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Out-of-hospital cardiac arrest is a major health problem, and immediate treatment is essential for improving the chances of survival. The development of technological solutions to detect out-of-hospital cardiac arrest and alert emergency responders is gaining momentum; multiple research consortia are currently developing wearable technology for this purpose. For the responsible design and implementation of this technology, it is necessary to attend to the ethical implications. This review identifies relevant ethical aspects of wearable-based out-of-hospital cardiac arrest detection according to four key principles of medical ethics. First, aspects related to beneficence concern the effectiveness of the technology. Second, nonmaleficence requires preventing psychological distress associated with wearing the device and raises questions about the desirability of screening. Third, grounded in autonomy are empowerment, the potential reidentification from continuously collected data, issues of data access, bystander privacy, and informed consent. Finally, justice concerns include the risks of algorithmic bias and unequal technology access. Based on this overview and relevant legislation, we formulate design recommendations. We suggest that key elements are device accuracy and reliability, dynamic consent, purpose limitation, and personalization. Further empirical research is needed into the perspectives of stakeholders, including people at risk of out-of-hospital cardiac arrest and their next-of-kin, to achieve a successful and ethically balanced integration of this technology in society., Competing Interests: None.

This contribution examines the compatibility of mandatory vaccination with the European Convention on Human Rights (ECHR) through an analysis of the relevant ECHR rights and related case law of the European Court of Human Rights (ECtHR). By focusing on Article 8 (Right to Private Life), Article 2 (Right to Life) and Article 9 (Freedom of Thought, Conscience and Religion) ECHR, we formulate conditions under which mandatory vaccination legislation is justified. With that, this analysis aims to provide national legislators with guidance on responsible legislative policy. Additionally, this article discusses the legal framework underlying the Dutch vaccination policy, including developments therein since COVID-19. Furthermore, the role of the European Union in the context of vaccination is briefly discussed. The importance of an extensive societal and parliamentary debate before implementing a mandatory vaccination policy is stressed, as is the need for proportionality in enforcement.

Developments in medical big data analytics may bring societal benefits but are also challenging privacy and other ethical values. At the same time, an overly restrictive data protection regime can form a serious threat to valuable observational studies. Discussions about whether data privacy or data solidarity should be the foundational value of research policies, have remained unresolved. We add to this debate with an empirically informed ethical analysis. First, experiences with the implementation of the General Data Protection Regulation (GDPR) within a European research consortium demonstrate a gap between the aims of the regulation and its effects in practice. Namely, strictly formalised data protection requirements may cause routinisation among researchers instead of substantive ethical reflection, and may crowd out trust between actors in the health data research ecosystem; while harmonisation across Europe and data sharing between countries is hampered by different interpretations of the law, which partly stem from different views about ethical values. Then, building on these observations, we use theory to argue that the concept of trust provides an escape from the privacy-solidarity debate. Lastly, the paper details three aspects of trust that can help to create a responsible research environment and to mitigate the encountered challenges: trust as multi-agent concept; trust as a rational and democratic value; and trust as method for priority setting. Mutual cooperation in research-among researchers and with data subjects-is grounded in trust, which should be more explicitly recognised in the governance of health data research., (© 2023. The Author(s).)

Tumour DNA and germline testing, based on DNA-wide sequencing analysis, are becoming more and more routine in clinical-oncology practice. A promising step in medicine, but at the same time leading to challenging ethicolegal questions. An important one is under what conditions individuals (patients and their relatives, research participants) should be recontacted with new information, even if many years have passed since the last contact. Based on legal- and ethical study, we developed a tool to help professionals to decide whether or not to recontact an individual in specific cases. It is based on four assessment criteria: (1) professional relationship (2) clinical impact (3) individual's preferences and (4) feasibility. The tool could also serve as a framework for guidelines on the topic., Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The authors have nothing to disclose for the work under consideration for publication. Prof. dr. van Harten reported non-restricted grants from Novartis, Intuitive Surgical and Agendia all ending over three years ago, Dr. Retèl reported non-restricted grants from Intuitive and Agendia outside the submitted work all ending over 3 years ago. The other authors have nothing to declare., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

