法研究第8号（甲斐克則責任編集、信山社、2023年12月）