IRB ID #: 202012143

IRB Approval Date: 08/08/2024

IRB Released Date: 08/09/2024

IRB Expiration Date: 03/24/2025

Version #: V7 -03/24/25

Project Title: The BJC, SLCH, and Washington University School of Medicine Electronic BioBank (BJC-WEBB)

Principal Investigator: Nathan Stitziel, MD, PhD 

Co-Principal Investigator: Kelly Bolton, MD, PhD

Research Team Contact:  Kelly Bolton, MD, PhD                                                 

bolton@wustl.edu

                                               Hannah Mitchell

314-273-7031

mitchellhannahr@wustl.edu

The visual key information document contains some key points that the research team thought you would find helpful to think about. The research study is described in more detail below.

If you are the parent/guardian providing parental permission the word "you" refers to your child.

If you are the legally authorized representative providing consent the word "you" in this document refers to the person you represent.

This consent form describes the research study and helps you decide if you want to participate. It provides important information about what you will be asked to do during the study, about the risks and benefits of the study, and about your rights and responsibilities as a research participant. By signing this form you are agreeing to participate in this study.

• You should read and understand the information in this document including the procedures, risks and potential benefits.
• If you have questions about anything in this form, you should ask the research team for more information before you agree to participate.
• You may also wish to talk to your family or friends about your participation in this study.
• Do not agree to participate in this study unless the research team has answered your questions and you decide that you want to be part of this study.

This is a research study. We invite you to participate in this research study because you have received healthcare at BJH, SLCH and/or Washington University School of Medicine within the last year.

The purpose of this research study is to develop the BJC, SLCH and Washington University School of Medicine Electronic BioBank (BJC-WEBB). A biobank is a collection of samples from the body from many people that can be used for a wide range of research. This BioBank will collect samples from as many people as possible who have received healthcare at BJH and/or Washington University School of Medicine. 

A biological sample is something from the body (like blood for example) that contains DNA. Genes are the basic "instruction book" for the cells that make up our bodies and are made out of DNA. Although the DNA of a person is more than 99% the same as the DNA of any other person, no two people have exactly the same DNA except identical twins. Differences in DNA is called genetic variation. Genetic variation explains some of the physical differences among people (like eye color or height), and partially explains why some people get diseases like cancer, diabetes, asthma, and depression, while others do not. Such diseases may also be affected by factors like diet, exercise, smoking, and pollution in the environment, which makes it hard to figure out which genes affect disease.

Our BioBank will extract information from the electronic medical records of those who participate and will try to determine what DNA differences are responsible for influencing physical differences (like eye color or height) along with why some people are predisposed to (or protected from) certain diseases. Our BioBank may also be used to identify and contact participants who qualify for future research studies based on their genetic variation.   

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.

One way we may obtain your sample is by using material that is usually thrown away after a medical test or procedure. 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. With your permission, we would like to use those materials for research instead of having them thrown away. We would also like to use biological samples obtained through past clinical care.  We may 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 BJH, SLCH or Washington University School of Medicine.  We may also request future saliva, urine or stool samples collected during routine clinical care at BJH, SLCH or Washington University School of Medicine or mailed to your home and returned to us with a prepaid container.

We will also 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, SLCH and/or BJH 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.

We may use your biological sample for genetic research. 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.

As part of this study, we may find that your DNA has genetic variation with the potential to impact the future health of you and your family members in a way that might be helped by additional testing or preventative care. Some people want to know this type of information while others do not wish to find this out. We want to know if you would like to receive this information. Along with the information about the potential impact on the future health of you and your family members, we would provide you with resources to discuss the potential impact and advice on steps that you could take to address the potential impact to the future health of you and your family.

It could take several months or even several years before we collect and sequence your DNA sample and find a meaningful genetic variant. If we find something in the future, and if you tell us you would like to know about it, we will contact you using the most recent contact information (address and telephone number) contained in your medical record. However, in general, less than 5% of people carry this type of genetic variant that has the potential to impact their future health so it would not be unusual if you do not hear from us and we will not contact you if you do not carry such a genetic variant.

Please answer the question below and place your initials in the blank field that appears after you answer:

If you agree to participate in this study, we will use the samples and data both generated from the analysis of your samples and 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. Your data and samples may also be used for broad sharing throughout the research community. This means your data and samples may be used for any sort of research and not just research related to your current condition including research to develop investigational tests, treatments, drugs or devices that are not yet approved by the U.S. Food and Drug Administration. These researchers may be at Washington University, at other research centers and institutions, or commercial sponsors of research. 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 for use of your data and samples. By allowing us to use your data and samples you give up any property rights you may have in the data and samples.

One way in which we may share your data with others is by putting it into a large database of information, called a data repository. If your data is placed in one of these repositories it will be placed in the "controlled-access" portion of the repository. This means that only qualified researchers, who have received permission from individuals that monitor the access to and use of the data, will be able to look at and use your information. Before we put it in this repository, we will remove any information, such as your name and birthdate, that might easily identify you. Even though these data will not have your name or other identifying information associated with it, it is still possible that someone may be able to trace these data back to you because genetic information is unique. Although your individual data will only be in the controlled access database certain summary information may be available to the general public.

