This paper considers what are the appropriate limits of parental or guardian proxy consent for a child's participation in medical or social science research. Such proxy consent, it is proposed, is invalid in regards “non-therapeuticresearch.” The latter research may add to scientific knowledge and/or benefit others, but any benefit to the child research participant is but a coincidental theoretical possibility and not a primary objective. Research involving children, without intended and acceptable prospect of (...) beneficial outcome to the individual participant, even if with negligible risk, does not meet the test for “best interests.” Proxy consent for children's involvement in research is justifiable only when given for and on behalf of the child in his or her best interest to enhance the child's well-being. Only in the latter case is the parental proxy consent situation analogous in regards key criteria to a competent individual consenting to research participation. (shrink)
Non-therapeuticresearch on children raises ethical concerns. Such research is not only conducted on individuals who are incapable of providing informed consent. It also typically involves some degree of risk or discomfort, without prospects of medically benefiting the participating children. Therefore, these children seem to be instrumentalized. Some ethicists, however, have tried to sidestep this problem by arguing that the children may indirectly benefit from participating in such research, in ways not related to the medical intervention (...) as such. It has been argued, for example, that non-therapeutic pediatric research does not instrumentalize the children enrolled since it has the prospects of furthering their moral development. We argue that this argument is far too undeveloped to be taken seriously. (shrink)
The question of whether or not children may be used as subjects in non-therapeuticresearch projects has generated a great deal of debate and received answers varying from 'no, never' to 'yes, if societal interests are served'. It has been claimed that a Kantian, deontological ethics would necessarily rule out such research, since valid consent would be impossible. The present paper gives a deontological argument for allowing children to be subjects in certain types of research.
The Kennedy Krieger lead paint study received a lot of attention after a US Court of Appeals ruled that a parent cannot consent to the participation of a child in non-therapeuticresearch. The ruling has raised fears that, if it goes unchallenged, valuable research might not proceed and ultimately all children would be harmed. The author discusses significant aspects of the study that have been neglected, and argues that the study was unethical because it involved injustice and (...) its design meant that the study lacked importance and value. Issues of benefit, risk, and consent are vital, but it is sometimes a mistake to consider these issues before settling questions about justice and the importance and value of a research project. The author concludes by offering a strategy for researchers and reviewers of research to appreciate, in a vivid way, the implications of research participation. (shrink)
This paper explores the use of advance directives in clinical dementia research. The focus is on advance consent to participation of demented patients in non-therapeuticresearch involving more than minimal risks and/or burdens. First, morally relevant differences between advance directives for treatment and care, and advance directives for dementia research are discussed. Then attention is paid to the philosophical issue of dementia and personal identity, and the implications for the moral authority of research advance directives. (...) Thirdly, a number of practical shortcomings of advance directives for non-therapeutic dementia research are explored and attention is paid to the role of proxies. It is concluded that upon a closer look the initial attractiveness of advance directives for dementia research is lessened, and that it is doubtful whether these instruments can compensate for the lack of subject consent in case of non-therapeutic dementia research involving more than minimal risks and/or burdens for the incompetent demented subject. (shrink)
Background Non-therapeutic trials in which terminally ill cancer patients are asked to undergo procedures such as biopsies or venipunctures for research purposes, have become increasingly important to learn more about how cancer cells work and to realize the full potential of clinical research. Considering that implementing non-therapeutic studies is not likely to result in direct benefits for the patient, some authors are concerned that involving patients in such research may be exploitive of vulnerable patients and (...) should not occur at all, or should be greatly restricted, while some proponents doubt whether such restrictions are appropriate. Our objective was to explore clinician-researcher attitudes and concerns when recruiting patients who are in advanced stages of cancer into non-therapeuticresearch. Methods We conducted a qualitative exploratory study by carrying out open-ended interviews with health professionals, including physicians, research nurses, and study coordinators. Interviews were audio-recorded and transcribed. Analysis was carried out using grounded theory. Results The analysis of the interviews unveiled three prominent themes: 1) ethical considerations; 2) patient-centered issues; 3) health professional issues. Respondents identified ethical issues surrounding autonomy, respect for persons, beneficence, non-maleficence, discrimination, and confidentiality; bringing to light that patients contribute to science because of a sense of altruism and that they want reassurance before consenting. Several patient-centered and health professional issues are having an impact on the recruitment of patients for non-therapeuticresearch. Facilitators were most commonly associated with patient-centered issues enhancing communication, whereas barriers in non-therapeuticresearch were most often professionally based, including the doctor-patient relationship, time constraints, and a lack of education and training in research. Conclusions This paper aims to contribute to debates on the overall challenges of recruiting patients to non-therapeuticresearch. This exploratory study identified general awareness of key ethical issues, as well as key facilitators and barriers to the recruitment of patients to non-therapeutic studies. Due to the important role played by clinicians and clinician-researchers in the recruitment of patients, it is essential to facilitate a greater understanding of the challenges faced; to promote effective communication; and to encourage educational research training programs. (shrink)
