Nanotechnology is an important platform technology which will add new features like improved biocompatibility, smaller size, and more sophisticated electronics to neuro-implants improving their therapeutic potential. Especially in view of possible advantages for patients, research and development of nanotechnologically improved neuro implants is a moral obligation. However, the development of brain implants by itself touches many ethical, social and legal issues, which also apply in a specific way to devices enabled or improved by nanotechnology. For researchers developing nanotechnology such issues (...) are rather distant from their daily work in the lab, but as soon as they use their materials or devices in medical applications such as therapy of brain diseases they have to be aware of and deal with them. This paper is intended to raise sensitivity for the ethical, legal and social aspects (ELSA) involved in applying nanotechnology in brain implants or other devices by highlighting the short term problems of testing and clinical trials within the existing regulatory frameworks (A), the short and medium-term questions of risks in the application of the devices (B) and the long-term perspectives related to problems of enhancement (C). To identify and address such issues properly nanotechnologists should involve ethical, legal and social experts and regulatory bodies in their research as early as possible. This will help to remove pressure from regulatory bodies, to settle public concern and to prevent non-acceptable developments for the benefit of the patients. (shrink)

This contribution addresses some bioethical and medico-legal issues of the opinion formulated by the Italian National Bioethics Committee (CNB) in response to the dilemma between the State’s duty to protect the life and health of the prisoner entrusted to its care and the prisoner’s right to exercise his freedom of expression. The prisoner hunger strike is a form of protest frequently encountered in prison and it is a form of communication but also a language used by the prisoner in order (...) to provoke changes in the prison condition. There are no rules in the prison regulations, nor in the laws governing the legal status of prisoners, that allow the conscious will of the capable and informed subject to be opposed and forced nutrition to be carried out. However, this can in no manner make therapeutic abandonment legitimate: the medical doctor should promote every action to support the patient. In the recent opinion formulated by the CNB it was remarked how self-determination is a central concept in human rights and refers to an individual’s ability to make autonomous and free decisions about his or her life and body. (shrink)

BackgroundMedia have increasingly reported on the difficulties associated with end-of-life decision-making in patients with Disorders of Consciousness (DOC), contextualizing such dilemma in detailed accounts of the patient’s life. Two of the first stories debated in the scientific community were those related to the cases of two women, one American, the other Italian, who captured attention of millions of people in the first years of this third millennium.MethodsMuch has been written about the challenges of surrogate decision-making for patients in DOC, but (...) less has been written comparing these challenges across legal systems and cultures. In our paper, we propose a systematic analysis of the final legal documents written by the American and Italian Courts in relation to the two cases, developing our discussion around three areas: the level of certainty/reliability of diagnosis and prognosis, the reconstruction of self-expression, time of illness and time of care. They are examples of the typical issues discussed by legal authors and allow us to understand the link and the difference between the legal and ethical perspectives.ResultsThe legal approach to the two cases has some common elements: the need to be certain about the diagnosis and prognosis and the fact that the clinical criteria are necessary in determining the most appropriate treatments, although these criteria are not sufficient unless they are supplemented by the patient’s will. The issue of relations takes on importance both from a legal and an ethical point of view, but from two different perspectives. While ethics safeguards relationships by guaranteeing their differences and makes them reconcilable, law safeguards relationships by guaranteeing the cold forms of respect, equality, impartiality, symmetry, reciprocity, and irreversibility. In this perspective, the link between the time of care and the decision of the family members assumes importance.ConclusionsThe most interesting point that emerges from our analysis is the issue of relationships and how they affect decisions, both from a legal and ethical point of view. For this reason, during the patients’ hospitalization, it is necessary to identify ways in which they might give their opinion about the moral issues underlying their choices. (shrink)

