We collect a blood or saliva sample from you so that we can extract your DNA and process it to look at your genetic code. We merge your genetic code with your health information from your electronic health record at UCHealth and make this available for research. Before we share your genetic or health information for research, we remove any personal identifiers so that researchers cannot identify you or other Biobank participants.
We get your sample by collecting an additional tube of blood when you are having a clinical blood draw at a UCHealth facility. We may also collect a saliva sample at certain clinics or events at UCHealth. As with any clinical sample, the tubes have some personal details such as your name and date of birth, in order to identify the sample. When the sample is used for research, it is given a unique code and only the Biobank is able to link that to your information.
Researchers outside the Biobank will generally not have access to information that can directly identify you, such as your name, address, or medical record number. Such information may be required by researchers for certain types of research. This would only happen with permission from the Biobank Access Committee and additional authorizations granted by the Colorado Multiple Institutional Review Board (COMIRB). COMIRB is an administrative body that protects the rights and welfare of human research subjects.
If you decide to be in this study, there is no limit on the length of time we will store your samples and health information. We may keep using them for research unless you decide to stop participating or we close the Biobank.
No. A large amount of information is generated when we process your sample. The vast majority of it is information that is only valuable for research purposes at this time. Because of the data size and the unknown impact, we are not returning data to participants at this time.
The original Biobank consent form you signed was limited in scope and
information. The Biobank research study has expanded and made much
progress, and the updated consent form contains new information about
the Biobank research study, your rights as a participant, how we share
information, and the potential return of genetic test results. More
details can be found here.
can take a long time; therefore, we cannot guarantee that we will find
information in your sample to return to you. As more samples are
processed and genotyping is completed, the Biobank may find information
that is medically important for some participants.
If we learn
something about your sample, we may be able to return this information
if you have consented to have results returned. If you signed a Biobank
consent form before October 2019, you have not
consented to get results from the Biobank, and you must update your
consent form if you wish to have results returned. We have recently
started to re-contact participants through My Health Connection to
invite them to update their consent. If you signed a Biobank consent
form on or after October 1, 2019, you have already
given us permission to share medically relevant information with you.
However, not everyone will have this information, so we cannot guarantee
that you will have results returned.
The genetic tests done on your sample were selected to answer research questions. However, the results from some of these tests are ‘medically actionable’, meaning that they could affect your health or medical care.
There are three types of clinical genetic test results the Biobank may be able to return:
Results that may predict your responses to medications.
Some clinical genetic test results may help a healthcare provider
understand if a person may need a different medicine or a different dose
of a medicine.
Results that may predict your risk of diseases.
Some clinical genetic test results predict that a person is at
increased risk of some cancers, heart diseases, muscle diseases, or
Results that may identify you as being a ‘carrier’ for a disease.
People who are ‘carriers’ usually remain healthy and do not develop
disease but they may have a higher risk of a disease occurring in their
blood relatives including current and future children.
Biobank will only complete limited clinical testing on some selected
genetic conditions, risks, and responses to medicines. Over time, the
number of Biobank tests may increase.
If you signed a Biobank consent form on or after October 1, 2019, you have given us permission to share medically relevant information with you. The Biobank will return results to your electronic health record. In certain circumstances, we may contact you about your results.
If you signed a Biobank consent form before October 2019, you have not consented to get results from the Biobank, and you must update your consent form if you wish to have results returned. We have recently started to re-contact participants through My Health Connection to invite them to update their consent.
We cannot guarantee that everyone will receive results. It is important that you know that in many people we will not find any relevant clinical genetic test results to report. Also, not all participant samples will have genetic testing done on them.
If you do not hear from the Biobank about your results, this does NOT mean that you are not at risk of getting some diseases or having adverse responses to medications.
Not everyone will receive results because for most individual participants we will find nothing of medical importance to return. It is important to remember that this is primarily a research project to make general discoveries about health and risk of disease using data analysis of large populations. We have only recently started processing the individual donated samples. We are working on ways to return medically important results to individual participants in a sensitive and ethical manner.
The initial results information and support Biobank gives you will be free of charge as part of the research program. Any appointments or testing that you choose to have done because of the information we share with you will be billed to you and/or your health insurance provider.
We are not related to 23 & me. The Colorado Center for Personalized Medicine has some very clever scientists that study population genetics and we hope that we will be able to return ancestry information to those participants that want to receive it.
Research Being Done
We will keep you informed about our work, updates to the Biobank, and new opportunities that you may be interested in through our Newsletter called ‘Discover’. We plan to send this out 3-4 times per year via email, and it will also be available on this website.
The Biobank has now consented over 200,000 people to take part in the study and we have collected nearly 100,000 samples. We have been able to generate genetic information for about 34,000 of these samples.
We have started to return some genetic results to participants who have signed a consent to receive results.
We hope to update participants on what type of general research is taking place in the future but will not be able to tell participants about which studies their individual sample or data is being used for. Participants will not be able to choose which studies their sample or information is used for.
We will use your samples and health information for all types of research, including looking at your genetic information. Types of research that may be done include looking for medically important genetic changes and analyzing your genetic ancestry.
The primary purpose of the Biobank is to help researchers study how our genes affect our health and well-being. More research can be done if Biobanks share information with other researchers or databases that have similar data. The Biobank plans to share some of the genetic data we have generated in databases such as dbGaP, which stands for ‘Database of Genotypes and Phenotypes’ that is sponsored by the National Institutes of Health (NIH). Data shared with dbGaP is de-identified to remove personal identifying information such as names, addresses, and date of birth. By sharing data, we hope to help researchers to conduct more research on more health conditions with the goal of finding better treatments.
For example, researchers will be able to access the data from many people with and without asthma and look for genetic differences that are shared between people with asthma that are not present in people without asthma. By doing this, researchers may be able to identify the genetic differences that may be related to asthma. Similar studies can be done for cancer and diabetes.
We may find something when we analyze your sample that may affect your care or treatment. However, nothing will be placed in your medical records without your consent. It is important to remember that this study is not a replacement for standard clinical testing that you and your physician may decide is appropriate for you.
We take the protection of your privacy very seriously. We will take all reasonable steps to keep your information private. All information used by this study will be protected using secure computers and locked files, so that only authorized people can access it.
Whenever possible, donated samples and your health information will be stored with a code and not your name, social security number, or other easily identifiable information. However, because some information such as your genetic information is unique to you, there is a small chance that someone could trace it back to you. The risk of this happening is very small.
A federal law, called the Genetic Information Non-discrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. In Colorado, additional genetic protection laws prohibit denial of health care insurance, Medicare supplement insurance coverage, group disability insurance, or long-term care insurance coverage based on your genetic information.
If you have further questions about this study, please call the Biobank at 303-724-9944 or email us at CCPM-Biobank@ucdenver.edu. You can also reach out to us using the contact page on this website.
If you have questions about your rights as a research subject or the conduct of this study, please contact the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055.
You can withdraw from the Biobank research study at any time and for any reason.. If you decide to withdraw, please submit a request in writing by clicking here. You may also call the Biobank at 303-724-9944. On notification of withdrawal, any unused samples will be destroyed. However, any information or samples already being used for research will continue to be used.