Ontology, since Aristotle, has been conceived as a sort of highly general physics, a science of the types of entities in reality, of the objects, properties, categories and relations which make up the world. At the same time ontology has been for some two thousand years a speculative enterprise. It has rested methodologically on introspection and on the construction and analysis of elaborate world-models and of abstract formal-ontological theories. In the work of Quine and others this ontological theorizing in abstract (...) fashion about the world was supplemented by the study, based on the use of logical methods, of the ontological commitments or presuppositions embodied in scientific theories. In recent years both types of ontological study have found application in the world of information systems, for example in the construction of frameworks for knowledge representation and in database design and translation. As ontology is in this way drawn closer to the domain of real-world applications, the question arises as to whether it is possible to use empirical methods in studying ontological theories. More specifically: can we use empirical methods to test the ontological theories embodied in human cognition? We set forth the outlines of a framework for the formulation and testing of such theories as they relate to the specific domain of geographic objects and categories. (shrink)

Background: Although the term “mental pain” is often the subject of expert opinions regarding claims for damages, there is still no standardized questionnaire in the German-speaking area to operationalize this concept. Therefore, the aim of this work is the development and validation of a self-assessment measurement for psychological pain after traumatic events.Methods:A first version of the questionnaire was applied on a sample of the German speaking general population. After performing an item analysis and exploratory factor analysis, the questionnaire was shortened (...) and tested on a second German speaking general population sample. Finally, the newly developed questionnaire was related to the extent of traumatization and already established instruments for the assessment of psychiatric symptom burden, which included the Brief Symptom Inventory-18 and the Post-traumatic-Stress-Scale.Results: The final version of the FESSTE consists of a total of 30 items and covers the subscales “Somatization,” “Depression,” “Intrusive Memories,” “Dissociation” and “Anxiety,” and a total scale “Mental Pain.” Based on the confirmatory factor analysis, it is assumed that the latent factor structure of the FESSTE can be best described as a bifactor-model. The final version shows a satisfactory model fit, high internal consistencies, and strong positive correlations with the BSI-18 and PTSS-10, as well as the extent of traumatic experiences.Discussion: The FESSTE enables an operationalization of mental pain comprising five subscales and one total scale. What is more, the trauma checklist attached to the FESSTE allows for the standardized assessment of potentially traumatic experiences and the corresponding extent of these experiences. The results indicate that the FESSTE is a reliable and valid self-assessment procedure for mental pain, which is suitable for use in research and in expert practice. (shrink)

On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of “untried and potentially dangerous” drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then (...) exposed how Lilly was able to keep costs down: by recruiting homeless alcoholics to serve as research guinea pigs. “In many ways,” Cohen reported, “the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug.” And the subjects “get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call easy money.”. (shrink)

Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored (...) in the nanomedicine translation arena. (shrink)

Informed consent is one of the foundational ethical and legal requirements of research with human subjects. The Nuremberg Code, the Helsinki Declaration, the Belmont Report, the Common Rule and many other laws and codes require that research subjects make a voluntary, informed choice to participate in research.12345 Informed consent is based on the moral principle of respect for autonomy, which holds that rational individuals have a right to make decisions and take actions that reflect their values and (...) preferences. 6 Whereas most guidelines and codes also require that informed consent be properly documented, informed consent is much more than signing a piece of paper: It is a continuous process of communication between the investigator and the research subject. 7 Because the body of knowledge impacting a study frequently changes, subjects should receive information from investigators after they have enrolled in a study, such as significant new findings that may affect their decision to participate in research or clinically useful tests results. 8910 In large studies, some investigators use newsletters to update subjects on the progress of research and other developments.11Most of the ongoing communications between investigators and subjects involve little more than information sharing, without revisiting the decision to participate in research or signing any additional documents. Sometimes, however, it may be necessary for subjects to reaffirm their decision to participate, to re-consent, or to sign or re-sign a document. 8 Re-consent can be defined as an action in which a subject makes the decision to participate in research once again. Re-consent is different from reaffirming a commitment to participate in a study, because in re-consent one actually reconsiders the information necessary to make decision, whereas in reaffirmation one simply expresses …. (shrink)

