Research ethics consultation : an attempt and 5-year experience in a Japanese University Hospital

Objective: Research ethics consultation is an advisory activity that differs from ethics committees, and its role is not yet widely known in Japan. Research ethics consultations were started in 2012 by members of the Clinical Trial Center of Tokushima University Hospital, a support section for clinical trials. We analyzed the research ethics consultation records from Tokushima University Hospital during the 5-year period of 2012–2016 to examine the Japanese context of research ethics consultation. Results: During the study period, 125 research ethics consultations were carried out, 115 (91%) before starting studies. All but one request were from investigators at Tokushima University. The main issue was compatibility with guidance and regulations (n = 74, 67.2%), such as ethical handling of human biological specimens and information utilized in research; only 6 (4.8%) requests involved research ethics issues that investigators face in their research. Therefore, it is necessary to expand the consultation function, with a nationwide system of consultant education and data sharing. Moreover, standardization of consultation should be considered

Present status of Japanese ethics committees : a survey in Tokushima Prefecture

Clinical research is important to improve medical quality, and ethics review is essential to conduct clinical research. Since the establishment of the first Japanese ethics committee at the University of Tokushima in 1982, Japanese ethics committees have increased. In this study, we surveyed the status of clinical studies and ethics committees in one Japanese region. The survey was conducted in collaboration with the Tokushima Medical Association. A questionnaire was established and mailed to all medical institutions (n=737) registered to the Tokushima Medical Association in 2012. Among 737, 223 (30.3%) questionnaires were returned and 221 were completed and are included in this analysis (respondents). Among respondents, 51 (23.1%) had performed clinical research, and of these, 17 had established ethics committees (though one was omitted from the following analysis due to an unsatisfactory response). Among 16 ethics committees, review of protocol amendments, review of serious adverse events, annual follow-up of approved protocols, and education for committee members were active in 10 (62.5%), 9 (56.3%), 6 (37.5%) and 4 (25.0%), respectively. Research ethics education was active in 4 (25.0%). Based on the results, we attempt to establish an appropriate system for ethical conduct of health-related research in Tokushima Prefecture

Willingness-to-Pay-Associated Right Prefrontal Activation During a Single, Real Use of Cosmetics as Revealed by Functional Near-Infrared Spectroscopy

Use of applied neuroscience to complement traditional methods of consumer research is increasing. Previously, fMRI has shown that prefrontal activity contains information relating to willingness-to-pay (WTP). The aim of the present study was to determine if functional near infrared spectroscopy (fNIRS) can record WTP-related brain activation in the dorsolateral prefrontal cortex (DLPFC) during a single, real use of cosmetic products. Thirty female participants, were divided into two groups (one low frequency users of foundation and one high frequency users of foundation), asked to apply different foundations to their face and then record how much money they were willing to pay. The oxyhemoglobin time series was analyzed with the GLM and the correlation between the beta scores for the foundations and their respective WTP values conducted for each participant. These subject level correlations were then converted to z scores and averaged for each group. The results revealed a significant mean correlation for the high but not low frequency group. In other words, the brain activity in right hemisphere dorsolateral PFC (RH-DLPFC) during single, real use of foundations correlated with their respective WTP values for the high frequency but not low frequency group. The difference between groups may reflect the importance of learning and automation on activity in RH-DLPFC. Our research provides further evidence supporting the use of fNIRS to complement traditional consumer research in a commercial setting and to extend neuroscience research into more naturalistic environments

