Not Fit for Purpose: The Ethical Guidelines of the Indian Council of Medical Research

In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India.     

A Decision Support Framework for Sustainable Waste Management

This article describes a decision support framework for the evaluation of scenarios for the integrated management of municipal solid waste within a local government area (LGA).
The work is initially focused on local government (i.e., municipal councils) in the state of Queensland, Australia; however, it is broadly applicable to LGAs anywhere. The goal is to achieve sustainable waste management practices by balancing global and regional environmental impacts, social impacts at the local community level, and economic impacts. The framework integrates life-cycle assessment (LCA) with other environmental, social, and economic tools. For this study, social and economic impacts are assumed to be similar across developed countries of the world. LCA was streamlined at both the life-cycle inventory and life-cycle impact assessment stages.
For this process, spatial resolution is introduced into the LCA process to account for impacts occurring at the local and regional levels. This has been done by considering social impacts on the local community and by use of a regional procedure for LCA data for emissions to the environment that may have impacts at the regional level.
The integration follows the structured approach of the pressure-state-response (PSR) model suggested by the Organisation for Economic Cooperation and Development (OECD). This PSR model has been extended to encompass nonenvironmental issues and to guide the process of applying multiple tools.
The framework primarily focuses on decision analysis and interpretation processes. Multiattribute utility theory (MAUT) is used to assist with the integration of qualitative and quantitative information. MAUT provides a well-structured approach to information assessment and facilitates objective, transparent decisions. A commercially available decision analysis software package based on MAUT has been used as the platform for the framework developed in this study.     

A Decision Making Framework for Sediment Assessment Developed for the Great Lakes

A rule-based, weight-of-evidence approach for assessing contaminated sediment on a site-by-site basis in the Laurentian Great Lakes is described. Information from four lines of evidence—surficial sediment chemistry, laboratory toxicity, invertebrate community structure and invertebrate tissue biomagnification—is integrated within each line to produce a pass (‘?’) or fail (‘+’) conclusion, then combined across lines resulting in one of 16 outcome scenarios. For each scenario, the current status of the site, interpretation, and management recommendations are given. Management recommendation(s) can range from no action to risk management required (9 of the 16 scenarios). Within each line of evidence, the strength of each response can also be ranked (e.g., score of 1 to 4), providing managers with more information to aid decision options. Other issues that influence scientific management recommendations include site stability, subsurface contamination and spatial extent of effects. The decision framework is intended to be transparent, comprehensive (incorporating exposure, effect, weight-of-evidence, and risk), and minimally uncertain.     

人体器官获取的法伦理思考

尊重供者意愿的器官获取是各国普遍遵从的方式。绝大多数国家采取无偿捐献的法律模式,少数国家为解决器官短缺问题,采取强制征收尸体器官或者国家控制下的有偿交易模式。这种模式尽管一定程度上解决了器官来源不足的问题,然而,却因违背了全球公认的人权理念和生命伦理原则而受到质疑。我国无偿自愿捐献的器官获取法律模式存在激励机制缺失和体系不完善等缺陷,对此进行了深入的法伦理分析,并提出了构建器官获取激励机制和完善器官获取体系等措施。     

To Supplement or Not to Supplement: A Metabolic Network Framework for Human Nutritional Supplements

Flux balance analysis and constraint based modeling have been successfully used in the past to elucidate the metabolism of single cellular organisms. However, limited work has been done with multicellular organisms and even less with humans. The focus of this paper is to present a novel use of this technique by investigating human nutrition, a challenging field of study. Specifically, we present a steady state constraint based model of skeletal muscle tissue to investigate amino acid supplementation''s effect on protein synthesis. We implement several in silico supplementation strategies to study whether amino acid supplementation might be beneficial for increasing muscle contractile protein synthesis. Concurrent with published data on amino acid supplementation''s effect on protein synthesis in a post resistance exercise state, our results suggest that increasing bioavailability of methionine, arginine, and the branched-chain amino acids can increase the flux of contractile protein synthesis. The study also suggests that a common commercial supplement, glutamine, is not an effective supplement in the context of increasing protein synthesis and thus, muscle mass. Similar to any study in a model organism, the computational modeling of this research has some limitations. Thus, this paper introduces the prospect of using systems biology as a framework to formally investigate how supplementation and nutrition can affect human metabolism and physiology.     

The Indonesian Legal Framework on Baselines,Archipelagic Passage,and Innocent Passage

As an archipelagic state, Indonesia is faced with a wide range of potential maritime security threats. This article analyzes the existing Indonesian legislation on baselines, archipelagic passage, and innocent passage in accordance with the 1982 United Nations Convention on the Law of the Sea. The article demonstrates the challenges that exist in implementing the key navigational rights laws.     

