Human-tissue-related inventions: ownership and intellectual property rights in international collaborative research in developing countries

There are complex unresolved ethical, legal and social issues related to the use of human tissues obtained in the course of research or diagnostic procedures and retained for further use in research. The question of intellectual property rights over commercially viable products or procedures that are derived from these samples and the suitability or otherwise of participants relinquishing their rights to the samples needs urgent attention. The complexity of these matters lies in the fact that the relationship between intellectual property rights and ownership or rights pertaining to the samples on which the intellectual property right is based may either be overlooked or taken for granted. What equally makes the matter complex is that samples may be obtained from participants in developing countries and exported to developed countries for analysis and research. It is important for research ethics committees to tread carefully when reviewing research protocols that raise such issues for purposes of ensuring that appropriate benefit sharing agreements, particularly with developing countries, are in place. This paper attempts to analyse the key questions related to ownership and intellectual property rights in commercially viable products derived from human tissue samples. Patent law is used as a point of reference as opposed to other forms of intellectual property rights such as industrial designs because it is the right that most inventors apply for in respect of human tissue-related inventions. The key questions are formulated following a systematic analysis of peer reviewed journal articles that have reported original investigations into relevant issues in this field. Most of the cases and reported studies that are referred to in this paper do not directly deal with HIV/AIDS research but the underlying principles are helpful in HIV/AIDS research as well. Pertinent questions, which members of ethics review committees should focus on in this regard are discussed and suggestions on appropriate approaches to the issues are proposed in the form of specific questions that an ethics review committee should consider. Specific recommendations regarding areas for further research and action are equally proposed.     

Proportional ethical review and the identification of ethical issues

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted.     

浅析人类生殖细胞基因治疗的伦理学问题及对策

人类生殖细胞基因治疗是一个全新的医学领域,它可以从根本上治疗许多疾病,但是由于技术不完善以及存在众多伦理问题,所以该技术未能广泛应用于临床治疗和研究.人类生殖细胞基因治疗引发的伦理问题有：科学不可预知性的问题;生殖细胞基因治疗的社会风险问题;生殖细胞基因治疗改变人类多样性的问题;生殖细胞基因治疗的人权问题;如何判断基因“好”与“坏”的问题;生殖细胞基因治疗的经济价值问题.避免这些问题的对策有：政府应建立有效的管理和法律制度;生殖细胞治疗基因应符合国际技术规范和伦理规范;科学家和医学工作者应该加强道德修养,掌握应有的伦理学知识;加强教育宣传工作,使公众了解并接受该治疗方法.     

Trade in human tissue products

Trade in human tissue in Australia is prohibited by state law, and in ethical guidelines by the National Health and Medical Research Council: National statement on ethical conduct in human research; Organ and tissue donation by living donors: guidelines for ethical practice for health professionals. However, trade in human tissue products is a common practice especially for: reconstructive orthopaedic or plastic surgery; novel human tissue products such as a replacement trachea created by using human mesenchymal stem cells; biomedical research using cell lines, DNA and protein provided through biobanks. Cost pressures on these have forced consideration of commercial models to sustain their operations. Both the existing and novel activities require a robust framework to enable commercial uses of human tissue products while maintaining community acceptability of such practices, but to date no such framework exists. In this article, we propose a model ethical framework for ethical governance which identifies specific ethical issues such as: privacy; unique value of a person's tissue; commodification of the body; equity and benefit to the community; perverse incentives; and "attenuation" as a potentially useful concept to help deal with the broad range of subjective views relevant to whether it is acceptable to commercialise certain human tissue products.     

对人类胚胎干细胞来源的伦理审视

伦理审查的重点之一:胚胎干细胞的来源是否符合了伦理要求,2003年出台的《人胚胎干细胞研究的伦理指导原则》没有提供可操作的审查要求。结合我国国情,审视了人胚胎干细胞来源中若干伦理问题,并提出了四点审查要点:①在目前的情况下,"冷冻的多余的胚胎"可以作为胚胎干细胞研究的主要来源,但研究者不可过度依赖多余的胚胎;②在接受自愿捐献的卵子时,研究者要实现对捐卵者的伤害最低化,不得采取胁迫、引诱的方式获取卵子;③在使用"流产胎儿"时,要获得孕妇或家庭的知情同意,不可为获得一个研究用的流产胎儿,而让一个妇女先怀孕。④为达治疗性克隆研究之目的,研究者可以通过体细胞核移植技术制造胚胎干细胞,但研究中胚胎要在14天内销毁。     

牙周病电子病历数据库建立的设想及其伦理问题分析

建立牙周病数据库可以系统地记载和积累患者病史资料,对患者病程进行长期跟踪分析,了解患者疾病的进程、变化以及其诊断治疗方案和治疗效果.但是也存在着诸如标准化与规范化、人力及时间成本、患者隐私的保护、患者知情同意权的保护、病历信息的安全、医学科研成果的知识产权保护等一系列伦理问题.从伦理道德教育、技术监控、制度控制、法律保障等方面来探讨应如何应对这些问题.     

