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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.

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.

International audience

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

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.

Wanneer onderzoekers patientgegevens uit de huisartsen-praktijk willen gebruiken zijn er juridisch gezien twee mogelijkheden. Vanuit het oogpunt van privacy is de meest wenselijke dat een patient daarvoor uitdrukkelijk toestemming geeft. Dit hoeft geen probleem te zijn wanneer de behandelaar geregeld contact heeft met de patient en deze gemakkelijk om toestemming kan vragen. Die situatie zal echter eerder uitzondering dan regel zijn. In dat geval is het mogelijk om van het toestemmingsvereiste af te wijken. Dit is alleen gerechtvaardigd wanneer het vragen van toestemming redelijkerwijs niet mogelijk is of niet kan worden verlangd. Maar dan gelden wel enkele randvoorwaarden.

Innovative ways of healthcare delivery like m-Health, the practice of medicine by mobile devices and wearable devices are the promising new technique that may lead to improvement in quality of care at lower costs. While fully acknowledging the importance of m-Health development, there are challenges on privacy legislation. We address the legal framework, especially the General Data Protection Regulation, applied to m-Health and its implications for m-Health developments in Europe. We discuss how these rules are applied using a representative example of an m-Health programme with remote monitoring in the Netherlands. We consider informing patients about the data processing and obtaining their explicit consent as main responsibilities of healthcare providers introducing m-Health in their practice.

A race equality taskforce has been launched in the UK to explore racial disparities in women’s healthcare and racism in the obstetric and gynaecology workforce.1 The risk of covid-19 related death among some ethnic groups is significantly higher than in those of white ethnicity.2 Without collecting, registering, and using data about patients’ ethnicity we would not be informed about these important (and undesirable) ethnic differences. …

Sequencing technology is increasing the scale of information that could benefit patients who have been tested in the past. This raises the question whether professionals have a duty to recontact such patients or their families. There is currently no clear basis for a legal duty to recontact, and professional guidelines are limited. We conducted interviews with 14 senior professionals from the Netherlands and UK to obtain a range of opinions on what obligations are estimated to be possible or desirable. There was (near) consensus that a lack of resources currently inhibits recontacting in clinical practice, that recontacting is less desirable in research, that information on recontacting should be part of informed consent, and that a legal duty should follow professional standards. There was a diversity of opinions on the desirability of a more systematic approach, potential obligations in hybrid clinical-research projects, and who should bear responsibility for seeking updates. Based on the literature, legal framework and these interviews, we conclude that a general duty to recontact is unlikely, but that in specific circumstances a limited duty may apply if the benefit to the individual is significant and the burden on professionals not too extensive. The variation in opinion demonstrates that further deliberations are desirable. The development of guidelines—a process the European Society of Human Genetics has begun—is important to ensure that the courts, in deciding a recontacting case, can take into account what professionals consider responsible standards in this field.

Systems based on artificial intelligence and machine learning that facilitate decision making in health care are promising new tools in the era of 'personalized' or 'precision' medicine. As the volume of patient data and scientific evidence grows, these computerised decision support systems (DSS) have great potential to help healthcare professionals improve diagnosis and care for individual patients. However, the implementation of these tools in clinical care raises some foreseeable legal challenges for healthcare providers and DSS-suppliers in Europe: How does the use of complex and novel DSS relate to professional standards to provide a reasonable standard of care? What should be done in terms of testing before DSS can be used in regular practice? What are the potential liabilities of health care providers and DSS companies if a DSS fails to function well? How do legal requirements for the protection of patient data and general privacy rights apply to likely DSS scenarios? In this article, we provide an overview of the current law and its general implications for the use of DSS, from a European perspective. We conclude that healthcare providers and DSS-suppliers will have the best chance of meeting legal challenges if: they are first tested in translational research with the patients' explicit, informed consent; DSS-suppliers and healthcare providers are able to clarify and agree on their individual legal responsibilities, and; patients are properly informed about privacy risks and able to decide themselves whether their data can be used for other purposes, or are stored and processed outside the EU. DSS developers and healthcare providers will need to work together closely to ensure compliance with national and European regulations and standards required for reasonable and safe patient care. Relevance for patients Advanced digital decision support systems have the potential to improve patient diagnosis and care. In this article we discuss key legal issues to support translational research using DSS and ensure that they meet the high standards for protection of patient safety and privacy in Europe.

