Participating in a Clinical Trial: Rights and Responsibilities

How are your rights protected?

You will want to know your rights and responsibilities as you think about joining a clinical study. Laws in the United States and Canada exist to make sure that people who are thinking about a clinical study will be protected and will know all of the details about a study. Special legal protections are given for pregnant women, human fetuses, neonates, and children.

What kind of information can you get about the study?

There are lots of ways that you might get information about a clinical study. With the permission of your child’s doctor, a member of the research team may contact you and speak with you. You may see a brochure or information sheet that gives some details about a study. But the most important way to get information is through the consent form . This form is required by law to have all of the following things included:

• A statement that the study involves research
• An explanation of why the study is being done
• The length of time the subject will be in the study
• The procedures to be followed and any procedures which are experimental
• A description of any potential risks or discomforts to the subject
• A description of any potential benefits to the subject or to others
• Appropriate alternative procedures or courses of treatment that might be good for the subject
• How privacy of records or confidentiality will be maintained
• An explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained
• Whom to contact for answers about the research and research subjects' rights
• Whom to contact in the event of a research-related injury to the subject
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits, and that the subject may stop the study at any time.

What are your rights?

• You have the right to be informed as fully as possible, to understand what has been explained to you, and to be given time to ask questions and have them answered by one of the investigators .
• Your consent to join a study must be voluntary and you must not be forced in any way to agree to join.
• You have the right to stop the study at any time and continue to receive your regular care. It will not harm your relationship with your doctors and nurses if you choose to stop the study.
• You must not be given promises of benefits that are not likely to result from being in a study.
• You must be given a copy of a signed and dated written consent form when one is required. The form must be written in simple language that you can understand.
• The research team will tell you how you may reach them in case you have questions or concerns and they will often contact you to see how you are feeling.

What are your responsibilities?

• Consider the extra time and effort that may be needed to be in a study.
• When you decide that your child will be in a study, it is important to follow the study instructions very carefully. This may mean giving the proper doses of study medicine and, at the right time, returning for each study visit and letting the study team know if your child had any adverse effects from the treatment.
• Keep in regular contact with the study team. Let the research team know if your address or phone number changes and how you can best be reached. Call the research team if you will not be able to go to one of the study visits. They will want to know that you are okay and will help you to find another time that is good for you. Talk with them if you have transportation, childcare, or other concerns. Often, the study team can help you to find other resources or departments at the hospital that can help you.
• If you decide to leave the study, talk with a member of the study team before you do so. Your child may need to be placed on a different medicine or need a certain test as you leave the study.