What risks should be permissible in controlled human infection model studies?

Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible risks according to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies.     

Use of primates in research: a global overview

We assessed the use of nonhuman primates and nonhuman primate biological material in research by reviewing studies published in 2001 in peer-reviewed journals. The number and species of primates used, the origin of the animals, the type of study, the area of research of the investigation, and the location at which the research was performed were tabulated. Additionally, factors related to the animals that may have affected the outcome of the experiments were recorded. A total of 2,937 articles involving 4,411 studies that employed nonhuman primates or nonhuman primate biological material were identified and analyzed. More than 41,000 animals were represented in the studies published in 2001. In the 14% of studies for which re-use could be determined, 69% involved animals that had been used in previous experiments. Published studies most commonly used nonhuman primates or nonhuman primate biological material from the species Chlorocebus aethiops (19%), Macaca mulatta (18%), M. fascicularis (9%), and Papio spp. (6%). Of these studies, 54% were classified as in vitro studies, 14% as noninvasive, 30% as chronic, and 1% were considered acute. Nonhuman primates were primarily used in research areas in which they appear to be the most appropriate models for humans. The most common areas of research were microbiology (including HIV/AIDS (26%)), neuroscience (19%), and biochemistry/chemistry (12%). Most (84%) of the primate research published in 2001 was conducted in North America, Europe, and Japan. The animals and conditions under which they were housed and used were rarely described. Although it is estimated that nonhuman primates account for an extremely small fraction of all animals used in research, their special status makes it important to report the many husbandry and environmental factors that influence the research results generated. This analysis has identified that editors rarely require authors to provide comprehensive information concerning the subjects (e.g., their origin), treatment conditions, and experimental procedures utilized in the studies they publish. The present analysis addresses the use of primates for research, including the effects of a shortage of suitable nonhuman primate subjects in many research areas.     

基于Web of Science的国际应用生态学研究进展

应用生态学是自然资源管理和生态环境保护最重要的科学技术工具之一.在当前自然资源短缺、环境污染严重、生态系统退化的严峻形势下,对国际应用生态学的理论基础、研究方法、研究热点进行分析,对夯实我国应用生态学的知识基础、指明研究方向、确定战略定位具有重要意义.本文基于文献计量学原理,借助CiteSpace、Carrot²等信息可视化软件,以Web of Science中1980—2018年国际应用生态学研究领域基于不同检索策略的两个文献数据集合为研究对象,从研究载体、研究力量及研究内容3个维度进行文献时空分布、核心研究力量、研究热点演进以及研究前沿及趋势分析,旨在揭示其学科发展轨迹、研究现状与发展趋势,以期为未来我国的应用生态学研究提供参考.     

Methods for testing hypotheses across studies: applications for teratologists and toxicologists

Methods are presented for analyzing research results across independent studies. These techniques allow researchers to test hypotheses across studies using multiple investigations as data points. The procedures and rationale are developed for purposes of research synthesis and interpretation in teratology and toxicology.     

土壤真菌研究进展

综述了土壤真菌的研究简史、研究方法的发展、多样性和现代真菌分类技术在土壤真菌研究中的应用和发展等。     

Radiation Protection in Canada: Part V. Radiobiological and Radiological Health Research in Canada

A recent survey was carried out with respect to radiobiological and radiological health projects in Canada. Letters of inquiry, followed by two questionnaires, were sent out to every institution where radiation research was likely to have been undertaken. Approximately 75% of those contacted replied. Of the total of 200 studies, 84% were classified as biological and medical studies, the remaining 16% as environmental radiation studies. Responses to the inquiry stressed the inadequacy of the present governmental budget for radiation research, the need for higher salaries for research workers, and the necessity of a more intensive teaching program for technicians and professional personnel. The granting of longer-term grants, rather than annually renewable grants, is urged.     