A Review of the Legal and Policy Framework for Vessel Source Pollution in Hong Kong

Vessel source marine pollution is an increasingly major concern at both the national and international levels. Hong Kong, as an important maritime center, is naturally concerned with vessel source pollution. To meet the challenges, Hong Kong has formulated policies and measures that emphasize “green shipping” as part of an overall planning strategy that promotes a “green economy.” This article provides a review and analysis of Hong Kong's marine pollution laws, with a view toward making policy suggestions. It argues that the general perception of the adequacy of Hong Kong's marine laws in combating vessel source pollution is flawed. It suggests that Hong Kong should adopt a more forward-looking perspective in the formulation of legal measures to control vessel source pollution.     

Revisiting the Freedom of Fishing and Legal Obligations on States Not Party to Regional Fisheries Management Organizations

For decades, states have cooperated through regional fisheries management organizations (RFMOs) on the conservation and management of living marine resources on the high seas. Nonmembers, or third states not bound by their decisions, have been an Achilles’ heel. In this article, the legal status of RFMO nonmembers and the freedom of fishing are examined. It is concluded that RFMO nonmembers have concrete obligations with respect to established fisheries subject to RFMO regulation.     

Focus: Bioethics: An Ethical Framework for Incorporating Digital Technology into Advance Directives: Promoting Informed Advance Decision Making in Healthcare

Despite the presumed value of advance directives, research to demonstrate impact has shown mixed results. For advance directives to serve their role promoting patient autonomy, it is important that patients be informed decision makers. The capacity to make decisions depends upon understanding, appreciation, reasoning, and communication. Advance directives are in part faulty because these elements are often limited. The present paper explores how the application of digital technology could be organized around a framework promoting these four elements. Given the state of digital advancements, there is great potential for advance directives to be meaningfully enhanced. The beneficial effects of incorporating digital technology would be maximized if they were organized around the aim of making advance directives not only documents for declaring preferences but also ethics-driven tools with decision aid functionality. Such advance directives would aid users in making decisions that involve complex factors with potentially far-reaching impact and would also elucidate the users’ thought processes to aid those tasked with interpreting and implementing decisions based on an advance directive. Such advance directives might have embedded interactive features for learning; access to content that furthers one’s ability to project oneself into possible, future scenarios; review of the logical consistency of stated preferences; and modes for effective electronic sharing. Important considerations include mitigating the introduction of bias depending on the presentation of information; optimizing interfacing with surrogate decision makers and treating clinicians; and prioritizing essential components to respect time constraints.     

Ethical, legal, and social aspects of farm animal cloning in the 6th Framework Programme for Research

Cloned livestock have potential importance in the provision of improved medicine as well as in the development of livestock production. The public is, however, increasingly concerned about the social and ethical consequences of these advances in knowledge and techniques. There is unevenness throughout Europe in different Member States' attitudes to research into livestock cloning. Although there is EU legislation controlling the use of animals for research purposes, there is no legislation specifically governing cloning in livestock production. The main EU reference is the 9th Opinion of the European Group on Ethics, which states "Cloning of farm animals may prove to be of medical and agricultural as well as economic benefit. It is acceptable only when the aims and methods are ethically justified and when carried out under ethical conditions." The ethical justification includes the avoidance of suffering, the use of the 3Rs principle and a lack of better alternatives. The Commission addresses these issues in the 6th Framework Programme by promoting the integration of ethical, legal and social aspects in all proposals where they are relevant, by fostering ethical awareness and foresight in the proposals, by encouraging public dialogue, and by supporting specific actions to promote the debate. Research must respect fundamental ethical principles, including animal welfare requirements.     

临床药师职业风险防范的伦理观照与法律思考

随着我国临床药学工作的普及和不断深入,有关临床药师职责的立法任务也越来越受重视。临床药师存在药学和法学的含义界定、产生背景不清,而临床药师职业中存在着法定权利空泛责任不清、专业地位及流向不明确、对临床药师的认知程度不高等风险,其职业风险防范具有行善、无害、自主、公平原则的伦理观照和立法、守法、司法的法律思考。     

Points to Consider: Ethical,Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents

In 1995, the American Society of Human Genetics (ASHG) and American College of Medical Genetics and Genomics (ACMG) jointly published a statement on genetic testing in children and adolescents. In the past 20 years, much has changed in the field of genetics, including the development of powerful new technologies, new data from genetic research on children and adolescents, and substantial clinical experience. This statement represents current opinion by the ASHG on the ethical, legal, and social issues concerning genetic testing in children. These recommendations are relevant to families, clinicians, and investigators. After a brief review of the 1995 statement and major changes in genetic technologies in recent years, this statement offers points to consider on a broad range of test technologies and their applications in clinical medicine and research. Recommendations are also made for record and communication issues in this domain and for professional education.