You should know as much as possible about the research study before you participate. It is important that you feel very comfortable asking questions and that the staff answers them in a way you can understand. When preparing for a meeting with the study coordinator or doctor you should plan ahead and write down the questions you want to ask. Review the study website to help you prepare questions to ask. You might ask a friend or relative to come with you for support and to hear the responses to your questions. You may want to ask the following questions when deciding whether to participate in a clinical trial:

• What questions should I ask?
• Why is this research being done?
• What is the purpose of the study?
• Who is sponsoring the study?
• Who has reviewed and approved this study?
• Why does the research team think the treatment, drug, or medical device will work?
• What kinds of therapies, procedures, and/or tests will I have during the trial?
• Will they hurt? If so, for how long?
• How will the tests in the study compare to tests I would have outside the study?
• How long will the study last?
• How often will I have to go to the study site?
• Will I be able to take my regular medications during the trial?
• What medications, procedures, or treatments must I avoid while in the study?
• What are my responsibilities during the study?
• Will I have to be in the hospital during the study?
• Will the study researchers work with my doctor while I am in the study?
• Can anyone find out that I am participating in a study?
• Can I talk to other people in the study?
• Will I be able to find out the results of the trial?
• Questions about risks and benefits include:
• How do the possible risks and benefits of the study compare with approved treatments for me?
• What are the possible immediate and long-term side effects?
• Will I have to pay anything to participate in the study?
• What are the charges likely to be?
• Is my insurance likely to cover those expenses?

 WHO CAN PARTICIPATE IN A CLINICAL TRIAL?

All clinical trials have criteria that determine who is allowed to participate. You cannot participate in a study if you don’t meet all of the study criteria. These criteria include such factors as age, type of disease, medical history, and current medical condition. Some studies seek volunteers with specific medical conditions and others seek healthy volunteers. It is important to note that these study entry 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.

WHAT HAPPENS DURING A STUDY?

The study procedures and process will vary depending on the type of clinical trial you participate in. Before you begin a study, the process and all procedures for that study will be explained to you. Throughout the study, the Study Coordinator and the Principal Investigator will assist you and can answer any questions you have. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study.

Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. Your participation will be most successful if you carefully follow all instructions, you are given and stay in contact with the research staff.

WHAT ARE THE RISKS OF PARTICIPATING IN A CLINICAL TRIAL?

Most all investigative treatments can cause side effects and other health risks. Side effects and health risks vary from patient to patient. The number of side effects, if any, you experience will depend on the type of treatment being studied and your medical condition. Because clinical trials evaluate new medical treatments, the risks of the treatments are not always known ahead of time. However, in every study several safeguards are put in place to protect the safety of the participants. Before you agree to participate in a study, it is important that you know what side effects may occur and, as much as possible, what unknown side effects or risks may occur. This information will be covered thoroughly during the informed consent process before you enroll

 WHAT IS A PLACEBO?

A placebo is an inactive substance (pill, liquid, or powder) that has no treatment value. It may be referred to as a “blank” or “sugar pill.” In placebo-controlled clinical trials, experimental treatments are compared with placebos to assess the treatment’s effectiveness.
Some participants in these studies may receive placebo rather than active treatment. In pain studies, patients who receive placebo (as well as those who receive active treatment) will always have access to ‘rescue medication’, which is a standard pain medication given for the condition or procedure being studied. As soon as you feel that you need more pain medication, you will be given a rescue dose of the standard pain medication. Asking for rescue pain medication will not in any way have a negative impact on your participation in the study.

WHAT IS AN ADVERSE EVENT?

The term adverse event, as used in the context of clinical research, means any untoward medical occurrence in a patient administered a pharmaceutical product which does not necessarily have to have causal relationship with this treatment. Adverse events can be a symptom (e.g., a headache), a finding during a physical exam (e.g., elevated blood pressure), a syndrome or disease (e.g., “flu syndrome” or meningitis), or an abnormal laboratory value.

WILL I GET PAID FOR PARTICIPATING IN A RESEARCH STUDY?

You will usually be paid for your time and travel while participating in a clinical study. Surgery, medical exams,medications and medical procedures may also be performed at no cost to you depending on the type of study. If a study requires