This future research may include genetic research as described earlier such as looking at the difference in genes between different groups of people or it may include studying your entire DNA sequence. Studying your entire DNA sequence will provide a detailed description of your DNA and is sometimes called whole genome sequencing.

If you later change your mind and do not want us to store and use your biological samples and data for future research you should contact the research team member identified at the top of this document. The biological samples and data will no longer be used for research purposes. However, if some research with your biological samples and data has already been completed, the information from that research may still be used. Also, if the biological samples and data has been shared with other researchers it might not be possible to withdraw the biological samples and data to the extent it has been shared.

Identifiers may be removed from your private information including biological data and data and used for future research or shared with others. If this occurs, we will not ask you for additional consent.

HOW MANY PEOPLE WILL PARTICIPATE?

Ultimately, every person who receives healthcare at BJH and/or Washington University School of Medicine might participate.   

HOW LONG WILL I BE IN THIS STUDY?

If you agree to take part in this study, although your involvement will only consist of providing us with permission to include you in the BioBank, your biological samples and EMR data will remain in the study indefinitely or until you later decide to withdraw from the study.

WHAT ARE THE RISKS OF THIS STUDY?

You may experience one or more of the risks indicated below from being in this study. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.

There may be information obtained from the genetic testing that indicates that you, or potentially a family member (since we inherit genes from our parents, and pass genes on to our children) are at risk for a particular disease or condition. For example, genetic sequencing may indicate that an individual is more prone to develop certain types of cancer or other types of diseases, (e.g. Alzheimer’s or other inherited diseases).

If made available to persons or agencies outside of our research group, information about genetic test results could affect your employment or insurance. For instance, employers, insurers, or others may use this information when making decisions about you or your family members regarding employment, insurance, or other benefits.

Genetic Research
There is a federal law called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans and employers with greater than 15 employees to discriminate against you based on your genetic information (if someone were to identify that you participated in this study, for example). However, it does not protect you against discrimination by companies that sell life insurance, disability insurance or long term-care insurance.

Re-identification from a genetic Sample
While the data developed for this study is being stored without traditional identifiers (stored only with coded ID numbers, no names), there may be ways of linking the genetic materials back to you. DNA does directly identify you (like a fingerprint), so it is possible that someone could look at the information in the DNA database and compare it to information in another database, and use that to identify you. This is difficult to do and we think is very unlikely to happen.

Breach of Confidentiality
One risk of participating in this study is that confidential information about you may be accidentally disclosed. We will use our best efforts to keep the information about you secure. Please see the section in this consent form titled “How will you keep my information confidential?” for more information.

WHAT ARE THE BENEFITS OF THIS STUDY?

You will not benefit from being in this study.

However, we hope that, in the future, other people might benefit from this study because your biological samples and EMR data will be used to advance science and better understand the genetic basis of certain diseases. The research discoveries may also allow for more personalized therapies for patients in the future.

WILL IT COST ME ANYTHING TO BE IN THIS STUDY?

You will not have any costs for being in this research study.

WILL I BE PAID FOR PARTICIPATING?

You will not be paid for being in this research study.

WHO IS FUNDING THIS STUDY?

The University and the research team are not currently receiving payment from other agencies, organizations, or companies to conduct this research study.

Other people such as those indicated below may become aware of your participation in this study and may inspect and copy records pertaining to this research. Some of these records could contain information that personally identifies you. We will keep your participation in this research study confidential to the extent permitted by law.

•  Government representatives (including the Office for Human Research Protections) to complete federal or state responsibilities
• The U.S. Food and Drug Administration
• People who use the BioBank
• Hospital or University representatives to complete Hospital or University responsibilities
• Information about your participation in this study may be documented in your health care records and will be available to anyone with access to your health care record, including your health insurance company. This information may also be released as part of a release of information request.
• Washington University’s Institutional Review Board (a committee that oversees the conduct of research involving human participants) and the Human Research Protection Office. The Institutional Review Board has reviewed and approved this study.
• Any report or article that we write will not include information that can directly identify you. The journals that publish these reports or articles require that we share your information that was collected for this study with others to make sure the results of this study are correct and help develop new ideas for research. Your information will be shared in a way that cannot directly identify you.

To help protect your confidentiality, your DNA and associated data will be tracked using a numerical study code ID. These data will be stored on a secure computer network behind an internet firewall. Access to these data will be restricted to members of the study team who have completed privacy training. All biological specimens will be stored in tubes that are labeled with a unique numerical study code ID in freezer space which has limited access. When biological specimens are being transported or transferred, they will be identified only by the unique numerical study code ID. The master list that links the unique numerical study ID code to patient identifiers will be kept separately and will only be accessible to members of the study team listed on the IRB protocol who have completed HIPAA training.