The natural epistemology of W. V. Quine has not been well understood. Critics argue that Quine's scientific approach to epistemology is circular and fails to be normative, yet these criticisms tend to be based on the very presuppositions concerning language, theory, and epistemology that Quine is at pains to reject or alter. ;Quine's views on the meaningfulness of language use imply a breakdown in the dichotomy between language as a theoretically neutral instrument and theory as the commitment to some subset (...) of the sentences allowed by a language. This breakdown, and the view of language which drives it, result in Quine's doctrine that speaking a language involves substantial theoretical commitments, and that inquiry must begin from within some ongoing theory of the world. That is, our epistemic practices, including epistemology itself, must be globally circular. The traditionally fundamental norm of linear propositional support, which drives the circularity objection, is thus seen as based in a misconception of language and theory. This not only explains Quine's lack of concern with the circularity of his view, but also illuminates the fundamental motivation for his general naturalism. ;Natural epistemology cannot be normative in the traditional sense of providing an independent ground for science. However, having accepted the "terminal parameter" of prediction as the test of theory, normativity becomes a matter of describing which procedures best promote predictively successful theory. Thus, epistemic norms emerge from science as hypotheses concerning the effectiveness of various methods in promoting predictively successful theory. Not only can natural epistemology prescribe and proscribe various epistemic practices, it offers the promise of an explanatory understanding of the strengths and weaknesses of those practices. Based on this understanding, natural epistemology further involves the improvement of current practices and the development of new ones. Crucial to this reconception of epistemology is the reconception of the knower as an adaptive organism employing the language/theory complex as an adaptive tool for interacting with the environment. ;The naturalism/anti-naturalism debate is advanced by acknowledging the substantial theoretical commitments implicit in the traditional view, and by examining Quine's reconception of language, theory, and the human knowing subject. (shrink)

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance, epidemiological investigations, and evaluation and monitoring. Few debate that these essential public health activities, often specifically authorized (...) by law, are classifiable as public health practice.Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects. (shrink)

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. (shrink)

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance, epidemiological investigations, and evaluation and monitoring. Few debate that these essential public health activities, often specifically authorized (...) by law, are classifiable as public health practice.Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects. (shrink)

As we aggressively pursue research to cure and prevent Alzheimer’s disease, we encounter important ethical challenges. None of these challenges, if handled thoughtfully, would pose insurmountable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and do damage to research recruits and others. These challenges are the necessity of very large cohorts of research subjects, recruited for lengthy studies, probably ending only in the subjects’ death; the creation of (...) cohorts of ’study ready' volunteers, many of whom will be competent to consent at the beginning of the process, but move into cognitive impairment later; reliance on adaptive trial design, creating challenges for informed consent, equipoise and justice; the use of biomarkers and predictive tests that describe risk rather than certainty, and that can threaten participants’ welfare if the information is obtained by insurance companies or long-term care providers; the use of study partners that creates unique risks of harm to the relationship of subject and study partner. We need greater attention, at all levels, to these complex ethical issues. Work on these issues should be included in research plans, from the federal to the local, and should be supported through NIH in the same way that it supported work on the ethical, legal and social implications of genetic research. (shrink)

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Public health activities that (...) might under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection, and laboratory testing.There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons. (shrink)

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Public health activities that (...) might under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection, and laboratory testing.There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons. (shrink)

Incidental findings in research with human participants may have implications for a person’s present health or future health outcomes. Current guidelines focus on methods for handling and reporting incidental findings from biological test data but incidental findings might also arise from non-biological tests. This article presents three examples in which the results from non-biological test data can be predictive of future disease and should be disclosed to research participants. It is intended to increase awareness and facilitate further discussion about (...) the reporting of incidental findings from non-biological data. (shrink)

Objectives The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries. Methods In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug tests were surveyed (...) by questionnaires. Results The CFs of medical researches in public hospitals with ethics committees in Shanghai were generally acceptable. However, there were some defects in the CFs. Although most of the surveyed PIs had correct recognition of informed consent, some processes of informed consent were not in accordance with generally accepted requirements. A large number of the PIs considered the greatest difficulty with informal consent was lack of correct recognition of subjects or legally authorised representatives on medical research. Discussion Informed consent in medical research should consider the research ethics, the background of potential subjects, the local resources and culture of medical research. In addition, special protection is needed for student subjects in informed consent as well as efforts for building and restoring the public's trust in biomedical research. Conclusion The informed consent in Shanghai's public hospitals with ethics committees was generally acceptable and the achievement of adequate informed consent is influenced by many factors. (shrink)

