Online research in philosophy

Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...

This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and ...

Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous (...) research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)

Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

Embryo litigation -- Access to ART treatment : insurance and discrimination -- General professional liability litigation -- Paternity and donor insemination -- Maternity and egg donation -- Traditional and gestational surrogacy arrangements -- Posthumous reproduction : access and parentage -- Same-sex parentage and ART -- Genetics (PGD) and ART -- ART-related embryonic stem cell legal developments -- ART-related adoption litigation -- ART-related fetal litigation and abortion-related litigation.

With the proliferation of networked electronic communication came daunting capabilities to collect, process, combine and store data, resulting in hitherto unseen transformational pressure on the concepts of trust, security and privacy as we know them. The Future Internet will bring about a world where real life will integrate physical and digital life. Technology development for data linking and mining, together with unseen data collection, will lead to unwarranted access to personal data, and hence, privacy intrusion. Trust and identity lie at (...) the basis of many human interactions and transactions, and societies have developed legitimate concern for privacy being essential for freedom and creativity. The burgeoning development of the Information Society, particularly during the past fifteen years, transcended the societal readiness to respond to the transformational change evoked by ICT. We have reached the eleventh hour for the preservation of trust and privacy as elements that can be transposed into our digital future. Europe has been at the forefront in recognizing the importance of privacy protection in relation to digital data, witness the advanced European legislation in this domain. The European Commission recognizes that appropriate measures need to combine technology development with legal means, user awareness and tools supporting data controllers to comply with law in an accountable and transparent way, and that empower users with a controlling stake in managing their personal data. Activities are underway at many levels. European RTD programmes play their role in supporting research in trustworthy ICT, privacy enhancing technologies, privacy-by-design in service layers as well as in networks, enabling technologies such as cryptography, and in generalized frameworks for trust and privacy-protective identity management. (shrink)

Millions of people undergo displacement in the world. Internally displaced people (IDP) are especially vulnerable as they are not protected by special legislation in contrast to other migrants. Research conducted among IDPs must be correspondingly sensitive in dealing with ethical issues that may arise. Muslim IDPs in Puttalam district in the North-Western province of Sri Lanka were initially displaced from Northern Sri Lanka due to the conflict in 1991. In the backdrop of a study exploring the prevalence of (...) common mental disorders among the IDPs, researchers encountered various ethical challenges. These included inter-related issues of autonomy, non-maleficence, beneficence, confidentiality and informed consent, and how these were tailored in a culture-specific way to a population that has increased vulnerability. This paper analyses how these ethical issues were perceived, detected and managed by the researchers, and the role of ethics review committees in mental health research concerning IDPs. The relevance of guidelines and methodologies in the context of an atypical study population and the benefit versus risk potential of research for IDPs are also discussed. The limitations that were encountered while dealing with ethical challenges during the study are discussed. The concept of post-research ethical conduct audit is suggested to be considered as a potential step to minimize the exploitation of vulnerable populations such as IDPs in mental health research. (shrink)

Purpose The purpose of this article is to assess the operation of the UK’s Public Interest Disclosure Act 1998 (PIDA 1998) during its first 10 years and to consider its implications for the whistleblowing process. Method The article sets the legislation into context by discussing the common law background. It then gives detailed consideration to the statutory provisions and how they have been interpreted by the courts and tribunals. Results In assessing the impact of the legislation’s approach to (...) whistleblowing both in the UK and elsewhere, the author draws upon empirical research. Conclusion The author concludes that PIDA 1998 has not adequately protected whistleblowers and makes 12 recommendations for change. Despite the European Commission’s acknowledgement that whistleblowers can play a part in the fight against corruption, the author notes that common standards for their protection still seem a long way off. (shrink)

Improving the treatment of life threatening emergency illness or disease requires that new or novel therapies be assessed in clinical trials. As most subjects for these trials will be incapacitated there is some controversy about they might best protected whilst still allowing research to continue. Recent European and UK clinical trials legislation, which has effectively stopped research into emergency conditions, is discussed. Possible changes to these regulations are proposed.

The discussion about relations between research and design has a number of strands, and presumably motivations. Putting aside the question whether or not design or “creative endeavour” should be counted as research, for reasons to do with institutional recognition or reward, the question remains how, if at all, is design research? This question is unlikely to have attracted much interest but for matters external to Architecture within the modern university. But Architecture as a discipline now needs to (...) understand research much better than in the past when ‘research’ was whatever went on in building science, history or people/environment studies. In this paper, I begin with some common assumptions about design, considered in relation to research, and suggest how the former can constitute or be a mode of the latter. Central to this consideration is an understanding of research as the production of publicly available knowledge. (shrink)

Climate engineering (CE), the intentional modification of the climate in order to reduce the effects of increasing greenhouse gas concentrations, is sometimes touted as a potential response to climate change. Increasing interest in the topic has led to proposals for empirical tests of hypothesized CE techniques, which raise serious ethical concerns. We propose three ethical guidelines for CE researchers, derived from the ethics literature on research with human and animal subjects, applicable in the event that CE research progresses (...) beyond computer modeling. The Principle of Respect requires that the scientific community secure the global public's consent, voiced through their governmental representatives, before beginning any empirical research. The Principle of Beneficence and Justice requires that researchers strive for a favorable risk–benefit ratio and a fair distribution of risks and anticipated benefits, all while protecting the basic rights of affected individuals. Finally, the Minimization Principle requires that researchers minimize the extent and intensity of each experiment by ensuring that no experiments last longer, cover a greater geographical extent, or have a greater impact on the climate, ecosystem, or human welfare than is necessary to test the specific hypotheses in question. Field experiments that might affect humans or ecosystems in significant ways should not proceed until a full discussion of the ethics of CE research occurs and appropriate institutions for regulating such experiments are established. (shrink)

The use of experimental animals, mostly rodents, in biomedical research and especially in oncology and immunology should be acknowledged with respect, recognizing the contribution of animal experimentation in the fascinating scientific progress in these disciplines of research. It is an obligation of the investigator to justify the scientific and ethical aspects of each study requiring the use of animals. The international guiding principles for using animals in biomedical research are well defined and have been distributed worldwide by (...) the International Council for Laboratory Animal Science (ICLAS) since 1956, when this Organization was founded. In Poland the ICLAS philosophy and principles are highly respected and were implemented firstly by the members of the Commission on Biology of Experimental Animals appointed in 1962 by the Department of Medical Science of the Polish Academy of Science in Warsaw. Animal Protection Acts, first proclaimed in 1928 were gradually modified and improved. Actual legislation (enacted in 1997, 2003 and 2005) is consistent with EU Directives (86/609/EEC) and follows the internationally recommended principles that include ICLAS guidelines concerning animal welfare and care condition in biomedical research. The problem of “alternative methods” is briefly discussed. Dr. Donald Boisvert, CCAC — Canadian Council on Animal Care. (shrink)

The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for biomedical (...) research involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (shrink)

Background Even though we are now well into the 21st century and notwithstanding all the abuse to individuals involved in clinical studies that has been documented throughout History, fundamental ethical principles continue to be violated in one way or another. Discussion Here are some of the main factors that contribute to the abuse of subjects participating in clinical trials: paternalism, improper use of informed consent, lack of strict ethical supervision, pressure exerted by health institutions to increase the production of scientific (...) material, and the absence of legislation regarding ethics in terms of health care and research. Are researchers ready to respect fundamental ethical principles in light of the ample window of information provided by individual genomes, while defending the rights of the subjects participating in clinical studies as a major priority? Summary As one of the possible solutions to this problem, education regarding fundamental ethical principles is suggested for participants in research studies as an initial method of cognitive training in ethics, together with the promotion of ethical behavior in order to encourage the adoption of reasonable policies in the field of values, attitudes and behavior. (shrink)

