If you decide to participate, your active participation will only consist of providing us with permission to include you in our BioBank.
With your permission, the BioBank will create a unique random code that will be used to identify your biological sample and data from your electronic medical record. No identifying information will be stored with your biological sample or data from your medical record.
How we obtain vital samples.
One way we may obtain your biological sample is simply by using discarded material. There is often extra fluid (like blood or urine) or tissue (like skin, muscle, or other tissue) that is left over after part of it was used for a medical test or procedure. After the test or procedure is done, any extra material left over is typically discarded. With your permission we would like to use those extra materials for research instead of having them thrown away. We can also obtain a biological sample by collecting an extra tube of blood as part of a future blood draw or IV placement during routine clinical care at Barnes-Jewish Hospital or Washington University School of Medicine.
How we obtain relevant information.
With your consent we may extract information from your electronic medical record (EMR data). This EMR data may include things like vital signs (height, weight, blood pressure, etc.), results of lab or imaging tests, and medical diagnoses among other things. If applicable, the diagnoses could include some that are related to mental health or substance abuse. Some of the information we collect might include personal health information (PHI). For example, we may collect PHI that could include, but might not be limited to: date(s) of service, age, race, gender, history of procedure(s) at Washington University and/or Barnes-Jewish Hospital and other pertinent clinical characteristics related to those procedure(s). We will also store contact information (address and telephone number) to let you know about future studies as well as any unknown potential incidental finding(s) that occur (described below). We also plan to periodically update that information.
How your sample can be utilized.
One of the more exciting aspects gained from your biological sample is for genetic research. Genes are a unique combination of molecules (called DNA) that we inherit from our parents. There are millions of tiny differences in our genes. These differences may make us more or less likely to develop certain diseases or conditions or to have certain characteristics. Genetic research involves studying the differences in genes and DNA between individuals. This type of testing creates information that is as unique to you as your fingerprint.
We may study your DNA and characterize your genetic variation. We would do this by reading all of your DNA using a technique called DNA sequencing. We would then compare each position of your DNA with other people in the BioBank. There are billions of positions in each person’s DNA which are different than other people’s DNA at millions of spots. By identifying these differences and determining which of them are associated with data from your and other people’s medical records, we hope to identify which differences may make someone more or less likely to develop certain diseases or conditions or to have certain physical characteristics. Genetic research using our BioBank could also be used to study the biology of DNA, how genetic variation arises, how evolution works, the composition and size of human groups, how people from different populations of the work are related to each other, and how genetic variation is related to health and disease.
We may also take cells from your biological sample and treat them so that they become a permanent “cell line,” which means that they can be grown in the laboratory whenever they are needed. Creating a cell line will allow us to have a source of your cells and DNA to use for research in the future. The cells derived from your biological sample could also be transformed into different types of cells for use in help future research studies. For example, cells from the cell line could be transformed into nerve cells or muscle cells.
As part of this study, we may obtain biological samples from you as outlined above. These may be used for commercial profit. There are no plans to provide financial compensation to you should this occur. By allowing us to use your biological samples you give up any property rights you may have in the biological samples.
If you agree to participate in this study, we will use the samples and data collected as part of this study (including information from your medical record (EMR) as described earlier) for studies going on right now as well as studies that are conducted in the future. These studies may provide additional information that will be helpful in understanding how genetic variation is related to traits, diseases, or other conditions, including research to develop investigational tests, treatments, drugs or devices that are not yet approved by the U.S. Food and Drug Administration. It is unlikely that what we learn from these studies will have a direct benefit to you. There are no plans to provide financial compensation to you should this occur. By allowing us to use your biological samples and EMR data you give up any property rights you may have in the biological samples and EMR data.
Click below to learn more about potential risks, how we will protect you and your information and other frequently asked questions.