|
Links |
| Document Title |
Synopsis |
Source |
Text |
| Constitution of the Republic of
Ecuador 2008 (Article: 92) |
Synopsis |
Source |
Text |
| New Political Constitution of
the State, Article 44 (2009) |
Synopsis |
Source |
Text |
| Regulation on Research,
Ministerial Agreement No.
0066, Public Registry No. 292 |
Synopsis |
Source |
Text |
| 10 CFR 745 |
Synopsis |
Source |
Text |
| 10 USC 980: Limitation on Use of Humans as Experimental Subjects |
Synopsis |
Source |
Text |
| 14 CFR 1230 |
Synopsis |
Source |
Text |
| 15 CFR 27 |
Synopsis |
Source |
Text |
| 16 CFR 1028 |
Synopsis |
Source |
Text |
| 21 CFR 312 |
Synopsis |
Source |
Text |
| 21 CFR 314 |
Synopsis |
Source |
Text |
| 21 CFR 320 |
Synopsis |
Source |
Text |
| 21 CFR 50 |
Synopsis |
Source |
Text |
| 21 CFR 54 |
Synopsis |
Source |
Text |
| 21 CFR 56 |
Synopsis |
Source |
Text |
| 21 CFR 807 |
Synopsis |
Source |
Text |
| 21 CFR 812 |
Synopsis |
Source |
Text |
| 21 CFR 814 |
Synopsis |
Source |
Text |
| 21st Century Cures Act |
Synopsis |
Source |
Text |
| 22 CFR 225: Protection of Human Subjects |
Synopsis |
Source |
Text |
| 24 CFR 60.101 |
Synopsis |
Source |
Text |
| 28 CFR 22 |
Synopsis |
Source |
Text |
| 28 CFR 46 |
Synopsis |
Source |
Text |
| 32 CFR 219 |
Synopsis |
Source |
Text |
| 34 CFR 350 |
Synopsis |
Source |
Text |
| 34 CFR 356 |
Synopsis |
Source |
Text |
| 34 CFR 97 |
Synopsis |
Source |
Text |
| 34 CFR 98 |
Synopsis |
Source |
Text |
| 38 CFR 17.85 |
Synopsis |
Source |
Text |
| 38 FR 16 |
Synopsis |
Source |
Text |
| 40 CFR 26 |
Synopsis |
Source |
Text |
| 42 CFR 11 |
Synopsis |
Source |
Text |
| 42 U.S.C. § 3789g |
Synopsis |
Source |
Text |
| 45 CFR 46 (Common Rule) |
Synopsis |
Source |
Text |
| 45 CFR 690 |
Synopsis |
Source |
Text |
| 49 CFR 11 |
Synopsis |
Source |
Text |
| 7 CFR 1c |
Synopsis |
Source |
Text |
| A Guide for Research Ethics Committees for Biological Research (2008) |
Synopsis |
Source |
Text |
| Accident Compensation Act2001 |
Synopsis |
Source |
Text |
| Act 851, Sections 150-166 |
Synopsis |
Source |
Text |
| Act C of 2012 on the Criminal Code, Chapter XVI Medical Procedures and Criminal Offenses Against the Order of Research |
Synopsis |
Source |
Text |
| Act CLIV of 1997 on Health Care |
Synopsis |
Source |
Text |
| Act CXII of 2011 on Right of Informational Self-Determination and Freedom of Information |
Synopsis |
Source |
Text |
| Act No. 1083 on Research Ethics Review of Health Research Projects (2013) |
Synopsis |
Source |
Text |
| Act No. 506 on Medicinal Products (2013) |
Synopsis |
Source |
Text |
| Act No. 620 on Clinical trials on Medical Products No. 620 (2016) |
Synopsis |
Source |
Text |
| Act Ratifying the 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, and of the Additional Protocol to the Convention for the Pro |
Synopsis |
Source |
Text |
| Act XLVII of 1997 on the Handling of Medical and Other Related Data |
Synopsis |
Source |
Text |
| Act on Scientific Research in the Health Sector No. 44/2014 |
Synopsis |
Source |
Text |
| Act on the Medical Use of Human Organs, Tissues, and Cells No. 101/2001 |
Synopsis |
Source |
Text |
| Additional Protocol I Relating to the Protection of Victims of International Armed Conflicts, Article 11 |
Synopsis |
Source |
Text |
| Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology of Cloning Human Beings (2003) |
Synopsis |
Source |
Text |
| Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research |
Synopsis |
Source |
Text |
| Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research |
Synopsis |
Source |
Text |
| Administrative Regulations on the Establishment of Human Biobanks |
Synopsis |
Source |
Text |
| Adults with Incapacity (Ethics Committee) (Scotland) Regulations (2002)) |
Synopsis |
Source |
Text |
| Adults with Incapacity (Scotland) Act 2000, Section 51 |
Synopsis |
Source |
Text |
| Appointment of the Bioethics Committee of Appeal |
Synopsis |
Source |
Text |
| Article 122 Regarding Clinical Trials |
Synopsis |
Source |
Text |
| Artificial Reproduction Act |
Synopsis |
Source |
Text |
| Assets and Poverty Dynamics in Rural Tajikistan |
Synopsis |
Source |
Text |
| Assissted Human Reproduction Regulations (Section 8 Consent) |
Synopsis |
Source |
Text |
| Assisted Human Reproduction Act |
Synopsis |
Source |
Text |
| Austrian Drug Law (2013) |
Synopsis |
Source |
Text |
| Austrian Medical Devices Law, Article 47 (2017) |
Synopsis |
Source |
Text |
| BAK: (Model) Professional Code for Physicians in Germany, Article 15 (2018) |
Synopsis |
Source |
Text |
| Best Practices for Protecting Privacy in Health Research |
Synopsis |
Source |
Text |
| Biosafety Law 11.105/05 (2005) |
Synopsis |
Source |
Text |
| Biosafety Law on Genetically Modified Organisms |
Synopsis |
Source |
Text |
| Building Research Ethics Review Capacity in Swaziland |
Synopsis |
Source |
Text |
| Care Act 2014 |
Synopsis |
Source |
Text |
| Changes of the Law on Ethics of Biomedical Research No. 536/2014 (2017) |
Synopsis |
Source |
Text |
| Charter of Ethics and Guiding Principles of Scientific Research in Lebanon |
Synopsis |
Source |
Text |
| Circular No 600-5776-14: Processes of Good Clinical Practice |
Synopsis |
Source |
Text |
| Civil Code Articles 16-10 to 16-13 |
Synopsis |
Source |
Text |
| Civil and Commercial Code, Articles 26, 58, and 59 (2015) |
Synopsis |
Source |
Text |
| Clinical Research in
Mauritius |
Synopsis |
Source |
Text |
| Clinical Trials Directive 2001/20/EC |
Synopsis |
Source |
Text |
| Code of Ethics |
Synopsis |
Source |
Text |
| Code of Ethics for Scientific Research in Belgium |
Synopsis |
Source |
Text |
| Code of Ethics of Estonian Scientists |
Synopsis |
Source |
Text |
| Code of Medical Ethics, Chapter II |
Synopsis |
Source |
Text |
| Code of Research Ethics for Biological Science |
Synopsis |
Source |
Text |
| Code on Childhood and
Adolescence. Law 100 Official
Register 737 of January 3, 2003
(2014) |
Synopsis |
Source |
Text |
| Commercialisation of human stem cells and other cell lines |