This article notes differences in legislation in Germany and Great Britain regarding human embryo research and looks for an explanation in their divergent intellectual traditions. Whereas the German Stem Cell Act invokes an anthropological concept of human dignity to ground its ban on using embryos for research, there is no definition of what it means to be human in either the British Human Fertilisation and Embryology Act or in the advisory Warnock-Report. After studying the differences and providing (...) some philosophical background, the essay distinguishes two notions that are significant for understanding human dignity. It then proposes from a theological point of view a basic understanding within a relational anthropology, and comes to the conclusion that because of continuity in development and their relational constitution, humans embryos should be accepted as human from the moment of conception. (shrink)

Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to (...) the trial drug and the uses of such reasons. Data sources: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications’ notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. Results: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason’s interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. Limitations: reason types could be applied differently. The quality of reasons was not measured. Conclusion: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature. (shrink)

Production methods for food from U.K. livestock industries (milk, dairy products, meat, eggs, fibre) are undergoing substantial change as a result of the need to respond to environmental and animal welfare awareness of purchasing customers, and to espouse the principles of environmental protection. There appears to be a strong will on the part of livestock farmers to satisfy the environmental imperative, led by the need to maintain market share and by existing and impending legislation. There has been support forthcoming (...) in the form of Government-sponsored scientific research and technological development to provide the necessary framework for new environmentally sensitive practices. The agricultural community has itself made substantial responses to market demand through the inception of Farm Assured Quality Assurance Schemes. These appear to have a more sustainable future than the extremes of organic farming and free-range practices. Pollution of agricultural land with nitrate and phosphate by intensive livestock industries is a greater problem in some parts of continental Europe than it is in the U.K. The distribution of livestock out of intensive units and into mixed farming systems, would require substantial restructuring of the industry. Many of the animal welfare requirements which have been forwarded as a part of the environmental agenda for agriculture have been voluntarily accepted by livestock producers. However, some major aspects, such as alternative housing systems for pigs and poultry, remain unresolved. Analysis of the science and technology support for the environmental imperative, especially from Government sources, would suggest that, although dramatically increased in recent years, environmentally orientated research remains a relatively small proportion of the whole. Whilst a movement away from governmental funding of volume production appears to be justifiable, there has not been an equivalent balancing of effort toward funding for product quality, sustainability, environmental protection and animal welfare. Nevertheless, the university education system is producing a generation of more environmentally aware agricultural science graduates who are opting to pursue Government-sponsored environmentally orientated postgraduate research programs. (shrink)

This paper considers the legislative debates in Australia that led to the passage of the Research Involving Human Embryos Act (Cth 2002) and the Prohibition of Human Cloning Act (Cth 2002). In the first part of the paper, we discuss the debate surrounding the legislation with particular emphasis on the ways in which demands for public consultation, public debate and the education of Australians about the potential ethical and scientific impact of human embryonic stem cells (hESC) research (...) were deployed, and the explicit and implicit framing of the scope of public consultation. We then ask whether, given the calls for public consultations, debate and understanding, current work in democratic theory could be helpful in analysing the process of policy-making in these areas. In particular, we canvass the literature relating to aggregative and deliberative models of democracy for processes that support the legitimacy of policy. We identify features of the debate that reflect the appeal of deliberative approaches as well as some of the possible hurdles or limitations to developing deliberative democratic approaches to policy in ethically contentious areas. (shrink)

This paper explores the perceptions and experiences of four doctoral researchers to examine how research ethics committee (REC) processes have shaped and influenced specific health-based ethnographic studies. This paper considers how a universal tightening of ethical REC scrutiny at university level, as well as those governing the health and social care sector in the United Kingdom, impacts upon social research involving the inclusion of participants from certain groups. Increased restrictions in ethics scrutiny is justified as protecting vulnerable people (...) from intrusive research and is embedded in legislation, specifically the UK Mental Capacity Act 2005. The general international trend towards greater ethical scrutiny is heralded as an uncontested social good, yet this unquestioned assumption is tested in relation to qualitative social research methodologies that seek to explore the experiences of ?vulnerable? individuals. It is consequently argued that ethics review restrictions are in danger of disenfranchising sectors of the community, excluding them from engaging in social research activities that would serve to highlight their experiential and lived conditions. The enhanced bureaucratic control of the doctoral process in conjunction with the REC is also discussed as inhibiting proposed studies. (shrink)

Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results (...) Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)

In common with much of theEnglish-speaking world, New Zealandersgenerally oppose the use of animalexperimentation where there is no demonstrableand immediate benefit for human, animal, orenvironmental health. Intrusive experiments onsheep internal and external parasites publishedbetween 1996 and 2000 are reviewed, anddiscussed in relation to these publicsensibilities. A total of 16 publishedexperiments on sheep parasites involvedsurgical manipulations or other intrusiveprocedures. Some of these experiments had noshort-term application, or the only applicationwas in increasing animal production. Otherscould have been modified at some extra expenseso (...) that they were less intrusive. Still otherswere duplications of previous work. All thesemanipulations would be unacceptable accordingto the orthodox morality of the general public.Breeding programs, rotation of grazing,``low-tech'' vaccination, and in vitromodels of sheep can provide insights intopreventing parasite infestation withoutintrusive experiments. Such research protocolsshould take priority over existing programs.The results also confirm earlier reports thatanimal ethics committees are not fulfillingtheir mandated objective of acting as watchdogsfor the public. Possible changes in New Zealandanimal welfare legislation and itsinterpretation by Animal Ethics Committees arediscussed. (shrink)

Lainie Ross presents a rigorous critical investigation of the development of policy governing the involvement of children in medical research. She examines the shift in focus from protection of medical research subjects, enshrined in post-World War II legislation, to the current era in which access is assuming greater precedence. Infamous studies such as Willowbrook (where mentally retarded children were infected with hepatitis) are evidence that before the policy shift protection was not always adequate, even for the most (...) vulnerable groups. Additional safeguards for children were first implemented in many countries in the 1970s and 1980s; more recent policies and guidelines are trying to promote greater participation. Ross considers whether the safeguards work, whether they are fair, and how they apply in actual research practice. She goes on to offer specific recommendations to modify current policies and guidelines. Ross examines the regulatory structures (e.g. federal regulations and institutional review boards), the ad hoc policies (e.g. payment in pediatric research and the role of schools as research venues), the actual practices of researchers (e.g. the race/ethnicity of enrolled research subjects or the decision to enroll newborns) as well as the decision-making process (both parental permission and the child's assent), in order to provide a broad critique. Some of her recommendations will break down current barriers to the enrolment of children (e.g. permitting the payment of child research subjects; allowing healthy children to be exposed to research that entails more than minimal risk without requiring recourse to 407 panels); whereas other recommendations may create new restrictions (e.g., the need for greater protection for research performed in schools; restrictions on what research should be done in the newborn nursery). The goal is to ensure that medical research is done in a way that promotes the health of current and future children without threatening, to use the words of Hans Jonas, 'the erosion of those moral values whose loss . . . would make its most dazzling triumphs not worth having'. (shrink)

