Consent and information letter in research, study and interview

• that they receive the necessary information in the form of an information letter,
• that the consent has been given freely (when using "special categories", such as health data, it must also be given explicitly) and provides on the basis of adequate information and
• that they provide consent, preferably by using a consent form (declaration of consent in writing or by electronic submission in a box). A valid consent must be "proven".

Research

You can read more about the cases in which “consent” is suitable as a lawful basis and find guidance for obtaining consent and a template information letter at the Data Protection for Research Services (Sikt) (sikt.no) website. Templates for participants information (sikt.no).

The Regional Committee for Medical and Health Research Ethics (REK) has drawn up a general template for information and consent for use in research that falls under the scope of the Norwegian Health Research Act. A copy of the information letter and consent form must be enclosed with the application to the REK. The information letter and consent form templates can be found in the REK case portal.

Survey/interview

Websites for inspiration. See guidance for obtaining consent and a template information letter at the Data Protection for Research Services (Sikt) (sikt.no) website. Templates for participants information (sikt.no).

Remember

It is important to ensure that the sample selection is well-informed of all aspects associated with the study/survey so that they can make a comprehensive assessment of whether or not they wish to participate. This applies to purpose, risk and potential benefits. An information letter must therefore be drawn up requesting participation and providing information about the study/survey.

Resources

• The European Commission has prepared guidance on obtaining consent (ec.europa.eu).
• Sikresiden.no: E-learning "How to obtain consent?" (nanolearning.com) (3-5 min).

If a participant withdraws their consent to take part in a research project/study, you need to ensure that any research/study of the participant’s biological materials, research data or other data ceases.

The participant may request that biological materials, research data or other data linked to the participant in the research project/study/interview be destroyed and deleted within 30 days. This right shall not apply:

• If, after processing, the material is included in another biological product.
• If the research data has already been included in completed analyses.
• In clinical trials.

As a project manager/person responsible for the processing, you will make decisions relating to deletion but your decision may be appealed to REK.

All deletion must be documented and traceable.

Following application, the REK may still permit continued research using the materials/research data if there are important societal or research considerations involved.

• In case of reduced capacity to give consent, see chapter 4 of the Norwegian Health Research Act (lovdata.no) (in Norwegian).
• Children must be given information directly from the age of 12 and must also be given the opportunity to consent or opt out of participation (etikkom.no).
• Data Protection Services for Research (Sikt) have drawn up information on procedures for research using vulnerable groups (sikt.no) (in Norwegian).
• The Norwegian Data Protection Authority's web page on consent from minors (datatilsynet.no) (in Norwegian).

In some cases, it will not be possible to obtain consent from an informant/research subject. In such cases, an exemption must be sought from the relevant department. For further information, please see access to confidential material.

The University has drawn up consent forms for use in connection with photographs, audio and films, see Film, audio and photographs.

The University has also drawn up a consent form (in Norwegian) that can be used in cases in which you need to take video recordings of informants for subsequent analysis or you have a need to copy materials produced by informants for subsequent analysis and/or you need to use video recordings or photographs of informants in connection with the publication of results.

• When do you need to use consent in research? See the National Research Ethics Committees webpage about consent (forskningsetikk.no).

• EDPB about the concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (.pdf)