An article, "Awareness and perceptions of patient and public involvement in rare disease research in Japan: the role of patient advocacy groups and family members", was published in Res Involv Engagem. (Watanabe S., Muto K., Nagai A. and Kiya Y.)
2026/08/25
Watanabe, S., Muto, K., Nagai, A., Yui, H. and Kiya, Y.
Awareness and perceptions of patient and public involvement in rare disease research in Japan: the role of patient advocacy groups and family members. Research Involvement and Engagement. 12, 125 (2026).
https://doi.org/10.1186/s40900-026-00955-9
https://link.springer.com/article/10.1186/s40900-026-00955-9
[Abstract]
Background
Patient and public involvement (PPI) in medical research has increasingly been incorporated into research policies and funding frameworks in Japan, but empirical evidence on how patients and family members perceive PPI remains limited. This is particularly important in rare disease research, where patient populations are small and involvement may depend on organised patient communities. This study explored awareness, experience, perceived benefits and barriers, and support needs regarding PPI among rare disease patients and family members in Japan.
Methods
A cross-sectional online survey was conducted between December 2021 and April 2022 through two national rare disease patient network organisations. Adults with a rare disease or family members of such individuals were eligible. Of 218 responses, 212 met the eligibility criteria and were analysed. Subgroup comparisons used Pearson’s chi-squared test, with Fisher’s exact test when expected cell counts were below 5.
Results
The sample comprised 101 patients (47.6%) and 111 family members (52.4%); 172 of 209 respondents (82.3%) reported prior participation in a patient advocacy group (PAG). Prior awareness of PPI was reported by 29.7% and prior experience by 20.8%. PAG participation was the only respondent characteristic examined that was associated with awareness (33.1% vs. 13.5%; p = 0.018). Nearly all respondents identified at least one perceived benefit of PPI, most commonly advancement of disease research (84.9%). Response patterns differed between PPI-aware and PPI-unaware respondents, and between patients and family members. Compared with patients, family members more often identified advancement of disease research and incorporation of patient and public perspectives as benefits, lack of knowledge about medical research as a barrier, and educational opportunities for patients and families as a needed form of support.
Conclusions
Prior PPI awareness was limited, and PAG participation was the only respondent characteristic examined that was associated with awareness. Patients and family members showed somewhat different perceptions, with family members more often emphasising both the value of PPI and the need for educational support. Meaningful PPI in rare disease research requires not only formal promotion but also practical infrastructure, including public information, education, and support for PAGs, to make involvement feasible and sustainable.
[Plain English summary]
Why did we do this study?
When patients and families help shape medical research, the research is more likely to reflect what matters to them. This is called patient and public involvement, or PPI. In Japan, interest in PPI is growing, but little is known about how people affected by rare diseases understand it, or what support they need.
What did we do?
A total of 212 people living with a rare disease or family members of someone with a rare disease completed an online survey. The survey asked about awareness and experience of PPI, its possible benefits and difficulties, and the support needed to promote it
What did we find?
Most respondents had not heard of PPI. However, people who had taken part in a patient advocacy group were more likely to know about it. Almost all respondents saw benefits of involvement, especially for advancing research into their disease. Family members were more likely than patients to see PPI as a way to advance research and incorporate patient and public perspectives. They were also more likely to view a lack of knowledge about medical research as a barrier.
What does this mean?
Rare disease patients and families see value in PPI, but many are not yet familiar with it. Meaningful PPI needs practical support, including accessible information, learning opportunities, and stronger support for patient advocacy groups.
An article, "Governing healthcare records of past medical injustice beyond consent-based research ethics: a cross-sectional survey of public attitudes toward purpose, proximity, and stewardship in Japan", was published in BMC Medical Ethics (Watanabe S.)
2026/08/21
Watanabe, S., Goto, M., Akashi, T., Suzuki, Y. and Matsubara, Y.
Governing healthcare records of past medical injustice beyond consent-based research ethics: a cross-sectional survey of public attitudes toward purpose, proximity, and stewardship in Japan. BMC Med Ethics (2026).
https://doi.org/10.1186/s12910-026-01571-8
https://link.springer.com/article/10.1186/s12910-026-01571-8
[Abstract]
Background
How can sensitive health information be governed when consent cannot provide the basis for its legitimate use? This question is acute for healthcare records created in contexts of historical injustice — such as forced sterilization and the segregation of stigmatized groups. Such records are indispensable for accountability and redress yet capable of inflicting renewed harm, while the people whose lives they document may be deceased, unreachable, or never have had a meaningful opportunity to consent. In Japan, the Supreme Court’s July 2024 ruling that the former Eugenic Protection Law was unconstitutional has sharpened these questions; however, public views on the conditions of legitimate preservation and use remain largely undocumented.
