Appendix 10d Chicago HCHS English version

UNIVERISITY OF ILLINOIS AT CHICAGO

Research Subject Authorization Confidentiality & Privacy Rights
Health lnsurance Portability and Accountability Act (HIPAA)
Protocol Title: Hispanic Community Health Study/Study of Latinos (HCSFVSOL)
Martha L. Daviglus, MD, PhD - Vice Chancellor for
Principal Investigator Name and Title:
Research; Director- Institute for Minority Health
Research (IMHR); Professor of Medicine'
1 8 19 W. Polk Suite 246, Chicago,IL 60612
Address and Contact Information:
T el. 3 12.4 13 .07 39 Email [email protected]
Emergency Contact Name and Information:

- Project Coordinator
Institute for Minority Health Research
840 S Wood Suite 120, Chicago, IL 60612

Cesar Alvarado

T el. 3 12.413 .325 4

Email calvar3

@u ic.edu

You have agreed to participate in the research Study mentioned above and have signed a separate
informed consent thãt explained the procedures ofthe research Study and the confidentiality ofyour
personal health information. This authorization form gives more detailed information about the following:

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What personal health information about you will be collected in this Study
Who will use your information within the institution and why
Who may disclose your information and to whom
Your rights to access your personal health information during the Study
Your right to withdraw your authorization (approval) for any future use of your personal health

information
By signing this document you are permitting your doctors and other health care providers to disclose
personal health information collected about you to the Universþ of Illinois at Chicago and the researcher
ii.t"d ubou" for purposes of the Study. You are also allowing UIC and the researcher to disclose that
personal health ínfoìmation to outside organizations or people involved with the processing of this Study,
as described in the separate informed consent form.

What personal information is collected and used in this Study, and might also be shared
(disclosed)?
personal contact and personal health information will be collected, used for this research
Study and maybe disclosed or released during your involvement with this research Study:
- Name
- Address
- Relatives' names or addresses
- Telephone number
- Participant ID number
- Social Security numbers
- Enrollment Date
- Medical Record number
- HospitalizationlBmergency department records

ihe following

other tests and procedures that will be performed in the Study include:
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Height and Weight Measurements
Blood Pressure

An echocardiogram an exam ofyour heart
A dental examination
Blood sugar test for diabetes
A test for cholesterol levels
It also includes questions about:

'Nutrition
' Stress and depression
' Work and home environment
' Physical activity and eating habits
' Family medical history
Why is your personal information being used?
Your personal contact information is important for the University of Illinois research team to contact you
during the Study. Your personal health information (including the results of tests and procedures) is being
collected during this research Study for purposes of the Study. The Principal Investigator may also use
the results ofthese tests and procedures to treat you.

Who within the University of Illinois at Chicago may use or disclose your personal health
information?
The following individuals and organizations within the University of Illinois at Chicago may use or
disclose your personal health information for this research project:
The Principal Investigator and the Investigator's Study team (other University staff associated
with the Study)
The University of Illinois at Chicago Institutional Review Boards (the committees charged
with overseeing research on human subjects)
The University of Illinois at Chicago Office for the Protection of Research Subjects (the
office which monitors research studies)
Authorized members of the Universþ of Illinois at Chicago workforce who may need to
access your information in the performance of their duties (for example: to make sure the
research is being done correctly).

Who outside of the University of Illinois at Chicago might receive your personal health
information?
As part of the Study the Principal Investigator, Study team and others listed above, may disclose your
personal health information, including the results of the research Study tests and procedures. to the

following:

-

Other academic research center(s) who are also working on the Study
University of North Carolina Chapel Hill Collaborating Center
National Heart, Lung, and Blood Institute (NHLBD who is sponsoring the study
Government agencies such as the Food and Drug Administration and Office of Human

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Research Protection
Other health care providers who are part of the Study (e.g., laboratories who perform tests)
The University of Illinois at Chicago Institutional Review Board
the University of Illinois Medical Center and its representatives, and other persons who watch
over the safety, effectiveness, and conduct ofresearch.

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The personal information of yours that is disclosed in connection with the Study may no longer be
protected by the federal privacy protection regulations.
o

In records and information disclosed outside of the University of Illinois at Chicago, you will be
assigned a unique code number. The Principal Investigator will ensure that the key to the code
will be kept in a locked file. The key to the code will be destroyed at the end of the research
Study.

How long will the University of Illinois at Chicago be able to use or disclose your personal health
information?
Your authorization for use of your personal health information for this specific Study does not expire.
This information may be maintained in a research repository (database). However, the University of
Illinois at Chicago may not re-use or re-disclose your personal health information collected in this Study
for another purpose other than the research Study described in this document unless it obtains permission
to do so from the University of Illinois at Chicago Institutional Review Board.

Will you be able to access your records?
Results ofall tests and procedures done solely for this research Study and not as part ofyour regular
and will not be included in your medical record. You will be able to request access to your medical

care

record when the Study is completed.

During your participation in this Study, you will have access to your medical record and any Study
information that is part of that medical record. The investigator is not required to release to you
information in the research records.

How will your health information be protected?
The researchers at the University of Illinois at Chicago and all sponsoring organizations listed above
agree to protect your health information and will only share this information as described within this
research consent/authorization form.
When your health information is given to people outside of the research study, those agencies that receive
your health information may not be required by federal privacy laws (such as the Privacy Rule) to protect
it. They may also share your information with others without your permission, if permitted by laws that
they have to follow.

Can you change your mind?
You may withdraw your permission for the use and disclosure of any of your personal information for
research, but you must do so in writing to the Principal Investigator at the address on the first page.
Even if you withdraw your permission, the Principal Investigator for the research Study may still use your
personal information that was collected prior to your withdrawal of permission if that information is
necessary to the integrity of the Study. If you withdraw your permission to use your personal health
information that means you will also be withdrawn from the research Study.

If you withdraw your permission to use any blood or tissue obtained for the Study, the Principal
Investigator will ensure that these specimens are destroyed or will ensure that all information that could
identifu you is removed from these specimens.

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What are my rights as a research subject?

If you have questions or concerns regarding your privacy rights under HIPAA, you should contact the
University of Illinois at Chicago Privacy Officer at Ph: (312) 996-2271.
You are not required to sign this authorization. If you decide not to sign the authorization:

Rieht to Refuse to Sien this Authorization
You do not have to sign this ConsentlAuthorization. However, because your health information is
required for research participation, you cannot be in this research study if you do not sign this form, If
you decide not to sign this ConsentlAuthorization form, it will only mean you cannot take part in this
research. Not signing this form will not affect your non-research related treatment, payment or enrollment
in any health plans or your eligibility for other medical benefits.

Ifyou

have not already received a copy

ofthe Notice ofPrivacy Practices, you should ask for one.

Your signature below indicates that you are providing both consent to participate in the research study
and authorization for the researcher to use and share your health information for the research.

Signature of Subject

Date

Printed name of Subject

Signature of Witness

Date (must be same as Sub.ject's)

Printed name of Witness

Signature of Parent / Guardian or
Legally Authorized Representative

Date (must be same as Subject's)

of

Subject

Printed name of Parent / Guardian or
Legally Authorized Representative of
Subject

Describe relationship to subject including the legal authority this individual has to act on behalf
of the subject. (Check one below)
Parent
Medical Power of attorney/representative
Legal guardian
Health care srrrogate
Other; specify

E

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