The combination of the issue of return of individual genetic results/incidental findings and paediatric biobanks is not much discussed in ethical literature. The traditional arguments pro and con return of such findings focus on principles such as respect for persons, autonomy and solidarity. Two dimensions have been distilled from the discussion on return of individual results in a genetic research context: the respect for a participant’s autonomy and the duty of the researcher. Concepts such as autonomy and solidarity do not (...) fit easily in the discussion when paediatric biobanks are concerned. Although parents may be allowed to enrol children in minimal risk genetic research on stored tissue samples, they should not be given the option to opt out of receiving important health information. Also, children have a right to an open future: parents do not have the right to access any genetic data that a biobank holds on their children. In this respect, the guidelines on genetic testing of minors are applicable. With regard to the duty of the researcher the question of whether researchers have a more stringent duty to return important health information when their research subjects are children is more difficult to answer. A researcher’s primary duty is to perform useful research, a policy to return individual results must not hamper this task. The fact that vulnerable children are concerned, is an additional factor that should be considered when a policy of returning results is laid down for a specific collection or research project. (shrink)

BackgroundBalancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide different stakeholders in an attempt to determine the rights and/or obligations held on human biological materials and data.MethodsTwenty-eight informants in the Benelux and Scandinavia were interviewed in order to capture the perspectives of experts and stakeholders in relation to the rights and obligations held by custodians and applicants with (...) respect to access to HBM and data.ResultsThere was no consensus among the informants on whether the custodian of a biobank should decide upon the scientific merits and the utility of an access request. Nearly all informants agreed that a new request or an amendment to the initial request has to be submitted when an applicant wants to use leftover HBM in a new or follow-up project. Several informants felt that it might be justified to charge higher access fees to external or industrial applicants that did not contribute to the collection of HBM and data. Most informants agreed that a custodian of a biobank could request the sharing and return of research results. It was furthermore argued that some of the benefits of research projects should be fed back into biobanks.ConclusionsThe interviews revealed a rather complex web of rights and obligations allocated to the custodian and the applicant in relation to access to HBM and data stored in biobanks. Some rights and obligations are negotiated on a case-by-case basis, while others are stipulated in access arrangements. We did find a consensus on the attribution of certain general rights to the custodians and the applicant. (shrink)

Balancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide dif..

The participation of minors in clinical trials is essential to provide safe and effective medical care to children. Because few drugs have been tested in children, pediatricians are forced to prescribe medications off-label with uncertain efficacy and safety. In this article, we analyze how the enrollment of minors in clinical trials is negotiated within relationships of mutual trust between clinicians, minors, and their parents. After a brief description of the problems associated with involving minors in clinical research, we consider how (...) existing “relationships of trust” can be used as a place where the concerns of research subjects can be more fully discussed and addressed. Building on the tacit recognition of trust found in The European Clinical Trials Directive we make policy recommendations that allow for clearer, more ethically informed guidelines for enrolling minors in clinical research. (shrink)

Purpose: A study was made of attitudes of clinical geneticists regarding the age at which minors should be allowed to undergo a carrier test and the reasons they provide to explain their answer. Methods: European clinical institutions where genetic counselling is offered to patients were contacted. 177 (63%) of the 287 eligible respondents answered a questionnaire. Results: Clinical geneticists were significantly more in favour of providing a carrier test to a younger person if the request was made together with the (...) parents than if the adolescent requested the test personally. Although a large fraction of respondents (16%–30%) were “neither unwilling nor willing” to provide a carrier test to a 16-year-old adolescent who requested the test personally, for most disorders slightly more clinical geneticists were “very willing” or “willing”. Conclusion: Age is not the only decisive element when considering the participation of adolescents in decisions affecting their health. The clinical geneticists referred to cognitive, emotional and sexual maturity and the support of parents as crucial elements in their comments regarding when to tell children about their genetic risk or to allow adolescents to request a carrier test. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for the database and (...) its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)

The Belgian health care system has a few features that may havecontributed to the rising costs of health care: patients' freechoice of physicians, large clinical freedom of physicians, essentiallya fee-for-service remuneration for medical specialists in which the feesare agreed between insurance funds and physicians. The increased medicalconsumption and costs have prompted the state and insurance companies totake measures that limit the professional autonomy of the physicians.Access to medical education, free until 1997, is now restricted. Themedical profession is organized in the (...) Order of Physicians that hasestablished a code of professional ethics that has moral but not legalforce. So far, there is no special legislation for thepatient–physician relationship, though laws on specific issueslike organ transplantation contain duties for physicians. In recentyears a debate is taking place on patients' rights, of which informedconsent is central and gaining importance in medico-legal publications.An analysis of (ethical and legal) regulations concerning thewithholding or withdrawal of treatment by physicians demonstrate thatthe profession still enjoys a large clinical autonomy, though duediscussion with the patient has become more explicitly required. Therespect for professional autonomy is not primarily due to any formalpower that the Order of Physicians would have, but is rather grounded inthe generally high quality of the patient–physician relationshipthat in ethical terms is considered essentially as a confidencerelationship rather than a contractual relationship. (shrink)