The Mental Capacity Bill endangers the vulnerable by inviting human rights abuse. It is perhaps these grave deficiencies that prompted the warnings of the 23rd Report of the Joint Committee on Human Rights highlighting the failure of the legislation to supply adequate safeguards against Articles 2, 3 and 8 incompatibilities. Further, the fact that it is the mentally incapacitated as a class that are thought ripe for these and other kinds of intervention, highlights the Article 14 discrimination inherent in this (...) and related legislation. The financial, medical and research interests that underpin the legislation highlight how the legilsation endangers the ulnerable. It appears to be both a responsibility shifting exercise. Most alarmingly of all, efforts to permit non-therapeuticresearch on the non-consenting vulnerable as well as sterilisation and abortion on those who do not consent suggest that the legislation heralds a new era o gross human rights abuse in instutions around the UK. (shrink)
Definition of the problem: Medical research with children, especially non-therapeuticresearch, requires particular consideration. In the current situation this kind of research is not clearly regulated by law in Germany. This entails practical problems in evaluating clinical studies from an ethical point of view. Arguments and conclusion: To develop a new policy framework the international ethical discussion is reviewed. The article analyzes the historical development of research with minors from an ethical perspective, the notion of (...) minimal risk, criteria for evaluating risk and harm in research, consent and assent procedures, and the participation of parents and children in the planning of clinical studies. A list of proposals for minimal standard in ethical regulation of research with minors is developed. (shrink)
The quality of the consent obtained from 41 volunteer subjects in eight experiments is evaluated. Five subjects (all physicians) gave informed consent; 22 subjects gave partially informed consent; and 14 subjects merely gave consent. It is argued that 'informed' consent is obtainable only from medically trained people, and that lip service to this concept in laymen should cease. The concept of medical competence should instead be introduced and a personal medical referee appointed to adjudicate on behalf of the volunteer.
The Mental Incapacity Bill not only paves the way for euthanasia, but invites wholesale abuse and homicide, writes Jacqueline Laing. On 19 October 2004, when the Mental Capacity Bill was at its crucial committee stage, the Law Society issued a statement of ‘strong support’, claiming that it empowers patients and in no way introduces euthanasia. Laing argues that the Bill threatens the incapacitated by granting a raft of new third parties power to require that health professionals withhold ‘treatment’, which, after (...) the controversial decision in Airedale NHS Trust v Bland  AC 789, includes food and fluids delivered both by tube and, in certain cases, by spoon. The Bill further endangers the vulnerable, first, by allowing non-therapeuticresearch on the non-consenting mentally incapacitated, in breach of the Nuremberg Code and First Declaration of Helsinki, and secondly, by permitting new agents power to undertake on people with learning disabilities certain questionable procedures currently authorised by the High Court, such as non-voluntary sterilisation. (shrink)
Stem cell research is very promising. The use of human embryos has been confronted with objections based on ethical and religious positions. The recent production of reprogrammed adult (induced pluripotent) cells does not – in the opinion of scientists – reduce the need to continue human embryonic stem cell research. So the debate continues.Islam always encouraged scientific research, particularly research directed toward finding cures for human disease. Based on the expectation of potential benefits, Islamic teachings permit (...) and support human embryonic stem cell research. The majority of Muslim scholars also support therapeutic cloning. This permissibility is conditional on the use of supernumerary early pre-embryos which are obtained during infertility treatment in vitro fertilization (IVF) clinics. The early pre-embryos are considered in Islamic jurisprudence as worthy of respect but do not have the full sanctity offered to the embryo after implantation in the uterus and especially after ensoulment.In this paper the Islamic positions regarding human embryonic stem cell research and therapeutic cloning are reviewed in some detail, whereas positions in other religious traditions are mentioned only briefly.The status of human embryonic stem cell research and therapeutic cloning in different countries, including the USA and especially in Muslim countries, is discussed. (shrink)
Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the (...) ethical and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a ‘collective’ TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism. (shrink)