Synopsis |
Source |
Text |
| Commission Directive 2005/28/EC |
Synopsis |
Source |
Text |
| Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the Detailed Arrangements for the Good Clinical Practice Inspection Procedures Pursuant to Regulation (EU) No 536/2014 of the European Parliament and Council |
Synopsis |
Source |
Text |
| Commission Staff Working Paper Report on Human Embryonic Stem Cell Research (2003) |
Synopsis |
Source |
Text |
| Commissioner's Directive- Research (DC009) |
Synopsis |
Source |
Text |
| Conflict of Interest in Biomedical Research (2014) |
Synopsis |
Source |
Text |
| Constitution of Colombia, Article 15 |
Synopsis |
Source |
Text |
| Constitution of Republic ofUzbekistan, Articles 24, 26, 40,44 (1992) |
Synopsis |
Source |
Text |
| Constitution of Ukraine Art. 28 (1996) |
Synopsis |
Source |
Text |
| Constitution of the Republic of Bulgaria, Amendment SG. 18/25, Article 29 (2015) |
Synopsis |
Source |
Text |
| Constitution of the Republic of Estonia, Paragraph 18 (2016) |
Synopsis |
Source |
Text |
| Constitution of the Republic of Poland, Article 39 |
Synopsis |
Source |
Text |
| Constitution of the Russian Federation, Article 21 |
Synopsis |
Source |
Text |
| Constitution, Article 46 (3) |
Synopsis |
Source |
Text |
| 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 |
Synopsis |
Source |
Text |
| Cooks Island National Research Policy |
Synopsis |
Source |
Text |
| Criminal Code of Finland (39/1889), Chapter 22, Section 4 |
Synopsis |
Source |
Text |
| Criminal Code of Ukraine2001, Article 141 and 142 |
Synopsis |
Source |
Text |
| DAOD 5061-0, Research Involving Human Subjects |
Synopsis |
Source |
Text |
| DHCR Conducting Research in DHCC- Policy and Procedures |
Synopsis |
Source |
Text |
| DHS Directive 026-04, Human Subjects Research |
Synopsis |
Source |
Text |
| DOE Order 443.1B |
Synopsis |
Source |
Text |
| DOE Order 481.1 |
Synopsis |
Source |
Text |
| DOST, DOH, CHED, and UPM: Joint Administrative Order No. 001: The Implementing Rules and Regulations of Republic Act 10532 Otherwise Known as “The Philippine National Health Research System Act of 2013:” |
Synopsis |
Source |
Text |
| DOST, DOH, CHED, and UPM: Joint Memorandum Order 001 Series of 2012 |
Synopsis |
Source |
Text |
| Data Protection Act (2018) |
Synopsis |
Source |
Text |
| Data Protection Act No. 165/1999 |
Synopsis |
Source |
Text |
| Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects |
Synopsis |
Source |
Text |
| Decree 18/1998 (XII 27) EüM on Implementing Act CLIV of 1997 on Health Care as Regards Transplantation and Storage of Organs and Tissues and Certain Histopathology Examinations |
Synopsis |
Source |
Text |
| Decree 23/2002 (V. 9.) of the Minister of Health on Biomedical Research on Human Beings |
Synopsis |
Source |
Text |
| 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 |
Synopsis |
Source |
Text |
| Decree 4/2009 (III. 17) |
Synopsis |
Source |
Text |
| Decree No. 2015-155 of 11 February, 2015: Public Health Code on Research on Embryos Article R2151-1 and Following Sections |
Synopsis |
Source |
Text |
| Decree No. 235/2009 (X.20.) from the Hungarian Government on the Regulations of Giving Permission for Human Medical Experiments, for Clinical Studies of Experimental Medicinal Products, and for the Clinical Studies of the Medical Devices |
Synopsis |
Source |
Text |
| Decree No. 5,591, of November 22, 2005 |
Synopsis |
Source |
Text |
| Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS), Chapters I and II (1998) |
Synopsis |
Source |
Text |
| Decree Ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research |
Synopsis |
Source |
Text |
| Decree of February 13, 2001 Implementing the Law of December 8, 1999 |
Synopsis |
Source |
Text |
| Decree of the Minister of Health on Clinical Trials of Investigative Medicinal Products for Human Use and on the Application of Good Clinical Practice |
Synopsis |
Source |
Text |
| Decree on Medical Research |
Synopsis |
Source |
Text |
| Directive 2001/20/EC of the European Parliament and of the Council |
Synopsis |
Source |
Text |
| Directive 93/42/EEC Concerning Medical Devices |
Synopsis |
Source |
Text |
| DoDI 3216.02 |
Synopsis |
Source |
Text |
| Drug Administration Law of the People's Republic of China |
Synopsis |
Source |
Text |
| Drug and Pharmacy Law No. 12 |
Synopsis |
Source |
Text |
| EPA Order 1000.17A |
Synopsis |
Source |
Text |
| EU Clinical Trials Register: FAQs |
Synopsis |
Source |
Text |
| EU General Data Protection Regulation (2016) |
Synopsis |
Source |
Text |
| Establishing Criteria for the Conduct of Health Research Projects |
Synopsis |
Source |
Text |
| Estonian Code of Conduct for Research Integrity |
Synopsis |
Source |
Text |
| Ethical Clearance Application Form |
Synopsis |
Source |
Text |
| Ethical Considerations in Biomedical HIV Prevention Trials |
Synopsis |
Source |
Text |
| Ethical Guidelines for Biomedical Research |
Synopsis |
Source |
Text |
| Ethical Guidelines for Human Biomedical Research |
Synopsis |
Source |
Text |
| Ethical Guidelines for InterventionStudies (2012) |
Synopsis |
Source |
Text |
| Ethical Guidelines for Medical and Health Research Involving Human Subjects |
Synopsis |
Source |
Text |
| Ethical Guidelines for ObservationalStudies: Observational Research, Audits and Related Activities (2012)) |
Synopsis |
Source |
Text |
| Ethical Issues in Connection with the Development of Foetal Genetic Testing on Maternal Blood |
Synopsis |
Source |
Text |
| Ethical Issues in Patient Safety Research: Interpreting Existing Guidance |
Synopsis |
Source |
Text |
| Ethical Reflection on Developments in Genetic Testing in Connection with Very High Throughput Human DNA Sequencing |
Synopsis |
Source |
Text |
| Ethical Review of Biomedical Research in the CIS Countries (Social and Cultural Aspects) |
Synopsis |
Source |
Text |
| Ethical principles of research in the humanities and social and behavioural sciences and proposals for ethical review |
