For Patients

“Samples” is a word used to describe blood, tissue removed during procedures (for example, biopsies), and other bodily fluids such as saliva or urine.

When you have a test or procedure, leftover blood, tissue and other bodily fluids are usually discarded and thrown away. When you donate your samples, you are allowing us to store these leftover samples in the Cleveland Clinic BioRepository whenever possible. Examples of reasons for why we may not store your samples in the Cleveland Clinic BioRepository include: not enough tissue left-over, timing of surgery did not coincide with timing of necessary research procedures, etc.

In certain patient populations, we would additionally like to process blood for cell lines (so that we would never run out of your DNA and be able to use it for future research). You may ask us to stop using your samples at any time by contacting at the number listed on the last page of this document.

When you come to the outpatient laboratory for a clinical blood draw, a caregiver will talk to you about the BioRepository. If you are having a surgery, then your surgeon will talk to you about the BioRepository when he/she talks to you about your surgery and obtains consent for your surgery. There will be a checkbox and signature line for you to indicate yes or no to your participation in the BioRepository. Your decision to participate or not in the BioRepository only applies to samples that will be removed from your blood draw or upcoming surgery.

There will also be a checkbox and signature line for you to indicate whether or not you would like clinically relevant research results returned to you via your healthcare provider.

The information about participating in the BioRepository will look like the following:

Cleveland Clinic BioRepository (CC-BioR): Cleveland Clinic (CC) maintains a BioRepository (BioR) that may store leftover blood, tissue and other bodily fluids that were collected during patient treatment and would normally be thrown away. These leftover sample(s) may be used to learn more about diseases and treatments, for quality improvement, medical education and research, which may include genetic testing. These leftover sample(s) and any genetic information obtained therefrom may be shared with other researchers, including the National Institutes of Health and its collaborating researchers. I have the option to donate my leftover sample(s) (or those of the patient named below) to the CC-BioR for the purposes stated above. If I do, I authorize CC to use my identifiable medical information and leftover sample(s) (or those of the patient named below) for the same purposes, provided that my identifiable medical information will be maintained in a confidential and secure manner. My identity (or that of the patient named below) will not be released to anyone outside of CC without a special review process required by applicable laws. By donating my leftover sample(s), I understand that my samples, genetic information and/or other information (or those of the patient named below) may be stored and shared for future research without additional consent if identifiable private information, such as my name and medical record number, are removed. If identifying information is removed from the leftover sample(s) or information, CC will no longer be able to identify and destroy them. I understand that if my information is released, my information may be re-disclosed by the recipient and may no longer be protected by law. By donating leftover sample(s), I acknowledge that CC researchers may contact me regarding future research. I understand that I (or the patient named below) will not receive, either now or in the future, any compensation or other financial benefits resulting from any product, procedure, or other items developed from the leftover sample(s). I understand that I can decide whether or not to be told any research results that could affect my risk for health-related problems. Donation of leftover sample(s) and participation in the CC-BioR is optional and your decision will not affect your (or the patient named below) current or future medical care at CC. I acknowledge that I have received the CC-BioR information pamphlet, which is also available on CC’s website, that explains how the CC-BioR works and whom to contact if I change my mind about the storage and use of the leftover sample(s). I have indicated my decision by checking one of the boxes below.

Future research with your samples may include genetic testing and would be performed for research purposes only. You can decide whether or not to be informed of any clinically relevant research results (meaning results that could affect your risk for health-related problems) if they become available in the future. Researchers may never find any clinically relevant research results using your samples; however, if the researchers do find clinically relevant results, and you have indicated that you want to be told about those results, then your referring health care provider or a genetic counselor will be told the overall research finding. Would you like to be contacted by your healthcare provider in the future if clinically relevant research results become available?

There will be no direct medical benefits to you for having your sample(s) stored in the BioRepository. The knowledge to be gained from research on your stored samples may be beneficial for others, society or science. The goal of the Cleveland Clinic BioRepository is to collect and provide human samples to help physicians and researchers understand how genetics, lifestyle and environment interact to affect health. Understanding these risk factors on an individual and population level may help doctors treat and even prevent diseases that might affect your health and the health of future generations.

