Catholic Health Initiatives Center for Translational Research (CTR) works with individual hospitals like CHI Health St. Francis to further research and development of personalized cancer treatments and diagnostics.
During your cancer treatment, you may be asked to donate biospecimens for research purposes. Access to biospecimens may help scientific researchers find effective treatments for people suffering from various types of disease such as cancer.
What are biospecimens?
Biospecimens are samples of tissue and blood collected from the body by trained medical professionals such as doctors and nurses.
How do you collect the biospecimens that I gave to research?
Your surgeon will remove biospecimens during an operation and send the tissue to the lab for examination by a pathologist. A pathologist is a doctor who looks at tissue under a microscope and diagnoses diseases. There is usually leftover tissue that is not needed after a diagnosis is made, and the lab discards or destroys that leftover tissue. With the donation of your biospecimens, the excess tissue that would otherwise be discarded will be collected and provided to cancer researchers. Additionally, you may be asked to donate other biospecimens such as blood, which will be collected at normally scheduled doctor visits. Be assured that your biospecimens cannot be used for research by anyone without your written consent.
Will donating my tissue sample mean that the surgeon has to remove extra tissue?
No. Choosing to donate tissue samples will not require removal of any extra tissue or change the quality care you will receive in any way. The pathologist will only release excess tissue that would otherwise be discarded.
Why do researchers need biospecimens?
Researchers need biospecimens and related medical information to better understand how human genes influence the development and growth of cancers, including those that are passed on in families. By understanding the genetic basis of the cancer, researchers can then develop new personalized tools to diagnose, manage and treat the disease.
What type of research will my biospecimens be used for?
Just as you don’t know or decide who receives your blood when you donate at a blood drive, you won’t know or decide the exact type of research for which your biospecimens are used. Discoveries are not made from just one person’s biospecimens. You will not receive payment or compensation for donating your biospecimens nor will you profit from any of the discoveries that may be developed from the research. However, you will have the reward of knowing your biospecimens may help researchers find new ways to diagnose, manage and treat diseases that could potentially benefit other patients, including your family members or others with similar medical conditions.
What happens to my biospecimens after they are collected?
After your doctor completes the surgery and/or all necessary medical procedures and tests, the leftover tissue and/or blood samples will be sent to the lab. At this facility, samples will be sent to the Catholic Health Initiatives Center for Translational Research (CTR). Your collected samples and medical data will then be de-indentified/coded, and ultimately shared with cancer researchers.
Why do you need information from my health records?
In order to do research with your biospecimens, researchers may need some background information, such as your age, gender, ethnic background, diagnosis, medication history, treatments, and follow-up data. This information helps researchers learn more about specific diseases and effective treatments.
How is my privacy protected?
To protect your confidentiality and privacy, your biospecimens will be de-identified and given a code before being transferred to the CTR’s Biorepository. The study staff will be the only people able to link the code to your personal identifying information. Direct identifiers such as your name, address, telephone number, social security number, medical record number, health insurance numbers or any other unique information that could be used to identify you will never be released to the researchers or outside parties.
What are the risks to me if I give my tissue to research?
There are very few risks to you. Providing biospecimen samples will not subject you to any additional medical risks.
One risk is the release of information from your medical records. Acknowledging this risk, the biorepository staff will take extensive precautions to keep your research data and medical information confidential. Confidentiality risks will be minimized by storing data in a secure location and following all privacy laws. Medical researchers with access to your information have a professional obligation to protect your privacy and maintain confidentiality.
Can I change my mind?
Yes, you can change your mind about participating and donating your biospecimens and medical information for research by contacting the CTR at any time, You may withdraw from study participation by contacting the CTR by phone at (844) 287-2474 or by sending a letter to:
Center for Translational Research
801 W. Baltimore Street, Suite 302
Baltimore, MD 21201
If you withdraw your authorization, no new information will be collected from you or your biospecimens in the Center for Translational Research. In addition, any remaining biospecimen samples that have not already been sent to a researcher will be removed from the tissue bank and destroyed. Your medical information will also be removed from the CTR databases. However, any biospecimens and medical data already released from the CTR cannot be recovered or returned.
What if I have more questions?
If you have any questions or are interested in participating, please contact:
Alicia Wicht, CRA
Clinical Research Associate, CHI Center for Translational Research
Phone: (308) 398-8917