The inauguration of Michigan’s BioTrust for Health, a research biobank for leftover neonatal blood spots, posed several novel questions for the state’s Department of Community Health institutional review board. The IRB’s response to these questions affirmed that respect for persons requires consent from donors for tissue donation to a public health biorepository with a research mission. It also acknowledged that the existence of potential risks and benefits to groups as well as to individuals necessitated new institutional collaborations between the IRB (...) and the appointed community oversight board for the BioTrust to foster consideration of the impacts on all stakeholders. (shrink)
Background: The banking of biological samples raises a number of ethical issues in relation to the storage,export and re-use of samples. Whilst there is a growing body of literature exploringparticipant perspectives in North America and Europe, hardly any studies have been reportedin Africa. This is problematic in particular in light of the growing amount of research takingplace in Africa, and with the rise of biobanking practices also on the African continent. Inorder to investigate the perspectives of African research participants, (...) we conducted a studywith research participants in a TB study in the Western Cape, South Africa. Methods: Semi-structured interviews were conducted using an interview guide which drew on the mostprominent themes expressed in current literature on sample storage, re-use and exportation.Interviews were conducted in Afrikaans and subsequently translated into English by the sameinterviewer. Interviews were transcribed verbatim and analysed qualitatively. Results: The results of our study indicate that the majority of participants were supportive of givingone-time consent to the storage and re-use of their samples. The concept of research being fora "good cause" was a central prerequisite. Additionally, a significant minority requested thatthey be re-contacted if a future use was not stipulated on the original consent. There was alsoconsiderable variation in how participants understood the concept of a 'good cause', withparticipants describing three distinct categories of research, of which two were generallythought to constitute 'good cause' research. Research that was for-profit was considered tofall outside the spectrum of 'good cause' research. Participants displayed confidence in theabilities of the researchers to make future decisions regarding sample use, but seemedunaware of the role of ethics committees in either this process or more generally. Conclusions: Participants expressed a wide and complex range of views about issues of sample storage andre-use, and they showed a great deal of trust in researchers. Participants' willingness to havetheir samples stored and re-used is consistent with findings from existing studies. However,in contrast to existing literature, participants were generally not in favour of for-profitresearch. Further research needs to be done to explore these ideas in other communities, bothin South Africa and other countries. (shrink)
The complexity of biobank research raises concerns about individuals’ understanding of the information conveyed in the consent process for such research.. We report the results of a qualitative, cognitive interview study with an ethnically, linguistically, and educationally diverse sample of 43 respondents to assess the clarity and utility of a multimedia tool developed for a biobank. Using weighted randomization, respondents were assigned to either view the multimedia tool or read a written consent document . The study illustrates the utility of (...) cognitive interviews for gaining insights from prospective research participants about the clarity of informed consent tools. Findings suggest that a multimedia tool is useful for communicating key messages but should be combined with a written consent document and personal interaction with the study staff. We recommend that the potential value of multimedia tools should be more rigorously tested in a randomized controlled trial. (shrink)
Erect posture and large brain are two of the most significant anatomical traits that distinguish us from nonhuman primates. But humans are also different from chimpanzees and other animals, and no less importantly, in their behavior, both as individuals and socially. Distinctive human behavioral attributes include tool-making and technology; abstract thinking, categorizing, and reasoning; symbolic (creative) language; self-awareness and death-awareness; science, literature, and art; legal codes, ethics and religion; complex social organization and political institutions. These traits may all be (...) said to be components of human culture, a distinctively human mode of adaptation to the environment that is far more versatile and successful than the biological mode. Cultural adaptation is more effective than biological adaptation because its innovations are directed, rather than random mutations; because it can be transmitted "horizontally", rather than only "vertically", to descendants; and because cultural heredity is Lamarckian, rather than Mendelian, so that acquired characteristics can be inherited. I explore ethics as a distinctive human trait. The question whether ethical behavior is biologically determined may refer either to the capacity for ethics (i.e., the proclivity to judge human actions as either right or wrong), or to the moral norms accepted by human beings for guiding their actions. I will propose: (1) that the capacity for ethics is a necessary attribute of human nature; and (2) that moral norms are products of cultural evolution, not of biological evolution. (shrink)