Background Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. Methods We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. Results Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories – evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation – were exempted by one country each. The remaining categories were exempted by two or three countries. Conclusions Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

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.

Er zullen weinig onderzoekers zijn die niet op de een of andere manier betrokken zijn bij de oprichting van biobanken, of bij het gebruik van hierin gearchiveerde lichaamsmaterialen en gegevens voor wetenschappelijk onderzoek. Dit geldt zeker ook voor het terrein van de kindergeneeskunde en het ontstaan, voorkomen en behandelen van aangeboren of op jonge leeftijd verworven ziekten en aandoeningen. Zulk onderzoek leunt in belangrijke mate op omvangrijke en duurzame collecties van materialen en gegevens van kinderen (hierna ‘kinderbiobanken’). Bekende Nederlandse voorbeelden zijn de ‘Amsterdam Born Children and their Development-studie’ (ABCD-studie), 1 het KOALA-onderzoek 2 en het Nederlandse Tweelingen Register. 3 In ons land is bovendien sprake van een landelijke kinderbiobank: het ‘hielprik screeningsprogramma’ van het RIVM. 4 Dit artikel betreft de vraag hoe de zeggenschap en het recht op privacy van kinderen moeten worden vormgegeven, wanneer hun lichaamsmateriaal voor later wetenschappelijk gebruik in een biobank wordt opgenomen

Presentation of all work packages at the TANGO project mini symposium in 2018, includes milestone achievements and preliminary results., The "Technology Assessment of Next Generation Sequencing in Personalized Oncology" (TANGO) project is funded by the ZonMw Personalised Medicine Programme under Dossier number: 846001002 in collaboration with KWF and Zilveren Kruis. The project period is 31 December 2016 – 31 May 2021.

Medical genetic testing, ‘next generation sequencing’, is increasingly generating data that could become useful for patients after they have been discharged from care. If new information is discovered that links a disease to a specific mutation, do health professionals have a legal duty to recontact their patients? Apart from other concerns (such as respecting the patient’s right not to know), in many cases, this would require re-evaluation or re-analysis of the data. Taking such issues into account, we conclude that, at least at this point in time, it is not arguable that there is an unconditional duty of this kind. Health professionals should always do what can be reasonably expected from them to do justice to the patient’s right to information. When there is reason to believe that recontacting would be of significant clinical relevance for the patient, they should do so, unless efforts and costs involved would be disproportional.

In this article, the phenomenon of unsolicited findings will be explored in the context of European and Dutch legal standards. It focuses on the responsibilities of care providers, and the rights of patients’ when unsolicited findings are discovered during regular diagnostics. On the basis of the latter, I will suggest some guidelines for the handling of unsolicited findings in clinical care; in doing so, some attention will be paid to the research context.

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.

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.

The electronic patient record (EPR) is a major technological development within the healthcare sector. Many hospitals across Europe already use institution-based electronic patient records, which allow not only for electronic exchange of patient data within the hospital, but potentially also for sharing medical data with external healthcare providers, involved in the patient’s care, such as general practitioners or pharmacists. In this article, we discuss the attempt made by the Dutch government to introduce a nationwide electronic patient record (n-EPR). Describing and analyzing the new legislation that is currently being developed to establish the infrastructure for the n-EPR and the related legal issues, we conclude that the introduction of a n-EPR give rise to some substantial concerns. These vary from technical and quality issues such as the reliability of patient data and sufficient standardization and interoperability of the systems used, to issues in the field of data security and confidentiality. For a successful introduction of the n-EPR within the healthcare sector, a condicio sine qua non is that the related legislation provides sufficient safeguards and clarity with respect to the responsibilities and liabilities of its main users: the healthcare professionals.

This article explores whether additional rules are needed for the regulation of tissue research in Europe. A human rights-based approach (referring to international documents and illustrative examples from national legislation) is taken to address the question: what is so special about tissue, in particular when compared to personal data? The existing regimes in Europe on data protection and clinical trials are presented and examined for their suitability to govern tissue research, taking into account the differences between data and tissue. Six recommendations are outlined, highlighting important points future legislation on tissue research must take into account.

