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235/2009. (X. 20.) Government Decree laying down rules governing the procedure for the authorization of medicinal products for human use, clinical trials of investigational medicinal products for human use, and clinical devices intended for clinical trials
Act XXI of 2008 on the Rules of Protection of Human Genetic Data, of Human Genetic Examinations and Research and of the Operation of Biobanks
Australian Code for the Responsible Conduct of Research
Bangladesh 2011
Bulgaria 2018
CETS 168.docx.pdf
Cape Verde 2007
Civil and Commercial Code, Articles 26, 58, and 59 (2015)
Clinical Research In Mauritius
CookIslands_Framework
Costa Rica 1
Cyprus Law for Good Clinical Practice (2004)
Cyprus Legislation Concerning Medicinal Products of Human Use (Good Clinical Practice) No. 452/2004 Article 11 (8)
DHS Directive 026-04, Human Subjects Research
EPA Order 1000.17A Approved 15Jun16 Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research
Final Draft National Biosafety Framework
Final Draft National Biosafety Framework
Guam Public Law 24/326
Guam_1983_InformedConsent
Guam_2019_IRBAssent
Guide for Assessing and Monitoring of Research Protocols
Guidelines 2006
Guidelines for Researchers Intending to Do Health Research in Rwanda
Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (2007)
Hungary Act C of 2012
Hungary Act CVIV of 1997, Chapters VIII and IX
Hungary Act CVIV of 1997, Chapters VIII and IX PDF
Hungary Act XLVII of 1997 on the Handling of Medical and Other Related Data
Hungary Decree 4/2009 (III. 17)
Hungary: Decree 23/2002 (V. 9.) of the Minister of Health on Biomedical Research on Human Beings
Hungary: Decree 35/2005 (VIII.26.) of the Minister of Health on the Clinical Trials of Investigational Medicinal Products for Human Use and on the Application of Good Clinical Practice
Iceland- Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine
Iceland: Act on Scientific Research in the Health Sector No. 44/2014
India- National Ethical Guidelines for Biomedical Research Involving Children
International Ethical Guidelines for Biomedical Research Involving Human Subjects
Latvia_Statutes of Central Medical Ethics Committees_1998
Law of Georgia on Healthcare
Law of the People's Republic of China on Practising Physicians
Law on Health Care
Law on Research Using Human Subjects 2011
Lithuania_Changes of Law on Ethics of Biomedical Research No. 536/2014 (2017)
Lithuania_Changes of Law on Ethics of Biomedical Research No. 536/2014_2017
Lithuania_Corrections of GCP Terminology in Lithuanian_2006
Lithuania_Decree No. 745 on the Rules of Compulsory Civil Liability Insurance for the Principal Investigator and the Sponsor_2016
Lithuania_Decree No. V-2 on the Procedure to Issue Approvals to Conduct Biomedical Research_2017
Lithuania_Decree No. V-6 on the Sample Form of the Request to Issue Favorable Opinion to Conduct Clinical Trial on Medicinal Product Form and the Ethical Assessment Form_2016
Lithuania_Decree No. V-659 on the Procedure for Importing of the Stem Cells_2017
Lithuania_Decree No. V-660 on the Procedure to Issue Authorization for the Transit of Tissues of Human Embryonic Tissue, Embryonic Stem Cells and their Lines, Fetal Tissue, and Fetal Stem Cells_2007
Lithuania_Guidelines for Patient Information Sheet and Informed Consent Form, Adopted by the Group of Experts on Biomedical Research of the LBEC_2016
Lithuania_Law on Ethics of Biomedical Research_2016
Lithuania_Law on Pharmacy_2017
Lithuania_V-1483, Decree on the List of Interventional Methods of Biomedical Research Causing a Slightly Detrimental and Temporary Impact on the Subject’s Health_2014
Lithuania_V-15, Decree on the Procedure for Calculating and Paying Compensation for the Expenses Incurred Due to Participation in Biomedical Research and the Time Spent_2018
Lithuania_V-235/A1-83, Decree on the Procedure for a Minor’s Participation in Biomedical Research_2018
Lithuania_V-24, Decree on the Procedure for Submission of the Documents_2016
Lithuania_V-28, Decree on the Detailed Requirements for the Content of a Person’s Consent to Participate in Biomedical Research and for the Information about the Biomedical Research as well as a Procedure for Giving and Withdrawing the Consent_2016
Lithuania_V-28, Decree on the Procedure to Conduct Biomedical Research on Medical Documents, No. V-28_2011
Lithuania_V-4, Decree on the Request to Issue Approval to Conduct Biomedical Research, the Application Form and the Biomedical Research Ethical Assessment Form_2016
Lithuania_V-405, Decree on the Procedure for Keeping a Record of Biomedical Research, Collecting, Storage, and Providing Information on Biomedical Research_2010
National Ethical Guidelines for Health Research 2011
Oviedo Convention
PRC_1
Philippines 2012
Poland_PharmaceuticalLaw
Recommendations on the ethical review of hESC FP7 research projects Opinion No 22
Research, Science and Technology Act 23 of 2004
Resolution 1480/2011: Approving the Guidelines for Human Health Research and Creating the National Registry of Health Research
Resolution No. 8430
Russia_2011_No.61FZ
Russia_2015_Federal Law #FZ55
Russia_2015_FederalLawFZ55
Russia_2016_OrderNo.200н
Singapore 2015
St Helena Research Policy
Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
Sweden 2018
Switzerland 2018
TRI-COUNCIL-POLICY-STATEMENT-Ethical-Conduct-for-Research-Involving-Humans.pdf
Uganda National Council for Science and Technology
ci_compensationguidelines