: Controversy has surrounded the institutions that facilitate discussion and regulation of American biomedical research for years. Recent challenges to the legitimacy of the President's Council on Bioethics have been focused on stem cell research. These arguments represent an opportunity to reconsider the legislation under which stem cell research is regulated, as well as to consider preexisting bodies like the Recombinant DNA Advisory Committee and National Bioethics Advisory Commission. This paper proposes a Federal Life Sciences Policy (...) Commission, a novel commission with advisory and regulatory powers that would benefit from the positive and negative lessons learned under the legislation that currently shapes the formation and institutional characteristics of advisory bodies in the United States. The Federal Life Sciences Policy Commission would have institutional independence not present in previous advisory bodies, while maintaining the tradition of broad societal representation and thoughtful discourse that has developed in the United States. (shrink)

The new generation of psychopharmacological products have proved their efficacy. Some neuro-degenerative diseases, such as Parkinson's and Alzheimer's diseases, could be treated by means of the gene therapy. Although the aetiology of such diseases is still not completely known, it has been proven that the patients lack some substances that could be produced by means of the transfer of in vivo or ex vivo genes that codify them in the proper places of the brain. Furthermore, it is announced that the (...) implantation in laboratory grown stem cells of diverse origins is very hopeful. Cerebral (micro)electronic implants could be effective to fight some motor diseases as well as sensory functions. All of these kinds of new treatments need to be tested through clinical research. Most national legislation includes provisions on the clinical trials of drugs and a series of guarantees, procedures and conditions which are designed to ensure protection for individuals used in experiments and to assure that the trial is indeed of scientific relevance. However, few lay down similar regulations or provide for specific controls for the research of other treatments. Finally, enhancement of psychic capacities pose new problems for society as well as do the need for new legal decisions. (shrink)

The use of medical records in research can yield information that is difficult to obtain by other means. When such records are released to investigators in identifiable form, however, substantial privacy and confidentiality risks may be created. These risks become more common and more serious as medical records move to an electronic format. In 1996, the state of Minnesota enacted legislation with respect to consent requirements for the use of medical records in research. This legislation has (...) been widely criticized because—it is claimed—it creates an unnecessary impediment to research. In this article, we show that these arguments rest upon misinterpretation and/or misrepresentation of the 1996 legislation. A consent requirement had actually been present in Minnesota since 1976 (though codified in a patient rights statute rather than a privacy statute). The 1996 law does not require specific consent, as often claimed, but rather only a general authorization. The campaign against the Minnesota legislation appears to have been motivated by concern with respect to the then impending federal privacy rule. The HIPAA rule, as enacted, is in fact less stringent with respect to consent than the Minnesota consent law. On the other hand, the Minnesota consent law has not been effectively applied or enforced. As we change the way we manage sensitive medical information, new efforts are needed to provide protection against the confidentiality risks in research. Patient consent is an important tool in this regard. New instrumentalities are needed to solicit and document consent. (shrink)

In 2006 the Government issued a White Paper in which it proposed a ban on human-animal embryo research pending greater clarity on its potential. The Commons Select Committee on Science and Technology initiated an Inquiry and concluded that such research was necessary and should be permitted immediately. The Government agreed and this is reflected in revised legislation. The Government has issued guidelines on the gathering and use of scientific advice and evidence, designed to ensure that these are (...) “credible, reliable and objective.” This article tests the Committee’s approach in the light of its remit and these, and other, relevant guidelines and concludes that it failed to meet these standards. Rather, it effectively ceded to an interest group the regulation of its own activities. The article ends by suggesting alterations to the Committee’s remit and composition designed to ensure that the public interest is better protected in future. (shrink)

While research on children is supported by many professional guidelines, international declarations and domestic legislation, when it is undertaken on children with no possibility of direct benefit it rests on shaky moral foundations. A number of authors have suggested that research enrolment is in the child's best interests, or that they have a moral duty or societal obligation to participate. However, these arguments are unpersuasive. Rather, I will propose in this paper that research participation by children (...) seems most reasonable when considered as an act of solidarity; a form of identification with, and provision of practical assistance to, those who are less well off. This is an articulation of the view that many children, and their parents, seem to take seriously the suffering of others, and wish to assist in advancing other children's wellbeing. Perhaps, by fostering an environment in which children are encouraged to take solidarity seriously, participation in research which holds out substantial hope of benefit to those less well off would come to be perceived as a behavioural norm rather than an exceptional practice. (shrink)

This article deals with the discussion on the status of the human embryo in Italy on a philosophical, socio-ethical and juridical level before, during and after the law (n. 40/2004). Different lines of thought are outlined and critically discussed. The focus is the debate over the so-called embryonic stem cells, pointing out the ethical premises and the juridical implications. The regulations in Italy are analysed in detail, referring to legislation and jurisprudence (showing analogies and differences). In particular the author (...) includes evidence for the debate after the law came in, with specific attention on the question of the use of imported embryonic stem cells and public financing for research and the problem of the use of frozen and non-implantable embryos. (shrink)

In this paper the permissibility of stem cell research on early human embryos is defended. It is argued that, in order to have moral status, an individual must have an interest in its own wellbeing. Sentience is a prerequisite for having an interest in avoiding pain, and personhood is a prerequisite for having an interest in the continuation of one's own existence. Early human embryos are not sentient and therefore they are not recipients of direct moral consideration. Early human (...) embryos do not satisfy the requirements for personhood, but there are arguments to the effect that they should be treated as persons nonetheless. These are the arguments from potentiality, symbolic value and the principle of human dignity. These arguments are challenged in this paper and it is claimed that they offer us no good reason to believe that early human embryos should be treated as persons. (shrink)

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell (...) class='Hi'>research -- International research. (shrink)

This book presents a comprehensive guide to interpretative phenomenological analysis (IPA) which is an increasingly popular approach to qualitative inquiry taught to undergraduate and postgraduate students today. The first chapter outlines the theoretical foundations for IPA. It discusses phenomenology, hermeneutics, and idiography and how they have been taken up by IPA. The next four chapters provide detailed, step by step guidelines to conducting IPA research: study design, data collection and interviewing, data analysis, and writing up. In the next section, (...) the authors give extended worked examples from their own studies in health, sexuality, psychological distress, and identity to illustrate the breadth and depth of IPA research. The final section of the book considers how IPA connects with other contemporary qualitative approaches like discourse and narrative analysis and how it addresses issues to do with validity. (shrink)

Some theorists who emphasize the complexity of biological and cognitive systems and who advocate the employment of the tools of dynamical systems theory in explaining them construe complexity and reduction as exclusive alternatives. This paper argues that reduction, an approach to explanation that decomposes complex activities and localizes the components within the complex system, is not only compatible with an emphasis on complexity, but provides the foundation for dynamical analysis. Explanation via decomposition and localization is nonetheless extremely challenging, and an (...) analysis of recent cognitive neuroscience research on memory is used to illustrate what is involved. Memory researchers split between advocating memory systems and advocating memory processes, and I argue that it is the latter approach that provides the critical sort of decomposition and localization for explaining memory. The challenges of linking distinguishable functions with brain processes is illustrated by two examples: competing hypotheses about the contribution of the hippocampus and competing attempts to link areas in frontal cortex with memory processing. (shrink)

This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, and (...) suggests procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (shrink)

The tension in evidence-based practice and reflective practice -- The relationship between reflection and action research -- An overview of theories of consciousness and unconsciousness -- What do we mean by creativity? -- Using metaphor and symbolism as analysis -- Infinite possibilities of knowing and transformation -- Concluding thoughts; the linkages to action research and critical creativity.