Implementation of next-generation DNA sequencing (NGS) technology into routine diagnostic genome care requires strategic choices. Instead of theoretical discussions on the consequences of such choices, we compared NGS-based diagnostic practices in eight clinical genetic centers in the Netherlands, based on genetic testing of nine pre-selected patients with cardiomyopathy. We highlight critical implementation choices, including the specific contributions of laboratory and medical specialists, bioinformaticians and researchers to diagnostic genome care, and how these affect interpretation and reporting of variants. Reported pathogenic mutations were consistent for all but one patient. Of the two centers that were inconsistent in their diagnosis, one reported to have found 'no causal variant', thereby underdiagnosing this patient. The other provided an alternative diagnosis, identifying another variant as causal than the other centers. Ethical and legal analysis showed that informed consent procedures in all centers were generally adequate for diagnostic NGS applications that target a limited set of genes, but not for exome- and genome-based diagnosis. We propose changes to further improve and align these procedures, taking into account the blurring boundary between diagnostics and research, and specific counseling options for exome- and genome-based diagnostics. We conclude that alternative diagnoses may infer a certain level of 'greediness' to come to a positive diagnosis in interpreting sequencing results. Moreover, there is an increasing interdependence of clinic, diagnostics and research departments for comprehensive diagnostic genome care. Therefore, we invite clinical geneticists, physicians, researchers, bioinformatics experts and patients to reconsider their role and position in future diagnostic genome care.European Journal of Human Genetics advance online publication, 28 January 2015; doi:10.1038/ejhg.2014.279.

What can a doctor do if he knows that an HIV-positive patient who is refusing antiretroviral therapy is going on a sex tourism holiday to Thailand, for example? A doctor in a moral dilemma could break professional confidentiality in order to protect any sexual partners, but in this case these partners are not known. In practice, the only thing the doctor can do is to talk to the patient about his responsibility to prevent infection of others and to point out the risks of unsafe sex for the patient himself.

Next-generation sequencing (NGS) involves the laying down of the sequence of the entire genome or exome at one time. This technique is expected to become one of the approaches in diagnostic testing. The genetically determined vulnerability of individuals to disorder and their response to treatment can be determined at one go. However, this gives rise to ethical and legal questions, particularly in the area of the protection of patient privacy. These questions include provision of information to the patient about the DNA investigation and the chance of incidental findings, feedback to the patient concerning incidental findings and the storage and reuse of the genetic information. It is important to begin discussion of the legal and ethical consequences of NGS investigations at an early stage. This article may be the stimulus for this discussion.

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.

The electronic patient record (EPR) is a major technological development within the healthcare sector. Many hospitals across Europe already use institution-based electronic patient records, which allow not only for electronic exchange of patient data within the hospital, but potentially also for sharing medical data with external healthcare providers, involved in the patient's care, such as general practitioners or pharmacists. In this article, we discuss the attempt made by the Dutch government to introduce a nationwide electronic patient record (n-EPR). Describing and analyzing the new legislation that is currently being developed to establish the infrastructure for the n-EPR and the related legal issues, we conclude that the introduction of a n-EPR give rise to some substantial concerns. These vary from technical and quality issues such as the reliability of patient data and sufficient standardization and interoperability of the systems used, to issues in the field of data security and confidentiality. For a successful introduction of the n-EPR within the healthcare sector, a condicio sine qua non is that the related legislation provides sufficient safeguards and clarity with respect to the responsibilities and liabilities of its main users: the healthcare professionals.

Recent developments in genomics have resulted in the increased availability of gene profiles for early diagnosis and prognosis in breast cancer. A request from a Dutch woman to have her tumour tissue tested years after treatment confronted the Netherlands Cancer Institute (NKI) and its staff with legal, ethical, and practical questions regarding patients' rights in relation to residual tissue storage and its use for clinical purposes. Was her tissue still available? If so, could she demand that the test be carried out or her tissue be transferred to another hospital? As it became apparent that appropriate guidance was lacking in this area, we developed guidelines on the issue, with the involvement of relevant professionals and patient representatives within the framework of a Technology Assessment project.1 Gene-expression profiling is an important development that is likely to predict the diagnosis and prognosis of malignant disease more accurately than existing clinicopathological parameters.2 Although gene-expression profiling is not yet routine, several tests are already applied in clinical practice. Additionally, the 70-gene signature (MammaPrint), which uses microarrays on fresh frozen tumour tissue, is being tested in a multicentre randomised trial (MINDACT).3 However, for such tests to be successful it is essential that sufficient tumour tissue is available.

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.

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. Electronic supplementary material The online version of this article (doi:10.1007/s00431-016-2810-y) contains supplementary material, which is available to authorized users.

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.