Bioethicists have long been concerned that seriously ill patients entering early phase (‘phase I’) treatment trials are motivated by therapeutic benefit even though the likelihood of benefit is low. In spite of these concerns, consent forms for phase I studies involving seriously ill patients generally employ indeterminate benefit statements rather than unambiguous statements of unlikely benefit. This seeming mismatch between attitudes and actions suggests a need to better understand research ethics committee members’ attitudes toward communication of potential benefits (...) and risks of early phase studies to potential subjects. We surveyed the members of two U.S. research ethics committees using a phase I gene transfer study scenario, and compared the results to a previous survey of potential subjects’ perceptions and attitudes toward benefit and risk for the same protocol. The results show that there is indeed a gap between the subjects’ perceptions and the committee members’ views on what is appropriate to be communicated to research subjects. This discrepancy is the product of both the commonly assumed optimism of the subjects and to a “protective pessimism” of the research ethics committee members. We discuss this discrepancy using “frameworks of trust” and demonstrate the need to incorporate these frameworks into the existing model of informed consent. (shrink)
Objective To document the legal guardian-related barriers to consent procurement, and their stated reasons for non-participation in a paediatric critical care research study. Study design A multicentre, prospective, cohort study. Participants Legal guardians of children who participated in a multicentre study on adrenal insufficiency in paediatric critical illness. Data were collected on all consent encounters in the main study. Methods Screening data, reasons for consent not being obtained, paediatric risk of mortality (illness severity) scores and age were collected on (...) all 1707 patients eligible for participation in the Adrenal Insufficiency Study. Results The main barriers to approaching legal guardians for consent were lack of availability of the legal guardians (321/1707) and language barriers (84/1707). Legal guardians of 917 patients were approached with an overall consent rate of 42% (range 14–56% across the seven sites). 81% of the 528 legal guardians who declined consent provided an unsolicited reason for refusal. The three most commonly stated reasons were: being overwhelmed (117/429), not wanting anything else done to their child (63/429) and not wanting an additional medication (53/429). In addition, 14.2% cited research-related concerns as the reason for their non-participation. Conclusions Barriers to consent procurement in a non-therapeutic paediatric critical care study appear to occur at many levels with lack of availability of legal guardians, and legal guardians feeling overwhelmed, being the most commonly recorded reasons. Further research into the impact of these findings on the validity and generalisability of the results of such studies is necessary prior to the development and study of future consent models. (shrink)
In this article, it is claimed that the protective provisions for adults with impaired decision-making capacity are misguided, insofar as they do not conclusively state whether research on this group should be permitted only as an exception, and as they arbitrarily allow for some groups to benefit from such research while others will not. Moreover, the presumed or former will of the subject is given insufficient weight, and the minimal risk standard does not make sense in this context. (...) Because of these problems, the present guidelines allow for the possibility of vulnerable people being exploited, something that is hidden behind a guise of solidarity. Instead we need to address the real issues at stake by rewriting the present statutes. It is suggested that new guidelines should be in some continuity with earlier efforts. However, in order to protect these subjects there is additional need for appointed representatives who monitor research and for legal obligations to compensate for any injuries suffered. Without these or similar measures we won't have an adequate system in place for the protection of non-benefiting persons who are unable to consent to research. (shrink)
Definition of the problem: The differentiation between ”therapeutic” and ”non-therapeutic” research has found broad acceptance within clinical research, law and medical ethics and is part of national law and international declarations. However, this terminology is problematic on the medical (descriptive) as well as on the ethical (normative) level. Arguments: On theoretical grounds and with an example from clinical practice it is argued that e.g. the terms ”therapeuticresearch” and ”experimental treatment” are rather manipulative to (...) the patient. Conclusion: In obtaining informed consent from human subjects in medical research the individual risk-benefit-assessment should be pointed out clearly rather than arguing in the category of ”therapeutic” versus ”non-therapeutic” research. (shrink)
Current General Medical Council guidelines state that any doctor who does not wish to carry out a non-therapeutic circumcision (NTC) on a boy must invoke conscientious objection. This paper argues that this is illogical, as it is clear that an ethical doctor will object to conducting a clinically unnecessary operation on a child who cannot consent simply because of the parents’ religious beliefs. Comparison of the GMC guidelines with the more sensible British Medical Association guidance reveals that both are (...) biased in favour of NTC and subvert standard consent procedures. It is further argued that any doctor who does participate in non-therapeutic circumcision of a minor may be guilty of negligence and in breach of the Human Rights Act. In fact, the GMC guidance implies that doctors must claim conscientious objection if they do not wish to be negligent. Both sets of guidelines should be changed to ensure an objective consent process and avoid confusion over the ethics of NTC. (shrink)
In this article I reply to Thomas Schramme's argument that there are no good reasons for the prohibition of severe forms of voluntary non-therapeutic body modification. I argue that on paternalistic assumptions there is, in fact, a perfectly good reason.