The administration of psychological tests is highly regulated. Test manuals prescribe the instructions to the test subject, the time the test should take, where it should take place, whether and how the test administrator should answer questions from the test subject, and other aspects of the testing situation. Through the manual, the behaviour of test administrator and test subject is disciplined so that the subject may become measurable. The manuals of four tests are analysed, and the disciplinary mechanisms that (...) operate in the administration of these tests are described. Attention is then given to the question whether the discipline of the test is repressive or productive. It is concluded that test manuals, while being central to the production of a psychological subject, also articulate an excess subjectivity in the measures they prescribe to exclude it from the testing situation. (shrink)

This special issue examines the diverse realities created by the intersection of emerging technologies, new scientific knowledge, and the human being. It engages with two key questions: how is the human being shaped and constructed in new ways through advances in science and technology? and how might these new ways of imagining the subject shape present and future human rights law and practice? The papers examine a variety of scientific technologies—personalized medicine and organ transplant, mitochondrial DNA replacement, (...) and scaffolds and regenerative medicine—and their implications for our conceptualization of the human subject. Each is then followed by a commentary that both brings to light new dimensions of the original paper and presents a new theoretical take on the topic. Together these papers offer a serious challenge to the vision of the human subject at the root of human rights law. Instead of the autonomous, rational, unique, and physically discrete individual who owns herself and her body, the subject that emerges from the human technology assemblage has physically porous boundaries and a relational self. This depiction of the human being as a relational subject enmeshed in her technoscientific environment requires that we reconceptualize human rights law and practice. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of (...) human subjects (45 CFR 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying (...) manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased. (shrink)

The aim was to verify the potential of holistic approaches towards the evaluation of human figure drawing. Groht-Marnat, Tharinger, Stark favour this approach, and findings seem to legitimize considerations about its diagnostic productivity. Yama, Dans-Lopez and Tarroja have identified bizarre and artistic quality criteria for drawing that have a relevant interpretative meaning. Within the study involving 525 normal adult subjects, the hypothesis of differences in personality traits and performance level produced by authors of selected types of drawings, was (...) verified. The criterium of bizarre drawing proved to be an important indicator of intellectual abilities monitored by subtests of the ISA-S test, the non-verbal CF 2A test, Decision-making test. They achieved the lowest scores in all parameters, with significance in relation to more detailed drawings. Results from IHAVEZ and DOPEN questionnaires suggest that bizarre character producers are more emotionally instable, less emotionally resilient, less anticipating, and less self-controlling, less rational, responding more intensely to problems and are less orientated towards their solution. They are more neurotic and present more psychotic experience. The main limitation is the chosen approach. Holistically evaluated drawing is rare in terms of its occurrence in a normal population. Even within the files involving several hundred participiants, it is possible to clearly classify drawing in the maximum number of tens. Diversity of the terminology and methodological ambiguity constitutes another limitation. The bizarreness itself is not interpreted clearly, rather the contrary. (shrink)

The Internet and social media have opened niches for political exploitation of human dispositions to hyper-alarmed states that amplify perceived threats relative to their objective probabilities of occurrence. Researchers should aim to observe the dynamic “ramping up” of security threat mechanisms under controlled experimental conditions. Such research necessarily begins from a clear model of standard baseline states, and should involve adding treatments to established experimental protocols developed by experimental economists. We review these protocols, which allow for joint estimation of (...) risk preferences and subjective beliefs about probabilities and their distributions. Results we have obtained on such estimates, from populations in various countries, are gathered for comparison. Most people show moderate risk aversion in non-alarmed states. We also find universal heterogeneity in risk preference structures, with substantial sub-samples weighting probabilities in such a way as to display “probability pessimism”, while others make risky choices in accordance with expected utility theory. (shrink)