ABSTRACT: Biological prospecting is being undertaken in the Antarctic and, as novel material starts to yield significantly higher commercial rewards, the Antarctic Treaty Consultative Parties might decide to regulate it through the Antarctic Treaty System. This will be problematic since activities are already being undertaken, patents have been filed and products developed. Furthermore, there are differing perceptions of the status of the Antarctic, with some considering it global commons and others considering it the common heritage of mankind. These 2 (...) doctrines can be inferred from the rhetoric of the Treaty and its subsequent legal instruments through which human activities, including the use of resources, are managed. However, the Antarctic Treaty System does not support either in practice because activities such as fishing and bioprospecting already return an exclusive reward for effort, with no benefit-sharing arrangements. Under the Convention on the Conservation of Antarctic Marine Living Resources, the Parties determine allowable catches for a fishery based on scientific assessment, and this may discharge them from providing access and benefit-sharing arrangements to the international community potentially available through other international law (e.g. the Law of the Sea Convention or the Convention on Biological Diversity). The major turning point in Antarctica came when the Convention on the Regulation of Antarctic Mineral Resource Activitieswhich acknowledged the rights of the international communityfailed to enter into force. Today the international community is rewarded with a relatively healthy Antarctic environment and free access to some scientific information, which are benefiting all mankind. But the international community does not get direct financial reward from Antarctic activities because access is constrained by law and by a lack of capacity. There is no mechanism for disbursing compensation to all mankind in any case, although the Antarctic Treaty Consultative Parties could certainly rectify this if they had the will to do so. So far they have not. (shrink)
Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed (...) the REC of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)
This article argues that underlying Thomas Hobbes' prescription for concentrated power is system of ethics based on his understanding of human nature and the biological processes that govern natural human function. His thesis in Leviathan is not so much an argument for how rulers should rule as much as it is an argument for why individuals should allow themselves to be ruled in a specific manner. The justification for accepting rule comes from right reason which, in turn, comes (...) to us from the dictates of the biological organism. If the biological organism is functioning correctly, it supports those processes and impulses which drive self-preservation. Anything that corrupts these natural processes and impulses are said to contravene right reason. Ultimately, the author believes that theoretical discourse concerning the essential interplay between political ethics and human nature should include consideration of Hobbes alongside Aristotle, David Hume, and others. (shrink)
BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines (...) in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi. (shrink)
A variety of cases of scientific misconduct have been documented since the 1980s among biological scientists. These cases have focused the attention of the public and scientific community on this behavior and made it the centerpiece of the concern about ethics in the biological sciences. In contrast, the ethics movement in clinical medicine, which arose in the 1960s, was not basically directed at the problems of wrong-doing. Instead it concentrated on the difficult ethical choices that had (...) to be made In the practice of medicine.In this essay, I discuss the two movements. The attention given to misconduct In the biological sciences has become excessive and diverts its ethics movement from exploring and teaching about the difficult ethical decisions scientists must make in weighing obligations to self, science, and society. A more balanced and selective approach to developing an ethical framework in the biological sciences is needed. (shrink)
This study examined how research conducted at several federally funded institutions designated as Clinical Research Centers or Specialized Programs of Research Excellence addressed the issues of consent, control over biological materials, confidentiality, and disclosure of results in protocols and consent forms for genetic research with stored biological materials. Although a majority of the documents reviewed addressed most of the issues raised in the research ethics literature, topics identified in the literature that were missing include the return of (...) research results, the right to withdraw from research involving biological materials, and the consent of children when they become legal adults. If typical, these findings suggest greater educational efforts may be needed to prompt investigators and IRBs to consider these and other issues that were either not addressed in the protocols or consent forms or were addressed inadequately. (shrink)
This article attempts to translate philosophical notions into biological terms in order to transform dualistic thinking into monistic thinking. What if ethics finds its cause in physical, molecular processes? In Ruling Passions Simon Blackburn acknowledges the biological fact that we are social animals and that we need to coordinate our efforts. Therein lies an opportunity for a fruitful discussion about the biological foundation of ethics. Although Blackburn thinks there cannot be a grand unifying theory or (...) a single driving force that underlies ethics, the spreading of our genes may well be the key. As cooperation is the means by which humans have been successfully spreading their genes, ethics in some sense can be regarded as a biological or even a physical force. Recognition of ethics as such a force can help overcome false dichotomies in contemporary ethics and law. Four natural laws of global ethics and law can be formulated on the basis of factual biological mechanisms – natural laws that have remarkable equivalents in religion and contemporary law. (shrink)