Ethical guidelines commonly state that research subjects should have a right to withdraw consent to participate. According to the guidelines we have studied, this right applies also to research on biological samples. However, research conducted on human subjects themselves differs in important respects from research on biological samples. It is therefore not obvious that the same rights should be granted research participants in the two cases. This paper investigates arguments for and against granting a right to withdraw consent to research (...) on biobank samples. We conclude that (1) there are no explicit arguments for such a right in the guidelines we have studied, (2) the arguments against such a right are inconclusive, (3) considerations of autonomy, privacy, personal integrity, and trust in medical research provide sufficient reasons for granting a right to withdraw consent to research on biobank samples, (4) in certain cases, research participants should be allowed to waive this right. (shrink)

The importance of non-codifying DNA polymorphism for the administration of justice is now well known. In Spain, however, this type of test has given rise to questions in recent years: Should consent be obtained before biological samples are taken from an individual for DNA analysis? Does society perceive these techniques and methods of analysis as being reliable? There appears to be lack of knowledge concerning the basic norms that regulate databases containing private or personal information and the protection that information (...) of this type must be given. This opinion survey and the subsequent analysis of the results in ethical terms may serve to reveal the criteria and the degree of information that society has with regard to DNA databases. In the study, 73.20% of the population surveyed was in favour of specific legislation for computer files in which DNA analysis results for forensic purposes are stored. (shrink)

: The current difference in attitude toward germ-line enhancement in humans and nonhumans is unjustified. Society should be more cautious in modifying the genes of nonhumans and more bold in thinking about modifying our own genome. I identify four classes of arguments pertaining to germ-line enhancement: safety arguments, justice arguments, trust arguments, and naturalness arguments. The first three types are compelling, but do not distinguish between human and nonhuman cases. The final class of argument would justify a distinction between human (...) and nonhuman germ-line enhancement; however, this type of argument fails and, therefore, the discrepancy in attitude toward human and nonhuman germ-line enhancement is unjustified. (shrink)

As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers’ practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication of (...) incidental findings in imaging research. We conducted an interview study with a purposive sample of researchers at research facilities across the Netherlands. Based on a qualitative analysis of these interviews and on existing guidelines found in the literature, we developed a prototype ethical framework, which was critically assessed and fine-tuned during a two-day international expert meeting with bioethicists and representatives from large population-based imaging studies from the United Kingdom, Germany, Sweden and Belgium. Practices and policies for the handling of incidental findings vary strongly across the Netherlands, ranging from no review of research scans and limited feedback to research participants, to routine review of scans and the arrangement of clinical follow-up. Respondents felt that researchers do not have a duty to actively look for incidental findings, but they do have a duty to act on findings, when detected. The principle of reciprocity featured prominently in our interviews and expert meeting. We present an ethical framework that may guide researchers and research ethics committees in the design and/or evaluation of appropriate pathways for the handling of incidental findings in imaging studies. The framework consists of seven steps: anticipation of findings, information provision and informed consent, scan acquisition, review of scans, consultation on detected abnormalities, communication of the finding, and further clinical management and follow-up of the research participant. Each of these steps represents a key decision to be made by researchers, which should be justified not only with reference to costs and/or logistical considerations, but also with reference to researchers’ moral obligations and the principle of reciprocity. (shrink)

The main goal of this article is to analyse the current status of the precautionary principle in international law and outline the tendencies of its development into a rule of customary law. The methods of comparative and systematic analysis were used in this paper. The article concludes that there is sufficient state practice and opinio iuris to support the position of the European Communities that the precautionary principle has already crystallized into a general customary rule. Evidence may be found in (...) international legally binding and non-binding documents, domestic law, and the jurisprudence of national and international courts and tribunals. (shrink)

