Document Title |
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 |