Background: The Multidimensional Inventory for Religious/Spiritual Well-Being was developed in order to address a religious/spiritual dimension as being an important part of psychological well-being. In the meantime, the instrument has been successfully applied in numerous studies. Subsequently, a short version, the MI-RSWB 12 was constructed, especially for the use in clinical assessment. Here it is intended to contribute to the further development of the MI-RSWB 12 by investigating its structural validity through structural equation modeling.Materials and Methods: A total sample of (...) 1,097 German-speaking adults from the normal population filled in the MI-RSWB 12 via an online-survey. In line with theoretical assumptions 5 different factor structure models for the MI-RSWB 12 were tested: a single-factor model, a model with four correlated RSWB dimensions, a single higher-order model with four lower order factors, a two higher-order model with four lower order factors, a bifactor model, which includes four specific RSWB dimensions.Results: The single-factor model provided the poorest model fit, with no indices falling within the acceptable range. The four-factor, two higher-order factors and the bifactor models showed overall acceptable fit indices. With regard to the Akaike information criterion, the four-factor model demonstrated superiority compared to both the two higher-order factor model and the bifactor model, which in turn showed did not differ from each other.Conclusion: Four different MI-RSWB 12 sub-scales should be calculated in future studies, while a general factor and two higher order factors are statistically valid as well. Further applications of the MI-RSWB 12, especially in the clinical patient groups, are encouraged. (shrink)

This thesis offers a re-definition of Kantian a priorism by expanding the notions surrounding it from within a Piagetian genetic epistemological viewpoint. ;In particular, the notion of "noumenon" is re-examined from within this viewpoint, and extended to all structural facets of the genetic epistemological knowing "situation". ;By means of these re-examinations of classical epistemological notions, the various forms of knowledge characteristically produced from within the bounds of that knowing "situation" can then be structurally located with respect to intent and focus (...) of the knowing activity, thereby making it possible to show the phenomenological connection between all these forms of knowledge, as well as to legitimize each form under the canopy of a common set of functional principles, such as truth, objectivity, progress, etc. This in turn allows for a re-definition of the Piagetian scientifically oriented "epistemic subject" into what I call the "complete epistemic subject", which takes account of all the forms of knowing occurring within the structure of the genetic epistemological "situation". ;Particularly are art and science focused upon as test cases for the re-oriented a priorism presented. ;Following the epistemological argument, the classical Progressive educational argument will be re-examined to determine whether any altered approaches and educational ideals result from analyzing the meaning of the "natural man" and "democratic man" and how these analyses can be seen to refer to an expanded type of knowing subject, the "complete epistemic subject". (shrink)

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social–psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices :168–175, 2001). Institutions such as Institutional Review Boards and Ethics (...) Committees oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki. Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants. The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees’ reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures. (shrink)

Testing of candidate biological control agents to estimate their likely field host ranges in the area of release has been part of weed biological control for several decades, with evolving techniques and goals. Similar efforts have been made less often for parasitoids and predators being introduced for arthropod biological control. Here, we review both techniques of host range testing and social objectives of such screening. We ask whether agents introduced for arthropod biological control should be subjected to host (...) range testing before release, and if so, are methods used for estimating host ranges of herbivorous arthropods appropriate, or are different approaches needed. Current examples in which host range testing has been employed for arthropod biological control are reviewed. We conclude with recommendations concerning guiding principles about use of host range testing. We recommend modest expansion of host range testing for arthropod biological control for projects on continents. We recommend more extensive testing for projects of introduction onto islands. We note that introductions to islands could provide opportunities to gain experience in use of host range estimation for this class of organisms and to conduct post release evaluations of host ranges. We urge caution in efforts to mandate host range testing but simultaneously recommend consultation between biological control workers and insect conservationists. (shrink)