Doctors are regularly confronted with requests for sterilisation of mentally handicapped people who cannot give consent for themselves. They ought to act in a medical vacuum because there doesn't exist a consensus about a model for decision making on this matter. In this article a model for decision making is proposed, based on a review of the literature and our own research data. We have attempted to select and classify certain factors which could enable us to arrive at an ethically (...) justifiable method of making a medical decision. In doing so we distinguish two major criteria: heredity and parenting competence, and six minor criteria: conception risk, IQ, age, personality, medical aspects and prognosis and finally support and guidance for the mentally handicapped person. The major criteria give rise to a "situation of necessity". In this situation the physician is confronted with a conflict of values and interests. The minor criteria are of an entirely different ethical order. They can only be considered once the major criteria have created a "situation of necessity". Ultimately it comes down to deciding whether the benefits of sterilisation outweigh the drawbacks and whether the means are appropriate to the end, where efficient contraception is the end and irreversible sterilisation is the means. (shrink)

Wrongful life claims have always been controversial. Courts in England,1 the USA,2 and Australia3 have generally refused to accept them. However, are wrongful life claims becoming more commonly accepted in continental Europe? After the widely discussed Perruche case in France ,4 and a judgment of a Brussels tribunal in July 2002 that has passed almost unnoticed, the Court of Appeal of The Hague, the Netherlands, in a lengthy and motivated judgment of 26 March 2003, awarded moral damages to a child (...) born with a severe chromosomal disease.5 This judgment differs from the Perruche and Brussels judgments in that both of the latter failed to show to what extent the negligence towards the mother can at the same time be a negligence towards the unborn child. The Court of Appeal of The Hague did at least attempt to explain this.According to the Court of Appeal the midwife looking after the mother had a legal obligation not only towards the pregnant woman but also towards her fetus. This obligation can be derived from the medical treatment contract concluded between, on one hand, the employer of the midwife, the Leiden University Medical Centre, and on the other hand, the parents of the child. The Court held that the unborn child could legally be considered as a party to this contract. But even when one does not accept the existence of a contract between the …. (shrink)

Bioethics has been in existence now for more than twenty years. Much has changed, however, since Van Rensselaer Potter2 first used the term bioethics in 1971. For Potter, bioethics was an applied science with its roots in the biological sciences and its orientation towards the betterment of human life. Today the concept is used in a different context. It has become the name given to the ethical research that has become necessary in light of the new possibilities created by revolutionary (...) developments in medical science. Generally speaking, bioethics is concerned with the beginning and the end of life. In a certain sense, however, this is merely a de facto definition which does not possess a great deal of internal logical consistency.If we attempt to reconstruct the incredibly rapid evolution of bioethics we quickly realize how the times were truly ripe for this new discipline to begin to mature. In a very short space of time bioethics was taken seriously in just about every University and medical centre the world over. There is no part of the world which has not organised a colloquium or developed a study programme or created a Centre for Biomedical Ethics. Yet this advance is hardly surprising if we consider the fact that there have been revolutionary developments in themedical world in the 1960’s which have made it necessary to engage in serious ethical reflection on the borderline questions of human life.From the start, bioethicists have concerned themselves primarily with ethical problems related to reproductive technology such as in vitro fertilization, medically assisted fertilization with donor gametes, pregnancy termination, and the status of the embryo. More recently, however, questions concerning the end of life have entered the bioethicist’s field of interest, e.g. ethical questions related to euthanasia and the problems surrounding the artificial nutrition and hydration of persistently vegetative patients. In the meantime, of course, bioethics has broadened its field of interest beyond questions related to the beginning and end of life. Serious ethical and juridical reflection has resulted from the problems surrounding organ transplantation, transplantation of brain tissue, and the problem of AIDS.With the many recent developments in genetics, the first applications of gene therapy, and the world-wide human genome research project bioethics is assured an exciting future. It is clear that the issues which grab the bioethicist’s attention are rather disparate. Moreover, we are now beginning to realize that a whole gamut of specific questions cannot be addressed unless the broader context of the ethics of health care in general is taken into account. Such a realization has led to something of a new movement within the bioethical sphere which is interested in widening the notion of ‘medical ethics’ or ‘ethics of health’.The purpose of this article is to help familiarize the reader with the world of bioethics. Such a task is both simple and complex; bioethics has become a house with many rooms, a house, furthermore, which is being constantly renovated and rebuilt. By way of introduction, we shall take an investigative and evaluative stroll through the broad landscape bioethics has traced in the first twenty years of its existence. (shrink)