It has been argued by some authors that our reaction to deaf parents who choose deafness for their children ought to be compassion, not condemnation. Although I agree with the reasoning proposed I suggest that this practice could be regarded as unethical. In this article, I shall use the term “dysgenic” as a culturally imposed genetic selection not to achieve any improvement of the human person but to select genetic traits that are commonly accepted as a disabling condition by the (...) majority of the social matrix; in short as a handicap. As in eugenics, dysgenics can be achieved in a positive and a negative way. Positive dysgenics intends to increase the overall number of people with a particular genetic trait. Marriage between deaf people or conceiving deaf children through reproductive technology are examples of positive dysgenics. Negative dysgenics can be obtained through careful prenatal or pre-implantation selection and abortion (or discarding) of normal embryos and foetuses. Only deaf children would be allowed to live. If dysgenics is seen as a programmed genetic intervention that undesirably shapes the human condition – like deliberately creating deaf or dwarf people – the professionals involved in reproductive technologies should answer the question if this should be an accepted ethical practice because the basic human right to an open future is violated. (shrink)

The purpose of this overview of published articles on decision making in paediatric care was to identify important aspects of its possible use in clinical practice and to obtain a base for future research. A literature review was undertaken utilizing snowball sampling to identify articles because of the diversity present within the area of decision making in paediatric care. The databases PubMed and CINAHL were used. The search was limited to articles published in English during the period 1994-2004. The analysis (...) entailed a series of comparisons across articles, focusing on major areas of enquiry and patterns of results. Various levels of decision making are described because these seem to form a basis for how decisions are made. Concepts found to be of importance for decision making are described under the following headings: competence, the child’s best interests, knowledge, values and attitudes, roles and partnership, power, and economy. Further research is suggested. (shrink)

It has become evident that neuroimaging raises new normative questions that cannot be addressed adequately within the (in this regard unspecific) frameworks of existing research ethics. Questions that are especially troubling are, among others, provoked by incidental findings. Two questions are particularly intricate in view of incidental findings: (1) How can the research subject’s right not to know be guaranteed? And (2) should a diagnostic check of scans by a neuroradiologist become an obligatory part of neuroscientific research protocols? The present (...) paper examines these question against the background of two recent recommendations. The differentiation between difference position and similarity position serves as an analytic tool to further investigate the issue and to develop a distinct proposal for answering the questions. (shrink)

Here we describe how more important findings were obtained in a delirium study by using an informal assessment of mental capacity, and, in those who lacked capacity, obtaining consent later when or if capacity returned or a proxy was found. From a total of 233 patients 23 patients lacked capacity as judged by our informal capacity judgment and 210 did not. Of those who lacked capacity, 13 agreed to enter in the study. Six of them regained capacity later. When these (...) 13 participants were excluded from analysis, significant findings were no longer evident. These results show that by the inclusion of subjects who lacked capacity the results of analyses of the condition from whish they suffer are altered. We suggest that this approach to the study of delirium is more ethical than the usual system of strict exclusion of people who lack capacity to give consent and for whom assent is not available. (shrink)

This article presents an overview ofregulations, guidelines and societal debates ineight member states of the EC about a)embryonic and fetal tissue transplantation(EFTT), and b) the use of human embryonic stemcells (hES cells) for research into celltherapy, including `therapeutic' cloning. Thereappears to be a broad acceptance of EFTT inthese countries. In most countries guidance hasbeen developed. There is a `strong' consensusabout some of the central conditions for `goodclinical practice' regarding EFTT.International differences concern, amongstothers, some of the informed consent issuesinvolved, and the (...) questions whether anintermediary organisation is necessary, whetherthe methods of abortion may be influenced bythe possible use of EFT, and whether EFTTshould only be used for the experimentaltreatment of rare disorders. The potential useof hES cells for research into cell therapy hasgiven a new impetus to the debate about (human)embryo research. The therapeutic prospects withregard to the retrieval and research use of hEScells appear to function as a catalyst for theintroduction of less restrictive regulationsconcerning research with spare embryos, atleast in some European countries. It remains tobe seen whether the prospect of treatingpatients suffering from serious disorders withtransplants produced by therapeutic cloningwill decrease the societal and moral resistanceto allowing the generation of embryos for`instrumental' use. (shrink)

