Consent
- Research participants have the right to withdraw their consent.
- It must be as easy to withdraw consent as it is to give it.
- If a participant withdraws their consent, any personal data that has been provided must be deleted. Biological material collected must be destroyed.
- Research participants should be aware that, in special cases, the Regional Committee for Medical and Health Research Ethics (REK) may grant exemptions from these requirements. Data that has already been anonymised cannot be deleted.
Legal basis
It is important to distinguish between consent in a research ethical sense and consent in a legal sense. It is a fundamental research‑ethical principle that research participants must consent to participating in a research project, but this does not necessarily mean that consent is the legal basis stated for the processing of personal data.
Even when a research participant withdraws their consent to participation, this does not necessarily mean that their withdrawal requires the deletion of personal data collected.
For example, data does not need to be deleted when:
- the data has already been anonymised,
- the data has already been used in data analyses or has been published,
- the processing of the data is based on a legal basis other than consent, such as when there is public interest.
Research participants should have been informed of these eventualities via the information sheet they will have received. If you receive a request for deletion of personal data, you should contact the Protection Officer at personvernombud@usn.no for advice on how to proceed.
For research projects in the health fields, the rules governing withdrawal of consent are regulated by Section 16, second and third paragraphs, of the Health Research Act.
Duty to Inform
- The project head must inform research participants about the purpose of the project, who is responsible for it, and the individual’s right to withdraw from future participation in the project.
- If their consent has not been obtained, research participants nevertheless have the right to information about a research project. This may be done via USN’s website, through the media, or by means of a project information sheet.
- The project head must immediately inform research participants when it is believed that participants may have been harmed or in the event of any complications having arisen as a result of the research project.
Right to Object (Withdrawal)
Anyone may object to the use of their biological material in research by registering in a national project withdrawal register. This can be done by contacting the Norwegian Institute of Public Health (FHI), Register of withdrawal of biological research consent.
Duty of Confidentiality
Anyone who gains access to health data in the course of conducting a research project is subject to a duty of confidentiality that is binding. This means that they must prevent others from gaining access to or knowledge of the data.
A duty of confidentiality does not, however, prevent a research participant from being informed about which health data have been collected about them.
Nor does the duty of confidentiality prevent supervisory authorities from accessing research data where this is necessary in connection with supervision of the project.
Right of Access
If an individual is identifiable in data collected, that person has the right to:
- access information about which of their personal and/or health data has been recorded,
- have incorrect data rectified,
- request deletion of their personal data,
- receive a copy of their personal data (data portability),
- be informed about how data security is ensured in the project, as long as such information does not undermine data security,
- submit a complaint to the Data Protection Officer or the Norwegian Data Protection Authority regarding the processing of their personal data.
If you have questions related to the processing of personal data at USN, you may contact personvernombud@usn.no.
Injury, Compensation, and Insurance
Some research projects involve a greater risk to participants than others. Research participants must always be informed of potential risks before deciding whether to participate. If a participant should, contrary to expectations, suffer harm or experience complications as a result of participation in a project, the project head must inform the participant immediately.
The project head must also inform participants of their right to seek compensation through the relevant insurance scheme, for example through the Norwegian System of Patient Injury Compensation if the research project is conducted within the health services, or through special insurance arrangements for clinical drug trials.
As a participant in a research project conducted in settings covered by the Patient Injury Act—i.e. specialist health services, municipal health services, during ambulance transport, or where healthcare is provided by health personnel—participants are insured through the Norwegian System of Patient Injury Compensation (NPE) just as any patients receiving treatment at a public healthcare institution would.
For research projects not covered by the Norwegian System of Patient Injury Compensation, USN, like other state institutions, acts as a self‑insurer. This means that the institution itself provides insurance coverage for participants.
Resources
- Act on Medical and Health Research (Health Research Act) – Chapter 10: Compensation, orders, penalties, etc. Follow this link for information about the Health Research Act.
- Norwegian System of Patient Injury Compensation (NPE)
If you need more information about participant’s rights
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