Broad consent for biobanks is best - provided it is also deep.

BACKGROUND: As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent. MAIN TEXT: In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants' values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication. CONCLUSION: We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research.

Communicating Identifiability Risks to Biobank Donors.

Recent highly publicized privacy breaches in healthcare and genomics research have led many to question whether current standards of data protection are adequate. Improvements in de-identification techniques, combined with pervasive data sharing, have increased the likelihood that external parties can track individuals across multiple databases. This article focuses on the communication of identifiability risks in the process of obtaining consent for donation and research. Most ethical discussions of identifiability risks have focused on the severity of the risk and how it might be mitigated, and what precisely is at stake in pervasive data sharing. However, there has been little discussion of whether and how to communicate the risk to potential donors. We review the ethical arguments behind favoring different types of risk communication in the consent process, and outline how identifiability concerns can be incorporated into either a detailed or a simplified method of communicating risks during the consent process.

The stigmatization dilemma in public health policy--the case of MRSA in Denmark.

BACKGROUND: Multi-resistant bacteria pose an increasing and significant public health risk. As awareness of the severity of the problem grows, it is likely that it will become the target for a range of public health interventions. Some of these can intentionally or unintentionally lead to stigmatization of groups of citizens. DISCUSSION: The article describes the phenomenon of stigmatization within the health care area by discussing the concept in relation to AIDS and psychiatric diagnosis. It unfolds the ethical aspects of using stigmatization as a public health instrument to affect unwanted behaviours e.g. smoking. Moreover it discusses stigmatization as an unintended albeit expected side effect of public health instruments potentially used to counter the challenge of multi-resistant bacteria with particular reference to the Danish case of the growing problems with Methicillin-resistant Staphylococcus aureus (MRSA) within pig production. We argue that using stigmatization as a direct means to achieve public health outcomes is almost always ethically illegitimate. Autonomy and dignity considerations count against it, and the cost-benefit analysis that might by some be taken to outweigh these considerations will be fundamentally uncertain. We further argue that interventions where stigmatization is a side-effect need to fulfil requirements of proportionality, and that they may fall prey to 'the stigmatization dilemma', i.e. the dilemma that arises when all policy options are potentially stigmatizing but stigmatize different groups. When this dilemma obtains the decision-maker should choose the intervention that does not lead to permanent stigmatization and that stigmatizes as few as possible, as briefly as possible, and as little as possible.

Primo non nocere or maximum survival in grade 2 gliomas? A medical ethical question.

BACKGROUND: Maximum safe resection is the "gold standard" in surgical treatment of grade 2 gliomas (G2Gs), aiming to achieve maximal survival benefit with minimal risk of functional deficit. OBJECTIVE: To investigate the attitude of patients and experts towards more extensive surgery with a trade-off between neurological function and survival time. METHODS: Eight patients and seven experts participated in semi-structured focus group interviews. RESULTS: Both patients and experts accepted the premise of balancing neurological function versus longevity. Some patients would accept an increased risk of permanent neurological deficits in order to obtain a chance of increased survival. There was a significant variance in what constituted "quality of life" both between patients and for the individual patient over time. CONCLUSIONS: In important life-changing decisions there is no "one size fits all". We find that it is ethically acceptable to offer more extensive surgery than is possible within the concept of maximal safe surgery as a treatment option, when balancing the principles of beneficence, non-maleficience, autonomy and justice supports the decision. At the same time it must be remembered that even when the patients have made a well-informed decision, some will regret it. In that situation it will be our job as healthcare professionals to support them and help carry some of this burden.

Ethical issues related to screening for preeclampsia.

The implementation of new methods of treating and preventing disease raises many question of both technical and moral character. Currently, many studies focus on developing a screening test for preeclampsia (PE), a disease complicating 2-8% of pregnancies, potentially causing severe consequences for pregnant women and their fetuses. The purpose is to develop a test that can identify pregnancies at high risk for developing PE sufficiently early in pregnancy to allow for prophylaxis. However, the question of implementing a screening test for PE does not only involve an evaluation of technical feasibility and clinical efficacy, it also requires an analysis of how the test influences the conditions and choices for those tested. This study evaluates state-of-the-art techniques for preeclampsia screening in an ethical framework, pointing out the central areas of moral relevance within the context of such screening activity. Furthermore, we propose ethical guidelines that a screening programme for PE should meet in order to become an uncontroversial addition to prenatal health care.

