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If there is a study you would like to take part in, you should talk to your physician or the research study coordinators about whether you may be eligible to participate. You should make sure you ask all the questions you may have about the study. The study team will make sure that they have answered all your questions, and that you are clear about what participation involves before you give your written agreement to take part, by signing the informed consent form.

If you are interested in participating in a clinical trial, you will be assessed by the study team to make sure that you meet the eligibility criteria for the study. This screening process, in addition to discussions about what participation in the study involves, will help you decide if participation is right for you.

Regulations require that you be given comprehensive information about the study to help you decide whether or not you would like to take part. The Informed Consent Form contains a lot of detail about the study and most everything you need to know about your participation. Your study team will make sure you have time to review this information carefully and that you have an opportunity to share it with whom you feel appropriate.

Each clinical trial has its own rules and regulations about who can and cannot take part. These guidelines are called ‘inclusion and exclusion criteria’ or ‘eligibility criteria.’ The inclusion criteria specify the characteristics (age range, health status, the severity of symptoms) of the people who qualify for participation. Exclusion criteria are in place to protect study participants who may not be compatible with the investigational medication. These criteria are used to identify appropriate participants and keep them safe; it is not used as a personal rejection of a particular person.

Participants in research studies can play a more active role in their own healthcare and gain access to new treatments before they are widely available, and help others by contributing to medical research. There is a real need to develop new treatments for many people who do not get adequate relief or results from the current treatments. You could contribute to the development of a new medication which may help you and others like you. ALL medications that are currently available by prescription underwent clinical trials prior to their FDA approval.