Appendix 10h San Diego English version

San Diego State University (SDSU)
San Diego State Research Foundation (SDSURF)
Research Subject Authorization
Confidentiality & Privacy Rights
Hispanic Community Health Study/ Study of Latinos (HCHS/SOL)-Visit 2
Study Investigator:

Gregory Talavera, MD MPH
Graduate School of Public Health
San Diego State University
9245 Sky Park Court., Suite 110
San Diego, CA 92123
Phone (619) 594-4086

You have agreed to participate in the Hispanic Community Health Study/Study of Latinos
(HCHS/SOL)-Visit 2 and have signed a separate informed consent that explained the
procedures of the research study and the confidentiality of your personal health information.
This authorization form gives more detailed information about the following:
• 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, and
• 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, health care providers, San Diego
State University (SDSU) and San Diego State University Research Foundation (SDSURF) to
obtain, use and disclose personal health information collected about you by the study
investigators for purposes of the research study. You are also allowing San Diego State
University, San Diego State University Research Foundation and their investigators to disclose
that personal health information to outside organizations or people involved with the
processing of the HCHS/SOL, as described in the separate informed consent form for this study.
What personal information is collected and used in this study that might also be shared
(disclosed)?
The following personal contact and personal health information will be collected, used, and
may be shared and disclosed during your involvement with this study:
• Name
• Address
• Relatives' names or addresses
• Telephone number
• Participant ID number
• Social Security numbers (optional)
• Enrollment Date
Other tests and procedures that will be performed in the study include:
• Height, weight, waist size, percent of body fat measurements
• Blood pressure
• An Echocardiogram
• Blood sugar test for diabetes
• A test for cholesterol levels and other blood fats

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It also includes questions about:
 Your health and your health care
 Medication use
 Family medical history
 Health during pregnancies
Why is your personal information being used?
Your personal contact information is important for San Diego State University and San Diego
State University Research Foundation investigators to contact you during the study. Your
personal health information (including the results of tests and procedures) is being collected
during this study for purposes of the research study. The study investigators may also use the
results of these tests and procedures to refer you to a health care provider to verify your study
results or to treat you.
Who within SDSU or SDSURF may share or disclose your personal health information?
The following individuals and organizations within San Diego State University may use or
disclose your personal health information for this study:
• Principal Investigators and the study research team (other university investigators
associated with the study);
• San Diego State University Institutional Review Board (the committees charged with
overseeing research on human subjects);
• Office for the Protection of Research Subjects (the office which monitors research studies);
and
• Authorized members of SDSU and SDSURF workforce who may need to access your
information in the performance of their duties (for example: to make sure the study is
being conducted correctly)
Who outside of San Diego State University might receive your personal health
information?
As part of the study, the Principal Investigator, personnel involved in the study 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) also collaborating on the study;
 University of North Carolina Chapel Hill Coordinating Center (UNC CC);
 National Heart, Lung, and Blood Institute (NHLBI) sponsor of the study;
 Government agencies such as the Food and Drug Administration (FDA) and Office
of Human Research Protection (OHRP); and
 Other health care providers who are part of the study (e.g., laboratories performing
tests).
Your personal information that is disclosed in connection with the study may no longer be
protected by the federal privacy protection regulations.
In records and information disclosed outside of San Diego State University, you will be assigned
a unique research 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.

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How long will SDSU 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 the study database. However, SDSU and/or
SDSURF may not reuse or re-disclose your personal health information collected in this study
for another purpose other than the study described in the informed consent document you
have signed, unless it obtains permission to do so from you and the San Diego State University
Institutional Review Board.
Will you be able to access your records?
Results of all tests and procedures done solely for this research study are not part of your
regular medical care and will not be included in your medical record. At any time during the
study, you will be able to request access to your study medical record.
Can you change your mind?
You may withdraw your permission for the use and disclosure of any of your personal
information collected for the purpose of this study. However, you must do so in writing to the
Principal Investigator at the address on the first page. 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 identify you is removed from these specimens.
You are not required to sign this authorization. If you decide not to sign this
authorization:
It will not affect the treatment you receive by any health care providers, or the payment or
enrollment in any health plans, or affect your eligibility for benefits. However, you may not be
allowed to participate in the study. You will be given a copy of this Research Subject
Authorization Form describing your confidentiality and privacy rights for this study.
By signing this document, you are permitting your doctors and other health care providers to
disclose your personal health information to San Diego State University, and permitting San
Diego State University to use and disclose personal health information collected about you for
research purposes as described above and the informed consent form. This authorization does
not have an expiration date. There is no set date at which you will information will be
destroyed or no longer used. This is because the information used and created for the study
may be analyzed for many years, and it is not possible to know when this will be completed.

____________________________
Participant Name [print]

______________________________
Participant Signature

___________________________
Authorized staff obtaining
authorization [print]

______________________________
Signature

HCHS/SOL Visit 2 HIPAA English Revised 1-17-2014

__________________________
Date

Date

___________________________

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