基因研究中的知情同意之惑

知情同意作为生命伦理的重要原则,在基因研究中同样占据重要的地位,由于基因研究中知情同意的异质性,在基因研究中面临着诸如如何理解其知情同意的异质性、群体知情同意、基因知情与基因隐私、利益冲突等问题。通过分析基因研究中知情同意的特殊性,综合国内外此领域的已有研究,运用理论联系实际的方法,得出结论认为,只有正确区分基因知情与基因隐私的权利主体,用伦理规范来解决利益冲突,在发展中不断完善知情同意,才能够取得科技与伦理的共赢。     

基因导向个体化医疗中的伦理问题研究

我国的精准医学计划正如火如荼的进行,基因导向个体化医疗是精准医学发展的基础,这种医疗模式的创新极大的推动了医学的发展和促进了人们的健康,与此同时,也对传统的疾病观、风险与受益评估、医疗资源的分配公正、知情同意与自主性、信息安全与隐私保护提出了挑战,个体化医疗中的伦理问题的研究将助力精准医学在我国科学并合乎伦理的创新发展。     

临床药品试验研究中的知情同意析要

临床药品试验研究的知情同意能否做好,事关能否更好地处理医疗及其研究中的利益冲突,和谐医(研究者)患(受试者)关系,真正地体现以患者和受试者为本的医学伦理、人道精神与行为.概要分析、讨论并提出了临床药品试验研究的知情同意的基本概念、要素以及问题的应对要略.     

基因隐私权的伦理之思

基因隐私权作为一种特殊的人格权,包含了身体隐私、财产隐私、信息隐私和自主决定等四个方面的内容。它的哲学基础可以追溯至康德哲学的理性与尊重自主性原则,道德基础奠基于位格伦理之上,并体现了一种主体与客体之间的辩证关系。基因隐私权的保护应该遵循知情同意、合理注意、诚实信用与利益平衡的四个基本伦理原则。     

论家系遗传学研究中的伦理问题

在家系遗传学研究中,尊重个人同意是首要原则,家族同意是个人同意的有益补充.家族成员间的利益冲突导致了基因保密权与知情权的冲突,保护个人基因隐私的同时需兼顾其他成员的利益.利益分配应平等惠及家族所有成员.在当前形势下,立法保护与提高基因技术水平尚需时日,可行方法是建设家系资源库并规范管理.     

国家级继续医学教育"研究伦理"培训班现在开始报名

经全国继续医学教育委员会批准、中国协和医科大学生命伦理学研究中心主办的国家级继续医学教育研究伦理培训项目第一期题目为“生物医学研究和临床试验伦理”的培训班拟于2 0 0 4年8月2 0～2 4日在安徽省合肥市开课,由中国协和医科大学生命伦理学研究中心和安徽医科大学共同承办。培训内容涉及:研究伦理学的基本伦理原则、国际国内的伦理准则和有关法律条例、研究设计和选择受试者中的伦理问题、不同文化中的知情同意、保护隐私和保密、利益冲突、IBR和伦理审查、研究人员对社区的责任以及遗传学研究、艾滋病药物和疫苗研究和人类生殖研…     

关于知情同意的伦理与法律意义之辨析

尊重和自主是知情同意的伦理底线,行善是知情同意的伦理基础.知情同意并不是评判医疗行为是否符合伦理的金标准.伦理上的知情同意与法律上的知情同意,既有区别又相互联系,德法并济是有效履行知情同意的前提.     

临床药品试验研究中的知情同意析要

临床药品试验研究的知情同意能否做好,事关能否更好地处理医疗及其研究中的利益冲突,和谐医(研究者)患(受试者)关系,真正地体现以患者和受试者为本的医学伦理、人道精神与行为。概要分析、讨论并提出了临床药品试验研究的知情同意的基本概念、要素以及问题的应对要略。     

基因组学研究免除具体知情同意的伦理挑战与审查实践

精准医学时代基因组学研究与临床的结合愈加紧密,研究规模和范围大大扩展。然而,机构既往采集保存样本和信息时征询知情同意的方式和质量不尽相同。指引研究者合法合理使用既往留存资源是伦理委员会面临的重要挑战。在适用国际和我国有关规范时,伦理审查应注意基因组信息的身份关联性、终身伴随性和族群相关性,不能仅以研究采样风险不大于最小风险、不免除知情同意增加研究难度为由批准研究者免除具体知情同意的申请,还应结合研究内容,从隐私保护、意外发现对资源提供者健康权益的影响等方面整体权衡个体和群体的风险受益,审慎决定。     

注重全人群、全方位、全过程——论受试者知情同意伦理审查的强化

通过对医药学研究人体试验受试者知情同意的伦理审查发展现状的说明,分析现阶段知情同意伦理审查工作中存在流于形式,审查结果不够科学、客观和公正等问题。再结合医药学研究的发展需要,说明知情同意伦理审查的工作情况和不断发展的要求。提出对知情同意做到全人群、全方位、全过程的伦理审查的覆盖。并通过实施全人群、全方位、全过程的伦理审查的过程,提高人体试验受试者知情同意伦理审查水平,促进医药学研究和社会医学的发展。     

DTC基因检测的伦理思考

直接面向消费者提供基因检测服务称为Direct-to-Consumer (DTC)基因检测.随着人类基因组计划测序工作的完成,DTC基因检测服务行业逐渐发展起来,它的出现与人们日益提高的健康需要相适应.但与此同时,一些社会伦理和法律问题也随之产生.对DTC基因检测的现状以及各国对其认可度进行阐述,剖析DTC基因检测存在的伦理问题,如隐私问题,有限的预测价值,检测信息的准确性,检测结果对受试者造成的负面心理影响,以及由此产生的基因歧视和卫生保健资源的浪费等.     