This paper distinguishes two conceptions of representation at work in the philosophical literature. On the first, "contentive" conception (found, for example, in Searle and Fodor), something is a representation, roughly, if it has "propositional content". On the second, "indicative" conception (found, for example, in Dretske), representations must not only have content but also have the function of indicating something about the world. Desire is representational on the first view but not on the second. This paper argues that philosophers and psychologists (...) have sometimes conflated these two conceptions, and it examines the consequences of this conflation for the developmental literature on the child's understanding of mind. Specifically, recent research by Gopnik and Perner on the child's understanding of desire is motivated by an argument that equivocates between the two conceptions of representation. Finally, the paper suggests that an examination of when the child understands the possibility of misrepresentation in art would be helpful in charting the child's understanding of indicative representation. (shrink)

The paper approaches the topic of what a general philosophy of science could mean today from the perspective of a historical epistemology. Consequently, in a first step, the paper looks at the notion of generality in the sciences, and how it evolved over time, on the example of the life sciences. In the second part of the paper, the urgency of a general philosophy of science is located in the history of philosophy of science. Two attempts at the beginning of (...) the twentieth century are particularly highlighted: that of Karl Popper and that of Martin Heidegger. Both of them concentrate, albeit in widely different form, on the phenomenon of research as an open-ended process. This trend is even more pronounced in Gaston Bachelard’s version of a historical epistemology, whose work is taken as a point of reference for a general historical epistemology of research. The paper concludes with a plea to look, with Georges Canguilhem, at the history of the sciences as a laboratory for epistemology. (shrink)

Abstract I argue that embryonic stem cell research is fair to the embryo, even on the assumption that the embryo has attained full personhood and an attendant right to life at conception. This is because the only feasible alternatives open to the embryo are to exist briefly in an unconscious state and be killed or to not exist at all. Hence, one is neither depriving the embryo of an enduring life it would otherwise have had nor is one causing (...) the embryo pain. I also argue that a rational agent in a situation relevantly similar to that of the embryo would consent to such research, and I use this insight to ground two justice-based arguments in favor of this research. Content Type Journal Article Category Original Research Pages 1-9 DOI 10.1007/s11673-012-9364-0 Authors Aaron Rizzieri, The Humanities Department (E-202), LaGuardia Community College, 31-10 Thompson Ave, Long Island City, NY 11101, USA Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529. (shrink)

Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at (...) leading cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)

It has often been argued, by philosophers and more recently by developmental psychologists, that our common-sense conception of the mind should be regarded as a scientific theory. However, those who advance this view rarely say much about what they take a scientific theory to be. In this paper, I look at one specific proposal as to how we should interpret the theory view of folk psychology--namely, by seeing it as having a structure analogous to that of a Lakatosian research (...) program. I argue that although the Lakatosian model may seem promising--particularly to those who are interested in studying the development of children's understanding of the mind--the analogy between Lakatosian research programs and folk psychology cannot be made good because folk psychology does not possess anything analogous to the positive heuristic of a Lakatosian research program. I also argue that Lakatos' account of theories may not be the best one for developmental psychologists to adopt because of the emphasis which Lakatos places on the social embeddedness of scientific theorising. (shrink)

Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the (...) unique concerns that arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that arise when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging issues in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (shrink)

0n a lucid, concise volume, Jeremy Waldron defends the role of legislation, presenting it as an important mode of governance. Aristotle, Locke and Kant emerge as proponents of the dignity of legislation. Waldron's arguments are of obvious importance and topicality, especially in countries that are considering the introduction of a Bill of Rights. The Dignity of Legislation is original in conception, trenchantly argued and very clearly presented, and will be of interest to a wide range of scholars (...) and thinkers. (shrink)

Biomedical Research and Beyond: Expanding the Ethics of Inquiry investigates the ethics of biomedical and scientific inquiry, including embryonic research, animal research, genetic enhancement, and fairness in research in the developing world. Core concerns of biomedical and scientific research ethics are then shown also to be key in humanistic areas of inquiry. Biomedical Research and Beyond concludes with a discussion of the virtues that all inquirers, scientific, medical, and humanistic, should possess.

As we approach the end of the twentieth century, the ways in which knowledge--scientific, social, and cultural--is produced are undergoing fundamental changes. In The New Production of Knowledge, a distinguished group of authors analyze these changes as marking the transition from established institutions, disciplines, practices, and policies to a new mode of knowledge production. Identifying such elements as reflexivity, transdisciplinarity, and heterogeneity within this new mode, the authors consider their impact and interplay with the role of knowledge in social relations. (...) While the knowledge produced by research and development in science and technology is accorded central focus, the authors also outline the changing dimensions of social scientific and humanities knowledge and the relations between the production of knowledge and its dissemination through education. Placing science policy and scientific knowledge within the broader context of contemporary society, this book will be essential reading for all those concerned with the changing nature of knowledge, with the social study of science, with educational systems, and with the correlation between research and development and social, economic, and technological development. "Thought-provoking in its identification of issues that are global in scope; for policy makers in higher education, government, or the commercial sector." --Choice "By their insightful identification of the recent social transformation of knowledge production, the authors have been able to assert new imperatives for policy institutions. The lessons of the book are deep." --Alexis Jacquemin, Universite Catholique de Louvain and Advisor, Foreign Studies Unit, European Commission "Should we celebrate the emergence of a 'post-academic' mode of postmodern knowledge production of the post-industrial society of the 21st Century? Or should we turn away from it with increasing fear and loathing as we also uncover its contradictions. A generation of enthusiasts and/or critics will be indebted to the team of authors for exposing so forcefully the intimate connections between all the cognitive, educational, organizational, and commercial changes that are together revolutionizing the sciences, the technologies, and the humanities. This book will surely spark off a vigorous and fruitful debate about the meaning and purpose of knowledge in our culture." --Professor John Ziman, (Wendy, Janey at Ltd. is going to provide affiliation. Contact if you don't hear from her.) "Jointly authored by a team of distinguished scholars spanning a number of disciplines, The New Production of Knowledge maps the changes in the mode of knowledge production and the global impact of such transformations. . . . The authors succeed . . . at sketching out, in very large strokes, the emerging trends in knowledge production and their implications for future society. The macro focus of the book is a welcome change from the micro obsession of most sociologists of science, who have pretty much deconstructed institutions and even scientific knowledge out of existence." --Contemporary Sociology "This book is a timely contribution to current discussion on the breakdown of and need to renegotiate the social contract between science and society that Vannevar Bush and likeminded architects of science policy constructed immediately after World War II. It goes far beyond the usual scattering of fragmentary insights into changing institutional landscapes, cognitive structures, or quality control mechanisms of present day science, and their linkages with society at large. Tapping a wide variety of sources, the authors provide a coherent picture of important new characteristics that, taken altogether, fundamentally challenge our traditional notions of what academic research is all about. This well-founded analysis of the social redistribution of knowledge and its associated power patterns helps articulate what otherwise tends to remain an--albeit widespread--intuition. Unless they adapt to the new situation, universities in the future will find the centers of gravity of knowledge production moving even further beyond their ken. Knowledge of the social and cognitive dynamics of science in research is much needed as a basis of science and technology policymaking. The New Production of Knowledge does a lot to fill this gap. Another unique feature is its discussion of the humanities, which are usually left out in works coming out of the social studies of science." --Aant Elzinga, University od Goteborg. (shrink)

When is clinical research ethical? The difficulty in answering this question lies in the dual nature of research on human subjects, which yields two somewhat conflicting sets of obligations. On the one hand, there is the traditional view of science that includes the idea of an obligation to learn about the world. On the other hand, there is the obligation of care on the part of researchers towards individual participants in the research ...

