Ethical standards for clinical trials conducted in third countries: the new strategy of the European Medicines Agency

Clinical trials increasingly occur on a global scale as industry and government sponsors in wealthy countries move trials to low- and middle-income countries. The globalization of clinical research raises important questions about the economical and ethical aspects of clinical research and the translation of trial results to clinical practice: which ethical standards are applied? Are trials results accurate and valid, and can they be extrapolated to other settings? This article provides an overview of the strategy approved by the European Medicines Agency (EMA) to clarify ethical standards for clinical research conducted outside the European Economic Area (EEA) and included in Marketing Authorization Applications. Reference to the EMA Reflection paper is made.     

European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population

This document has been developed by the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, chaired by the European Commission. The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood. This will contribute to the protection of all children who are the subject of clinical trials. As the approval of clinical trials, including ethical approval, is performed by the Member States, any recommendations on ethical aspects of clinical trials in children will also facilitate a harmonised approach to the application of the clinical trials directive across the EU, thereby facilitating the conduct of clinical trials in the EU and in whichever country the paediatric trial occurs. The protection against the risks of research in such a vulnerable population is paramount whilst this should not lead to denying them the benefits of research. Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent (in the legal sense) but their assent should be sought using age appropriate information. Ethics Committees need paediatric expertise to balance the benefits and risks of research in children. The lack of legal ability to consent has implications on the design, analysis and the choice of comparators used in trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The neonate represents the most vulnerable of all paediatric age groups and requires even more careful review. Finally, various other aspects relating to the performance of trials in children are discussed.     

Why do young people start and continue with ethical hacking? A qualitative study on individual and social aspects in the lives of ethical hackers

Research Summary

This qualitative interview study examined individual and social aspects in the lives of 15 hackers who started with ethical hacking before the age of 18. We examined what motivated and stimulated them to start with ethical hacking and how and why they continued. Results show that individual aspects, such as an early interest in ICT (Information and Communication Technology), the motivation to make systems more secure, and thinking of reporting vulnerabilities as a moral duty, contribute to the initiation of ethical hacking. Social aspects, such as role models, mainly play a role in the further development of the ethical hacking career. For example, peers, parents, friends, and hacker communities have a motivating and stimulating effect on young ethical hackers. Similarly, positive reactions from public and private system owners can further stimulate the development and self-image of ethical hackers.

Policy Implications

In contrast to criminal hackers, ethical hackers improve cybersecurity, for example, by reporting weaknesses or errors in computer systems. Nowadays, an increasing number of public and private organizations around the world are creating cybersecurity policies and practices around ethical hacking. The interest in hacking usually arises at an early age, making it important to gain knowledge about what stimulates and motivates young people to start and continue with ethical hacking, to inform these policies and practices. Our results show that recognition and reactions from system owners are important in the ethical hacking career. Our recommendations based on these results could stimulate more young people to take the ethical path. Simultaneously, this increases the security of public and private organizations, reducing opportunities for criminal hackers.     

The legal basis for ethical withholding and withdrawing of life-sustaining medical treatment in children

Withholding and withdrawing life-sustaining medical treatment are common in paediatric practice, especially in intensive care units. However, not all clinicians apparently adhere to principles in ethical guidelines or to the principles which are to be found in judgments from common law cases arising when doctors and parents dispute treatment. This article examines selected ethical guidelines and compares them to judgments in leading cases. The rationale to forgo treatment is usually the child's "best interests" in both clinical practice guidelines and legal cases but in the former "best interests" may remain ill defined. Although "best interests" must essentially pertain to the individual child, the interests of others are not irrelevant. In legal cases "best interests" of the child are defined in terms such as "burden versus benefit", "futility", "indignity", "intolerability", "prolonging death rather than saving life" and "quality of life". These or like terms should form the basis of ethical decisions in discussions with parents when contemplating withholding or withdrawing life-sustaining treatment.     

Screening by Healthcare Staff for Domestic Violence Against Women in Israel - Ethical and Legal Aspects

This paper describes the ethical and legal aspects involved in healthcare Staff screening women for domestic violence in Israel. The primary aim of this article is to present the legal and ethical aspects of domestic violence in general, and of screening for violence, in particular. This article describes tools that play a crucial role in helping care for women who have been subjected to domestic violence, with an emphasis on the ethical dilemma stemming from the conflict between upholding moral conduct and individual autonomy versus ensuring the safety of patients who have been subjected to domestic violence and the need to provide high quality professional care.     

