Management of DNA banks: analysis of practices in 20 hospital units

OBJECTIVE: in order to analyze the constitution and management of DNA banks and the limitations on procedures currently used in France, we conducted a study in a sample of French hospital units. A DNA bank was defined as any facility where individual samples of DNA, irrespective of the form, are sto red for ongoing or future gene studies. The aim of this work was to focus a ttention on the need for in-depth thought on the ethical issues involved in storing and using DNA as part of everyday clinical practice and research a nd to provide elements for a debate on the interest and limitations of the French bioethics laws whose revision is currently being considered. METHODS: A questionnaire was sent to the heads of departments in two univer sity hospitals. Five areas were retained for evaluation. the nature and deg ree of DNA storage activities, procedures followed for reporting the DNA ba nk procedures used to protect confidentiality, information given to patient s and procedures used for informed consent, and finally internal rules gove rning the bank's operation. The answers to the questionnaires were analyzed anonymously. RESULTS: Among 20 hospital units collecting DNA samples, 70% also stored ot her samples (DNA, blood, tissue, cell lines) including a large proportion o f tissue samples. These samples were collected for purposes of fundamental research and clinical practice. The number of samples stored was quite vari able, ranging from a few dozen samples to more than 40 000. Only 55% of the units had reported the facility to a control body, in compliance with curr ent law. Seventy percent maintained computerized data bases but only 50% us ed an anonymous code. Seventy-five percent obtained written consent bur pat ients were not always informed of the site of the storage or the transfer o f their DNA. in addition, the validity of the consent over rime, the durati on of storage and the types of studies that could be conducted on the DNA w ere poorly detailed. Internal rules governing the bank's activities were no t implemented by most of the units (65%). CONCLUSION: The responses to our questionnaire survey show that there is cu rrently a gap between everyday practice and regulatory procedures concernin g DNA banks in France. Further analysis of current practices would appear t o be necessary so professionals could become more aware of the human and so cial issues involved with the use of DNA banks. These data on everyday prac tices should be made available to health care workers, public officials and law makers in order to promote ethical practices that, as has been observe d, are not dictated solely by legislation which often lags behind everyday activities. All those involved in the management of DNA banks must be aware of their responsibilities in protecting patients' rights within the framew ork of a system based on information, consent, and over-the-board trustwort hiness regularly submitted to short and long term assessments. A correct re sponse to ethical issues is the only means of developing a real process of social interaction which cannot be achieved by revision of the bioethics la ws alone.