全球长期城市生态研究中的社会经济要素:指标、数据与应用前景

社会经济要素作为城市生态系统的重要组成部分,能够反映居民特征、衡量居民福祉,是城市生态研究中不可或缺的内容。然而,在城市生态研究中合理、有效利用社会经济要素的规范和框架尚未得到充分研究。城市生态研究中常用的社会经济指标包括哪些？社会经济指标的常见数据源有哪些？社会经济要素可协助回答哪些方面的科学问题？为回答上述问题,本文综述了全球范围内11个长期城市生态研究站点开展的系统性调查和案例研究,总结社会经济指标的内容、数据来源,以及这些研究的议题。结果表明：常用社会经济指标可分为人口基本信息、认知和意愿、行为三类,前两者在城市生态研究中的应用已较为普遍。数据的主要来源包括政府部门提供的统计资料或普查数据、商业数据,以及研究人员开展的独立调查。在城市生态研究中纳入社会经济要素有助于分析社会与环境的相互关系,进而揭示城市系统中人与自然的耦合效应。近年来,我国城市生态研究快速发展,但研究中欠缺对社会经济要素的考虑与利用,可能会逐渐偏离国际上城市生态学的主流研究方向。社会经济数据获取困难是当前研究者面临的重大挑战,同时也存在一些机遇能够促进我国城市生态研究纳入社会经济要素,例如利用新兴数据和大数据手段、构建统一的指标框架和数据共享机制,以及充分了解和利用政府公开的统计数据。     

‘It is an entrustment’: Broad consent for genomic research and biobanks in sub‐Saharan Africa

In recent years, there has been an increase in the establishment of biobanks for genetic and genomic studies around the globe. One example of this is the Human Heredity and Health in Africa Initiative (H3Africa), which has established biobanks in the sub‐region to facilitate future indigenous genomic studies. The concept of ‘broad consent’ has been proposed as a mechanism to enable potential research participants in biobanks to give permission for their samples to be used in future research studies. However, questions remain about the acceptability of this model of consent. Drawing on findings from empirical research about the role of trust in decision‐making, we argue that an account of entrustment may be an appropriate way of addressing current challenges of seeking consent for biobank research in Africa. We propose a set of key points to consider that can support the proposed entrustment framework.     

紫黑米种质功能成分综合研究与利用

紫黑米富含花青素、黄酮、多酚等功能成分,着重介绍了花青素等功能成分的含量差异及其影响因素、功能研究、基于代谢机理与育种及食品加工工艺的功能成分强化研究、功能成分的利用及提取工艺等领域的研究进展。针对国内外紫黑米功能成分综合研究利用进展,提出紫黑米的育种利用、食品保健、医药研发和分子机理研究及其新型功能食品研制与产业化对策,以期为紫黑米相关研究提供参考。     

Gynaecological cancers and their cell lines

Cell lines are widely used for various research purposes including cancer and drug research. Recently, there have been studies that pointed to discrepancies in the literature and usage of cell lines. That is why we have prepared a comprehensive overview of the most common gynaecological cancer cell lines, their literature, a list of currently available cell lines, and new findings compared with the original studies. A literature review was conducted via MEDLINE, PubMed and ScienceDirect for reviews in the last 5 years to identify research and other studies related to gynaecological cancer cell lines. We present an overview of the current literature with reference to the original studies and pointed to certain inconsistencies in the literature. The adherence to culturing rulesets and the international guidelines helps in minimizing replication failure between institutions. Evidence from the latest research suggests that despite certain drawbacks, variations of cancer cell lines can also be useful in regard to a more diverse genomic landscape.     

Why is it crucial to reintegrate pathology into cancer research?

The integration of pathology with molecular biology is vital if we are to enhance the translational value of cancer research. Pathology represents a bridge between medicine and basic biology, it remains the gold standard for cancer diagnosis, and it plays an important role in discovery studies. In the past, pathology and cancer research were closely associated; however, the molecular biology revolution has shifted the focus of investigators toward the molecular alterations of tumors. The reductionist approach taken in molecular studies is producing great insight into the inner workings of neoplasia, but it can also minimize the importance of histopathology and of understanding the disease as a whole. In turn, pathologists can underestimate the role of molecular studies in developing new ancillary techniques for clinical diagnosis. A multidisciplinary approach that integrates pathology and molecular biology within a translational research system is needed. This process will require overcoming cultural barriers and can be achieved through education, a more effective incorporation of pathology into biological research, and conversely an integration of biological research into the pathology laboratory.     

