What is a Clinical Trial?
What is an Institutional Review Board (IRB)?
What is a Protocol?
What is Informed Consent?
Who can participate in a clinical trial?
Do I have to have insurance to participate in a clinical trial?
Does my primary physician have to refer me to ACIP before I can be considered for a clinical trial at ACIP?
Do I have to be a UAB patient in order to participate in a trial at ACIP?
How much does it cost to participate in a clinical trial?
If I choose to participate in a clinical trial do I have to sign a contract stating that I will complete the trial?
What does “Phase I, Phase II, Phase III, and Phase IV” study mean?
Will I be paid if I participate in a clinical trial?



What is a clinical trial?

A clinical trial is a research study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work. Ideas for clinical trials usually come from researchers. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning the clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.

What is an Institutional Review Board (IRB)?

An IRB is an independent group or committee whose primary purpose is to review and assure the protection of the safety, rights and welfare of the human subjects in clinical research studies. The people that serve on IRB’s come from diverse backgrounds including physicians, scientists, clergy, nurses, social workers, patient advocates and regular healthcare consumers.

What is a protocol?

All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications and dosages; and the length of the study. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

What is Informed Consent?

Informed consent is the process of learning the key facts about a clinical trial before you decide whether to participate. You should be given complete answers to all of the following questions, including the fact that you have the right to leave the trial at any time: Why the research is being done? What do the researchers want to accomplish? What will be done during the trial and for how long? What risks are involved in the trial? What benefits can be expected from the trial? What other treatments are available? If you are considering joining a clinical trial, the research staff will give you informed consent documents that include the details about the study. If English is not your native language, you can ask for the consent documents in languages other than English. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and the consent forms before you make a decision. It is also a good idea to take the consent documents home and discuss them with family members or friends. Talking about your options can help you to feel comfortable with your decision. If you decide to join the clinical trial, be sure to ask for a copy of the informed consent documents so you can review them at any time. Remember informed consent is more than signing a form. It is a process that continues through the study. You should feel free to ask the research team questions before, during and after the study. Informed consent continues as long as you are in the study.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can get into the program. Guidelines are based on such factors as age, type of disease, medical history and current medical condition. Before you join a clinical trial, you must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Healthy volunteers participate in Phase I trials, vaccine studies, and trials for preventive care for children or adults. The factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

Do I have to have insurance to participate in a clinical trial?

No, not typically. We rarely conduct clinical trials that require the patient to have insurance coverage. If insurance coverage is required to participate in one of our trials, the patient will be notified prior to signing an informed consent form.

Does my primary physician have to refer me to ACIP before I can be considered for a clinical trial at ACIP?

No, you do not have to be referred to ACIP by your primary provider. However, we will keep your primary physician updated on lab results and your participation in the clinical trial.

Do I have to be a UAB patient in order to participate in a trial at ACIP?

No. You can participate in a clinical trial at ACIP while you continue to see your primary care provider.

How much does it cost to participate in a clinical trial?

Patients do not have to pay anything to participate in our clinical trials. The medication, laboratory assessments, radiology assessments and physician assessments are provided at no cost to the patient.

If I choose to participate in a clinical trial do I have to sign a contract stating that I will complete the trial?

No. Participation in a clinical trial is voluntary. It is your right to discontinue participation at anytime. We do encourage patients to complete the trial for the patients’ safety and the integrity of the data that will be collected and analyzed throughout the duration of the trial.

What does “Phase I, Phase II, Phase III, and Phase IV” study mean?

Phase I is the first of four phases of clinical trails designed to establish the effects of a new drug in humans. Phase I studies are conducted on small populations of healthy humans to specifically determine a drug’s toxicity, absorption, distribution and metabolism. Phase II is the second of four phases of clinical trials that takes place only after the successful completion of phase I trials. In this phase, a drug is tested for safety and effectiveness in a slightly larger population of individuals who have been diagnosed with the disease or condition for which the drug was developed. Phase III is the third and last “pre-drug approval” round of testing of a drug that is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results in these trials usually provide the information that is included in the package insert and labeling. Phase IV clinical trials take place after a drug has been approved by the FDA. These studies are conducted to compare the drug to a competitor, explore different patient populations, and/or to study further any adverse events.

Will I be paid if I participate in a clinical trial?

Most of our clinical trials do modestly compensate patients for their time at each visit.