Legislation and review of medical research with minors in The Netherlands

In The Netherlands medical research with minors is regulated in the Medical Research Involving Human Subjects Act. During the legislation process in the Houses of Parliament in the 1990s the issue of nontherapeutic research with minors and incapacitated subjects was heavily debated. Stringent regulations were formulated for this type of research and the Act became operational in December 1999. In order to implement the Clinical Trial Directive 2001/20/EG, the Act was modified on several issues. However, the Act was not modified on the issue of non-therapeutic research with minors and incapacitated subjects. As a result at present the Dutch law is more restrictive on non-therapeutic research with minors than the EU Directive. Currently, discussion is ongoing to adapt the Dutch law in order to harmonize it with the EU Directive.     

Ireland and medical research with minors: some medico-legal aspects

The practice of medical research with minors in Ireland consist of practices pertaining to therapeutic and non-therapeutic medical research. Clinical trials (a category of therapeutic research), is governed by legislation. However, any other therapeutic research (non-clinical trials research) and non-therapeutic research, e.g. observational medical research such as a longitudinal study of children or non-therapeutic research such as blood sample collection for analysis of cause of disease, are unregulated by legislation. This, article will outline and describe some of the medico-legal issues involved in both types of research and will comment on matters such as what national law exists, how the directive on good clinical practice has been implemented, what guidelines, if any, exist.     

Research with minors in Germany

The European GCP Directive has been implemented into German law in sect. 40 ff. AMG (German pharmaceutical law). Unlike the Directive, German pharmaceutical law basically differentiates between three constellations of clinical trials on minors: clinical trials on healthy minors, clinical trials on ill minors with an individual benefit for the individual participant, and clinical trials on ill minors without direct benefit for the individual participant, but with a so-called "group benefit". Particularly the latter possibility of conducting clinical trials on minors even if no individual benefit can be expected is not a matter of course in Germany since due to historical experiences a sceptical attitude towards clinical research on humans prevailed for a long time. German legislature has availed itself of the option granted by Article 3 of the GCP Directive to establish a higher level of protection of clinical trial subjects than the European level.     

Pitfalls in state-authorized treatment of minors

Recently a federal court in Georgia ruled that several physicians and several state officials could be sued for state-authorized treatment of a minor over his father's objection. State authorization protects providers only if it is properly obtained and the authorizing official has the power to grant the authorization in the existing circumstances.     

Sterilisation of intellectually disabled minors

The complex issue of sterilisation of minors with intellectual disabilities has arisen again for Australia with proposals for a uniform approach by the Standing Committee of Attorneys-General under which the principal forum for decision-making about such matters will be State and Territory administrative tribunals. This provides an opportunity not just for scrutiny of the proposed legislation and model but evaluation of the role of decision-making bodies, their procedural supports and the criteria on the basis of which sterilisations of young people should be authorised by Australia's courts and tribunals. The opportunity exists for an approach to be forged on the basis of empirical assessment of the success of administrative tribunal involvement, understanding of the phenomenon of "therapeutic" and "non-therapeutic" sterilisation of minors in contemporary Australia and current medical and psychological awareness of ways to manage menstruation and the potential for pregnancy for vulnerable young people.     

Research with minors in Greece and the EU Directive on clinical trials

This article describes the legal rules for research with minors in Greece in relation to the EU Directive on clinical trials and the Greek Code of Medical Ethics.     

Cybersex with minors: forensic implications.

This paper is designed to assist forensic psychiatrists/psychologists who evaluate adults who commit sexual crimes against children on the Internet. The typical offender is an adult male who logs onto the Internet and enters a chat room in which children congregate. Unbeknownst to the offender, undercover police officers are posing as minors in the chat rooms. The undercover officer (pretend kid) and offender engage in increasingly explicit, sexual conversation; the offender may transmit erotic photographs to the undercover officer and/or arrange to meet at a motel in order to have sexual intercourse. The authors will discuss the relevant legal, clinical, and ethical aspects of examining these offenders, and describe specific cases that the author (2) evaluated.     

Cybercrime investigation in Finland

Nordic police cooperation concerning cybercrimes has been developed during the last few years, e.g. through the Nordic Computer Forensics Investigators (NCFI) and Nordplus training programmes. More empirical research is needed in order to enhance cybercrime investigation and address the training needs of police officers. There is a knowledge gap concerning organizational models for the police’s cybercrime investigation: How the function is organized, what the professional characteristics of the staff are and how to combine computer forensics with crime investigation? The purpose of this paper was to study the organization of cybercrime investigation in Finland. Data were collected by a questionnaire from all 11 local police districts and the National Bureau of Investigation in July–August 2014. In addition, six thematic interviews of cybercrime investigators were conducted in 2014. Three investigation models of computer integrity crimes were found: (1) Computer forensic investigators conduct the entire pre-trial examination, (2) Computer forensic investigators conduct only the computer forensics, and tactical investigation is done by an occasional investigator, (3) Computer forensic investigators conduct only the computer forensics and tactical investigation is centralized to designated investigators. The recognition of various organizational models and educational backgrounds of investigators will help to develop cybercrime investigation training.