Know Your Rights
If you’re currently taking part in, have been asked to, or are thinking about taking part in a research study, please review the following carefully.
You have the right to refuse to join a study. In fact, no one is allowed to perform research with you unless you have given your permission and signed an informed consent document (sometimes just called a “consent form”). The purpose of an informed consent document is to help you understand everything that will (or could) happen during the study in which you are being asked to participate. You do not give up any of your legal rights when you sign the informed consent document and join a study.
You have the right to stop participating in a study, for any reason, and at any time, without losing any of your medical care options.
You have the right to know the purpose of the research study that you are being asked to join.
You have the right to know all of the risks that you are taking if you choose to take part in a study (as well as anything that might be of benefit to you).
You have the right to be told about all other medical options available to you if you choose not to participate in the study. You have the right to be told if there are any medical options available that may be better for you than participating in the study.
You have the right to ask any question about the study before you join, and you have the right to ask questions as the study continues and after it ends. You also have the right to have all of your questions answered to your satisfaction.
The FDA suggests you ask the following questions to a study doctor before you join a study:
- What is the study trying to find out?
- What kinds of tests and exams will I have to take while I’m in the study? How much time do these take? What is involved in each test?
- How often does the study require me to go to the doctor or clinic?
- Will I be hospitalized? If so, how often and for how long?
- What are the costs to me? Will my health insurance pay for it?
- What will happen at the end of the study?
- Will some type of follow-up take place after my participation in the study ends?
- What are my other treatment choices? How do they compare with the treatment being studied?
- What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment?
- How long will the study last?
You have the right to take plenty of time, without anyone pressuring you, to decide whether or not to join a study.
You have the right to discuss with your doctor, your family, and your friends, whether or not you should join a study. You have the right to receive a copy of the informed consent document to help you make your decision.
You have the right to keep your medical information confidential.
You have the right to receive medical treatment for any injury that might happen to you on a study.
If you sign an informed consent document, you have the right to receive a copy of that form for your own personal records. If you have any questions, concerns, complaints about a research study under the review of Sterling IRB, or would like to obtain information or offer input, call (888) 636-1062 and ask to speak to a member of the Sterling IRB Regulatory Department.
The main reason for any type of study is to answer questions. The purpose of a research study (or “clinical trial”) is to answer research questions. Research studies are usually performed for one or more of the following reasons:
- To test new drugs or techniques to see if they may treat or prevent a health problem.
- To improve current methods of treating health problems.
- To learn how to prevent health problems from happening in the first place.
A research study is not medical care. Medical care is always available to you outside of joining a research study. If you are a volunteer in a research study, you are not a patient; you are a participant (or subject).
People participate in research studies for many reasons, including:
- The opportunity to help solve health problems for future generations.
- The possibility of receiving experimental (or “investigational”) drugs and treatments that are not currently approved for use outside of research studies.
- The opportunity to contribute to the study of groups of people who, in the past, were not usually asked to participate in research studies (e.g., women, African Americans, Hispanic Americans, Asian Americans, American Indians).
If someone has asked you to join a study, you are thinking about joining a study, or you have already joined a research study, please read our Participant Rights page for a list of your rights as a research participant.
The most important thing to remember is that the decision to participate in a research study is entirely up to you; it is a personal choice.
Before you decide to join a research study, you should consider:
- What will happen throughout the study.
- What type of health care you will receive.
- What specific study procedures will take place.
- All of the risks and possible benefits of the study.
- Any costs to you.
- What will happen to your medical information and study results.
You should also seek advice from a trusted doctor or health care professional and be sure that all of your questions are answered to your satisfaction.
Research studies are paid for by a “sponsor.” Sponsors may be drug companies, hospitals, individuals, or government agencies. Oftentimes, the sponsor is the one who is making the drug or treatment that is being studied.
If you are participating in a medical research study, the type of treatment that you receive may be different than what your regular doctor would prescribe. In fact, as a medical research participant, you may not receive treatment at all. Furthermore, there is no guarantee that any treatment that you may receive will help you. Before volunteering to participate in a medical research study, you should be aware of your alternatives because there may be better options for you.
An important part of any research study is the “informed consent” process. This process involves the various discussions that take place as a study is being fully explained to you (and your questions are being answered to your satisfaction). It also involves the reading and signing of a document called the “informed consent document (ICD).”
