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Why should I join? What do I get out of this?
- The treatment being tested may work for you.
- Clinical Trials may be the only way for you to receive a promising new drug.
- Drugs taken as part of a clinical trial are usually free.
- You can help in the development and availability of new medications. This is especially important for medications being studied to treat life threatening conditions, chronic illnesses or contagious diseases.
What is Informed Consent?
Researchers are required by law to give you all the facts about a study before you join. This information must be explained in a way that you can understand. Before you join a study, you will be asked to read and sign a consent form. This is called giving informed consent. When you sign the consent form, it means that you understand all the information you have been given about the study and that you agree to join. The consent form is not a contract. You do not give up any rights if you sign the consent form. Entering and leaving a clinical trial is strictly voluntary.
What should I know before I sign the consent form?
Before you sign the consent form, you should know:
- The reasons for using the experimental treatment.
- The risks and benefits of taking part in the study. If there are any costs.
- How many office visits you will have to make.
- The number and type of medical procedures you will have.
Are there any other questions I should ask before I sign the consent form?
Before you decide to join a clinical trial, you may want to know:
- How will information about me be handled to protect my privacy?
- Will I continue to receive drug after the trial is over?
- Will I have to pay for it?
- Will I be taken off the trial if I get sick or develop health problems?
- How can I find out results of the trial?
- Are there other studies of this drug I should know about?
- Will I have to use birth control? If so, what kind? If my partner or I become pregnant will I have to leave the study?
- Are there medications that I cannot take while participating in this trial?
Why do some studies pay people to participate?
Some research studies pay the volunteers. Usually studies pay only when there is not an expected medical benefit directly to participants, such as when a drug is being tested for only a short amount of time. Sometimes studies pay when they require a lot of time and energy from participants. Some feel that the offer of money is not always ethical because it may tempt some people to take risks that they would not otherwise take. Ask if the study is paying participants before you decide to join. Keep in mind that studies usually do not pay until you have completed your visits.
What if the drug makes me sick or sicker?
The researchers who design the trials always plan what to do if a volunteer becomes sick from the drug they are studying. If the drug makes you sick, you may have to take a lower dose, or stop taking the drug completely. In some trials, you might be switched to another drug. You should keep in close contact with your health care provider, as well as the research coordinator assigned to you, so they can treat any side effects as soon as possible.
Will I have to take a placebo (“sugar pill”)?
Placebos are usually used only when it is not known if the medication being studied is effective. A “placebo controlled” study is the only reliable way to find out if the drug works. Some subjects are asked to take placebos so researchers can learn whether the drug causes changes in their health, or if changes occurred regardless of the medication they were taking. Usually the study physician, research coordinator and the subject do not know if the subject is receiving the active study medication or the placebo. Please be assured that all subjects, even those who take placebos, receive the same medical attention.
What are my rights as a research subject?
The people involved in your care must treat you with consideration and respect. You have the right to:
- Be treated with respect and dignity.
- Be told all the important details about your care.
- Ask questions and have them answered.
- Say no to any test, procedure, or medication.
- Go to another health care provider to get more information.
- Know the names of anyone you talk to.
- Read your medical records with your health care provider.
- Make your own decisions about your health care.
- Know that your medical records will be kept confidential.
What are my responsibilities as a research subject?
The researchers have a right to expect certain things from you, too. As a research subject you have the responsibility to:
- Be honest about your medical history and anything in your lifestyle that may affect your health.
- Follow instructions and take the study drugs(s) as prescribed.
- Keep appointments or reschedule them in advance.
- Be on time to your appointments.
- Report any changes in your health.