What happens during a clinical trial?

The University of Iowa Vaccine Research Unit follows a strict protocol for all studies. After a phone screening for a specific study, our healthcare team will invite you to our unit for a screening visit. Screening visits can vary for each study but typically consist of educating the participant on the study, going through the informed consent and answering any questions before the participant signs it, checking the health of the participant and possibly running tests to find out if they are eligible to be enrolled. Once enrolled, the participant will begin the study. During the trial our healthcare team will give specific instructions as well as monitor participants closely. After the trial is complete, our healthcare team will stay in touch to ensure the participant’s safety. For specific information on how a study will be conducted please feel free to contact us.

Photo of VTEU

Before participating in any study you will be introduced to the study’s informed consent document. This document contains vital information about the trial that is necessary in order to make an informed decision. Our healthcare team will go over the informed consent in detail with you at your screening visit and will be able to answer any questions that you have. The informed consent includes the study’s purpose, duration, procedure, visit information, key contact information, as well as the risks and potential benefits to the study. It’s important to understand that the informed consent document is not a contract and the participant may withdraw from the trial at any time.

All of our studies vary in nature. Some of our studies include placebo groups that you could randomly be assigned to. Additionally, some studies are designed to test safety instead of efficacy. Therefore, there is a chance that you may not benefit directly from the study vaccine or treatment. However, by participating in clinical trials research, you play a role in bettering your own health care as well as contributing to medical research that may benefit other people around the world. The research that you participate in could create a safer vaccine, a more efficient treatment, or help someone in need.

The studies we conduct vary and it is important that before you participate you understand the risks. Depending upon the study, there may be unpleasant, serious, or even life-threatening side effects to the experimental treatment. Additionally, there is a risk that the treatment may not be effective for the participant or that the participant could be assigned to a placebo group. Please contact us to learn more about the risks of specific studies.

Each study will be different and many trials/treatments have only been studied on animals, therefore side effects and adverse reactions in humans may not be known at the time. It is important to discuss the potential risks known of a specific trial with our healthcare team before you make the decision to participate. A side effect is any effect in addition to the intended effect that is undesired or unpleasant. An adverse reaction is a negative or harmful result from an experimental trial/treatment.

Yes, if you are eligible to participate most of our studies require multiple visits. The visits that follow vaccination or treatment days may include blood draws for additional testing, safety labs, vitals, and inquiries about your current health. Some follow up visits are emails or telephone calls and do not require you to come in. Please contact the Vaccine Research Unit with specific questions about the study because each study is different.

Occasionally we conduct studies that include mileage in addition to compensation. If you are willing to travel from a distance for a specific study please contact us to see if this is an option.

If the trial is phase I the drug/treatment has been used in the laboratory on animals. If the trial is phase II or III the drug/treatment has been used in other studies involving people. Please contact us for more information on the phase of the study you are interested in.

Before participating in any study you should read the informed consent and ask our healthcare team any questions you have. The follow questions are answered in the informed consent and may be helpful to discuss with our healthcare team in order to make an informed decision.

  1. 1. What is the purpose of this study? 2. Has there been a previous trial in humans? 3. What kinds of tests and experimental treatments are involved? 4. What are the potential risks? 5. Are there any potential benefits? 6. Are there any known side effects? 7. How long will the trial last? 8. How many visits are there and what do they consist of? 9. Is there compensation? 10. Will long term follow up care be necessary? 11. Will the results of the trial be provided to me? 12. Who will be in charge of my care? 13. What should I do if I have an adverse reaction?

Please read over the informed consent that was sent via email and write down any questions that come to mind. Discuss your participation in the study with your family or friends and feel free to email or call us before your visit with any questions.

Yes. Throughout the study our healthcare team will be following up with you about your current health. Our healthcare team will counsel you on what to do if you need to see your primary care provider for any reason while participating in our study.

Absolutely, if a participant decides that they want to leave a clinical trial they can do so at any time. When making this decision it is imperative to notify the research team and let them know the reason for leaving the study. Depending on the trial, it may be necessary for our healthcare team to follow up with the participant about their health status via telephone or email after they decide to leave.

Please contact us at (319) 356-4848 or recruit-vaccine-research@uiowa.edu with any questions.