Frequently Asked Questions About Research Participation

Each research study is different. Each study tries to find answers to a specific question. Researchers must follow strict rules to decide who may take part in research. Not everyone with the disease or problem being studied can take part in a research study. If your doctor thinks you might qualify for a study, they may ask if you want 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.

To be included in research, you must agree to take part. You may drop out of 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.

Cedars-Sinai also conducts nonmedical or nonintervention (observational) types of research. For example, you could be asked to participate in a study as a "normal control," you could be asked for permission to allow researchers to collect information from your medical record or you could be asked to fill out a questionnaire. Cedars-Sinai conducts many research studies in which patients are simply asked for permission to use their leftover surgical or tissue specimens that would otherwise be discarded.

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.

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.

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

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.