[Accessing medical records for research purposes]

The Organic Law 15/1999 of 13 December on the Protection of Personal Data and the Law 41/2002 of 14 November regulating patient autonomy and rights and obligations of information and clinical documentation are the basic rules which govern the medical history in Spain. However, the lack of development of these laws regarding data protection in clinical research, particularly in terms of access to the medical history, repeatedly causes doubts about its construction by the Research Ethics Committees. Therefore, the aim of this paper is to analyze the rules which govern the access to the medical history for research purposes, with particular emphasis on the common problems that arise in the Committees for the ethical evaluation of these projects and finally setting a series of recommendations. The use for research purpose of genetic personal data contained in the medical history is also addressed in this paper. In this sense, a key contribution of the Law on Biomedical Research is relating to the specific regulation of the genetic personal data, both with respect to their production and access to the data as a support and regarding to its use for research purpose.