The question whether ethical behavior is biologically determined may refer either to the capacity for ethics (i.e., the proclivity to judge human actions as either right or wrong), or to the moral norms accepted by human beings for guiding their actions. I herein propose: (1) that the capacity for ethics is a necessary attribute of human nature; and (2) that moral norms are products of cultural evolution, not of biological evolution. Humans exhibit ethical behavior by nature because (...) their biological makeup determines the presence of three necessary conditions for ethical behavior: (i) the ability to anticipate the consequences of one’s own actions; (ii) the ability to make value judgments; and (iii) the ability to choose between alternative courses of action. Ethical behavior came about in evolution not because it is adaptive in itself, but as a necessary consequence of man’s eminent intellectual abilities, which are an attribute directly promoted by natural selection. That is, morally evolved as an exaptation, not as an adaptation. Since Darwin’s time there have been evolutionists proposing that the norms of morality are derived from biological evolution. Sociobiologists represent the most recent and most subtle version of that proposal. The sociobiologists' argument is that human ethical norms are sociocultural correlates of behaviors fostered by biological evolution. I argue that such proposals are misguided and do not escape the naturalistic fallacy. The isomorphism between the behaviors promoted by natural selection and those sanctioned by moral norms exist only with respect to the consequences of the behaviors; the underlying causations are completely disparate. (shrink)
This paper is interested in the relationship between evolutionary thinking and moral behavior and commitments, ethics. There is a traditional way of forging or conceiving of the relationship. This is traditional evolutionary ethics, known as Social Darwinism. Many think that this position is morally pernicious, a redescription of the worst aspects of modern, laissez-faire capitalism in fancy biological language. It is argued that, in fact, there is much more to be said for Social Darwinism than many think. (...) In respects, it could be and was an enlightened position to take; but it flounders on the matter of justification. Universally, the appeal is to progress—evolution is progressive and, hence, morally we should aid its success. I argue, however, that this progressive nature of evolution is far from obvious and, hence, traditional social Darwinism fails. There is another way to do things. This is to argue that the search for justification is mistaken. Ethics just is. It is an adaptation for humans living socially and has exactly the same status as other adaptations, like hands and teeth and genitalia. As such, ethics is something with no standing beyond what it is. However, if we all thought that this was so, we would stop being moral. So part of the experience of ethics is that it is more than it is. We think that it has an objective referent. In short, ethics is an illusion put in place by our genes to make us good social cooperators. (shrink)
: Ronald Dworkin claims that if we are able to control our own biology, "our most settled convictions will . . . be undermined [and] we will be in a kind of moral free-fall." This is so because he takes moral convictions to be determined by the choices we make against a fixed biological background. It would seem that if Confucian ethics is grounded in ren xing (human nature) and if ren xing refers to a fixed biological (...) background, then the Confucian moral agent will be in a state of moral free-fall in the age of biological control—that is, if Dworkin is right. We can try to read ren xing as a creative process rather than a fixed nature, but any such reading inevitably grounds ren xing in something else that is biological. There is a way out for Confucians: the Dworkinian choice/chance distinction that is crucial for morality can be relocated away from the boundary between free choice and fixed biology to the boundary between the choices that we make and the fixed background of tradition. (shrink)
A system of environmental ethics recently developed by Lawrence Johnson may be used to analyze the moral implications of biological control. According to this system, entities are morally relevant when they possess well-being interests (i.e., functions or processes that can be better or worse in so far as the entity is concerned). In this formulation of ethical analysis, species and ecosystems are morally relevant because they are not simply aggregates of individuals, so their processes, properties, and well-being interests (...) are not reducible to the sum of their individual members. Following Johnson's thesis, species and ecosystems have morally relevant interests in surviving and maintaining themselves as integrated wholes with particular self-identities. This theoretical structure gives rise to a number of ethical criteria that are particularly relevant to biological control, which apply to the ecosystem (the extent to which it is large, native, unique, and integrated) and to the action being considered (the extent to which it is novel, omnipresent, monitored, reversible, and necessary). In these terms, it is evident that not all biological control efforts are ethically defensible. In general terms, natural biological control is most desirable, followed by augmentative strategies, classical approaches, and finally neoclassical biological control. Two specific cases (neoclassical biological control of rangeland grasshoppers and classical biological control of prickly pear cactus) illustrate the ethical concerns. Finally, it can be shown that formalized restrictions of biological control are necessary, given the unique properties of this technology. (shrink)
