ASSENT DOCUMENT by lbK8L7VH

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                              SAMPLE ASSENT DOCUMENT
                              Required for children ages 12-17 years old

                                       INSTRUCTIONS

[TEXT FOUND THROUGHOUT THIS DOCUMENT IN BOLDFACE, ITALICS, AND
BRACKETS OFFERS GUIDANCE AND SUGGESTIONS. DELETE THIS TEXT AND
REPLACE IT WITH THE APPROPRIATE WORDING FOR YOUR PROJECT.]

The Assent Document is used when the investigator recruits subjects who, by age or
circumstance, are not able to give legally effective informed consent. When legally effective
informed consent cannot be obtained, the investigator should obtain the “assent” of the minor or
cognitively impaired subject. This form documents the minor’s or cognitively impaired subject’s
affirmative agreement, or assent, to participate in a research project. The investigator should
respect the decision of a minor or cognitively impaired subject not to participate, even when the
parent or legally authorized representative is willing to sign the Informed Consent Document.

In the case of minor subjects, the IRB require this form to be used with children who are 12 thru
17 years old, but it may also be used for impaired adults to enhance their comprehension if the
study involves complicated procedures.

When using an Assent form, the child or cognitively impaired adult signs the Assent to indicate
knowledgeable agreement (assent) to participate. In addition, the parent/guardian or legally
authorized representative signs the full Informed Consent Document to document legal consent
for the minor or cognitively impaired adult.




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                                  CHILDREN’S ASSENT DOCUMENT
                   Separate Parental Permission Consent Required for minors 12 thru 17 years old
                                             Unless Waived by the IRB

Project Title: [Title]
Investigator(s): [List Principal Investigator and all other all individuals (name and degree)
                 who will obtain informed consent from subjects; other members of
                 research team may be listed at the PI’s discretion.]
Investigator(s): Phone numbers
We are doing a research study. A research study is a special way to find out about something.
We are trying to find out [purpose of study in simple language].

If you decide that you want to be in this study, we will ask you to do several things. [Describe
procedures simply, including how many contacts.]

We want to tell you about some things that might happen to you if you are in this study.
[Describe risks – e.g., painful procedures, other discomforts, things that take a long time.]

Not everyone who is in this study will benefit. A benefit means that something good happens to
you. We don’t know if you will benefit. But we hope to learn something that will help other
people some day.

[For treatment studies only:] If you don’t want to be in this study, we will tell you about the
other things we can do for you.

When we are done with the study, we will write a report about what we found out. We won’t use
your name in the report.

You don’t have to be in this study. It’s up to you. If you say okay now, but you want to stop
later, that’s okay too. All you have to do is tell us.

It’s ok to ask your doctor if you have questions about your treatment. If you have questions
about your participation in this research you can talk to the Institutional Review Board
committee. This committee is a group people who protect your rights while you are in this study.
The Institutional Review Board can be research at (954) 355-4941.

If you want to be in this study, please sign your name.

I, ____________________________________, want to be in this research study.
       (Print your name here)

_____________________________________                                         _________________
      (Sign your name here)                                                         (Date)

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