Law & regulations reference list
Overview of laws and regulations
Research Integrity
- Netherlands Board on Research Integrity (LOWI): https://lowi.nl/en/home/Â
- Netherlands Code of Conduct for Research Integrity: http://www.vsnu.nl/files/documents/Netherlands%20Code%20of%20Conduct%20for%20Research%20Integrity%202018.pdfÂ
- KNAW Research Integrity: https://www.knaw.nl/en
- KNAW advisory report: Responsible research data management and the prevention of scientific misconduct:Advisory_Responsible_research_data_management_and_the_prevention_of_scientific_misconduc_web (knaw.nl)
- National Ethics Council for Social and Behavioural Sciences (Nationaal Ethiek Overleg Sociale en Gedragswetenschappen): https://nethics.nl/Welkom-Welcome/Â
- Amsterdam UMC – Research code: https://www.amsterdamumc.org/research/integrity.htm
Research involving human subjects
- BROK® Education and Examination Regulations (EER): https://www.nfu.nl/themas/randvoorwaarden-wetenschappelijk-onderzoek/brokrÂ
- Declaration of Helsinki (World Medical Association): https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/Â
- Dutch Medical Research (Human Subjects) Act (WMO): https://english.ccmo.nl/investigatorsÂ
- CCMO: underage and incapacitated subjects; https://www.ccmo.nl/publicaties/publicaties/2017/02/01/toetsingskader-onderzoek-met-minderjarige-proefpersonenÂ
- WMO-governed or Non-WMO research?: https://english.ccmo.nl/investigators/additional-requirements-for-certain-types-of-research/non-wmo-researchÂ
- Medical Ethical Committee (METc): Ethical review Research Support Amsterdam UMC
- Wet Bevolkingsonderzoek: https://wetten.overheid.nl/BWBR0005699/2019-04-02 ; https://wetten.overheid.nl/BWBR0007499/2020-10-01 ; https://www.ccmo.nl/onderzoekers/aanvullende-eisen-voor-bepaalde-soorten-onderzoek/overig-onderzoek/bevolkingsonderzoek/bescherming-proefpersonenÂ
- International Conference of Harmonisation-Good Clinical Practice (ICH-GRP): https://www.ich.org/page/ich-guidelinesÂ
- Dutch Medical Devices Act 2018 (available in Dutch only): https://wetten.overheid.nl/BWBR0002697/2018-08-01 Â
- CCMO information on research with a medical device: https://www.ccmo.nl/onderzoekers/klinisch-onderzoek-naar-medische-hulpmiddelen/wet-en-regelgeving-richtsnoeren-en-standaarden-voor-onderzoek-medische-hulpmiddelen
- Dutch policy guidelines for inducements under the Medical Devices Act (available in Dutch only): https://wetten.overheid.nl/BWBR0039932/2018-01-01Â
- Amsterdam UMC - Europese wetgeving medische hulpmiddelen (MDR) en in-vitro diagnostica (IVDR): Veilige patiëntenzorg door veilige technologie | NFU
- Research on gene therapy/medicinal product with Genetically Modified Organisms (GMOs): Research on gene therapy, other products that specifically influence the functioning of the genetic material, naked DNA/ (m)RNA or a medicinal product with GMO | Investigators | The Central Committee on Research Involving Human Subjects (ccmo.nl)Â
- International Ethical Guidelines for Biomedical Research involving Humans Subjects (Council International Organizations of Medical Sciences (CIOMS): https://cioms.ch/publications/product/international-ethical-guidelines-for-biomedical-research-involving-human-subjects-2/Â
- NFU Quality assurance in research involving human subjects - Richtlijn Kwaliteitsborging Mensgebonden Onderzoek: https://www.nfu.nl/themas/randvoorwaarden-wetenschappelijk-onderzoek/klinisch-onderzoek
Trial register
- Netherlands Trial Register: Nationaal Trial Register (NTR) niet meer beschikbaar | Nieuwsbericht | Centrale Commissie Mensgebonden Onderzoek (ccmo.nl)