This book defends the prospects for a science of society. It argues that behind the diverse methods of the natural sciences lies a common core of scientific rationality that the social sciences can and sometimes do achieve. It also argues that good social science must be in part about large-scale social structures and processes and thus that methodological individualism is misguided. These theses are supported by a detailed discussion of actual social research, including theories of agrarian revolution, organizational ecology, (...) social theories of depression, and supply-demand explanations in economics. Professor Kincaid provides a general picture of explanation and confirmation in the social sciences and discusses the nature of scientific rationality, functional explanation, optimality arguments, meaning and interpretation, the place of microfoundations in social explanation, the status of neo-classical economics, the role of idealizations and non-experimental evidence, and other specific controversies. (shrink)

To determine the knowledge, attitude, and ethical concerns of medical students and graduates with regard to Embryonic Stem Cell (ESC) research. This questionnaire based descriptive study was conducted at the Civil Hospital Karachi (CHK), Pakistan from February to July 2008. A well structured questionnaire was administered to medical students and graduate doctors, which included their demographic profile as well as questions in line with the study objective. Informed consent was taken and full confidentiality was assured to the participants. Data (...) were entered in a Statistical Package for Social Sciences (SPSS version.12) and analyzed. A total of 204 male and 216 female medical students and doctors were administered questionnaires out of which 105 males (51.4%) and 108 females (50%) were aware of the embryonic stem cell research and its ethical implications. Forty percent males and 47% of females were of the opinion that life begins at conception. Forty-six percent males and 39% females were in favor of stem cell research while only 31% males and 28% females supported the ESC research. Less than 1/3 of students supported using frozen embryos for research purposes while more than 2/3 indicated that they were unlikely to support abortion for stem cell research purposes. The majority of the students were in favor of stem cell research with some reservations regarding ESC research. A sizeable number of students withheld their views, reflecting their poor understanding of medical ethics. The result of the study indicates a need for incorporating bioethics into the medical curriculum. (shrink)

Group Rationality in Scientific Research.

It is important to be able to offer an account of which activities count as scientific research, given our current interest in promoting research as a means to benefit humankind and in ethically regulating it. We attempt to offer such an account, arguing that we need to consider both the procedural and functional dimensions of an activity before we can establish whether it is a genuine instance of scientific research. By placing research in a broader schema (...) of activities, the similarities and differences between research activities and other activities become visible. It is also easier to show why some activities that do not count as research can sometimes be confused with research and why some other activities can be regarded only partially as research. Although the concept of research is important to delimit a class of activities which we might be morally obliged to promote, we observe that the class of activities which are regarded as subject to ethical regulation is not exhausted by research activities. We argue that, whether they be research or not, all the activities that are likely to affect the rights and interests of the individuals involved and impact on the rights and interests of other individuals raise ethical issues and might be in need of ethical regulation. (shrink)

This discussion paper proposes that a meaningful distinction between science and technoscience can be found at the level of the objects of research. Both notions intermingle in the attitudes, intentions, programs and projects of researchers and research institutions—that is, on the side of the subjects of research. But the difference between science and technoscience becomes more explicit when research results are presented in particular settings and when the objects of research are exhibited for the specific (...) interest they hold. When an experiment is presented as scientific evidence which confirms or disconfirms a hypothesis, this agrees with traditional conceptions of science. When organic molecules are presented for their capacity to serve individually as electric wires that carry surprisingly large currents, this would be a hallmark of technoscience. Accordingly, we propose research on the ontology of research objects. The focus on the character and significance of research objects makes this a specifically philosophical project. (shrink)

Ethics and Educational Research: An Introduction Robert G. Burgess Ethical questions are the subject of interdisciplinary discussions and debates. ...

It is widely agreed that foreign sponsors of research in low- and middle-income countries (LMICs) are morally required to ensure that their research benefits the broader host community. There is no agreement, however, about how much benefit or what type of benefit research sponsors must provide, nor is there agreement about what group of people is entitled to benefit. To settle these questions, it is necessary to examine why research sponsors have an obligation to benefit the (...) broader host community, not only their subjects. Justifying this claim is not straightforward. There are three justifications for an obligation to benefit host communities that each apply to some research, but not to all. Each requires a different amount of benefit, and each requires benefit to be directed toward a different group. If research involves significant net risk to LMIC subjects, research must provide adequate benefit to people in LMICs to avoid an unjustified appeal to subjects’ altruism. If research places significant burdens on public resources, research must provide fair compensation to the community whose public resources are burdened. If research is for profit, research sponsors must contribute adequately to the upkeep of public goods from which they benefit in order to avoid the wrong of free-riding, even if their use of these public goods is not burdensome. (shrink)

On both sides of the debate on the use of embryos in stem cell research, and in reproductive technologies more generally, rhetoric and symbolic images have been evoked to influence public opinion. Human embryos themselves are described as either “very small human beings” or “small clusters of cells.” The intentions behind the use of these phrases are clear. One description suggests that embryos are already members of our community and share with us a right to life or at least (...) respectful treatment, whereas the other focuses on the differences between embryos and adult human beings with normal capacities, that is, their lack of sentience and of personal identity. The research on stem cells has been nicknamed “Frankenstein science” or presented as “research that could stop Parkinson disease.” Again, one description reminds us of scary science-fiction scenarios where the scientist is guilty of “playing God,” whereas the other description highlights the worth and potential benefits of the research outcomes. (shrink)

The art, craft, and science of policing -- Crime and criminals -- Criminal process and prosecution -- The crime-preventive impact of penal sanctions -- Contracts and corporations -- Financial markets -- Consumer protection -- Bankruptcy and insolvency -- Regulating the professions -- Personal injury litigation -- Claiming behavior as legal mobilization -- Families -- Labor and employment laws -- Housing and property -- Human rights instruments -- Constitutions -- Social security and social welfare -- Occupational safety and health -- Environmental (...) regulation -- Administrative justice -- Access to civil justice -- Judicial recruitment, training, and careers -- Trial courts and adjudication -- Appellate courts -- Dispute resolution -- Lay decision-makers in the legal process -- Evidence law -- Civil procedure and courts -- Collective actions -- Law and courts on development and democratization -- How does international law work? -- Lawyers and other legal service providers -- Legal pluralism -- Public images and understandings of courts -- Legal education and the legal academy -- The (nearly) forgotten early empirical legal research -- Quantitative approaches to empirical legal research -- Qualitative approaches to empirical legal research -- The need for multi-method approaches in empirical legal research -- Legal theory and empirical research -- Empirical legal research and policy-making -- The place of empirical legal research in the law school curriculum -- Empirical legal training in the US academy. (shrink)

This volume assesses the ethical, quantitative, and qualitative questions posed by the current financing of biomedical research.