Publication of OIG compliance program guidance for clinical laboratories--HHS. Notice

This Federal Register notice sets forth the OIG's recently-issued Compliance Program Guidance for Clinical Laboratories. The OIG had previously developed and published a model compliance plan for the clinical laboratory industry on March 3, 1997. This Compliance Program Guidance for Clinical Laboratories is intended to be more consistent with compliance program guidances issued by the OIG with respect to the hospital industry and to home health agencies, and serves to clarify various aspects of the original model plan. As with previously-issued compliance program guidances, we believe that the development of this guidance for clinical laboratories will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the entire health care community.     

Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule

The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies.     

信用权性质辨析——以信用的涵义为线索

文章分析了信用的涵义,认为信用有表现为道德评价的信用、作为道德准则的信用和表现为经济评价的信用之别,而信用权的客体是表现为经济评价的信用,在考察相关特征后指出,信用权客体的财产性是占主导地位的,学理上信用权应定位为无形财产权为宜。     

Cybersex with minors: forensic implications.

This paper is designed to assist forensic psychiatrists/psychologists who evaluate adults who commit sexual crimes against children on the Internet. The typical offender is an adult male who logs onto the Internet and enters a chat room in which children congregate. Unbeknownst to the offender, undercover police officers are posing as minors in the chat rooms. The undercover officer (pretend kid) and offender engage in increasingly explicit, sexual conversation; the offender may transmit erotic photographs to the undercover officer and/or arrange to meet at a motel in order to have sexual intercourse. The authors will discuss the relevant legal, clinical, and ethical aspects of examining these offenders, and describe specific cases that the author (2) evaluated.     

Bioethics from a social perspective: European Biopolitics Conference]

The European Congress on biopolitics entitled "Connecting civil society implementing basic values" was held in March 2006 in Berlin. It was organised by the Heinrich B?ll foundation and the Institut Mensch, Ethik und Wissenschaft. The aim of the Congress was to provide a forum for discussion on the ethical and social aspects derived from biotechnology and genetics on human beings. This work summarises some of the aspects that reveal the international interest and relevance of this meeting.     

Age estimation

While age estimation of unidentified corpses and skeletons for identification purposes has a long tradition in forensic sciences, age estimation of living persons has formed a relatively recent area of forensic research which is becoming increasingly important. The international interdisciplinary Study Group on Forensic Age Diagnostics (AGFAD) issued recommendations for age estimation of living persons for the purpose of criminal, civil, asylum and old-age pension procedures as well as for determining the sex and age of skeletons. In the present work, the authors set out state-of-the art age estimation methods for specific case groups, define minimum requirements for reference studies and specify the need for further research. In addition, ethical and medico-legal aspects as well as issues relating to quality assurance are discussed.     

The forensic evaluation and treatment of children: ethics and values

This article will review the history of ethics and values in the forensic evaluations and treatment of children. Topics to be discussed include paternalism, advocacy, parental responsibility, and legal doctrine of parens patriae. Various aspects of the treatment of children, including medications, behavior modification, and psychotherapy, are also examined for ethical considerations. Agency consultation in conflicts of ethics that are associated with public laws are also addressed. The ethical implications of the use of children in any research as research subjects is also addressed.     

Defining a clinically useful model for assessing competence to consent to treatment

Burdened with the responsibility of making an initial assessment of their patients' capacity to make treatment decisions, clinicians need a sound clinical assessment model. Drawing on ethical, legal, and clinical sources, the author reviews the appropriateness of existing models and standards and describes why each fails the needs of the clinician. The patient's ability to form a therapeutic alliance is shown to be a valid assessment model for defining a treatment decision-making ability threshold because it adheres to widely accepted ethical and legal standards. Using threshold because it adheres to widely accepted ethical and legal standards. Using this model to set a threshold for the decision to bring cases to the attention of a court or administrative body, the therapist arrives at a satisfactory balance between competent treatment, patient autonomy, and judicially mandated due process imperatives while providing a forum for patient education and assessment of the clinician's technical skill. Explanations of case examples illustrate the use of the therapeutic alliance for this purpose in a variety of clinical situations. Specific recommendations are made on what may be represented to court in cases in which the patient's competence appears to fall below this treatment threshold.     