An informed consent document is a written document that clearly explains everything that will take place during a study and all of the details involved with your participation. By signing this form, you are stating that you have given your informed consent to participate; you are verifying that you have volunteered to participate after being told everything that the study involves.
Your informed consent is always confirmed before your participation in a study begins (before study procedures are performed). The informed consent process continues throughout the entire study because your “informed consent” is only genuine if you are truly aware of everything involved with participating in the study.
If you choose to join a research study, there will be specific study procedures involved. Study procedures may include attending scheduled study visits, having certain medical tests performed, completing forms at home, and other tasks (all of which will be explained to you before joining). Some studies will have more procedures than others. Going to study visits and completing the study requirements may take up a lot of your time. However, each research study is different, and things that participants are required to do will depend on the study.
Many research studies use drugs or treatments that may have unpleasant side effects (sometimes called “adverse events” or “adverse effects”). Some side effects can be minor, some can be serious, and some can actually be life-threatening.
While some side effects do not last very long, some can be permanent. There is even a possibility that side effects will happen after you are finished with a study. The risks involved with volunteering for a study depend on the type of research being performed. Because of this, you should know all of the risks involved in a study before you join. You should also ask if there are any unknown side effects.
Some studies use a “placebo,” which is something that looks like a drug/treatment but does not contain any active medicine or offer possible treatment. In this case, your symptoms might get worse since you are not receiving any possible treatment for your condition.
Even if a study does not use a placebo, the study drug/treatment that you receive may not help you. This is true both for drugs and treatments that are approved by the FDA and also for those that are experimental.
Usually, participants do not have to pay for any procedures or research in which they take part. However, a study might require that you cover certain expenses out of pocket or with your health insurance coverage.
Many research studies will pay you money for your time and effort. Some will give you items such as gift certificates, and some will not pay you anything at all.
Before joining a study, you should know if and how you will be paid, as well as what costs, if any, the research study will require you to cover. All of this information should be clearly outlined in the informed consent document.
Joining a research study (or quitting a research study) will not affect your medical care. You always have the right to receive medical care, whether you participate in a research study or not.
If you decide to participate in a research study, it is important that you be completely honest during the screening process and throughout the entire study. The screening process takes place when the study doctor and the study staff ask questions and perform tests to check and see if you can participate in the research study.
Because some drugs and treatments are harmful to people who take certain medications, or people who have a history of certain diseases, it could be very risky to your health if you join a study without being fully honest with the study doctor and study staff. It will also be your responsibility to report any side effects that happen to you (no matter how minor) to the study doctor or study staff as soon as possible.
Throughout the course of the study, you will be expected to follow all instructions and come to all scheduled study visits. The study doctor and his/her study staff will tell you what your specific responsibilities will be as a study participant.
“IRB” stands for “institutional review board.” An IRB is a group of doctors, scientists, and other people from the community who help to make sure that your rights and your safety are being protected as a research participant. The IRB is particularly interested in the risks that are involved in studies under its review and how well those risks are being explained to potential and current participants. If a study is not being conducted properly, the IRB has the authority to stop a research study from continuing (or put it temporarily on hold).
If you did not find the answer to your question about medical research studies here, please email the Sterling IRB Regulatory Department with your inquiry; you may also call us at 888-636-1062, and ask for a member of the regulatory department.
An adverse event is a negative reaction that a participant may experience while taking a study drug or receiving some type of study treatment. Adverse events may happen suddenly or develop over time (even after the study is complete). Adverse events include minor events such as a sore throat as well as major events such as the death of a participant.
In a blind study, there is more than one drug/treatment being used, and you will not be told which one you are receiving. In a double-blind study, neither you nor the study staff will know what type of drug/treatment you are receiving. Blind and double-blind studies are performed so that the procedures and results of a study are not unnecessarily influenced by you or the study staff. For example, it might be difficult for you to continue following the study procedures if you were aware that your study medication/treatment was actually a placebo.
Inclusion/exclusion criteria are the standards used to determine whether or not people can participate in research studies. These criteria are based on characteristics such as age, gender, medical history, and the medication that a person is currently taking. The purpose of inclusion/exclusion criteria is to keep people safe and to help the study staff select the best participants for a study. For example, a person with a history of high blood pressure should not be participating in the study of a drug that might increase blood pressure. Inclusion criteria are the characteristics that you must have in order to participate. Exclusion criteria are the characteristics that you must not have in order to participate.