Non-therapeutic ventilation of potential organ donors would increase the supply of kidneys for transplantation. There are no major ethical objections to it. The means of permitting it are forbidden by laws with an ethical basis. A law permitting it would need an ethical basis. Introducing a third legal method of diagnosing death would be unethical. Expanding the power of the advance directive to permit procedures involving minimal harm would be ethical but not helpful. Extending the power of proxies to (...) permit specific non-therapeutic procedures which caused or risked minimal harm to incompetent patients is the best way forward. (shrink)
The chronic worldwide lack of organs for transplantation and the continuing improvement of strategies for in situ organ preservation have led to renewed interest in elective non-therapeutic ventilation of potential organ donors. Two types of situation may be eligible for elective intensive care: patients definitely evolving towards brain death and patients suitable as controlled non-heart beating organ donors after life-supporting therapies have been assessed as futile and withdrawn. Assessment of the ethical acceptability and the risks of these strategies is (...) essential. We here offer such an ethical assessment using the four principles of medical ethics of Beauchamp and Childress applying them in their broadest sense so as to include patients and their families, their caregivers, other potential recipients of intensive care, and indeed society as a whole. The main ethical problems emerging are the definition of beneficence for the potential organ donor, the dilemma between the duty to respect a dying patient's autonomy and the duty not to harm him/her, and the possible psychological and social harm for families, caregivers other potential recipients of therapeutic intensive care, and society more generally. Caution is expressed about the ethical acceptability of elective non-therapeutic ventilation, along with some proposals for precautionary measures to be taken if it is to be implemented. (shrink)
Background: Although genetic research into Alzheimer disease (AD) is increasing, the ethical aspects of this kind of research and the differences between ethical issues related to genetic and non-genetic research into AD have not yet received much attention. Objectives: (1) To identify and compare the five ethical issues considered most important by surveyed expert panellists in non-genetic and genetic AD research and (2) to compare our empirical findings with ethical issues in genetic research in general (...) as described in the literature. Method: A modified Delphi study in two rounds Results: Genetic and non-genetic research into AD generated an approximately equal number of topics with a considerable overlap. Different priorities in the ethics of both types of research were found. Genetic research raised new topics such as “confidentiality of genetic information” and “implications of research for relatives” which changes the impact and application of existing ethical topics such as “informed consent” and is judged to have more impact on both individuals and society. A difference with the results of more theoretical approaches on ethical aspects related to AD research was also found. Conclusions: Different priorities are given to ethical issues in genetic and non-genetic research. These arise partly because genetic research causes unique and new questions, mostly related to the position of family members and the status of and access to genetic information. Differences found between the results of our empirical study and the more theoretical literature, suggest an additional value for empirical research in medical ethics. (shrink)
The principle of the child's right to an open future was first proposed by the legal philosopher Joel Feinberg and developed further by bioethicist Dena Davis. The principle holds that children possess a unique class of rights called rights in trust—rights that they cannot yet exercise, but which they will be able to exercise when they reach maturity. Parents should not, therefore, take actions that permanently foreclose on or pre-empt the future options of their children, but leave them the greatest (...) possible scope for exercising personal life choices in adulthood. Davis particularly applies the principle to genetic counselling, arguing that parents should not take deliberate steps to create physically abnormal children, and to religion, arguing that while parents are entitled to bring their children up in accordance with their own values, they are not entitled to inflict physical or mental harm, neither by omission nor commission. In this paper, I aim to elucidate the open future principle, and consider whether it is applicable to non-therapeutic circumcision of boys, whether performed for cultural/religious or for prophylactic/health reasons. I argue that the principle is highly applicable to non-therapeutic circumcision, and conclude that non-therapeutic circumcision would be a violation of the child's right to an open future, and thus objectionable from both an ethical and a human rights perspective. (shrink)