Genetic Protection Modifications: Moving Beyond the Binary Distinction Between Therapy and Enhancement for Human Genome Editing.

The current debate and policy surrounding the use of genome editing in humans typically relies on a binary distinction between therapy and human enhancement. Here, we argue that this dichotomy fails to take into account perhaps the most significant potential uses of CRISPR-Cas9 genome editing in humans. We argue that genetic treatment of sporadic Alzheimer's disease, breast and ovarian cancer predisposing BRCA1/2 mutations, and the introduction of human immunodeficiency virus resistance in humans should be considered within a new category of genetic protection treatments. We suggest that if this category is not introduced, life-altering research might be unnecessarily limited by current or future policy. Otherwise ad hoc decisions might be made, which introduce a risk of unforeseen moral costs, and might overlook or fail to address some important opportunities.

Science and technology of farm animal cloning: state of the art.

Details of the first mammal born after nuclear transfer cloning were published by Steen Malte Willadsen in 1986. In spite of its enormous scientific significance, this discovery failed to trigger much public concern, possibly because the donor cells were derived from pre-implantation stage embryos. The major breakthrough in terms of public recognition has happened when Ian Wilmut et al. [Wilmut, I., Schnieke, A.E., McWhir, J., Kind, A.J., Campbell, K.H., 1997. Viable offspring derived from fetal és adult mammalian cells. Nature 385, 810-813] described the successful application of almost exactly the same method, but using the nuclei of somatic cells from an adult mammal, to create Dolly the sheep. It has become theoretically possible to produce an unlimited number of genetic replicates from an adult animal or a post-implantation foetus. Since 1997 a number of different species including pigs, goats, horses, cats, etc. have been cloned with the somatic cell nuclear transfer technique. Although the technology still has relatively low success rates and there seems to be substantial problems with the welfare of some of the cloned animals, cloning is used both within basic research and the biomedical sector. The next step seems to be to implement cloning in the agricultural production system and several animals have been developed in this direction. This article reviews the current state of the art of farm animal cloning from a scientific and technological perspective, describes the animal welfare problems and critically assess different applications of farm animal cloning. The scope is confined to animal biotechnologies in which the use of cell nuclear transfer is an essential part and extends to both biomedical and agricultural applications of farm animal cloning. These applications include the production of genetically identical animals for research purposes, and also the creation of genetically modified animals. In the agricultural sector, cloning can be used as a tool within farm animal breeding. We do not intend to give an exhaustive review of the all the literature available; instead we pinpoint issues and events pivotal to the development of current farm animal cloning practices and their possible applications.

After Dolly--ethical limits to the use of biotechnology on farm animals.

The cloning of Dolly the sheep gave rise to a widespread call for limits on interference with life. Until recently, the main limits were technical: what it is possible to do. Now scientists are faced with ethical limits as well: what it is acceptable to do. In this context, we take ethics to involve systematic and rational reflection on moral issues raised in the public sphere. The concerns of the general public are not necessarily valid, but they are the best point of departure if the discussion is to lead to a socially robust framework for setting limits to the use of animal biotechnology. To assess public understanding, we examine two sources of data: Eurobarometer surveys from 1991 to 2002 and a qualitative interview study carried out in Denmark in 2000. Based on these sources, we formulate, and then discuss closely, the following concerns: dangers to human health and the environment, animal welfare, animal integrity, and usefulness. In the final part of the article, it is proposed that a principle of proportionality should be the foundation for socially robust applications of animal biotechnology. Only in cases where the usefulness of the technology can be said to outweigh countervailing moral concerns, as in biomedical research, will applications of animal biotechnology stand up to scrutiny in the public sphere.

[Treatment of cardiac arrest in potential organ donors creates ethical conflicts]. / Hjertestopbehandling af potentielle organdonorer skaber etiske konflikter.

This article describes the results of an interview study on the ethical issues related to treating cardiac arrest in potential organ donors in Denmark. The medical background and the Danish guidelines relevant to the issue are described. The results from the interview study are then summarized and analyzed from an ethical perspective in order to clarify the ethical issues and value conflicts experienced by health personnel in this situation. It is recommended that the ethical components in the decision-making process and the dilemmatic nature of the situation are made transparent.