基因信息在保险核保中的应用及其限度

基因信息可应用于保险核保的理论基础在于保险的风险分类理论与保险法的对价平衡原则。政策、伦理、道德、技术等方面的反对意见并不足以否定基因信息应用于保险核保的正当性,因为商业保险不应承担社会保障职能;基因信息相比一般医疗信息不具有特殊性;保险承保的本来就是具有不确定性的风险,基因检测的准确性也在逐步提高。是故,应当允许基因信息应用于保险核保,但为防止基因信息的滥用,还须通过规范的方式明确基因信息的应用限度:明晰保险人获取基因信息的方式;设定保险人使用基因信息的条件;规定保险人对于依据基因信息作出不利被保险人决定之理由的披露义务;强化基因咨询师的咨询与建议职责;完善对被保险人的救济机制及其具体运作规范。     

基因隐私权的法学思考

由于基因科学迅速发展以及基因技术的广泛使用,对个人基因信息的法律保护问题日显突出.从民法上的隐私权出发,提出基因隐私权的概念,并继而探讨基因隐私权与其他权利,尤其是基因知情权的冲突.通过比较美国与我国对基因隐私权的法律保护,提出了对基因隐私权进行系统法律保护的立法建议.     

基因信息与基因隐私权的保护

基因信息包含了一个人生命的全部秘密，应纳入隐私权的保护范围。基因隐私权的内容包括采样时的知情同意权，基因信息的知晓权，基因信息的保密权，基因信息的利用权。侵犯基因隐私权具有便捷性、隐蔽性、关联性、实质性、长久性等特点。我国立法应确立基因隐私权。侵害基因隐私权应承担相应民事责任。     

基因权的私法证成和价值分析

人类基因本质上是一种人格利益,通过法解释的路径能够在私法上生成基因权概念。在私法上,基因权是人基于自己的特定基因而享有的权利,属于人格权范畴,包括基因平等权、基因自主权、基因隐私权、基因公开权等。基因公开权具有财产权属性,是基因人格权在不可让渡规则下的延伸,公开只是基因人格利益的物化之利用。基因权存在的正当性基础在于自然权利的实质法源。基因权的法价值在于人性尊严之表彰、人格利益之维护、技术理性之历练等方面。     

The governance of human genetic research databases in mental health research

The field of mental health offers a valuable context in which to examine new challenges presented by human genetic research databases to the legal, ethical and regulatory frameworks for human genetic research. Longitudinal prospective genetic research of psychiatric disorders often involves access to human genetic research databases and to stored tissue for future uses that cannot be specified at the time the patient consents to their collection. The potential of such research to contribute to an improved understanding and treatment of complex genetic diseases such as schizophrenia presupposes sound ethical, legal and regulatory frameworks to ensure public trust and preparedness to participate in such research. This article provides a brief overview of some of the ethical and legal challenges posed by human genetic research databases and their implications for how genetic research should be conducted in the field of mental health.     

Classify and control: genetic information in the schools

Recent advances in molecular and behavioral genetics are providing theoretical models to explain complex behavior--learning disabilities and behavioral problems--in simple biological terms. There are intrinsic difficulties in interpreting genetic information. Yet genetic explanations are particularly appealing in school systems pressed by demands for efficiency and accountability. Thus, genetic explanations are affecting the way children are categorized in the schools. This Article reviews genetic advances bearing on educational issues and their implementation through biological tests. It suggests the social consequences and legal implications of the growing prevalence of genetic assumptions.     

肿瘤组织9个STR基因座及Amelogenin基因座突变

目的 探讨CODIS系统中的9个STR基因座及Amel基因座在肿瘤组织中的变异。方法 收集20个个体的肿瘤组织及其血样,Chelex100法提取DNA,用Profiler plus系统复合扩增,310型遗传分析仪检测。结果 检验的10个基因座均有基因发生突变;20个个体肿瘤组织有6个个体的基因发生突变,变异率超过30％;同一个体的肿瘤组织发生基因突变的基因座最多为6个。结论 慎用肿瘤组织作为医疗纠纷、失踪人员的检材及对照样本。     

Genetic testing,genetic medicine,and managed care

As modern human genetics moves from the research setting to the clinical setting, it will encounter the managed care system. Issues of cost, access, and quality of care will affect the availability and nature of genetic testing, genetic counseling, and genetic therapies. This Article will explore such issues as professional education, coverage of genetic services, privacy and confidentiality, and liability. It will conclude with a series of recommendations for the practice of genetic medicine in the age of managed care.     

Correlation of paternity index with probability of exclusion and efficiency criteria of genetic markers for parternity testing

The statistical correlation between the chance of paternity exclusion and paternity index is explored to derive a new criterion of judging the efficiency of an array of genetic determinations for parentage diagnosis. The theoretical basis is illustrated with allele frequency data on genetic markers used in a paternity testing protocol to examine the possible effects of changing the genetic systems on the prospect of identifying fathers by genetic markers.     

