Research Center Information for Patients
What are clinical research studies?
Clinical trials are scientific research studies designed to find better ways to treat or prevent diseases. Clinical trials can involve different types of treatments,including devices, medications, or a diagnostic tool, like a test or machine used to detect a disease.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. Research may help individual participants, but this is not always the case.
What is a protocol?
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.
Who monitors the conduct of protocols?
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.
Who gets to be in a study?
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.
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 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.
Franciscan Health System 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.
Should I be in a research study?
This is entirely up to you. You should never feel pressured into being part of a research study. It is your right to decline being part of a study and even if you initially decide to be part of a study, you can terminate your involvement at any time.
There may be a cost benefit to you while you are in the study. For example, study medications or some testing could be offered at no charge to you. The study coordinator and physician directing the study should outline this for you prior to entering the study.
You will be contributing to medical advancement. The information gathered in clinical research studies leads to advancements in medications, diagnostic procedures and devices used to treat patients
You might have the opportunity to receive treatment that would have a greater benefit to you, but would not have been available to you outside of a research study.
New treatments could have side effects that are not expected.
If you are in a study, which is randomized, this means you and/or your doctor may not know what treatment you receive (you will be monitored closely for your safety). You could receive 1 or more possible combinations.
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?
What is informed consent?
Informed consent is a process that helps you learn about the research study. This information is presented verbally and by means of an informed consent form. This form helps you learn the important details of a clinical trial before deciding to participate. This includes:
- why the research is being done
- what the researchers hope to accomplish
- what evidence exists that the treatment, drug or medical device will work
- what will be done during the trial – and for how long
- what risks are involved
- what benefits can be expected from the trial
- what other treatments are available
- who has access to health information during a 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.
What are my rights as a research participant?
Patient's Bill of Rights; as a subject in a research study, you are entitled to:
- be told what the study is trying to find out
- be told what will happen to you and whether any procedures, drugs, or devices differ from what would be used in the standard practice
- be told about the frequent and /or important risks, side effects, or discomforts of the things that will happen to you for research purposes
- be told if you can expect any benefit from participating, and, if so, what the benefit might be
- be told about other choices you have and how they may be better or worse than being in the study
- be allowed to ask questions concerning the study, both before agreeing to be involved and during the course of the study
- be told of what sort of medical treatment is available if any complications arise
- refuse to participate at all or to change your mind about participating after the study is started, this decision will not affect your right to receive the care you would receive if you were not in the study
- receive a copy of the consent form
- be free of pressure when considering whether you wish to agree to be in the study
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.
Will it cost me anything to take part in a research study?
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.
How am I protected from injury in a study or a trial?
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.
Who oversees the research study?
As a participant in a research study, a physician oversees that specific study. This person is called the principal investigator (PI). He or she will oversee your care and review your medical information while you are in the study. The “PI” will usually talk with you about the study to explain it and you are free to ask any questions or direct any concerns to the “PI”. A study coordinator will also work directly with you in the research study. This person will meet with you several times for the duration of the study, will review all information about the study with you, and will be available for any questions or concerns you may have.
How are research subjects protected?
The Institutional Review Board (IRB) at Franciscan Health System protects people in research studies. The IRB includes scientists, non-scientists, and community members. The IRB reviews, approves, and monitors all research within Franciscan Health System 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.
Current IRB Membership:
Members include: physicians, registered pharmacist, registered nurses, lawyer, and members of the community.
How do I contact the IRB?
If you have a concern, complaint or compliment about research, please contact the 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, e-mailing, or mailing a letter to:
Medical Research Evaluation Committee (MREC), c/o
Emily Bruey, Secretary
1717 South J Street
Tacoma, WA 98405
What to expect when you are presented with the option of joining a research study
The Study Coordinator and/or Principal Investigator will talk with you about the study. They will present the information about the study and will encourage you to ask any questions. They will ask you to read a document called an Informed Consent. This document overviews the research study, discusses risks and benefits, gives a general outline of the study and defines who is sponsoring the study (often the company which makes the drug or device which is being used in the study). If you decide to participate in the study, you will sign the Informed Consent and will be given a copy of it to take with you. All studies are different in their layouts and what will be required of you. It is important that you take into consideration how much time you will need to give to be involved in a study. A study can last anywhere from one visit to many visits over several years.
Do research participants get paid?
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.
What happens when the study is over?
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.
What is a randomized trial?
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 I 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.