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【Paper Publication Announcement】 Informed consent in clinical trials using stem cells: Suggestions and points of attention from informed consent training workshops in Japan (M Kusunose, F Nagamura, K Muto)


A paper titled “Informed consent in clinical trials using stem cells: Suggestions and points of attention from informed consent training workshops in Japan” written by Mayumi Kusunose, Fumitaka Nagamura, and Kaori Muto has been published by the South African Journal of Bioethics and Law. This paper is based on a training workshop on informed consent (IC) for members of stem-cell research teams and an educational workshop for a certain patients’ group. The paper discusses necessary aspects in promoting and conducting IC appropriately. Additionally, it emphasizes the importance of continuous education for improving the IC skills and competency of people responsible for obtaining IC.

M Kusunose, F Nagamura, K Muto. Informed Consent in Clinical Trials Using Stem Cells: Suggestions and Points of Attention from Informed Consent Training Workshops in Japan. S Afr J BL 2015;8(2 Suppl 1):49-54. DOI:7196/SAJBL.8016

Informed consent (IC) is an essential requirement of ethical research involving human participants, and usually is achieved by providing prospective research participants (PRPs) with a document that explains the study and its procedures. However, results of a series of IC workshops held in Tokyo during 2014 indicate that consent forms alone are not enough to achieve full IC in regenerative medicine research due to the necessity of long-term patient-safety observations to meet the ethical challenges of such research. Adequate training of the people who are responsible for obtaining IC (elucidators) is also necessary to ensure full IC. Elucidators must be able to provide PRPs with sufficient information to assure adequate comprehension of the study and its potential aftereffects; judge PRPs’ voluntariness and eligibility; and establish/maintain partnerships with PRPs. The workshops used role-playing simulations to demonstrate how to effectively obtain fuller IC to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information is patients want when considering participation in iPSC research. The correlated results showed the need for continuous training and education of elucidators in order to have them acquire and maintain IC competency.



Public attitudes to the promotion of genomic crop studies in Japan


Dr Izumi Ishiyama and us published a paper on public attitude towards genomic crop in Japan.
This study aimed to assess public attitudes in Japan to the promotion of genomic selection in crop studies and to examine associated factors. We analysed data from a nationwide opinion survey. A total of 4,000 people were selected from the Japanese general population by a stratified two-phase sampling method, and 2,171 people participated by post; this survey asked about the pros and cons of crop-related genomic studies promotion, examined people's scientific literacy in genomics, and investigated factors thought to be related to genomic literacy and attitude. The relationships were examined using logistic regression models stratified by gender. Survey results showed that 50.0% of respondents approved of the promotion of crop-related genomic studies, while 6.7% disapproved. No correlation was found between literacy and attitude towards promotion. Trust in experts, belief in science, an interest in genomic studies and willingness to purchase new products correlated with a positive attitude towards crop-related genomic studies.

Izumi Ishiyama, Tetsuro Tanzawa, Maiko Watanabe, Tadahiko Maeda, Kaori Muto, Akiko Tamakoshi, Akiko Nagai, Zentaro Yamagata:Public attitudes to the promotion of genomic crop studies in Japan: correlations between genomic literacy, trust, and favourable attitude.Public Understanding of Science.21(4):498-516, 2012.



Children and the Genetic Identification of Talent


Yusuke Inoue and Kaori Muto published a short review on children and the genetic identification of talent in Hastings Center Report.
The regulation of direct-to-consumer genetic testing has till now focused on identifying predispositions to specific health problems and quality issues in testing, such as analytical and clinical validity criteria. In the United States, for example, the Food and Drug Administration warned that federal regulations for medical devices will apply to commercial genetic tests for health purposes. By contrast, the regulation of commercial genetic testing for other purposes is rarely discussed. These tests are advertised as identifying intelligence, athletic ability, and artistic sensibility in children. One company offers testing for a “gold medalist gene” purportedly associated with remarkable athletic talent; in Japan, the test has been favorably featured on some television programs and is recruiting customers through the Internet.

Inoue, Y and Muto, K.
Children and the Genetic Identification of Talent
Print:Hastings Center Report, Vol 41, No 5 (September-October 2011), inside back cover.



Our paper has been selected for highlighting on the A-IMBN Research web


Our paper on better communication methods to build trust with participants of biobank projects has been selected for highlighting on the A-IMBN Research website. Special thanks for all authors and editors!

Watanabe, M.,Inoue, Y., Chang, C., Hong, H., Kobayashi, I., Suzuki, S. & Muto, K. For what am I participating? The need for communication after receiving consent from biobanking project participants: experience in Japan. Journal of Human Genetics advance online publication 10 March 2011 (doi: 10.1038/jhg.2011.19)



The first paper on consent and communication of Biobank Japan participants


We published a new paper titled as 'For what am I participating? The need for communication after receiving consent from biobanking project participants: experience in Japan'.
Watanabe M, Inoue Y, Chang C, Hong H, Kobayashi I, Suzuki S, Muto K.
Journal of Human Genetics. 2011 Mar 10. [Epub ahead of print]

This paper introduces methods used to communicate with participants in the 'Biobank Japan Project (BBJP)', which is a disease-focused biobanking project. The methods and their implications are discussed in the context of the ethical conduct of the biobanking project. Informed consent, which ensures the autonomous decisions of participants, is believed to be practically impossible for the biobanking project in general. Consequently, the concept of 'trust', which is 'judgement and action in conditions of less than perfect information', has been suggested to compensate for this limitation. As a means to maintain the trust participants feel for the project, this paper proposes communication with participants after receiving their consent. After describing the limitations of informed consent within the BBJP, based on a survey we conducted, we introduce our attempts to communicate with participants, discussing their implications as a means to compensate for the limitations of informed consent at the biobanking project.Journal of Human Genetics advance online publication, 10 March 2011; doi:10.1038/jhg.2011.19.



Living liver transplantation in Japan (Muto K)


International Journal of Japanese Sociology No 19 features 'Social context of Medicine in Japan'.
Kaori MUTO edited this issue and published on living liver transplantation in Japan.

IJJS Volume 19, Issue 1
Special issue: Social context of Medicine in Japan

Introduction (pages 2–3)
Kaori Muto (武藤香織)

Unintended Consequences of “Soft” Regulations: The Social Control of Human Biomedical Research in Japan (pages 4–17)
Shimon Tashiro (田代志門)

Reproductive Technologies and Parent–Child Relationships: Japan's Past and Present Examined through the Lens of Donor Insemination (pages 18–34)
Chiaki Shirai (白井千晶)

Organ Transplantation as a Family Issue: Living Liver Donors in Japan (pages 35–48)
Kaori Muto (武藤香織)

“Good Manner of Dying” as a Normative Concept: “Autocide,”“Granny Dumping” and Discussions on Euthanasia/Death with Dignity in Japan (pages 49–63)
Izumi Otani (大谷いづみ)