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INDIANA UNIVERSITY INFORMED CONSENT STATEMENT FOR UNITED WAY DATA INTEGRATION PLAN (UWDIP)
Note: In this document, the word “you” refers to yourself. You are a client whose data is being requested. If you are enrolling your child between 7-17 years of age, “you” refers to your child, who is a client.
You are invited to take part in a research study about the services nonprofits provide their clients. You may choose to take part or not. Your choice will not affect the services you receive from this agency. Please take as much time as you need to read this information sheet. You will receive a copy of this form.
The study is being performed by The Polis Center (“the Center”). The Center is a research unit of Indiana University in Indianapolis that works on better understanding communities in order to bring about meaningful change.
PURPOSE OF THE STUDY
This research project hopes to better understand the people who use services from some nonprofit agencies, what their outcomes are, and whether or not they use services from several agencies. You are invited to take part in this study because you are seeking services from this agency. We are asking you to participate because we are trying to learn more about the combination of services from many agencies that lead to improved outcomes for people and families. This project will last for at least two years starting in April 2017 but may continue beyond that time.
PROCEDURES
If you choose to participate, you agree to share data this agency has already collected or will collect about you with the Center. You will receive another document listing the types of data this agency might share about you. Your data will only be shared if you choose to participate.
If you choose to participate in this study, you will need to sign this form and give it to a staff member at this agency. If you do not wish to participate, you will not sign this form, and your data will not be shared with the Center. Your decision to participate will not affect the services you receive.
If you choose to participate, this agency will transfer your data to the Center. Your data will be stored in a database and may be combined with records about you from other nonprofit agencies where you have given your consent. The Center’s goal is to create a list of people served and the services they received.
Your data also may be combined with your records from state agencies including the Indiana Network of Knowledge (INK), Indiana Department of Education (IDOE), Indiana Family and Social Services Administration (FSSA), Indiana Department of Workforce Development (DWD), Indiana Commission on Higher Education (CHE) and/or local school corporations. For example, we will try to link to records about student education outcomes like school performance, attendance, assessments, and disciplinary measures.
The Center will use this information to create summary reports about the programs and services offered by this agency and other nonprofit agencies. The summary reports will not contain any information that could identify you or anyone else participating in the study.
IRB Study #1608061974
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Protocol 1608061974 IRB Approved
IRB Study #1608061974 The study will continue for two years. After two years, the study may be extended.
RISKS TO YOU
While taking part in the study, there could be a risk of your private data being released. However, a very high level of security is in place to lower the chances of this happening.
In case private data is released, the Center will work with agencies involved to find out how the data was released, and will act quickly to prevent the problem from happening again. The Center or the agency involved in the release of data will supply relevant records, logs, files, and security reports to the correct parties. This is to follow the appropriate laws regarding data security, including laws related to any investigation as a result of the data release.
COSTS & COMPENSATION
It will not cost you anything to participate in the study, and you will not be paid to participate.
BENEFITS
You will not benefit directly from this study. No one will benefit financially from the study. The study will help United Way, this agency, and other agencies improve the services provided to all of their clients. The study will also help agencies make choices that improve the outcomes of their clients after receiving services.
PRIVACY AND CONFIDENTIALITY
Efforts will be made to keep your personal information confidential, but we cannot guarantee absolute confidentiality. Your identity will be not be disclosed in any reports that may be published as result of this study. Your records may be shared if required by law.
Organizations that may inspect and/or copy all or part of your research records for quality assurance and data analysis include groups such as the study investigator and his/her research associates, the Indiana University Institutional Review Board or its designees, and (as allowed by law) state or federal agencies, specifically the Office for Human Research Protections (OHRP), who may need to access your medical and/or research records.
CERTIFICATE OF CONFIDENTIALITY
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National
Institutes of Health. We can use this Certificate to legally refuse to disclose information that may
identify you in any federal, state, or local civil, criminal, administrative, legislative, or other
proceedings, for example, if there is a court subpoena. We will use the Certificate to resist any
demands for information that would identify you.
However, you should understand that a Certificate of Confidentiality does not prevent you or a member
of your family from voluntarily releasing information about yourself or your involvement in this
research. If an insurer, medical care provider, or other person obtains your written consent to receive
research information, then the researchers will not use the Certificate to withhold that information.
VOLUNTARY NATURE OF THE STUDY
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Protocol 1608061974 IRB Approved
You may choose to participate in this study or not. You will receive the same services no matter what you choose. There will be no penalties to you if you choose not to participate.
You have the right to withdraw your consent to participate at any time. Nothing bad will happen if you do. To withdraw your consent, contact this agency’s staff or the study team directly. If you withdraw your consent, the Center will remove your personal information from its database to the extent possible. You are not waiving any legal rights by participating in this study. If you have any questions about your rights as a participant in this study, please contact the study team using the contact information below.
STUDY CONTACTS FOR QUESTIONS
If you have any questions about the study that were not answered today, please call Kelly Davila at 317- 274-4510, or email at davilak@iu.edu. For questions about your rights as a participant, or to talk about your concerns about the study, contact the Indiana University Human Subjects Office at 317-278-3458 or 800-696-2949 or via email at irb@iu.edu.
CONSENT
By signing below, you agree to participate in the study. You will get copy of this document to keep. Children between 12 and 17 years of age must sign their assent below to participate. For children under 12, a parent or legal guardian may sign this form allowing the child to participate.
Subject’s Printed Name:  ______
Subject’s Signature:  Date:
(The subject must write today’s date.)
If subject is under 18 years of age or has a legal guardian/representative signing on behalf of the subject (Please use only one):
Printed Name of Parent or Legal Guardian:
Signature of Parent or Legal Guardian:  Date:
Printed Name of Legally Authorized Representative:
Signature of Legally Authorized Representative:  Date:
IRB Study #1608061974
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Protocol 1608061974 IRB Approved
For staff obtaining consent:
Printed Name of Person Obtaining Consent:
Signature of Person Obtaining Consent:  Date:
IRB Study #1608061974
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Protocol 1608061974 IRB Approved
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