Tremendous development in recent medical science and the consequent discoveries resulting in successful prevention and also cure of different diseases are shared by clinical research involving the human volunteers. Preceding the trials in the human subjects, and to ensure safety, the proposed drug and other interventions are either tested in animals (vivo) or in laboratory (vitro) to evaluate initial safe starting dose for the human beings and to key out the benchmarks for the clinical monitoring for (...) the potential unfavorable effects. These pre human trials might not necessarily protect against the untoward effects in the human beings as happened in the case of thalidomide tragedy, which caused disability and killed thousands of babies born to the mothers, those who took this medicine. Use of healthy human volunteers in the preliminary experiments or phase I clinical trials either reduces or excludes risks of subsequent undesirable effects in the future trails (1). Phase-1 trials are conducted in order to test the safety, reactions and immunogenicity of vaccines in volunteers. Novel treatments for the cancer are first tested in phase 1 trials enrolling the patients with advanced disease, who have exhausted the standard treatment options. Phase-1 oncology trials are the pivot point in the translation of new cancer therapies from bench to bedside. Nevertheless, these trials remain ethically controversial. The controversy stems from the fact that, classically, phase-1 oncology clinical trials involve first-in-human testing of experimental treatment candidates in patients with a terminal diagnosis, who typically have exhausted standard treatment options. Commentators on the ethics of phase-1 clinical trials make diametrically opposed claims about the prospect of direct medical benefit from participation in these trials-benefits that can be attributed to receiving the experimental treatment intervention. One camp of benefit skeptics, inhabited mainly by bioethicists, characterizes this form of research as lacking any reasonable prospect of direct medical benefit. They see an ethical cloud hovering over phase-1 trials, because the vast majority of patients volunteer for phase-1 trials out of a motivation to receive medical benefit. In the view of these skeptics, such patients therefore harbor a ‘therapeutic misconception’ about research participation. This misconception calls into question the validity of informed consent and thereby undercuts the ethical basis of these trials (2). In this paper, I will discuss the ethical justification of the participation of human volunteers in phase-1 trials. (shrink)

“Privacy considerations no longer arise out of particular individual problems; rather, they express conflicts affecting everyone.”Along with the promise of assuaging the scourge of disease, the so-called genetic revolution unquestioningly imports a slew of thorny human rights issues that touch on matters such as dignity, disclosure, and the subject of this article – genetic testing and the social stigma potentially deriving therefrom.It is now rather evident that certain otherwise therapeutically promising forms of research can inadvertently involve social risks (...) exceeding the individual preoccupations of eclectic study participants. With that as the case, the following proposes to examine the peculiar stigma attached to genetic information and its potential human rights implications extending beyond the insurance and employment context. In so doing, it raises the intersection of interests between self-identified members of historically vulnerable groups and the group itself, which the law seems to take for granted in the genetics context. (shrink)

This uniquely inspirational and practical book explores human simulation, which is the application of computational modeling and simulation to research subjects in the humanities disciplines. It delves into the fascinating process of collaboration among experts who usually don’t have much to do with one another – computer engineers and humanities scholars – from the perspective of the humanities scholars. It also explains the process of developing models and simulations in these interdisciplinary teams. Each chapter takes the reader on (...) a journey, presenting a specific theory about the human condition, a model of that theory, discussion of its implementation, analysis of its results, and an account of the collaborative experience. Contributing authors with different fields of expertise share how each model was validated, discuss relevant datasets, explain development strategies, and frankly discuss the ups and downs of the process of collaborative development. Readers are given access to the models and will also gain new perspectives from the authors’ findings, experiences, and recommendations. Today we are in the early phases of an information revolution, combining access to vast computing resources, large amounts of human data through social media, and an unprecedented richness of methods and tools to capture, analyze, explore, and test hypotheses and theories of all kinds. Thus, this book’s insights will be valuable not only to students and scholars of humanities subjects, but also to the general reader and researchers from other disciplines who are intrigued by the expansion of the information revolution all the way into the humanities departments of modern universities. (shrink)

Spoken communication between social robotic devices, powered by generative AI tools such as ChatGPT, and the senior population offers great potential for researching social interaction and robot identity perceptions as well as exploring the potential opportunities and challenges when implementing this human-machine interactions in real life situations and health care. In this paper we explore people’s perceptions of the social robot Furhat when administering verbal tasks similar to those used in screening for Alzheimer’s disease. We describe the Slovak system (...) mounted on the robot that includes a speech recognizer, the scenarios powered by generative large language model ChatGPT, and a speech synthesizer. We tested the functionality of the proposed approach with two groups of participants: attendees of a large science fair and a scientific conference. The observations from 87 collected questionnaires suggest good potential and applicability of such an approach for the given task and more positive attitudes of older subjects compared to younger ones. (shrink)

