A medical research study, also known as a clinical trial, is carefully designed for eligible participants who are asked to take an investigational medication or vaccine under the supervision of a physician and other research professionals.

Medical research studies must be reviewed by an Institutional Review Board (IRB) or Ethics Committee (EC). An IRB or EC is a group that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with medical tests and study-related exams before, during and sometimes after the study.

Before you participate in a study screening visit, the study procedures will be explained to you, and the possible risks and benefits of taking the study medication or vaccine will be reviewed. All of this will be discussed with you, and you will be provided in writing with an “Informed Consent Form” (ICF). You will be asked to review and sign the ICF prior to participating. Your medical history will be reviewed, and you will be given study-related procedures and tests at no cost to you.

If you qualify, you will be enrolled in the study. Once enrolled, and at any time during the study, you are encouraged to discuss your research care with the study physician or research team members. Information collected during a medical research study may or may not ultimately lead to a drug being approved by the FDA or other regulatory health authorities and may or may not result in future developments of safer and more effective drugs.

• Attend all scheduled visits
• Describe your feelings and well being accurately and honestly to the study staff
• Address any questions regarding your study participation and symptoms during the study with the study staff

By taking part in a clinical trial, you can try a new treatment that may or may not be better than those that already exist. You can also help others better understand how the treatment works in people of different races and genders.