- Be told what kind of study it is and why it is being done.
- Be given an explanation of the procedures to be used, as well as a description of any drug or device to be used.
- Be given a description of any discomforts and risks to be expected, as well as whether there will be any financial costs to you or your insurance company.
- Be given an explanation of benefits to be expected, if any.
- Be told of procedures, drugs, or devices that might help you if you do not participate in the study, as well as how the risks and benefits of such options compare with those of participating.
- Be told of any treatment or alternative treatment, if any, available to you during and after the study.
- Be given an opportunity to ask any questions about the study or the procedures involved.
- Be told of new findings that could change your willingness to consent and be informed that you may withdraw your consent to participate at any time, without penalty to you.
- Be given a copy of any consent form used in relation to the study.
- Be given the time and opportunity to decide freely whether to consent or not consent to participate in the study.
Regardless of the nature of the study or the participant group you might be placed in, you have the same rights.
Your general rights are outlined above. The researchers may give you more information on these rights during the informed consent process. They will also tell you what is expected of you (your responsibilities) while you are in the study.
Most studies involve no more than minimal risk to children, or they offer some possibility of direct benefit. No undue risks are taken with children who participate in research.
As a parent, you plan an important role in this process. Make sure you understand the risks as well as any possible benefits of your child participating in the study.
Ask questions of anyone involved in the study and feel free to discuss the study with your child’s regular pediatrician as well. Children also have the right to an age-appropriate explanation of the research.
We want both you and your child to be comfortable. If you have questions, please ask!
You will be given a person’s name and telephone contact for the study. If not, ask anyone working on the study. Wondering about benefits and risks of the study? Ask. Wondering whether you’ll be paid? Ask.
You can also use the web to learn about research with humans at any of these sites:
Telephone: (240) 453-6900
Fax: (240) 453-6909
Tuskegee, Alabama 36088
Telephone: (334) 727-8011