There are more and more possibilities to screen individuals early for health problems or risks thereof. When it comes to screening, it is tempting to think: the sooner a disease (risk) is detected, the better. But screening also has disadvantages, such as distress and fear among participants and the need for further diagnostics in the event of a positive result, with all the related medical risks and burden on the health care system. In short, screening is only useful if the benefits outweigh the disadvantages. In this article we discuss - by means of examples - ethical considerations relevant for weighing the benefits and disadvantages of screening. In closing we reflect on future legislation pertaining to screening that - in our opinion - leaves too much leeway for screening of which the disadvantages outweigh the benefits.

Background: In some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects., Methods: Paper-based surveys were sent to patients who were randomly assigned in the Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage (ULTRA) trial between 2015 and 2018 in two tertiary referral centers and to physicians of centers who agreed or declined to participate. The primary outcome measure was the proportion of respondents who agreed with deferral of consent in the ULTRA trial. Secondary outcomes included respondents' preferred consent procedure for the ULTRA trial, the effect of deferred consent on trust in physicians and scientific research, and the willingness to participate in future research., Results: Eighty-nine of 135 (66%) patients or proxies and 20 of 30 (67%) physicians completed the survey. Of these, 82 of 89 (92%) patients or proxies and 14 of 20 (70%) physicians agreed with deferral of consent in the ULTRA trial. When asked for their preferred consent procedure for the ULTRA trial, 31 of 89 (35%) patients or proxies indicated deferred consent, 15 of 89 (17%) preferred immediate informed consent, and 32 of 89 (36%) had no preference. None of the patients' or proxies' trust in physicians or scientific research had decreased because of the deferred consent procedure. Willingness to participate in future studies remained the same or increased in 84 of 89 (94%) patients or proxies., Conclusions: A large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent., (© 2021. The Author(s).)

Background: With advances in sequencing technologies, increasing numbers of people are being informed about a genetic disease identified in their family. In current practice, probands (the first person in a family in whom a genetic predisposition is identified) are asked to inform at-risk relatives about the diagnosis. However, previous research has shown that relatives are sometimes not informed due to barriers such as family conflicts. Research on family communication in genetic diseases aims to explore the difficulties encountered in informing relatives and to identify ways to support probands in this., Main Body: Research on family communication may also reveal that participants did not inform their relatives about the risk of a serious genetic condition, even when preventive and treatment options are available. Researchers may then face a dilemma: Do they need to warn at-risk relatives about the finding? Or do they keep silent due to prior confidentiality agreements with study participants?, Conclusions: We believe that the absolute confidence promised to research participants outweighs the interests of their relatives, even though it can be claimed that relatives at risk of a genetic disease do, in principle, have a right to know information collected about their health. Not respecting confidentiality agreements could cause distrust between researchers and research participants and possibly harm the relationship between probands and relatives. Relatives' health interests can still be taken into account without jeopardizing participant trust, by considering alternative scenarios, including sharing general study findings on the barriers participants experience with their healthcare professionals and by offering participants psychosocial support for family communication., (© 2021. The Author(s).)

Learning healthcare systems have recently emerged as a strategy to continuously use experiences and outcomes of clinical care for research purposes in precision medicine. Although it is known that learning healthcare transitions in general raise important ethical challenges, the ethical ramifications of such transitions in the specific context of precision medicine have not extensively been discussed. Here, we describe three levers that institutions can pull to advance learning healthcare systems in precision medicine: (1) changing testing of individual variability (such as genes); (2) changing prescription of treatments on the basis of (genomic) test results; and/or (3) changing the handling of data that link variability and treatment to clinical outcomes. Subsequently, we evaluate how patients can be affected if one of these levers are pulled: (1) patients are tested for different or more factors than before the transformation, (2) patients receive different treatments than before the transformation and/or (3) patients' data obtained through clinical care are used, or used more extensively, for research purposes. Based on an analysis of the aforementioned mechanisms and how these potentially affect patients, we analyze why learning healthcare systems in precision medicine need a different ethical approach and discuss crucial points to consider regarding this approach.