Synopsis |
Source |
Text |
| Ethical reflection concerning research on human embryonic cells and on human embryos in vitro |
Synopsis |
Source |
Text |
| Ethics Committee DL |
Synopsis |
Source |
Text |
| Ethics Committee Guidelines: Procedures for Researchers |
Synopsis |
Source |
Text |
| Ethics Committee Protocols |
Synopsis |
Source |
Text |
| Ethics in Health Research |
Synopsis |
Source |
Text |
| EudraLex Volume 10: Clinical Trials |
Synopsis |
Source |
Text |
| Executive Order 12333 |
Synopsis |
Source |
Text |
| Executive Order No. 1464 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects (2016) |
Synopsis |
Source |
Text |
| Executive Order No. 1464 on Information and Consent at Inclusion of trial Subjects in Biomedical Research Projects (2018) |
Synopsis |
Source |
Text |
| Executive Order No. 295 on Clinical Trials of Medicinal Products on Humans (2006) |
Synopsis |
Source |
Text |
| Exempt Resolution 2263, July 30th 2015 Modifying Resolution Nº 403 Ex. February 5, 2015 that Approves the Guidelines for Use Control of Pharmaceuticals Products in Scientific Research |
Synopsis |
Source |
Text |
| External Circular No. 600-1414-16:
Notification of Deviations |
Synopsis |
Source |
Text |
| External Circular No. 600-2006-16:
National Reporting Serious Adverse
Events |
Synopsis |
Source |
Text |
| External Guidance on the Implementation of the European Medicines Agency Policy on the Publication of Clinical Data for Medicinal Products for Human Use (2016) |
Synopsis |
Source |
Text |
| FAQs and Vignettes |
Synopsis |
Source |
Text |
| FDA Guidelines: Regulation of Clinical Trials in the Philippines |
Synopsis |
Source |
Text |
| FDA: Guideline for Good Clinical Practice |
Synopsis |
Source |
Text |
| FDA: Pharmaceutical Affairs Act |
Synopsis |
Source |
Text |
| Faculty of Medicine- Cairo University Ethical Review Board Policies & Procedures Manual |
Synopsis |
Source |
Text |
| Family Educational Rights and Privacy Act (FERPA) |
Synopsis |
Source |
Text |
| Federal Act on Research involving Human Beings |
Synopsis |
Source |
Text |
| Federal Act on the Organisation of Universities and their Studies (Universities Act 2002 - UG) |
Synopsis |
Source |
Text |
| Federal Constitution of theSwiss Confederation of 18April, 1999, RS 101, Article 118b |
Synopsis |
Source |
Text |
| Federal Law #FZ 323 “On Foundations of Protection of Citizen’s Health in the Russian Federation” |
Synopsis |
Source |
Text |
| Federal Law for the Protection of Personal Data in the Possession of Private Individuals |
Synopsis |
Source |
Text |
| Federal Law on Transparency and Access to Public Information |
Synopsis |
Source |
Text |
| Final Draft National Biosafety Framework |
Synopsis |
Source |
Text |
| Food and Drug Administration Amendments Act |
Synopsis |
Source |
Text |
| Food and Drug Administration Modernization Act |
Synopsis |
Source |
Text |
| Food and Drugs Act (1975) |
Synopsis |
Source |
Text |
| Food, Drug, and Cosmetic Act |
Synopsis |
Source |
Text |
| Framework for Research Ethics |
Synopsis |
Source |
Text |
| GCC Book |
Synopsis |
Source |
Text |
| Gene Technology Act (2012) |
Synopsis |
Source |
Text |
| General Health Law |
Synopsis |
Source |
Text |
| General Privacy/Data Protection Guidelines |
Synopsis |
Source |
Text |
| General Privacy/Data Protection Guidelines |
Synopsis |
Source |
Text |
| General Technical Rule No. 140 Regarding the National System of Pharmacovigilance of Pharmaceutical Products for Human Use |
Synopsis |
Source |
Text |
| Geneva Convention Relative to the Treatment of Prisoners of War, Articles 13 and 30 |
Synopsis |
Source |
Text |
| Global Code of Conduct for Research in Resource-Poor Settings |
Synopsis |
Source |
Text |
| Goals, Objectives, and DesiredOutcomes of an Ethical Review System(2003) |
Synopsis |
Source |
Text |
| Good Clinical Practice and Human Subject Protections in FDA-Regulated Clinical Trials |
Synopsis |
Source |
Text |
| Good Clinical Practice and Human Subject Protections: Drugs |
Synopsis |
Source |
Text |
| Good Participitory Practice: Guidelines for Biomedical HIV Prevention Trials |
Synopsis |
Source |
Text |
| Good Practice in Research: Internet-Mediated Research |
Synopsis |
Source |
Text |
| Good Practice in Research: Internet-Mediated Research (2016) |
Synopsis |
Source |
Text |
| Good Research Practice |
Synopsis |
Source |
Text |
| Good Research Practice: Principles and Guidelines |
Synopsis |
Source |
Text |
| Governance Arrangements forResearch Ethics Committees(2018): |
Synopsis |
Source |
Text |
| Governance Framework for Biomedical Research in Singapore |
Synopsis |
Source |
Text |
| Governing Biomedical Research on Humans |
Synopsis |
Source |
Text |
| Governmental Agreement 712- 99, Articles 91-94 (1999) |
Synopsis |
Source |
Text |
| Guidance to Applicants For the Approval of Health Research In Human Subjects |
Synopsis |
Source |
Text |
| Guide for Assessing and Monitoring of Research Protocols |
Synopsis |
Source |
Text |
| Guide for Ethics Committees |
Synopsis |
Source |
Text |
| Guide of Medications and Supplies for
Clinical Research, Version 1 |
Synopsis |
Source |
Text |
| Guideline for Good Clinical Practice |
Synopsis |
Source |
Text |
| Guideline for Good Clinical Practice (GCP) |
Synopsis |
Source |
Text |
| Guideline for Good Clinical Practice (GCP) E6 (R1) |
Synopsis |
Source |
Text |
| Guideline for Good Clinical Practice E6(R2) (2016) |
Synopsis |
Source |
Text |
| Guidelines about Notification (Checklist) (2017) |
Synopsis |
Source |
Text |
| Guidelines for Clinical Trials in Human Subjects |
Synopsis |
Source |
Text |
| Guidelines for Ethical Review for Clinical Research or Research Involving Human Subjects |
Synopsis |
Source |
Text |
| Guidelines for Good Clinical Practice |
Synopsis |
Source |
Text |
| Guidelines for Institutional ReviewCommittees (IRCs) for Health Research inNepal (2016) |
Synopsis |
Source |
Text |
