Research: University of Virginia Paticipating in research Paticipating in researchPaticipating in research Paticipating in research
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Questions

Seeking answers to at least some of these questions might help you decide whether being in the research study is right for you.

Click here for a list of the 10 questions that you can print out to take with you at your next visit with the researchers. If you feel uncomfortable asking the researcher one of these questions, please contact the Institutional Review Board (the research ethics board).

1. Why am I being asked to participate in the research study? Do I have to participate? These questions are important for you to ask the researchers because:

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 a right to know about other options available to you if you decide not to participate.

If you are a student or an employee of a researcher, your standing as a student or as an employee should not be compromised if you decide not to participate. Please contact the researcher or the Institutional Review Board (the research ethics board) if you have any concerns.

2. ¿Qué si el investigador no comparte mis creencias culturales o habla mi idioma primario? Es importante que haga la pregunta de porque:

El idioma y las barreras culturales pueden interponerse en el proceso para dar un consentimiento bien informado. El documento para dar su consentimiento debe de estar escrito en el idioma que usted habla para que pueda leerlo y entenderlo. El equipo de investigación debe de respetar sus creencias sociales y religiosas al igual que sus costumbres. Favor de contactar al investigador o al Comité Institucional de Revisión si tiene alguna preocupación.

3. What if I feel pressured to participate because the researcher is also my boss or my professor/teacher/mentor? This question is important to ask because:

You should never feel pressured to participate in a research study. You have a right to refuse to participate and not suffer any consequences as a result of your decision. You also have a right to enter the study and then withdraw your participation (leave the study) at any time. Please contact the researcher or the Institutional Review Board (the research ethics board) if you have any concerns.

4. What if I feel pressured to participate because the researcher is also my doctor? This question is important to ask because:

You should never feel pressured to participate in a research study. You have a right to refuse to participate. You also have a right to be told about any other options available to you if you decide not to participate. If you enter the study, you have a right to enter the study and then withdraw your participation (leave the study) at any time.

People often confuse a clinical trial with medical care. It can be especially confusing if your doctor is also the researcher. It is important to understand that a clinical trial 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 your doctor/the researcher. Please contact the researcher or the Institutional Review Board (the research ethics board) if you have any concerns.

5. If I decide not to participate in a research study, what are my other choices? What other medical treatments or procedures can I receive, besides the ones being tested in this research study? How do my other choices compare with this study? These questions are important for you to ask because:

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 with the study but given in different amounts or different frequencies. 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.

6. How will this study help me? If it won't help me, why might I still want to participate? These questions are important for you to ask because:

You should know what if any health benefit might come from your participation in the study. You should ask the researcher to clearly explain how you might be helped. Keep in mind that there can be no GUARANTEE that you will be helped by being in the study.
If the researcher tells you there is no possibility that the study will improve your health, you might still decide to participate simply because you want to help in the advancement of medical or social science research.

7. What exactly will happen to me if I decide to participate? How many extra visits to UVa will this require of me? These questions are important for you to ask because:

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 even 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, and how many extra visits will be required. This document will also explain any expenses you might have to pay for being in the research study. In some cases, your insurance company might cover some visits or procedures not covered by the study. In other cases, you might be asked to pay out-of-pocket. Please ask the researcher if there will be any costs to you for participating in the study.

Efforts are made to make 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, including what you might be expected to pay, if anything at all. If you decide to sign the consent form but then change your mind about participating, that is perfectly fine to do. You can sign up and then withdraw your participation in the study at any time.

8. An experimental drug is a new drug that has never been used before. An experimental drug might also be an existing drug that is given for a brand new reason. How do I know if taking this experimental drug is safe for me? How much is known about safety? These are important questions to ask because:

You should know about prior safety studies that were completed on humans and animals involving the experimental drug you might take if you enter the study.
Research studies involving experimental drugs answer important questions:
Is the new treatment effective? Is it better than what’s now available to treat a specific disease? If it’s not better, is it at least as good, perhaps while causing fewer side effects? Or does it work in some people who don't benefit from current treatments? In other words, is it a step forward?

Is the new treatment safe? This must be answered while realizing that no treatment or procedure—even one already in use—is entirely without risk. But do the benefits of the new treatment outweigh the possible risks?
Answering these questions, while exposing as few people as possible to an unknown treatment, often requires several different 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.

Knowing the phase of the clinical trial you are considering is important because it may give you some idea about how much is known about the treatment being studied. There are advantages and disadvantages to taking part in each phase of clinical trial. Please talk to your doctor about the phase of clinical trial you would enter and its possible risks and benefits. For a definition of the different phases of a clinical trial, please go to our glossary.

9. Could I get hurt by being in this research study? This question is important for you to ask because:

Risks are different for each and every study, and might also depend in part on your own health status. 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 you might learn that study might not be effective for you. Again, it's different for each study. The most important thing is for you to know the risks and ask the researchers questions about anything you don't understand.

10. Will there be any costs to me? Will any of the treatment be free? Will insurance cover the rest? These questions are important for you to ask because:

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.

INCREASING costs to you and/or your insurance company might result from involving an experimental drug or an experimental medical or non-medical procedure that is not covered by the sponsor of the study.

DECREASING 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 outside of the research study.

The researchers should explain to you what if any costs of being in the study will be paid by the sponsor of the research, and/or your insurance company if that is applicable, 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, a new medical or non-medical procedure, special testing or extra doctor visits. Other sponsors might not be able to cover some or all of these costs.
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. Ask the researcher your questions about who if anybody will pay for you to be in the study, and what exactly will be paid for.

For more information about clinical trials and insurance coverage, see the National Cancer Institute web page.



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Last Modified: Wednesday, 09-Jun-2010 09:33:49 EDT
Copyright 2014 by the Rector and Visitors of the University of Virginia

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