Healthy Skepticism Library item: 9007

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Publication type: Journal Article

Sprumont D, Gytis A.
The importance of national laws in the implementation of European legislation of biomedical research.
Eur J Health Law 2005 Sep; 12:(3):245-67
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17302046&query_hl=9&itool=pubmed_DocSum

Abstract:

The industrialization and internationalization of biomedical research is not without consequences on the regulation of research or, at least, on the interpretation of that regulation. As more research is done at the international level, the pharmaceutical industry and the research community are calling for a harmonized regulation to limit the administrative burden of controlling clinical trials and to fasten the R&D process. The purpose of this paper is to analyse briefly the role of the national laws in that process. Part I will outline the structure and the nature of the international regulation of research in a European perspective. Using the examples of research ethics committees (RECs), informed consent and the question of liability and liability insurance, Part II will analyze the importance of the national laws in the implementation of this international regulation.

Keywords:
MeSH Terms: Biomedical Research/legislation & jurisprudence* Drug Industry Europe International Cooperation* Liability, Legal