What you should know about clinical research studies.

What is a clinical research study?

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

Clinical research studies must be approved by an institutional review board (IRB) prior to subjects being enrolled. An IRB 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 even after the study.

What should I expect for myself as a participant?

Before you participate in a clinical research study, a detailed description of the study, as well as possible risks, will be provided in writing in an “informed consent document” and discussed with you. You will be asked to review and sign the informed consent document prior to participating. Your medical history will be reviewed, and you will be given a study-related physical exam and laboratory tests.

If you qualify, you will be enrolled in the clinical research study. Once enrolled, feel free to discuss your research care with the study doctor or research site staff at any time during the course of the study. Information collected during a clinical research study may or may not ultimately lead to the study drug’s being approved by the FDA or other regulatory health authorities, and may support the future development of new drugs.

It is important for you to:

  • Attend all scheduled visits
  • Describe your physical state, feelings, and well-being accurately and honestly to the study doctor
  • Use the investigational medication as prescribed
  • Discuss any questions regarding the study with the study doctor

As a study participant, you will have the right to contact the study’s IRB representative regarding your rights as a research participant at any time. You will also have the right to leave the study at any time.

What should I expect for my child?

Before your child participates in a clinical research study, a detailed description of the study, as well as possible risks, will be provided in writing in an “informed consent document” and discussed with you and your child. You will be asked to review and sign the parental or legal guardian informed consent document prior to participating. Your child’s medical history will be reviewed to see if it meets the listed inclusion or exclusion criteria of the study. He or she will then be given a study-related physical exam and laboratory tests.

If your child qualifies, he or she may be enrolled in the study. Once enrolled, feel free to discuss his or her research care with the study doctor or research staff at any time during the course of the study. Information collected during a clinical research study may or may not ultimately lead to the investigational drug being approved by the FDA or other regulatory health authorities, and may or may not result in future developments of new drugs.

It is important for your child to:

  • Attend all scheduled visits
  • Describe his or her physical state, feelings, and well-being accurately and honestly to the study doctor
  • Use the investigational medication as prescribed
  • Discuss any questions regarding the study with the study doctor

As the parent or legal guardian of a study participant, you will have the right to contact the study’s IRB representative regarding your child’s rights as a research participant. Your child will also have the right to leave the study at any time.

Find a participating site About the T1GER study