Cytomegalovirus (CMV) Vaccine Clinical Research Study

Clinical Research FAQs

Clinical studies, also called clinical trials, are research studies that test new ways to prevent, detect, diagnose, and/or treat diseases and conditions. Clinical research studies help see if study medications or vaccines are safe and effective for their intended use. Before any medication can be approved and made available to the general public, it has to go through several phases of clinical research.

Why do people participate in studies?

Study participation is completely voluntary. People participate in clinical research studies for many reasons. Clinical research studies may help researchers find better treatments for others in the future.

Are clinical studies safe?

Clinical studies test potential new ways to treat diseases. Clinical studies help researchers see if potential new medications are safe and work to improve the health of people who take them. Studies may test if a new therapy may be more effective than an existing therapy.

What requirements are in place to help protect clinical trial participants?

There are many rules in place to protect the rights, safety, and well-being of people who take part in clinical studies. These rules are meant to make sure that studies are run according to strict scientific and ethical principles.

Before a clinical research study can begin, a review board must review and approve the study. This group is called an IRB or institutional review board. IRBs are made up of doctors, scientists, and members of the community.

What is the informed consent process?

Many clinical studies test potential new medications. Therefore, there are risks that come with volunteering for a study. It is important that you understand these risks before enrolling in this study. You will discuss the possible risks and benefits with your study doctor. You may bring up any concerns you have with the study, and ask as many questions as you like.

If you decide to volunteer for the study, you will be asked to sign an informed consent form. This document will tell you important facts about the study. It will also help you decide whether or not to volunteer for the study. You will get a copy of the informed consent form to take with you.

What if I have questions during the study?

You can ask questions of the study team at any point before, during, and after the study. Before agreeing to participate, please make sure that you understand what you will have to do in the study. If you have any concerns about taking part in the study, you can talk with a member of the study team at any time.

Can I leave the study once it has started?

Taking part in a study is completely voluntary. The decision to volunteer is completely up to you. You may leave the study at any time, for any reason. You should talk to the study doctor and staff any time about any concerns and questions you have. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit. Leaving the study will not affect the quality of the care you receive.

Can I see other doctors during the study?

You can visit your regular doctor or any other doctor you need to during the study. Please let the study doctor know that you will be seeing another doctor and if any medication is prescribed during the visit.