| Guidelines for Patient Information Sheet and Informed Consent Form, Adopted by the Group of Experts on Biomedical Research of the LBEC (2017) |
Synopsis |
Source |
Text |
| Guidelines for Reseachers Intending to do Health Research in Rwanda |
Synopsis |
Source |
Text |
| Guidelines for Research Ethics in the Social Sciences Humanities and Theology |
Synopsis |
Source |
Text |
| Guidelines for Researchers on HealthResearch Involving Māori (2010) |
Synopsis |
Source |
Text |
| Guidelines for the Conduct of Research on Human Subjects |
Synopsis |
Source |
Text |
| Guidelines on Ethical Review or Waiver 31 October 2006 |
Synopsis |
Source |
Text |
| Guides for the Conduct of Clinical Trials |
Synopsis |
Source |
Text |
| HIV AND AIDS PREVENTION AND CONTROL ACT |
Synopsis |
Source |
Text |
| HRC Research Ethics Guidelines(2017) |
Synopsis |
Source |
Text |
| Handbook for Good Clinical Research Practice (GCP) |
Synopsis |
Source |
Text |
| Health Code, Decree No. 65-91, Articles 175 and 176 |
Synopsis |
Source |
Text |
| Health Research Council Act 1990, Sections 24 and 25 |
Synopsis |
Source |
Text |
| Health Research Guideline |
Synopsis |
Source |
Text |
| Health Research with Consent (2018) |
Synopsis |
Source |
Text |
| Health Research without Consent (2018) |
Synopsis |
Source |
Text |
| Health Research: CNIL Adopts New Simplification Measures (2018) |
Synopsis |
Source |
Text |
| Health Service Executive National Consent Policy, Part 3 |
Synopsis |
Source |
Text |
| Health and DisabilityCommissioner Act 1994 |
Synopsis |
Source |
Text |
| Health and Social Care Act |
Synopsis |
Source |
Text |
| Healthway Strategic Plan |
Synopsis |
Source |
Text |
| Horizon 2020: How to Complete your Ethics Self-Assessment |
Synopsis |
Source |
Text |
| Hospital Act 2014 |
Synopsis |
Source |
Text |
| Human Biobank Management Act |
Synopsis |
Source |
Text |
| Human Biomedical Research Bill No. 25/2015: |
Synopsis |
Source |
Text |
| Human Research Ethics Committee FAQs |
Synopsis |
Source |
Text |
| Human Sciences Research Council Act No. 17 |
Synopsis |
Source |
Text |
| Human Subjects Ethics Sub-committee FAQs |
Synopsis |
Source |
Text |
| Human Subjects Research Act (2011): |
Synopsis |
Source |
Text |
| ICH E6(R2): Good Clinical Practice- Integrated Addendum to E6(R1) |
Synopsis |
Source |
Text |
| IMDRF: Statement Regarding Use of ISO 14155:2011 “Clinical Investigation of Medical Devices for Human Subjects- Good Clinical Practice” |
Synopsis |
Source |
Text |
| Implementation Act of the General Data Protection Act (NN 42/18) (2018) |
Synopsis |
Source |
Text |
| Implementing Regulations of the Law of Ethics of Research on Living Creatures |
Synopsis |
Source |
Text |
| Import and Export of Human
Biological Samples for research.
Ministerial Agreement No. 0088,
Public Registry No. 34 |
Synopsis |
Source |
Text |
| In Vitro Diagnostic Medical Devices Regulation 2017/746 |
Synopsis |
Source |
Text |
| Instruction CTNBio No. 9 of 10 October 1997 |
Synopsis |
Source |
Text |
| Instructions on Manner of Reporting on Safety in the Framework of Clinical Trials (2016) |
Synopsis |
Source |
Text |
| Internal CONEP Regulation (2001) |
Synopsis |
Source |
Text |
| International Compilation of Human Research Standards |
Synopsis |
Source |
Text |
| International Covenant on Civil and Political Rights, Article 7 |
Synopsis |
Source |
Text |
| International Data Transfer (2018) |
Synopsis |
Source |
Text |
| International Ethical Guidelines for Biomedical Research Involving Human Subjects |
Synopsis |
Source |
Text |
| International Ethical Guidelines for Health-Related Research Involving Humans |
Synopsis |
Source |
Text |
| Ionising Radiation (Medical Exposure) (Northern Ireland) Regulations (2018) |
Synopsis |
Source |
Text |
| Ionising Radiation (MedicalExposure) Regulations (2017) |
Synopsis |
Source |
Text |
| Law 13.123/2015 (2015): Brazilian Legislation on Biodiversity Access (Genetic Heritage) |
Synopsis |
Source |
Text |
| Law 14/2007 onBiomedical Research |
Synopsis |
Source |
Text |
| Law 1581 of 2012: General Regimen of Protection of Personal Data |
Synopsis |
Source |
Text |
| Law 29733 for the Protection of Personal Information |
Synopsis |
Source |
Text |
| Law Decree No 8.772/2016 (2016), Regulating Law No. 13.123/2015 |
Synopsis |
Source |
Text |
| Law No. 20.120 Regarding Scientific Research in Human Beings, their Genome, and the Prohibition of Human Cloning (2006) |
Synopsis |
Source |
Text |
| Law No. 20.724 Modifying the Health Code in the Area of the Regulation of Pharmacies and Medications (2014) |
Synopsis |
Source |
Text |
| Law No. 2005-31 |
Synopsis |
Source |
Text |
| Law No. 2012-300 of 5 March 2012 on Research Involving Human Persons |
Synopsis |
Source |
Text |
| Law No. 2013-715 of 6th August 2013 |
Synopsis |
Source |
Text |
| Law No. 574 of 2004 on Patients Rights and Informed Consent |
Synopsis |
Source |
Text |
| Law Nº 6360/76 |
Synopsis |
Source |
Text |
| Law Nº 9782/99 Defining the National Health Surveillance System |
Synopsis |
Source |
Text |
| Law Ratifying the Additional Protocol on Biomedical Research (2006) |
Synopsis |
Source |
Text |
| Law Relating to Experimentation on Humans (2004) |
Synopsis |
Source |
Text |
| Law about Blood and Blood Products (2006) |
Synopsis |
Source |
Text |
| Law for Electronic Medical Charts (2013) |
Synopsis |
Source |
Text |
| Law for Good Clinical Practice (2004) |
Synopsis |
Source |
Text |
| Law for Protection of Personal Data |
Synopsis |
Source |
Text |
| Law for the Protection of Private Life No. 19.628 |
Synopsis |
Source |
Text |
| Law no. 2010-40 of 2010, Regarding the Ethical Code and Duties in Health Research |
Synopsis |
Source |
Text |
| Law of Donation and Transplantation of Anatomical Organs in Human Beings (2014) |
Synopsis |
Source |
Text |
| Law of the People's Republic of China on Practising Physicians |
Synopsis |
Source |
Text |
| Law of the People's Republic of China on Practising Physicians |
Synopsis |
Source |
Text |