药品知识产权国际保护的中庸之道

药品知识产权国际保护中存在着多重权利冲突，其中最为突出的就是专利权与生命健康权的对立。试从伦理的角度来审视药品知识产权，以中庸之道来解决药品知识产权国际保护中的权利冲突与道德困境。一方面，作为私权与财产权的药品专利权并没有与更优于它的其他权利发生冲突时，应该保护药品专利权并努力促使这一权利得以实现；另一方面，当药品专利权与位阶上更优于它的生命健康权相冲突时，专利权应让位与生命健康权，作出必要的自我牺牲。在具体实践中，药品知识产权国际保护应尊重差别原则，建立相应的专利药品价格差别制度，高扬救死扶伤的人道精神以维护生命健康权。     

人类胚胎干细胞研究中的伦理学问题

目的 探讨人类胚胎干细胞研究中的伦理学问题。方法 由人类胚胎干细胞研究所引发的伦理学争论及带来的伦理忧患，导出应注意的医学伦理方面的问题。结果 人类胚胎干细胞研究应遵循一定的伦理原则。结论 医学伦理学应规范和引导人类胚胎干细胞研究。     

Research on leukaemia cells surplus to diagnostic needs in children.

The ability to improve diagnosis and refine prognosis in children with acute leukaemia is improving steadily. A growing number of tests can and are being performed on leukaemic cells. These include surface-marker analysis, DNA content, cytogenetics and studies of gene rearrangements. Increasingly large bone-marrow samples, now usually obtained under general anaesthesia, are required to make secure diagnoses. Ethical issues arise from three major areas. 1) Current research on leukaemia cells requested by the Medical Research Council is considered by local research ethics committees, but parents are not regularly given detailed information about or asked specifically to consent to such research; 2) substantial quantities of excess cells are stored indefinitely. This archive of stored material is a valuable resource for research but there has been little consideration of the ethical issues which arise from this practice, and 3) there is a potential for pressure to obtain increasingly large samples. 'Creeping growth' in sample size is likely to continue unless ethics committees consider future research proposals in more detail. These issues deserve attention in order that worthwhile research and its publication are not impeded for want of ethical consideration. The implications extend beyond the field of childhood leukaemia.     

Disability, gene therapy and eugenics--a challenge to John Harris

This article challenges the view of disability presented by Harris in his article, "Is gene therapy a form of eugenics?"¹ It is argued that his definition of disability rests on an individual model of disability, where disability is regarded as a product of biological determinism or "personal tragedy" in the individual. Within disability theory this view is often called "the medical model" and it has been criticised for not being able to deal with the term "disability", but only with impairment. The individual model of disability presupposes a necessary causal link between a certain condition in the individual and disablement. The shortcomings of such a view of disability are stated and it is argued that in order to have an adequate ethical discourse on gene therapy perspectives from disability research need to be taken into consideration. Key Words: Disability theory ? gene therapy ? eugenics     

Institutional ethics review of clinical study agreements

Clinical Study Agreements (CSAs) can have profound effects both on the protection of human subjects and on the independence of investigators to conduct research with scientific integrity. Sponsors, institutions, and even investigators may fail to give adequate attention to these issues in the negotiation of CSAs. Despite the key role of CSAs in structuring ethically important aspects of research, they remain largely unregulated and unreviewed for adherence to ethical norms. Academic institutions routinely enter into research contracts that fail to meet adequate ethical standards. This is a failing that can have serious consequences. Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board (IRB or REB) is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator's freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review.     

异种角膜移植的伦理学探讨

通过实验室方法处理后,异种角膜具有无细胞、无病源、低抗原的特点,所以异种角膜移植在临床应用具有了技术上的可能性,但其能否通过伦理学的论证需要探讨：①异种角膜移植后能否引起人的特性改变,是否违背伦理道德;②动物保护问题;③异种角膜移植是否会传播某些人源性疾病从而可能危害公众健康。异种角膜移植同其他异种器官移植相比较有明显优势。可操作性强。在临床使用前应对其“安全性、有效性和伦理学”问题进行论证评估,对使用异种角膜的患者进行心理疏导,加强异种角膜“安全性”的研究,应重视对实验动物的尊重。异种角膜移植的开展在一定程度上可解决临床角膜匮乏的问题,为众多盲人重见光明开辟新的治疗途径。     

