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How does research affect me? If you participate in a clinical trial, you may have an opportunity to try new or experimental treatments. For research involving your medical records, leftover blood or tissue, or genetic testing, all of the samples and information collected do not disturb or change your care in any way. The physical or medical risk to you is minimal. You receive no direct benefit from this research, but your participation may benefit patients like you and contribute to advances in medical care and treatment.

How can my medical records or leftover blood or tissue help researchers?

The information contained in your electronic medical record is a powerful tool for research. For example, it helps doctors conduct studies on a large number of patients over long periods of time and helps them identify patients who may be eligible for research studies. This translates into improved medical treatments for everyone. Your leftover blood or tissue is another way for researchers to learn about diseases. When you have a medical test or procedure, your doctor only takes the amount needed for this purpose, but there may be some leftover tissue. By studying your leftover blood or tissue, researchers can obtain valuable information. It can help them find out how different diseases start and progress over time. It can also help researchers develop new tests or medicines or learn more about diseases that are passed on in families.

Help us discover.

Be part of Clinical Research at Yale.

Yale has a strong tradition of developing promising new treatments. The insulin pump, medications to treat HIV infections, and other promising therapies were developed here.

You may be contacted for clinical trials at Yale and your leftover blood and/or tissue may be used for research purposes unless you opt out. To opt out of being included in research studies, you may choose one of three ways. Please provide your full name, address, and date of birth. Email:

optout@yale.edu

Call:

1-877-978-8343, option #3

Write:

Office of Research Services Attn: Opt-Out Recruitment Yale School of Medicine PO Box 208054 New Haven, CT 06520-8054

To learn more about clinical trials at Yale, visit our website: www.yalestudies.org. Or call 1-877-y-studies (1-877-978-8343) for more information.

Whether providing top-quality medical care or conducting research to develop better treatments, Yale is committed to protecting your privacy. We take every precaution to safeguard you and your medical information.

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Yale

All of the advanced and effective treatments you receive at Yale were developed through medical research that takes place here and at other sites around the world. These discoveries involve people like you who agree to participate in research studies. Your participation allows us to develop safe, cutting-edge treatments and procedures that would not otherwise be possible.

How you can be a part of medical research As a patient, you can play an important role in improving health care. You can help doctors and scientists learn about different diseases and how to treat them in several ways: • By participating in a clinical trial that investigates a new medicine or procedure for your particular illness. • When information in your medical record is used to study diseases and the effect of treatments.

Amy and her son, Mitchell, who participates in an observational research study.

Help us discover. Be part of Clinical R esearch at Yale.

• When leftover blood and body tissue that have been used for your diagnosis and treatment are saved and used for research. • When doctors use some of your leftover blood and body tissue for genetic studies. Genetic information can be helpful in determining which people are at risk for certain disorders, to individualize care, and to prevent diseases. Researchers may use some of your blood or tissue to map out parts or the complete set of human genes. They may also use certain cells from your tissue to create a cell line for future research. In a cell line, identical cells are grown in small amounts in the laboratory for use in research.


It’s surprising how many ordinary people have helped make extraordinary discoveries. Each of us benefits every day from clinical research. Your blood pressure medicine, your child’s asthma inhaler, the latest antidepressant medication that your friend is taking – all these are available to you because of clinical studies that show they are safe and effective. None of them would be possible without volunteers willing to take part in clinical studies.

• Many people choose to participate in a study even though it might not help them directly. Knowing that others may benefit from their efforts is a rewarding experience. • Sometimes people volunteer because they are compensated financially for their time and effort. Please visit our website, www.yalestudies.org, where you can review available trials and build your personal profile. Or call 1-877-y-studies (1-877-978-8343) for more information.

At Yale there are hundreds of clinical studies under way for a wide variety of conditions.

How is my privacy protected?

• Some trials need volunteers with a particular illness or condition.

We protect your privacy in several ways:

• There are also many trials that require healthy volunteers. Healthy participants are often needed to provide information that can be compared with data from people who have a specific illness or condition, and to help establish the safety, dosage, and side effects of a new medicine or treatment. All these research studies are an important and necessary step in the process of making sure new treatments are safe and effective. There are many reasons why people volunteer to take part in a clinical trial: • Some volunteers have a condition that is being treated effectively, but they want to help doctors find out more about it in order to develop new treatments. • Sometimes volunteers have a friend or loved one with an illness or injury, and they want to participate in a research study as a way to help those who suffer from the same condition. • Participating in a clinical trial may offer potential experimental options that might be unavailable otherwise.

• Protecting the confidentiality of medical records is the law. We keep any information that identifies you or your material confidential. • Whenever possible, researchers connect information from your medical records to your tissue or blood using a code rather than your name. • If researchers need to use some identifying information about you for their research, they are required to undergo an approval process by a special committee that is responsible for protecting research participants. • We make every effort to ensure that your genetic information from research is not available to any of your caregivers and is not included in your medical record. This helps make sure that outsiders, such as insurance companies or employers, do not discover anything about your genes. • Researchers at Yale sometimes work with colleagues at other universities and research sites to develop new treatments. We make every effort to ensure your identity and information are never released to researchers outside of Yale. Your materials are provided to outside researchers either anonymously or with a code that only Yale researchers know.

Be part of Clinical Research at Yale.

“We need volunteers to help us turn the latest medical discoveries into medical advances that help patients.” Paul Taheri, MD, MBA Deputy Dean for Clinical Affairs and CEO, Yale Medical Group

What if i decide i don’t want my medical records, blood or tissue used for research?

What if i have additional

When you undergo treatments or tests at Yale, your medical records, leftover blood and/or tissue may be used for research purposes unless you opt out. You may opt out at any time by calling 1-877-y-studies (1-877-978-8343). You can change your mind about allowing your medical records or tissue to be used for research at any time.

If you would like to find out more about the kinds of research conducted at Yale or how your information or leftover samples are used for research, call 1-877-y-studies (1-877-978-8343).

questions about participating in research studies?

If you are concerned about your safety in connection with a research study, call the Human Research Protection Program at 203-785-4688. If you have concerns regarding your privacy in connection with participating in research, call the Yale University HIPAA Privacy office at 203-432-5919 or the Yale-New Haven Hospital HIPAA Compliance office at 203-688-8416.

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