Biomedical Research

Last updated on: 27 May 2022

This page is currently being updated

On this page, you’ll find websites and other resources related to human subject research and good research practices.

The information on this page was previously available through the following subpages:

  • International
  • Laws, regulations, and guidelines – by country
  • Research in the Netherlands
  • Research in Belgium

Please use the contact form to report broken links, outdated information and missing webpages.

Deze pagina wordt momenteel vernieuwd

Op deze pagina vindt u verwijzingen naar websites en andere bronnen met betrekking tot medisch- en gedragswetenschappelijk onderzoek en goede onderzoekspraktijken.

De informatie op deze pagina was voorheen beschikbaar via de volgende subpagina’s:

  • International
  • Laws, regulations, and guidelines – by country
  • Research in the Netherlands
  • Research in Belgium

Gebroken verwijzingen en suggesties voor nieuwe verwijzingen kunt u aan mij doorgeven via het contactformulier.

 


Index

Please use the contact form to report broken links, outdated information and missing webpages.


Worldwide

An useful document is the International Compilation of Human Research Standards. It contains an overview of laws, regulations and guidelines from more than 100 countries and organisations.

Please use the contact form to report broken links, outdated information and missing webpages.


Animal research

Authorities

Replacement, Reduction and Refinement

Organisations

World Medical Association (WMA)

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Alliances, Associations, Federations, Organizations & Research Infrastructures

Alliances

Associations

Centre for Evidence-Based Medicine (CEBM)

Clinical Research Organisations

Clinical trial improvement

Cochrane

Federations

Nuffield Council on Bioethics

Organisations

Research Infrastructures

Societies

The Global Health Network

Wellcome Trust

Please use the contact form to report broken links, outdated information and missing webpages.


Behavioral sciences, Psychology

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Biobanking & Genetic research

Authorities

Biobanken

Organisations

Biobanking and BioMolecular resources Research Infrastructure (BBMRI)

European Science Foundation (ESF)

Human Genome Organisation

International Society for Biological and Environmental Repositories (ISBER)

Public Population Project in Genomics (P3G)

UKCRC Tissue Directory and Coordination Centre

Vereniging Samenwerkende Ouder- en Patiëntenorganisaties (VSOP)

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Clinical Trial Registries, Clinical trial results reporting, Clinical trial trackers and viewers

Clinical Trial Registries

World Health Organization

Commercieel/Industrie

Europe

Verenigde Staten

Pre-Clinical Trials

Systematic reviews

Other Clinical Trial Registries

Clinical trial results reporting

Clinical trial trackers and viewers

Artis Ventures:

Bill & Melinda Gates Foundation, Cytel

London School of Hygiene & Tropical Medicine

Milken Institute

Regulatory Focus

STAT

Trial Insights

Trial Scope

Other

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Communication

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Data Protection

European Union (EU), General Data Protection Regulation (GDPR)

International Association of Privacy Professionals (IAPP)

Netherlands

Ha Vincent, m.b.t. dit thema hebben we alles wat je moet weten uiteengezet in het Datasolidariteit-rapport (dec. 2020). Zie laatste bijlage voor beslisbomen! https://www.rathenau.nl/nl/maakbare-levens/datasolidariteit-voor-gezondheid

Joost Gerritsen (@JBAGerritsen) May 14, 2021

Tools

Please use the contact form to report broken links, outdated information and missing webpages.


Ethical Principles, Guidelines, Standards, Codes of Conduct

World Medical Association (WMA)

Nuremberg Code

The Belmont Report

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Council for International Organizations of Medical Sciences (CIOMS)

Countries

European Committee for Standardization (CEN) – European Committee for Electrotechnical Standardization (CENELEC)

International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

International Organization for Standardization (ISO)

Organisation for Economic Co-operation and Development (OECD)

Pan American Health Organization (PAHO)

United Nations (UN)

United Nations Educational, Scientific, and Cultural Organization (UNESCO)

Committees

Unicef

World Medical Association (WMA)

Please use the contact form to report broken links, outdated information and missing webpages.


Ethics Committees (EC), Research Ethics Committees (REC), Medical Research Ethics Committees (MREC)

Countries

Belgium – Ethische Comités met een volledig erkenning

Volgens artikel 10 van de Wet van 7 mei 2004 inzake experimenten op de menselijke persoon, mag een experiment slechts beginnen op voorwaarde dat de opdrachtgever en de onderzoeker in het bezit zijn van een gunstig advies van een volledig erkend ethisch comité.

