Committee on Publication Ethics (COPE)
Council for International Organizations of Medical Sciences (CIOMS)
Data Monitoring Committee (DMC)
- DAMOCLES studygroup. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. The Lancet , Volume 365 , Issue 9460 , 711 – 722. DOI: http://dx.doi.org/10.1016/S0140-6736(05)17965-3
- DAMOCLES template DSMB-charter
- Drazen, J. M., & Wood, A. J. J. (2010). Don’t Mess with the DSMB. New England Journal of Medicine, 363(5), 477–478.
- EMA Guideline on Data monitoring committees (CHMP/EWP/5872/03)
- FDA Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
- National Institute on Drug Abuse (NIDA) – Draft Guidelines for Establishing and Operating a Data and Safety Monitoring Board
- NCI Data and Safety Monitoring Guidelines – Essential Elements of a Data and Safety Monitoring Plan for Clinical Trials Funded by the National Cancer Institute
- NIH – Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing Some Issues
- NIH – Further NIH Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials (June 5, 2000)
- NIH Policy for Data and Safety Monitoring (June 10, 1998)
- NIH/NIDCR – Data and Safety Monitoring Board (DSMB) Guidelines
- WHO – Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards
Enhancing the QUAlity and Transparency Of health Research (EQUATOR)
Good Manufacturing Practice (GMP)
Human Biobanks and Research Databases
Human Genome Organization
- Imagined Futures: Capturing the Benefits of Genome Sequencing for Society, December 2014
- International code of conduct for genomics and health-related data sharing, June 2014
- Statement on Benefit Sharing, April 2000
- Statement on Cloning, March 1999
- Statement on DNA Sampling: Control and Access (February 1998)
- Statement on Gene Therapy Research (April 2001)
- Statement on Human Genomic Databases (December 2002)
- Statement on Stem Cells, November 2004
- Statement on Supreme Court: Genes are not patentable, June 2013
- Statement on the Principled Conduct of Genetic Research (December 1995)
- The Human Genome Organisation: towards next generation ethics, April 2013
International, accreditation
International, blood
International Ethics
International, publication
International Commission on Non-Ionizing Radiation Protection (ICNIRP)
International Committee of Medical Journal Editors (ICMJE)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
International Medical Device Regulators Forum (IMDRF)
International Society for Biological and Environmental Repositories (ISBER)
- International Society for Biological and Environmental Repositories
- ISBER ‘Best Practices: Recommendations for Repositories’ (Fourth Edition, 2018)
International Society for Pharmacoeconomics and Outcomes Research
International Society for Stem Cell Research
Organisation for Economic Co-operation and Development (OECD)
- OECD Best Practice Guidelines for Biological Resource Centres (2007)
- OECD ‘Good Laboratory Practice (GLP)’
- OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring
- OECD Guidelines on Human Biobanks and Genetic Research Databases 2009
- OECD report Best Practices for Ensuring Scientific Integrity and Preventing Misconduct, 2007
Organisations and associations
- Dutch Association of Research Quality Assurance (DARQA)
- European Forum for Good Clinical Practice (EFGCP)
- European Network of Research Ethics Committees (EUREC)
- European Quality Assurance Confederation (EQAC)
- French Quality Assurance Society – Société Française d’Assurance Qualité (SOFAQ)
- German Society for Good Research Practice – Deutsche Gesellschaft für Gute Forschungspraxis (DGGF)
- Japanese Society of Quality Assurance (JSQA)
- Research Quality Association (RQA)
- Society of Quality Assurance (SQA)
- Swedish Association of Research Quality Assurance (SARQA)
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)
The Cochrane Collaboration
The IDEAL Collaboration
United Nations Educational, Scientific, and Cultural Organization (UNESCO)
- Code of Conduct and Ethical Guidelines for Social Science Research
- International Declaration on Human Genetic Data: Section 22 of Major Programme III – Social and Human Sciences (2003)
- Universal Declaration on Bioethics and Human Rights (2005)
- Universal Declaration on the Human Genome and Human Rights Section 16 of III Programme for 1998 – 1999 (1997)
World Health Organization (WHO)
- Ethical Issues in Patient Safety Research: Interpreting Existing Guidance (2013)
- Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells, and Fluids in Research (2003)
- Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens (1997)
- Guidelines on Ethical Issues in Public Health Surveillance (2017)
- Handbook for good clinical research practice (GCP) : guidance for implementation (2005)
- International Clinical Trials Registry Platform (ICTRP)
- Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005)
- Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
- Resolution WHA 58.34 (2005)
- Standards and Operational Guidance for Ethics Review of Health – Related Research with Human Participants (2011)
- The WHO Ethics Review Committee (ERC)
World Medical Association (WMA)
- Human, D. & Fluss, S.S. (2001). The World Medical Association’s Declaration of Helsinki: Historical and Contemporary Perspectives.
- WMA Declaration of Geneva, amended by the 68th WMA General Assembly, Chicago, United States, October 2017
- WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 64th WMA General Assembly, Fortaleza, Oct 2013
- WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks, revised by the 67th WMA General Assembly, Taipei, Taiwan, October 2016
- WMA Declaration on Medical Ethics and Advanced Medical Technology, revised by the 63rd WMA General Assembly, Bangkok, Thailand, October 2012
- WMA Statement on Animal Use in Biomedical Research, reaffirmed by the 203rd WMA Council Session, Buenos Aires, Argentina, April 2016
- WMA Statement on Embryonic Stem Cell Research, 60th WMA General Assembly, New Delhi, India, October 2009
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