Participants’ rights in public health studies
In 2002, when the central health administration was reorganized, the Norwegian Institute of Public Health (NIPH) took over responsibility for a number of large, ongoing public health studies. These were previously run by institutions which were incorporated into the institute in 2002. These include the Norwegian Mother and Child Cohort Study, the Twin Study programme and data from previous health studies such as the Cardiovascular Study, which was conducted in the 1970s through to 2000. As a participant, you have rights.
What am I consenting to?
The consent declaration form differs between health studies, depending on the study purpose. In general, you give consent so that
- results can be used in medical research (often with more detailed information about the type of research)
- results (after approval from the Data Inspectorate) can be combined with information in other registers. These can be the registers for health, social security and disease, or the registers for income, education and occupation, as well as information from previous health studies that you may have participated in. Examples of such records include the Norwegian Cancer Registry, the Cause of Death Register and the Income and Education register from Statistics Norway
- blood samples can be stored and used in medical research. Any use of this analysis will only take place after approval from the Data Inspectorate and the Regional Committee for Medical Research Ethics.
What happens to the information from the questionnaires and results from blood samples etc?
The information from the questionnaires is stored anonymised (name and national identity number is removed), which means that health information is stored separately from the personal information that could identify you; health information is only identified by a random serial number.
Blood samples and any other biological material are marked with serial numbers and frozen in one of the department’s biobanks.
What does the NIPH use the information for?
The information that you have supplied to a project is only used for research that has a purpose that is consistent with the permission you gave in your consent.
Such projects are often created when information from the study that you are participating in is linked to other registers, usually one of the central health registers. Links are made only if you have given consent, or the Norwegian Directorate of Health and the Data Inspectorate has given permission.
Your information may be used in large studies, for example to study the relationship between height, weight and subsequent illnesses, and how occupation, education and income affect health.
How is anonymity ensured and who has access to my name / national identity number?
If you are, or have been, a participant in such a health study, your data is now stored in the NIPH. Health information is stored separately from personal data. Only specially authorized personnel within the NIPH, with confidentiality required by law, have access to information.
The information from health studies will be treated with strict confidentiality. No research projects contain personal information, and no-one will be given identifiable information.
The information is never used for anything related to the participant in person. Only if consent is given will any results from measurements in a survey be sent to your general practitioner.
Results from the survey will be analyzed and published in respected journals. Results will be presented so that no individuals can be recognized.
May I access my data?
Those who request it have the right to access and be informed about
- the health information the NIPH has stored about you and which will be used for research and
- the security measures that were taken for handling the health information
Please apply in writing to the NIPH, see address below.
May I get the results from the analysis of blood samples?
In some studies, such as the cardiovascular study, the participants will receive a letter with the results of blood samples (for example, cholesterol values). In other surveys (Mother and Child Cohort Study) participants are not notified about the discoveries that are made in connection with blood sample analysis. Participants are made aware of this in the invitation to take part in a health study.
Can I withdraw from the study and request deletion of my information?
As a participant in a public health study you are entitled, at any time, to withdraw from the study and request that your information be deleted.
You can get more information by looking at the websites of the study you are taking part in, by phone 21 07 70 00 or by applying in writing, either by e-mail to firstname.lastname@example.org or to the NIPH, PO Box 4404 Nydalen, 0403 Oslo.