美国生命科学两用性研究监管政策分析

目的:近年来高致病性禽流感H5N1病毒基因改造研究及美国国家生物安全科学咨询委员会的监管建议引起广泛争议,美国发布了生命科学两用性研究监管政策。本研究旨在通过对美国生命科学两用性研究监管政策进行分析,探讨两用性研究发展和监管趋势。方法:通过文献检索,获取生命科学两用性研究监管政策相关的情报源,对美国政府生命科学两用性研究监管的政策背景、主要内容、政策评论、政策动因进行系统梳理与分析。结果:美国政府出台的生命科学两用性研究监管政策,有助于美国对整个生命科学研究周期(从最初提交资助申请到研究结论和研究成果交流)潜在的误用风险进行管理。结论:美国生命科学两用性研究引发极大争议,两用性研究监管主要依靠生命科学团体的自我管理,政策具有指导性而非强制性。     

Taking the "I" out of IRB--and putting "community" in

If one looks back on the history of American research ethics, a bold pattern emerges. Since World War II, about every twenty years or so a breach of the social contract between investigators and human research subjects galvanizes public and professional interest in the ethical foundations and oversight mechanisms governing research with humans.     

Survey of environmental enhancement programs for laboratory primates

Animal welfare regulations in the United States require that nonhuman primate environmental enhancement plans be made in accordance with currently accepted professional standards; however, little information is available for quantifying common practice. Here we report the results of a 2003 survey that was sent to individuals overseeing enrichment programs at a variety of primate research institutions. The surveys requested information on program administration and management, implementation standards, procedures, and constraints pertaining to major categories of environmental enrichment, as well as intervention plans for animals exhibiting behavioral pathologies. Data were obtained on the management of 35,863 primates in 22 facilities. Behavioral scientists performed program oversight at the majority of facilities. Most programs reported recent changes, most commonly due to external site visits, and least commonly resulting from internal review. Most facilities' institutional animal care and use committees (IACUCs) included of individuals with behavioral expertise, and about two-thirds reported that enrichment issues could influence research protocol design. While most primates were reported to be housed socially (73%), social housing for indoor-housed primates appears to have changed little over the past 10 years. Research protocol issues and social incompatibility were commonly cited constraints. Implementation of feeding, manipulanda, and structural enrichment was relatively unconstrained, and contributions to these aspects of behavioral management generally included individuals in a wide variety of positions within a facility. In contrast, enrichment devices were used on a less widespread basis within facilities, and positive reinforcement programs that involved dedicated trainers were rare. We suggest that altering the role of the IACUC would be a productive avenue for increasing the implementation of social housing, and that an emphasis on prevention rather than intervention against behavioral pathology is warranted. The data from this survey may be useful for anticipating future program evaluations, establishing more effective internal evaluations, and assessing program progress and resource allocation.     

Post-Approval Monitoring and Oversight of U.S.-Initiated Human Subjects Research in Resource-Constrained Countries

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide.     

Pharmacogenetics: the bioethical problem of DNA investment banking

Concern about the ethics of clinical drug trials research on patients and healthy volunteers has been the subject of significant ethical analysis and policy development--protocols are reviewed by Research Ethics Committees and subjects are protected by informed consent procedures. More recently attention has begun to be focused on DNA banking for clinical and pharmacogenetics research. It is, however, surprising how little attention has been paid to the commercial nature of such research, or the unique issues that present when subjects are asked to consent to the storage of biological samples. Our contention is that in the context of pharmacogenetic add-on studies to clinical drug trials, the doctrine of informed consent fails to cover the broader range of social and ethical issues. Applying a sociological perspective, we foreground issues of patient/subject participation or 'work', the ambiguity of research subject altruism, and the divided loyalties facing many physicians conducting clinical research. By demonstrating the complexity of patient and physician involvement in clinical drug trials, we argue for more comprehensive ethical review and oversight that moves beyond reliance on informed consent to incorporate understandings of the social, political and cultural elements that underpin the diversity of ethical issues arising in the research context.     

Research in nondomestic species: experiences in reproductive physiology research for conservation of endangered felids

