HARD PATERNALISM,FAIRNESS AND CLINICAL RESEARCH: WHY NOT?

Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non‐therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision‐makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons. First, the idea of poor decision‐makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be practicable for regulators to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision‐makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk‐benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize.     

医学研究伦理学的发展现状与前景

创新技术的开展和转化医学的注重给医学的发展注入了新的活力,但同时,也带来了一系列社会伦理问题和法律问题。生命医学伦理学的兴起和发展催生了医学研究伦理学分支学科形成,目的在于推进解决涉及人体的医学研究的伦理问题。当前,面临的最突出的伦理问题在于,对医学研究合法性、先进性及伦理性的把握,对医学研究伦理审查必要性的认知,对医学研究方案设计与伦理道德的匹配,对医学研究知情同意的告知,对医学研究风险与受益的平衡。逐步与国际接轨,加强伦理委员会制度建设;提高伦理审查能力建设,形成高水平的伦理审查队伍;学术组织和团体共同努力,推进医学研究伦理学的发展,这将助推医学研究伦理学的发展。     

Importance of basic research in applied phycology

Utilization of algae has extended considerably from the middle of this century, with the consequence of more and more applied research in various directions and fields, the most important of which deals with phycocolloid production and algal cultivation to provide raw material and foodstuff. It is noteworthy that this research can not avoid the use of knowledge obtained by basic research; applied phycology is especially indebted to basic research in adopting biotechnologies which are typically coming from basic research. In counterpart, such a situation is beneficial to basic research. According to the dependence of applied phycology to basic research and the fact that restricted research programs only are nowadays financially supported, the fate of all research seems to be questionable.     

Partner choice creates fairness in humans

Many studies demonstrate that partner choice has played an important role in the evolution of human cooperation, but little work has tested its impact on the evolution of human fairness. In experiments involving divisions of money, people become either over-generous or over-selfish when they are in competition to be chosen as cooperative partners. Hence, it is difficult to see how partner choice could result in the evolution of fair, equal divisions. Here, we show that this puzzle can be solved if we consider the outside options on which partner choice operates. We conduct a behavioural experiment, run agent-based simulations and analyse a game-theoretic model to understand how outside options affect partner choice and fairness. All support the conclusion that partner choice leads to fairness only when individuals have equal outside options. We discuss how this condition has been met in our evolutionary history, and the implications of these findings for our understanding of other aspects of fairness less specific than preferences for equal divisions of resources.     

我国资源植物化学与天然产物化学基础研究的现状与发展

本文从生物活性成分的筛选与分离、植物次生代谢产物生物合成及其分子调控、环境因子对植物次生代谢产物合成和积累的影响、植物体内生菌与植物次生代谢产物的关系等方面介绍了我国资源植物化学与天然产物化学领域基础研究的现状与发展。     

What constitutes fair shared decision-making in global health research collaborations?

Funders (located primarily in high-income countries) and high-income country researchers have historically dominated decision-making within global health research collaborations: from setting agendas and research design to determining how data are collected and analysed and what happens with findings and outputs. The ethical principle of shared decision-making has been proposed as a way to help address these imbalances within collaborations and to reduce semicolonial and exploitative forms of global health research. It is important to be clear about what shared decision-making means in order to ensure that it is not done in a tokenistic, shallow way. Thus far, the principle’s content has not been examined and articulated in detail. This paper aims to start the process of delineating a concept of fair shared decision-making as a minimum standard for global health research. Using two hypothetical case examples, the paper will demonstrate that global health research practice is often inconsistent with ideal shared decision-making. In such instances, it can be difficult to decide whether shared decision-making within collaborations is fair. The paper describes how the two cases do not meet criteria for unfair or non-ideal shared decision-making, despite having potentially morally troubling features. The nuances of these examples of research practice help to generate clearer ideas about how to judge fairness in shared decision-making. The paper concludes by presenting ideas about when soft power can be fairly employed between high-income-country and low- and middle-income-country partners and what fair compromise agreements may look like in shared decision-making.     

Clinical research law in Jordan: an ethical analysis

An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research injuries and a system of fines and punishments for noncompliance with the Law. There are, however, some key items missing in the Jordanian Law. For example, the Law does not mention the requirement of a favourable assessment of risks and benefits, the fair selection of subjects, or articles regarding the protection of the rights and welfare of children and other vulnerable subjects participating in research. The paper concludes with the suggestion that new amendments should be considered for future revisions of the Clinical Research Law in Jordan.     