Bioethics has been in existence now for more than twenty years. Much has changed, however, since Van Rensselaer Potter2 first used the term bioethics in 1971. For Potter, bioethics was an applied science with its roots in the biological sciences and its orientation towards the betterment of human life. Today the concept is used in a different context. It has become the name given to the ethical research that has become necessary in light of the new possibilities created by revolutionary (...) developments in medical science. Generally speaking, bioethics is concerned with the beginning and the end of life. In a certain sense, however, this is merely a de facto definition which does not possess a great deal of internal logical consistency.If we attempt to reconstruct the incredibly rapid evolution of bioethics we quickly realize how the times were truly ripe for this new discipline to begin to mature. In a very short space of time bioethics was taken seriously in just about every University and medical centre the world over. There is no part of the world which has not organised a colloquium or developed a study programme or created a Centre for Biomedical Ethics. Yet this advance is hardly surprising if we consider the fact that there have been revolutionary developments in themedical world in the 1960’s which have made it necessary to engage in serious ethical reflection on the borderline questions of human life.From the start, bioethicists have concerned themselves primarily with ethical problems related to reproductive technology such as in vitro fertilization, medically assisted fertilization with donor gametes, pregnancy termination, and the status of the embryo. More recently, however, questions concerning the end of life have entered the bioethicist’s field of interest, e.g. ethical questions related to euthanasia and the problems surrounding the artificial nutrition and hydration of persistently vegetative patients. In the meantime, of course, bioethics has broadened its field of interest beyond questions related to the beginning and end of life. Serious ethical and juridical reflection has resulted from the problems surrounding organ transplantation, transplantation of brain tissue, and the problem of AIDS.With the many recent developments in genetics, the first applications of gene therapy, and the world-wide human genome research project bioethics is assured an exciting future. It is clear that the issues which grab the bioethicist’s attention are rather disparate. Moreover, we are now beginning to realize that a whole gamut of specific questions cannot be addressed unless the broader context of the ethics of health care in general is taken into account. Such a realization has led to something of a new movement within the bioethical sphere which is interested in widening the notion of ‘medical ethics’ or ‘ethics of health’.The purpose of this article is to help familiarize the reader with the world of bioethics. Such a task is both simple and complex; bioethics has become a house with many rooms, a house, furthermore, which is being constantly renovated and rebuilt. By way of introduction, we shall take an investigative and evaluative stroll through the broad landscape bioethics has traced in the first twenty years of its existence. (shrink)

World Health Organization [WHO] -- Australia -- Belgium -- Bulgaria -- Canada -- [People's Republic of] China -- Czech Republic -- France -- Hellas [Greece] -- Hungary -- Ireland -- Israel -- Malaysia -- The Netherlands -- Nigeria -- Peru -- Poland -- Singapore -- South Africa -- Spain -- Sweden -- United Kingdom -- United States of America -- Uruguay.

Patients who search for a better treatment, an increased quality of life, or even a chance to preserve life itself may claim to have an interest in accessing investigational medicinal products (IMP), particularly when no validated treatment for their disease or condition exists. For many, awaiting the uncertain and time-consuming process of converting an IMP into an approved drug may not appear a realistic option, as prognoses may be grim and a dramatic outcome may seem hard to avert. Gaining access (...) to an IMP, however, often proves to be a difficult enterprise with a highly uncertain outcome. In addition, the process of seeking access to IMP is surrounded by various ethical issues that will be explored in this article. This paper explores the ethical concerns in two potential tracks of seeking access to IMP for minors: on an individual basis, or collectively, as a patient organisation. In this discourse, several unique ethical and regulatory concerns related to the direct negotiation of access to IMP for minor patients are identified, with a focus on product safety, the recruitment of research subjects, the unnoticed entry of market mechanisms in the recruitment of research subjects, and the sidelining of third parties in the recruitment process. The paper concludes with a concise reflection on the way forward. The quest for access to investigational drugs is particularly relevant to paediatric practice, in which a significant share of the drugs prescribed has never been tested in children or labelled for use in the paediatric population. (shrink)

This paper discusses the legal implications of setting up two new biobanks in Belgium. The first is hospital-based and will archive tissue from patients with haematologic cancer, whereas the second is linked to a general practice based morbidity registry and will involve storage of blood samples. To date, Belgium has no specific legislation that regulates storage of human tissue and related databases. Several issues concerning the protection of individuals with regard to the processing of personal medical data are discussed from (...) the existing privacy legislation. We will address the principle of consent (broad versus specific) and the type of data recorded (anonymous, encoded and identifiable) for both biobanks. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for the database and (...) its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)

The discriminatory effects of categorizing psychiatric patients into competent and incompetent, have urged lawyers, philosophers and health care professionals to seek a functional approach to capacity assessment. Dutch and English law have produced some guidelines concerning this issue. So far, most legal systems under investigation have concentrated on alternatives for informed consent by the patient in case of mental incapacity, notably substitute decision-making, intervention of a judge and advance directives. It is hard to judge the way in which the law (...) may further adapt to a more functional assessment of capacity, because the nature of law shows that legal reforms usually take place only when new methods have been accepted by the field. This is not yet the case today. (shrink)