Economic markets are not morally free zones. Contrary to popular misconceptions, market functioning rests on the ethical principles of fairness and voluntariness. This ethical foundation can be traced back at least to moral philosopher Adam Smith, one of the founders of modern economics. In the inconspicuous form of microeconomic axioms, these moral foundations are preserved. Thus, virtually all “neo-classic” economic concepts presuppose a market ethics of fairness and voluntariness. In a world of pervasive uncertainty on the long-term development of (...) the human-environment interaction, the protection of the global life-support systems is an important test case for the scope of the ethical content of market ethics. We review risk protection strategies in the face of this uncertainty that are (i) based on the insurance effect of biological diversity, and (ii) that employ a safe minimum standard (SMS). Because the fairness principle of market ethics requires that economic agents who cause “external” costs must, at least, compensate those who are burdened with these costs, the interests of future generations have to be included in responsible economic decision-making. The market and market ethics approach is applied to the analysis of a SMS for biological diversity, and to the inherent problems of such an approach. At the microeconomic level of individual decision-making, an unconditional protection is supported by market ethics neither for the putative interests of future generations nor for biological diversity: Poor people who struggle to cover their basic needs cannot not be required to care for biological diversity. In all other cases, the protection of biological diversity in favour of future generations is supported—if costs are not “unacceptably high”. At which cost level this point is approached, market ethics is not designed to decide. (shrink)
Designer Biology: The Ethics of Intensively Engineering Biological and Ecological Systems consists of thirteen chapters that address the ethical issues raised by technological intervention and design across a broad range of biological and ecological systems. Among the technologies addressed are geoengineering, human enhancement, sex selection, genetic modification, and synthetic biology.
Of the four types of biological control, (1) natural, (2) conservation, (3) augmentation, and (4) importation), ethical concerns have been raised almost exclusively about only one type: importation. These concerns rest largely on fears of extinction of animal species. Importation biological control is a cost-effective alternative to chemical control for basic food crops of resource-poor farmers. Regarding the other types of biological control, natural biological control is not consciously manipulated by humans. Augmentation has some technical concerns, (...) but is generally an environmentally-sound, viable alternative to chemicals and offers local employment. Conservation can help empower farmers to preserve native species, while saving labor and money and reducing chemical insecticides. (shrink)
Social and behavioral scientists - that is, students of human nature - nowadays hardly ever use the term ‘human nature’. This reticence reflects both a becoming modesty about the aims of their disciplines and a healthy skepticism about whether there is any one thing really worthy of the label ‘human nature’.
We should all agree that each of us is bound to show kindness to his parents and spouse and children, and to other kinsmen in a less degree; and to those who have rendered services to him, and any others whom he may have admitted to his intimacy and called friends; and to neighbours and to fellow-countrymen more than others; and perhaps we may say to those of our own race more than to black or yellow men, and generally to (...) human beings in proportion to their affinity to ourselves. (shrink)
Social and behavioral scientists — that is, students of human nature — nowadays hardly ever use the term ‘human nature’. This reticence reflects both a becoming modesty about the aims of their disciplines and a healthy skepticism about whether there is any one thing really worthy of the label ‘human nature’. For some feature of humankind to be identified as accounting for our ‘nature’, it would have to reflect some property both distinctive of our species and systematically influential enough to (...) explain some very important aspect of our behavior. Compare: molecular structure gives the essence or the nature of water just because it explains most of its salient properties. Few students of the human sciences currently hold that there is just one or a small number of such features that can explain our actions and/or our institutions. And even among those who do, there is reluctance to label their theories as claims about ‘human nature’. Among anthropologists and sociologists, the label seems too universal and indiscriminant to be useful. The idea that there is a single underlying character that might explain similarities threatens the differences among people and cultures that these social scientists seek to uncover. Even economists, who have explicitly attempted to parlay rational choice theory into an account of all human behavior, do not claim that the maximization of transitive preferences is ‘human nature’. I think part of the reason that social scientists are reluctant to use ‘human nature’ is that the term has traditionally labeled a theory with normative implications as well as descriptive ones. (shrink)
BackgroundEthical and regulatory guidance on the collection and use of human biospecimens for research forms an essential component of national health systems in Sub-Saharan Africa, where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks.MethodsAn extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in (...) which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens.ResultsOf the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent, ownership, reuse, storage, and export/import/transfer. Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS.ConclusionsDespite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise. (shrink)
In this commentary on a previous Ethics and Social Welfare publication, the authors argue that inclusive and expansive dialogue about interprofessional ethics is more a matter of ??revitalizing?? traditional professional ethics than developing a new field. The dialogue will be most productive of care improvements if it incorporates the service user, includes both health and social care professions, and occurs across countries.