The professional regulatory system known as medical ethics has been one of the most visionary and socially valuable creations of the medical profession. Its beneficial influence has extended beyond physician/patient relations, to the shaping of many key humanistic and egalitarian features of the world’s legal and political institutions. The continued existence of medical ethics as a professionally influential normative system, however, is being challenged by international human rights. The UNESCO Universal Declaration on Bioethics and Human Rights, is likely to be (...) an important point of intersection in this process. (shrink)

The main objection to genetic enhancement is that it will create a “genetic apartheid,” deepening existing inequalities. This paper offers considerations that can weaken the inequality argument against genetic enhancement. First, I question the dichotomy of treatment versus enhancement since the differences between the two are unclear. Second, I argue that human enhancement is part of human nature and that there is no sound reason to accept it in other domains while rejecting it in genetics. The paper also demonstrates that (...) inequality is present in every dimension of society, that “God-given” genetics is profoundly unequal, and that genetic enhancement can operate as a mechanism by which a new genetic equality can be achieved. However, the paper underlines that genetic equality is not, per se, a value to which we ought to aspire if it leads us to a uniform community of downsized human beings. Genetic equality is only valuable if it enhances humankind in general. (shrink)

Can the view that medical science is more important than the individual properly persuade recruitment to trials? This paper considers the nature and interests of the person and their relationships to the concepts of science and society; and analyses a conception of value used to balance the interests of science and research subjects. The implications of arguments opposing the primacy of the individual are set out to indicate their implausibility; while the primacy principle is described to show its necessity in (...) any moral society. Finally, the importance of fully informed consent to participate is explained with the requirement that the individual human life provide the criteria of moral value for human life. (shrink)

This paper examines the ability of countries in Central and Eastern Europe to ensure appropriate protection of research participants in the field of increasingly globalizing biomedical research. By applying an analytical framework for identifying gaps in policies and programs for human subjects protection to four countries of CEE—Belarus, Latvia, Lithuania, and Poland, substantial gaps in the scope and content of relevant policies and major impediments to program performance have been revealed. In these countries, public policies on the protection of research (...) participants lack consistency and reliable mechanisms for their implementation. Impediments to program performance most often relate to inadequacies in the national research ethics systems with regard to organizational structure, budgetary support, supervision, and training. The level of research ethics capacity varies from country to country and depends on socio-economic and political factors of post-communist transition. The breadth and depth of the problems identified suggest that the current level of protection for research participants in CEE might be inadequate to the challenges posed by the globalization of biomedical research. In CEE countries, there is a need for strengthening research ethics capacity through modification of relevant policies and improvement of program management. The differences among the countries call for further research on identifying the best approaches for filling the gaps in the policies and programs aimed at ensuring effective protection of research participants. (shrink)

Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union .Methods Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states (...) various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries.Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. (shrink)

Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due to the (...) novelty of the approach, they become more pronounced for medical applications of emerging technologies like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using ‘risk assessment’ as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as ‘risk’ and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue. (shrink)

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good (...) Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. (shrink)

Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a short period of (...) time, and the more time is wasted, the more the risk of death or severe tissue damage and incapacity increases. Consent requests take time, and so the time period before treatment might put the patient’s life in jeopardy. Not requesting consent before a trial is also contradictory. A person should not be forced to participate in a trial against his or her will. Due to the dark history of medical research previously, international declarations and conventions have set up ethical principles for medical research. They emphasize the autonomy of the research participant—or his or her legal representative—to give a free and informed consent prior to the initiation of research. In the case of a critical emergency, the unconscious state of the patient, the emotional stress of family members or the lack of time to start life-sustaining measures may often restrict the possibilities of communicating with the patient or his/her representative. Therefore, written informed consent is difficult to achieve, and its voluntariness in emergency situations is, at best, open to question. The mortality of patients is high without clinical interventions in emergency research. Random selection of patients is difficult and requires extra work from personnel in the emergency rooms. Recruitment, information and asking for consent may also take time, postpone the initiation of treatment and increase the risk of death and irreversible tissue and organ damage, and therefore be risky for the patient. It is therefore essential that the health care professionals recruiting suitable research participants are well motivated and well trained. Medical research in an emergency setting should always be regarded as an exceptional situation requiring special provisions. Only such research should be done as cannot be done in other conditions. An independent body must approve the research protocol and the ways in which the consent of the participant or proxy are to be sought. In addition, the trial must be expected to result in direct and significant benefit for the research participants. If research without prior consent is not approved, the development of emergency care is threatened. On the other hand, if prior consent is not required, a person could be recruited into a clinical trial against his or her will. Doing good and avoiding harm, and respecting the autonomy of the patient are in conflict in the context of emergency medical research. To develop better medicines for patients experiencing acute medical emergencies, research into such conditions should be allowed. Research participants should have the possibility to participate or refuse to participate in research that may benefit them and other patients. The risk of irreversible damage occurring as the consequence of time delays for seeking consent is unacceptable. A prior wish about participation in clinical trials should be respected, if known. The conditions under which medical research in emergencies can be considered acceptable can be determined and agreed upon nationally and internationally. (shrink)