Tremendous strides have been made in recent years to broaden our understanding of reproductive processes in nondomestic felid species and further our capacity to use this basic knowledge to control and manipulate reproduction of endangered cats. Much of that progress has culminated from detailed scientific studies conducted in nontraditional laboratory settings, frequently at collaborating zoological parks but also under more primitive conditions, including in the field. A mobile laboratory approach is described, which incorporates a diverse array of disciplines and research techniques. This approach has been extremely useful, especially for conducting gamete characterization and function studies as well as reproductive surveys, and for facilitating the development of assisted reproductive technology. With continuing advances in assisted reproduction in rare felids, more procedures are being conducted primarily as service-related activities, targeted to increase effectiveness of species propagation and population management. It can be a challenge for both investigators and institutional animal care and use committees (IACUCs) to differentiate these service-based procedures from traditional research studies (that require IACUC oversight). For research with rare cat species, multi-institutional collaboration frequently is necessary to gain access to scientifically meaningful numbers of study subjects. Similarly, for service-based efforts, the ability to perform reproductive procedures across institutions under nonstandard laboratory conditions is critical to applying reproductive sciences for managing and preserving threatened cat populations. Reproductive sciences can most effectively assist population management programs (e.g., Species Survival Plans) in addressing conservation priorities if these research and service-related procedures can be conducted "on the road" at distant national and international locales. This mobile laboratory approach has applications beyond endangered species research, notably for other scientific fields (e.g., studies of hereditary disease in domestic cat models) in which bringing the laboratory to the subject is of value.     

Consistent behavioral phenotype differences between inbred mouse strains in the IntelliCage

The between‐laboratory effects on behavioral phenotypes and spatial learning performance of three strains of laboratory mice known for divergent behavioral phenotypes were evaluated in a fully balanced and synchronized study using a completely automated behavioral phenotyping device (IntelliCage). Activity pattern and spatial conditioning performance differed consistently between strains, i.e. exhibited no interaction with the between‐laboratory factor, whereas the gross laboratory effect showed up significantly in the majority of measures. It is argued that overall differences between laboratories may not realistically be preventable, as subtle differences in animal housing and treatment will not be controllable, in practice. However, consistency of strain (or treatment) effects appears to be far more important in behavioral and brain sciences than the absolute overall level of such measures. In this respect, basic behavioral and learning measures proved to be highly consistent in the IntelliCage, therefore providing a valid basis for meaningful research hypothesis testing. Also, potential heterogeneity of behavioral status because of environmental and social enrichment has no detectable negative effect on the consistency of strain effects. We suggest that the absence of human interference during behavioral testing is the most prominent advantage of the IntelliCage and suspect that this is likely responsible for the between‐laboratory consistency of findings, although we are aware that this ultimately needs direct testing.     

Culture,biology, and human behavior

Social scientists have not integrated relevant knowledge from the biological sciences into their explanations of human behavior. This failure is due to a longstanding antireductionistic bias against the natural sciences, which follows on a commitment to the view that social facts must be explained by social laws. This belief has led many social scientists into the error of reifying abstract analytical constructs into entities that possess powers of agency. It has also led to a false nature-culture dichotomy that effectively undermines the place of biology in social scientific explanation. Following the principles of methodological individualism, we show how behavioral explanations supported by data and theory from the neurosciences can be used to correct the errors of reificationist thinking in the social sciences. We outline a mechanistic approach to the explanation of human behavior with the hope that the biological sciences will begin to find greater acceptance among social scientists.     

Preventing biological weapon development through the governance of life science research

The dual-use dilemma in the life sciences-that illicit applications draw on the same science and technology base as legitimate applications-makes it inherently difficult to control one without inhibiting the other. Since before the September 11 attacks, the science and security communities in the United States have struggled to develop governance processes that can simultaneously minimize the risk of misuse of the life sciences, promote their beneficial applications, and protect the public trust. What has become clear over that time is that while procedural steps can be specified for assessing and managing dual-use risks in the review of research proposals, oversight of ongoing research, and communication of research results, the actions or decisions to be taken at each of these steps to mitigate dual-use risk defy codification. Yet the stakes are too high to do nothing, or to be seen as doing nothing. The U.S. government should therefore adopt an oversight framework largely along the lines recommended by the National Science Advisory Board for Biosecurity almost 5 years ago-one that builds on existing processes, can gain buy-in from the scientific community, and can be implemented at modest cost (both direct and opportunity), while providing assurance that a considered and independent examination of dual-use risks is being applied. Without extraordinary visibility into the actions of those who would misuse biology, it may be impossible to know how well such an oversight system will actually succeed at mitigating misuse. But maintaining the public trust will require a system to be established in which reasonably foreseeable dual-use consequences of life science research are anticipated, evaluated, and addressed.     

Stem cell politics, ethics and medical progress

Tremendous controversy has surrounded efforts to undertake research on totipotent human stem cells. To date public policy in the United States has attempted to skirt the ethical and social questions raised by this research. Annas et al. argue that research using human embryos as a source of totipotent stem cells can secure broad public support if there is an open and public discussion about the ethical justification for undertaking such research and the assurance of adequate federal regulation and oversight.     

Ethical Review of Research on Human Subjects at Unilever: Reflections on Governance

This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research.     