The increased use of the automated external defibrillator (AED) contributes to the rising survival rate after sudden cardiac arrest in the Netherlands. When used, the AED records the unconscious person's medical data (heart rhythm and information about cardiopulmonary resuscitation), which may be important for further diagnosis and treatment. In practice, ethical and legal questions arise about what can and should be done with these 'AED data'. In this article, the authors advocate the development of national guidelines on the handling of AED data. These guidelines should serve two purposes: (1) to safeguard that data are handled carefully in accordance with data protection principles and the rules of medical confidentiality; and (2) to ensure nationwide availability of data for care of patients who survive resuscitation, as well as for quality monitoring of this care and for related scientific research. Given the medical ethical duties of beneficence and fairness, existing (sometimes lifesaving) information about AED use ought to be made available to clinicians and researchers on a structural basis. Creating a national AED data infrastructure, however, requires overcoming practical and organisational barriers. In addition, further legal study is warranted.

Whole-bodies, or human cadavers, are of great value for medical education and science. The process of body donation and its regulation is, however, questionable. The Dutch legal framework is not sufficient. For example, the collaboration of anatomy departments with industry is not covered by existing regulations. Also, it is unclear what should be done in case of unexpected findings. Moreover, consent in whole-body donation does not meet specific conditions for informed consent. It takes the form of 'broad consent', allowing for unspecified use of the bodies. A monitoring system concerning the use for a specific educational program or research falls is absent. Therefore, we propose to develop a Code of Conduct and an adequate system of monitoring.

Investigator-initiated clinical trials are crucial for improving quality of care for children and pregnant women as they are often excluded from industry-initiated trials. However, trials have become increasingly time-consuming and costly since the EU Clinical Trial Directive entered into force in 2001. This directive made compliance with ICH-Good Clinical Practice Guidelines (ethical and quality standard for conducting human subject research) mandatory for all clinical trials, regardless of its risk-classification. By discussing two investigator-initiated, 'low-risk' drug trials, we aim to illustrate that compliance with all GCP requirements makes trials very laborious and expensive, while a clear rationale is missing. This discourages clinical researchers to start and carry out investigator-initiated research. However, the forthcoming EU Clinical Trial Regulation (No 536/2014) seems to provide a solution as it allows for less stringent rules for low-risk trials. We want to raise awareness for these developments in both the clinical research community and the European and national regulatory authorities. Implementation of this forthcoming Regulation regulatory policies should be done in such a way that investigator-initiated trials evaluating standard care interventions will become more feasible. This will allow us to obtain evidence on optimal and safe treatments, especially for groups that are underrepresented in medical research. What is Known • Investigator-initiated trials are indispensable for improving care for children and pregnant women as they are often excluded from industry-initiated trials • Trials have become increasingly time-consuming and costly because of mandatory compliance with ICH-GCP guidelines What is New • The forthcoming EU Clinical Trial Regulation allows less stringent rules for low-risk trials • The national legislator and regulatory authorities should recognize the importance of this opportunity and implement the Regulation in such a way that investigator-initiated trials will become more feasible.

The majority of biobank policies and consent forms do not address post-mortem use of data for medical research, thus causing uncertainty after research participants' death. This systematic review identifies studies examining stakeholders' perspectives on this issue. We conducted a search in MEDLINE, CINAHL, EMBASE and Web of Science. Findings were categorised in two themes: (1) views on the use of data for medical research after participants' death, and (2) perspectives regarding the post-mortem return of individual genetic research results. An important subtheme was the appropriate authority and degree of control over posthumous use of data. The sixteen included studies all focused on genetic data and used quantitative and qualitative methods to survey perspectives of research participants, family members, researchers and Institutional Review Board members. Acceptability of post-mortem use of data for medical research was high among research participants and their relatives. Most stakeholders thought participants should be informed about post-mortem research uses during initial consent. Between lay persons and professionals, disagreement exists about whether relatives should receive actionable genetic findings, and whether the deceased's previous preferences can be overridden. We conclude that regulations and ethical guidance should leave room for post-mortem use of personal data for research, provided that informed consent procedures are transparent on this issue, including the return of individual research findings to relatives. Future research is needed to explore underlying causes for differences in views, as well as ethical and legal issues on the appropriate level of control by deceased research participants (while alive) and their relatives.