The present paper examines the arguments and data presented by Nisbett and Wilson relevant to their thesis that subjects do not have access to their own cognitive processes. It is concluded that their review of previous research is selective and incomplete and that the data they present in behalf of their thesis does not withstand a demand characteristics analysis. Furthermore, their use of observer-subject similarity as evidence of subjects' inability to access cognitive processes makes tests of their hypothesis (...) confounded and, at the same time, reveals limitations in the application of the pre-inquiry quasi-control to research on social behavior. Problems with postexperiment questionnaires, such as the demand characteristics of the inquiry procedure are also considered. Although there are difficulties in assessing subjects' cognitive processes, many of these may be overcome through the application of novel techniques and research conducted on more traditional methods. In contrast to the view that subjects have limited access to cognitive processes and that their verbal reports are not valid, it is concluded that subjects' verbalizations are a rich source of psychological data which must be pursued if we are to tap their cognitive processes and are to gain an adequate understanding of human behavior. (shrink)

It has recently been argued that a person’s moral judgments (about both their own and others’ actions) are constrained by the nature and extent of their relevant ignorance and, thus, that such judgments are determined in the first instance by the person’s epistemic circumstances. It has been argued, in other words, that the epistemic is logically prior to other normative (e.g., ethical, prudential, pecuniary) considerations in human decision-making, that these other normative considerations figure in decision-making only after (logically and (...) temporally) relevant ignorance has constrained the decision-maker’s menu of options. If this is right, then a person’s moral judgments in some set of circumstances should vary with their knowledge and ignorance of these circumstances. In this study, we test the hypothesis of the logical priority of the epistemic. We describe two experiments in which subjects’ knowledge and ignorance of relevant consequences were manipulated. In the second experiment, we also compared the effect of ignorance on moral judgments with that of personal force, a factor previously shown to influence moral judgments. We found broad empirical support for the armchair arguments that epistemic considerations are logically prior to normative considerations. (shrink)

This book provides a novel framework for understanding and revising labor markets and education policies in an era of machine learning. It posits that while learning and knowing both require thinking, learning is fundamentally different than knowing because it results in cognitive processes that change over time. Learning, in contrast to knowing, requires time and agency. Therefore, “learning algorithms”—that enable machines to modify their actions based on real-world experiences—are a fundamentally new form of artificial intelligence that have potential to be (...) even more disruptive to labor markets than prior introductions of digital technology. To explore the difference between knowing and learning, Turing’s “Imitation Game,”—that he proposed as a test for machine thinking—is expanded to include time dependence. The arguments presented in the book introduce three novel concepts: (1) Comparative learning advantage: This is a concept analogous to comparative labor advantage but arises from the disparate times required to learn new knowledge bases/skillsets. It is argued that in the future, comparative learning advantages between humans and machines will determine their division of labor. (2) Two dimensions of job performance—expertise and interpersonal: Job tasks can be sorted into two broad categories. Tasks that require expertise have stable endpoints, which makes these tasks inherently repetitive and subject to automation. Tasks that are interpersonal are highly context-dependent and lack stable endpoints, which makes these tasks inherently non-routine. Humans compared to machines have a comparative learning advantage along the interpersonal dimension, which is increasing in value economically. (3) The Learning Game is a time-dependent version of Turing’s “Imitation Game.” It is more than a thought experiment. The “Learning Game” provides a mathematical framework with quantitative criteria for training and assessing comparative learning advantages. The book is highly interdisciplinary—presenting philosophical arguments in economics, artificial intelligence, and education. It also provides data, mathematical analysis, and testable criteria that researchers in these fields will find of practical use. The book calls for a rethinking of how labor markets operate and how the education system should prepare students for future jobs. It concludes with a list of counterintuitive recommendations for future education and labor policies that all stakeholders—employers, employees, educators, students, and political leaders—should heed. (shrink)

