As part of our series on frequently asked questions about Kimmel Cancer Center clinical trials, this post looks at patient safety during a trial.
Dina George Lansey, a nurse and clinical research recruitment specialist for the Kimmel Cancer Center, notes that there are many rules in place to make sure that patients in studies are kept safe. “All clinical trials must be reviewed, approved and monitored by an Institutional Review Board (IRB). The IRB is made up of physicians, researchers, and members of the community. They review the study and the informed consent form to make sure that it is ethical and that the rights and welfare of participants are protected.” she says. “Clinical trials are also monitored by safety committees and various federal agencies that work to assure that research participants are protected and informed.”
Before taking part in a clinical trial, each participant must sign a document called an informed consent form. This document explains why the study is being done, the risks of taking part in the study, the benefits of taking part, the side effects of the treatment, and what other treatment options are available if you choose not take part in the study. "Although the ‘informed consent’ refers to a document, it also refers to a process , a discussion that takes place between patients and research staff and/or their doctors, before, during and sometimes after their participation in a clinical trial,” says Lansey. “The goal of both the informed consent form and process are to make sure that patients have all of the information they need to help them decide whether they want to take part or continue to take part in a trial.” It is important to note that patients that decide to sign the informed consent form may ask questions about the study at any time while they are taking part in the study, and they may decide at any time that they no longer want to take part in the study. Neither their questions nor their decision to stop participating will affect their treatment or their relationship with their doctor.