Research Recruitment Database Consent Form

INDIANA UNIVERSITY INFORMED CONSENT STATEMENT FOR

RESEARCH RECRUITMENT DATABASE

for Department of Otolaryngology-Head and Neck Surgery

IRB Study #1603207953

You are being asked to participate in a research recruitment database. Scientists do research to answer important questions that might help change or improve the way we do things in the future. This consent form will give you information about the research recruitment database to help you decide whether you want to participate. Please read this form, and ask any questions you have, before agreeing to be in the study.

All research is voluntary. You can choose not to join in this research recruitment database. If you decide to participate, you can change your mind later and leave the database at any time. If you are contacted about a possible study opportunity, you may choose not to participate in the study. You will not be penalized or lose any benefits if you decide not to participate or choose to leave the study later.

Purpose of the Research Recruitment Database:

You and/or your child are invited to join the Research Recruitment Database for the Department of Otolaryngology-Head and Neck Surgery, which is being run by Dr. William Kronenberger from Indiana University School of Medicine. You are being invited because you have shown interest in participating in research studies. The purpose of this Research Recruitment Database is to help our department contact families interested in learning about research opportunities.

In this consent form, “you” always means the study participant. If you are a legally authorized representative (such as a parent or guardian), please remember that “you” refers to the study participant.

Procedure for being added to the Research Recruitment Database:

If you agree to enroll yourself or your child in the database, you will be asked to provide the following information:

Participant name (and parent/guardian name, if applicable)
Date of birth
Language used in the home
Level of hearing loss
Age of hearing loss diagnosis
Current amplification (e.g. cochlear implant, hearing aid, not applicable)
Age at first amplification
Mode of communication
Medical and developmental diagnoses
Contact information - address, phone number, email

This information will be added to a secure recruitment database which will be accessed only by authorized research team members. Researchers will use the database to determine possible eligibility of participants for future studies. You may be contacted in the future to provide you with more information about potential research opportunities in our department.

Enrolling in this recruitment database does not obligate you to participate in any future research studies.

Before agreeing to participate, please consider the risks and potential benefits of taking part in this study. There are minimal risks associated with enrolling into this research database. There is always a risk of loss of confidentiality in a research study, but great effort will be made to keep your personal information confidential at all times.

Your participation in this database will allow researchers to contact you about potential research studies. If you/your child decide to participate in a specific research study, you/your child may or may not receive benefits. However, feedback from the tests could be used to develop successful rehabilitative programs for those with hearing loss.

You will not be paid for participating in this database, and there is no cost to join.

We will protect your information and make every effort to keep your personal information confidential, but we cannot guarantee absolute confidentiality.

Your personal information may be shared outside the research study if required by law. We also may need to share your research records with other groups for quality assurance or data analysis. These groups include the Indiana University Institutional Review Board or its designees, and state or federal agencies who may need to access the research records (as allowed by law).

Information collected in this study may be used for other research studies or shared with other researchers for future research. If this happens, information that could identify you, such as your name and other identifiers, will be removed before any information or specimens are shared. Since identifying information will be removed, we will not ask for your additional consent.

If you have questions about the database or encounter a problem with the research, contact the research coordinator Allison Ditmars at (317) 274-4915 or aditmars@iupui.edu or the principal investigator, Dr. William Kronenberger at 317-944-8162,

For questions about your rights as a research participant, to discuss problems, complaints, or concerns about a research study, or to obtain information or to offer input, please contact the IU Human Research Protection Program office at 800-696-2949 or at irb@iu.edu.

If you decide to participate in this database, you can change your mind and decide to leave the database at any time in the future. If you decide to withdraw, please contact the research coordinator, Allison Ditmars at (317) 274-4915 or aditmars@iupui.edu.

Agreement to be Contacted by Text and/or Email

We would like to communicate with you about study opportunities by text message and/or email. We might use text or email to notify you of new studies or invite you to participate.

Text messaging and email are not secure methods of communication. The information sent over text or email, which may include sensitive or personal information, such as protected health information, could be accessed or read by someone other than you. If you would like us to communicate with you via text or email, please indicate your choice below and provide the phone number(s) and/or email address(es) you would like us to use.

Email Communication

* must provide value

YES, I authorize the researchers to send me emails related to research studies.

NO, I do not wish to receive emails from the study team

reset

Email address for this communication:

Text Communication

* must provide value

YES, I authorize the researchers to send me text messages related to research studies.

NO, I do not wish to receive text messages from the study team

reset

Phone number for this communication:

PARTICIPANT'S CONSENT

In consideration of all of the above,

* must provide value

YES, I agree to enroll in the Research Recruitment Database

NO, I do not want to enroll in the Research Recruitment Database at this time

reset

I am at least 18 years old.

Must be at least 18 to enroll.

If you are a parent enrolling your child into the database, and you are over 18, please select "True"

True

False

reset

Participants need to be at least 18 years old to provide consent to enroll into the Research Recruitment Database.

Parents may enroll their children who are under age 18. If you are a parent, please list YOUR information on this consent form.

Thank you!

Please enter your first and last name

* must provide value

Date:

* must provide value

Y-M-D

Signature:

* must provide value

Add signature

Thank you for your interest in the Research Recruitment Database! If you change your mind, please free to come back and enroll in the future.

If you have any questions, please contact the Study Team at (317) 274-4915 or Devinfo@iupui.edu

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