Co-evolution of physical and social sciences in synthetic biology

Emerging technologies research often covers various perspectives in disciplines and research areas ranging from hard sciences, engineering, policymaking, and sociology. However, the interrelationship between these different disciplinary domains, particularly the physical and social sciences, often occurs many years after a technology has matured and moved towards commercialization. Synthetic biology may serve an exception to this idea, where, since 2000, the physical and the social sciences communities have increasingly framed their research in response to various perspectives in biological engineering, risk assessment needs, governance challenges, and the social implications that the technology may incur. This paper reviews a broad collection of synthetic biology literature from 2000–2016, and demonstrates how the co-development of physical and social science communities has grown throughout synthetic biology’s earliest stages of development. Further, this paper indicates that future co-development of synthetic biology scholarship will assist with significant challenges of the technology’s risk assessment, governance, and public engagement needs, where an interdisciplinary approach is necessary to foster sustainable, risk-informed, and societally beneficial technological advances moving forward.     

Neither Adaptive Thinking nor Reverse Engineering: methods in the evolutionary social sciences

In this paper I argue the best examples of the methods in the evolutionary social sciences don’t actually resemble either of the two methods called “Adaptive Thinking” or “Reverse Engineering” described by evolutionary psychologists. Both AT and RE have significant problems. Instead, the best adaptationist work in the ESSs seems to be based on and is aiming at a different method that avoids the problems of AT and RE: it is a behavioral level method that starts with information about both the trait in question and knowledge of the EEA. I describe some examples from the literature, and suggest how a behavioral level ESS might still contribute to the discovery and understanding of human psychology. Finally, I describe some remaining problems for adaptationist reasoning of this kind.     

Bystanders and ethical review of research: Proceed with caution

Scientists seeking to conduct research with human subjects must first submit their proposals to research ethics committees (Institutional Review Boards [IRBs], in the United States). Some of these studies pose risks to “bystanders,” i.e., people who may be affected by the research but who are not enrolled as study subjects. Should IRBs expand their scope to include oversight over possible harms to bystanders as well as research subjects? This paper presents arguments against this step. Prior review of research with human subjects, despite its evident burden on the research enterprise, is a necessary caution, because the tension between the objectives of humane treatment of research subjects and sound scientific design and procedure has in the past led to serious abuses. This rationale is inapplicable in the case of bystanders. Moreover, in view of the many and varied effects of both research practices and scientific advances on the broader public over time, those who may be considered to be “bystanders” may potentially expand without limit; requiring IRBs to anticipate these distant and long-term effects as part of prior ethical review could greatly increase its burden and its deterrent effect on research. While conducting research without concern for serious potential harm to bystanders may be irresponsible and unethical, expanding the scope of prior review by IRBs to include risks to bystanders is not required by the principles governing human subjects research, and the costs and burdens of this expansion may outweigh any expected gains.     

Individual acquisition of “stick pounding” behavior by naïve chimpanzees

Many studies investigating culture in nonhuman animals tend to focus on the inferred need of social learning mechanisms that transmit the form of a behavior to explain the population differences observed in wild animal behavioral repertoires. This research focus often results in studies overlooking the possibility of individuals being able to develop behavioral forms without requiring social learning. The disregard of individual learning abilities is most clearly observed in the nonhuman great ape literature, where there is a persistent claim that chimpanzee behaviors, in particular, require various forms of social learning mechanisms. These special social learning abilities have been argued to explain the acquisition of the relatively large behavioral repertoires observed across chimpanzee populations. However, current evidence suggests that although low‐fidelity social learning plays a role in harmonizing and stabilizing the frequency of behaviors within chimpanzee populations, some (if not all) of the forms that chimpanzee behaviors take may develop independently of social learning. If so, they would be latent solutions—behavioral forms that can (re‐)emerge even in the absence of observational opportunities, via individual (re)innovations. Through a combination of individual and low‐fidelity social learning, the population‐wide patterns of behaviors observed in great ape species are then established and stably maintained. This is the Zone of Latent Solutions (ZLS) hypothesis. The current study experimentally tested the ZLS hypothesis for pestle pounding, a wild chimpanzee behavior. We tested the reinnovation of this behavior in semi‐wild chimpanzees at Chimfunshi Wildlife Orphanage in Zambia, Africa, (N = 90, tested in four social groups). Crucially, all subjects were naïve to stick pounding before testing. Three out of the four tested groups reinnovated stick pounding—clearly demonstrating that this behavioral form does not require social learning. These findings provide support for the ZLS hypothesis alongside further evidence for the individual learning abilities of chimpanzees.     