| Law of the People's Republic of China on Practising Physicians |
Synopsis |
Source |
Text |
| Law of the Republic of Armenia of May 4, 1996: About Medical Aid, The Maintenance of the Population, Article 21 |
Synopsis |
Source |
Text |
| Law on Blood and Blood Products, Official Gazette of Bosnia and Herzegovina No. 09/10 |
Synopsis |
Source |
Text |
| Law on Ethics of Biomedical Research |
Synopsis |
Source |
Text |
| Law on Health Care |
Synopsis |
Source |
Text |
| Law on Health Care System, Articles 40, 46 (2010) |
Synopsis |
Source |
Text |
| Law on Health Insurance of the Republic of Srpska, Official Gazette Republic of Srpska No. 106/09 |
Synopsis |
Source |
Text |
| Law on Health Protection, MoH Federation of Bosnia and Herzegovina, No 46/10 |
Synopsis |
Source |
Text |
| Law on Health Protection, MoH Republic of Srpska (2015) |
Synopsis |
Source |
Text |
| Law on Implementation of Human Tissues and Cells (2012) |
Synopsis |
Source |
Text |
| Law on Mandatory Health Insurance (2013) |
Synopsis |
Source |
Text |
| Law on Quality and Safety of Human Tissue and Cells (2013) |
Synopsis |
Source |
Text |
| Law on Research Using Human Subjects |
Synopsis |
Source |
Text |
| Law on Safety of Blood (2009) |
Synopsis |
Source |
Text |
| Law on Transplantation of Human Organs for the Purpose of Treatment (2012) |
Synopsis |
Source |
Text |
| Law on Transplantation of Human Tissues and Cells (2010) |
Synopsis |
Source |
Text |
| Law on Transplantation of Organs (2010) |
Synopsis |
Source |
Text |
| Legislation Concerning Medicinal Products of Human Use (Good Clinical Practice) No. 452/2004 Article 11 (8) |
Synopsis |
Source |
Text |
| MEdical Professions Act |
Synopsis |
Source |
Text |
| MOH: Decision No. 460/QD-BYT – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of the Ministry of Health, Period 2012- |
Synopsis |
Source |
Text |
| MOH:Decision No. 111/QD-BYT – On Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at Grass-Roots Level, Chapter I (Articles 3 and 4), Chapter II, and |
Synopsis |
Source |
Text |
| Managing Ethical Issues in Infectious Disease Outbreaks: Guidance Document |
Synopsis |
Source |
Text |
| Manual for Submission of Modifications, Amendments, Suspensions and Cancellations on DDCM (2018) |
Synopsis |
Source |
Text |
| Manual for Submission of Modifications, Amendments, Suspensions, and Cancellations on DICD (2015) |
Synopsis |
Source |
Text |
| Manual for Submission of “Drug Clinical Development Dossier” (DDCM) (2017) |
Synopsis |
Source |
Text |
| Manual of Adverse Event Notification and Safety Monitoring in Clinical Trials Involving Drugs (2016) |
Synopsis |
Source |
Text |
| Manual of Adverse Event Notification and Safety Monitoring in Clinical Trials Involving Medical Devices (2016) |
Synopsis |
Source |
Text |
| Manual on the Functioning of the Health Research Ethics Committee |
Synopsis |
Source |
Text |
| Medical Care Act (2014): |
Synopsis |
Source |
Text |
| Medical Devices Act (2014) |
Synopsis |
Source |
Text |
| Medical Devices Act (2016) |
Synopsis |
Source |
Text |
| Medical Devices Regulation 2017/745 |
Synopsis |
Source |
Text |
| Medical Devices Regulations (SOR/98-282) |
Synopsis |
Source |
Text |
| Medical Devices Rules |
Synopsis |
Source |
Text |
| Medical Fertilization Act, Article 31: (2012) |
Synopsis |
Source |
Text |
| Medical Profession Act, Articles 21-29 |
Synopsis |
Source |
Text |
| Medical Research Act No. 488/1999 |
Synopsis |
Source |
Text |
| Medical Research Involving Adults Who Cannot Consent (2007) |
Synopsis |
Source |
Text |
| Medical Research Involving Children (2004) |
Synopsis |
Source |
Text |
| Medical Research for and with Older People in Europe |
Synopsis |
Source |
Text |
| Medicinal Product Act (2013) |
Synopsis |
Source |
Text |
| Medicinal Products in Human Medicine Act (2017) |
Synopsis |
Source |
Text |
| Medicinal Products in Human Medicine Act, Chapter 4 (2018) |
Synopsis |
Source |
Text |
| Medicinal Products in Human Medicine Act, Chapter 4, Articles 91 and 92 (2016) |
Synopsis |
Source |
Text |
| Mental Capacity Act |
Synopsis |
Source |
Text |
| Mental Health Act, Official Gazette Nos. 77/2008 and 46/2015 |
Synopsis |
Source |
Text |
| Ministry of Heatlh Research Policy |
Synopsis |
Source |
Text |
| NBC Duty to report unexpected events |
Synopsis |
Source |
Text |
| NBC Informed Consent |
Synopsis |
Source |
Text |
| NBC Vulnerable Groups Including Children |
Synopsis |
Source |
Text |
| NBC Withdrawal of Consent |
Synopsis |
Source |
Text |
| NCIP AO No. 3 Series 2012: Revised Guidelines on Free and Prior Informed Consent |
Synopsis |
Source |
Text |
| NCRT: Regulation on the Permission of Foreign Researchers (1982) |
Synopsis |
Source |
Text |
| NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information |
Synopsis |
Source |
Text |
| NIH privacy rules and research |
Synopsis |
Source |
Text |
| NIH privacy rules and research |
Synopsis |
Source |
Text |
| National Code of Health Research Ethics |
Synopsis |
Source |
Text |
| National Ethical Guidelines for Biomedical Research Involving Children |
Synopsis |
Source |
Text |
| National Ethical Guidelines for Biomedical and Ethical Guidelines Involving Human Participants |
Synopsis |
Source |
Text |
| National Ethical Guidelines for Health Research |
Synopsis |
Source |
Text |
| National Ethical Guidelines for Health Research in Nepal and Standard Operating Procedure |
Synopsis |
Source |
Text |
| National Ethical Guidelines for Health and Health-Related Research, Pages 108-118 (2017): |
Synopsis |
Source |
Text |
| National Guidelines for Ethical Conduct of Research Involving Human Subjects |
Synopsis |
Source |
Text |
| National Guidelines for Integration and Operation of the Research Ethics Committee |
Synopsis |
Source |
Text |
| National Health Act |
Synopsis |
Source |
Text |
| National Health Policy |
Synopsis |
Source |
Text |
| National Health Research Act |
Synopsis |
Source |
Text |
| National Research Ethics Committees Bill |
Synopsis |
