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.     

Problem solving and youth violence: an evaluation of the Boston Gun Project

The Boston Gun Project is a problem-solving policing initiativeaimed at reducing homicide victimization among young peoplein the city of Boston. It represented an innovative partnershipbetween researchers and practitioners to assess the city's youthhomicide problem and implement an intervention intended to havepowerful impacts in the near term. In early 1996, a workinggroup representing a variety of law enforcement and social serviceagencies implemented an intervention that strategically respondedto gang violence, focused enforcement efforts on gun trafficking,and emphasized communication of the strategy to generate deterrence.The intervention is associated with a 60% decline in youth homicidevictimization (i.e., two fewer victims per month). There aresmaller declines in other measures of violence. The declinein youth homicide is sharp and occurs coincident with the introductionof the intervention. Competing hypotheses appear unable to accountfor the decline.     

Political Islamists Have Hijacked Arab World

These comments are adapted from an interview conducted by Ammar-al Jundi for Asharq Al Awsat/Global Viewpoint in London.     

Roles of Psychopathic Personality,Mental Health,and Recidivism in Criminal Behavior: Survey of Brunei Inmates

The survey investigated the contributions of sociodemographics, psychopathic personality, mental health, and recidivism to criminal behavior in a random sample of 64 Brunei convicts representing both genders. Participants committed five major types of crime related to stealing, drugs, sex, violence, and deception. Hierarchical multiple regression analysis revealed gender, age, the inmates’ marital status and marital status of the inmates’ parents as significant demographic predictors of criminality. Multinomial logistic regression analysis identified the demographic, psychopathic, and mental health variables that were related to committing the specific crimes. Significant psychopathic predictors were interpersonal and affective (stealing-related offenses), interpersonal and affective (drug crimes), interpersonal (sex offenders), and interpersonal (violent/ aggressive felonies). The best mental health predictors included: depression and psychoticism (stealing-related offenses); depression, hostility, and psychoticism (drug crimes); psychoticism (sex offenses); and depression, paranoid ideation, and psychoticism (violence/aggression). Binary logistic regression analysis showed male gender and inmates with married parents as the main predictors of recidivism (while other variables with high odds for re-offending included age-group 30–35, inmates with primary education, affective, lifestyle, antisocial, interpersonal sensitivity, depression, paranoid ideation, and psychoticism). Future research which incorporates interviews with probes and appropriate interventions to address crimes were recommended.     

The Data Protection (Amendment) Act, 2003: the Data Protection Directive and its implications for medical research in Ireland

Directive 95/46/EC on the Protection of Individuals with regard to the Processing of Personal Data and on the Free Movement of Such Data has been transposed into national law and is now the Data Protection (Amendment) Act, 2003. The Directive and the transposing Act provide for new obligations to those processing data. The new obligation of primary concern is the necessity to obtain consent prior to the processing of data (Article 7, Directive 95/46/EC). This has caused much concern especially in relation to 'secondary data' or 'archived data'. There exist, what seem to be in the minds of the medical research community, two competing interests: (i) that of the need to obtain consent prior to processing data and (ii) the need to protect and foster medical research. At the same time as the introduction of the Act, other prior legislation, i.e. the Freedom of Information Act, 1997-2003, has encouraged candour within the doctor-patient relationship and the High Court in Ireland, in the case of Geoghegan v. Harris, has promulgated the 'reasonable-patient test' as being the correct law in relation to the disclosure of risks to patients. The court stated that doctors have a duty to disclose all material risks to patients. The case demonstrates an example of a move toward a more open medical relationship. An example of this rationale was also recently seen in the United Kingdom in the House of Lords decision in Chester v. Afshar. Within the medical research community in Ireland, the need to respect the autonomy of patients and research participants by providing information to such parties has also been observed (Sheikh A. A., 2000 and Irish Council for Bioethics, 2005). Disquiet has been expressed in Ireland and other jurisdictions by the medical research communities in relation to the exact working and meaning of the Directive and therefore the transposing Acts (Strobl et al). This may be due to the fact that, as observed by Beyleveld "The Directive makes no specific mention of medical research and, consequently, it contains no provisions for medical research as an explicitly delineated category." (Beyleveld D., 2004) This paper examines the Irish Act and discusses whether the concerns expressed are well-founded and if the Act is open to interpretation such that it would not hamper medical research and public health work.