title: [The system of protection of scientific biomedical research participants in France and in Poland].
abstract: Realizing scientific biomedical research conducted on human-beings demands obeying ample ethical rules. However, states keep independence in the means of implementing deontological guidelines to legislative acts. The aim of the article is to compare rules of law relative to protection of scientific biomedical research participants in two European Union member states--France and Poland. French regulations cover more types of scientific biomedical research than those in Poland. In France almost all types of interventional scientific biomedical research including research on human biological samples and research on cosmetics are covered by the rules of law. Polish regulations are limited to interventional research conducted by doctors and dentists. In both states projects of clinical trials of medicinal products demands double acceptance - from bioethics committee and from competent state authority. In protection of scientific biomedical research participants the role of state authority competent for personal data is more vital in France than it is in Poland. In France there is also National Ethics Advisory Committee whereas in Poland there is no such institution. The systems protecting scientific biomedical research participants differs therefore in both states in many vital aspects and French measures cover more types of scientific biomedical research, hence the level of participants protection in various types of research is more equitable.
authors.affiliation: Warszawski Uniwersytet Medyczny, Klinika Chorób Wewnétrznych i Endokrynologii. mczark@gmail.com
authors.forename: Marek
authors.initials: M
authors.lastname: Czarkowski
authors.forename: Alicja
authors.initials: A
authors.lastname: Sieczych
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D005062:European Union; D005602:France; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D011044:Poland; D035842:Research Subjects / Q000331:legislation & jurisprudence*