International Guidelines

• Code of conduct and best practice guidelines for journal editors. Committee on Publication Ethics (2011)
• COPE Guidelines (website)
• Journals’ Best Practices for Ensuring Consent for Publishing Medical Case Reports, version 1, published december 2016.

• International Ethical Guidelines for Epidemiological Studies, Council for International Organizations of Medical Sciences (CIOMS), 2009
• International Ethical Guidelines for Health-related Research involving Humans, Council for International Organizations of Medical Sciences (CIOMS), 2016.

• 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

• EQUATOR Network – Enhancing the QUAlity and Transparency Of health Research

• EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines
• IGZ: Apotheken – GMP-Z en grootbereiden
• Nederlandse Vereniging van Ziekenhuisapothekers – GMP-Z Richtlijn
• RQA – Good Manufacturing Practice (GMP) Committee

• Go to section “Human Biobanks & Research Databases”

Human Genome Organization

• Association for the Accreditation of Human Research Protection Programs (AAHRPP)
• Joint Commission International (JCI)
• Qmentum International accreditation program

• Richtlijnen voor bloed(-afnames)

• “Universele Verklaring van de Rechten van de Mens”
• Nuremberg Code
• Online Ethics Center (OEC)
• The Belmont Report
• The Belmont Report, Appendix Volume I
• The Belmont Report, Appendix Volume II

• International DOI Foundation (IDF)
• Tilburg University – Bronvermelding volgens de richtlijnen van de APA (.pdf)

• International Commission on Non-Ionizing Radiation Protection (ICNIRP)

• Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors – June 2017
• Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• ICH E6(R2) Good Clinical Practice (GCP) Guideline

• International Medical Device Regulators Forum (IMDRF)
• Statement Regarding Use of ISO 14155:2011 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice ” (2015)

• International Society for Biological and Environmental Repositories
• ISBER ‘Best Practices: Recommendations for Repositories’ (Fourth Edition, 2018)

International Society for Pharmacoeconomics and Outcomes Research

• ISPOR Code of Ethics 2017 (4th Edition), Santos J, Palumbo F, Molsen-David E et al., Value Health 2017; (20) 1227-1242.

International Society for Stem Cell Research

• Guidelines for the Conduct of Human Embryonic Stem Cell Research (2006)

• 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

• 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)

• Cochrane Handbook for Systematic Reviews of Interventions

• The IDEAL Collaboration – Idea, Development, Exploration, Assessment, Long-term follow-up

• 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)

• 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