Methods
We conducted a cross-sectional online panel survey in Japan in November 2024 (n = 1,143), using quotas for sex, age group, and prefecture among adults aged 20–69. Respondents reported their attitudes toward preservation and preferred custodians; the acceptability of six purposes of research use under three personal-proximity conditions (no personal information; self or living family members; ancestors); and their perceptions of benefits and risks. Variation by proximity and purpose constituted the primary comparison; demographic comparisons were exploratory and were summarized using Cramér’s V.
Results
Most respondents (86.8%) supported preservation, but support was conditional, with opposition centered on uncertainty about future purposes and privacy; acceptance of research use varied by purpose and proximity. Medical research was the most widely accepted purpose (77.4% in the no-personal-information condition); humanities and social science research, citizen-led inquiry, and journalistic investigations were less widely accepted. Acceptance was lowest for records concerning respondents themselves or their living family members. Originating medical or welfare institutions received the strongest support as custodians. Women expressed greater concern about psychological risks, particularly the possibility of recalling painful past experiences (Cramér’s V = 0.13).
Conclusions
Sensitive historical healthcare records can be governed neither by preservation imperatives alone nor by consent-based research ethics; their legitimate governance requires purpose-sensitive justification, relational privacy safeguards, and accountable stewardship. Public attitudes do not settle these normative questions but map the social conditions under which governance is likely to command legitimacy, indicating where explanation and trust-building are needed. They form one component of ethical legitimacy, complementing rather than replacing the moral perspectives of survivors, affected families, and disability communities.
An article, “Exploring Patient and Public Involvement and Engagement in Allergy Research: Cross-Disease and Cross-Stakeholder Perspectives in Japan”, was published in Allergy. (Watanabe S. and Muto K.)
2025/10/09
(LETTER)
Adachi, T., Watanabe, S., Kuwabara, Y., Abe, Y., Futamura, M., Inomata, T., Ito, K., Kimura, M., Kan-o, K., Koguchi-Yoshioka, H., Kurashima, Y., Masaki, K., Matsunaga, M., Miki, H., Nakajima, S., Nakamura, Y., Ogawa, Y., Oka, A., Sakashita, M., Sato, S., Takahashi, K., Tamari, M., Tsuda, T., Yonekura, S., Tamari, M., Muto, K. and Morita, H.
Exploring Patient and Public Involvement and Engagement in Allergy Research: Cross-Disease and Cross-Stakeholder Perspectives in Japan.
Allergy, 81: 902-905. (2026)
An article, “What does "appropriate scientific justification" mean for the review of human pluripotent stem cell, embryo, and related research?” was published in Stem Cell Reports. (Muto K.)
2025/04/30
Jonlin EC, Fujita M, Isasi R, Kato K, Munsie M, Muto K, Niakan K, Saha K, Sugarman J, Turner L, Hyun I.
What does "appropriate scientific justification" mean for the review of human pluripotent stem cell, embryo, and related research? Stem Cell Reports. 2025 Apr 17:102479.
https://doi.org/10.1016/j.stemcr.2025.102479 Epub ahead of print.
https://linkinghub.elsevier.com/retrieve/pii/S2213-6711(25)00083-9
[Summary]
This article complements the 2021 International Society for Stem Cell Research (ISSCR) Guidelines for Stem Cell Research and Clinical Translation by explaining what “adequate and appropriate scientific justification” means for human pluripotent stem cell, embryo, and related research, thus providing practical advice for review and oversight bodies, regulators, and investigators who conduct research in these areas.
Notes:
Japanese language version of ISSCR (International Society for Stem Cell Research) 2021 Guidelines for Stem Cell Research and Clinical Translation was published in March 2023. Some members of our department collaborated on the translation.
An article, “Ethical, legal, and social issues (ELSI) and reporting guidelines of AI research in healthcare”, was published in PLOS Digital Health. (Kameyama J. and Inoue Y.)
2024/10/07
Dr Junko Kameyama (Faculty of Humanities and Social Sciences, University of Tsukuba ), a project research fellow who worked in our department until March 2024, and Dr Yusuke Inoue (School of Public Health, Kyoto University), a visiting researcher, have published an article.
(OPINION)
Kameyama J, Kodera S, Inoue Y.