- UK Trial Register: https://www.isrctn.com/Â
- USA Trial Register : https://clinicaltrials.gov/Â
- EU Trial Register: https://www.clinicaltrialsregister.eu/joiningtrial.htmlÂ
- WHO Trial Register: http://www.who.int/ictrp/en/
Dutch Medicines Act (inducements)
- Code of Conduct for Pharmaceutical Advertising: https://www.cgr.nl/en-GB/Gedragscode-Geneesmiddelenreclame
- Dutch Policy Guidelines on Inducements under the Medicines Act (available in Dutch only): http://wetten.overheid.nl/BWBR0035546/2014-05-01Â
- Healthcare Transparency Register Foundation: Stichting Transparantieregister Zorg - Home
Codes of conduct regarding expressions of objection by incapacitated research subjects
- The expression of objection by incapacitated (psycho)geriatric patients: http://www.ccmo.nl/attachments/files/code-of-conduct-incapacitated-elderly.pdfÂ
- Code of conduct relating to expressions of objection by minors participating in medical research: http://www.ccmo.nl/attachments/files/code-of-conduct-minors.pdfÂ
- The expression of objection by people with mental disabilities in the context of the WMO: http://www.ccmo.nl/attachments/files/code-of-conduct-mental-disabled.pdf
Research involving animal subjects
- Animal experiments (available in Dutch only): Toezicht en handhaving op dierproeven | Dierproeven | Rijksoverheid.nl
- Animal experiments at the Amsterdam UMC : https://www.amsterdamumc.org/research/support/about/ethical-review.htmÂ
- Netherlands Code of Conduct for Research Integrity: http://www.vsnu.nl/files/documents/Netherlands%20Code%20of%20Conduct%20for%20Research%20Integrity%202018.pdf
Research using human tissue and patient data
- Code of conduct for responsible use: Federa_code_of_conduct_english.pdf (bbmri.nl)
- Gametes and embryos: Research with gametes and/or (leftover) embryos | Investigators | The Central Committee on Research Involving Human Subjects (ccmo.nl)
- Information about the General Data Protection Regulation (GDPR): https://autoriteitpersoonsgegevens.nl/sites/default/files/atoms/files/dutch_data_protection_authority_eipa_15-02-2017.pdfÂ
- GDPR in the Official Journal of the European Union: https://autoriteitpersoonsgegevens.nl/sites/default/files/atoms/files/gdpr.pdfÂ
- Code of conduct for health research: Code of Conduct for Health Research | Investigators | The Central Committee on Research Involving Human Subjects (ccmo.nl)
Research data
- KNAW topic: Integrity: Klachtenregeling wetenschappelijke integriteit KNAW - KNAW
- AVG: https://wetten.overheid.nl/BWBR0040940/2020-01-01/0/Â
- GDPR: https://eur-lex.europa.eu/eli/reg/2016/679/ojÂ
- NFU Data4lifesciences: http://data4lifesciences.nl/Â
- NFU Handbook for Adequate Natural Data Stewardship (HANDS): https://data4lifesciences.nl/hands2/data-stewardship/
Publication
- International committees and the ethics of research publication: http://www.icmje.org/icmje-recommendations.pdfÂ
- San Francisco Declaration on Research Assessment: https://sfdora.org/Â
- Committee on Publication Ethics (COPE): https://publicationethics.org/Â
- Equator network: STAndards for Reporting: http://www.equator-network.org/reporting-guidelines/stardÂ
- CCMO statement on publishing policy: https://english.ccmo.nl/publications/publications/2002/03/01/ccmo-statement-on-publication-policy
Ethics in EU projects
- Ethics self-assessment guide: http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdfÂ
- Infographic on EU grants (Albinusnet): https://www.albinusnet.nl/tools/eu-grants/Â
- Clinical trials - Regulation EU No 536/2014: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
Â
Â
Â