Participating in Clinical Trials

How does M. D. Anderson protect patients?

When conducting clinical trials, M. D. Anderson’s most important responsibility is to protect patients through well-designed protocols, a dedicated Institutional Review Board (IRB) and a careful informed consent process.

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 participate, what medical tests they will receive and how often, and the treatment and monitoring plan. Researchers must follow the protocol approved by M. D. Anderson’s Institutional Review Board (IRB).

If you have questions or concerns about safety while participating in a clinical trial, please contact a member of your clinical trial team. If you still have questions about the study or your rights as a participant, contact the Chairman of the Institutional Review Board (IRB) at (713) 792-2933.

The Institutional Review Board

M. D. Anderson has four Institutional Review Boards (IRBs). 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.

Photo of Institutional Review Board Members

Before a clinical trial can 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 protocol will not cause excessive harm to any patient.

After a clinical trial begins, the IRB monitors the trial at least once a year and stops it if any safety concerns arise. For example, if a patient developed dangerous side effects, then the trial would be stopped. 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 participants may receive the better treatment.

The FDA regulates M. D. Anderson’s IRBs by auditing IRB minutes, staff and facilities every five years. FDA officials also can visit M. D. Anderson at any time and review anything they choose related to clinical trials.

The Informed Consent Process

If your doctors offers you the option to participate in a clinical trial, you will first take part in a process called informed consent. In this process you will learn details about a specific clinical trial so that you may decide whether you want to participate. The informed consent process is designed to make sure patients 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 by listening to the explanation, asking questions and recording answers. Some doctors encourage patients to bring tape recorders so they can review the information afterwards.

You can take the informed consent form with you to think about whether you would like to participate in the clinical trial.

Information on the Informed Consent Form

Informed consent forms are different, but they should include:

• The reason for the clinical trial (what the researchers hope to learn)
• Who is eligible to take part in the clinical trial
• What is known about the type of treatment being studied
• The possible risks and benefits (based on what is known so far)
• Other treatments that may be options
• The clinical trial’s design (randomized, single blind, double blind, etc.)
• Types of tests, the number of tests and doctor’s visits required
• Who is responsible for the costs of the clinical trial (tests, doctor’s visits, etc.)
• Who is responsible for the costs if a patient needs additional care as a result of the clinical trial
• A statement about conflicts of interest
• A statement about protecting the patient’s privacy
• A statement about the clinical trial being voluntary and the patient’s rights to leave the clinical trial at any time
• Contact information for further questions

Some informed consent forms are translated into Spanish. If you decide to participate in a clinical trial that has an informed consent form written in Spanish, you, your doctor, and a witness who is fluent in Spanish will sign and date the form, and you will be given a copy.

If the informed consent form is written in English, then you will be given a Verbal Translation Preparative Sheet written in Spanish.

The Verbal Translation Preparative Sheet provides information about the informed consent process. It will prepare you for the information you should hear when your doctor, or the interpreter explains the clinical trial and reviews the informed consent with you.

You can take the Verbal Translation Preparative Sheet and the informed consent form with you to take time to think about whether or not you would like to participate in the clinical trial.

Signing the Form

If you want to participate in a clinical trial after learning all that is involved and what you would be expected to do, then you, the trial’s principal investigator (or nurse, if called for in the protocol) and a witness will sign and date the informed consent form. A copy of the form will be given to you.

The informed consent process does not end once you sign the form. If new benefits, risks or side effects are found during a trial, the doctor must inform all of the participants in the trial.You will be encouraged to keep asking questions throughout the trial.

M. D. Anderson will take appropriate steps to keep your personal information private. However, there is no guarantee of absolute privacy. The Food and Drug Administration (FDA), the IRB of M. D. Anderson and the clinical trial’s sponsor might review your record to collect data or to see that the research is being done safely and correctly. Under certain circumstances, the FDA could be required to reveal the names of participants.