See Scientific Integrity

Research compliance

Good research practices imply that researchers take into account relevant ethical norms and standards, as well as observing statutory regulations. In the case of research a broad set of regulations apply. The table below offers an overview of regulations. The overview is not comprehensive, additional rules and regulations on national, supranational or local levels may apply.

RegulationsUT contact

Animal by-products (dierlijke bijproducten)

Besluit en regeling dierlijke bijproducten. Implementation of regulation (EU) No 142/2011 and regulation (EC) No 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption. ().  

HR - Biological Safety Officer

Besluit Voorschrift Informatiebeveiliging Rijksdienst Bijzondere Informatie 2013 (VIRBI 2013)

Dutch Opium legislation (Opiumwetbesluit)

TechMed – support staff

Embryos Act (Embryowet) 

Environmental Management Act (Wet milieubeheer)

Foetal Tissue Act (Wet foetaal weefsel)  

General Data Protection Regulation (GDPR) 

Data protection officers

Genetically Modified Organisms Decree (Besluit genetisch gemodificeerde organismen) 

Genetically Modified Organisms Regulations

HR - Biological Safety Officer

Higher Education and Research Act (WHW).

UT general affairs

International, European and national legislation regarding intellectual property, including:

a. Copyright Act (Auteurswet)  

b. Patents Act 1995 (Rijksoctrooiwet 1995)  

c. Neighbouring Rights Act (Wet op de naburige rechten)  

d. Seeds and Plant Materials Act 2005 (Zaaizaad- en plantgoedwet 2005) 

Novel-T/General Affairs – legal advisors

Kennisregeling Noord Korea, Sanctieregeling Iran  

HR

Legislation and regulations related to public and state security and state secrets, including:

a. General Security Requirements for Ministry of Defence Assignments (ABDO 2006 for ongoing assignments, ABDO 2017 for new assignments) (Algemene beveiligingseisen voor defensieopdrachten 2006 en 2017)   

b. Civil Service Information Security (Classified Information) Decree 2013 (Besluit Voorschrift Informatiebeveiliging Rijksdienst Bijzondere Informatie 2013)

c. Judicial Data and Criminal Records Act (Wet justitiële en strafvorderlijke gegevens)

d. Police Data Act (Wet politiegegevens) 

e. Intelligence and Security Services Act 2017 (Wet op de Inlichtingen- en veiligheidsdiensten 2017)

f. Security Screening Act (Wet veiligheidsonderzoeken)

Medical Research involving Human Subjects Act (Wet medisch wetenschappelijk onderzoek met mensen) 

TechMed – support staff

Medical Devices Act (Wet op de medische hulpmiddelen)

TechMed – support staff

Medical Treatment Contracts Act (Wet op de geneeskundige behandelingsovereenkomst)

Nagoya Protocol- regulation on Access and Benefit Sharing (ABS) of genetic resources and traditional knowledge. 

Wet implementatie Nagoya protocol (elaboration of EU regulation 511/2014) 

TechMed – support staff HR – Biological Safety Officer

Population Screening Act (Wet op het bevolkingsonderzoek)

Public Records Act (Archiefwet)

LISA - Archive

Radiation Protection Decree (Kernenergiewet, Besluit stralingsbescherming)  

HR – Coordinating radiation expert

Regulations and the classification of dual use research:

1.https://www.rijksoverheid.nl/onderwerpen/exportcontrole-strategische-goederen/beleid-controle-strategische-goederen-en-diensten (Dutch government);

2.https://ec.europa.eu/trade/import-and-export-rules/export-from-eu/dual-use-controls/ (EU)

3.https://trade.ec.europa.eu/doclib/docs/2016/august/tradoc_154880.pdf; (EU)

Novel-T/General Affairs – legal advisors

Remotely Piloted Aircraft Systems (RPAS)-drones (Besluit op afstand bestuurbare luchtvaartuigen, EU policy in progress))

a.     Operator certificate (ROC)

b.     Use of mini-drones (Beleidsregel verlenen van ontheffingen voor micro- en minidrones) 

Use of drones weighing no more than 4 kg is not applicable at this moment (ROC-license and regime)

HR - Health and Safety Officer

Research Databases Act (Onderzoeksgegevensbankenwet)

Standard for the protection of animals used for scientific purposes  

Experiments on Animals Act (Wet op de dierproeven) 

TechMed – support staff