FAQs for Participants

You have the right to not take part in a research study. You have the right to drop out at anytime. You have the right to be given new information about the study. You have the right to ask questions at any time and have them answered as soon as possible.

You have the responsibility to ask questions about anything you do not understand or simply want to know. As a research participant, unless you formally withdraw from the study, you are responsible for completing all research procedures to the best of your ability. If you are in a study with follow-up activities, it is your responsibility to notify study staff of all changes to your contact information, including your address, phone numbers, and email address.

The Institutional Review Board (IRB) at Cedars-Sinai protects people involved in research studies. The IRB includes scientists, non-scientists, and community members, and reviews, approves, and monitors all research at Cedars-Sinai in which human subjects take part. This oversight keeps risks to research participants as low as possible. The IRB also keeps track of ongoing studies to make sure they are being done in the right way. The IRB requires that all researchers treat research participants with respect. The IRB protects your rights and welfare if you take part in a research study. If you have a concern, complaint or compliment about research, please contact the Cedars-Sinai Medical Center IRB. The IRB takes all complaints very seriously. The IRB investigates all complaints and concerns. You may contact the IRB at any time by calling (310) 423-3783.

At Cedars-Sinai, only IRB-certified research staff have access to data collected for research purposes. If any of your information is sent to an outside study sponsor (as specified in the Informed Consent Form and HIPAA consent), we will first remove your identifiable information (name, medical record number, etc). Research files are confidential and secured by password-protection and/or locked in restricted areas.

Some studies compensate participants for the time they spent participating in a trial; generally this amount is given to cover expenses for parking, transportation, meals, and possibly for lost work time; however, payment may not be substantial enough to constitute inducement to participate for monetary gain. Study-specific payment information can be found in the study's Informed Consent Form.

What happens when the study is over varies from study to study. In general, at the end of a study, researchers analyze the data collected from all participants throughout the study. Findings from the analyses are reported to the medical community through presentations at scientific meetings and published manuscripts in peer-reviewed medical journals. De-identified data may also be shared with experts and various government agencies responsible for the approval of new drugs, biologics and devices.

Study results are usually not immediately available. After a study is completed, it takes time to analyze the data and communicate results to the medical community. Findings published in peer-reviewed medical journals can be found at PubMed, a biomedical literature search engine run by the US National Institutes of Health (www.pubmed.gov)

Research that includes humans is clinical research. Clinical research helps researchers understand how best to treat patients or helps them learn more about a particular condition or disease. A common type of clinical research is a clinical trial. In a clinical trial, researchers test new drugs, medical devices or treatments. Clinical trials may seek to discover new drugs, new ways of giving patients approved drugs, new combinations of approved drugs, new surgical techniques, devices, or biological products. Clinical trials are also conducted to test cutting-edge and novel therapies, like studies that involve gene therapy or gene transfer.

"Randomized" is used to describe a research study that hopes to compare two or more different treatments or procedures. In a randomized trial, you will be assigned to a study group by chance, like flipping a coin.

A registry is a database comprised of information and/or tissues 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. Registries are established for the purpose of collecting as much information as possible about a particular illness or a group of people. 

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:

• the purpose of the study
• the procedures involved in the study
• the possible benefits and risks of taking part in the study
• the rights of people who take part in research
• that taking part in research is your choice
• how the research team will give you any new information that may be learned after you decide to take part in a study that might cause you to change your mind

Informed consent is a process that helps you learn about the research study. After learning about the study, you will be able to ask the researcher or his/her staff questions. You should only agree to take part after you clearly understand the study and feel comfortable. If you agree to take part, you will be asked to sign an "informed consent form". The informed consent form contains a detailed summary of all important points related to a particular research study. It is important to keep a copy of the informed consent form for at least the duration of your participation.

A Privacy Rule was issued by the US Department of Health and Human Services with the enacting of HIPAA (Health Insurance Portability and Accountability Act of 1996). The Privacy Rule assures that individuals' health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public's health and well being.

In research, 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 to his/her 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.