Frequently Asked Questions About Research Participation
Research is a way to answer questions and gain knowledge. We use that knowledge to come up with new treatments. Medical practice is a way to care for the health and wellbeing of patients. The main purpose of research is to test new scientific ideas or new treatments, which, if successful, may be used later in medical practice. Individuals participating in research may also be helped by it, but this isn’t always the case.
A research study is a defined effort by doctors and scientists to investigate a research question. This effort includes the functions of study design, implementation, measurement and reporting.
Doctors and scientists at Cedars-Sinai are involved in many kinds of research studies. Some research doesn’t require human volunteers, which is referred to as nonclinical or preclinical research. Research that includes human participants is called clinical research.
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 drugs, new ways of giving patients approved drugs or new combinations of approved drugs as well as new surgical techniques, devices or biological products. Clinical trials are also conducted to test leading-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 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 are conducted in phases. The trials at each phase have a different purpose and help researchers answer different questions.
- Phase I trial – The first evaluation of an experimental drug or treatment in a small group of people (20–80). The purpose is to evaluate its safety and identify side effects.
- Phase II trial – The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
- Phase III trial – The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects and compare it with standard or equivalent treatments.
- Phase IV trial – After a drug is licensed and approved by the FDA, researchers track its safety, seeking more information about its risks, benefits and optimal use.
- Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
- Natural history studies provide valuable information about how disease and health develop.
- Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning.
- Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
- Screening trials test the best way to detect certain diseases or health conditions.
- Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy
When you participate in a clinical trial, you can play a more active role in your own healthcare, gain access to new research treatments before they are widely available, and help us develop new medical treatments and cures for diseases. Clinical research can only be done with volunteers—either ill or healthy people—who agree to take part in the studies. For research to succeed, we need people of all ages and ethnic groups. Research can sometimes improve the health of individual people, communities and future generations.
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.
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:
- 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 tthe research team will give you new information that may cause you to change your mind about participating in the study
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.
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.
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 have the right to not take part in a research study.
- You have the right to drop out at any time.
- 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.
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.