The dangers of medical ethics

The dominant conception of medical ethics being taught in British and American medical schools is at best pointless and at worst dangerous, or so it will be argued. Although it is laudable that medical schools have now given medical ethics a secure place in the curriculum, they go wrong in treating it like a scientific body of knowledge. Ethics is a unique subject matter precisely because of its widespread familiarity in all areas of life, and any teaching has to start from this shared ethical understanding and from the familiar ethical concepts of ordinary language. Otherwise there is a real risk that spurious technocratic jargon will be deployed by teacher and student alike in the futile search for intellectual respectability, culminating in a misplaced sense of having "done" the ethics module. There are no better examples of such jargon than "consequentialism", "deontology", and the "Four Principles". At best, they cannot do the work they were designed to do and, at worst, they can lead student and practitioner into ignoring their own healthy ethical intuitions and vocabulary.     

The views of members of Local Research Ethics Committees, researchers and members of the public towards the roles and functions of LRECs.

BACKGROUND: It can be argued that the ethical conduct of research involves achieving a balance between the rights and needs of three parties-potential research participants, society, and researchers. Local Research Ethics Committees (LRECs) have a number of roles and functions in the research enterprise, but there have been some indications that LREC members, researchers and the public can have different views about these responsibilities. Any such differences are potential sources of disagreement and misunderstanding. OBJECTIVES: To compare the views of LREC members, researchers and the public towards the roles and functions of LRECs. DESIGN: A questionnaire that contained items concerned with a variety of such roles was distributed to general practice patients (as proxies for potential research participants), researchers and LREC members. FINDINGS: While general practice patients believed that the main function of LRECs is to ensure that research participants come to no harm, LREC members were more concerned with the protection of participants' rights. There was also some disagreement between members and researchers with regard to the consideration of proposals on the grounds of scientific merit. CONCLUSIONS: Local Research Ethics Committee members need to be aware of potential differences in views, that they ought to make their priorities clear, and that membership of LRECs ought to reflect the views of both researchers and potential research participants.     

转基因技术的伦理学研究

转基因技术的飞速发展在给人类带来巨大利益的同时也产生众多的伦理问题。一是转基因技术存在不可预知的生态破坏及对人类健康损害的生态伦理问题;二是由技术专利带来的商业垄断所引起权利冲突和利益分配的伦理问题。转基因技术的应用和推广需要同时考虑生态伦理问题和利益分配问题,唯有权衡利弊,慎重决策,秉承预防为主、平衡发展的伦理原则,坚持以人为本、科学的、可持续发展,才能使转基因技术真正造福于人。     

Embryonic stem cell production through therapeutic cloning has fewer ethical problems than stem cell harvest from surplus IVF embryos

Restrictions on research on therapeutic cloning are questionable as they inhibit the development of a technique which holds promise for successful application of pluripotent stem cells in clinical treatment of severe diseases. It is argued in this article that the ethical concerns are less problematic using therapeutic cloning compared with using fertilised eggs as the source for stem cells. The moral status of an enucleated egg cell transplanted with a somatic cell nucleus is found to be more clearly not equivalent to that of a human being. Based on ethical considerations alone, research into therapeutic cloning should be encouraged in order to develop therapeutic applications of stem cells.     

CRISPR/Cas 基因组靶向编辑技术综述

Clustered regularly interspaced short palindromic repeats （CRISPR）/CRISPR-associated（Cas）是细菌特有的一种获得性免疫系统,研究人员将其改造成为靶向基因组编辑的工具,由于操作简单、成功率高且效率高,成为了靶向基因组编辑工具中的佼佼者。同时CRISPR/Cas系统也被改造作为一种极为有效的位点特异性的转录抑制/激活的工具而在研究工作中广泛应用,不仅如此,具有靶向细胞转录过程中产生的RNA底物的利用前景,从而起到与RNAi技术相类似的效果。 CRISPR-Cas技术已经在基因功能研究、动物模型建立、基因治疗等领域得到广泛的推广和应用,有力地推动了相关领域的研究进展。     

“基因革命”及其伦理初探

人类基因组研究在过去11年中取得了重要成果,是人类科学上的又一次革命,基因组研究给生命科学带来了革命性的变化,同时也带来了一系列社会伦理的挑战,笔者认为,在这场革命中恪守人类伦理实践,构建基因科技－伦理互动协调机制,有利于协调两者之间的关系,更好地促进基因科技健康发展,为人类社会造福。     

实施辅助生殖技术的伦理问题与原则

实施辅助生殖技术涉及许多伦理问题,本文剖析和探讨了其内在的伦理功用和常见的伦理问题,提出了应遵循的伦理原则,以期该项技术能健康有序地开展,以减少医疗纠纷和真正造福于人类。     

Selecting subjects for participation in clinical research: one sphere of justice

Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer''s theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research.