When conducting research and the associated data management, there are many things to consider from a legal perspective.

General Data Protection Regulation

From 25 May 2018, the General Data Protection Regulation (GPDR) will apply. This means that, from that date, the same privacy legislation will apply throughout the European Union.

The GDPR provides, among other things:

  • Strengthening and extending privacy rights
  • More responsibilities for organisations
  • The same robust powers for all European privacy regulators, such as the power to impose fines of up to 20 million euros 

The GDPR also has important consequences for working with research data. Read more about this under Data and Privacy. Read more about THUAS privacy policy and the conditions for processing and storing personal data. 

Intellectual Property

Intellectual property is the collective name for rights to intellectual creations, such as texts, pictures, software, inventions, brand names and valuable knowledge. Intellectual property can also play a role in data. You can read more about this under Data and Ownership and THUAS publishing policy.

Consortium Agreement NWO

If you cooperate with other parties in the context of research, a cooperation agreement is highly desirable and sometimes required (e.g. for grant projects). An agreement clearly sets out the rights and obligations of all parties involved, including agreements on the research data, intellectual property rights and liability. In need of a consortium/coopeation agreement? Reach out to [email protected]

Medical Research Involving Human Subjects Act

Research involving human subjects must undergo a medical-ethical review if it falls under the Medical Research Involving Human Subjects Act (WMO). Research falls under the WMO if the following two conditions are met:

  • Medical scientific research is involved
  • Persons are subjected to actions or imposed rules of conduct

Read more about the assessment procedure of the WMO on the website of the Central Committee on Research Involving Human Subjects

For more information contact the datastewards of the library.

The 6 GDPR Principles

The GDPR has 6 principles for the processing of personal data:

Categories of Personal Data

The 10 GDPR Legal Exceptions

The GDPR contains 10 exceptions to the ban on processing special personal data. This means that the ban on processing special personal data does not apply if you can rely on 1 of the 6 principles for processing 'ordinary' personal data and:

Data and Privacy

Data and Ownership

Consortiumovereenkomst

Indien je in het kader van onderzoek samenwerkt met andere partijen, dan is een samenwerkingsovereenkomst zeer wenselijk en soms ook vereist (bijv. bij subsidieprojecten). In een overeenkomst worden de rechten en plichten van alle betrokken partijen duidelijk vastgelegd. Inclusief de afspraken m.b.t. de onderzoeksdata, intellectuele eigendomsrechten en aansprakelijkheid. Neem contact op met [email protected] voor het inwinnen van advies m.b.t. een consortiumovereenkomst. 

Wet medisch-wetenschappelijk onderzoek met mensen

Onderzoek met mensen moet een medisch-ethische toets ondergaan als het valt onder de Wet medisch-wetenschappelijk onderzoek met mensen (WMO). Onderzoek valt onder de WMO als aan de volgende twee voorwaarden is voldaan:

  • Er is sprake van medisch-wetenschappelijk onderzoek
  • Personen worden aan handelingen onderworpen of hen worden gedragsregels opgelegd.

Je leest meer over de toetsingsprocedure van de WMO op de website van de Centrale Commissie Mensgebonden Onderzoek

Voor meer informatie neem contact op met de datastewards van de bibliotheek.

The Medical Device Regulation (MDR) is a European regulation for medical devices that has been in force since 2021. This legislation ensures the safe use of medical devices.   

A medical device is an article that, either alone or in combination with other articles, is used for medical purposes. Medical devices definition includes, among other things, devices, software, or materials. Medical purposes are, for example, diagnosing, monitoring, predicting, or treating diseases.   

More information about legislation regarding MDR, frameworks, and procedures can be found on the CCMO website."