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Lithuania (434) > Human rights (18)

Name: Law No.VIII-1679 of 17 September 2015 "On Ethics of Biomedical Research".
Country: Lithuania
Subject(s): Human rights
Type of legislation: Law, Act
Adopted on: 2015-09-17
Entry into force:
ISN: -2015-L-102253
Bibliography: Legislation On-Line Legislation On-Line Seimas of the Republic of Lithuania , Lithuania PDF in English PDF in English PDF in Lithuanian PDF in Lithuanian (consulted on 2016-07-05)
Abstract/Citation: Sets general provisions, including the purpose of the law, definitions of main concepts and terms (Chapter I); ethical requirements for biomedical research, including, inter alia, vulnerable subjects and protection of their interests, person's consent to participate in research, confidentiality of health information (Chapter II); terms of bio banking activity, including, inter alia, bio banking activity definition, processing of human biological samples and health information, notification of human biological samples and/or health information and of information which is important for a person's health (Chapter III); supervision of conduct of biomedical research, specifying, inter alia, the institutions authorizing the conduct of biomedical research, biomedical research committees (Chapter IV); final provisions establishing the liability for infringements of ethical requirements for biomedical research.

Implements the Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ 2004 special edition, Chapter 13, Volume 26, p. 299).

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