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.