Background and rationale Several factors that motivate individuals to participate in non-therapeutic studies have been identified. This study was conducted as limited data is available regarding these motivations from developing countries. Methods This was a single-centre study conducted over 4 months in which a questionnaire was administered to 102 healthy participants and 16 patient participants who had earlier taken part in non-therapeutic studies at our centre. Descriptive statistics and univariate analysis were used to analyse data. Results The most (...) common motivation among healthy participants was financial reward (65%) followed by altruism, free medical check up, curiosity and personal health benefit. Patient participants, however, most commonly said they consented to take part in the trial as they were ‘invited to participate by the treating physician’ (88%). In comparison with the patient participants, healthy participants were more likely to be satisfied with the financial reward (p=0.02), and recommend participation in studies to friends or relatives (p=0.0013). Conclusions The most common motivating factor to participate in non-therapeutic studies appears to be different for healthy participants (financial reward) and patient participants (invitation to participate by the physician). Participants also felt that adequate information and care was given to them during the trial, and that they would participate in future clinical studies, and would also recommend such studies to their friends. (shrink)
Audit standards require auditors to conduct audits being independent in mental attitude from their clients. Regulators and financial statement users are concerned that auditors compromise their independence by allowing clients that contract for consulting services, i.e., non-audit services, more financial statement discretion relative to clients that demand relatively little non-audit services from their auditor. This paper begins by discussing the role of auditing in the capital markets and the various stakeholders that rely on audited financial information in making their capital (...) allocation decisions. The paper continues by explaining the ethical dilemma inherent in audit contracts in general, and more specifically, how the provision of non-audit services threatens auditor independence. The paper concludes by summarizing research studies that report conflicting evidence that there is a violation of auditor independence due to the provision of non-audit services to audit clients. (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)
A REFERENCE UUH FOR Llb^nv, J'-t ONLY Operations Research With Special Reference to Non-Military Applications A Comprehensive Scientific Aid to Executive Decisions OPERATIONS Research (or, as the British say, Operational Research) is ...
Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state supreme (...) court has essentially prohibited it. It also appears that the only plausible rationale for this research is utilitarian, as it risks some children for the good of all. But that rationale is troubling. This Article answers two related questions: (1) What is the appropriate legal relationship between NBPR and the "best interests of the child" standard? (2) What is the ethical justification for this research? I argue that courts should hold that the "best interests" standard governs pediatric research. But, contrary to existing case law, courts must consider the benefits to each child, including pediatric subjects, from a policy that permits NBPR, and not simply consider that a non-beneficial protocol presents more risk than potential benefit to a child. Moreover, I argue that the justification for the practice need not be utilitarian. There is no need to appeal to the greater good to justify the research because each child has reason to endorse a policy permitting NBPR where there is a very low ceiling on acceptable risk, and each child has reason to participate in a practice from which she benefits. More controversially, I argue that each child, like other persons, has reason to help others when she can do so at little to no cost to herself. The Article then highlights practical implications of the offered justifications. (shrink)
: "Therapeutic misconception" has been misconstrued, and some of the newer, mistaken interpretations are troublesome. They exaggerate the distinction between research and treatment, revealing problems in the foundations of research ethics and possibly weakening informed consent.
The study examines, in the context of Crawford's (1970) study items, the influence of non-anonymity deriving from feedback of research results on marketing professionals' research ethics judgements, particularly that of response patterns (social desirability of responses) and item omissions. The results indicate that such non-anonymity does not significantly influence the social desirability of responses or item omissions — thus suggesting the appropriateness of its use to stimulate research ethics responses.
The second International Knowledge and Discourse Conference, held at the University of Hong Kong in June 2002, was the forum for the long-awaited debate between Bruno Latour and Steve Fuller. Bruno Latour counts beyond two. He places the blame for the emphasis in academia on the subject-object distinction on Kant. Latour wants academics to acknowledge that things act, and suggests we look at other traditions, e.g. the Chinese, for alternatives to the subject-object dichotomy. Steve Fuller concentrated on the moral project (...) of science, which is to draw a distinction between the human and the non-human and, to highlight the fact that, as the culmination of the sciences, social science has a particular responsibility to make this distinction. He accused Bruno Latour of evading the moral issue. The debate can be read as a reiteration of the postions of Bruno Latour and Steve Fuller on the question of heterogeneity at the theoretical level, but it did not address the topic at the practical or research level. (shrink)
This paper offers a non-paternalistic justification for prospective research review as providing a credible social assurance that the institutions of scientific advancement respect and affirm the moral equality of all community members and as creating a “market” in which stakeholders working to advance diverse ends also advance the common good.
