Benefits:

• You may get a new treatment for a disease before it is available to everyone.
• You play a more active role in your own health care.
• Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
• You may have the chance to help others get a better treatment for their health problems in the future.
• You may be able to get information about support groups and resources

Risks:

• The new treatment may cause serious side effects or be uncomfortable.
• The new treatment may not work, or it may not be better than the standard treatment.
• You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo.
• The clinical trial could inconvenience you. For example, medical appointments could take a lot of time. You might need to travel to the study site several times or stay in the hospital

Yes. The informed consent form must describe the study in full, including:

• The trial’s purpose,
• What’s required of you,
• The risks and benefits,
• Protection of your privacy,
• Coverage of costs, and
• Other options for care.

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No. You can drop out at any time for any reason. Participation is completely voluntary

Yes. We adhere to The Health Insurance Portability and Accountability Act (HIPAA)

As a participant, you may be asked to attend study-related visits at our clinical site.  While in the trial, your health and welfare will be continually monitored. There is no cost for you to participate, and there is no need for health insurance.  In exchange for your participation, you may be compensated for your time and travel. Compensation varies by studies and overall study requirements. 

No. Depending on the study, a participant may randomly receive a placebo treatment. Placebos are harmless, inactive substances made to look like the real medicine used in the clinical trial. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment. In many studies, there are successive time periods, with either the placebo or the real medicine. In order not to introduce bias, the patient, and sometimes the staff, are not told when or what the changes are. If a placebo is part of a study, you will always be informed in the consent form given to you before you agree to take part in the study. When you read the consent form, be sure that you understand what research approach is being used in the study you are entering.

You will continue to receive care from your physician/specialist. You may be able to stay continue the trial by participating in a study extension, but this doesn’t happen often.