FAQs

Can I be harmed in a research study?

You have a right to be concerned about yourself. Study teams know that there are honest risks and possible benefits to every study. Before you join a study, you must be told about these benefits and risks. You will also get a written consent that tells you about all of the known risks and benefits.

A new cancer treatment is tried on lab animals first in order to understand the risks and benefits of the new treatment or drug. Human beings try the new treatments and drugs only after these lab studies are done. In other words, you will never be part of an animal lab experiment.

Doctors and research teams have a duty to protect your rights and safety. Sadly, in the past, there have been a few studies that did not carry out this duty. Patients were harmed and the harm became widely known. Due to these harmful acts, hospitals and federal agencies check up on research studies to make sure the study is following all rules.

Talk to your doctor and the research team. Decide if they treat you with respect and answer your questions. If so, this is likely how they will treat you in a study.

What is a placebo?

You may hear the word placebo (pla • SEE • bow) when learning about cancer treatment research studies. This is a pill, injection or something that looks the same as the treatment that is being tested and it is given to patients the same way as the new treatment being tested. However, it does not help treat your disease. It has no effect at all.

When would a placebo be used?

It is extremely rare for a placebo to be used in human cancer research. Only if there are no known treatments for a certain type or stage of cancer would a placebo be given (since no standard treatment exists.) Most research studies compare the standard treatment (or the standard treatment plus a placebo) to a new treatment or drug. This means that a patient is given the standard treatment [Click for definition] or the new treatment while they are in the study. By joining a study, you have an equal chance of getting a new treatment or drug.

What is “no active” treatment?

For some types of cancer, no treatment has been shown to help patients. The standard treatment for those types of cancer would be no treatment at all. Instead, patients have frequent follow-ups and doctors keep track of the cancer. In these cases a study compares a new treatment with a placebo. However, before you decide whether or not to take part in the study, you will be told during the informed consent process that there is a possibility that you will get a placebo. Again, however, this is a case where “no treatment” is the standard treatment.

How do I know if I could get a placebo?

The research team must tell you if a placebo will be used before you decide to join a study. It must also be on the informed consent form. If you are worried about getting a placebo, ask the study team. You have a right to know.

Who can help me understand more about research studies?

We urge you to learn as much as you can about research studies. Sometimes, even the most caring doctors don’t have time to answer all patients’ questions. Also, there are times when patients want to get information from someone who is not on a study team. Here are three accurate sources for more information:

• This website. Check the section at the end marked “Additional Resources” to find other websites with accurate information.
• The Cancer Information Service, which is run by the National Cancer Institute (NCI). You can call and talk with Cancer Information Specialists. Call: 1-800-4-CANCER. The specialists can explain more about research studies, answer your questions, and send you more information in the mail. Just ask!
• Your doctor or hospital. Many hospitals and cancer treatment centers provide patient education services run by librarians, health educators, or nurses. They can give you material to read.  They can also help you find information on websites you can trust. Feel free to ask your doctor or nurse where you can get more information.

What if I change my mind about joining a study?

You have the right to change your mind about being in a study and leave the study at any time, even after the study has started. The consent form must state that you are allowed to leave a study at any time. It will also explain what will happen to the information that the study has already collected about you.

If you decide not to join or to leave a study, the law protects you from harm. Your doctor must still provide the standard treatment. If this is a concern, talk to your doctor about how your treatment will go if you decide later to leave the study.