How are patients protected?
Patients are protected through the:
1. Clinical trial protocol. A protocol is a detailed plan that explains what will be done in a clinical trial and why. It outlines how many patients will take part in the clinical trial, what medical tests they will receive and how often, and the treatment and monitoring plan. Researchers must follow the protocol approved by the research institution's Institutional Review Board.
2. Institutional Review Board. An IRB is a committee of people, such as doctors, nurses, scientists, dentists, chaplains, social workers, attorneys, and patients who are responsible for protecting clinical trial participants and making sure that the trials follow federal laws.
Before a clinical trial is allowed to begin, the IRB reviews and approves the protocol to make sure that it is based on reliable scientific evidence. The IRB attempts to ensure that the health risks that patients take on as a result of joining the trial are not out of proportion to the benefits they stand to gain if the experimental treatment is effective against their cancer
After a clinical trial begins, the IRB typically monitors the trial at least once a year and stops it if any safety concerns arise. It also may stop a clinical trial early if it becomes clear that the new treatment is much more effective than standard treatment so that all the clinical trial participants may receive the better treatment.
The FDA regulates an institution's IRBs by auditing IRB minutes, staff, and facilities every five years. FDA officials also can visit an institution at any time and review anything they choose related to clinical trials.
3. The Informed consent process. If your oncologist (cancer doctor) gives you the option of participating in a clinical trial, you will go through a process called informed consent. In this process you will learn about a specific clinical trial so that you may decide whether to participate.
The informed consent process protects patients who are offered a clinical trial because it ensures that they understand the clinical trial's plan before agreeing to participate. The researcher or nurse from the clinical trial team will review the informed consent form in detail with you. This form explains a specific clinical trial's purpose, procedures, risks, and benefits. You will be encouraged to ask questions about terms or ideas that are confusing. A family member or friend may be helpful in the meeting by listening to the explanation, asking questions, and recording answers. Some oncologists also encourage patients to bring tape recorders so that they can review the information afterward. You can take the informed consent form with you to take time to think about whether you would like to participate in the clinical trial.
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