The impact of development of population-based study in the biomedical field on laws and regulations: a cross-strait experience on biobank development

Together with the completion of the Human Genome Project, biomedical research has marched into the "Post-Genomic Era." In order to take advantage of this extracted gene related information extensively and precisely so as to realize man's biological phenomena as well as the mechanism of pathogenesis, consequentially, a large scale sample collection of different geological areas and/or ethnic groups becomes necessary for the future population based genetic research of a country and, in turn, the construction of population-based genetic database (Biobank). In recent years, both mainland China and Taiwan have not only made great progress in information and computation technologies, but have also gradually taken a close look into the quality of medicine delivery. Thus, it becomes unavoidable for both sides to create each one's population-based genetic databases (Biobank). Theoretically speaking, the Biobank development shall benefit the study on the correlation between genes and disease and also the solution for disease treatment as well. At the same time, medical diagnostic technology has also been significantly improved. It is believable that the population-based genetic database might be utilized to promote medical quality and to reduce the cost of public health delivery. Further; in the near future, it might become the "raw materials "for medical research application. However when taking promotion of public welfare as the premises for a Biobank development, the severe and multi challenge occurred against the traditional legal rules in terms of the privacy protection, public trust development, the compliance of informed consent principle, the implementation of benefit-sharing doctrine and the possible discrimination concern about the population/participants selection and some other ELSI issues. In this paper, the major legal issues encountered by the Biobank development will first be reviewed accompanied by the background information concerning the Biobank development scenario crossing the Taiwan Strait. Also, mainly following the realm of comparative policy or legal approaches, the paper learning from the fruits of this comparative study, tries to propose some recommendations for future legislative consideration by both mainland China and Taiwan. It's been this author's wish that, when establishing a large scale population based Biobank, the promotion of public trust shall be placed as the primary goal together with the emphasis on supporting publicity and transparency on the administrative practices, so as to encourage the public participation in observing the principle of altruism and, in turn, benefit the future biomedicine development.     

An Analysis on the Research Ethics Cases Managed by the Committee on Publication Ethics (COPE) Between 1997 and 2010

The growing emphasis on the importance of publishing scientific findings in the academic world has led to increasing prevalence of potentially significant publications in which scientific and ethical rigour may be questioned. This has not only hindered research progress, but also eroded public trust in all scientific advances. In view of the increasing concern and the complexity of research misconduct, the Committee on Publication Ethics (COPE) was established in 1997 to manage cases with ethical implications. In order to review the outcomes of cases investigated by COPE, a total of 408 cases that had been managed by COPE were successfully extracted and analysed with respect to 7 distinct criteria. The results obtained indicate that the number of ethical implications per case has not changed significantly (p?>?0.01) since the year COPE was instigated. Interestingly, the number of ethical cases, and to some extent, research misconduct, is not diminishing. Therefore, journal editors and publishers need to work closely together with COPE to inculcate adoption of appropriate research ethics and values in younger researchers while discouraging others from lowering standards. It is hoped that with a more concerted effort from the academic community and better public awareness, there will be fewer incidences of ethically and scientifically challenged publications. The ultimate aim being to enhance the quality of published works with concomittant public trust in the results.     

Gelotophobia and thinking styles in Sternberg's theory'

A hypothesis was examined, that gelotophobia (the fear of being laughed at) was negatively related to Type I thinking styles and positively related to Type II thinking styles as defined in Sternberg's theory of mental self-government. 431 university students (250 women, 181 men; M age = 20.4 yr., SD = 1.2) completed self-report measures of gelotophobia (GELOPH <15>) and thinking styles (Thinking Styles Inventory-Revised). Correlation and regression analyses were conducted. The results indicated that gelotophobia was negatively and significantly related to four Type I thinking styles (legislative, judicial, liberal, and hierarchical thinking styles) and a Type III thinking style (external), while it was positively and significantly related to a Type II thinking style (conservative). Thinking styles uniquely explained 18% of the total variance in gelotophobia scores. Possible interventions from the perspective of thinking styles in the treatment of gelotophobia were discussed.     

Non-target language processing in Chinese-English bilinguals: a study of event-related potential

The event-related brain potential (ERP) technique was used to investigate the neural mechanism of non-target language processing in Chinese-English bilinguals. Participants were presented with a mixed list of Chinese and English words and required to make conceptual decisions for words in one language and ignore words in the other non-target language. Regardless of whether the nontarget word was in Chinese or English, the ERPs they elicited were modulated by word frequency, suggesting that their meaning had been accessed. The N400 peak was delayed in the English as the non-target language condition, probably because participants were less proficient in English. The results suggest that the non-target language can be processed during conceptual tasks with participants' proficiency in this language being a critical factor.     

微流控分析芯片在循环肿瘤细胞检测中的运用

随着人们对于肿瘤性疾病的发生、发展、转移机制的进一步探索,循环肿瘤细胞（CTCs）逐渐进入人们视野,其应用价值日益体现,可用于肿瘤性疾病的早期诊断及治疗效果的监测,尤其是对于早期肿瘤的诊断具有独特优势。其富集技术及检测方法也在发生着日新月异的变化。近年来,微流控分析芯片技术运用于 CTCs 的富集及检测,具有高丰度、高富集度、高活性及不需要对样本进行预处理等优点使得人们聚焦于此技术,本文对微流控分析芯片在 CTCs 检测中的运用做简要综述。     