基于文献计量的牡蛎礁研究现状与热点分析

牡蛎礁作为重要的海岸带生态系统,具备水质净化、提供栖息地等多种生态系统服务功能。为了解国内外牡蛎礁研究的现状与热点,分别以Web of Science 核心合集数据库和中国期刊全文数据库为数据源,通过国内外发文趋势分析、高频关键词分析、关键词共现和聚类分析及主题时间演变分析等,分析牡蛎礁研究热点与趋势。研究结果表明：（1）国际与国内牡蛎礁研究发文量总体呈现上升趋势,但国内研究增长速率低于国际研究;（2）牡蛎礁生态恢复研究是国内外研究的共同关注点,但国内相关研究起步较晚;（3）以外,国际上对牡蛎礁的研究更加关注生态系统服务功能、气候变化等,而国内主要倾向于从地质学角度进行研究;（4）近年来,气候变化成为国际牡蛎礁研究新的热点,但国内对此关注较少。本研究将为了解当前国内外牡蛎礁研究现状及发展态势提供借鉴,并为我国牡蛎礁保护与修复方面的政策制定、科学研究等工作的开展提供情报参考。     

Judging the social value of controlled human infection studies

In controlled human infection (CHI) studies, investigators deliberately infect healthy individuals with pathogens in order to study mechanisms of disease or obtain preliminary efficacy data on investigational vaccines and medicines. CHI studies offer a fast and cost-effective way of generating new scientific insights, prioritizing investigational products for clinical testing, and reducing the risk that large numbers of people are exposed to ineffective or harmful substances in research or in practice. Yet depending on the pathogen, CHI studies can involve significant risks or burdens for participants, pose risks to individuals or communities not involved in the research, and lead to public controversy. It is therefore essential to ensure that the risks of CHI studies are justified by their social value—that is, their potential to generate benefits for society—and that public trust can be maintained. In this paper, we aim to clarify how research sponsors, research ethics committees and other reviewers should judge the social value of CHI studies. We develop a list of relevant considerations for making social value judgments based on the standard view of social value. We then use this list to discuss the example of potentially conducting dengue virus CHI studies in endemic settings. We argue that dengue virus CHI studies in endemic settings would fall on the higher end of the spectrum of social value, mostly because of their potential to redirect all fields of future dengue research. Drawing on this discussion, we derive several general recommendations for how reviewers should judge the social value of CHI studies.     

Reexamining the categorical exclusion of pediatric participants from controlled human infection trials

Controlled human infection (CHI) models have been developed for numerous pathogens in order to better understand disease processes and accelerate drug and vaccine testing. In the past, some researchers conducted highly controversial CHIs with vulnerable populations, including children. Ethical frameworks for CHIs now recommend vulnerable populations be excluded because they cannot consent to high risk research. In this paper we argue that CHI studies span a wide spectrum of benefit and risk, and that some CHI studies may involve minimal risk. The categorical exclusion of children from CHIs therefore departs from the standard approach to evaluating research risks, as international regulations and ethical guidance for pediatric research generally permit non-beneficial research with low risks. The paradigm in research ethics has also shifted from focusing on protecting vulnerable participants to recognizing that inclusion can be important as a matter of justice, providing new reasons to question this default exclusion of children from CHIs. Recognizing that pediatric CHIs can raise complex ethical issues and are easy to sensationalize in ways that may threaten the public’s trust in research and sponsor institutions, we conclude by describing additional complexities that must be addressed before pediatric CHIs beyond licensed vaccine studies might be ethically acceptable.     

