What is LifeGene
LifeGene is a unique project for better knowledge of how our genes, our environment and our way of life affect our health. LifeGene consists of two parts, a web-based questionnaire and a health test with sampling. The questionnaire was answered annually, the health test was carried out on one occasion.
LifeGene started in September 2009 and contains information from a total of 52,107 participants. Blood, serum and urine from more than 29,500 participants are stored at KI Biobank.
A unique project for better health
LifeGene is a unique project for better knowledge of how our genes, our environment and our way of life affect our health. In medical science there are still unexplored areas and we believe that LifeGene will provide completely new opportunities to gain more knowledge about our most common diseases and health problems such as asthma, allergies, infections, obesity, chronic fatigue and pain, and the major diseases later in life – cardiovascular diseases and cancer.
LifeGene consists of two parts, a web-based questionnaire and a health test with sampling. The questionnaire was answered annually, the health test on one occasion. If you want to read more about our recruitment, you can take a look at our brochure which is attached as a document to this page. LifeGene began in September, 2009 and contains information from a total of 52,107 participants. Blood, serum and urine from more than 29,500 participants are stored at the KI biobank.
Swedish researchers in a joint effort for better health
Behind LifeGene are seven Swedish universities with their medical faculties. Karolinska Institutet hosts the project and has a leading and coordinating function. The other participating universities were: Lund University, Gothenburg University, Linköping University, Uppsala University, Örebro University and Umeå University.
Several research projects are underway at LifeGene. https://ki.se/en/research/ongoing-research-in-lifegene
LifeGene has been financed through grants from Vetenskapsrådet, Karolinska Institutet, AFA Försäkring samt Ragnar och Torsten Söderbergs stiftelser.
Medically trained staff conducted health checks on over 29,500 LifeGene participants.
Measuerements used in i LifeGene:
- Waist, hip and chest measurements
- Fat distribution in the body (complete BMI included)
- Blood pressure and pulse
The results of the physical measurements were made known to the participants immediately after the measurements were taken.
In addition, the participants tested their:
- Lung function
Participants donated blood and urine samples. Adults were allowed to donate up to 50 ml of blood (non-fasting) and the amount of blood for children depended on age. All participants over the age of 15 had the results of the following analyzes sent home to their civil registration address:
- Glucose (HbA1c)
- Apolipoprotein A1
- Apolipoprotein B
Personal data for research purposes may not be collected unless the person submitting the data has expressly consented to the personal data being collected and processed in accordance with Act 2013:794. At LifeGene we place great importance on consent and we wanted to be sure that participants had all the information needed to feel safe when they joined our study.
When was consent collected?
When participants registered as participants in LifeGene, they could log in either with e-identification or with a password and one-time PIN code.
The participants who logged in with e-identification signed consent immediately in connection with the first login by reading through the consent and then clicking on approve. Participants who logged in with a password had to sign a consent form when visiting the LifeGene Test Center to have a health check.
The consent looked the same regardless of login method. If you want to see what the consent looks like and read it through, it is attached as a document to this page.
What does consent mean?
When research involves people, the participants must be informed about the research and their participation in order to be able to freely choose whether they want to participate or not.
LifeGene is a research project and resource that collected data from a large number of individuals to enable future research on what heredity and environment mean for the onset and development of various types of diseases and for human health in general.
On December first 2013, Law 2013:794, on certain rules for research on what heredity and environment mean for human health, came into force. The basic rule is that research may only be carried out if the research subject has consented to the research concerning him or her. Consent only applies if the research subject has previously received information about the research. The consent must be voluntary and explicit, and must be documented. A consent may be withdrawn at any time with immediate effect. This means for the participants they must consent to us saving personal data in accordance with the law. It is important that the participants have read the consent information below.
Please note that the consent information and the Informed Consent form was given to participants before GDPR was in place. LifeGene complies fully to current legislation.
LifeGene is a research infrastructure and resource that researchers can use in their research. We are extremely careful about which researchers get access to our material and what type of research it is about.
As a research infrastructure, LifeGene does not have its own defined questions and does not conduct its own research on collected information. Only researchers affiliated with a Swedish research institution can apply to use material and data from LifeGene. In order for research projects to be carried out, it must be approved by the Swedish Ethical Review Authority(Etikprövningsmyndigheten) and by LifeGene's board of directors (NSAB). Since December 2013, LifeGene has been subject to the new law Lag om vissa register för forskning om vad arv och miljö betyder för människors hälsa (SFS 2013:794)
LifeGene protects the privacy of participants
LifeGene takes integrity and ethics very seriously. We protect and respect the privacy of our participants. Trust, integrity, honesty, openness and empathy are fundamental values for everyone who works with LifeGene. Respect for people, a good intention, a desire not to harm and to be fair are basic rules.
All research on information collected by LifeGene is ethically reviewed according to law and done by special ethics review boards (EPM). The ethical requirements are high – the researcher must be professional, use accepted scientific methods and know their field. He or she must also be honest in his analysis and presentation. Medical research is about trust.
Biological samples are stored in the biobank and are coded, which means that information about participants cannot be directly linked to individuals. LifeGene belongs to Karolinska Institutet, which applies the Biobank Act, which means that biological samples are not released for anything other than research. In the case of serious crimes, a court can decide that material can be confiscated according to the procedural and criminal codes.
LifeGene will not transfer biological samples or collect samples for profit.
Personal data, information about participants and survey responses are processed in accordance with SFS 2013:794 and GDPR. All information is coded or encrypted when processed in a computer. Results will be presented in the form of, for example, tables together with the answers from others who participate in the survey. It will not be possible to identify your answers in the published results.
An important part of privacy protection in research is that you, as a participant, have the right once a year after a written, signed request to access the personal data that is registered about you and you have the right to request that incorrect data be corrected or removed.
Employees at LifeGene have a duty of confidentiality
Everyone who works, practices or has assignments within LifeGene has a duty of confidentiality according to the Publicity and Privacy Act OSL (2009:400). Secrecy and confidentiality apply to all oral and written participant information, regardless of whether it is on paper, in a computer or otherwise.
Karolinska Institutet is responsible for your data
Karolinska Institutet is responsible for the information about you and that it is processed in a legal and secure manner so that no unauthorized persons have access to it. Responsible researcher is Nancy Pedersen, tel: 08-524 874 18
LifeGene is voluntary
Last but not least, participation in LifeGene is voluntary and consent can be withdrawn at any time.