Ethical, legal, and social issues (ELSI) and reporting guidelines of AI research in healthcare. PLOS Digit Health. 2024 Sep 19;3(9):e0000607.
https://doi.org/10.1371/journal.pdig.0000607
https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000607
An article, “Attitudes of patients with IVF/ICSI toward human embryo in vitro culture beyond 14 days”, was published in Regenerative Therapy. (Kiya Y., Watanabe S. and Muto K.)
2024/09/24
Yukitaka Kiya, Saori Watanabe, Kana Harada, Hideki Yui, Yoshimi Yashiro, Kaori Muto.
Attitudes of patients with IVF/ICSI toward human embryo in vitro culture beyond 14 days.
Regenerative Therapy. 2024. 26: 831-836.
https://doi.org/10.1016/j.reth.2024.09.005
[Abstract]
When the International Society for Stem Cell Research revised its 2021 guidelines, it reversed its ban on the in vitro culture of human embryos beyond 14 days. However, despite widespread recognition of the importance of public debate on embryo research, it remains unclear how patients who have undergone in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) perceive this change in the guidelines. Three focus group interviews were conducted with IVF/ICSI patients to understand their opinions on extending the in vitro culture of human embryos beyond 14 days. Thematic analysis revealed a primarily favorable attitude toward the extension of in vitro embryo culture, identifying six reasons for this positive perspective. However, two reasons for negative attitudes were identified, along with some concerns that need to be addressed. To facilitate an open discussion, the following suggestions were made to the government and scientific community. The government and scientific community should provide sufficient knowledge to IVF/ICSI patients about research before discussions. It's important to consider diverse views on embryo models, including distrust and resistance. Ensuring IVF/ICSI patients' psychological safety is essential. “Public conversations” with citizens, including IVF/ICSI patients, should be promoted, and their opinions should be considered as part of a broader public spectrum.
An article, “(Not So) Lost in Translation: Considering the GA4GH Diversity in Datasets Policy in the Japanese Context.”, was published in Asian Bioethics Review. (Sato M. and Muto K.)
2024/08/19
Sato, M., Muto, K., Momozawa, Y, and Joly Y.
(Not So) Lost in Translation: Considering the GA4GH Diversity in Datasets Policy in the Japanese Context. Asian Bioethics Review (2024).
https://doi.org/10.1007/s41649-024-00305-5
[Abstract]
The genomics community has long acknowledged the lack of diversity in datasets used for research, prompting various stakeholders to confront this issue. In response, the Global Alliance for Genomics and Health (GA4GH) formulated a policy framework that recognizes the multiplicity of perspectives on diversity and proposed a systemic approach for more optimal data diversity. Given the importance of the research context, assessing this policy’s applicability within countries where diversity is less discussed is important. This study investigated the feasibility of implementing the GA4GH policy in Japan, a nation with a smaller genetic diversity than many Western countries. As the proportion of East Asian genomic research is limited internationally, focusing on the Japanese genome contributes to enhancing diversity. Meanwhile, labelling findings as “Japanese” can inadvertently reinforce perceptions of homogeneity and overlook ethnic minorities. Regions and socioeconomic status are also recognized as substantial factors of diversity within academia, yet concerns persist among the public regarding the heritability of stigmatized conditions. Social inclusion of sexual minorities has begun in Japan, but research surveys generally still use binary sex and gender categories, which underscores the need for additional variables. This study found that both academia and the public need to confront the overemphasis on homogeneity within Japanese society and hesitancy in addressing genetic factors. By doing so, more inclusive and diverse datasets can advance the field both ethically and scientifically. Perhaps the most important impact of the GA4GH policy will be to draw greater attention to the complex diversity challenges ahead in Japan.
An article, “Hope for the best, but prepare for the worst: Social media posted by participants in stem cell clinical trials”, was published in Regenerative Therapy. (Muto K. and Takashima K.)
2023/08/08
(COMMENTARY)
Takashima K, Minari J, Chan S, Muto K.
Hope for the best, but prepare for the worst: Social media posted by participants in stem cell clinical trials. Regen Ther. 2023 Aug 9;24:294-297.
https://doi.org/10.1016/j.reth.2023.07.009
https://pmc.ncbi.nlm.nih.gov/articles/PMC10440399/
[Abstract]
This article examines the influence of social media posts on clinical trials involving stem cell–based interventions. Based on the literature review, we identified three potential risks associated with social media posts regarding clinical trials that involve stem cell–based interventions: (1) threats to scientific validity, (2) amplification of excessive expectations, and (3) breaches of confidentiality. Additionally, preliminary recommendations are provided to safeguard the value of stem cell clinical trials for future patients in the age of social media. Our approach aims to safeguard the well-being of forthcoming participants and ensure the scientific validity of stem cell research, as well as possibly aid in the further development of shared guidelines for posting stem cell clinical trial information on social media platforms.
