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The study protocol outlines who can participate in a clinical research study referred to as the Inclusion/Exclusion Criteria. The criteria that allows a person to participate in a clinical research study are called inclusion criteria; and the criteria that disqualifies a potential research subject are called exclusion criteria. These criteria are based on factors such as age, gender, the type and stage of a disease, previous/current treatment history, and other medical conditions. A research subject is a person who meets the inclusion/exclusion criteria and agrees to take part in a clinical research study. A research subject may be either a healthy individual or an individual with a specific disease or condition.

To help you decide if you want to be in a study, the FDA requires that study participants are given complete information about the study before they agree to take part.

Informed consent forms should be written so the participant can easily understand it and should include:

• purpose of the research
• how long the study will take
• what will happen in the study and which parts of the study are experimental
• possible risks or discomforts
• possible benefits
• other procedures or treatments that the participant might want to consider instead of the treatment being studied
• that FDA may look at study records, but the records will be kept secret
• whether any medical treatments are available if the participant is hurt, what those treatments are, where they can be found, and who will pay for the treatment
• the person to contact with questions about the study, participant rights, or if the participant can get hurt
• the participant can quit at any time

If you don’t understand the information included in the informed consent form, be sure to ask the doctor or other research staff member to explain it. This discussion should take place in private, and you must be given enough time to make an informed decision. In most studies, you should be allowed to take the consent form home for further discussion with others, such as family, caregivers and primary care physicians. Make sure you understand all of it before you agree to be in the study.

Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason. You may ask questions at any time throughout the study.

In addition, you must also be informed of any new information learned during the study that may affect your willingness to continue to participate in the study.

The clinical research team will make every effort to assure that your Personal Health Information (PHI) is kept extremely confidential. Your information will not be shared without your permission or except required by law. If you choose to submit your information to use through this website, with your permission, this information will be entered into our clinical research database for both current and future study opportunities. You can ask to have your information removed at any time. If you choose to call in and speak to one of our research specialists over the phone, your information will be captured in the same electronic database. Again, this is voluntary and can be removed at any time.

In most clinical research studies all visits, tests, and procedures related to the study are free of charge. If you qualify for one of our research studies, you may be compensated for your time and travel. The amount of compensation (as well as any expenses not covered by the study) will be reviewed during the informed consent process.

The number of study visits, duration and frequency will vary depending on the study design. Typically, the study visits are at least 30 minutes, however some may be a few hours. The initial visit (screening visit) will generally be longer as it will include an the informed consent process, an assessment of your medical history, collection of laboratory samples, and various study related questionnaires. During the informed consent process, participants will be provided detailed information regarding the study visits and overall duration of the study.