Informed, voluntary and fair consent to participate in a study is very important for any research project that involves human participants. It is through this consent process that research participants can understand what taking part in a specific study will mean for them, and how their data will be handled during the research project. Each person can then choose whether to participate using the consent form. See also the Guide for Ethical Research.
Note that the informed consent form is considered to be personal data and should therefore be handled with the same care as other personal data. Do not store the consent forms where you store the rest of the data you collect; use a separate locked cabinet or an encrypted folder for example.
In case you cannot use a written consent form, try to make a recording of verbal consent.
Consent documentation should include:
a participant information sheet and
a consent form signed by the participant.
The participant information sheet is used to inform participants about the study. The information should be clear and easy to understand and should cover the following:
What the project is about.
What their participation will involve and what (types of) data you will be collecting.
Any risks involved for participants and safeguards to minimise those risks.
Assurances about data security and participant confidentiality.
Mention who has access to the data.
How the data will be used in the study (for published articles, reports and presentations).
Proposed plans for archiving data at the end of the study and potential future secondary re-use of data.
Tiered consent may be a solution here, by allowing the participants to choose what type of information will be shared for re-use.
If you work under the General Data Protection Regulation (GDPR), describe participants’ rights and how they can exercise those rights, such as the right to data erasure and the right to contact the institution’s Data Protection Officer (if present).
Details of the organisation overseeing the research.
Whom to contact for more information about the study.
The consent form is used to verify that the research participant understands and agrees to participate in the study. The consent form should cover the following points at a minimum:
has read and understood the participant information sheet
has been given the opportunity to ask questions
understands that participation is voluntarily
understands that they may withdraw from the study at any time without giving reasons and without penalty
understands how the data will be managed, shared and archived (as detailed in the information sheet)
to increase the chance of your data to be re-used, do not promise to delete the data but instead ask for consent to retain and share the data (see [Mey18])
An action of providing consent. This is often a signatures of both the participant and the researcher, and the date of signing. However, ticking a simple check box can sometimes also suffice, depending on the type of research.
Think ahead and plan how you will:
collect, store and manage the data (see Data storage and organisation)
control access permissions
prepare data for archiving/sharing at the end of the project if possible (see Sharing and archiving data)