An article, “Is legislation to prevent genetic discrimination necessary in Japan? An overview of the current policies and public attitudes", was published in Journal of Human Genetics. (Muto K., Nagai A. and Ri I.)
2023/06/09
(PERSPECTIVE)
Muto K, Nagai A, Ri I, Takashima K, Yoshida S.
Is legislation to prevent genetic discrimination necessary in Japan? An overview of the current policies and public attitudes. J Hum Genet. 2023 Sep;68(9):579-585.
https://doi.org/10.1038/s10038-023-01163-z (Epub 2023 Jun 8.)
https://www.nature.com/articles/s10038-023-01163-z
[Abstract]
Genetic discrimination (GD) has not been discussed in East Asia as extensively as in Europe and North America. Influenced by UNESCO’s universal declaration in 1997, the Japanese government took a stringent approach toward GD by releasing the Basic Principles on Human Genome Research in 2000. However, Japanese society has mostly been ignoring the prevention of GD for decades, and the principle of prohibiting GD was never adhered to in any of the Japanese laws. We conducted anonymous surveys among the general adult population in 2017 and 2022 to explore their experiences of GD and attitudes toward laws carrying penalties to prevent GD in Japan. In both years, approximately 3% of the respondents had experienced some unfavorable treatment regarding their genetic information. They showed higher recognition of the benefits of using genetic information and lower recognition of concerns about using genetic information and GD in 2022 than in 2017. However, the awareness regarding the need for legislation with penalties on GD had increased over the five-year period. In 2022, the framework of a bill to promote genomic medicine and prevent GD without any relevant penalties was released by the Bipartisan Diet Members Caucus. Considering that the absence of regulations may be a barrier to obtaining genomic medicine, as the initial step toward making the prohibition of GD more effective, legislation that no form of GD will be tolerated may stimulate education and awareness regarding respect for the human genome and its diversity.
An article "Public attitudes toward cloud computing and willingness to share personal health records (PHRs) and genome data for health care research in Japan" was published in Journal of Human Genome Variation. （Kusunose M. and Muto K.）
2023/04/17
Public attitudes toward cloud computing and willingness to share personal health records (PHRs) and genome data for health care research in Japan
Japan’s government aims to promote the linkage of medical records, including medical genomic testing data and personal health records (PHRs), via cloud computing (the cloud). However, linking national medical records and using them for health care research can be controversial. Additionally, many ethical issues with using cloud networks with health care and genome data have been noted. However, no research has yet explored the Japanese public’s opinions about their PHRs, including genome data, being shared for health care research or the use of the cloud for storing and analyzing such data. Therefore, we conducted a survey in March 2021 to clarify the public’s attitudes toward sharing their PHRs, including genome data and using the cloud for health care research. We analyzed data to experimentally create digital health basic literacy scores (BLSs). Our results showed that the Japanese public had concerns about data sharing that overlapped with structural cloud computing issues. The effect of incentives on changes in participants’ willingness to share data (WTSD) was limited. Instead, there could be a correlation between WTSD and BLSs. Finally, we argue that it is vital to consider not only researchers but also research participants as value cocreators in health care research conducted through the cloud to overcome both parties’ vulnerability.
Kusunose M, Muto K. Public attitudes toward cloud computing and willingness to share personal health records (PHRs) and genome data for health care research in Japan. Hum Genome Var. 2023 Mar 30;10(1):11. doi: 10.1038/s41439-023-00240-1. PMID: 36990988; PMCID: PMC10060394.
“Tell me what you suggest, and let’s do that, doctor”: Patient deliberation time during informal decision-making in clinical trials (Nakada H et al.)