法律生态化趋势初探

法律生态化趋势是生态伦理观在法律上的反映 ,从人类中心主义伦理观到可持续发展伦理观的革命是法律生态化的伦理基础 ,正是这种变化了的价值观引发了法律生态化的趋势。这种趋势表现为在确立可持续发展战略的宪法地位以及创设新型权利 ,承认环境组成部分的内在价值及其有限的法律主体资格 ,承认非人类存在物的诉讼主体资格 ,生态本位的立法目的 ,民法生态化等方面。     

法律实证研究中的伦理问题 以刑事法为视角

在刑事法律实证研究中,由于被研究者多为极易受到研究伤害的弱势群体,研究过程及结果又往往涉及司法改革和司法公正等重大问题,因而研究伦理亟需规范。实证研究本质上是一种生产知识的方法,对刑事法律实证研究的伦理规范主要是对研究权力的规范,目的是防止知识、权力与资本的“共谋”。应当遵循自律、纪律和法律的总体思路,设立伦理审查委员会,依据尊重、保护、公正、全面的原则,规范我国的刑事法律实证研究。在规范的同时还要建立相应的保障机制,以解决实践中法律实证研究难以开展的不利局面。     

Ethics at Phase 0: Clarifying the Issues

The Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) recently issued documents encouraging sponsors to consider microdose testing before launching Phase I trials, and many commentators predict that such methodologies will be applied more routinely in drug development. However, exploratory testing has provoked several ethical criticisms. Skeptics question the value and validity of microdose trials, and whether they present a reasonable balance of risks and benefits for subjects. Another major criticism is that such studies serve mainly commercial ends. The present article explores these and other ethical concerns for studies conducted in the oncology setting. It concludes that microdosing is not inconsistent with prevailing practices in Phase I research, and that in principle, such studies could strengthen the ethical basis for Phase I trials by providing them better evidentiary justification.     

Ethical Considerations in the Conduct of Electronic Surveillance Research

The extant clinical literature indicates profound problems in the assessment, monitoring, and documentation of care in long-term care facilities. The lack of adequate resources to accommodate higher staff-to-resident ratios adds additional urgency to the goal of identifying more cost-effective mechanisms to provide care oversight. The ever expanding array of electronic monitoring technologies in the clinical research arena demands a conceptual and pragmatic framework for the resolution of ethical tensions inherent in the use of such innovative tools. CareMedia is a project that explores the utility of video, audio and sensor technologies as a continuous real-time assessment and outcomes measurement tool. In this paper, the authors describe the seminal ethical challenges encountered during the implementation phase of this project, namely privacy and confidentiality protection, and the strategies employed to resolve the ethical tensions by applying principles of the interest theory of rights.     

Corporate social responsibility as new challenge for the IT industry

Corporate social responsibility (CSR) has become a relevant topic for enterprises offering products and services on a global scale. International organizations provide for guidelines and private associations publish codes of conduct requiring businesses to integrate social, environmental and ethical aspects, human rights as well as consumer concerns into their operations. Not at least the EU is promoting CSR through an Agenda for Action 2011–14. The implementation of CSR is a multidimensional ethical process and gains particular importance for the IT industry which by its nature is global. Therefore, IT enterprises are invited to conduct a CSR assessment, to develop a CSR strategy and to implement CSR commitments. These tasks are to be done by introducing specific CSR processes and compliance measures for risk assessment and risk mitigation.     

中国古代道家责任心理思想及其现代意义

传统道家责任心理思想是中国人责任心理结构认知链条上的重要一环。本文立足于有无相生的道体论和自然、无为的伦理价值观,归纳提取出该文化内部为政、养生、经世三方面相辅相成的责任心理结构;并指出真人人格的培养是促成这一结构现实实践的关键所在;坐忘心斋、谦下守柔、知和不争,构成了责任心理品质养成的主要策略机制。传统道家责任心理思想研究对当代责任心理学理论建构、个人生命意义探究及社会价值观反思,都具有重要借鉴意义。     

Retracing One’s Steps: Searching for the Ethics of Legal Interpretation

The article discusses the problem of interpretation in law. Are there some criteria by which we can distinguish a good interpretation from a bad one, interpretation from over-interpretation? It is argued in this article that there is always a choice in defining the meaning of a text and this choice can be seen as an ethical one. This article thus studies the question of limits of interpretation by focusing on the ethical elements of interpretation. It is argued here that legal interpretation contains a requirement of justice that shapes the responsibility that the interpreter carries for his choices of meaning. Therefore the ethical elements of interpretation are especially pressing in the interpretation of legal texts.