Date:Valid for Use Through:

Study Title:

Principal Investigator:

COMIRB No:

Version Date:

Version No:

Informed Assent for: Name of the Study

Person In Charge of the Study: PI

Name of Organization (e.g. University of Colorado Denver)

COMIRB #

What is this study about?

I am being asked if I want to be in this study. The goal of this study is to [explain the study in one or two sentences. Use only idea per sentence.]

Why are you asking me?

I am being asked to be in the study because I have [insert disease or condition]

What Do I Have to Do or What Will Happen to Me?

If I am in the study, I will: [one idea per bullet]

  • [Explain in very simple terms exactly what is expected of the child. Use bullets for each item.]
  • [Explain how long they study will last and how much time they will have to spend each visit]
  • [If this is a longitudinal study a table indicating what is expected and when is useful].

[If applicable] If I am in this study I will be asked questions. I will be asked about: [list topics]

Will this Hurt?

[tell the child which procedure may hurt].

Do I get anything for being in the study?

If I am in the study, I will get . . . . .

Can I ask Questions?

I asked any questions I have now about the study. All my questions were answered.

I know that if I have a question later, I can ask and get an answer. If I want to, I can call [person] at [phone number].

Do I Have to Do This?

I know that I do not have to be in this study. No one will be mad at me if I say no.

I want to be in the study at this time.  yes no

I will get a copy of this form to keep.

Child’s Printed Name:______

Child’s Signature:______

Date:______

Witness or Mediator:______

Date:______

I have explained the research at a level that is understandable by the child and believe that the child understands what is expected during this study.

Signature of Person Obtaining Assent:______Date:______

Initials:______

Assent Format for Children NOT Agreeing to Participate with Override

If there will be a potential direct benefit to the child but the child does not want to be in the study, use the following assent.

Dr. ______has told me the research study is about [use same explanation as was used in Assent].

Dr. ______has also told me what I would have to do if I was in the study.

I have thought about whether I want to be in this study. I have asked all the questions I have. My questions were answered.

I have told my parents and Dr. ______that I don't want to do this. I know they have decided I need to be in this study anyway.

Child’s Printed Name:______

Child’s Signature:______

Date:______

Witness or Mediator:______

Date:______

Assent Template Form

CF-016, Effective 4-20-2010