Consent requirements
- Consent must be given freely and not given under pressure.
- Consent must be informed, and the research participant must understand what they are consenting to.
It is important to distinguish between consent in general and consent as a legal basis for the processing of personal data. Although consent is the main rule for research involving humans, it is often not the most appropriate legal basis for the processing of personal data. , As a rule, “public interest” is a more appropriate legal basis for research projects. However, even when another legal basis is relevant, consent should still be obtained from research participants.
When obtaining consent, it is important to have a clear understanding of roles, so that consent to participate in a research project is not given under any form of pressure. This is particularly important in situations where one person holds multiple roles, for example as both teacher and researcher, or clinician and researcher. In such situations, there is an asymmetric power relationship between the person requesting consent and the participant, and it may be necessary to implement measures to ensure that consent is not given under any form of pressure.
Consent as a legal basis for the processing of personal data
If consent is the legal basis for processing personal data, a participant may not participate in a research project before they have provided written consent. Consent documentation may be collected electronically.
Informed consent refers to the communication and information that enables each participant—regardless of age or mental capacity—to make an informed decision as to whether or not they will participate in a research project. Informed consent provides the necessary information about the project and serves as a formal agreement regulating participation. The informed consent must also state whether the legal basis for processing personal data is based on consent, or whether it is based on “public interest” or some other legal basis (see GDPR Articles 6 and 9).
The consent must include a description of how a participant’s privacy will be protected during the project and in the presentation of results. As a general rule, informed consent should include information about long-term storage and sharing of anonymised data. For example, it may state that:
Your responses to the questionnaire will, in anonymised form, be deposited and stored long-term in the USN Research Data Archive and made available for future research purposes and/or teaching.”
Important points related to the use of consent:
- Consent must be stored securely and confidentially.
- If there are significant changes to the project, it may be necessary to obtain new consent.
- An adult’s ability to provide consent may be compromised in the event of a physical or psychological condition that clearly prevents them from understanding what the consent entails.
- Persons who have been declared legally incapacitated should, when possible, consent themselves. A legal guardian must provide consent when necessary.
- The requirement for consent may, under certain conditions, be waived. In such cases, the project head still has a duty to inform participants unless an exemption from the duty to inform applies (see exemptions from consent).
- Be aware of which legal basis you use when completing a notification of consent. The legal basis for processing personal data is usually a participant’s consent or public interest.
- Special rules apply regarding collective consent in addition to individual consent in Sami health research projects. See the Application Guide for Collective Consent.
Consent of minors
- Health research: Minors between the ages of 16 and 18 may consent to the collection of data related to them unless otherwise specified by special statutory provisions or the nature of the intervention. The consent of parents/legal guardians is required if the research involves bodily intervention or clinical drug trials. Section 17 of the Health Research Act contains more detailed provisions on the ability to consent.
- Other research: The standard practice, depending on the nature and scope of the project, is a lower age limit of 15 years for independent consent. Where sensitive personal data are involved, the age limit is 16–18 years. For minors under 18 years to provide valid consent, they must understand the consequences of providing personal data. This understanding depends on factors such as age, the nature and scope of the personal data, and the purpose of the data collection. It must always be clearly stated which age limit applies when minors are expected to provide personal data.
- When including minors, age-appropriate information must be made available which takes into account a participant’s level of maturity and prior experience.
Broad consent
For some health research projects, participants may be asked to consent to a set of broadly defined research questions (Section 14 of the Health Research Act).
In such cases, the Regional Committee for Medical and Health Research Ethics (REK) may impose conditions on the use of the consent and require the project head to obtain new consent if deemed necessary. Research participants are also entitled to regular project updates.
Exemptions from consent
It is possible that it is not necessary to obtain consent from some research participants—for example, when it is very difficult or impossible to do so due to the number of project participants.
For projects covered by the Health Research Act, REK may grant an exemption from the requirement to obtain consent in such cases In such cases, the research has to be of significant relevance to society. The welfare of the participants must also be safeguarded.
Consent is the main rule, and even when exemptions exist, they must be used with caution. Consent is important for maintaining the public’s trust in research. Even if it is possible in some cases to avoid obtaining consent, this should not be a goal in itself.
Please note that even if it is very difficult or impossible to obtain consent, you should still provide information about the research, either through an information sheet or by publishing information about the project on USN’s website: Personal Data in Research Projects (Norwegian only).
Resources
Read more about consent on the websites of Sikt, REK, The National Research Ethics Committees and the Norwegian Data Protection Authority . When in doubt, contact Sikt, REK, or USN’s Data Protection Officer.
Issues related to consent are also discussed in: Guidelines for Research Ethics and Scientific Assessment of Qualitative Research Projects in Medicine and Health Sciences.