Research on animal-assisted intervention and autism spectrum disorder, 2012–2015

Including animals in autism intervention is growing in both research and practice. A systematic literature review was conducted to collate and synthesize all empirical research on animal-assisted intervention (AAI) for autism published from 2012 to 2015. Findings from 28 included studies revealed that AAI programs generally include one animal per participant with a total contact time of approximately 10 hours over the course of 8 to 12 weeks. Research methodology is diverse and though limited in many cases, has improved over the last few years. The most commonly reported outcome was increased social interaction, which was unanimously significant across 22 studies. The need for further research is highlighted, calling for a focus on refining AAI techniques, identifying optimal circumstances for positive change as well as individuals who may not benefit, and independent replication of high quality studies to move AAI from an enrichment activity to an evidence-based practice for autism.     

Research on Children's Environmental Programmatic Efforts Pertaining to Fatherhood

Programmatic initiatives for fathers have grown rapidly in early childhood settings during the past decade. This article reviews the research literature on attitudes about father involvement in programs, patterns of father involvement, studies about program development, outcome studies, and correlates of father involvement in programs. Recommendations for future research on fatherhood initiatives and the relevance of research for programs and policy are also discussed.     

Species,Habitats, Society: An Evaluation of Research Supporting EU's Natura 2000 Network

The Natura 2000 network is regarded as one of the conservation success stories in the global effort to protect biodiversity. However, significant challenges remain in Natura 2000 implementation, owing to its rapid expansion, and lack of a coherent vision for its future. Scientific research is critical for identifying conservation priorities, setting management goals, and reconciling biodiversity protection and society in the complex political European landscape. Thus, there is an urgent need for a comprehensive evaluation of published Natura 2000 research to highlight prevalent research themes, disciplinary approaches, and spatial entities. We conducted a systematic review of 572 scientific articles and conference proceedings focused on Natura 2000 research, published between 1996 and 2014. We grouped these articles into ‘ecological’ and ‘social and policy’ categories. Using a novel application of network analysis of article keywords, we found that Natura 2000 research forms a cohesive small-world network, owing to the emphasis on ecological research (79% of studies, with a strong focus on spatial conservation planning), and the underrepresentation of studies addressing ‘social and policy’ issues (typically focused on environmental impact assessment, multi-level governance, agri-environment policy, and ecosystem services valuation). ‘Ecological’ and ‘social and policy’ research shared only general concepts (e.g., Natura 2000, Habitats Directive) suggesting a disconnection between these disciplines. The UK and the Mediterranean basin countries dominated Natura 2000 research, and there was a weak correlation between number of studies and proportion of national territory protected. Approximately 40% of ‘social and policy’ research and 26% of ‘ecological’ studies highlighted negative implications of Natura 2000, while 21% of studies found positive social and biodiversity effects. We emphasize the need for designing inter- and transdisciplinary research in order to promote a social-ecological understanding of Natura 2000, and advance EU conservation policies.     

Chimpanzees in AIDS research: A biomedical and bioethical perspective

The present article represents a consensus view of the appropriate utilization of chimpanzees in AIDS research arrived at as a result of a meeting of a group of scientists involved in AIDS research with chimpanzees and bioethicists. The paper considers which types of studies are scientifically justifiable in this species, the conditions under which such studies should be carried out, and the conditions which should be encouraged for post-experimental retirement of these animals.     

Improving design and analysis of research: lessons from clinical research

There is a clear need to optimise the use of animals in research and to ensure that the studies that are done make a worthwhile contribution to scientific knowledge. Research that has an inappropriate study design, or is improperly analysed or interpreted, may mislead and is not defensible. Published reviews of the quality of design and analysis in clinical studies are used to see what lessons can be drawn in respect of animal research. The need for clear and full reporting of research is discussed.     

Chimpanzees in AIDS research: A biomedical and bioethical perspective

The present article represents a consensus view of the appropriate utilization of chimpanzees in AIDS research arrived at as a result of a meeting of a group of scientists involved in AIDS research with chimpanzees and bioethicists. The paper considers which types of studies are scientifically justifiable in this species, the conditions under which such studies should be carried out, and the conditions which should be encouraged for post-experimental retirement of these animals.