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[Clinical scientific research with ionizing radiation in Italy. The standards-setting and legal aspects].

INTRODUCTION
The paper reviews the laws that regulate the clinical scientific research with ionizing radiations in Italy. Although recent (all introduced after 1990), the laws are a maze of rules sometimes contradictory and unclear, with frequent cross-references which make them difficult to disentangle. The aim of the paper is to provide the researcher with a technical and legal guide to find his/her way in the labyrinth of rules, and to constitute a basis for a possible future rationalization of the regulations.


MATERIALS AND METHODS
The contents of the article n. 108 of the law by decree 230/1995 and of the Minister's Decree 21/11/1997 together with the ICRP 62 (introduced in Italy by the Minister's Decree 21/11/1997) are extensively reviewed. The authors stress the fact that these laws apply only to prospective, but not to retrospective studies. The procedure to obtain ministerial authorization of the research project is illustrated, together with the possibility of a bureaucratic shortcut whereby the ethical committee states that the project conforms to ICRP 62. Special attention is paid to the cases of contrast between the ICRP 62 and previously promulgated laws: dose thresholds in non-therapeutic research, research on pregnant women or in child-bearing age and the issue of the preliminary assessment of new radiopharmaceuticals on monkeys (recommended by ICRP 62 but strongly restricted by the law by decree 116/1992). As for studies with radiopharmaceuticals, the problem of the double authorization required by the Minister's Decree 21/11/1997 and by the memorandum 10/07/1997, n. 8 of the Ministry of Health is also discussed.


DISCUSSION AND CONCLUSIONS
The authors express the opinion that the Minister's Decree 21/11/1997, together with ICRP 62, render invalid all previous rules and regulations which contrast with them. The Minister's Decree 21/11/1997 and ICRP 62 are practical and exhaustive and offer the researchers and ethical committees precise and reliable guidelines. The paper aims to offer a contribution for the rationalization of the rules that regulate the field. To this regard, an accurate design of the future regulations, reflecting Euratom Directive 43/97 is expected by May 13, 2000. The authors' conclusion is that laws must regulate, not strangulate, clinical scientific research with ionizing radiations: incongruities, uncertainties and bureaucratic excesses must be corrected.