Frequently Asked Questions About Consent for Research

Completing your consent form to help medical research is fast and easy, and we make sure participation is safe and private. We realize, though, that you may have questions before taking the next step, which we are happy to answer.

From our experience, participants share many common questions, which we’ve grouped below with our replies. We answer a wide range of questions about two main topics: use of your biological samples and the return of genetic results.

Questions and answers are also available as PDFs in: English | Spanish | Arabic | Farsi | Mandarin | Korean

Or you can contact us directly:

• For questions related to your rights as a research subject, contact the UCLA Office of the Human Research Protection Program, at 310-825-5344.
• For general questions or to learn how to navigate the consent application, please call 310-794-0981.
• To reach the UCLA Institute for Precision Health, please call 310-206-6907.

Questions about biological sample use

The following questions provide answers about consenting to the use of your biological samples.

What is a biological sample?
A biological sample is any bodily fluid or tissue (e.g., blood, saliva, urine, skin or other tissues) that may be collected when you go to the doctor or have a medical procedure. More often, these samples are collected to help diagnose or monitor your health condition.

After being used, anything that’s left over is thrown away or destroyed. With your permission, these leftover materials will be sent to the UCLA Biobank for research instead of being discarded.

What is the UCLA Biobank?
The UCLA Biobank collects biological samples from as many people as possible. It then codes the samples and removes any information that could identify you. The Biobank then sends the samples, along with some of your health information, to approved researchers who will use the information to find new ways to prevent, detect and treat health problems.

Will my consent decision affect my care?
No. Your universal consent decision (opting in or out of donating your biological samples) will have no impact on your clinical care. If you say YES to the collection of an additional blood tube and/or saliva sample, the clinical staff will need to know in advance in order to collect the additional sample. No matter what you decide, it will not affect your relationship with UCLA Health or the services you are receiving.

Why do we want an extra tube of blood?
Having an extra tube of blood (up to 2 teaspoons), or in some cases saliva, provides us with enough volume for multiple research purposes and permits certain research not possible on leftover samples.

How will samples be collected?
We will collect some biological samples from some of your future routine clinical lab work done at any UCLA Health laboratory. With your permission, we may: 1) use leftover biological specimens from any future routine lab work done at any UCLA Health laboratory, 2) collect an extra tube of blood as part of a future blood draw or IV placement during a routine visit, and/or 3) collect saliva if you are at a clinic that collects samples for precision medicine.

*You will not need to undergo any additional needle sticks, tests or procedures.

How long will my samples be stored?
Your samples will be stored indefinitely.

How could my samples be used for research?
Your samples may be used for a variety of research purposes (e.g., cancer, heart disease, diabetes) and for product development.

Examples:

• Genetic research: Your sample may be used to study how genes affect health or respond to treatment. Genes contain pieces of DNA that control how our cells and bodies develop and work. The DNA code is what you inherit from your parents and pass on to your children. Researchers can use a number of methods, including whole genome sequencing, to look at parts or all of your DNA code.
• Scientific databases: Researchers also put genetic and other non-identifiable information about you and your health conditions, along with information from their research studies, into a scientific database. This increases knowledge and can make future research discoveries happen more quickly.
• Other uses: Researchers may use your samples to create new products useful for research or clinical treatment. Your sample may include cells that can be made to grow indefinitely in the laboratory, called a “cell line,” or your sample could be used to develop or test new treatments.

Who will conduct research on the samples?
Only researchers and research projects approved by a UCLA research-review process may receive samples for research. Most samples will go to UCLA researchers, but we may also choose to share samples with researchers from other universities, government researchers and researchers from private companies that work on developing new tests or treatments.

Will I get any results from research done with my samples?
You will not get any results back unless you let us know that you want to receive genetic results. The research community will not know who you are, but the UCLA Biobank will be able to work with your health care team to notify you only if there are results that may affect your care.

Please know that there is often a delay of months to years before a result is available. If you do not want to be notified of any results, UCLA will publish a newsletter that provides overall information about new discoveries made from the samples. If any results are returned to you, a genetic counselor will be available to provide more information on your results either in person or over the phone .

If you or your doctor are concerned that you have a medical condition that requires genetic testing, we encourage your doctor to order a clinical genetic test to get you answers sooner. Please know that this does not substitute the need for a clinical genetic test.

