International scope of biomedical research ethics review.

Many countries consider long-term implications for society.

[Access to the medical file of a deceased person]. / Mogen nabestaanden het dossier van een wilsonbekwame ouder inzien?

The Dutch Act on Patients Rights requires that physicians record all forms of treatment in the medical file of the patient concerned. This obligation ends once the patient dies. Do family members of the deceased patient then have the right to consult the medical file? This question regularly emerges when family members question the competence of a deceased person, notably when the latter before its death changed its will. According to the Act on Patients Rights access to the medical file of a deceased person by relatives is restricted to three situations. In these cases the treating physicians is required to provide access. Family members do not have the right to require the treating physician to retrospectively report on the competence of the deceased person. Family members can only ask an independent physician to advice on the competence of the deceased individual.

Concordance of International Regulation of Pediatric Health Research.

OBJECTIVE: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. STUDY DESIGN: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. RESULTS: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.

[What do parents know of patient rights of minors in the Netherlands?] / Wat weten ouders over de patiëntenrechten van kinderen?

INTRODUCTION: In the Netherlands, medical decision-making without parental permission is allowed from the age of 16. The aim of this study was to examine parents' knowledge of this age-based framework to discover potential knowledge gaps that hinder the communication between doctors, parents, and their children. METHODS: Survey-based research was conducted to examine parents' knowledge of the age-based framework that applies to minors in Dutch healthcare. The survey was based on 5 topics: medical diagnosis and treatment, medical advice, reproductive and sexual health services, abortion, and euthanasia. The survey was sent to 1,010 Dutch parents, aged 35-55 years, with at least one child. The data were analysed using SPSS. Percentages and means were calculated. RESULTS: Parental knowledge of the age-based framework varied depending on the topic. CONCLUSION: This study provides insights into parents' current level of knowledge of the age-based framework that applies to minors in Dutch healthcare. This information is useful in the conversation between health care professional, parents, and their children.

[The Dutch Mandatory Mental Health Care Act allows more care for pregnant women under coercion]. / Wet verplichte ggz biedt meer mogelijkheden om zwangeren te begeleiden.

Women with mental health issues may wish to get pregnant. In some situations a pregnancy is contra-indicated or not be in the best interests of the future child. This article analyses the way treating physicians may assist these women and, if needed, treat these women by using somatic of psychiatric care. This on the basis of the Dutch Patients' Rights Act and mental health legislation. The recent Dutch Mandatory Health Care Act provides physicians more opportunities to act in comparison with the previous situation.

[Are hospitals allowed to give general physicians access to the electronic medical file?] / Mag een ziekenhuis de huisarts toegang geven tot het elektronisch patiëntendossier?

By law hospitals are allowed to give general physicians access to the electronic medical file of a patient on the basis of the patient's consent. There are two exceptions to this general rule. Despite the fact that new national and EU legislation is on its way, the possibilities of giving more access to general physicians remain restricted. This despite the fact that hospitals, physicians and patients are generally in favour of giving general physicians more access to electronic medical files in hospitals.

[Does Dutch medical disciplinary law fit within Safety II?] / Kwaliteit van zorg en het recht.

Dutch medical disciplinary law aims to promote quality of care. Safety II is a scientific approach to quality promotion that is increasingly being adopted in the Dutch healthcare system. We compared both approaches. Safety II recognises that doctors act based on efficiency-thoroughness trade-offs and identifies factors that lead to success. Disciplinary law answers culpable actions with disciplinary measures. We conclude that for Safety II, the distinction between culpable and inculpable is meaningless, while the disciplinary approach mainly provides a negative warning function. Safety II is better suited for medical practice, because healthcare is complex and benefits from a high degree of discretion. Disciplinary law should therefore be given a role that facilitates more reflection on success factors. The fact that it can take action against doctors who perform poorly does not detract from that: Safety II fulfils this function better because it does not wait for something to go wrong but acts proactively.

[Whiplash in insurance medicine: lessons for physicians]. / Whiplash in de verzekeringsgeneeskunde.

The number of employees applying for a labour disability benefit due to whiplash has gradually decreased during the last 25 years in the Netherlands. The total number of applicants seems to stabilise around 30% of the number around the turn of the century. This is surprising given that the professional standards for social insurance physicians emphasise the importance of rehabilitation, while courts hardly ever judge in favour of benefit claimants. We investigate the underlying reasons for the changing statistics and make a recommendation on how social insurance physicians can best approach a claimant.

Regulating Privacy and Biobanks in the Netherlands.

The Netherlands does not have any specific legislation pertaining to human biological materials and data collection by biobanks. Instead, these issues are governed by a patchwork of laws, codes of practices, and other ethical instruments, where special emphasis is given to the right to privacy and self-determination. While draft legislation for biobanking was scheduled to enter into force in 2007, as of mid-2015 such legislation was still under consideration, with the intent that it would focus particularly on individual self-determination, the interests of research, the use of bodily materials collected by biobanks for criminal law purposes, and dilemmas around results that are clinically relevant for biobank participants. Under the current framework, the amount of privacy protection afforded to data is linked to its level of identifiability. International sharing of personal data to non-EU/European Economic Area countries is allowed if these countries provide adequate protection.

[The WKKGZ, a new act with far-reaching consequences for physicians]. / En toen was er de Wkkgz: nieuwe wet met vergaande gevolgen voor artsen.

The introduction of the Act on Quality, Complaints and Disputes in Health care (WKKGZ) on 1 January 2016, brings changes for physicians in the Netherlands. Even though not all the implications of the Act are yet known, it is clear that the new provisions on quality entail a substantial increase in the administrative workload. With respect to the right of complaint a great deal will change for physicians and other care providers. Independent complaints committees are no longer mandatory. They are to be replaced by dispute settlement authorities that are able to make binding decisions with the possibility of awarding damages for patient claims. The legal position of physicians is not satisfactorily regulated in a well-balanced way in all areas, and deserves further attention.

[Disciplinary proceedings on screening and preventive diagnostics]. / Tuchtrechtuitspraken over screening en preventieve diagnostiek.

OBJECTIVE: To gain insight into the disciplinary verdicts on screening and preventive diagnostics and their contribution to the professional standard. DESIGN: Descriptive research, analysis of disciplinary proceedings. METHOD: Two Dutch electronic databases containing disciplinary proceedings were searched using 18 search terms for disciplinary court rulings on screening and preventive diagnostics. Two researchers independently examined which of the 213 decisions retrieved actually concerned screening and preventive diagnostics. The selected verdicts were subsequently categorised according to type of prevention and type of screening, followed by a content analysis. RESULTS: 28 out of 213 cases concerned screening or preventive diagnostics. 12 cases related to universal prevention, 12 to indicated prevention, 2 to health-related prevention and 2 cases concerned preventive screening at the request of the patient. Of the 12 universal prevention cases, 6 concerned breast cancer screening and 4 involved cervical cancer screening. Initially, the disciplinary courts applied the same criteria for these proceedings as for curative care. In 3 cases concerning breast cancer screening, the courts ruled that the screening participants should have been better informed. The women should be made aware that breast cancer cannot be ruled out even if no abnormalities are found. CONCLUSION: There are few disciplinary verdicts about screening and preventive diagnostics. In these cases, the courts initially used the same standards as in cases concerning curative care. Through their statements about the duty to provide information to screening subjects, the courts have contributed to the professional standard for universal prevention.