Frequently Asked Questions
Why Join:
We are recruiting and collecting samples from patients at UCHealth hospitals and clinics to learn how differences between people can affect health and disease. Learning more about this could, in the future, help us make discoveries that could improve healthcare for everyone.
With this kind of large-scale genomic research study, the more participants the better because the more samples we have, the more successful we will be in studying how genes impact human disease. This is why we are recruiting as many participants as possible, from as varied and diverse backgrounds as possible, and making it easy to participate.
Our hope is that these studies will help researchers find new ways to detect, treat, and even prevent or cure disease.
This is a research program so the primary benefit is to help researchers understand how differences among people, such as in their genetic information, affect health, and risk of disease. When we analyze your sample, we may learn something that is medically relevant for you. If you signed a Biobank consent form before September 2019, we will ask your permission to share medically relevant information with you using a second consent form. If you signed a Biobank consent form after September 2019, you have already given us permission to share medically relevant information with you. We cannot guarantee that we will find such information to give to you. In the future, we also hope to be able to return information on your genetic ancestry, if you want it.
While there is no direct benefit for participating in the Biobank study, your contribution may help further the research needed to improve future medical care. These improvements may help us better fight the diseases that affect you, your loved ones, future generations and the community at large.
You will not receive payment for being part of this research study and you will not have to pay anything to be in this study. You and your insurance will not be billed for donating a sample to the Biobank.
My Sample:
We take a blood sample from you so that we can extract the DNA (deoxyribonucleic acid) from it. DNA is how people store information we inherit from our parents; that information directs how we grow and develop. The DNA information is contained in pieces, called genes. We analyze the DNA to understand how peoples’ genetic information differs. We also store some of the sample for future research. We hope to make new discoveries that will improve our understanding of disease and lead to new diagnoses and treatments.
There are three ways we could collect a blood sample from you. We may use a leftover sample from a clinical test, we may take additional tubes when your physician orders a clinical test, or we may ask you for research specific samples.
We get your sample by either collecting additional tubes of blood when you are having a clinical blood draw or by accessing a leftover sample from your routine testing. 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.
My Results:
Research 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 signed a Biobank consent form before September 2019, we will ask your permission to share medically relevant information with you using a second consent form. If you signed a Biobank consent form after September 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 other diseases.
- 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.
The 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 before September 2019, and we find one or more genetic results that are relevant to your health, you may be invited to sign a consent form that allows the Biobank to return your results. The Biobank may return results to your electronic health record. In certain circumstances, we may contact you about your results.
If you signed a Biobank consent form after September 2019, you have already 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.
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.
When signing a consent before September 2019, you agreed to give the Biobank a blood sample and you gave the Biobank permission to perform certain genetic tests on your sample. While many genetic tests are done for research, a small number of genetic test results may give information about your health and could affect your medical care. Having this information may benefit an individual. You were invited to sign a consent to receive this information, because some genetic test results from your sample may be available.
If you signed a Biobank consent form after September 2019, you have already given us permission to share your clinical genetic test results with you.
You can contact the Biobank staff and request a new consent form.
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.
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:
The Biobank has now consented over 87,000 people to take part in the study. In August of 2018, we expanded enrollment across the UCHealth system by using My Health Connection as our online consenting platform.
We have also had our Biobank Laboratory licensed and inspected to process clinical samples and have processed 23,000 samples to date.
The Biobank has now consented over 100,000 people to take part in the study. In August of 2018, we expanded enrollment across the UCHealth system by using My Health Connection as an online consenting platform. The more people that take part, the more discoveries we can make.
We have also had our Biobank Laboratory licensed and inspected to process clinical samples and have processed 35,000 samples to date.
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.
More information about dbGaP can be found at https://www.nih.gov/news-events/news-releases/nih-launches-dbgap-database-genome-wide-association-studies. If you have any questions or concerns about this, please contact the Biobank Team.
Protections:
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.
Other questions:
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 form 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.