Are there financial factors I should consider?
You will not be charged for donating your samples, and you won’t receive any money for doing so. If there is commercial value, it will belong to UCLA and its collaborators. You will not be paid if any new products, tests or discoveries result from any research performed with your samples.

Who benefits from biological samples?
Your samples will be used to advance science and better understand specific diseases. In the past, some UCLA samples have developed new treatments for serious diseases. The research discoveries in the future may allow for more personalized therapies for patients — a primary goal of precision health at UCLA.

Are there any risks?
There are no physical risks. There is a very small chance that someone could obtain information that would connect the sample to you. Since only you have your unique genetic makeup, information on your ancestry, ethnic group or other people with your disease might be identified and connected with your sample.

There is also a small chance that information from your health records could be accidentally released. Currently, only large state and federal agencies have the ability to identify individuals just based on a complete DNA profile. We can’t predict how future technology might affect confidentiality.

Federal and California laws provide certain protections against discrimination based on genetic information.

Some people may have moral, religious or cultural concerns about some kinds of research.

How will my privacy be protected?
UCLA will remove your name and other information that could identify you before sharing your samples for research. A list of names and matching code numbers will be kept separate from coded samples and data. Only authorized UCLA staff can access this list. Those working on the research projects will not have access to any information that links your samples to you.

Jane Smith -> becomes -> 1493526807

The samples are kept in locked freezers in locked buildings. All information is kept secure on password-protected computers located behind a firewall.

Researchers who study your samples will not know who you are. The Biobank will only give them a code number without any identifying information. UCLA Health and its Biobank must follow state and federal laws and UCLA policies that require protection of your information. The Biobank will only give out limited information to other collaborators and none of the information will include identifying information.

The Biobank has a Certificate of Confidentiality by the National Institutes of Health. This certificate prevents UCLA from sharing any information that could identify you in any civil, criminal, administrative, legislative or other proceeding whether at the federal, state or local level.

Your privacy will always be protected whether you choose to share your leftover sample or donate an additional tube of blood and/or saliva sample for research. If you would like to be contacted for future research, then we may contact you for other research opportunities that may or may not relate to a biological sample you may have given.

Your specimens and information about you are/is protected by a federal Certificate of Confidentiality. This means that we cannot be forced to release your specimens or information about you for any legal proceeding, even if the court asks.

The Certificate allows us to use your specimens and information about you for purposes of this research, or to disclose it for other research when allowed by law. The Certificate requires other researchers to also protect specimens and information we share with them.

There are limits to this protection. The Certificate does not protect your information when:

1. You or your family voluntarily share information about yourselves.
2. You agree to the specific release of information (for example, if you sign release forms for employment, insurance or medical care).
3. A federal agency audits or evaluates research that it funds.

How do I withdraw from the UCLA Biobank?
Your participation in the UCLA Biobank is voluntary. If you agree to participate but change your mind, we will honor your request. To make sure you have the time to think over your decision carefully, there will be a 10-day window from the time you sign the consent to the time your sample becomes available for researchers. Even after the 10-day window, you can still change your mind at any time.

To stop the use of your sample or health information in a study, you may return to the same location where you first completed the consent to change your consent decision. You may also stop the use of your sample or data by contacting the Biobank at 310-825-4136.

Any researcher who received your samples will be asked to destroy them. Please note that we cannot get back any samples that have already been used by researchers.

Whom do I contact with questions?
For any questions related to your rights as a research subject, contact the UCLA Office of the Human Research Protection Program at 310-825-5344.

For general questions or to learn how to navigate the consent application, please call 310-794-0981.

To reach UCLA Precision Health, please call 310-206-6907 or visit uclahealth.org/precision-health.

Questions about return of genetic results

The following questions provide answers about receiving genetic test results.

Consent and program background

When did I decide to receive genetic results?
Participants can choose to potentially receive genetic results when they complete the Universal Consent for Biological Samples. If you completed the Universal Consent in your MyChart account, your portal should show you the date and time you submitted it . If you completed the Universal Consent another way, you can contact the UCLA medical records office or speak with front desk staff for the information.

Who manages the Return of Results program?
The Clinical Genetic Counseling team at the UCLA Institute for Precision Health manages the program.

Confirmation of research results

What genetic changes are considered actionable?
Genetic changes are considered actionable when they raise your risk for certain diseases and you can take steps to prevent or treat them. We start with a list of genes from the American College of Medical Genetics and Genomics. We then add a few more, mainly cancer related. We look at the change, or variant, in question to determine if it’s pathogenic, or able to cause disease.