There is no cost to participate in the Cleveland Clinic BioRepository.

The BioRepository will maintain a record of your choice to donate, and your choice will be included in your medical record.

No. You are not being asked to donate samples through extra blood draws or biopsies. While receiving care at Cleveland Clinic your doctor may order clinical tests that require a blood or tissue sample. When these clinical tests are complete, there is often leftover blood or tissue that is normally just thrown away. The BioRepository is asking for your permission to collect only those samples left over from your treatment, IF there are any samples left over.

Yes. Your sample(s) will be assigned a code that will replace your name. The code will be kept in a confidential and secure manner with your age, gender, race and diagnosis. Researchers will work with your samples, but the release of your identity to them is not allowed unless they go through a special process required by law to protect your privacy. Release of your identity outside the Cleveland Clinic is not allowed without your permission.

Yes. Cleveland Clinic values your privacy and security. While no data storage system can be guaranteed to be 100% secure, all data at Cleveland Clinic is protected through both server authentication and data encryption technology.

The BioRepository stores your leftover blood, tissue and other bodily fluids in a laboratory. The purpose of the BioRepository is to learn more about diseases and treatments through quality improvement, education and medical research, including genetic analysis research.

The samples may be used by:

• Cleveland Clinic researchers,
• Outside researchers at other medical institutions, and
• Outside researchers in businesses like drug and medical device companies.

We will store your samples and information in the BioRepository. Some of your genetic and health information might also be put into one or more scientific databases.

Researchers can ask to study the materials stored in the BioRepository. This includes researchers from Cleveland Clinic, as well as from other universities, the government, and drug- or health-related companies. Some researchers will be from the U.S., some may be from other countries around the world. A science committee at the BioRepository will review each request. There will also be an ethics review. This kind of review is to make sure that any risks are minimized and that your rights and welfare are protected. If a study is approved, we might give a part of your sample and information to the researchers, along with samples and information from many other people. We will not give researchers information that could directly identify you without your permission.

To do more powerful research, it is helpful for researchers to share information they get from studying human samples. They do this by putting it into one or more scientific databases, where it is stored along with information from other studies. Researchers can then study the combined information to learn even more about health and disease. If you agree to take part in the BioRepository, some of your genetic and health information might be placed into one or more scientific databases. There are many different kinds of scientific databases; some are maintained by Cleveland Clinic, some are maintained by the federal government, and some are maintained by private companies. For example, the National Institutes of Health (an agency of the federal government) maintains a database called “dbGaP.” A researcher who wants to study the information must apply to the database. Different databases may have different ways of reviewing such requests. Researchers with an approved study may be able to see and use your information, along with that from many other people. Your name and other information that could directly identify you (such as address or telephone number) will never be placed into a scientific database. However, because 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, but may grow in the future. Researchers will always have a duty to protect your privacy and to keep your information confidential.

A researcher will submit a request to the BioRepository describing the type of research to be done and the type of samples the researcher is requesting. The BioRepository will review the request and decide whether or not to provide the samples to the requesting researcher. The BioRepository may require the requesting researcher to go through a special review process overseen by the Cleveland Clinic IRB.

Yes. The purpose of the BioRepository is to learn more about diseases and treatments, partly through medical research, which may include genetic testing. Genetic research allows researchers to develop more effective diagnostic tests and new treatments for disease.

Future research may include genetic testing – the study of genes found in the body’s cells. Genes are made of DNA. DNA (deoxyribonucleic acid) contains the instructions for your body’s development and function. This information determines traits that are passed on from parent to child, such as eye and hair color and the risk/chance you will get certain diseases. RNA (ribonucleic acid) is made from DNA. RNA is a genetic material that has a major role in making proteins. Researchers now and in the future may examine your DNA, RNA and proteins (called “biomarkers”) to look for genetic changes that cause cells to not work properly.

Genetic research may help physicians better diagnose, treat and prevent disease. More information about genetic research can be found at www.genome.gov.

