Consent to the Collection of Health Data and Biological Material for Research

When you become pregnant, blood and urine samples are usually collected to look for signs of disease. We will ask if we can use the leftovers from these samples and collect some extra samples. We will only request small additional amounts within medically justifiable limits. 

We will also ask you to take an extra urine sample and blood and hair sample during the ultrasound examination at around week 18 of pregnancy. In addition, we ask for a urine and blood sample from you in connection with the delivery, and that we take a small blood sample from the umbilical cord of your child immediately after birth. 

Some participants will also be contacted for further samples of breast milk and other biological samples (blood, urine, stool and hair) of the child within the first two years of life.

It is up to you whether you want to provide biological samples to the MoBI-Biobank. 

Clinical information about your pregnancy, birth, and postpartum period is collected in your medical record, in addition to the child’s clinical information in the child’s medical record from birth, and until the child has reached the age of 16.

In addition to the information from the clinical record we also want you and your partner to fill in questionnaires about mental and physical health and growth and development of your child. You will receive the electronic questionnaires via SMS or email maximum twice during pregnancy, and at regular intervals throughout your child’s upbringing. It is up to you whether you want to answer these questionnaires or not.

The research projects will not have any direct impact on the choice of treatment for you at any time. However, the research projects can provide valuable knowledge that can lead to a better understanding of health, disease, and development, and better diagnostics and treatment in the future.

When you provide biological material to this general research biobank, you also give broad consent for the material and relevant health information to be used and reused for future research on maternal and child health, disease, and development. 

This includes research on diseases during pregnancy, birth processes, infections, nutrition, toxicology (environmental pollutants), hormones (metabolism and diabetes), and mental health. 

In other words, IHOP and MoBI-Biobank have a broad objective within these three main themes: 

1. Pregnancy, birth, and the postpartum period, including research on ailments, diseases, and factors that affect the mother’s risk of illness during this phase of life. 
2. The child in the mother’s womb, including factors that influence pregnancy, such as familial conditions, well-being, nutrition, and disease. 
3. The child’s health and development, where we investigate causal relationships for disease, well-being, and development, as well as the significance of genetic and environmental factors. 

Participation is voluntary. We cannot store test material or information about you without your written consent. 

If you decide to withdraw your consent, this will not have any consequences for you or your treatment at the hospital. Additionally, stored samples from you will be destroyed, and information about you will be deleted. 

Published information cannot be deleted, but it will not be reused in new studies. You have the right to access the data stored about you and request corrections if any incorrect information has been recorded. 

IHOP will include information about you and your child from various sources at Innlandet Hospital Trust (patient records, radiology, laboratories, internal quality registers, etc.) and primary health services (healthcare station). An overview will also be created for the samples stored in the MoBI-Biobank.

The consent you provide will be stored in an electronic consent register. To protect your identity, personal information will be replaced with a code during the storage and processing of data. Innlandet Hospital Trust is responsible for securely storing and managing the code list that links this code to your personal information.

The material and information about you will be stored permanently and will only be used in connection with ethically approved research projects. It will not be possible to recognize personal information in any of the publications or reports from the project.

In certain research projects, it may be relevant to combine information from IHOP and MoBI-Biobank with data from central health registries such as the Cancer Registry of Norway, Medical Birth Registry of Norway, Norwegian Cause of Death Registry, Norwegian Patient Registry, Norwegian Prescribed Drug Registry, Norwegian Registry for Primary Health Care, among others.

The CEO of Innlandet Hospital Trust holds the overall responsibility for all processing of such data. Necessary approvals in accordance with current Norwegian law will be in place before such linkages are made.

It may be relevant to analyze genetic material from the collected samples. For example, we can investigate which genes are turned on or off (epigenetics) and determine the aging rate of a cell by measuring the length of something called telomeres. In addition, we may perform genetic analyses to map genes from bacteria, fungi, and viruses (the microbiome) in both the mother and the child.

All genetic analyses must be approved in advance by the ethics committee for health research and other relevant institutions in accordance with the Health Research Act. We will not perform analyses on known genes that could predict potential diseases in you or your child. 

Results from various research projects will be published in national and international journals and presented at scientific meetings and congresses. Many scientific articles and several dissertations are expected from this registry.

The results from the different research projects will also be communicated to the public through articles in popular science journals, presentations at professional and user-focused forums, including for midwives, health nurses, and other healthcare workers, as well as through brochures and meetings, and national and international conferences.

All research projects that use material from IHOP and MoBI-Biobank must be approved in advance by a regional committee for medical and health research ethics. In some cases, we may need to request new consent from you.

Further information about the studies can be found on our IHOP and MoBI-Biobank website. On the website, you will also find information about which projects have utilized data and material from IHOP and MoBI-Biobank. In addition, you can follow news and updates on the registry’s Facebook page.

It may be relevant to disclose information and biological material to research institutions both domestically and abroad. Names, social security numbers, or other directly identifiable information will not be disclosed.

Providing information, medical records, and biological material is voluntary and requires consent. It will not affect your treatment if you choose not to provide information, medical records, and samples, or if you later wish to withdraw your consent.

You can at any time request to know what information and materials are stored about you. You can at any time request that the material to be destroyed without providing any reason. However, the destruction of the material will not result in the deletion of any information that has already been included in compilations or analyses.

If you wish to withdraw, you can send us an email or fill out this form (nettskjema.no). Log in through ID-porten with digital ID. 

Your child will be informed about the possibility of withdrawing their information upon turning 16 years old.