Ethical concerns on sharing genomic data including patients’ family members (Takashima K)
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
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.
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.
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)
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）
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)
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)
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
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.
This study examines parents’ attitudes towards telling their children about their participation in a specific birth cohort study.
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.
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.
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)
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
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.”
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)
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)
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 (I. Ishiyama)
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
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 the Genetic Identification of Talent (Y. Inoue)
Children and Genetic Identification of Talent
Inoue, Y and Muto, K.
Hastings Center Report, Vol 41, No 5 (September-October 2011), inside back cover.
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.
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(M. Watanabe)
'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) 56, 358–363; doi: 10.1038/jhg.2011.19 ;
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.
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）