Source |
Text |
| National Research Ethics Review Guideline |
Synopsis |
Source |
Text |
| Nepal Health Research Council Act, 1991, Section 3(1) |
Synopsis |
Source |
Text |
| New Zealand Bill of RightsAct, Article 10 (1990) |
Synopsis |
Source |
Text |
| New Zealand Public Healthand Disability Act 2000, Section 16 |
Synopsis |
Source |
Text |
| Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) (1997) |
Synopsis |
Source |
Text |
| On the Protection of Traditional Knowledge |
Synopsis |
Source |
Text |
| Operating Procedures of the National Committee on Medical Research Ethics |
Synopsis |
Source |
Text |
| Operational Guidelines and Procedures for Human Research Ethics Committee |
Synopsis |
Source |
Text |
| Operational Procedures for Research Ethics Committees: Guidance 2004 |
Synopsis |
Source |
Text |
| Opinion No. 13: Regarding Experimentation on Man (2001) |
Synopsis |
Source |
Text |
| Opinion No. 22 - The Ethics Review of hESC FP7 Research Projects (2007) |
Synopsis |
Source |
Text |
| Opinion No. 31: Regarding Experimentation Involving Pregnant and Breastfeeding Women (2004) |
Synopsis |
Source |
Text |
| Opinion No. 33: Somatic and Germinal Line Gene Modification (2005) |
Synopsis |
Source |
Text |
| Opinion No. 40: Scope of the Law Relating to Experimentation on umans (2007) |
Synopsis |
Source |
Text |
| Opinion No. 51: Publication of the Results of Human Experimentation (2012) |
Synopsis |
Source |
Text |
| Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine (2012) |
Synopsis |
Source |
Text |
| Opinion No. 54: Post Mortem Removal of Human Body Material for Human Medical Applicataions or for Scientific Research Purposes (2012) |
Synopsis |
Source |
Text |
| Opinion No. 69: Experiments and Other Scientific Research Involving Inmates (2017) |
Synopsis |
Source |
Text |
| Opinion no. 36 of 11 September 2006 on the ethical testing of research in certain branches of the life sciences |
Synopsis |
Source |
Text |
| Opinion on Incidental Findings in Research and Clinical Practice (2015) |
Synopsis |
Source |
Text |
| Opinion on Research Ethics for Biological Sciences (2008) |
Synopsis |
Source |
Text |
| Opinion on the Ethics of Research in the Science of Human Behavior No. 38 |
Synopsis |
Source |
Text |
| Opinion on the Ethics of Research in the Sciences of Human Behaviour |
Synopsis |
Source |
Text |
| Order No. 387 Relating to Clinical Trials |
Synopsis |
Source |
Text |
| Order of the Minister of Health and Social Welfare on How to Establish, Finance, and the Mode of Action of Bioethics Committees |
Synopsis |
Source |
Text |
| Ordinance No. 10 of 2008 on the Documents Required from the Principal/Coordinating Investigator or Sponsor for Obtaining an Ethics Committee Statement and on the Procedure for Safety Monitoring of Medical Devices During Clinical Investigations and Assessm |
Synopsis |
Source |
Text |
| Ordinance of 20 September2013 on Clinical Trials inHuman Research (Clinical TrialsOrdinance, ClinO), RS 810.305 |
Synopsis |
Source |
Text |
| Ordinance of 20 September2013 on Clinical Trials inHuman Research with theException of Clinical Trials(Human Research Ordinance,HRO), RS 810.301 |
Synopsis |
Source |
Text |
| Ordinance of 20 September2013 on Organizational Aspectsof the Human Research Act(HRA Organisational Ordinance,OrgO-HRA), RS 810.308 |
Synopsis |
Source |
Text |
| Ordinance on Amendments to the Ordinance on Amendments to the Ordinance on Clinical Trials and Good Clinical Practice (2015) |
Synopsis |
Source |
Text |
| Ordinance on Clinical Trials and Good Clinical Practice (2015) |
Synopsis |
Source |
Text |
| Ordinance on the Conditions of Space, Professional Workers, Medical-Technical Equipment and Quality Assurance for Collection, Retrieval, Testing, Processing, Preservation, Storage, and Allocation of Human Tissues and Cells (2013) |
Synopsis |
Source |
Text |
| Organic Health Law of 22
December 2006, Articles 207-
208 |
Synopsis |
Source |
Text |
| Organic Law on the Donation
and Transplantation of Organs,
Tissues, and Cells |
Synopsis |
Source |
Text |
| Oviedo Convention |
Synopsis |
Source |
Text |
| Oviedo Convention on Human Rights and Biomedicine |
Synopsis |
Source |
Text |
| Pacific Health Research Guidelines(2014) |
Synopsis |
Source |
Text |
| Patient Rights Act, Official Gazette No. 15/2008 |
Synopsis |
Source |
Text |
| Personal Data Protection Act
No. 25.326 (2000) |
Synopsis |
Source |
Text |
| Personal Information Protection Act |
Synopsis |
Source |
Text |
| Personal Information Protection and Electronic Documents Act |
Synopsis |
Source |
Text |
| Pharmaceutical Affairs Act Enforcement Rules |
Synopsis |
Source |
Text |
| Pharmacological Trials on Women |
Synopsis |
Source |
Text |
| Policy Governing Research Involving Human Subjects |
Synopsis |
Source |
Text |
| Policy and Procedure Regarding Use of Human Subjects in Research |
Synopsis |
Source |
Text |
| Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research |
Synopsis |
Source |
Text |
| Policy on Research Integrity |
Synopsis |
Source |
Text |
| Política de Ética de la
Investigación,
Bioética e Integridad Científica |
Synopsis |
Source |
Text |
| Preamble Code of Conduct and Ethical Guidelines for Social Science Research |
Synopsis |
Source |
Text |
| Privacy Act Sections 7-8 |
Synopsis |
Source |
Text |
| Protection of Natural Persons Against the Processing of Personal Data and the Free Circulation of such Data Act of 2018 (Law 125 (1)) |
Synopsis |
Source |
Text |
| Protection of Pupil Rights Amendment |
Synopsis |
Source |
Text |
| Provision 10017-E/2017 ANMAT: Promoting Cooperation Between ANMAT and Jurisdictional Health Authorities for the Evaluation and Oversight of Clinical Research Sites and Investigators |
Synopsis |
Source |
Text |
| Provision 10017-E/2017 ANMAT: Promoting Cooperation Between ANMAT and Jurisdictional Health Authorities for the Evaluation and Oversight of Clinical Research Sites and Investigators |
Synopsis |
Source |
Text |