Following the publication of the Weatherall report on the use of non-human primates in research, this paper reflects on how to provide appropriate and ethical models for research beneficial to humankind. Two of the main justifications for the use of non-human primates in biomedical research are analysed. These are the “least-harm/greatest-good” argument and the “capacity” argument. This paper argues that these are equally applicable when considering whether humans are appropriate subjects of biomedical research.
The ‘best interests’ decision making standard is used in clinical care to make necessary health decisions for non-capacitated individuals for whom neither explicit nor inferred wishes are known. It has been also widely acknowledged as a basis for enrolling some non-capacitated adults into clinical research such as emergency, critical care, and dementia research. However, the best interests standard requires that choices provide the highest net benefit of available options, and clinical research rarely meets this criterion. In the (...) context of modern norms of bioethics, the best interests standard rarely supports surrogate consent for research and should not be accepted as a routine provision. (shrink)
In this paper we address the ethical challenges of research on cytoplasmic hybrid embryos, or “cybrids”. The controversial pronouncement of the UK’s Human Embryology and Fertilisation Authority of September 2007 on the permissibility of this area of research is the starting point of our discussion, and we argue in its favour. By a rigorous definition of the entities at issue, we show how the terms “chimera” and “hybrid” are improper in the case of cybrids, and how their use (...) can bias the debate creating moral prejudices. After analysing the scientific aspects of cybrids research and sketching out current alternatives, we enter the ethical debate, starting from the premise that research on early human embryos is ethically permissible under some circumstances. We emphasise how research on cybrids has positive consequences in terms of scientific and therapeutic applications, since it allows the derivation of human embryonic stem cells genetically tailored to the somatic cell donor. Such cell lines offer a unique in vitro model both for studies of human pathogenesis and for drug screening and discovery. Research on cybrids also circumvents the problem of the scarcity of human oocytes and their ethically dubious donation. Finally, we object to the most common arguments against cybrids research, that is, moral repugnance, the slippery slope argument, the appeal to “nature”, and the unfair distribution of economical resources. (shrink)
That the present day society profits from research in many areas is evident. This has stimulated a keen desire to emulate similarly advantageous contributions in other areas. It appears to imply not only a need to know how to (better) support action in general or any action, but also how to support the act of making "better" itself (better businesses, better houses, better emotions, better objectives, etc.). Developing the latter type of knowledge has proved to pose a major challenge, (...) however. Although the challenge has been taken up in areas such as social policy, economics, therapy, management, architecture, design, and others, leading to a number of responses, a complete characterisation seems still to be lacking. Such a characterisation is attempted in this article. Typical characteristics are the inclusion of non-observational experiences and a simultaneous striving for individual and collective high quality. (shrink)
Purpose: Explaining the relationship between theory and empirical research within the research process. The main motivation is to show that non-dualizing epistemology and constructivism have approximately the same ideas to explain this relationship. Problem: Josef Mitterer criticizes constructivism as a dualizing epistemology and "overlooks" that non-dualizing philosophy and constructivist perspectives are similar with regard to the relationship between theory and empirical research. Method: (1) Reconstruction of non-dualizing argumentation, (2) non-dualizing implications for the description of the relationship between (...) theory and empirical research, (3) comparison of non-dualizing implications for the relationship between theory and empirical research with constructivist implications for this relationship. Solution: Finding a position on the description of the relationship between theory and empirical research that fits both epistemologies i.e. non-dualizing philosophy and constructivism. If we discard the critical rationalist idea to falsify theory with the help of empirical research (which reflects reality), we better conceive the relationship between theory and empirical research as a permanent and mutual refinement, stabilization and irritation. Implications: With the help of non-dualizing argumentation, constructivists have to clarify their position towards the relationship between theory and empirical research, particularly towards the choice of methods and the interpretation of the results; and non-dualizing epistemology can profit from constructivist second-order argumentation. (shrink)
