Verbal Assent

ASSENT (13-15) FOR PARTICIPATION IN A RESEARCH PROJECT

<Affiliated Medical Center or Dept of Health>

VERBAL ASSENT

Study Title: Surveillance for Clostridium difficile Infection (CDI)

Principal Investigator: <EIP site PI or local PI>

Funding Source: Emerging Infections Program, Centers for Disease Control and Prevention

We are calling you to invite you to take part in a research study. The purpose of the study is to learn about a diarrheal illness that you had that is caused by a bacteria called Clostridium difficile. Your [parent/guardian] has agreed that you and/or they will answer some questions about your illness. The survey will take about 40 minutes and we will use what you and/or they tell us to help us understand and prevent this type of illness in others. There is no right or wrong answer to these questions and you do not have to agree to be in this study. There is no harm in being in this study and no one will be upset if you do not want to be in it.

There is also no direct benefit to you. Your name and facts will be kept private as much allowed by law. You and/or Your [parent/guardian] can also refuse to answer any questions or stop the interview at any time.

.

Now that I have told you about the study, do you have any questions for me about the study? (answer all questions before proceeding).

Have I answered all of your questions? (if no, probe, and answer any remaining questions)

If you have questions about the study at a later time or if you feel you may have been harmed in any way by taking part of this study, you or your [parent/guardian] may call the <EIP site> at <contact number>.

Do you understand and agree with the decision to participate?

(Verbal assent given) Yes _____ No _____

___________________________________________ ___________________

Interviewer signature Date