Quality-of-care registries have been shown to improve quality of healthcare and should be facilitated and encouraged. The data of these registries are also very valuable for medical data research. While fully acknowledging the importance of re-using already available data for research purposes, there are concerns about how the applicable privacy legislation is dealt with. These concerns are also articulated in the new European law on privacy, the 'General Data Protection Regulation' (GDPR) which has come into force on 25 May 2018. The aim of this review is to examine what the implications of the new European data protection rules are for quality-of-care registries in Europe while providing examples of three quality-of-care registries in the field of cardiology and cardiothoracic surgery in Europe. A general overview of the European and national legal framework (relevant data protection and privacy legislation) applying to quality-of-care registries is provided. One of the main rules is that non-anonymous patient data may, in principle, not be used for research without the patient's informed consent. When patient data are solely and strictly used for quality control and improvement, this rule does not apply. None of the described registries (NHR, SWEDEHEART, and NICOR) currently ask specific informed consent of patients before using their data in the registry, but they do carry out medical data research. Application of the GDPR implies that personal data may only be used for medical data research after informing patients and obtaining their explicit consent.

Large sets of data and human specimens, such as blood, tumour tissue and DNA, are deposited in biobanks for research purposes, preferably for long periods of time and with broadly defined research aims. Our research focuses on the retention of data and biological materials obtained from children. However important such paediatric biobanks may be, the privacy interests of the children involved and the related risks may not be ignored. The privacy issues arising from paediatric biobanks are the central focus of this article. We first review the international regulations that apply to biobanks and then summarise viewpoints expressed by experts in a round-table discussion. We confine ourselves here to two normative questions: (1) How much control should children's parents or legal representatives, and later the children themselves, have over the stored materials and data? (2) What should be done if research findings emerge that have serious implications for a child's health?, Conclusion: On the basis of international legal standards and the views of experts, involved in paediatric biobanking, we argue that biological material of children may only be stored in a biobank for scientific purposes if parents provide their explicit consent, the child is re-contacted at 16 or 18 years of age to reconsider storage and use of its material, and the biobank maintains a limited policy in disclosure of individual research findings to the child's parents. What is Known: • Increasingly, biological material of children is stored in biobanks for research purposes. • Clear standards on the conditions under which children's cells or tissues may be stored and used are lacking. What is New: • According to experts, storage and use of children's materials should only be allowed if performed in accordance with appropriate consent procedures and feedback policies., Competing Interests: Compliance with ethical standards This article does not contain results of studies with human participants. Conflict of interest The authors declare that they have no conflict of interest.

As a result of increasing digitisation of medical record keeping, electronic health records (EHRs) are an attractive source for data reuse. However, such record-based research is still suffering from poor quality of data stored in EHRs. Lack of consent for reuse of data also plays an impeding role, especially in retrospective record-based research. That said, increasing cooperation between healthcare institutions and current attention for EHR organisation also offer opportunities for record-based research. Patient data can be recorded in more standardised ways and in increasingly harmonised EHRs. In addition, if healthcare institutions were to establish a generic consent procedure - preferably with national scope - the potential of EHRs for scientific research could be exploited in considerably better ways.

