Talking Point to Minors

How to Talk to a Minor about Research

 

Notice to adults enrolling on behalf of a child under the age of maturity:

 

Please read the following information regarding the research if you would like your child to take part in the study. Your child must be older than 3 months in order to take part in the study.

 

All survey questions on the uBioDiscovery website address the research participant. We ask you to answer these surveys with or on behalf of your child, depending on his or her age, maturity, and understanding.

 

In addition, for studies like superbioME, when children or minors are involved in research, the regulations require the assent of the child or minor and the permission of both parents, in place of the consent of the subjects.

 

Assent is a child’s affirmative agreement to participate in research. Mere failure to object should not be construed as assent.

 

On this page, you will be asked to read the informed consent document and provide permission for your child to participate in this research. Your child must also be informed about the research and decide if he or she wishes to participate. If a child expresses discomfort with a survey topic, question, or the study in general, they may choose to stop participating.

 

If your child is mature enough to understand the informed consent document, please have the child read it and discuss any concerns with you.

 

If your child cannot read and understand the informed consent document, here are some suggested ways to discuss this research, including the potential risks and benefits, with your child:

 

  1. For Ages 9-12:

 

What is Bacteria?

 

  • Bacteria are small cells that live everywhere inclusive in your body.
  • Your bacteria also helps your body to work. Certain kinds of bacteria could make a person have a health problem or get a disease.
  • Your bacteria is very unique. Nobody else has bacteria exactly like yours.
  • You even have bacteria in your gut! Scientists at uBioDiscovery can look very, very closely at your stool to take a picture of your bacteria. All you have to do is send a small amount of stool in a special tube and mail it to our lab.

 

Why uBioDiscovery wants my Bacteria?

 

Our scientists are trying to learn how bacteria from your gut affects people’s health. Some people get sick with a disease. Some don’t. We want to learn why. Maybe a person’s bacteria affects whether or not they get a disease, or if a medicine will help them. We also want to know how bacteria affects other things, like weight or mood. If you want to, you can mail us your stool so we can look at your bacteria. Then your parents can tell us about you on our website.

 

What will uBioDiscovery do with my Bacteria?

 

Our scientists will compare your Bacteria to other people’s Bacteria. Some of those other people have some bacteria in common with you. Some of them don’t. This might help us learn a lot of things. For example, we could learn that certain Bacteria may make it more likely that a person will be overweight or more likely to get sick.

 

Is sharing my Bacteria with uBioDiscovery safe?

 

Your Bacteria is very special, just like you. Remember that your Bacteria is like extra help or can hurt your body. If someone looked at your bacteria, they might learn things about you that you don’t want to tell them. We are very careful with your bacteria information and we will do our best to keep it safe. The computers where we keep your bacteria information have strong protections to keep other people from breaking in and looking at your information.

 

How does helping with this Bacteria study help me?

 

Since Bacteria help or affect your body, we want to see if sick people and healthy people have different Bacteria. If sick people have different Bacteria, that could help doctors. Doctors might be able to make a better medicine for sick people. Maybe doctors could warn people before they

got sick. It could take a long time, but if we learn something important in the study, that could help you. Doctors might be able to keep you from getting sick, or help you get better faster.

 

Who decides if I join this study?

 

You and your parents do. If you want to and your parents say it’s okay, then you can be in our study. If you don’t want to be in our study, that’s fine! Just make sure to tell your parents so. Even if you decide to join this study today, you can change your mind later and quit. If you join, we will contact you when you are older so you can decide for yourself if you would like to keep being in the study.

 

  1. For Ages 13 and Older:

 

What is Bacteria?

 

  • Bacteria are small cells that live everywhere inclusive in your body.
  • Your bacteria also helps your body to work. Certain kinds of bacteria could make a person have a health problem or get a disease.
  • Your bacteria is very unique. Nobody else has bacteria exactly like yours.
  • You even have bacteria in your gut! Scientists at uBioDiscovery can look very, very closely at your stool to take a picture of your bacteria. All you have to do is send a small amount of stool in a special tube and mail it to our lab.

 

Why uBioDiscovery wants my Bacteria?

 

The scientists at uBioDiscovery are trying to learn more about how Bacteria affects health and diseases in humans. We know that some people get a certain illness and other people don’t, but we don’t know why. uBioDiscovery scientists want to find out if a person’s Bacteria might affect whether or not they get a certain disease, or if a certain medication or treatment will work for them. uBioDiscovery scientists also want to find out how a person’s Bacteria affects other things, like weight. If you want to, you can help by mailing us a sample of your stool so we can look at your Bacteria. Then your parent or guardian will answer questions on our website about you.

 

What will uBioDiscovery do with my Bacteria?

 

uBioDiscovery scientists will compare your Bacteria to other people’s Bacteria. Some of those other people have something in common with you and some of them don’t. This might help us learn a lot of things, such as whether Bacteria affects a person’s chances of being skinnier or of getting a certain illness.

 

Is sharing my Bacteria with uBioDiscovery risky?

 

We know that your Bacteria is very special, just like you, and we will be very careful to protect it. Remember that your Bacteria help or hurt your body. If someone were to break into our computers and look at your Bacteria, they might be able to use it to learn things about you that you didn’t know, or that you don’t want to tell them. uBioDiscovery scientists are very careful with your Bacteria and we do our best to keep our computers safe. We will put special protections in place to try to stop any other people from breaking into our computers and looking at your

Bacteria without our permission.

 

How does helping with this Bacteria study help me?

 

Right now, scientists and doctors are trying to learn more and more about health and disease in humans. If we can learn more about this by looking at Bacteria, then the scientists and doctors might be able to create better medicines to help other people who have certain health problems. If you help by answering questions about yourself on our website, then you may be able to help other people with health problems to get better medications or treatments.

 

Who gets to decide if I join this study?

 

You and your parents do. If you want to help with this study, and your parents say that’s okay, then you can participate. If you don’t want to join the study, that’s okay, too! Just be sure to tell your parents that you don’t want to take part. Even if you decide to join this study today, you can still change your mind at any time. You can choose not to take any of the surveys on the uBioDiscovery website or even ask your parent to remove you from the study on the uBioDiscovery website. If you join the study now, we will contact you when you reach the age of

maturity to encourage you to read the consent document and decide for yourself if you would like to continue to participate.