| Provision ANMAT 6677/10:
Regulatory Guideline for Good
Clinical Practices in Clinical
Pharmacological Studies (2010) |
Synopsis |
Source |
Text |
| Public Health Code Articles R1121-1 and subsequent sections |
Synopsis |
Source |
Text |
| Public Health Service Act |
Synopsis |
Source |
Text |
| Public Health Service Act (42 USC 262) |
Synopsis |
Source |
Text |
| Public Law 108-458, Section 8306 |
Synopsis |
Source |
Text |
| Public Law 24-326 |
Synopsis |
Source |
Text |
| RA Law on Prevention of Disease Caused by HIV (2012) |
Synopsis |
Source |
Text |
| Reflection Paper on Ethical and GCP Aspects of Clinical Trials of Medicinal Products for Human Use Conducted Outside of the EU/EEA and Submitted in Marketing Authorization Applications to the EU Regulatory Authorities (2012) |
Synopsis |
Source |
Text |
| Reform Regulation to the
Biomedical Research Regulatory
Law |
Synopsis |
Source |
Text |
| Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No. 726/2004 |
Synopsis |
Source |
Text |
| Regulation No. 31 from 12 August 2007 for Determining the Principles of Good Clinical Practice (2012) |
Synopsis |
Source |
Text |
| Regulation No. 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use Repealing Directive 2001/20/EC |
Synopsis |
Source |
Text |
| Regulation about Clinical testing of IMP and Medical Devices (2010) |
Synopsis |
Source |
Text |
| Regulation about Medical Devices (2010) |
Synopsis |
Source |
Text |
| Regulation for the
Approval, Development,
Oversight, and Control of
Clinical Trials |
Synopsis |
Source |
Text |
| Regulation for the Approval
of Ethics Committees |
Synopsis |
Source |
Text |
| Regulation for the Health Control of Products |
Synopsis |
Source |
Text |
| Regulation of Resolution CNS No. 292/99 on Research with Foreign Cooperation |
Synopsis |
Source |
Text |
| Regulation of the Biosafety Law on Genetically Modified Organisms |
Synopsis |
Source |
Text |
| Regulation of the General Law of Health in Matter of Transplants |
Synopsis |
Source |
Text |
| Regulation on Leading Ethics Committees (2004) |
Synopsis |
Source |
Text |
| Regulation on Tissue Banks (2014) |
Synopsis |
Source |
Text |
| Regulation on the General Health Law in the Matter of Health Research |
Synopsis |
Source |
Text |
| Regulations Amending the Food and Drug Regulations (1024 – Clinical Trials) |
Synopsis |
Source |
Text |
| Regulations Governing the Organization and Operational Management of the Institutional Review Board for Human Subject Research |
Synopsis |
Source |
Text |
| Regulations for Drug Safety Monitoring |
Synopsis |
Source |
Text |
| Regulations for Governing the Management of Medical Devices |
Synopsis |
Source |
Text |
| Regulations for Implementation of the Drug Administration Law of the People's Republic of China |
Synopsis |
Source |
Text |
| Regulations for Insurance on Research-Related Injury |
Synopsis |
Source |
Text |
| Regulations on Human Trial |
Synopsis |
Source |
Text |
| Regulatory Law of Biomedical
Research No. 9234 (2014) |
Synopsis |
Source |
Text |
| Report on Children in Medical Research |
Synopsis |
Source |
Text |
| Report on Stem Cells, Cloning, and Research |
Synopsis |
Source |
Text |
| Reproductive Medicine Act (2010) |
Synopsis |
Source |
Text |
| Requirements for the Use of Unclaimed Cadavers for Research Purposes, Resolution No. 002640, Article 21 (2005) |
Synopsis |
Source |
Text |
| Research Ethics Policy Directive, Version No.: 3.1 |
Synopsis |
Source |
Text |
| Research Governance Framework |
Synopsis |
Source |
Text |
| Research Governance Framework (2008) (PDF) |
Synopsis |
Source |
Text |
| Research Guidelines for Privacy/Data Protection |
Synopsis |
Source |
Text |
| Research Involving Human Embryos Act 2002 |
Synopsis |
Source |
Text |
| Research Involving Human Subjects |
Synopsis |
Source |
Text |
| Research Regulation Number (6) of 2013 |
Synopsis |
Source |
Text |
| Research involving Human Participants in Developing Societies |
Synopsis |
Source |
Text |
| Research on Persons without the Capacity to Consent (2013) |
Synopsis |
Source |
Text |
| Research, Science and Technology
Act 23 of 2004 |
Synopsis |
Source |
Text |
| Resolution 1480/2011 Approving a Guide for Human Subjects Research |
Synopsis |
Source |
Text |
| Resolution 1480/2011: Approving the Guidelines for Human Health Research and Creating the National Registry of Health Research |
Synopsis |
Source |
Text |
| Resolution ANVISA 09/15 - Regulations for Clinical Trials with Drugs |
Synopsis |
Source |
Text |
| Resolution CFM Nº 1.821, 23 November 2007 |
Synopsis |
Source |
Text |
| Resolution CFM Nº 1.885, 2008 – about placebo |
Synopsis |
Source |
Text |
| Resolution CNS No 580/2018 on Research of Strategic Interest for the Unified Health System (SUS) |
Synopsis |
Source |
Text |
| Resolution CNS No. 240/97 - Defining "Participating User" According to IRB |
Synopsis |
Source |
Text |
| Resolution CNS No. 251/1997: On Complimentary Rules for Research with New Pharmaceutical Products, Medicines, Vaccines, and Diagnostic Tests |
Synopsis |
Source |
Text |
| Resolution CNS No. 301, 16th March 2002: Regarding Placebos |
Synopsis |
Source |
Text |
| Resolution CNS No. 304/2000: Rules on Research Involving Human Beings – Area of Indigenous Peoples |
Synopsis |
Source |
Text |
| Resolution CNS No. 340/2004: On Research on Human Genetics (2004) |
Synopsis |
Source |
Text |
| Resolution CNS No. 346/2005 on Multicenter Research |
Synopsis |
Source |
Text |
| Resolution CNS No. 446/2011on Composition of the National Commission on Research Ethics |
Synopsis |
Source |
Text |
| Resolution CNS No. 466/2012 on Guidelines and Rules for Research Involving humans Subject |
Synopsis |
Source |
Text |
| Resolution CNS Nº 506/2016 Accreditation of CEP |
Synopsis |
Source |
Text |
| Resolution N#304 |
Synopsis |
Source |
Text |
| Resolution No. 2011020764 |
Synopsis |
Source |
Text |
| Resolution No. 2378 |
Synopsis |
Source |
Text |
| Resolution No. 510 |
Synopsis |
Source |
