Cancer : Taking Part in Clinical Trials, Part 3

by National Cancer Institute

(Page 3 of 3)

What Is Informed Consent

Informed consent is a process during which you learn key facts about a clinical study before you decide whether or not to join. These facts include details about the study approach and tests you may have, and the benefits and risks that could result.

The doctor or nurse will give you a form that goes over key facts. It's called a consent form. If you decide to take part in the study, you'll be asked to sign this form. You can take the form home and discuss it with your family, friends, or others before you make your decision. If you do decide to join the study, be sure to ask for a copy of the consent form so you can look it over at any time.

Don't be afraid to ask questions until you get all the facts you need to decide. This is an important decision, and you should feel at ease with the choice you make. In fact, you should feel free to ask the research team questions at any time.

Informed consent is more than a piece of paper; it's a process that lasts throughout a study. For example, you may be told about new risks or other findings from the study, and asked to sign a new consent form. As always, the choice to join or to continue is yours.

You Can Leave the Study at Any Time

Informed consent lasts as long as you're in the study. You can change your mind and leave the study any time you want--before the study starts or at any time during the study or follow-up period. If you decide to leave, you'll have a chance to talk about other prevention options with your own doctor or with a doctor from the study.

What Protections Do You Have?

Before and during a cancer prevention trial, you have several important rights:

Informed consent - the right to know all you need to make a thoughtful decision about joining a study.

Changing your mind - the right to leave the study at any time.

Medical monitoring - the right to have your health watched throughout the study.

Removal from harm - the right to be taken off the study if doctors learn that an agent may harm you.

Should I Take Part in a Prevention Trial?

People decide to be part of a cancer prevention clinical trial for many reasons. For example:

Some people who have a higher cancer risk join a cancer prevention trial because they want to take a more active role in their health care. Also, because study participants get regular and careful medical attention, some health problems may be found early.

Some people feel good about helping medical knowledge advance. If the study agent turns out to work against cancer, it may help others. For example, prevention trials showed that aspirin helps prevent heart attacks, and now many people take aspirin daily on their doctor's advice.

Even when they don't lead to new therapies, clinical trials often answer important questions and help move research forward.

You need to weigh the benefits and risks for yourself. The list in the next section may help you do that. You also may find it useful to talk with family members or friends, your health care providers, and anyone you know who has been in a clinical trial.

Remember: You are the only person who can make this decision, and if you join a clinical trial, you can change your mind at any time - even after the study starts.

Weighing the Pros and Cons

Possible Benefits

• If the agent being studied is found to be helpful, you may be among the first to benefit.
• In a cancer prevention clinical trial, your health is reviewed with care.
• A cancer prevention clinical trial gives you a chance to help doctors learn more about cancer prevention and help others.

Possible Drawbacks

• New agents may have side effects or risks unknown to the doctors.
• The side effects, and results, of the agent may be worse than what's now recommended.
• Even if a new agent is helpful, it may not work for you.
• Health insurance and managed care providers don't always cover all costs in a clinical trial. (To find out what costs are likely to be covered for you, talk to a member of the research team or a social worker.) Even when they don't lead to new therapies, clinical trials often answer important questions and help move research forward.

Questions You Should Ask

Finding answers, and making choices, may be hard for people who are at risk for cancer - and for those who care about them. It's important for you to discuss your concerns and your choices with your doctor and with the staff of any clinical study that you're thinking of joining.

Ask questions about any issues that concern you. You need to review your choices.

Tips for Getting Information

When you talk with your doctor or members of the research team:

• Take a family member or friend along for support and for help in asking questions or recording answers.
• Plan ahead what to ask--but don't be afraid to ask any new questions you think of while you're there.
• Write down your questions in advance, to make sure you remember to ask them all.
• Write down the answers someplace where you can review them when you want.
• Bring a tape recorder to make a record of what's said (even if you write down answers).

Here are some questions you may want to ask about:

The Study

1. What's the purpose of the study?
2. Why do doctors think the approach may work? (For example, how has it been studied bef
3. Who will sponsor the study?
4. Who has reviewed and approved it?
5. How are the study results and safety of participants being checked?
6. How long will the study last?
7. What will I have to do if I join?
8. Will I ever know if I'm taking the study agent that's being studied?

Possible Risks and Benefits

1. What are the short-term benefits for me?
2. What are the long-term benefits for me?
3. What are the short-term risks, such as side effects, for me?
4. What are the long-term risks for me?
5. What other prevention options do people with my risk for cancer have?
6. How do the risks and benefits of this trial compare with those options?

Your Participation and Care

1. What kinds of therapies, tests, or procedures will I have during the trial?
2. Will they hurt, and if so, for how long?
3. How do they compare with the care I'd have outside the trial?
4. How often, and for how long, will I take the study agent that is being studied?
5. Will I be able to take my regular medications?
6. Where will I have my medical exams?
7. Will I be able to see my own doctor?
8. Who will be in charge of my care?

Personal Issues

1. How could being in the study affect my daily life?
2. Can I talk with other people who are in the study?

Cost Issues

1. Will I have to pay for any part of the trial, such as tests or the study agent
2. If I will, what are the charges likely to be?
3. What is my health insurance likely to cover?
4. Who can help answer any questions from my insurance company or health plan?

About the Author

www.nci.nih.gov
The National Cancer Institute's research programs are extensive and contain many innovative initiatives. I invite you to explore our Web site to find out more about the exciting work being conducted here at NCI and by NCI-supported scientists throughout the country.