Hundreds of clinical trials are underway at Cedars-Sinai, in dozens of clinical areas and across the entire spectrum of disease investigation. Here, you’ll find answers to the questions people ask most about clinical trials, how patients can take part in trials, the protections in place during trials and much more.
For information about participation in research at Cedars-Sinai, the following Patient Research brochure (PDF) and Frequently Asked Questions (FAQs) about clinical trials are available here for your review. If you are interested in reviewing the FAQs or any other information on the Cedars-Sinai internet in a language other than English, please see instructions to access additional language options at the bottom of the page. The Patient Research brochure is also available in other languages upon request—please see the information below.
Please contact us by email or phone if you have any additional questions or would like more information
Additional terms can be seen at the National Institute of Health, Glossary of Common Terms
Informed cconsent is the process that gives information to people who are thinking about taking part in research. After learning about the research, you should understand:
Informed consent helps you learn about the research study. After learning about the study, you will be able to ask the researcher or staff members questions. You should only agree to take part after you clearly understand the study and feel comfortable being part of it. You should take time to talk over your decision with your doctors, family and friends. If you agree to take part, you will be asked to sign an informed consent form. The informed consent process goes on even after you are taking part in the study. If researchers learn new information after you begin the study, they must share this with you.
Research includes children as well as adults. The law states that children cannot make their own decisions about research. At Cedars-Sinai, however, we feel it’s important that children receive an explanation of the research and have a chance to ask questions. If your child's doctor tells you that your son or daughter must assent to participate, it is because we respect the child's rights as a person. "Assent" refers to the process by which we ask for a child's agreement to participate. In most cases, investigators will obtain a child's assent for children over the age of 7. It is important that the information shared with your child be understandable. The researcher will consider your child's age and maturity level when presenting information. Doctors and parents need to work together to help the child understand what a study involves.
Adults who cannot legally make decisions for themselves may also agree to participate through an assent process. Researchers must also obtain the consent of an individual who represents such. Investigators want to make sure that the person whose mental abilities are impaired has some understanding of what will happen to them and can say no, if they so choose.
Sometimes assent is not required. In situations where the research may be the only way to help a patient with a life-threatening illness, assent is not required if the research is expected to be beneficial to the individual. Even so, researchers are encouraged to discuss the research with the patient.
You may consider taking part in a study because:
You might consider not taking part in a study because:
When deciding whether to participate, you should ask the following questions and you should feel comfortable with the answers:
You should discuss the answers you receive to these questions with your doctors, family and loved ones.
Clinical trials test new drugs, devices or treatments. In some cases, taking part will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for drugs, devices and services they provide. It is possible that your insurance company will not pay for some or all of the charges and you may receive a bill for those costs. The study's informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you should ask the research team to explain any costs before you sign the consent form.
Some studies compensate participants for the time they spent in a trial; generally, this amount is given to cover expenses for parking, transportation, meals and, possibly, for lost time at work.
At the end of a study, the researchers analyze the data that was collected from all participants throughout the study. Findings and data collected about you will be compared to other participants. In clinical trials, doctors and specialists in biostatistics will conduct the analysis and report the findings to scientific meetings and medical journals. Data will also be shared with experts and various government agencies responsible for the approval of new drugs, biologics and devices. Not all experimental treatments receive final FDA approval in the end.
What happens when the study is over also varies from study to study. Sometimes, patients can remain on the study drug if they are responding to the new treatment; however, this is the exception rather than the rule. Generally, participation ends when the study ends because it might not be safe or effective to continue treatment based on what is known at the time. Clinical trial participants can withdraw from the study at any time without jeopardizing the rest of their standard medical care.
You can search for a trial on the Cedars-Sinai website. If you find a study on the internet that you would like to participate in, you can contact the study staff directly. Otherwise, your healthcare provider may refer you for a particular study.
The United States National Library of Medicine at the National Institutes of Health maintains a registry of clinical trials at clinicaltrials.gov.
The website provides patients, their family members, healthcare professionals, researchers, and the public with information on publicly and privately supported clinical studies on a wide range of diseases and conditions. Clinical trials meeting certain definitions must be registered on that website. In some cases, research results must be reported there, too. Cedars-Sinai Medical Center investigators are required to register studies when they are serving as the Responsible Party (sponsor-investigator) for the research and it is deemed an applicable clinical trial.
The Association for the Accreditation of Human Research Protection Programs (AAHRPP) promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs. AAHRPP accreditation offers assurances to research participants, researchers, sponsors, government regulators and the general public that an HRPP is focused first and foremost on human protections
Cedars-Sinai was awarded full reaccreditation in 2020 and has been fully accredited by AAHRPP since 2004.
Your informed consent form explains your rights as a participant, which includes the following:
You also have the responsibility to stay informed during your participation in a study. You should ask questions about anything you do not understand or simply want to know.
As part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which was originally passed as a means of maintaining healthcare coverage, Congress included Administrative Simplification provisions in HIPAA directed at standardizing how healthcare information and claims are processed and used. The privacy provisions (as well as the security provisions) were then added to HIPAA's Administrative Simplification provisions to protect how patient health information or protected health information (PHI) is stored, transmitted and used.
The Health Insurance Portability and Accountability Act Privacy Rule establishes the conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes. The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes, and their rights to access information about them held by covered entities.
It may be necessary for a researcher to create new health information about you or to review information in your medical records as part of your participation. Before being able to do this, the researcher must obtain your authorization to access your health information. As part of the informed consent process, you will receive a description of the type of health information to be viewed or created as part of the research, understand who will view the information, for what purposes and for how long. After reviewing this information, you will be asked to grant permission for the use of your information by providing authorization.
You have the right to revoke or withdraw your authorization for the researcher to use your identifiable health information. If you wish to revoke or withdraw your authorization, you must do so in writing and provide that written revocation to the researcher at the researcher’s mailing address. The researcher will no longer be able to allow you to participate in the research study and will stop collecting any additional identifiable health information about you. However, the researcher may, by law, continue to use the health information about you previously collected, as necessary, to maintain the integrity of the research study and make reports to oversight agencies
The word "randomized" is used to describe a research study that hopes to compare two or more different treatments or procedures. If you are participating in a randomized trial, it means that you will be assigned to a study group by chance, like flipping a coin.
For most randomized trials, this kind of information will only be disclosed when the study has been completely finalized; this is done to protect the integrity of the research data and results. If the trial is a double-blind trial, the doctor will not even know which substance you received. Most protocols will have information regarding when a study will be "unblinded." If this is something that you want to know more about, ask the investigator what the study's policy is before you agree to participate.
A registry is a database comprised of information and/or tissue specimens obtained from individuals. This information is collected in a standardized way so that it can be used in research; in this way, it is different from information collected typically by the patient's doctor. These registries are also called "banks." Registries are established for the purpose of collecting as much information as possible about a particular illness or a group of people. Some registries are very large and may include family members of people with specific illnesses. Agreeing to participate in a registry could be as simple as allowing a research study to collect tissue specimens that would normally be thrown away after surgery; or a registry could be designed to collect blood, tissue specimens and information from your medical records for many years. A registry could have information on 100 people or it could have information on 10,000 people. It’s from registries and banks that many researchers develop ideas for new research studies.
Instructions for viewing information on this page in additional languages: Click on the arrow next to the word “English” at the top right of this page and then click on the language of your choice. Once selected, the information on the page will be translated to the language selected. If your preferred language is not available, please contact the Office of Research Compliance & Quality Improvement at 310-423-3783