遗传资源法律问题初探

随着生物技术的迅猛发展,遗传资源作为一国重要的战略物资,不仅在解决粮食、健康和环境问题方面发挥着重要作用,而且其在商业上的使用更会产生巨大的经济价值,已经成为各国争夺的目标。由此,引发了有关遗传资源的诸多法律问题,许多至今未有定论。对什么是遗传资源、遗传资源的权属问题进行分析,对遗传资源获取和惠益分享以及遗传资源的保护方式进行探讨具有重要的理论意义和现实意义。     

Disentangling privacy from property: toward a deeper understanding of genetic privacy

With the mapping of the human genome, genetic privacy has become a concern to many. People care about genetic privacy because genes play an important role in shaping us--our genetic information is about us, and it is deeply connected to our sense of ourselves. In addition, unwanted disclosure of our genetic information, like a great deal of other personal information, makes us vulnerable to unwanted exposure, stigmatization, and discrimination. One recent approach to protecting genetic privacy is to create property rights in genetic information. This Article argues against that approach. Privacy and property are fundamentally different concepts. At heart, the term "property" connotes control within the marketplace and over something that is disaggregated or alienable from the self. "Privacy," in contrast, connotes control over access to the self as well as things close to, intimately connected to, and about the self. Given these different meanings, a regime of property rights in genetic information would impoverish our understanding of that information, ourselves, and the relationships we hope will be built around and through its disclosure. This Article explores our interests in genetic information in order to deepen our understanding of the ongoing discourse about the distinction between property and privacy. It develops a conception of genetic privacy with a strong relational component. We ordinarily share genetic information in the context of relationships in which disclosure is important to the relationship--family, intimate, doctor-patient, researcher-participant, employer-employee, and insurer-insured relationships. Such disclosure makes us vulnerable to and dependent on the person to whom we disclose it. As a result, trust is essential to the integrity of these relationships and our sharing of genetic information. Genetic privacy can protect our vulnerability in these relationships and enhance the trust we hope to have in them. Property, in contrast, by connoting commodification, disaggregation, and arms-length dealings, can negatively affect the self and harm these relationships. This Article concludes that a deeper understanding of genetic privacy calls for remedies for privacy violations that address dignitary harm and breach of trust, as opposed to market harms, as the property model suggests.     

A nation's genes for a cure to cancer: evolving ethical, social and legal issues regarding population genetic databases

The advent of the human genome sequence has focused research on understanding underlying genetic links to complex diseases such as cancer, asthma and heart disease. In the past few years, individual countries, such as Iceland, Estonia, Singapore and the United Kingdom, have created national databases of their citizens' DNA for comparative research. Most recently, an international consortium including Nigeria, Japan, China and the United States launched a $100 million project called the International HapMap to map the human genome according to haplotypes, blocks of DNA that contain genetic variation. Such population genetic databases present challenging ethical, social and legal issues, yet regulation of genetic information has developed sporadically, from region to region, without a consistent international standard. Without a clear understanding of the consequences of genetic research in terms of individual and community-wide discrimination and stigmatization, genetic databases raise concerns about the protection of genetic information. This Note provides a survey of the evolving landscape of population genetic databases as a legislative and public policy tool for national and international regulators. It compares different approaches to regulating the collection and use of population genetic databases in order to understand what areas of consensus are formulating a foundation for an international standard. As the first population genetics project that will span multiple countries for the collection of DNA, the International HapMap has the potential to become an influential standard for the protection of population genetic information. This Note highlights issues among the national databases and the HapMap project that raise ethical, social and legal concerns for the future and recommends further protections for both individual donors and community interests.     

遗传性心律失常猝死的分子解剖研究现状及展望

遗传性心律失常所致猝死的死因鉴定是法医病理学领域亟待解决的难题之一。近年来心律失常易感基因/突变的发现和高通量组学技术的推广,使得利用分子遗传学方法筛查猝死的遗传学病因（即＂分子解剖＂）成为可能。本文通过汇总心律失常分子遗传研究的进展,综述传统遗传分析和近期全基因组关联性研究（GWAS）筛查的结果,为心源性猝死的＂分子解剖＂研究提供候选基因列表;并进一步比较针对不明原因猝死所开展的回顾性＂分子解剖＂筛查的结果,探讨新技术在该领域的应用前景。这一综述有助于更好的认识心律失常所致猝死的分子机制,并为借助新一代遗传分析技术进行分子解剖提供有益参考。     

论遗传资源获取与来源披露对专利授权的影响

随着生物技术的迅猛发展,遗传资源的价值越来越突显出来。在我国最新修改的《专利法》中对遗传资源的保护作了规定,但是存在一些值得商榷的地方。将遗传资源获取与来源披露同专利授权联系在一起,作为专利授权的条件,在理论和实践上都有不合理之处。在我国遗传资源保护的专门立法尚未出台,国际公约和其他国家立法不够完善,且存在很大分歧的情况下,我国应该在专利法中规定将遗传资源来源披露作为专利取得的独立形式要件;将遗传资源作为生物技术研发必不可少的物质技术条件,规定遗传资源提供者与生物技术开发者之间的利益分享,使遗传资源的保护与专利制度得到最好的衔接。     

Genetic Data and the Data Protection Regulation: Anonymity,multiple subjects,sensitivity and a prohibitionary logic regarding genetic data?