With the introduction of oocyte vitrification, a special form of intergenerational intrafamilial medically assisted reproduction (IMAR) has now become feasible: fertility preservation for mother-to-daughter oocyte donation (FPMDD). For girls diagnosed with premature ovarian insufficiency (POI), banking of their mothers' oocytes can preserve the option of having genetically related offspring. Since policy documents on IMAR do not discuss specific concerns raised by FPMDD, clinicians can feel at a loss for guidance with regard to handling these requests. Through a comparison of FPMDD with reproductive practices in which similar concerns were raised, proportionality of cryopreservation for self-use and pressure to use the oocytes in fertility preservation in minors, we argue that FPMDD can be acceptable under conditions. The paper ends with recommendations for handling FPMDD-requests, including different options for the legal construction of this form of oocyte donation., (© The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The use of 'next-generation' genetic sequencing technology that allows the sequencing of large parts, or even the entirety, of a patient's genome is advancing rapidly in the UK and around the world. This is set to greatly increase the level of health information that will be of relevance to relatives and the latest medical guidance advises that there is a professional duty to consider warning a patient's relatives of a serious genetic risk in limited circumstances. However, the High Court in ABC v St George's Healthcare NHS Trust [2015] EWHC 1394 (QB), recently found that a legal duty on the part of doctors to warn a patient's daughter of a genetic risk of Huntington's Disease without the patient's consent, was not even 'reasonably arguable' and would not be 'fair, just and reasonable'. This article considers the courts' approach to a duty of care towards 'third parties' in this context and concludes that some form of a duty of care to genetic relatives in clinical genetics is at very least arguably 'fair, just and reasonable'.

The Dutch Embryos Act (2000) contains a temporary ban on the creation of embryos for research, meaning that, at present, only research using "spare" IVF embryos is allowed. Recently, the government has announced a plan to lift this ban. This is in line with the original intention of the Act, which already contains conditions for research with specially created embryos that will come into force after the lifting of the ban, including the restriction that the research must be expected to yield new insights in the domains of infertility, assisted reproduction, hereditary or congenital disorders, or transplantation medicine. The government plans announced allow research only in the first three of these domains, adding the further criterion that the research must be 'directly relevant for clinical application'. According to the government, the reason for these additional restrictions was the need to protect 'human dignity'. The authors of this paper are not convinced.

Many current paediatric studies concern relationships between genes and environment and discuss aetiology, treatment and prevention of Mendelian and multifactorial diseases. Many of these studies depend on collection and long-term storage of data and biological material from affected children in biobanks. Stored material is a source of personal information of the donor and his family and could be used in an undesirable context, potentially leading to discrimination and interfering with a child's right to an open future. Here, we address the normative framework regarding biobanking with residual tissue of children, protecting the privacy interests of young biobank donors (0-12 years). We analyse relevant legal documents concerning storage and use of children's material for research purposes. We explore the views of 17 Dutch experts involved in paediatric biobank research and focus on informed consent for donation of leftover tissue as well as disclosure of individual research findings resulting from biobank research. The results of this analysis show that experts have no clear consensus about the appropriate rules for storage of and research with children's material in biobanks. Development of a framework that provides a fair balance between fundamental paediatric research and privacy protection is necessary.

According to the Declaration of Helsinki, participation of human subjects in medical research is only acceptable if subjects have given their consent. But in child abuse and neglect, many studies use a design in which subjects do not actively participate. Data in these studies are gathered from sources such as medical records or Child Protective Services. As long as such data are used anonymously, this does not interfere with individual privacy rights. However, some research is only possible when carried out with personally identifiable data, which could potentially be misused. In this paper, we discuss in which situations and under which conditions personal data of children may be used for a study without obtaining consent. In doing so, we make use of two recent studies, performed in our hospital, in which we encountered this issue. Both studies involved collecting personal data. After careful consideration, we decided not to ask informed consent; instead, we arranged for specific safeguards to protect the subject's and their parents' privacy as well as possible., Conclusion: Altogether, we conclude that our approach fits within the Dutch legal framework and seems a reasonable solution in situations in which individual privacy rights are at odds with the public interest of child abuse and neglect research. We argue that, although, in principle, data research is only acceptable after informed consent is obtained, the law should allow that, under specific circumstances and safeguards, this requirement is put aside to make research in the field of child abuse and neglect possible., What Is Known: • In principle, data research is only acceptable after informed consent is obtained.• In practice, this is not always feasible., What Is New: • Under specific circumstances and safeguards, the informed consent requirement can be put aside.

The use of patient histories has become an essential part of medical education. Patient histories are important for the relevance, effectiveness and appeal of medical education. The sharing of patient-related information in education and further training is expected to increase in the coming years. The sharing of patient information with colleagues, students or other interested parties can conflict with the rules protecting patient privacy. The most important rule in this context is that it is the patients who decide whether their cases can be shown to others for educational purposes. Patient consent is not required if the data or images used have been fully anonymized. If the information can be traced to the patient, consent is required, preferably documented in writing. The teaching physician is responsible for the storage, protection and destruction of patient data and for controlling access to information.

