Rights of research participants

Research participants are entitled to information about important aspects of the research project, such as the project's objectives, potential benefits for the participants themselves and others, the risk of injury, burden and inconvenience, the handling of biological material and health data, and insurance schemes. Participants must also be informed that participation is voluntary and based on consent.

Research participants also have the right to information about significant changes in the research project that might influence their willingness to continue participating.

Right of access
Research participants have the right of access to personal data about themselves and information about the security measures in the research project, as long as such access does not jeopardize security. Access to information may be restricted or refused for medical or other reasons based on the Health Research Act.

Research participants can also require correction of incorrect data. Deletion of data can take place only if it is required by someone on whom the information may have a direct impact and the deletion does not have a decisive effect on the research results.

Requests for access to information, etc., should be in writing and should be dated and signed by the research participant or guardian.    

The project manager must deal with such requests on an ongoing basis, and answer them within 30 days. Refusal of access to and deletion of data can be appealed to the regional committee for medical and health research ethics (REK).

The right to confidentiality
Research participants are entitled to confidentiality, which means that researchers must observe their duty of confidentiality and not disclose health information where there is no legal basis for this.

Consent and withdrawal of consent
The general rule is that the research participant must consent to research. Consent can be withdrawn at any time. Research on the person's health data or biological material must then stop. Research participants may also require that the biological material be destroyed and that health data be deleted or surrendered within 30 days, unless the exceptions in the Health Research Act apply.

Research participants who have given broad consent are entitled to receive information about the project at regular intervals. Broad consent means that research participants have consented to the use of personal health data or human biological material for specific, broadly defined research purposes.

Refusal to be involved in research on human biological material
REK 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. The Institute's website provides a form for use by people who do not wish their own biological material to be used in research without their prior approval.

The right to information
Research participants are entitled to information about injury caused to the participant, complications, unexpected side effects and other issues of importance to the risk assessment. Research participants who are injured during the research are entitled to information about the right to seek compensation from the Norwegian System for Compensation to Patients (Norsk Pasientskadeerstatning, NPE)

Research participants may also be entitled to information about unintended findings that have implications for their state of health. In assessing whether participants should be informed about unintended findings on the researchers' initiative, one must take into account the participants' presumed interest in receiving the information, expectations about getting the information, the security of the information, and the potential usefulness of the information to the participants. When in doubt, consult REK and/or the Norwegian Board of Health (Statens helsetilsyn). If life is at stake, the participant must be contacted immediately.