Debates in the philosophy of science typically take place around issues such as realism and theory change. Recently, the debate has been reformulated to bring in the role of experiments in the context of theory change. As regards realism, Ian Hacking’s contribution has been to introduce ‘intervention’ as the basis of realism. He also proposed, following Imre Lakatos, to replace the issue of truth with progress and rationality. In this context we examine the case of the vitalism — reductionism debate (...) in biology inspired by the works of Indian physicist-turned-biologist Jagadish Chandra Bose (1858–1937), in the early twentieth century. Both camps had their characteristic hardcores. Vitalists led by John S. Burdon-Sanderson and Augustus D. Waller accepted religious metaphysics to support their research programme, which ultimately degenerated. Bose worked more with the ideals of science such as Occam’s razor, large-scale systematization of phenomena and novel prediction. I argue that his religious metaphysics, instead of acting as a protective shield, helped him to consolidate his position and allowed further problem shift resulting in a research programme that involved consciousness too. His research programme remains relevant even today. (shrink)
Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeuticresearch exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be (...) practicable for regulators to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize. (shrink)
On 25 April 2002, the German Parliament has passed a strict new law referring to stem cell research. This law took effect on July 1, 2002. The so-called embryonic Stem Cell Act ( Stammzellgesetz â StZG ) permits the import of embryonic stem (ES) cells isolated from surplus IvF-embryos for research reasons. The production itself of ES cells from human blastocysts has been prohibited by the German Embryo Protection Act of 1990, with the exception of the use of (...) ES cells which exist already. The debate on the legitimate use of ES cells escalated, after the main German research funding agency, the Deutsche Forschungsgemeinschaft (DFG), unexpectedly published new guidelines recommending are stricted use of human ES cells for research. Meanwhile, the debate has ethically dividedsociety, political parties, government and church members into a group supporting and a group rejecting ES cell research. The arguments in favour of such a research can be summarized as arguments derived from a new ethics ofhealing calling for a therapeutic imperative, whereas the arguments against can be summarized as arguments violating the fundamental principle of human dignity as they imply the destruction of human embryos. This article willtry to present and evaluate various ethical arguments founded on the latest biological and medical data on the potential use of stem cell technologies. It will finally come to the conclusion that ES cell research is opposed to human dignity, since the procedures of isolating ES cells require the destruction and instrumentalization of human embryos. Human embryos are human beings at a very early stage of their development, fully possessing the ability of completing their development. At this very early stage, human embryos are extremely dependent and fragile, and thus vulnerable corporealities. Vulnerability and human dignity demand the protection of the embryo's corporeal integrity. Hence, this essay will try to propagate research with adult stem(AS) cells, a procedure which does not require the destruction of human embryos; with regard to the necessary plasticity, it should be emphasized that AS cells very much resemble ES cells. (shrink)
The surgical treatment of breast cancer has changed in recent years. Analysis of the research that led to these changes yields apparently good arguments for all of the following: (1) The research yielded very great benefits for women. (2) There was no other way of obtaining these benefits. (3) This research violated the fundamental rights of the women who were research subjects. This sets a problem for ethics at many levels.
Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeuticresearch. However, there appears to be very little work conducted with participants who have joined non-therapeuticresearch. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the (...) potential benefits of enrollment.Methods: In-depth interviews lasting between 45 and 60 minutes were conducted with a convenient sample of 25 ill patients and 25 healthy accompanying relatives enrolled in a genetic epidemiological study of tuberculosis. Recorded interviews were transcribed and analyzed using content analysis.Results: Participants perceived that research was beneficial and some of the benefits included the generation of new knowledge, finding the cause of diseases, as well as the control, eradication and prevention of disease. Some thought that research was risky whilst others thought that the benefits outweighed the risks.Conclusion: Participants perceived research to be beneficial and most of them thought that, though it was risky, the benefits outweighed the risks. It is our view that researchers need to give serious consideration to participant's perception of benefits in designing their consent forms, to see to the fulfillment of achievable goals. (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)
Although there is extensive information about why people participate in clinical trials, studies are largely based on quantitative evidence and typically focus on single conditions. Over the last decade investigations into why people volunteer for health research have become increasingly prominent across diverse research settings, offering variable based explanations of participation patterns driven primarily by recruitment concerns. Therapeutic misconception and altruism have emerged as predominant themes in this literature on motivations to participate in health research. This (...) paper contributes to more recent qualitative approaches to understanding how and why people come to participate in various types of health research. We focus on the experience of participating and the meanings research participation has for people within the context of their lives and their health and illness biographies. (shrink)