Why can’t you tell me what was found in the genetic testing done for research?
That analysis was done in a research lab, not in a clinical lab following standards for medical care. We need to perform another test to ensure the results are accurate and clinically valid before reporting them to you. If you or your doctor are concerned that you have a genetic medical condition, we encourage you to pursue clinical testing sooner.

Can’t you use my blood sample you used for research?
Unfortunately, no. We need a new sample for clinical genetic testing.

Will you tell me if I have more than one genetic variant?
If research discovers more than one actionable genetic finding, we’ll provide a clinical genetic test for each variant to confirm.

How is the clinical genetic testing done?
The UCLA Molecular Diagnostics Laboratories oversees testing to confirm results. You will give blood at your local UCLA clinical lab. The methods to evaluate genetic changes vary  by test.

How accurate is the clinical genetic test?

What are the limitations of genetic testing?
Genetic testing provides limited information about inherited conditions. It can’t tell us whether a person will develop symptoms, how severe those symptoms may be or how the condition may progress.

Should I stop taking medication before I give blood?
No, don’t stop taking any prescribed medications unless instructed to do so by your provider. Your medication doesn’t impact the genetic test.

What happens if my blood sample can’t be processed?
Your sample quality is checked throughout testing. Occasionally, a low volume of DNA, contamination or another reason means a sample is not suitable for analysis. If that happens, we’ll contact you and discuss your options.

How is my lab test tracked?
Your sample is collected and processed just like any other clinical lab test at UCLA.

How long does it take for results from the confirmatory genetic test?
Results for the clinical genetic test may take 3-4 weeks from the date the sample was received by the laboratory.

Will I be billed for the clinical genetic test? Will my insurance company be billed?
The genetic test isn’t billable and you shouldn’t receive a bill or statement containing any costs from the test. Please contact  (enter #) if you do receive something in error.

Notification and health impact

How will I be notified if clinical genetic testing confirms the results are actionable?
You will be notified by a genetic counselor, who will thoroughly discuss the results with you during a video consultation. After you meet with the genetic counselor, your results will be available in your MyChart account.

What information should I bring to the genetic counseling session?
Gather as much family medical history as you can, from both your mother’s and father’s sides.

Will the genetic results become part of my medical record?
Yes. Since a clinical genetic test will be ordered and performed as part of your care, the results will go in your medical record.

Will you notify my provider/doctor of my genetic results?
Your clinical genetic test results will become part of your medical record, which your provider may access when caring for you.

What do the results mean about my risk for other illnesses and diseases?
Disease risk is an important consideration with actionable genetic results. But each case is different and involves many specific details. The discussion is best left to the genetic counselor.

If I receive a genetic test result that can impact my health, will UCLA Health help out if my insurance doesn’t cover the full cost of care?
UCLA Health covers only the initial, confirmatory clinical genetic test. All other care is billed to the patient and/or relevant insurance company.

If genetic testing confirms an actionable genetic change, what are the risks to my relatives?
Specific circumstances vary and are best left to the conversation you’ll have with the genetic counselor.

Privacy and access

Who has access to my genetic test results from research?
Only authorized UCLA staff have access, including the UCLA Health genetic counseling team.

Will my life insurance company or health insurance company have access to the research genetic test results?
No. We do not give life insurance companies or health insurance companies access to research genetic test results.

Will you sell my research genetic test results?
No. We don’t sell research genetic test results. But UCLA may share them with other universities, government entities or private companies that conduct certain health care research.

How is my genetic information from clinical testing protected?
Your clinical genetic test results will become part of your electronic medical record and will have the same level of security.

Can I get a copy of my research genetic test results?
We don’t provide the research genetic test results directly. But you can ask to be notified when a finding may impact your health. In such cases, you need a separate confirmation test before receiving a copy of results. Learn more about receiving individual research results.

Can I get this information for a court hearing or legal team review?
Yes, after the confirmatory clinical test results have been posted to your electronic health record. At that point, you may contact the UCLA medical records office and request that your results be released to a particular recipient. You will need to complete a medical release form.

I received a call about my family member’s clinical genetic test results but the person has passed away. If I’m the medical proxy, can you tell me what was found?
Unfortunately, since your family member passed away, we’re not able to provide any information about the genetic test results.