Owing to the unique qualities of genetic data, there have been numerous criticisms of the current data protection framework's ability to protect genetic data. It has been suggested that the Directive did not recognise the sensitivity of genetic data and that it ignored a number of legitimate interests in this data (in particular interests which multiple data subjects may have and those which may remain in anonymous data). In 2012, the first results of a reform process of EU data protection law were released. These results included a draft Regulation (to replace the Directive) which introduced a new framework for the protection of genetic data. This Article considers whether the innovative approach to genetic data in the Regulation will provide a more adequate framework for the protection of genetic data. It concludes that the Regulation has rectified the lack of recognition of sensitivity, but still stutters in recognising a number of legitimate interests.     

Investigating genetic discrimination in the Australian life insurance sector: the use of genetic test results in underwriting, 1999-2003

A major component of the Genetic Discrimination Project (GDP), an Australia-wide study to examine the advantages and disadvantages for individuals of having genetic information and cases of alleged genetic discrimination, is the analysis of insurers' use of genetic test results. The peak life insurance body, IFSA, had collected data through the Australian Institute of Actuaries (AIA) for the period June 1999-May 2003 from life insurance companies in Australia regarding their use of genetic test results in insurance underwriting. The GDP negotiated with IFSA and the AIA for access to this data for independent analysis. Applications from 288 individuals who had disclosed a genetic test result included products for cover for death, trauma/crisis, income protection/disability and total and permanent disablement. A total of 81% (234/288) contained usable data for analysis. These cases involved the genetic conditions haemochromatosis (71%), Huntington disease (12%) and breast/ovarian cancer (6%). In 49% of cases, the genetic test result was described as the only influencing factor and of these, 32% involved a "positive" genetic test result. Whilst underwriting in most cases appeared to be reasonable, the article highlights several cases involving disclosure of a positive predictive test result for breast/ovarian cancer that required further investigation.     

An exploration of the legal and socio-ethical implications of predictive genetic testing of children

This article explores the current position in relation to predictive genetic testing of children, highlighting some of the legal and socio-ethical issues and complexities that such testing presents. It evaluates the existing regulatory framework for predictive genetic testing of children in Australia, including the possible role of the Family Court in protecting children from inappropriate testing, and suggests that introducing a more interventionist approach would create its own difficulties. The article also considers a particular issue arising in the context of predictive genetic testing of children which the ALRC/AHEC inquiry canvassed concerning disclosure obligations to insurers. The article argues that creating an exception to established principles of disclosure would mitigate the impact of predictive genetic testing of children and would be consistent with international instruments which seek to protect against unfair genetic discrimination.     

Duty to warn of genetic harm in breach of patient confidentiality

Harm caused by the failure of health professionals to warn an at-risk genetic relative of her or his risk is genetic harm. Genetic harm should be approached using the usual principles of negligence. When these principles are applied, it is shown that (a) genetic harm is foreseeable; (b) the salient features of vulnerability, the health professional's knowledge of the risk to the genetic relative and the determinancy of the affected class and individual result in a duty of care being owed to the genetic relative; (c) the standard of care required to fulfil the duty to warn should be the expectations of a reasonable person in the position of the relative; and (d) causation is satisfied as the harm is caused by the failure of intervention of the health professional. Legislation enacted subsequent to the Report of the Commonwealth of Australia, Panel of Eminent Persons (Chair D Ipp), Review of the Law of Negligence Report (2002) and relevant to a duty to warn of genetic harm is considered. The modes of regulation and penalties for breach of any future duty to warn of genetic harm are considered.     

Inevitable, influential, or unnecessary? Exploring the utility of genetic explanation for delinquent behavior

In the field of criminology there have been a few recent articles addressing genetic influence on delinquent behavior. The scarcity of research within the field of criminology into genetic influence may be the result of two intertwined factors: methodological difficulties and the lack of a theoretical framework to guide research. The current research addressed these two issues in determining if genetic factors are a necessary part of the delinquency equation. Using Harris' group socialization theory as a framework, the results from the random effects regression and DF analyses indicated that there was a utility to genetic explanations of delinquent behavior. The results further implicated the importance of gene-environment interactions in understanding the true impact of genetic influence on behavior. Implications of the results are discussed.     

生物基因资源获取和利益分享的国际法规制--兼论对我国基因资源保护的启示

在国际法上,基因资源的获取和利益分享涉及三个主要的国际公约,即《生物多样性公约》(CBD)、《粮食和农业植物遗传资源国际公约》和《TRIPS协议》,其中以CBD为核心,确立了基因资源的国家主权控制、事先知情同意和合理分享利益的原则和制度,确立了基因资源保护机制和产权设定的基本框架,对保护我国的基因资源具有重要的借鉴意义。