Development and progress of Ireland's biobank network: Ethical, legal, and social implications (ELSI), standardized documentation, sample and data release, and international perspective.

Biobank Ireland Trust (BIT) was established in 2004 to promote and develop an Irish biobank network to benefit patients, researchers, industry, and the economy. The network commenced in 2008 with two hospital biobanks and currently consists of biobanks in the four main cancer hospitals in Ireland. The St. James's Hospital (SJH) Biobank coordinates the network. Procedures, based on ISBER and NCI guidelines, are standardized across the network. Policies and documents-Patient Consent Policy, Patient Information Sheet, Biobank Consent Form, Sample and Data Access Policy (SAP), and Sample Application Form have been agreed upon (after robust discussion) for use in each hospital. An optimum sequence for document preparation and submission for review is outlined. Once consensus is reached among the participating biobanks, the SJH biobank liaises with the Research and Ethics Committees, the Office of the Data Protection Commissioner, The National Cancer Registry (NCR), patient advocate groups, researchers, and other stakeholders. The NCR provides de-identified data from its database for researchers via unique biobank codes. ELSI issues discussed include the introduction of prospective consent across the network and the return of significant research results to patients. Only 4 of 363 patients opted to be re-contacted and re-consented on each occasion that their samples are included in a new project. It was decided, after multidisciplinary discussion, that results will not be returned to patients. The SAP is modeled on those of several international networks. Biobank Ireland is affiliated with international biobanking groups-Marble Arch International Working Group, ISBER, and ESBB. The Irish government continues to deliberate on how to fund and implement biobanking nationally. Meanwhile BIT uses every opportunity to promote awareness of the benefits of biobanking in events and in the media.

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.

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.

Maternal brain death, pregnancy and the foetus: the medico-legal implications for Ireland.

This paper examines some of the medico-legal issues that arose as a result of a situation which occurred in May 2001 in Ireland when a woman who was a British citizen and who was fourteen weeks pregnant collapsed and suffered a brain haemorrhage. She was taken to hospital where she was placed on life support but declared brain-dead. As a result of the uncertainty regarding the hospital's obligation to the foetus, life-support was maintained until further opinion was sought. After two weeks the foetus died and life support was only then discontinued. In Ireland there currently exists neither medical guidelines nor legislation to regulate such areas of medical practice. Also, the courts have not had the opportunity to comment on this particular matter and thus there exists widespread concern as to how healthcare providers will act if such situation were to occur again in the future. This article examines the following difficult medico-legal implications that arise from the above situation and especially in light of the constitutional protection of the unborn child in Ireland.

Genetic research & human biological samples: some legal and ethical considerations.

This paper examines the medico-legal and medico-ethical issues that ethics committees and researchers will have to consider when examining proposals pertaining to non-therapeutic genetic research. This paper is limited to the examination of issues that relate to those individuals who donate bodily/DNA samples for the purposes of non-therapeutic genetic research. The issues that arise are those of (i) informed consent and those with diminished capacity (ii) the drafting of consent forms as they relate to genetic research (iii) confidentiality, genetic research with non-EU countries and the implications of the EC Directive on the Protection of Data: 95/46/EC and (iv) an examination of international ethical guidelines. The paper concludes with (i) a summary of the main points of concern that ethics committees must consider before the approval of genetic research (ii) the manner in which consent forms must be drafted and (iii) a brief look at medico-legal issues that will become important and will have to be considered in Ireland in the near future in relation to genetic research.