This site is for anyone who is in the process of deciding whether to join a research study at the University of Virginia. The information on this site applies to research studies involving patients (including clinical trials), as well as non-medical research studies. We hope this information will help you make the right decision for yourself about being in a research study at UVA.
Questions, Concerns or Suggestions?
If you have questions (including questions about your rights as a research participant), concerns, a research-related injury or suggestions, you may call the Office of the Vice President for Research at (434) 924-6853 or the Research Compliance Helpline at (800) 235-8700. Please call this number if you are unable to reach the research staff, or if you wish to talk to someone other than the researchers. You may leave an anonymous message, or you may leave your name and phone number if you would like a response. The email address is firstname.lastname@example.org.
Deciding whether to be a research participant?
Here is a list of questions that you can take with you to your next visit with the researchers. Asking the researcher some of these questions might help you decide whether to join the research study. If you feel uncomfortable asking the researcher one of these questions, please contact the Institutional Review Board for Health Sciences Research (IRB-HSR) at 434-924-9634, or the Institutional Review Board for Social and Behavioral Sciences (IRB-SBS) at 434-924-5999.
Some research studies seek volunteers with certain illnesses or conditions, while other studies want to enroll people who are healthy. Be sure you know the purpose of the study and why you are being asked to participate.
The research team has a duty to make sure that you understand why you are being asked to participate, what question the study is asking, and what the study involves.
You always have the right to choose whether or not you will take part in a research study. You have the right to know about other options available to you if you decide not to participate, and you have the right to enter the study and then withdraw your participation (leave the study) at any time.
The consent document must be written in the language you speak so that you can read and understand it or the information must be provided to you in a language you understand. The research team must respect your social and religious beliefs as well as your customs. Please contact the investigator or Institutional Review Board if you have any concerns.
You should never feel pressured to participate in a research study. If you are a student or an employee of a researcher, your standing should not be compromised if you decide not to participate.
You have a right to refuse to participate and not suffer any consequences as a result of your decision. Please contact the researcher or the Institutional Review Board (the research ethics board) if you have any concerns.
People often confuse research studies, including clinical trials, with medical care. It can be especially confusing if your doctor is also the researcher. It is important to understand that a research study is an experiment. By its nature, that means the answer to the research question is still unknown. You might or might not benefit directly by participating in a research study. It is important to talk about this topic with the researcher. Please contact the researcher or the Institutional Review Board (the research ethics board) if you have any concerns.
You have a right to be told about treatment options available to you if you decide not to participate in the research study. Your other choices might be the same treatment as the study treatment, but given in different amounts or at different times. In other cases, your choices might be completely different treatment options from what is involved in the study. It is important that you ask the researcher to clarify your options if you decide not to participate so you can understand the differences and make the best decision for yourself.
You should know what benefit might come from your participation in the study. Some studies include a possible health benefit, or a new method of learning. Other studies will offer no benefit to you, but will increase researchers’ knowledge about an illness, or about our world. You should ask the researcher to clearly explain how you might be helped.
There is NO GUARANTEE that you will be helped by being in a study. If the researcher tells you there is no possibility that the study will be of benefit to you, you might still decide to participate simply because you want to help in the advancement of medical or social science research.
You have a right to understand what's involved and what is expected of you. The researchers are required to get your informed consent before you take part in any way (often before you have any tests to see if you are eligible for the study). In the informed consent process, the researchers will explain the details of the study to you and answer your questions.
Be sure someone from the research team goes over the consent document with you in as much detail as you want. This document will explain exactly what will happen during the study, including how many extra visits will be required.
Researchers try to make the consent document and discussion as understandable as possible, but there still may be terms or ideas that might be confusing to you. Please ask the researchers about any topic you don't understand.
If you decide to sign the consent form but then change your mind about participating, that is perfectly fine. You can sign up and then withdraw your participation at any time.
An experimental drug is a new drug that has never been used before in a large number of people. An experimental drug might also be an existing drug that is given for a new reason, in a new way, or using a new dose.
The researcher should inform you about studies that have been completed in humans and animals, using the experimental drug you might take if you enter the study.
A research study involving an experimental drug is trying to answer important questions about the drug’s safety and effectiveness (how well it works).
Answering these questions often requires several different studies, called clinical trials. These are usually divided into "phases”. Each phase is designed to answer certain questions, while trying to ensure the safety of the people taking part. Each new treatment is tested in several phases of clinical trials before being considered reasonably safe and effective.
Please talk to your doctor about the phase of clinical trial you would enter and its possible risks and benefits. To learn more about clinical trials, see the National Institutes of Health web page, NIH Clinical Research Trials and You.
Risks are different for every study. The researcher will describe the risks of being in the study to you. Risks may be unknown, there might be unpleasant or serious risks involved, or the study might not be effective or help you. It is very important for you to be informed about the risks and ask the researchers questions about anything you don't understand.
As compared with usual medical care, your participation in a medical research study might increase costs to you, decrease costs to you, or keep costs the same.
Participating in a non-medical research study also might increase costs to you.
INCREASED costs to you and/or your insurance company might result from the use of an experimental drug or device, or an experimental procedure that is not covered by the sponsor of the study.
You might also have the added expense of travel to study visits, or time missed from work as a result of your participation.
DECREASED costs to you and/or your insurance company might result from procedures that reduce the amount of time you are in the hospital or reduce the number of drug treatments you need as compared with your usual medical care.
The researchers should explain to you what costs of being in the study will be paid by the sponsor of the research and/or your insurance company, and what you will be responsible for paying.
The study sponsor (whether it is the government or a drug company) might pay for a new drug or procedure, special testing or extra doctor visits.
It is very important for you to find out what the sponsor will pay for, and what you will be expected to pay before you decide to enter the study.