Predicting Survey Responses: How and Why Semantics Shape Survey Statistics on Organizational Behaviour

Some disciplines in the social sciences rely heavily on collecting survey responses to detect empirical relationships among variables. We explored whether these relationships were a priori predictable from the semantic properties of the survey items, using language processing algorithms which are now available as new research methods. Language processing algorithms were used to calculate the semantic similarity among all items in state-of-the-art surveys from Organisational Behaviour research. These surveys covered areas such as transformational leadership, work motivation and work outcomes. This information was used to explain and predict the response patterns from real subjects. Semantic algorithms explained 60–86% of the variance in the response patterns and allowed remarkably precise prediction of survey responses from humans, except in a personality test. Even the relationships between independent and their purported dependent variables were accurately predicted. This raises concern about the empirical nature of data collected through some surveys if results are already given a priori through the way subjects are being asked. Survey response patterns seem heavily determined by semantics. Language algorithms may suggest these prior to administering a survey. This study suggests that semantic algorithms are becoming new tools for the social sciences, opening perspectives on survey responses that prevalent psychometric theory cannot explain.     

Rethinking the oversight conditions of human–animal chimera research

New discoveries are improving the odds of human cells surviving in host animals, prompting regulatory and funding agencies to issue calls for additional layers of ethical oversight for certain types of human–animal chimeras. Of interest are research proposals involving chimeric animals with humanized brains. But what is motivating the demand for additional oversight? I locate two, not obviously compatible, motivations, each of which provides the justificatory basis for paying special attention to different sets of human–animal chimeras. Surprisingly, the sets of animals that actually get flagged for special scrutiny by research and funding guidelines do not correlate with either of the sets of animals that arise when we think about what is motivating additional oversight. What this shows is that existing research policies and funding guidelines are disconnected from their motivation: the rationale for flagging certain types of human–animal chimeras as requiring special oversight is ignored in execution.     

我国生物多样性保护自然-社会科学交叉融合与发展

保护科学前沿研究重视克服单一学科的局限而向超越自然科学和社会科学跨学科交叉融合转型。基于世界自然保护联盟-世界保护区委员会(IUCN-WCPA)自然保护地管理有效性框架,从规划制定、执行和评估三个方面系统梳理了我国保护科学的研究进展,分析了保护自然科学和社会科学在研究内容、方法和视角等方面的差异,识别出潜在的跨学科综合研究领域。结果表明,我国保护自然科学与社会科学研究大多相互独立、缺乏融合协作,少有的跨学科研究在整体性、系统性、兼容性、深入性和规范性上有待提高。自然科学家在介入社会科学研究时缺乏对现实制度的科学理解,所提出的保护政策和行动建议偏向理想主义,阻碍保护科学跨学科知识生产;社会科学家则缺乏自然科学方法和数据的知识积累,所提出的政策和行动建议脱离事实和证据,偏向主观主义,不利于保护科学知识进步。为此,构建了基于自然保护地适应性管理逻辑下的保护科学跨学科整合框架,以推动保护科学共同话语的形成,实现社会与生态的耦合协调发展。     

Evolutionary Psychology��s Place in Evolutionary Studies: a Tale of Promise and Challenge

The Evolutionary Studies (EvoS) Consortium and the academic programs born from its creation have been wildly successful in their initial ventures. These achievements are marked by feedback from across the EvoS campuses, the resultant scholarly work produced by participating students, and faculty collaborations spurred by exposure to the organization. The success of EvoS is probably best marked by the recent National Science Foundation grant (CCLI Award #0817337), awarded jointly to SUNY New Paltz and Binghamton University, with the purpose of expanding EvoS beyond the bounds of these two institutions. A particularly noteworthy element of many EvoS programs is the role of Evolutionary Psychology (EP), a perspective in the behavioral sciences that addresses questions of human behavior from the perspective of evolution. In light of several forms of data, including analyses of a variety of disciplines drawn on from evolutionary psychologists in their work, we argue that evolutionary psychologists may well be the most naturally interdisciplinary scholars within the behavioral sciences, making them highly appropriate for inclusion in EvoS. But our research shows not only promise regarding the relationship between EP and EvoS—challenges are raised as well. We present additional data showing that EP is currently represented disproportionately within the EvoS world—a fact that clearly shows that there are currently limitations to the potential impact of EvoS in modern academia. Scholars from other disciplines, particularly within the humanities and social sciences, seem to be missing the evolution revolution. Implications regarding how EvoS can broaden its scope to be even more powerful in its integrative scope are discussed.     

Deciding what to observe: Thoughts for a post-WEIRD generation

The evolutionary social sciences (ESSs) are thriving, and seem to have entered a period of normal science. This is a good time to examine our own practices, theoretical and empirical, and to ask how we might improve. Here I review papers published in the past five years in EHB to explore major trends in the field. Theoretically, the popularity of certain topics (cooperation, mating, life history) has led to great progress, but might have narrowed our theoretical vision. Empirically, most research is still conducted in WEIRD populations, with a smaller mode of research in small-scale societies, and very little in the middle. I offer suggestions for broadening our theoretical and empirical scope, centered around the project of constructing a representative map of the human psychological and behavioral phenome.