Are there additional protections for my health information?
Protected Health Information (PHI) is health information that identifies you. PHI is protected by federal law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this research, you must give the research team permission to use and disclose (share) your PHI for the study as explained in this consent form. The research team will follow state and federal laws and may share your health information with the agencies and people listed under the previous section titled, “How will you keep my information confidential?”

Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA.

The research team will only use and share your information as talked about in this form or as permitted or required by law. When possible, the research team will make sure information cannot be linked to you (de-identified). Once information is de-identified, it may be used and shared for other purposes not discussed in this consent form. If you have questions or concerns about your privacy and the use of your PHI, please contact the University’s Privacy Officer at 866-747-4975.

Although you will not be allowed to see the study information, you may be given access to your healthcare records by contacting your healthcare provider.

If you decide not to sign this form, it will not affect

• your treatment or the care given by your health provider.
• your insurance payment or enrollment in any health plans.
• any benefits to which you are entitled.
  However, it will not be possible for you to take part in the study.

If you sign this form:

•  You authorize the use of your PHI for this research
• This authorization does not expire.
• You may later change your mind and not let the research team use or share your information (you may revoke your authorization).
• To revoke your authorization, complete the withdrawal letter, found in the Participant section of the Human Research Protection Office website at hrpo.wustl.edu or you may request that the investigator send you a copy of the letter.
  •  If you revoke your authorization
    • The research team may only use and share information already collected for the study.
    • Your information may still be used and shared as necessary to maintain the integrity of the research, for example, to account for a participant's withdrawal from the research study or for safety reasons.
    • You will not be allowed to continue to participate in the study.

Can we contact you by email?

We would like to contact you by email for the purposes listed below. Some of these messages may contain health information that identifies you.

• Provide a signed copy of this completed consent form.
• Contact for return of results if applicable.
• Contact for re-consent if applicable.
• General study updates.

Only the research team will have access to your email communications. We will only communicate in this method to send you the information listed above. If you have any questions, wish us to stop sending these messages, or need to contact us for an urgent or emergent situation, please contact the research team member identified at the top of this document.

You should be aware that there are risks associated with sending your health information via email.

• There is always a risk that the message could be intercepted or sent to the wrong email address. To avoid this, we will send a test message to ensure we have the correct email address..
• When using any computer you should be careful to protect your username and password. Make sure you log out before getting up from the computer.
• If you share a home computer with other family members and do not want them to know you are participating in this study make sure you provide an email address that only you can access.
• Your employer will have access to any messages sent or received on any electronic devices used for work or through a work server.
• If you lose your phone, others may be able to access the messages that we send.

Please answer the question below and place your initials in the blank field that appears after you answer:

IS BEING IN THIS STUDY VOLUNTARY?

Taking part in this research study is completely voluntary. You may choose not to take part at all. If you decide to be in this study, you may stop participating at any time. Any data that was collected as part of your participation in the study will remain as part of the study records and cannot be removed.

If you decide not to be in this study, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you otherwise qualify.

What if I decide to withdraw from the study?

You may withdraw by telling the study team you are no longer interested in participating in the study or you may send in a withdrawal letter. A sample withdrawal letter can be found in the Participant section of the Human Research Protection Office website at hrpo.wustl.edu.

WHAT IF I HAVE QUESTIONS?

We encourage you to ask questions. If you have any questions about the research study itself, please contact Nathan Stitziel at 314-747-8394 or reach out to the study team via email at BJCWEBB@wustl.edu. If you experience a research-related injury, please contact Nathan Stitziel at 314-747-8394.

If you have questions, concerns, or complaints about your rights as a research participant, please contact the Human Research Protection Office 1-(800)-438-0445, or email hrpo@wustl.edu. General information about being a research participant can be found on the Human Research Protection Office website, http://hrpo.wustl.edu. To offer input about your experiences as a research participant or to speak to someone other than the research staff, call the Human Research Protection Office at the number above.

This consent form is not a contract. It is a written explanation of what will happen during the study if you decide to participate. You are not waiving any legal rights by agreeing to participate in this study. As a participant you have rights and responsibilities as described in this document and including:

• To be given enough time before signing below to weigh the risks and potential benefits and decide if you want to participate without any pressure from the research team or others.
• To understand all of the information included in the document, have your questions answered, and receive an explanation of anything you do not understand.
• To follow the procedures described in this document and the instructions of the research team to the best of your ability unless you choose to stop your participation in the research study.
• To give the research team accurate and complete information.
• To tell the research team promptly about any problems you have related to your participation, or if you are unable to continue and wish to stop participating in the research study.

Who should sign as the Legally Authorized Representative (LAR)?
If the participant has a legal guardian or attorney-in-fact this individual must sign as the LAR.

If there is no legal guardian or attorney-in-fact the individuals listed below may sign in order of priority.

(1) Spouse unless the participant has no spouse, or is separated, or the spouse is physically or mentally incapable of giving consent, or the spouse's whereabouts is unknown or the spouse is overseas;
(2) Adult child;
(3) Parent;
(4) Brother or sister;
(5) Relative by blood or marriage