Welcome! We are excited you are interested in learning more about research. Hundreds of clinical trials are currently underway at Cedars-Sinai, in dozens of clinical areas and disease types. The knowledge gained through research would not be possible without the people volunteering to participate in research. So, thank you for your interest in learning more!
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This page includes the following sections:
A clinical trial is a common form of clinical research. It helps investigators understand how best to treat patients or helps them learn more about a particular condition or disease.
Clinical trials may seek to discover new:
Clinical trials are also conducted to test leading-edge and novel therapies, like studies that involve gene therapy or gene transfer.
The Food and Drug Administration (FDA) regulates clinical trials. The FDA gives investigators permission to test a new drug, biologic or device under strict regulatory conditions. Clinical trials must be conducted before a new drug, biologic or device may be marketed in the United States.
Clinical trials are conducted in phases. If you are being asked to take part in a clinical trial, the Study Consent Form will describe the specific phase of the study. As clinical trials progress through different phases, the number of people involved generally increases. The trials at each phase have a different purpose (help researchers answer different questions) as follows:
There are many types of clinical trials that have different goals, some include:
A registry is a database comprised of information and/or specimens obtained from individuals. This information is collected in a standardized way so that it can be used in research. Researchers often use information and/or specimens from registries to develop ideas for new research studies.
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. A registry could have information on 100 people or it could have information on thousands of people.
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.
Participation in research is voluntary.
Informed consent 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.
You may stop participating in a research study at any time, even if you already agreed to participate. Saying no to participating in research will not change your standard of medical care at Cedars-Sinai in any way. If you have questions about participating, you may talk to your doctor, or to another doctor who is not a member of the research team about your other choices.
Assent is when a child gives their permission to be in research. Legally children cannot provide consent. The researcher will consider your child's age and maturity level when presenting information to ensure it is presented in an age-appropriate way.
Adults who cannot legally make decisions for themselves may also agree to participate through an assent process.
Children and adults who cannot legally make decisions for themselves are only included in certain types of studies where the inclusion of these groups has been considered as part of the ethical review of the research.
You may consider taking part in a study because:
You might consider not taking part in a study because:
You should ask the following questions and you should feel the responses are adequate before deciding to participate:
You should discuss the answers you receive to these questions with your doctors, family and loved ones.
Click here for a printable guide of questions to consider asking when deciding to participate.
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.
If you are invited to take part in a study, the study's Informed Consent Form will describe in detail which procedures, if any, will be billed to you/your insurance.
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 do pay participants for the time they spent in a trial. This amount is given to cover expenses for parking, transportation, meals and, possibly, for your time.
At the end of a study, the researchers analyze the information that was collected from all participants throughout the study.
Findings and information collected about you will be compared to other participants.
In clinical trials, doctors and specialists in biostatistics will analyze the data and report the findings to scientific meetings and medical journals. Data will also be shared with 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, receiving a study drug ends when the study ends because it might not be safe or effective to continue treatment based on what is known at the time.
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 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.
If your doctor thinks you might qualify for a study, they may ask if you want to take part. You can also ask your doctor if they are aware of any studies that you may be eligible for. To be included in research, you must agree to take part.
Many patients also look for research studies on their own through websites or support groups. The Cedars-Sinai website provides information on clinical research.
If you find a Cedars-Sinai study on the internet that you would like to participate in, you can contact the study staff directly.
You can also go to clinicaltrials.gov and search for current studies.
If you are interested in finding out about a research study at Cedars-Sinai, but did not find what you are looking for through any of the above options, feel free to reach out to us at: ClinicalTrials@cshs.org
If you are Cedars-Sinai patient, you may occasionally be contacted about research opportunities.
IRB: The Cedars-Sinai Institutional Review Board (IRB) protects your rights and welfare if you take part in a research study. The IRB includes scientists, non-scientists and community members who review, approve and monitor all research at Cedars-Sinai in which people take part. This oversight keeps risks to research participants as low as possible.
The IRB also tracks ongoing studies to make sure they are being done in the right way.
You can contact the IRB with any concerns, questions, complaints or compliments. The IRB takes all complaints very seriously. The IRB investigates all complaints and concerns. You may contact the IRB at any time by calling, emailing or mailing a letter to:
For more information about Cedars-Sinai’s Human Subjects Protection Program and IRB, visit the Cedars-Sinai Institutional Review Board.
FDA: The U.S. Food and Drug Administration (FDA) audits the IRB’s files. FDA officials may visit Cedars-Sinai at any time and review anything they choose related to clinical trials.
Monitoring of study: The conduct of research protocols is monitored by doctors, nurses, sponsors, auditors, statisticians, and federal and nonfederal regulatory bodies. They carefully monitor the actual conduct and safety of protocols—the rules being followed during the research. This means that different groups are reviewing the safety and progress of each study on a regular basis. If any of these groups determine that there is a concern with how the study is conducted, the study will stop.
Protections from injury: You are protected first and foremost by being told honestly and without bias what the known and potential risks are for participating in the trial. This information will be submitted to you in a language you will be able to understand. There is an IRB requirement that every participant in a clinical trial be informed about the possible risks, benefits and available alternatives.
The information necessary to assist you in determining whether or not to participate in a clinical trial is provided in a document called the Informed Consent Form. This document informs you of how to let the investigator know if you think you are experiencing a problem with the research and what resources are available to help you.
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.
The Health Insurance Portability and Accountability Act (HIPAA) 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 how 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.
Providing HIPAA authorization:
With your participation in a research study, researchers may need to:
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:
After reviewing this information, you will be asked to give permission for the use of your information by providing authorization.
Revoking HIPAA authorization:
You have the right to revoke or withdraw your authorization for the researcher to use your identifiable health information. If you want to revoke or withdraw your authorization, you must:
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 (FDA, NIH, etc.).
Download a copy of the Patient Research brochure:
If you have questions, contact the Office of Research Compliance and Quality Improvement at 310-423-3783 .