The current neurosciences contribute to the construction of gender/sex to a high degree. Moreover, the subject of gender/sex differences in cognitive abilities attracts an immense public interest. At the same time, the entanglement of gender and science has been shown in many theoretical and empirical analyses. Although the body of literature is very extensive and differentiated with regards to the dimensions of ‘neuroscience of gender’ and ‘gender in neuroscience’, the feeding back of these findings into the field of neuroscience remains (...) a desideratum. Especially, the question of how gender knowledge, i.e. insights from feminist theory on gender/sex and from gender and science studies on knowledge production, may be integrated and applied within the neurosciences has been strongly neglected. Presumably due to their epistemic culture and epistemological presuppositions, these critical engagements are conceived as externalist by critical scholars and neuroscientists alike. In this context, the question arises of how substantiated gender knowledge may be accounted for in neuroscientific research practice? The article outlines methodological considerations for a critical research agenda in the cognitive neurosciences. I present thoughts on how insights and expertise from gender and science studies can be taken into account in the neuroscientific practice of knowledge production. Starting from the assumption that changes in neuroscientific research practices are possible, my aim is to point out possibilities of integrating gender knowledge into the neurosciences. (shrink)

Both professors and institutions of higher education benefit from a vision of academic life that is grounded more firmly in myth than in history. According to the myth created by that traditional vision, scholars pursue research wherever their drive to knowledge takes them, and colleges and universities transmit the fruits of that research to contemporary and future generations as the accumulated wisdom of the ages. Yet the economic and social forces operating on colleges and universities as institutions, as (...) well as on the interests of faculty members within them, are making the myth embodied in the traditional ideal of the academy more and more difficult to sustain. Questions about what an institution of higher education ought to be, about what professors ought to do, and about what relations professors ought to have to the institutions which employ them are being raised and pushed to the fore. These are not theoretical questions, but practical questions of immediate import that must be answered relatively quickly -- and wisely -- if institutions of higher education and professors are not to find themselves inextricably in the grip of forces they cannot change. The myth of disinterested academic research-however beautiful -- and however beneficial -- is under siege. (shrink)

An understanding of the ethical problems that have arisen in the funding of scientific research at universities requires some attention to doctrines that have traditionally been held about science itself. Such doctrines, we hope to show, are themselves central to many of these ethical problems. It is often thought that the questions examined by scientists, and the theories that guide scientific research, are chosen for uniquely scientific reasons, independently of extra-scientific questions of value or merit. We shall argue (...) that this is an illusion. It is an illusion to think, especially in the present era, that science can even have a coherent direction apart from extra-scientific considerations. (shrink)

A common complaint against the increasing privatization of research is that research that is conducted with the immediate purpose of producing applicable knowledge will not yield knowledge as valuable as that generated in more curiosity‐driven, academic settings. In this paper, I make this concern precise and reconstruct the rationale behind it. Subsequently, I examine the case of industry research on the giant magnetoresistance effect in the 1990s as a characteristic example of research undertaken under considerable pressure (...) to produce applicable results. The example permits one to arrive at a more optimistic assessment of the epistemic merits of private, application‐driven research. I attempt to specify the conditions that, in this case, advanced the production of interesting and reliable knowledge. (shrink)

Over the last decade, stem cell research has generated an enormous amount of public, political and bioethical debate. These debates have overwhelmingly tended to focus on two moral issues: the moral status of human embryos and the duty to care for the sick and vulnerable. This preoccupation, especially on the question of moral status, has not only dichotomized the debate around two fundamentally incommensurable positions, it has come at the cost of other important issues largely being ignored. In highlighting (...) some of the bioethical and regulatory deficiencies of this fixation, we draw on recent developments in the experimental use of autologous adult stem cells to argue for a more inclusive approach to the ethical issues surrounding stem cell research. (shrink)

Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1–8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65–81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75–98, 2010) and “sham” surgery (Macklin in N Engl J Med 341:992–996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research is more (...) than minimal risk with no promise of direct benefit. The principal reason given for allowing research that is more than minimal risk without benefit is that we should respect the autonomy of competent subjects. I argue that though the moral intuitions informing respect for autonomy are sound, there is another set of intuitions regarding what we take to be just treatment of another when one agent knowingly causes or allows suffering on another agent. I argue that concerns generated by commutative justice serve as limitations on permissible research. I highlight our intuitions informing this notion of justice by appealing to work done on theodicy; what counts as a morally sufficient reason for God to allow suffering in humans is applicable also to the researcher-subject relationship. I conclude that all human subjects who are exposed to more than minimal risk research should enjoy the same actual protections (e.g., subpart D) as those given subjects who cannot consent. (shrink)

The issue of plagiarism—claiming credit for work that is not one’s own, rightly, continues to cause concern in the academic community. An analysis is presented that shows the effects that may arise from metrics-based assessments of research, when credit for an author’s outputs (chiefly publications) is given to an institution that did not support the research but which subsequently employs the author. The incentives for what is termed here “institutional plagiarism” are demonstrated with reference to the UK (...) class='Hi'>Research Assessment Exercise in which submitting units of assessment are shown in some instances to derive around twice the credit for papers produced elsewhere by new recruits, compared to papers produced ‘in-house’. (shrink)

In early 2009, President Obama overturned the ban on federal funding for research involving the derivation of human embryonic stem cells (hESC). The Food and Drug Administration (FDA) also approved Geron’s first-in-human hESC trial for spinal cord injury (SCI) patients. We anticipate an increase in both research in the United States to derive hESC and applications to the FDA for approval of clinical trials involving transplantation of hESCs. An increase of such clinical trials will require a concomitant increase (...) in the number of preceding preclinical assays. We examine important issues concerning the use of animals in SCI stem cell research that require a reevaluation of the moral permissibility of studies such as Geron’s. (shrink)

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (...) (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. (shrink)

In their recent paper in this journal, Heinz and colleagues accuse proponents of cognitive enhancement of making two unjustified assumptions. The first of these is the assumption that neuroenhancing drugs will be safe; the second is that research into cognitive enhancement does not pose particular ethical problems. Heinz and colleagues argue that both these assumptions are false. Here, I argue that these assumptions are in fact correct, and that Heinz and colleagues themselves make several assumptions that undermine their argument. (...) Neuroenhancement does raise several ethical concerns, but safety and research in this area pose no unique difficulties. (shrink)

This study looks at some of the traits that characterized Argentina’s scientific and university policies under the military regime that spanned from 1976 through 1983. To this end, it delves into a rarely explored empirical observation: financial resource transfers from national universities to the National Scientific and Technological Research Council (CONICET, for its Spanish acronym) during that period. The intention is to show how, by reallocating funds geared to Science and Technology, CONICET was made to expand and decentralize to (...) the detriment of universities. This was the primary tool used by the military regime to thwart higher education’s research development, bolstering research efforts at other realms. Thus, CONICET grew in budget, number of researchers, and staff size, creating new research institutes, while national universities struggled with reduced funding and were forced to shut down their institutes and programs. As a result, CONICET virtually concentrated all scientific research, foregoing the knowledge accumulated at universities, which drove a wedge between both institutions. This military approach to science and technology policy-making is discussed, bearing in mind the notion of dependence—both in terms of the state’s intervention in the inner workings of the scientific-university field as well as regarding the role played by international financial support in scientific research development. (shrink)

In this paper, the results of a pilot interview study with 19 subjects participating in an EEG-based non-invasive brain–computer interface (BCI) research study on stroke rehabilitation and assistive technology and of a survey among 17 BCI professionals are presented and discussed in the light of ethical, legal, and social issues in research with human subjects. Most of the users were content with study participation and felt well informed. Negative aspects reported include the long and cumbersome preparation procedure, discomfort (...) with the cap and the wet electrodes, problems concerning BCI control, and strains during the training sessions. In addition, some users reflected on issues concerning system security. When asked for morally problematic issues in this field of non-invasive BCI research, the BCI professionals stressed the need for correct information transfer, the obligation to avoid unrealistic expectations in study participants, the selection of study participants, benefits and strains of participation, BCI illiteracy, the possibility of detrimental brain modifications induced by BCI use, and problems that may arise at the end of the trials. Furthermore, privacy issues were raised. Based on the results obtained, psychosocial and ethical aspects of EEG-based non-invasive BCI research are discussed and possible implications for future research addressed. (shrink)

Pt. 1. Conceputal issues -- pt. 2. Qualitative research -- pt. 3. Quantitative approaches.