Background: Several countries are implementing a national electronic patient record (n-EPR). Despite the assumed positive effects of n-EPRs on the efficiency, continuity, safety and quality of care, their overall adoption remains low and meets resistance from involved parties. The implementation of the Dutch n-EPR also raised considerable controversy, which eventually caused the Dutch government to stop its contribution to the national infrastructure., Aim: To explain Dutch health care providers' reluctance in adopting the n-EPR, we investigated their perceptions of problems associated with the n-EPR and their legal position regarding then-EPR. We hereby aim to provide suggestions about approaches that could promote successful implementation., Methods: The study consisted of two parts. The empirical part of the study was conducted in three health care settings: acute care, diabetes care, and ambulatory mental health care. Two health care organisations were included per setting. Between January and June 2010, 17 stakeholders working in these organisations were interviewed to investigate health care providers' perceptions of problems associated with the n-EPR. In the legal part of the study, legal documents were analysed to study health care providers' legal position regarding the n-EPR and any associated problems., Results: The respondents expressed concerns about the confidentiality and safety of information exchange and the reliability and quality of patient data in the n-EPR, and indicated that their liability in case of medical errors was not sufficiently clear. The perceived problems could partly be attributed to legal uncertainties., Conclusions: It is recommended to start the implementation of an n-EPR in limited geographical areas. This will allow health care providers to experience benefits of electronic information exchange before being asked to participate in information exchange at a larger scale. The problems that health care providers perceive in the n-EPR should be minimised. Legislation underlying the n-EPR should provide sufficient clarity about health care professionals' responsibilities and liabilities.

Solidarity is essentially the willingness to contribute to the community and its demands, which may even involve contributing more than one is expecting to receive. Another principle is mutuality: this refers to a balance between rights and obligations or between mutual obligations. In its advisory document 'The importance of mutuality......solidarity takes work!', The Dutch Council for Public Health and Health Care underlines the importance of ensuring solidarity within the Dutch health care system, e.g. by encouraging patients to take responsibility for their own health, possibly by introducing elements of mutuality. In our contribution, we comment on the Council's advice. Although we fully agree with the overall conclusion that solidarity should be maintained within the system, we do not see how the introduction of increased mutuality will contribute to this goal.

If no therapy is available for a disease and a new therapy may have beneficial effects, a well-designed placebo-controlled randomized trial will not immediately raise ethical questions. Pre-2008 versions of the Helsinki Declaration reflect this. However, the Declaration of 2008 allows placebo-controlled randomized trials even where an established effective therapy is available, providing this is methodologically inevitable and safe for patients. Placebo-controlled trials have important advantages for sponsors: they are easier to perform because fewer patients are required and small improvements are sufficient to show the efficacy of a new therapy. The authors consider both arguments open for interpretation and argue that the current revision of the Declaration of Helsinki should return to its pre-2008 version. They also suggest that, independently of this, IRBs should resume the policy of rejecting protocols that use placebo while withholding an effective treatment.

When all standard care options are exhausted, it may be justifiable to carry out an experimental treatment. In the Netherlands, experimental treatment is distinguished from medical research; the latter primarily serves the public interest (obtaining medical knowledge), while the former does not. In experimental treatment, it is a doctor's duty to explain the treatment to the patient carefully and to obtain the patient's explicit consent. In addition, the doctor needs to list all relevant aspects of the treatment in the patient's medical record. A medical practitioner who abides by these rules has acted in accordance with the Dutch law. But, given the sometimes highly risky nature of experimental treatments, is this enough? We do not think so and therefore argue for two additional conditions which are focused on transparency. First, there is a need for a service to ensure that experimental treatments are registered. Second, the effects and side effects of each experimental treatment should be reported. We envision the further elaboration of these conditions to be not only a task for the medical profession but possibly also for government-appointed institutions.