The ICD is a document that the study staff will give you that explains all of the main details of a study, including the purpose, the risks and possible benefits, what procedures will take place, how your privacy will be protected, if and how much you will be paid, how long the study will take to complete, and what alternatives you have instead of participating in the study.
No study procedures may be performed on you until you sign an informed consent document. If all of your questions have not been answered in that document, the study staff is required to answer any other questions you may have. If you sign an informed consent document, you can decide to withdraw your decision to participate at any time, for any reason, with no penalty to you or your medical care.
Please see Participant FAQs for a description of “informed consent,” the process that involves signing the informed consent document.
In an open-label study, both you and the principal investigator (or study doctor) know which study drug/treatment you are receiving.
A placebo is something that looks like a drug/treatment, but does not actually contain any medicine or offer possible treatment. Sometimes people call the placebo a “sugar pill,” but a placebo is not always in the form of a pill. Placebos can also be medical devices or administered with injections. Placebos are used in studies to make sure that the real study drug or treatment is more effective than taking nothing at all.
The principal investigator, or PI, is the main researcher in charge of a study. The PI agrees to follow the protocol and commits to protecting the safety of the participants in the study. The PI, usually a medical doctor, is responsible for what happens during the study, including the actions of every member of the study staff. The study staff may include one or more subinvestigators, study coordinators, and other research professionals.
The PI may be a physician who also conducts research studies, or the PI may be an individual who only conducts research studies. Your personal physician may be a PI on a study, and he/she may ask you to participate in one of his/her research studies.
A protocol is a detailed plan that is designed for conducting a research study properly. It explains the questions that the research is trying to answer as well as the steps and rules that the researchers should follow to get accurate results and to help ensure the safety of the participants. If a protocol is not followed correctly, the study results could be incorrect and/or the research participants could be harmed.
Some research studies have groups of participants who are receiving different doses or types of drug/treatment. These studies are called “randomized” studies. When participants are “randomized” to groups, they are assigned by chance (like flipping a coin) to one of two or more groups. Randomization, the act of assigning participants to groups, ensures that the study is being fair to the participants, particularly when some groups will be receiving placebo. The groups in a randomized study are sometimes called “treatment arms” (see below).
Screening refers to the period when tests are performed and questions are asked to see if you can participate in a research study. During the screening (sometimes called a “screening period” or “screening visit”), the study staff will find out whether or not you meet the inclusion/exclusion criteria. The screening may take place during one visit or over the course of several visits.
Studies are often divided into four categories or phases.
Phase I studies are usually performed on a very small group of people because the drugs or treatments have only been tested with animals. Phase I researchers cannot accurately predict how humans will react and whether or not they may be harmed. Small groups are used in Phase I studies to reduce the number of people who are taking the risks involved with a new drug or possible treatment. This phase is often used to study the dose or amount of drug that humans can tolerate. Both healthy participants and patients can participate in Phase I studies.
Phase II studies take place when a drug or treatment has been used in Phase I studies, and it did not cause major harm or create significant risk to humans. Phase II is used to see if a drug or treatment can treat a disease or health problem. There are usually many more participants involved, and they last longer when compared to Phase I studies. Common side effects, risks, and treatment possibilities are examined during Phase II studies.
Phase III studies are the final stage a study has to go through before a drug/treatment or device is given approval by the FDA (U.S. Food and Drug Administration). Phase III studies are often much longer (even years longer) than previous phases, and they may involve thousands of people across the world. After this phase is complete, if results are still promising, a drug or device company can seek FDA approval to sell the drug in the United States.
Phase IV studies use drugs or devices that have already been approved by the FDA to see if they can be used in other ways. For example, a researcher might combine an FDA-approved drug with another drug, or study an FDA-approved drug to see if it can be used to treat another type of disease or health problem.
Treatment arms are different study groups that are used in randomized studies (see Randomization above). Sometimes a research study may require different groups of participants to receive different types of treatment. There are many types of treatment arms, including groups that receive different doses of study drug, groups that receive a completely different type of drug/treatment, and groups that receive placebo instead of a real drug/treatment.