This article addresses five research questions: What specific behaviors are described in the literature as ethical or unethical? What percentage of business people are believed to be guilty of unethical behavior? What specific unethical behaviors have been observed by bank employees? How serious are the behaviors? Are experiences and attitudes affected by demographics? Conclusions suggest: There are seventeen categories of behavior, and that they are heavily skewed toward internal behaviors. Younger employees have a higher level of ethical consciousness than older (...) employees. The longer one works for a company, the more one may look to job security as a priority; this can lead to rationalizing or overlooking apparently unethical behaviors. More emphasis is needed on internal behaviors with particular attention on the impact that external behaviors have on internal behaviors. (shrink)
Recent advances in genetic engineering nowallow the design of programmable biologicalartifacts. Such programming may include usageconstraints that will alter the balance ofownership and control for biotechnologyproducts. Similar changes have been analyzedin the context of digital content managementsystems, and while this previous work is usefulin analyzing issues related to biologicalprogramming, the latter technology presents new conceptual problems that require morecomprehensive evaluation of the interplaybetween law and technologically embeddedvalues. In particular, the ability to embedcontractual terms in technological artifactsnow requires a re-examination of (...) disclosure andconsent in transactions involving such artifacts. (shrink)
The world's aging populations face novel health challenges never experienced before in human history. The moral landscape thus needs to adapt to reflect this novel empirical reality. In this paper I take for granted one basic moral principle advanced by Peter Singer and explore the implications that empirical considerations from demography, evolutionary biology, and biogerontology have for the way we conceive of fulfilling this principle at the operational level. After bringing to the fore a number of considerations that Singer ignores, (...) such as the probability that nonintervention will result in harm and the likelihood that different kinds of extrinsic and intrinsic harms can be prevented, I argue that the aspiration to extend the human biological warranty period (by retarding the rate of aging) is a pressing moral imperative for the twenty-first century. In the final sections I briefly address some standard objections raised against life extension and conclude that, while there may be some legitimate concerns worth addressing, they are not compelling enough to provide a rational basis for forfeiting the potential health and economic benefits that could be realized by extending the biological warranty period. (shrink)
The world's aging populations face novel health challenges never experienced before in human history. The moral landscape thus needs to adapt to reflect this novel empirical reality. In this paper I take for granted one basic moral principle advanced by Peter Singer — a principle of preventing bad occurrences — and explore the implications that empirical considerations from demography, evolutionary biology, and biogerontology have for the way we conceive of fulfilling this principle at the operational level. After bringing to the (...) fore a number of considerations that Singer ignores, such as the probability that nonintervention will result in harm and the likelihood that different kinds of extrinsic and intrinsic harms can be prevented, I argue that the aspiration to extend the human biological warranty period is a pressing moral imperative for the twenty-first century. In the final sections I briefly address some standard objections raised against life extension and conclude that, while there may be some legitimate concerns worth addressing, they are not compelling enough to provide a rational basis for forfeiting the potential health and economic benefits that could be realized by extending the biological warranty period. (shrink)
This book consists of thirteen chapters that address the ethical issues raised by technological intervention and design across a broad range of biological and ecological systems. Among the technologies addressed are geoengineering, human enhancement, sex selection, genetic modification, and synthetic biology.
This book consists of thirteen chapters that address the ethical issues raised by technological intervention and design across a broad range of biological and ecological systems. Among the technologies addressed are geoengineering, human enhancement, sex selection, genetic modification, and synthetic biology.