2019/01/29
Informed consent is an essential part of an ethical clinical trial; to this end, researchers have developed several interventions to promote participants' full understanding of trials and thereby improve the consent process. However, few empirical studies have examined how patients make the decision of whether to give consent. The objective of this study, therefore, is to analyze patients' decision-making process when participating in clinical trials. We conduct an internet survey (n = 2,045) and interview data analysis (n = 40) with patients and categorize respondents into three types of participants: active, passive, and non-participation. Our results show that patients often make informal and quick decisions before medical staff provide them with relevant information during the informed consent process. For example, 55.9% of patients received initial information on clinical trials from an online article or web advertising, and 54.5% consulted no one about whether to participate in the clinical trial before making a decision. Only 20.7% of respondents subjectively spent time making the decision whether to participate; 43.0% of patients who said that they “spent time” coming to a decision took four or more days to reach a decision, while 8.3% of people who “did not spend time” making a decision took this among of time. Based on these results, we were able to break patients' decision-making process into four steps: first contact, informal decision making, relevant information, and formal decision making. Our results show that patients are most likely to make a decision based on the first information they receive on the clinical trial, whatever the source. To this end, having a list of questions for potential participants to ask researchers would be useful in helping better collecting information of clinical trials. In addition, research teams should give patients more than four days to decide between providing them with relevant information and obtaining written consent, even if the patient seems to make a quick decision.
Ethical concerns on sharing genomic data including patients’ family members (Takashima K)
2018/06/19
Kyoko Takashima, Yuichi Maru, Seiichi Mori, Hiroyuki Mano, Tetsuo Noda, Kaori Muto
Ethical concerns on sharing genomic data including patients' family members
BMC Medical Ethics 2018;19:61
https://doi.org/10.1186/s12910-018-0310-5
Background
Platforms for sharing genomic and phenotype data have been developed to promote genomic research, while maximizing the utility of existing datasets and minimizing the burden on participants. The value of genomic analysis of trios or family members has increased, especially in rare diseases and cancers. This article aims to argue the necessity of protection when sharing data from both patients and family members.
Main text
Sharing patients' and family members' data collectively raises an ethical tension between the value of datasets and the rights of participants, and increases the risk of re-identification. However, current data-sharing policies have no specific safeguards or provisions for familial data sharing. A quantitative survey conducted on 10,881 general adults in Japan indicated that they expected stronger protection mechanisms when their family members' clinical and/or genomic data were shared together, as compared to when only their data were shared. A framework that respects decision-making and the right of withdrawal of participants, including family members, along with ensuring usefulness and security of data is needed. To enable this, we propose recommendations on ancillary safeguards for familial data sharing according to the stakeholders, namely, initial researchers, genomic researchers, data submitters, database operators, institutional review boards, and the public and participants.
Conclusions
Families have played significant roles in genetic research, and its value is re-illuminated in the era of genomic medicine. It is important to make progress in data sharing while simultaneously protecting the privacy and interests of patients and families, and return its benefits to them.
Survey on the perception of germline genome editing among the general public in Japan (Uchiyama M)
2018/03/18
Masato Uchiyama, Akiko Nagai, Kaori Muto.
Survey on the perception of germline genome editing among the general public in Japan.
Journal of Human Genetics(2018)
doi: 10.1038/s10038-018-0430-2
https://www.nature.com/articles/s10038-018-0430-2
Abstract
Genome editing of human embryos could become a fundamental treatment approach for genetic diseases; however, a few technical and ethical issues need to be resolved before its application in clinical settings. Presently, the Japanese government has issued a statement prohibiting human germline editing and emphasizing the need for discussions that include a wide range of perspectives. However, current discussions tend to exclude the general public. Therefore, we conducted a survey of 10,881 general adults and 1044 patients in Japan who indicated that their disease conditions are related to their genetic makeup, and clarified their attitude toward this technology. The results clearly indicated that the Japanese people generally accepted the use of genome editing for disease-related genes, but many were concerned about the risks. In addition, many Japanese people did not understand the technology well. To improve awareness and understanding about genome editing, it is important that scientists and science communicators create opportunities for the public to participate in relevant discussions without harming vulnerable participants. It is also important to continuously track changes in the acceptance of genome editing by the public.
Lessons for reviewing clinical trials using induced pluripotent stem cells: examining the case of a first-in-human trial for age-related macular degeneration (Takashima K)
2017/12/19
Kayo Takashima, Yusuke Inoue, Shimon Tashiro & Kaori Muto.
Lessons for reviewing clinical trials using induced pluripotent stem cells: examining the case of a first-in-human trial for age-related macular degeneration.
