Research about/with Human Participants

Personal data can be processed, according to the EU's regulation on privacy and personal data protection (General Data Protection Regulation, GDPR), if you have legal grounds for it. By processing, we mean all processes that can be done with personal data, including, but not limited to, 'collecting, recording, organisation, structuring, storing, adapting or altering, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction of data' (see [1]).

According to the GDPR, personal data is defined as 'any information relating to an identified or identifiable natural person (the data subject). An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.' (see [1], pp. 6).

It is important to mention that for anonymised data (i.e., data where the person is no longer identifiable), the GDPR does not apply. However, for pseudonymised data, where individuals can still be re-identified when combined with additional data, the GDPR does applies. Therefore, organisations and researchers need to adhere to the GDPR regulations when processing personal data and take necessary measures, especially when dealing with pseudonymised information, to protect individuals' privacy rights.

 For more information

• If you want to know more about the GDPR and its definitions visit Cyber Safty: General Data Protection Regulation website. 
• Further information on UT recommendations for 'appropriate use of personal data in scientific research according to the GDPR' is available.

References

[1]Kamp, M., Kamphuis-Blikman, L., Koelen, M., Koster, N., van de Ven-Davids, M., and Willigen, P. (2022). 'Appropriate Use of Personal Data in Scientific Research According to the GDPR'. University of Twente

What do we mean by 'informed consent'?

‘Informed consent’ refers to the voluntary agreement given by research participants, providing the researcher(s) with a legal basis for processing personal data. It is a crucial step in obtaining permission to collect, share, preserve, and use a participant's personal data for research purposes.

For consent to be considered informed and freely given, participants must be provided with clear and comprehensive information about the research activities they will be involved in, the details of data processing, and their rights as research participants. Specifically, participants should have unambiguous knowledge about the type of data that will be collected, the entity responsible for controlling their data, and how their data will be utilised.

According to the General Data Protection Regulation (GDPR), participants must be informed about their rights, including the right to withdraw consent and, if possible, to remove their data from the research analysis. The process of withdrawing consent and removing data should be as straightforward as the initial consent process.

All personal data processing must align with the details outlined in the informed consent form provided to participants. This ensures transparency, respect for participants' autonomy, and compliance with data protection regulations.

How can 'informed consent' be given and documented?

Informed consent can be given and documented through various methods. The most common forms include:

• Written and signed (participants are provided with printed consent forms).
• Verbal/oral consent (this is usually recorded).
• Online consent (after being provided with detailed information on the activity, when a participant, for instance, submits an online survey, actively ticks boxes agreeing to the uses of their data, etc).

There is also passive consent. Nonetheless, this is not recommended in most cases and might only be acceptable in specific and special conditions.

For more information and more details on the types of consent, you can visit the Humanities and Social Sciences (HSS) Ethics Committee website, where detailed explanations of each type of consent are available.

informed consent examples

These are examples of informed consent forms you could use. Please be aware that they are only examples and need to be adjusted to your specific research, activities, and types of data processing. Look at them carefully and adapt them to your research.

We are sharing an example of an informed consent form further adapted from a GDPR-compliant version created by the HSS Ethics Committee (BMS Faculty) Template with input from TU Delft. We have adapted it considering further scenarios we have frequently seen in GEO research projects.

Download an Informed Consent Example (English) Last update: November 2022

MORE INFORMATION

UT's domain-specific committee on Human and Social Sciences (HSS) website provides more details and resources on Informed Consent, what it entails, the different types, and further guidance documents.