International ethical regulations on placebo-use in clinical trials: a comparative analysis

The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo-use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the conditions justifying placebo-use according to each guideline are the focus of our attention. We will first propose a formalized general principle that defines the ethical acceptability of placebo-use. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow the participants in clinical trials to be exposed to a risk of serious harm, while others do not. Finally, we try to show how the normative difference of each guideline could influence the decision of researchers or IRBs concerning the ethical acceptability of placebo-use.     

Reflections on clinical research in sub-Saharan Africa

The urgent need for new, safe and sustainable interventions against diseases that disproportionally affect the poor is finally receiving global attention and the funding landscape for development projects has significantly improved during the past decade. For the development of new drug and vaccine candidates, clinical trials have become the most important tool to assess their safety and efficacy. Recently, there has been a seismic shift in the number of clinical trials conducted in resource-limited settings. We discuss the current framework of clinical research in sub-Saharan Africa, from building product pipelines to the capacities needed for the conduct of trials according the harmonised Good Clinical Practice (GCP) ICH E6 guideline. We place emphasis on clinical research in neglected tropical diseases which still frequently has to be conducted with limited financial, logistical and human resources. Given those short-comings we recommend minimum standards needed at the local, national and sponsor levels to provide GCP-compliant clinical research.     

Conducting Research with Human Subjects in International Settings: Ethical Considerations

Biomedical research in international settings is undergoing expansive growth andmay potentially result in far-reaching benefits, such as direction of researchresources toward solving basic health care needs of world populations. However,key ethical concerns surround this expansion and must be carefully considered byinternational researchers. International research is impacted by differences inlanguage, culture, regulatory structures, financial resources, and possiblyethical standards. Local community leadership involvement in the planning stagesof research is imperative. Especially in resource-poor countries, the researchagenda must be designed to address local needs and provide local benefit.Capacity strengthening efforts, aimed at improving institutional support forethical conduct of human subjects research, must continue to be supported bywealthier nations.     

国家自然科学基金资助的生物入侵基础研究概况

基于1999~2010年国家自然科学基金资助项目,分析了我国生物入侵基础研究概况。在这期间,生物入侵领域得到资助的项目数和经费均呈现快速上升的趋势,资助的项目从1999年的3个增加到2010年的69个,资助的经费从1999年的94万元增加到2010年的1838万元。得到资助的项目数在不同学科的分布不均匀,其中,植物保护学科得到资助的项目数为123个,生态学科得到资助的项目数为82个,这2个学科得到资助的项目数占总项目数的67.9%,得到资助的经费占总经费的66.3%。资助项目的主要研究内容涉及22种入侵植物病原微生物、26种入侵动物和24种入侵植物,从中可以透视本领域的研究重点。资助的项目主要集中在华北、华东和华南地区的国家级科研机构和高等院校,这种区域分布格局与我国入侵生物的地理分布格局相吻合。为了进一步推动国家自然科学基金对生物入侵领域各项工作的资助,本文提出了一些合理化的建议。     

Challenges faced by research ethics committees in El Salvador: results from a focus group study

Objective:  To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building.
Methods:  Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed.
Results:  Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight.
Conclusions:  Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research.     

Ethical Issues in the Use of Data from Testing of Human Subjects to Support Risk Assessment

The public understands and supports the ethical use of human subjects in medical research, recognizing the unique role for this type of study in the development of new drugs and therapeutic strategies for treatment of disease. The use of data from human subjects can also be of value in understanding the circumstances under which individuals exposed to chemicals in the food supply, in the workplace, or in the environment might experience toxicity, i.e., in support of risk assessment. However, questions have been raised as to whether this latter type of research is ethical, or can be performed in an ethical manner. Under what circumstances is it acceptable to intentionally expose human subjects to potentially toxic agents? This is an extremely important issue for the risk assessment community to address, because it affects in a fundamental way the types of information that will be available to conduct human health risk assessments. Four papers in this issue offer viewpoints on the value of human data, the circumstances under which human subjects might be exposed to toxic chemicals for research purposes, the ethical problems associated with this research, and the role of human vs. animal data in the development of toxicity values for human health risk assessment