Background: This article describes the types of community-wide benefits provided by investigators conducting public health research in South Asia as well as their self-reported reasons for providing such benefits. Methods: We conducted 52 in-depth interviews to explore how public health investigators in low-resource settings make decisions about the delivery of ancillary care to research subjects. In 39 of the interviews respondents described providing benefits to members of the community in which they conducted their study. We returned to our (...) narrative dataset to find answers to two questions: What types of community-wide benefits do researchers provide when conducting public health intervention studies in the community setting, and what reasons do researchers give when asked why they provided community-wide benefits? Findings: The types of community-wide benefits delivered were directed to the health and well-being of the population. The most common types of benefits delivered were the facilitation of access to health care for individuals in acute medical need and emergency response to natural disasters. Respondents' self-reported reasons when asked why they provided such benefits fell into 2 general categories: intrinsic importance and instrumental importance. (shrink)

BackgroundDue to the important role of depression in major illnesses, screening measures for depression are commonly used in medical research. The protocol for managing participants with positive screens is unclear and raises ethical concerns. The aim of this article is to identify and critically discuss the ethical issues that arise when a positive screen for depression is detected, and offer some guidance on managing these issues.DiscussionDeciding on whether to report positive screens to healthcare practitioners is both an ethical and (...) a pragmatic dilemma. Evidence suggests that reporting positive depression screens should only be considered in the context of collaborative care. Possible adverse effects, such as the impact of false-positive results, potentially inappropriate labelling, and potentially inappropriate treatment also need to be considered. If possible, the psychometric properties of the selected screening measure should be determined in the target population, and a threshold for depression that minimises the rate of false-positive results should be chosen. It should be clearly communicated to practitioners that screening scores are not diagnostic for depression, and they should be informed about the diagnostic accuracy of the measure. Research participants need to be made aware of the consequences of the detection of high scores on screening measures, and to be fully informed about the implications of the research protocol.SummaryFurther research is needed and the experiences of researchers, participants, and practitioners need to be collated before the value of reporting positive screens for depression can be ascertained. In developing research protocols, the ethical challenges highlighted should be considered. Participants must be agreeable to the agreed protocol and efforts should be made to minimise potentially adverse effects. (shrink)

Globalization, political upheavals, and Western economic struggles have caused a geographical reprioritization in the realm of drug development and human clinical research. Regulatory and cost hurdles as well as a saturation of research sites and subjects in Western countries have forced the pharmaceutical industry to place an unprecedented level of importance on emerging markets, injecting Western corporate initiatives into cultures historically and socially isolated from Western-centric value systems. One of the greatest recipients of this onslaught of Western business (...) and research practices is the Russian Federation. Namely, market forces are dictating a focused research initiative in the traditional emerging markets, but this focus may be at the expense of individual and societal dignity. (shrink)

This article analyses current trends in and future expectations of nanotechnology and other key enabling technologies for security as well as dual use nanotechnology from the perspective of the ethical Just War Theory (JWT), interpreted as an instrument to increase the threshold for using armed force for solving conflicts. The aim is to investigate the relevance of the JWT to the ethical governance of research. The analysis gives rise to the following results. From the perspective of the JWT, military (...) research should be evaluated with different criteria than research for civil or civil security applications. From a technological perspective, the boundaries between technologies for civil and military applications are fuzzy. Therefore the JWT offers theoretical grounds for making clear distinctions between research for military, civil security and other applications that are not obvious from a purely technological perspective. Different actors bear responsibility for development of the technology than for resorting to armed force for solving conflicts or for use of weapons and military technologies in combat. Different criteria should be used for moral judgment of decisions made by each type of actor in each context. In addition to evaluation of potential consequences of future use of the weapons or military technologies under development, the JWT also prescribes ethical evaluation of the inherent intent and other foreseeable consequences of the development itself of new military technologies. (shrink)

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC’s compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009–February 2011) divided into quarters to better value the influence of the new insurance coverage (...) regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC’s opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place. (shrink)

Background: Waiving parent permission can be an option in some epidemiological and social research with adolescents. However, exemptions have not been uniformly considered or applied. Our aim is to critically assess the different factors that could be taken into account when making decisions about waiving active parental permission in observational research with adolescents.DiscussionIn some cases alternatives to parental permission could be applied to protect the rights of both adolescents and parents and also to assure the benefits to adolescents (...) as a group that can come from appropriately conducted studies. However, the criteria of ensuring minimal risk can be difficult to define and apply and a distinction between harm and discomfort is reviewed. Waiving active parental permission could be acceptable when the risk of harm is minimal; when the research questions are related to an activity for which adolescents are not legally considered to be children; when the risk of harm or discomfort may increase if parental permission is required; and when risk of discomfort is low because the questionnaire is not potentially offensive for some adolescents and/or for some parents.SummaryStringent rules concerning parental permission in some studies could be detrimental to adolescents. A framework and a decision tree guide are proposed to help researchers and Research Ethics Committees in their decisions on whether active parental permission must be obtained. (shrink)

We argue that the recommendations made by the Institute of Medicine’s 2011 report, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity, are methodologically and ethically confused. We argue that a proper understanding of evolution and complexity theory in terms of the science and ethics of using chimpanzees in biomedical research would have had led the committee to recommend not merely limiting but eliminating the use of chimpanzees in biomedical research. Specifically, we argue that a proper understanding (...) of the difference between the gross level of examination of species and examinations on finer levels can shed light on important methodological and ethical inconsistencies leading to ignorance of potentially unethical practices and policies regarding the use of animals in scientific research. (shrink)

The Hwang affair, a dramatic and far reaching instance of scientific fraud, shocked the world. This collective national failure prompted various organizations in Korea, including universities, regulatory agencies, and research associations, to engage in self-criticism and research ethics reforms. This paper aims, first, to document and review research misconduct perpetrated by Hwang and members of his research team, with particular attention to the agencies that failed to regulate and then supervise Hwang’s research. The paper then (...) examines the research ethics reforms introduced in the wake of this international scandal. After reviewing American and European research governance structures and policies, policy makers developed a mixed model mindful of its Korean context. The third part of the paper examines how research ethics reform is proactive (a response to shocking scientific misconduct and ensuing external criticism from the press and society) as well as reactive (identification of and adherence to national or international ethics standards). The last part deals with Korean society’s response to the Hwang affair, which had the effect of a moral atomic bomb and has led to broad ethical reform in Korean society. We conceptualize this change as ethical modernization, through which the Korean public corrects the failures of a growth-oriented economic model for social progress, and attempts to create a more trustworthy and ethical society. (shrink)

As the_number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled. Includes a (...) manual for investigators, research nurses and study coordinators with minimal experience or who are new to clinical research An easy-to-read and open text design using ‘sidebars’ of examples and information boxes related to the main text Includes a list of Frequently Asked Questions and Glossary Duke Clinical Research Institute is the world’s largest academic clinical research organisation and is well known and respected within the clinical research community. (shrink)

There is currently a gap between assessment and intervention in the literature concerned with climate change and food. While intervention is local and context dependent, current assessments are usually global and abstract. Available assessments are useful for understanding the scale of the effects of climate change and they are ideal for motivating arguments in favor of mitigation and adaptation. However, adaptation projects need assessments that can provide data to support their efforts. This requires the adoption of a more local and (...) context-sensitive approach to assessments. I suggest that Community-Based Participatory Research has the potential to be a tool for such an approach. (shrink)

To identify motivational factors linked to child health status that affected the likelihood of parents’ allowing their child to participate in pediatric research.