You can decide whether or not to be told any clinically relevant research results (meaning that the result could affect your risk for health-related problems) that become available in the future. Researchers may never find any clinically relevant research results using the stored genetic materials; however, if the researchers do find clinically relevant results, and you have indicated you want to be told about the results, your referring health care provider or a genetic counselor will be told the overall research finding. Genetic counseling and/or clinical testing (in order to confirm the research finding) may be recommended by your health care provider when a research study identifies a potentially significant genetic finding. The costs of such counseling and/or testing are not covered under this research protocol.

If you decide to be told of any future research results, it is your responsibility to update your healthcare provider of any change in your contact information. The researchers will attempt to contact you through your healthcare provider using the most current address that has been provided.

Yes. Researchers may use samples in collaboration with other BioRepositories and private industry to discover new ways to treat disease.

No. There are no plans to compensate you for any products developed. By donating your samples as a gift to the BioRepository, you are giving up any rights that you might have to financial benefit from your samples.

There is a potential risk of loss of confidentiality. The leftover samples and information obtained will be stored at the Cleveland Clinic and may be shared with other study collaborators. The samples and data obtained will be labeled with a numeric code and not your name. Cleveland Clinic will do our best to ensure your information is kept confidential and that only the health information which is minimally required to conduct the research is used or disclosed to collaborators outside Cleveland Clinic; however, this cannot be guaranteed. Any genetic analysis done on your samples will be kept strictly confidential and will be identified through a numeric code and not by your name.

The BioRepository does provide samples to outside researchers. The BioRepository charges a processing fee to recover costs when it does this. The BioRepository is not for profit.

No. Research results from BioRepository samples are not placed in your medical record and are therefore not available to insurance companies or employers.

The Genetic Information Nondiscrimination Act (GINA) is a federal law designated to protect you from health insurance and employment discrimination based on genetic information. It is illegal for health insurance providers and most employers to ask for genetic information to make decisions about a person’s eligibility or coverage or to make employment decisions.

The law will not stop health insurance companies from using genetic information to decide whether to pay claims and also does not apply to life insurance, disability insurance or long-term care insurance.

To protect your identifiable data and/or samples collected and used under this research, a Certificate of Confidentiality from the United States Department of Health and Human Services (DHHS) and the National Institutes of Health (NIH) has been obtained.

This added protection to your privacy, limits the re-disclosure of your private identifiable data by the researchers without your permission in any federal, state, or administrative proceedings.

The Certificate will not prevent the researchers from notifying the appropriate authorities when there is a federal, state or local law that requires reporting, such as reporting communicable diseases or child/elderly abuse. The Certificate cannot be used during required auditing or evaluation of federally-funded projects or when required by the Federal Food and Drug Administration (FDA).

This Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If an insurer or employer learns about your participation, and obtains your consent to receive research information, we may not use the Certificate of Confidentiality to withhold this information. This means you must actively protect your own privacy.

If you would like to read more about Certificate of Confidentiality, the NIH has a website you can visit online at: https://grants.nih.gov/policy/humansubjects/coc.htm.

Your samples will be stored in the BioRepository for as long as they are useful for medical research, quality improvement or educational purposes. The BioRepository may keep your samples for a short time or for many years.

Yes. Pediatric research is within the purposes of the BioRepository. Leftover samples from children are stored with the permission of a parent or guardian.

If you are the parent, legal guardian, or other legally authorized representative of the patient, you may authorize the donation of samples of that patient. When you sign the registration consent form on behalf of that patient, you can choose to donate that patient’s samples. The answers shown here would apply to the samples of a person you have signed for even though the answers here use wording like “my” samples.

Your samples will continue to be stored in the BioRepository after your death as long as they are useful for medical research, quality improvement or educational purposes.

Participation in the BioRepository program is completely voluntary. Your decision to participate in the BioRepository program will not affect your current or future medical care at the Cleveland Clinic.

This means that the Cleveland Clinic BioRepository would no longer contact you, but would still have your permission to store and use samples and information that have already been collected and to obtain and use information from your health records in the future.

This means that the Cleveland Clinic BioRepository would no longer contact you or obtain further information from your health records in the future, but would still have your permission to store and use samples and information that have already been collected.

This means that in addition to no longer contacting you or obtaining further information from your health records, the Cleveland Clinic BioRepository would destroy your stored samples. Samples and data that were already given out to researchers cannot be recalled, and we cannot send your samples to you.