内隐多效性选择的ERP证据

采用事件相关电位技术,考察内隐多效性选择及其神经机制。被试的任务是认真观看配对的纯色图片刺激,并进行分类按键反应。实验结果发现,在P2上,积极启动刺激比对照刺激激发了更大的P2波幅; 对比对照刺激,积极启动刺激在左脑、大脑中部和后脑诱发了更大的P2波幅,其中右脑的效应最大。在N2上,积极启动刺激比对照刺激激发了更小的N2波幅; 对比对照刺激,积极启动刺激在左脑、大脑中部和后脑诱发了更小的N2波幅,其中右脑的效应最大。在P3上,积极启动刺激比对照刺激激发了更大的P3波幅; 对比对照刺激,积极启动刺激在左脑、大脑中部和后脑诱发了更大的P3波幅,其中右脑的效应最大。研究结果表明当外显目标与内隐目标同时被呈现时,被试趋向于做多效性选择,这可能表明无意识信息加工具有相当大的权重。且右后部脑区可能是加工多效性刺激的核心和关键区域,P3成分可能反应了内隐多效性选择的精细加工过程,能够作为内隐多效性选择的有效的ERPs指标。     

自我损耗、情绪动机对冲动决策的影响

以大学生为被试,探讨自我损耗、情绪动机对冲动决策的影响。采用2×2×2的混合实验设计,组内变量为自我损耗,组间变量为情绪动机方向和强度,使用双任务范式操作自我损耗,使用情绪动机图片启动被试的情绪动机,使用延迟折扣任务的指标k值测量冲动决策。结果发现,高趋近动机的k值大于低趋近动机,高回避动机的k值大于低回避动机。结果表明,自我损耗、情绪动机对冲动决策有明显影响。     

青少年大五人格对网络成瘾的影响:家庭功能的中介作用

目的:探究家庭功能在人格特征与网络成瘾之间的中介作用。方法:973名中学生被试完成基本人口学问卷、网络成瘾量表、人格五因素问卷、家庭功能评定量表。结果:(1)人格特征可以显著预测网络成瘾。其中,情绪性人格可以显著正向预测网络成瘾,责任心、宜人性显著负向预测网络成瘾。(2)家庭功能在情绪性、责任心对网络成瘾的影响具有部分中介作用、在宜人性对网络成瘾的影响具有完全中介作用。结论:在治疗中,可针对网络成瘾者的家庭功能进行积极干预,从而减轻其成瘾症状。     

Impact of a Patient-Facing Enhanced Genomic Results Report to Improve Understanding,Engagement, and Communication

“The objective of this study was to” test the effectiveness of an enhanced genomic report on patient-centered outcome domains including communication, engagement and satisfaction. “Study design utilized” a prospective, randomized, mixed-methods desctiptive study of a whole genome sequencing results report, GenomeCOMPASS?, that was accessed by providers through the electronic health record and by patients through the associated patient portal. “The study was set in” an integrated healthcare delivery system in central Pennsylvania. “Eighty-four” parents of 46 children with undiagnosed Intellectual Disability, Autism Spectrum Disorder and/or multiple congenital anomalies who had participated in a previous study offering whole genome sequencing for their affected child were invited to enroll. Fifty-two parents enrolled. Following a traditional genetics results informing visit, the study coordinator stratified families by diagnostic result and uninformative result and then randomized families within each group to an intervention arm to receive the GenomeCOMPASS? report or to the usual care arm to receive a summary letter from the medical geneticist. A letter inviting enrollment included a baseline survey, which once returned, constituted enrollment. Surveys were administered at 3 months post-genetics visit. At 6 months, the usual care arm crossed over to receive the intervention and were administered an additional survey at 3 months. Qualitative interviews were conducted following survey completion to augment the survey data regarding the patient centered outcomes of interest. Patient reported outcomes including communication, engagement, empowerment and satisfaction. In the intervention arm, GenomeCOMPASS? reports were released to 14 families (N?=?28 parents) and of those 21 (75%) returned 3 month surveys. In the usual care arm, 12 families (N?=?24 parents) received usual care summary letters and of those 20 (83%) returned 3 month surveys. At crossover, GenomeCOMPASS? reports were released to 20 individuals and 15 (75%) returned 3 month surveys. Qualitative interviews were conducted with 5 individuals. Use of the GenomeCOMPASS? report was reported by this small group of parents to improve communication with providers and non-health professionals such as educators and therapists and led to increased engagement and high satisfaction. Providers and others involved in the children’s care also endorsed the report’s effectiveness. Reports that addressed negative findings, i.e. uninformative results, were not found to be useful. Although the number of users was small, this study supports that customizable template reports may provide a useful and durable source of information that can support and enhance the information provided by genetics professionals in traditional face-to-face encounters. Trial registration: Clinicaltrials.gov (Record 2013–0594).     

Sequence effects of the involuntary and the voluntary components of symbolic cueing

The orienting of attention has been found to be influenced by the previous cueing status in a spatial-cueing paradigm. The explanation for this sequence effect remains uncertain. This study separated the involuntary and the voluntary components of arrow cueing by manipulating the predicted target locations. For example, a left arrow cue may have indicated that the target was more likely to appear at the up location. Therefore, three trial types were repeated or switched between trials: cued (targets appeared along the direction of the arrows), predicted (targets appeared at the locations predicted by the arrows), and unrelated (targets appeared at the other two locations, neither cued nor predicted). RTs of cued trials were found to be significantly facilitated after a previous cued trial; however, the same effect was not observed for predicted trials. The results suggest that significant sequence effects are induced only in the involuntary component of arrow cueing. The findings support the feature-integration hypothesis for the sequence effect of symbolic cueing.