In this article, the place and the nature of an ethical dialogue that develops within Christian healthcare institutions in Flanders, Belgium is examined. More specifically, the question is asked how Christian healthcare institutions should position themselves ethically in a context of a pluralistic society. The profile developed by Caritas Catholica Flanders must take seriously not only the external pluralistic context of our society and the internal pluralistic worldviews by personnel/employees and patients, but also the inherent inspiration of a Christian healthcare (...) institution. This article concludes with ten general orientations that could shape the ethical dialogue from a Christian inspiration in a pluralistic context. (shrink)

The paper concerns the uncertainty in current propositions for the regulation of tissue donation. It focuses mainly on two statements issued in Germany. The scope of the paper is to give a systematic approach to ethical problems coming up in this field. Both statements try to maintain the idea of positive autonomy in regard to tissue donation, but their attempt eventually is forced to fail. Different procedures are proposed that most often are not practicable (because a truly “informed” consent is (...) impossible, or because optional models tend to overwhelm donors). Blanket consent is also proposed, but this form of consent cannot be seen as an expression of self-determination. Under the pretence of autonomy, donors are left alone with the task to control scientific research and to have their personal and property rights respected. Following this rather weak position of autonomy, in one statement there is a clear tendency to place the intrinsic value of research over the autonomy of the donor. In order to avoid this conclusion, autonomy has to be more than individual decision making. It has to be embedded in social and institutional rules which support and protect individual choice. If the benefits of research are supposed to lead to a common good and to satisfy public interests, then research has to be controlled through public institutions. Autonomy does not exclude institutional support, as institutional support is the only way to take the autonomy of donors seriously. (shrink)

This paper highlights a feature common to many ethical guidelines—namely, the idea that the interests of the individual shall always prevail over the interests of science and society. The paper presents how some major ethical guidelines treat the balancing of research interests against those of research subjects and spells out the difficulties in interpreting the principle of the primacy of the individual in a way that can be action-guiding. It suggests various alternative interpretations of the primacy of the individual and (...) argues that they do not hold. Finally, the implications of this analysis for ethical guidelines are discussed. (shrink)

(No abstract is available for this citation).

Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without direct benefit (...) that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent. (shrink)

The rule that one must obtain informed consent is well established in medical ethics and an intrinsic part of clinical practice and of research in biomedicine. However, there is a tendency that the rule today is being applied too rigidly and with too little sensitivity to the values that are at stake in connection with different kinds of research protocols. It is here argued that the quality of consent needs to be balanced against variables such as degree of confidentiality and (...) importance of values at stake, in order to be ethically acceptable. Appropriate information and consent procedures should be adjusted accordingly. Three levels are suggested, ranging from extensively informed consent with both written and oral information, through informed refusal with only a limited amount of information given to, at the other end of the scale, just making relevant information available. (shrink)

We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical (...) biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems. (shrink)