Regenerative Medicine .2017 (Ahead of print)
“Telling” and assent: Parents' attitudes towards children's participation in a birth cohort study (I. Ri)
2017/09/22
ORIGINAL RESEARCH PAPER
“Telling” and assent: Parents' attitudes towards children's participation in a birth cohort study
Izen Ri MA, Eiko Suda PhD, Zentaro Yamagata MD, PhD, Hiroshi Nitta PhD,Kaori Muto PhD
Health Expectations (2017) DOI:10.1111/hex.12630
Abstract
Introduction
One of the ethical issues surrounding birth cohort studies is how to obtain informed assent from children as they grow up. What and how parents tell their children affects children's future choices about the study, yet few studies have focused on parents' influence on children.
Objective
This study examines parents' attitudes towards telling their children about their participation in a specific birth cohort study.
Methods
We conducted surveys and in-depth interviews with the parents of children who participated in the “Japan Environment and Children's Study” (JECS), which follows children from the foetal stage to age 13.
Results
Forty-four mothers and 23 fathers answered the survey, and 11 mothers and 3 fathers participated in in-depth interviews. Parents' attitudes towards “telling” were categorized into 3 communication styles depending on their perception of the risk/benefits for their children. Most parents predicted that the study would benefit their children and preferred “directive telling,” which we divided into “empowered telling” (provides children with a positive identity as participants) and “persuasive telling” (attempts to persuade children even if they express reluctance as they grow). A few parents, weighing the study's potential risk, preferred “non-directive telling,” which respects children's choices even if that means withdrawing from the study.
Discussion
While “directive telling” may lead children to have positive associations with the study, children should also be told about the risks. Investigators can provide materials that support parents and give children age-appropriate information about their participation, as well as ensure opportunities for children to express their feelings.
A Preliminary Study Exploring Japanese Public Attitudes Toward the Creation and Utilization of Human-Animal Chimeras: a New Perspective on Animals Containing “Human Material” (ACHM) (M. Kusunose)
2017/09/05
A Preliminary Study Exploring Japanese Public Attitudes Toward the Creation and Utilization of Human-Animal Chimeras: a New Perspective on Animals Containing “Human Material” (ACHM)
Kusunose, M., Inoue, Y., Kamisato, A. et al.
Asian Bioethics Review (2017)https://doi.org/10.1007/s41649-017-0020-1
Abstract
Ongoing research on making “human-animal chimeras” or “animals containing human material” (ACHM) to solve the shortage of organs available for transplantation has raised many ethical issues regarding the creation and utilization of such constructs, including cultural views regarding the status of those creations. A pilot study was conducted to explore Japanese public attitudes toward human-animal chimeras or ACHM. The February 2012 study consisted of focus group interviews (FGIs) with citizens from the Greater Tokyo Area, aged between 20 and 54. The 24 participants were divided into four groups. Transcripts of the interviews were analyzed and participants' attitudes categorized. Five categories of participant attitudes were identified: (1) resistance to the unnatural, (2) concerns about animal welfare, (3) concerns about controlling human-animal chimeras, (4) concerns about the possible birth of intermediate entities, and (5) resistance to creating and utilizing animals containing my material or my child's material. Our FGI results showed a broader and greater variety of public concerns than those reported in previous studies. While researchers have tried to establish new methods to avoid creating intermediate entities, our participants expressed concerns about not only intermediate entities but also animals containing their own material or their child's material. Based upon their responses in the interviews, we are introducing a new ethical concern: “animals containing my material/my child's material.”
Keywords
Human-animal chimeras, ACHM, Japanese public attitudes, Focus group interviews, Qualitative research
Current Public Support for Human-Animal Chimera Research in Japan Is Limited, Despite High Levels of Scientific Approval (Y. Inoue)
2016/08/04
LETTER
Current Public Support for Human-Animal Chimera Research in Japan Is Limited, Despite High Levels of Scientific Approval
Yusuke Inoue, Ryuma Shineha, Yoshimi Yashiro
Cell Stem Cell. 2016 Aug 4;19(2):152-153.
Informed consent in clinical trials using stem cells: Suggestions and points of attention from informed consent training workshops in Japan (M Kusunose)
2015/08/21
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
Abstract
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: Correlations between genomic literacy, trust, and favourable attitude
Izumi Ishiyama, Tetsuro Tanzawa, Maiko Watanabe, Tadahiko Maeda, Kaori Muto, Akiko Tamakoshi, Akiko Nagai, Zentaro Yamagata
Public Understanding of Science．21(4)：498-516, 2012.
Abstract
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.
Children and Genetic Identification of Talent
Inoue, Y and Muto, K.
Hastings Center Report, Vol 41, No 5 (September-October 2011), inside back cover.
DOI:10.1002/j.1552-146X.2011.tb00142.x
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.