This monograph examines the past, present, and potential relationship between American pragmatism and communication research. The contributors provide a bridge between communication studies and philosophy, subjects often developed somewhat in isolation from each other. Addressing topics, such as qualitative and quantitative research, ethics, media research, and feminist studies, the chapters in this volume: *discuss how a pragmatic, Darwinian approach to inquiry has guided and might further guide communication research; *advocate a functional view of communication, based on (...) Dewey's mature notion of transaction; *articulate a pragmatist's aesthetics and connect it to Deweyan democracy; *discuss the similarities and differences between Dewey's notion of inquiry and the philosophical hermeneutics of Hans-Georg Gadamer; *apply accommodation theory, linked to symbolic interactionism and more generally to the social behaviorism of George H. Mead and his followers, to media research; *interpret media-effects evidence in light of pragmatist ideas about inquiry; and *argue that pragmatism theorizes about despair and life's sense of the tragic. This book is written to be readily accessible to students and professional academics within and outside the field of communication studies without extensive training in specialized areas of communication study. (shrink)

Health research has been identified as a vehicle for advancing global justice in health. However, in bioethics, issues of global justice are mainly discussed within an ongoing debate on the conditions under which international clinical research is permissible. As a result, current ethical guidance predominantly links one type of international research (biomedical) to advancing one aspect of health equity (access to new treatments). International guidelines largely fail to connect international research to promoting broader aspects of health (...) equity – namely, healthier social environments and stronger health systems. Bioethical frameworks such as the human development approach do consider how international clinical research is connected to the social determinants of health but, again, do so to address the question of when international clinical research is permissible. It is suggested that the narrow focus of this debate is shaped by high-income countries' economic strategies. The article further argues that the debate's focus obscures a stronger imperative to consider how other types of international research might advance justice in global health. Bioethics should consider the need for non-clinical health research and its contribution to advancing global justice. (shrink)

It is the epistemic as well as the ethical responsibility of academics to aim to approach their research and teaching with a proper understanding of the ultimate ethical purpose or telos of their defining activities and products, which is the practical aim of promoting human flourishing. Minimally, academics should aim at understanding, and a key component of understanding is to understand the ideal ethical purpose of what is being researched and taught. For instance, sadistic Nazi medical researchers and teachers—Mengeles (...) of sorts—in addition to having reprehensible commitments, would be significantly ignorant about their own intellectual concerns by virtue of their abject (belief-expressing) commitments. I will show that insights drawn from extreme cases such as this one apply across disciplines and in less extreme cases. (shrink)

The metaphysics of legalism -- The individual in context -- Rationality in context -- Freedom in context -- Strong legalism or the absent theory of legislation -- Legitimacy and legitimation : from strong legalism to legisprudence -- From proxy to trading off : the principles of legisprudence -- Legisprudence and the duties of power : a legisprudential assessment of rational legislation.

In this paper we argue that the consensus around normative standards for the ethics of research in clinical trials, strongly influenced by the Declaration of Helsinki, is perceived from various quarters as too conservative and potentially restrictive of research that is seen as urgent and necessary. We examine this problem from the perspective of various challengers who argue for alternative approaches to what ought or ought not to be permitted. Key themes within this analysis will examine these claims (...) and argue they have implications for the interests of the research subject, research governance and regulation. Using our work with TREAT-NMD, the neuromuscular clinical trials network, we posit that there is a place for advancing the discourse of moral rights and moral duties in the context of research, especially from the perspective of patients and their families, and for including the politics of patient activism and empowerment. At the same time we remain vigilant to the danger that the therapeutic misconception and other serious vulnerabilities for the patient population in clinical trials, are at risk of being overlooked. (shrink)

This text is an ideal introduction for students to the basic mathematics of operations research as well as a valuable source of references to early literature ...

Background Continued advances in human microbiome research and technologies raise a number of ethical, legal, and social challenges. These challenges are associated not only with the conduct of the research, but also with broader implications, such as the production and distribution of commercial products promising maintenance or restoration of good physical health and disease prevention. In this article, we document several ethical, legal, and social challenges associated with the commercialization of human microbiome research, focusing particularly on how (...) this research is mobilized within economic markets for new public health uses. Methods We conducted in-depth, semi-structured interviews (2009–2010) with 63 scientists, researchers, and National Institutes of Health project leaders (“investigators”) involved with human microbiome research. Interviews explored a range of ethical, legal, and social dimensions of human microbiome research, including investigators’ perspectives on commercialization. Using thematic content analysis, we identified and analyzed emergent themes and patterns. Results Investigators discussed the commercialization of human microbiome research in terms of (1) commercialization, probiotics, and issues of safety, (2) public awareness of the benefits and risks of dietary supplements, and (3) regulation. Conclusion The prevailing theme of ethical, legal, social concern focused on the need to find a balance between the marketplace, scientific research, and the public’s health. The themes we identified are intended to serve as points for discussions about the relationship between scientific research and the manufacture and distribution of over-the-counter dietary supplements in the United States. (shrink)

The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to ...

BackgroundObtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements.MethodsEmploying a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics (...) boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed.ResultsThe review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study.ConclusionsThe analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics. (shrink)

In this paper we analyse the degree to which a distinction between social science and public health research and other non-research activities can account for differences between a number of large scale social surveys performed at the national and European level. The differences we will focus on are differences in how participation is elicited and how data are used for government, research and other purposes. We will argue that the research / non-research distinction does not (...) account for the identified differences in recruitment or use and that there are no other convincing justifications. We argue that this entails that eliciting participation by coercion or manipulation becomes very difficult to justify. (shrink)

In Sweden, most patients are recruited into biobank research by non-researcher doctors. Patients' trust in doctors may therefore be important to their willingness to participate. We suggest a model of trust that makes sense of such transitions of trust between domains and distinguishes adequate trust from mistaken trust. The unique position of doctors implies, we argue, a Kantian imperfect duty to compensate for patients' mistaken trust. There are at least three kinds of mistaken trust, each of which requires a (...) different set of countermeasures. First, trust is mistaken when necessary competence is lacking; the competence must be developed or the illusion dispelled. Second, trust is irrational whenever the patient is mistaken about his actual reasons for trusting. Care must therefore be taken to support the patient's reasoning and moral agency. Third, some patients inappropriately trust doctors to recommend only research that will benefit them directly. Such trust should be counteracted by nurturing a culture where patients expect to be asked occasionally to contribute to the common good. (shrink)

While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the (...) period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research. (shrink)