If in the Netherlands a doctor offers experimental treatment to patients purely because it is in their patients' best interest, thus without serving any scientific goal, this does not fall under the scope of the Dutch Medical Research involving Human Subjects Act (WMO), but under specifications on the medical treatment agreement (WGBO) laid down in the civil code. If the doctor deviates from professional standards and the current protocols and guidelines, he or she must be able to account for that. The WMO applies as soon as doctors offer experimental treatments within the context of a research protocol, or perform research interventions such as randomization or the removal of extra tissue. Then specific provisions regarding medical ethical protocol review and written informed consent should be met.

Registration of an individual's ethnicity is, in the light of the potential risks of stigmatization and discrimination, rightfully considered a sensitive issue. Traditionally, privacy legislation offers special legal protection in the collection, registration etc. of data relating to race and ethnic background. However, if it can be established that registration of ethnicity is necessary for providing good care, registration is lawful. However, registration for health research purposes requires the explicit consent of the persons involved.

Child abuse can be overlooked as a cause of death, particularly in cases in which there is initially no known cause of death and the death remains unexplained. To rectify this serious situation, both the government and member of parliament Arib have developed proposals to amend the procedures found in the Burial and Cremation Act regarding the deaths of minors. The government hopes to promote closer post-mortem examination for those paediatric cases, including sudden infant death syndrome, in which the cause of death remains unexplained by requiring further investigation into the cause of death (the so-called NODO procedure). Arib proposed a bill in May 2006 that would require all deceased minors to be examined by a forensic expert. Arguments against the latter proposal include the unnecessary burden it would place on surviving relatives of children who die of clearly natural causes. At this time, the NODO procedure proposed by the government appears to be the more rational choice. At the same time, training for medical professionals, particularly general practitioners and paediatricians, should give ample attention to identifying injuries caused by child abuse and how best to deal with the parents.

Medical assistance by doctors on board an aircraft The number of in-flight medical emergencies continues to increase due to the rise in the number of (older) passengers, the greater capacity of new airplanes and the constant increases in the distances flown. The most common medical problems on board an aircraft are vasovagal collapse, dizziness, and gastro-intestinal and cardiac complaints. According to Dutch law, a physician on board an aircraft is obliged to deliver medical assistance in case of a medical emergency involving a passenger if requested by the cabin crew. The chances of being involved in a lawsuit afterwards are, however, very small because the usual medical standards do not apply and because the patient usually does not know the doctor that has assisted him. Even if it should come to a legal procedure, the chance that a physician will be found guilty of malpractice is very small because of the special circumstances and limitations in an airplane.

After a patient's death, the obligation of medical secrecy remains in force; the physician is still bound to confidentiality and when necessary should invoke his right to remain silent. However, it is generally accepted that circumstances can occur in which a doctor may disclose confidential information to third parties like the relatives Inspection of the medical file after the patient's death is subject to the following principles. Disclosure of medical data after a patient's death is--apart from the general exceptions on medical secrecy--justified when the wish of the deceased can be reconstructed, or (if this is impossible) if there are such important interests of third parties involved that the obligation to maintain confidentiality may be put aside. The relatives have no personal right of access to medical data of the deceased, and they cannot authorize disclosure of data to other parties (e.g. the attorney of the hospital). With regard to the ex-mentor it seems as if the traditional opinion on medical secrecy after a patient's death has been abandoned. In principle, the physician should inform this person, unless it can be proven that disclosure is in conflict with the wish of the deceased.

This paper focuses on the processing of medical data for scientific research and the protection of privacy. Attention will be given to the collection, storage and use of medical data for research. First, the international framework, as provided by the Council of Europe's Convention for the protection of individuals with regard to automatic processing of personal data--and Recommendation No. R (83) 10 on the protection of personal data used for scientific research and statistics, and Draft Recommendation on the protection of medical data, based on this Convention--and the European Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data, will be described in broad outlines. Within this international context, the relevant Dutch laws, that is to say the Law on Registration of Personal Data and the Medical Contract Act, will be discussed. The paper concludes with some remarks on the (Dutch) Code of Conduct on Health Care Research.