Consent from participants in health research - Kunnskapsbasen
Consent from participants in health research
Norsk versjon: Samtykke fra forskningsdeltakere i helseforskning
Also see: Rights of research participants rights in health research | Health research topic page | Consent for processing of personal data
After the General Data Protection Regulation (GDPR) entered into force, there are stricter rules for processing of personal data. To process personal data, you must have a basis for processing. Consent directly from the research participants is an example of a valid basis for processing.
The research participants must give voluntary and informed consent. Consent must be given through an active action and before consent is given, research participants must get specific information about what they are consenting to, what the information will be used for, and how the personal data will be processed. If there are substantial changes in the project, the project manager must consider whether new consent is necessary.
See more about consent on the Data Protection Authority’s website.
The project manager must inform research participants about the project, the role of the research participants, risks of injury, disadvantages, benefits for the participant and others, which data will be collected about the individual, and how the data will be processed and stored. Research participants must also be informed about insurance schemes and their right to refuse and to withdraw from the project.
In connection with the approval of the research project, the regional committee for medical and health research ethics (REC) may specify conditions for the content in the information letter. The Norwegian Medicines Agency (Statens legemiddelverk) can specify conditions for research projects that involve clinical trials of medicines. The REC has prepared templates for information letters and consent forms, which should be followed.
Read more about the basis for processing.
Research participants may consent to human biological material and personal health data being used for specific, broadly defined research purposes. This means that the research participant gives consent for research involving one or more overarching research purposes, research fields and projects. The REC may impose conditions for the use of broad consent.
The research participant must be informed about the implications of giving broad consent. Research participants who have given broad consent are entitled to receive information about the project at regular intervals.
Consent from children and young people
For children and adolescents under the age of 16, the parents must consent to the child’s participation in the research project. The main rule is that both parents must consent.
In certain research projects, children and adolescents between the ages of 12 and 16have the right to consent to participation in medical and health research. This follows from Forskrift om barn mellom 12 og 16 år sin rett til selv å samtykke til deltakelse i medisinsk og helsefaglig forskning (Regulations on the right of children between the ages of 12 and 16 to consent to participation in medical and health research). It must be assumed that the project cannot be carried out with parental consent because it might reveal information that the parents, or others with parental responsibility, have their own interests in concealing, such as information about violence or neglect.
Young people over the age of 16 must give consent on their own behalf. For research that involves bodily intervention or drug trials, young people aged between 16 and 18 years give their consent together with parents or guardians.
For participation in long-running projects, a requirement may be imposed for collecting young people’s own consent after they have reached the age of 16.
People without capacity to consent
For people who lack competence to give their consent due to their state of health, intellectual disabilities or legal incapacity, there are special regulations about who must give consent; see Section 17 of the Health Research Act (Helseforskningsloven) where it is stated that the next of kin according to Section 1-3(b) of the Patient Rights Act must give their consent. Section 18 of the Health Research Act has certain additional criteria that must be met for research that includes these groups. For research in clinical emergencies, consent may be given afterwards as long as the other provisions of the Act are fulfilled; see Section 19.
Research without consent
The REC may decide that human biological material collected as part of research or in diagnosis and treatment may or must be used for research purposes without obtaining consent. The same applies to data gathered in connection with research or by the health service.
Consent is the normal rule. For this reason, it is a prerequisite that it is difficult or impossible to obtain consent. In other words, there must be good reasons for exceptions to the rules about consent and for exemption from the duty of confidentiality in connection with disclosure.
Exceptions to the requirement for consent may be made only if such research is of significant interest to society and the participants’ welfare and integrity are ensured; see sections 15, 28 and 35 of the Health Research Act.
The REC may impose conditions for use, such as requirements for information to the participants. The patient must have been informed in advance that in some cases human biological material may be used for research and must have been given the opportunity to refuse to be involved in research on human biological material.
People who reserve the right to require prior approval for any use of their own biological material for research must be listed in the Reservation Register at the Norwegian Institute of Public Health.
Withdrawal of consent
Consent can be withdrawn at any time, and research on the material or personal health data must then stop. A person who withdraws their consent may demand that their biological material be destroyed and that the personal health data be deleted or surrendered within 30 days; see Section 16 of the Health Research Act. This does not apply if:
- the material or the information has been anonymized
- after it has been processed, the material is included in another biological product
- the data have already been included in analyses that have been performed
The REC may decide that further research is to be permitted and that the destruction, deletion or surrender of the material is to be postponed until the research project is completed. A prerequisite is that this is justified by particularly strong societal or research interests.
Withholding consent for research use of human biological material
The REC may decide that human biological material collected in the health service may or must be used for research purposes without obtaining the patient’s consent. This applies to research projects that are of great interest to society. Patients must have been informed of this and must have been given the opportunity to be excluded from such research unless they have given prior consent.
The Norwegian Institute of Public Health has created a Reservation Register.
A form for people who do not want their own biological material to be used in research without their prior approval is available at the Norwegian Institute of Public Health website.