This is the second paper in a two-part series describing subject and family perspectives from the CENTURY-S (CENtral Thalamic Deep Brain Stimulation for the Treatment of Traumatic Brain InjURY-Safety) first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury (msTBI). To participate, subjects were independently assessed to formally establish decision-making capacity to provide voluntary informed consent. Here, we report on post-operative interviews conducted after a successful trial of thalamic stimulation. All five msTBI (...) subjects met a pre-selected primary endpoint of at least a 10% improvement in completion time on Trail-Making-Test Part B, a marker of executive function. We describe narrative responses of subjects and family members, refracted against that success. Interviews following surgery and the stimulation trial revealed the challenge of adaptation to improvements in cognitive function and emotional regulation as well as altered (and restored) relationships and family dynamics. These improvements exposed barriers to social reintegration made relevant by recoveries once thought inconceivable. The study’s success sparked concerns about post-trial access to implanted devices, financing of device maintenance, battery replacement, and on-going care. Most subjects and families identified the need for supportive counseling to adapt to the new trajectory of their lives. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Gene TherapyMary Carrington Coutts (bio)On September 14, 1990, researchers at the U.S. National Institutes of Health (NIH) performed the first approved gene therapy procedure on a four-year-old girl named Ashanti DeSilva. Born with a rare genetic disease, severe combined immune deficiency (SCID), Ashanti lacked a healthy immune system and was extremely vulnerable to infection. Children with SCID usually develop overwhelming infections and rarely survive to adulthood; even (...) a common childhood illness like chicken pox is life-threatening. Ashanti led a cloistered existence, avoiding contact with people outside her family, remaining in the sterile environment of her home, and battling frequent illnesses with massive amounts of antibiotics.In Ashanti's gene therapy procedure, her own white blood cells were genetically modified and then infused back into her bloodstream. Laboratory tests show that the therapy has strengthened Ashanti's immune system. She no longer has recurrent colds, has been allowed to attend school, and has been immunized against whooping cough. This gene therapy procedure is not a cure, however. The genetically-treated white blood cells only survive for a few months and must then be replaced, but Ashanti's future is much brighter because of the new therapy (VI, Thompson [The First] 1993).Although this simplified description of Ashanti's gene therapy procedure sounds like a happy ending, it is little more than an optimistic chapter in a long story. The road to the first approved gene therapy procedure was rocky and fraught with controversy. The biology of human gene therapy is very complex, and there are still many techniques that need to be developed and diseases that need to be understood more fully before gene therapy is well established. The public policy debate surrounding the possible use of genetically engineered material in human subjects is equally complex. Major participants in the debate come from the fields of biology, government, law, medicine, philosophy, politics, and religion, each bringing different views to the discussion.In studying the ethics of gene therapy, one should draw a distinction between [End Page 63] therapy on somatic (non-reproductive) cells and germ (reproductive) cells. Only the germ cells carry the genes that will be passed on to the next generation. Reactions to gene therapy have varied widely. Some commentators on gene therapy object to any form of genetic manipulation, no matter how well-intentioned (VI, Rifkin 1983). Another reaction is to allow the use of somatic-cell therapy, but not to approve the use of germ-line therapy, which could have unforeseeable effects on future generations. A different stance is that, with proper regulation and safeguards, germ-line gene therapy is a logical extension of the progress made to date and that it is an ethically acceptable procedure.TechniquesTo date, 43 research protocols have been approved for somatic-cell gene therapy in the United States. The techniques employed in each protocol vary, but in general a virus is used as a "vector" to insert the desired gene into the DNA of the patient's cells, in order to compensate for a defective gene. For Ashanti's gene therapy, this technique involved obtaining white blood cells and introducing properly functioning genes into as many of the cells as possible. The normal genes were delivered through the use of a specially-engineered virus.Although similar techniques are used in germ-line gene therapy, the procedure is more difficult. There are two basic ways to perform germ-line gene therapy: (1) to treat a preimplantation embryo that carries a serious genetic defect before its implantation in the mother, which necessitates the use of in vitro fertilization techniques; or (2) to treat the germ cells (sperm or egg cells) of afflicted adults so that the genetic defects would not be passed on to their offspring, which requires the technical expertise to delete the defective gene and insert a properly functioning replacement. Because of the complexity of the procedures involved and the attendant ethical controversy, germ-line therapy is not currently performed.Candidate Diseases for Gene TherapyAt present, gene therapy is likely to be most successful in treating diseases that are caused by single-gene defects and has been approved for treating diseases such... (shrink)