超吸水性ポリマー球状塞栓物質の高張食塩水を用いた膨潤抑制法の開発

PURPOSE: To analyze size changes of superabsorbent polymer (SAP) microspheres with the reduced expansion technique, and to evaluate pharmacological advantages of transarterial chemoembolization using cisplatin-loaded SAP microspheres with the reduced expansion technique. MATERIALS AND METHODS: In an in vitro study, diluted contrast materials containing different concentrations of sodium ions were examined to expand SAP microspheres and determined the reduced expansion technique. Size distributions of cisplatin-loaded SAP microspheres were analyzed. In an in vivo study, TACE was performed using cisplatin-loaded SAP microspheres with the reduced expansion and control techniques in 18 VX2 rabbits. RESULTS: The degree of expansion was reduced to the greatest extent by using a mixture of non-ionic contrast material and 10% NaCl at a 4:1 ratio. The mean diameter of the reduced expansion of cisplatin-loaded SAP microspheres was 188.4 μm, while that of the control expansion was 404.9 μm. The plasma platinum concentrations of the reduced expansion group at 5 min after TACE were significantly higher than those of the control expansion group (2.19 ± 0.77 vs. 0.75 ± 0.08 μg/mL, P = .01). The tumor platinum concentrations of the reduced expansion group at 1 h were significantly higher than those of the control expansion group (10.76 ± 2.57 vs. 1.57 ± 0.14 μg/g, P = .044). CONCLUSION: The expanding level of SAP microspheres can be reduced by using hypertonic saline. Cisplatin-loaded SAP microspheres with the reduced expansion technique have the advantages of achieving higher cisplatin tissue concentration in TACE for liver tumors.博士（医学）・甲第709号・令和元年6月26日© Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2018This is a post-peer-review, pre-copyedit version of an article published in Cardiovascular and interventional radiology. The final authenticated version is available online at: http://dx.doi.org/10.1007/s00270-018-1990-4

長野県内における子供服の洋装への移行

The purpose of this study was to investigate the changes to the Western style from Japanese style in the children\u27s clothes in Nagano Prefecture. The cause of wearing the Western style clothes in children in Nagano Prefecture was guessed by the documents that the school child, being dressed in Western style, came out to greet Emperor Meiji in Ueda-shi, Nagano in 1878. The start of spread of Western children\u27 clothes was guessed when the factory of a ready-made was built by Tokyo Akasaka in 1912. After that, it seemed that the Western children\u27s clothes were spread from Tokyo tothe whole country. We found the finishing-kindergarten photograph in Nagano-shi from 1920 and the photograph of a child wearing the Western style dress in Suzaka-shi. It is common that these children had many opportunities for their parents to goto Tokyo. It seemed that the children wearing the Western stvle dress at the time were still restricted. Transition of the Western style dress of ordinarychildren in Nagano Prefecture, was guessed from the graduation photograph in three elementaryschools since 1926. We found that wearing the Western style dress was earlier in boys than girls, andalso in city than suburb. ln 1947 the Western style dress wearer became 100% also at the elementary school of the suburbs in boys and girls. However, these findings were on a graduation album, and it is considered to be later that the Western style dress becames natural by the usual life of children

Clinical trials for drug approval : a pilot study of the view of doctors at Tokushima University Hospital

The development of new and useful pharmaceutical drugs is essential in order to improve the quality of drug therapeutics. Clinical trials play a central role in drug development. Over time, the clinical trial infrastructure has improved and is now integrating the contribution of clinical research coordinators (CRC). Nevertheless, the attitude of doctors towards clinical trials still favors conventional/historical methodologies. In the present study, we explored the view of doctors towards clinical trials for drug development, in order to improve communication among participants, sponsors, and investigators. A questionnaire was designed for this pilot study. The questionnaire included general attitudes, difficult points, the benefit of doctors in participating as investigators, special attention requirements, and the expected role of CRC in clinical trials for drug approval. In addition, the appropriate use of the outpatient clinic was examined. The questionnaire was provided to doctors in each department of Tokushima University Hospital in 2000 and 2004. Because of the small number of subjects included in this pilot study, no statistical analysis is presented. A total of 89 (81%) and62 (56%) doctors among 110 responded to the survey in 2000 and 2004, respectively. Inquiries about the familiarity of the physicians with clinical trials for drug approval revealed that 84% in 2000 and 66% in 2004 were aware of such trials. The attitude towards participating as investigators in the clinical trials was favorable, with a response of 66% in 2000 and 58% in 2004. Patients’ refusal and the informed consent process were considered difficult areas by many doctors. Expected roles of CRC included activities based on the nurse’s specialty. Although many doctors agreed to take care of the study participants separately from the clinical practice, they lacked the time to do so. In spite of the doctors’ workload reduction by introduction of the CRC concept, their views regarding clinical trials for drug approval remain conventional. Further refinement in the support process by CRC should be considered in our hospital, and the views of the doctors should be investigated in a larger study, in order to promote clinical trials for drug approval in Japan