Distinguishing genetic from nongenetic medical tests: Some implications for antidiscrimination legislation

Genetic discrimination is becoming an increasingly important problem in the United States. Information acquired from genetic tests has been used by insurance companies to reject applications for insurance policies and to refuse payment for the treatment of illnesses. Numerous states and the United States Congress have passed or are considering passage of laws that would forbid such use of genetic information by health insurance companies. Here we argue that much of this legislation is severely flawed because of the difficulty in distinguishing genetic from nongenetic tests. In addition, barring the use by insurance companies of a genetic test but not a nongenetic test (conceivably for the same multifactorial disease) raises issues of fairness in health insurance. These arguments suggest that ultimately the problems arising from genetic discrimination cannot be solved by narrowly focused legislation but only by a modification of the entire health care system.     

关于基因检测的伦理思考

随着基因组学的发展,在临床医学中出现了基因检测的新方法,它的临床应用带来了一些伦理、法律和社会问题.从伦理学的角度出发,对基因检测中出现或有可能出现的伦理问题进行探讨,提出进行基因检测应遵循的伦理原则.     

Probability Biases in Genetic Problem Solving: A Comparison of Undergraduates, Genetic Counseling Graduate Students, and Genetic Counselors

Heuristics are mental shortcuts that aid people in everyday problem-solving and decision-making. Although numerous studies have demonstrated their use in contexts ranging from consumers’ shopping decisions to experts’ estimations of experimental validity, virtually no published research has addressed heuristics use in problems involving genetic conditions and associated risk probabilities. The present research consists of two studies. In the first study, 220 undergraduates attempted to solve four genetic problems—two common heuristic problems modified to focus on genetic likelihood, and two created to study heuristics and probability rule application. Results revealed that the vast majority of undergraduates used heuristics and also demonstrated a complete misuse of probability rules. In the second study, 156 practicing genetic counselors and 89 genetic counseling students solved slightly modified versions of the genetic problems used in Study 1. Results indicated that a large percentage of both genetic counselors and students used heuristics, but the counselors demonstrated superior problem-solving performance compared to both the genetic counseling students and the undergraduates from Study 1. Research, training, and practice recommendations are presented.     

Billing and Record-Keeping for Familial Cancer Risk Counseling: A National Survey

We surveyed 111 genetic counselors providing cancer risk counseling (CRC) in order to document their billing and record-keeping practices. Of the 75 respondents, billing was generally done under the supervising physician with a wide variation in charges. Follow-up telephone interviews with 28 counselors who charge patients revealed that billing was usually done using the CPT codes for consultations, and the ICD-9 diagnostic codes for cancer (if applicable), a medical complaint, or a family history of cancer code. Most counselors exclude some clinical information from the patient's medical record. In consultation notes, 81% of counselors document a discussion of genetic testing, but only 37% document the patient's actual testing decision, and only 19% document test results. In anticipation of increased referrals for CRC, data are needed on the components of a CRC visit, the amount of time required to provide CRC, patient outcomes measures, and charges and reimbursement. The feasibility and advisability of keeping results separate from the patient's medical record also needs to be addressed.     

Resistance and adherence to the norms of genetic counseling

Genetic counseling for women of advanced maternal age who are considering prenatal testing continues to be based on a principle of nondirectiveness. We interviewed 11 genetic counseling students and four counselors about how they experience and manage, in practice, the tensions between the ideology of nondirectiveness and the acknowledged reality that one can never be truly nondirective. We found that our respondents creatively resolve this tension—simultaneously resisting and adhering to the values of nondirectiveness and information-giving—in individual and situation-specific ways. This resolution is facilitated by the extent to which information given to counselees is fluid, mobile and context-dependent, but these very features of information also have critical implications for both the norms and the practice of genetic counseling.     

The Nature and Significance of Behavioural Genetic Information

In light of the human genome project, establishing the genetic aetiology of complex human diseases has become a research priority within Western medicine. However, in addition to the identification of disease genes, numerous research projects are also being undertaken to identify genes contributing to the development of human behavioural characteristics, such as cognitive ability and criminal tendency. The permissibility of this research is obviously controversial: will society benefit from this research, or will it adversely affect our conceptions of ourselves and each other? When assessing the permissibility of this research, it is important to consider the nature and deterministic significance of behavioural genetic information. Whilst todate there has been much discussion and debate about the properties of genetic information per se and genetic determinism, this has not been applied to behavioural genetic research and its ethical implications. Therefore, this paper elucidates how behavioural genetic information can be distinguished from other types of genetic and non-genetic information and also synthesises the determinative significance of genetic factors for the development of human behavioural traits. Undertaking this analysis enables the ethical issues raised by this research to be debated in an appropriate context and indicates that separate policy considerations are warranted.

     

Development of the Critical Elements of Genetic Evaluation and Genetic Counseling for Genetic Professionals and Perinatologists in Washington State

We present a method for the development of consensus documents describing the components of genetic evaluation and genetic counseling for various diagnoses. These documents were developed to encourage consistency among genetic professionals in Washington State. Other possible uses of these documents are to provide information regarding genetic evaluations for health care practitioners and payers, and to assist in quality assurance and genetic training programs. A working group of six genetic professionals developed two templates for the critical elements of genetic evaluation and genetic counseling, for clinical (nonprenatal) and prenatal patients. The working group then completed prototype templates for several specific genetic disorders. The templates and prototypes were sent to interested genetic professionals and perinatologists who submitted a total of 76 draft critical elements (CE's) to the working group. At two statewide meetings, participating practitioners modified and unanimously approved the CE templates, then unanimously approved the 21 draft CEs that had been finalized in small group discussions. Approved CE's were distributed to genetic professionals and perinatologists within the state.