Text |
| Resolution No. 8430 |
Synopsis |
Source |
Text |
| Resolution RDC No. 29, 12 May 2008 |
Synopsis |
Source |
Text |
| Resolution RDC No. 9, 14 March 2011 |
Synopsis |
Source |
Text |
| Resolution of the Government of Armenia of January 24, 2002: Procedure for Clinical Trials of New Mediations of Armenia |
Synopsis |
Source |
Text |
| Resolution – RDC No. 20 of 10 April 2014 |
Synopsis |
Source |
Text |
| Rule Book on Amendments to Law about Blood and Blood Products (2011) |
Synopsis |
Source |
Text |
| Rulebook about Testing Procedure for Donor of Transplant Organs in Terms of Diseases Which can be Transmitted by Transplantation (2010) |
Synopsis |
Source |
Text |
| Rules for the Regulation of Human Clinical Trials. Ministerial Accord SP-M-466- 2007 |
Synopsis |
Source |
Text |
| SOR/2001-7 |
Synopsis |
Source |
Text |
| SOR/2001-8 |
Synopsis |
Source |
Text |
| Scientific and Ethical Approaches for Observational Exposure Studies |
Synopsis |
Source |
Text |
| St Helena Research Institute Policy |
Synopsis |
Source |
Text |
| Standard Operating Procedures |
Synopsis |
Source |
Text |
| Standard Operating Procedures for Health and Disability Ethics Committees (2012) |
Synopsis |
Source |
Text |
| Standard Operating Procedures for Research Ethics Committees |
Synopsis |
Source |
Text |
| Standard Operating Procedures for the National Health Research Ethics Committee |
Synopsis |
Source |
Text |
| Standard operating Procedures for the Ethical Evaluation of Health Research |
Synopsis |
Source |
Text |
| Standards & Requirements for Independent Research Ethics Committee (IREC) Involved in Clinical Trials in the kingdom of Bahrain |
Synopsis |
Source |
Text |
| Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants |
Synopsis |
Source |
Text |
| Standards of GCP in Conducting CTs (2012) |
Synopsis |
Source |
Text |
| Statement of the Commission Related to Research Activities Involving Human Embryonic Stem Cells (2013) |
Synopsis |
Source |
Text |
| Statement on Genome Editing Technologies by the Committee on Bioethics (2015) |
Synopsis |
Source |
Text |
| Statements by the Commission Re: Article 6 (2006) |
Synopsis |
Source |
Text |
| Statutes of Central Medical Ethics Committees (1998) |
Synopsis |
Source |
Text |
| Supreme Decree No. 021-2017- SA. Regulation of Clinical Trials (2017) |
Synopsis |
Source |
Text |
| Supreme Decree No. 114 of 2010: Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome, and the Prohibition of Human Cloning |
Synopsis |
Source |
Text |
| Supreme Decree No. 3 of 2010. Regulation of the National Control System of Pharmaceutical Products for Human Use |
Synopsis |
Source |
Text |
| Supreme Decree No. 41 of 2012: Regulation Regarding Clinical Records |
Synopsis |
Source |
Text |
| Supreme Decree Nº 30/2013 Regulation on Law Nº20.120 Modifying Supreme decree Nº114/2010, Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome, and the Prohibition of Human Cloning |
Synopsis |
Source |
Text |
| Synopsis |
Synopsis |
Source |
Text |
| Te Ara Tika. Guidelines for MāoriResearch Ethics: A Framework forResearchers and Ethics CommitteeMembers (2010) |
Synopsis |
Source |
Text |
| The Act concerning the Ethical Review of Research Involving Humans |
Synopsis |
Source |
Text |
| The Belmont Report |
Synopsis |
Source |
Text |
| The Belmont Report |
Synopsis |
Source |
Text |
| The Ethical Guidelines for Research on Human Subjects |
Synopsis |
Source |
Text |
| The Framework of Guidelines for Research in the Social Sciences and Humanities in Malawi |
Synopsis |
Source |
Text |
| The Safeguarding and Protection of Patients' Rights Law (2004) |
Synopsis |
Source |
Text |
| Transfers of Personal Data to Third Countries: Applying Articles 25 and 26 of the EU Data Protection Directive (1998): Consent (2018) |
Synopsis |
Source |
Text |
| Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans |
Synopsis |
Source |
Text |
| Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans |
Synopsis |
Source |
Text |
| Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans |
Synopsis |
Source |
Text |
| UK Policy Framework for Health and Social Care Research |
Synopsis |
Source |
Text |
| UWI Policy on Research Ethics |
Synopsis |
Source |
Text |
| Uganda National Council for Science and Technology |
Synopsis |
Source |
Text |
| Universal Declaration on Bioethics and Human Rights |
Synopsis |
Source |
Text |
| User’s Guide for the Application of Clinical Investigation Protocols |
Synopsis |
Source |
Text |
| 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) |
Synopsis |
Source |
Text |
| 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) |
Synopsis |
Source |
Text |
| V-235/A1-83, Decree on the Procedure for a Minor’s Participation in Biomedical Research (2018) |
Synopsis |
Source |
Text |
| V-24, Decree on the Procedure for Submission of the Documents to the Lithuanian Bioethics Committee to Issue Favorable Opinion to Conduct a Clinical Trial on Medicinal Products or Approval to Conduct Biomedical Research by the Sponsor of the Clinical Tria |
Synopsis |
Source |
Text |
| 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) |
Synopsis |
Source |
Text |
| V-28, Decree on the Procedure to Conduct Biomedical Research on Medical Documents, No. V-28 (2011) |
Synopsis |
Source |
Text |
| V-4, Decree on the Request to Issue Approval to Conduct Biomedical Research, the Application Form and the Biomedical Research Ethical Assessment Form (2016) |
Synopsis |
Source |
Text |
| V-405, Decree on the Procedure for Keeping a Record of Biomedical Research, Collecting, Storage, and Providing Information on Biomedical Research (2010) |
Synopsis |
Source |
Text |
| Various Guidelines on Drugs, Biologics, and Devices |
Synopsis |
Source |
Text |
| Various ethics guidelines |
Synopsis |
Source |
Text |
| Vulnerable Populations in Vulnerable Situations |
Synopsis |
Source |
Text |
| WHO Guidelines on Ethical Issues in Public Health Surveillance |
Synopsis |
Source |
Text |