Volgens het overzicht ‘Ethische Commissies‘ (versie 11 april 2018) van het Federaal agentschap voor geneesmiddelen en gezondheidsproducten (FAGG) telt België in totaal 25 Ethische Comités met een volledige erkenning. Op twee na zijn alle commissies op internet terug te vinden.

Netherlands

Erkende METC’s

Volgens het overzicht op de CCMO website telt Nederland 15 erkende METC’s.

* Voorheen CMO Regio Arnhem-Nijmegen. Toetst ook onderzoek van Wageningen University, Wageningen Research en Ziekenhuis Gelderse Vallei Ede. METC-WU opgeheven per 1 januari 2021.

** onstaat uit fusie METC AVL en METC Utrecht

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Funding

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Good Practices (GxP)

Good Clinical Data Management Practices (GCDMP)

Good Clinical Practice (GCP)

Investigational Medicinal Products

Medical Devices & In Vitro Diagnostic Medical Devices

Good Laboratory Practice (GLP)

Good Lay Summary Practice (GLSP)

Good Machine Learning Practice (GMLP)

Good Manufacturing Practice (GMP)

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History of Clinical Trials

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Integrity

European Network of Research Ethics and Research Integrity (ENERI)

H2020 INTEGRITY Project

SOPs4RI (Standard Operating Procedures for Research Integrity)

Other

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Legal

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Legislation

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Measurement instruments (questionnaires, surveys, rating scales, projective techniques, interview schedules, and tests)

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Medical Devices & In Vitro Diagnostic Medical Devices

Authorities

European Union (EU)

International Medical Device Regulators Forum (IMDRF)

Please use the contact form to report broken links, outdated information and missing webpages.


(Investigational) Medicinal Products

Authorities

Drugs.com

ECA Academy

European Union (EU)

COVID-19

Genetically modified organism (GMO)

Good Manufacturing Practice (GMP)

Medical Dictionary for Regulatory Activities (MedDRA)

RxISK

University of Liverpool

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Pediatric research

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Quality of research

Accreditation

Bloedafnames, bloedsamples

Compliance

Consent

Data Monitoring Committee (DMC)

Endpoint Adjudication

Endpoints, Outcomes

Multi-Regional Clinical Trials (MRCT) Center Brigham and Women’s Hospital and Harvard University

Open Science, projectmanagement & data-sharing

Process map

Protocol violations, deviations

Research ethics

Please use the contact form to report broken links, outdated information and missing webpages.


Radiological Protection & Non-Ionizing Radiation Protection

International Commission on Non-Ionizing Radiation Protection (ICNIRP)

International Commission on Radiological Protection (ICRP)

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Regulatory Authorities

European Union (EU)

International Coalition of Medicines Regulatory Authorities (ICMRA)

Other countries

Africa

Asia

Europe

North America

Middle East

Oceania

South America

Please use the contact form to report broken links, outdated information and missing webpages.


Research Data Management

Clinical Data Interchange Standards Consortium (CDISC)

(Clinical study) Data Repositories

Journals

Science Europe

Society for Clinical Data Management (SCDM)

Please use the contact form to report broken links, outdated information and missing webpages.


Research output, Publications

Committee on Publication Ethics (COPE)

International Committee of Medical Journal Editors (ICMJE)

Miscellaneous

Open Access & Open Science

Center for Open Science

European Commission

OECD

UNESCO

Publication of negative results

Publishers

Reporting Guidelines

Salami Slicing

Systematic reviews

Please use the contact form to report broken links, outdated information and missing webpages.


Training, education and practical

Books & journals

Books

Courses and training

Informative

Practical toolbox

Good Practice Cases

Q&A

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United Kingdom (UK)

Autorities

Funding

Organisations

Research Application System

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United States of America

Authorities & organisations

Centers for Disease Control and Prevention (CDC)

National Academy of Sciences, Engineering, and Medicine

National Institutes of Health (NIH)

U.S. Department of Health & Human Services (HHS)

U.S. Food and Drug Administration (FDA)

Regulations

Organizations and associations

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Universities

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World Health Organization (WHO)

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News

Events

Consultations