Consent and information letter - Ansatt

Consent and information letter

Consent and information letter

The main rule set out in the Personal Data Act is that personal data can only be processed with the consent of the person whom the data concerns.

As a rule, participation in research shall be based on the consent of the participants.

What do I have to be aware of when I use participants in my research project?

If you are the project manager for a project that involves research on people – research participants (informants/human test subjects) – you must ensure that they are given the necessary information in the form of an information letter and give their consent, preferably, by signing a declaration of consent.

In order for a person's consent to participate in research to be valid pursuant to the Personal Data Act, consent must have been given voluntarily, be specific and have been given on the basis of adequate information. Read more about the conditions on NSD's website.

It is important that the sample is well informed about all aspects of the relevant study, so that they can make an overall assessment of whether they want to participate or not. This applies to the objective, risks and possible benefits. An information letter must therefore be prepared in which participants are informed about the study and asked whether they wish to participate.

The Regional Committees for Medical and Health Research Ethics (REC) have drawn up a general information and consent template to be used in research that is covered by the Health Research Act. The information letter and declaration of consent must be enclosed with the application to REC. Templates for information and consent are available at REC's case portal.

The Norwegian Social Science Data Services has also drawn up guidelines for consent information and a form.

What do I do if a research participant wants to withdrawal his/her consent?

If a research participant withdraws his/her consent to participate in a research project, you must ensure that the research on the participant's biological material or research data is discontinued.

Participant may require that biological material and research data related to the participant in the research project are destructed and destroyed within 30 days. Except in these cases:

  • If the material after metalworking is a part of another biological product.
  • If research data already has entered into the analyzes performed.
  • In clinical trials.

You as a project manager makes decisions about deletion, but the decision may be appealed to the REC.
All deletions must be documented and be traceable.
Upon application, the REC can still allow continued research on the material / research data, because of strong social or research considerations.

How to proceed if the research participant has reduced capacity to give consent or is a child/has no legal competence?

  • In the event of reduced capacity to give consent, see chapter 4 of the Health Research Act.
  • The Norwegian Social Science Data Services (NSD) has information about the procedure for obtaining consent when children and minors are to participate in research, see NSD's web page.

What can I do if it is impossible to obtain consent from the research participant?

In some cases, it will not be possible to obtain consent from the project participants. In such cases, you must apply for a dispensation from the relevant sector ministry. For more information, see access to confidential material.

Consent to the use of photos, video material and other material in research.

The university college has prepared a declaration of consent that can be used in cases where you need to record participants on video for subsequent analysis, take a copy of the material the participant has produced for subsequent analysis, and/or use video recordings and photos of participants in the publication of results.