The safety and well-being of patients participating in clinical trials are protected by the informed consent process, as well as regulations in place by the Institutional Review Boards (IRB), the U.S. Food and Drug Administration (FDA), and Scientific Review Committees (SRC).
- IRBs ensure that clinical trials are ethical and your rights, such as confidentiality, are protected. They monitor progress and review results during the trial. Moffitt’s IRBs are independent committees made up of doctors, statisticians, and community members. All U.S. clinical trials must have IRB approval based on high standards of scientific integrity and protection of all participants.
- The FDA oversees clinical trials that are testing new medicines or medical devices. They review trial proposals before any testing on patients is done and ensure studies have proper informed consent and protection for participants.
- SRC review is a requirement of the National Cancer Institute as part of our Comprehensive Cancer Center designation. Scientific review is required for all clinical interventional studies that involve cancer, cancer prevention, or survivorship. A review by the SRC ensures:
- A clear research question
- A proper research design
- Sound and doable methods
- Qualifications of the research team
- Adequate sample size
- The validity of the statistical analysis plan
Your doctor may suggest a clinical trial to treat your cancer. Informed consent is the process of learning the details of a clinical trial in order to make an educated decision about whether or not you want to participate. If you agree to take part in the trial, you will be asked to sign a consent form and be given a copy of the consent for your records.
You should ask questions about the trial to make sure you understand what is involved. The research team will explain the key facts of the study:
- The purpose of the study
- The procedures for the study, such as frequency and timing of visits
- The risks and benefits of the study
- Your right to leave the study at any time
- Your right to learn about all your treatment options
- Your right to learn about all treatments and tests involved in the study