Clinical Trials Frequently Asked Questions
- What is research?
- What is a clinical trial?
- What is a protocol?
- Who monitors the conduct of protocols?
- Who gets to be in a study?
- What is informed consent?
- What is assent?
- What are my rights as a research participant?
- What should I consider before agreeing to participate?
- Will it cost me anything to take part in a research study?
- How am I protected from injury in a study or a trial?
- How are research subjects protected?
- How do I contact the IRB?
- Do research participants get paid?
- What happens when the study is over?
- What is a randomized trial?
- If I withdraw from a randomized trial, will I be told if I received the placebo (an inactive, dummy pill), or the active drug?
- What is a registry?
- What is HIPAA?
- How does HIPAA apply to research?
Research is a way to answer a question and to gain knowledge. We use knowledge gained from research to come up with new treatments. Medical practice is different from research. The main purpose of medical practice is to care for the health and well being of patients. The main purpose of research is to test new scientific ideas or new treatments. Research may help individual participants, but this is not always the case.
Doctors and scientists at Cedars-Sinai Medical Center take part in many different kinds of research studies. Some research does not include living human beings. 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. There are many different forms of clinical research. One common form 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.
Clinical trials must be conducted before a new drug, biologic, or device may be marketed in the United States. The FDA regulates clinical trials. The FDA gives investigators permission to test a new drug, biologic or device under strict regulatory conditions.
A protocol describes the rules to follow during the research. For example, a protocol states why it is important to study the research question and how the research team will answer the research question. A protocol also states how the research team will protect the health and well being of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.
Physicians, nurses, sponsors, auditors, statisticians, and federal and non-federal regulatory bodies carefully monitor the actual conduct and safety of protocols. This means that different groups are reviewing the safety and progress of each protocol 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.
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 that is being studied can take part in a research study. If your doctor thinks that you might qualify for a study, he or she 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 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 non-medical or non-intervention types of research. 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 simply fill out a questionnaire. Cedars-Sinai conducts many research studies where patients are simply asked for permission to use their leftover surgical or tissue specimens that would otherwise be discarded.
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
- what you can do instead of taking part in the study
- 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. 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 at Cedars-Sinai includes children as well as adults. The law states that children cannot make their own decision about research. We, however, feel it is important that children but receive an explanation of the research and have a chance to ask questions. If your child's doctor tells you that your son/daughter must "assent" to participate, it is because we respect his/her rights as a person. "Assent" refers to the process by which we ask a child's agreement to participate. In most cases, investigators will obtain a child's assent if he or she is 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 him/her and can say no if he/she so chooses.
Sometimes assent is not required. In situations where the research may be the only way to help a patient with a life-threatening illnesses, 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 individual patient.
- 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 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.
You may consider taking part in a study because:
- You may benefit from the best possible treatment or an experimental treatment that would otherwise not be available to you.
- The physicians and nurses will closely monitor your progress throughout the trial.
- You would be helping researchers to improve the treatments for future patients.
You might consider not taking part in a study because:
- The experimental treatment may not work for you, or it could make your condition worse.
- The experimental treatment may cause side effects that no one anticipated.
- Your health insurance may not cover research procedures.
- If the trial is randomized and includes a placebo (an inactive, dummy pill), you may not be given the experimental treatment.
- The amount of testing for efficacy and safety purposes may involve too many trips to the research office and take too much time.
When deciding whether or not to participate, you should ask the following questions and you should feel comfortable with the answers:
- If I am ill, will this research help me?
- What are the risks?
- What is involved? What will I have to do?
- Will I be charged anything or compensated for my participation?
- How can I end my participation if I change my mind?
- What will happen when the study is over? Will I be told the results?
- Is the study controversial?
- Whom do I contact to express concerns or obtain information?
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 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.
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. All of 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 document." 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. You should ask any questions you may have about a clinical trial before signing the informed consent document. Even after you have signed the informed consent document to participate in a clinical trial, you should always speak to the investigator if you have questions or problems.
The Institutional Review Board (IRB) at Cedars-Sinai protects people in research studies. The IRB includes scientists, non-scientists, and community members. The IRB reviews, approves, and monitors all research at Cedars-Sinai in which people 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, emailing, or mailing a letter to:
|Institutional Review Board|
|Cedars-Sinai Medical Center|
|8383 Wilshire Blvd., Suite 742|
|Beverly Hills, CA 90211|
|Phone: (310) 423-3783|
|Send Us a Message|
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.
At the end of a study, the researchers analyze the data that were 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 would 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.
Randomized is used to describe a research study that hopes to compare two or more different treatments or procedures. Randomized means that you will be assigned to a study group by chance, like flipping a coin.
If I withdraw from a randomized trial, will I be told if you received the placebo (an inactive, dummy pill), or the active drug?
Most randomized trials will only disclose this kind of information 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 with respect to 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 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. 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 tissues 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 is from registries and banks that many researchers develop new ideas for new research studies.
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 health care 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 (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 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 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.