Emergence of novel genome engineering technologies such as clustered regularly interspaced short palindromic repeat has refocused attention on unresolved ethical complications of synthetic biology. Biosecurity concerns, deontological issues and human right aspects of genome editing have been the subject of in-depth debate; however, a lack of transparent regulatory guidelines, outdated governance codes, inefficient time-consuming clinical trial pathways and frequent misunderstanding of the scientific potential of cutting-edge technologies have created substantial obstacles to translational research in this area. While a precautionary principle (...) should be applied at all stages of genome engineering research, the stigma of germline editing, synthesis of new life forms and unrealistic presentation of current technologies should not arrest the transition of new therapeutic, diagnostic or preventive tools from research to clinic. We provide a brief review on the present regulation of CRISPR and discuss the translational aspect of genome engineering research and patient autonomy with respect to the “right to try” potential novel non-germline gene therapies. (shrink)

Research on incompetent humans raises ethical challenges, especially when there is no direct benefit to these research subjects. Contemporary codes of research ethics typically require that such research must specifically serve to benefit the population to which the research subjects belong. The article critically examines this “same-population condition”, raising issues of both interpretation and moral justification. Of particular concern is the risk that the way in which the condition is articulated and rationalized in effect disguises or downplays the instrumentalization of (...) incompetent individuals. (shrink)

Bangladesh, a Muslim-majority country, has a national organ donation law that was passed in 1999 and revised in 2018. The law allows living-related and brain-dead donor organ transplantation. There are no legal barriers to these two types of organ donations, but there is no legislation providing necessary costs and incentive measures associated with successful organ transplants. However, many governments across the globe provide different types of incentives for motivating living donors and families of deceased donors. This study assesses the merits (...) and demerits of incentive measures already in use around the world and proposes ethical measures that can promote organ donation in Bangladesh. The primary focus of this paper is to present an ethical analysis of the comparison of incentive measures on organ donation between Bangladesh and the Islamic Republic of Iran as two Muslim countries that operate organ donation for transplantation practices according to Islamic principles. In this paper, I mainly argue that providing a fixed bare minimum financial incentive measure to distantly related living donors and families of deceased donors will encourage Bangladeshis to donate organs in a manner that is ethically justifiable, morally permissible, and socio-economically appropriate. The government of Bangladesh should revise the existing biomedical law to include a provision related to incentive measures and set a strict policy to properly regulate these measures as key stewardship that can ethically promote organ donation for transplantation. (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)

Deep brain stimulation (DBS) as investigational intervention for symptomatic relief from Alzheimer disease (AD) has generated big expectations. Our aim is to discuss the ethical justification of this research agenda by examining the underlying research rationale as well as potential methodological pitfalls. The shortcomings we address are of high ethical importance because only scientifically valid research has the potential to be ethical. We performed a systematic search on MEDLINE and EMBASE. We included 166 publications about DBS for AD into the (...) analysis of research rationale, risks and ethical aspects. Fifty-eight patients were reported in peer-reviewed journals with very mixed results. A grey literature search revealed hints for 75 yet to be published, potentially enrolled patients. The results of our systematic review indicate methodological shortcomings in the literature that are both scientific and ethical in nature. According to our analysis, research with human subjects was performed before decisive preclinical research was published examining the specific research question at stake. We also raise the concern that conclusions on the potential safety and efficacy have been reported in the literature that seem premature given the design of the feasibility studies from which they were drawn. In addition, some publications report that DBS for AD was performed without written informed consent from some patients, but from surrogates only. Furthermore, registered ongoing trials plan to enroll severely demented patients. We provide reasons that this would violate Art. 28 of the Declaration of Helsinki, because DBS for AD involves more than minimal risks and burdens, and because its efficacy and safety are not yet empirically established to be likely. Based on our empirical analysis, we argue that clinical research on interventions of risk class III (Food and Drug Administration and European Medicines Agency) should not be exploratory but grounded on sound, preclinically tested, and disease-specific a posteriori hypotheses. This also applies to DBS for dementia as long as therapeutic benefits are uncertain, and especially when research subjects with cognitive deficits are involved, who may foreseeably progress to full incapacity to provide informed consent during the required follow-up period. (shrink)

Finland has aimed to make itself an international leader in genomic research and related business and, in working towards that goal, has enacted biobank legislation. The Biobank Act requires biobanks to gain approval, be supervised, and register at the national level. Numerous other laws may also apply in any given research setting, such as the Personal Data Act, the Medical Research Act, and the Act on Medical Use of Human Organs and Tissues. In terms of privacy protection, anonymization is generally (...) not permitted under Finnish law and therefore most biobanks pseudonomize data and samples. However, the broad understanding of what is identifiable data in Finland has created difficulties in sharing with non-EU countries. Furthermore, consent to biobank research is only applicable to the sample and related data, not to data stored in other health-related registries, and consent is only to the field of research for that particular biobank. These restrictions impede the sharing of samples and data for research. (shrink)

BackgroundSharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of (...) individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function.Main textWe propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics.ConclusionsIn this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them. (shrink)

Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient—professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or (...) surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients’ consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions. (shrink)

Free and informed choice is an oft-acknowledged ethical basis for living kidney donation, including parental living kidney donation. The extent to which choice is present in parental living kidney donation has, however, been questioned. Since parents can be expected to have strong emotional bonds to their children, it has been asked whether these bonds make parents unable to say no to this donation. This article combines a narrative analysis of parents’ stories of living kidney donation with a philosophical discussion of (...) conditions for parental decision-making. Previous research has shown that parents often conclude that it is “natural” to donate. Our study shows that this naturalness needs to be understood as part of a story where parental living kidney donation is regarded as natural and as a matter of non-choice. Our study also highlights the presence of a parenthood moral imperative of always putting one’s child’s needs before one’s own. On the basis of these results, we discuss conditions for decision-making in the context of parental LKD. We argue that the presence of a parenthood moral imperative can matter with regard to the decision-making process when parents consider whether to volunteer as living kidney donors, but that it need not hamper choice. We emphasise the need for exploring relational and situational factors in order to understand parental decision-making in the context of parental LKD. (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-therapeutic research 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)

Biobanks are an important resource for medical research. Genetic research on biological material from minors can yield valuable information that can improve our understanding of genetic–environmental interactions and the genesis and development of early onset genetic disorders. The major ethical concerns relating to biobanks concern consent, privacy, confidentiality, commercialisation, and the right to know or not to know. However, research on paediatric data raises specific governance and ethical questions with regard to consent and privacy. We have considered the Italian normative (...) context focusing on what is mentioned in each document on the ethical and legal requirements that guarantee the rights of minors. We found out that there is no systematic reflection on the ethical and policy issues arising from the participation of minors in biobank research. Moreover, we have focused on the same aspects for the new Italian Law on the National Forensic Biobank. (shrink)

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society (...) and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects. (shrink)

According to Howick (2009a), the three main reasons for believing that placebo-controlled trials (PCTs) are methodologically superior to active-controlled trials (ACTs)—sensitivity, absolute effect...

In this paper, a personalist ethical perspective on end-of-life care of severely ill newborns is presented by posing two questions. (1) Is it ethically justified to decide not to start or to withdraw life-sustaining treatment in severely ill newborns? (2) Is it ethically justified, in exceptional cases, to actively terminate the life of severely ill newborns? Based on five values—respect for life and for the dignity of the human person, quality of life, respect for the process of dying, relational autonomy, (...) and justice—an ethical assessment is conducted that brings us answers to the two ethical questions. (1) Noninitiation or withdrawal of life-sustaining medical treatment in severely ill newborns is ethically acceptable, and might even be a moral duty, when initiation or continuation of medical treatment can be considered futile or even harmful. (2) However, according to the personalist approach, it is not ethically acceptable to actively terminate the life of a severely ill newborn. (shrink)