Att 4 - Consents

UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER
HIPAA 1 AUTHORIZATION TO USE AND DISCLOSE
PROTECTED HEALTH INFORMATION FOR RESEARCH PURPOSES
Title of Study: The Navajo Birth Cohort Study
Principal Investigator:
UNMHSC Department:
Mailing Address:
Co-Investigators:

Johnnye L. Lewis Ph.D., D.A.B.T.
College of Pharmacy/ Pharmaceutical Sciences
University of New Mexico / 1 University of New Mexico / MSC 09 5360 /
Albuquerque, NM 87131-0001
David Begay, Ph.D., Adrienne Ettinger, ScD., MPH, and Christopher Shuey,
MPH

Sponsor: Centers for Disease Control and Prevention / Agency for Toxic Substance and Disease Registry
1. What is the purpose of this form? You have been asked to take part in a research study. The consent form
for this study describes your participation, and that information still applies. This extra form is required by
the federal Health Insurance Portability and Accountability Act (HIPAA). The purpose of this form is to get
your permission (authorization) to use health information about you that is created by or used in connection
with this research.
2. What if I don’t want my personal health information (PHI) to be used in this research study? You do
not have to give this permission. Your decision not to sign this form will not change your ability to get health
care outside of this research study. However, if you do not sign, then you will not be allowed to participate in
the study.
3. What PHI am I allowing to be used for this research? The information that may be used includes:
Current and past medical problems for yourself; for female participants all pregnancy related care, treatment,
and outcome; medications you are taking; your height and weight; diet and exercise level; and if you have a
chronic disease and medications prescribed.
4. Where will researchers go to find my PHI? We may ask to see your personal information in records at
hospitals, clinics or doctor’s offices where you may have received care in the past, including but not limited to
facilities in the UNM health care system.
5. Who will be allowed to use my information for this research and why? The researchers named above and
their staff will be allowed to see and use your health information for this research study. It may be used to
check on your progress during the study, or analyze it along with information from other study participants.
Sometimes research information is shared with collaborators or other institutions. Your records may also be
reviewed by representatives of the research sponsor or funding agency, the Food and Drug Administration
(FDA) to check for quality, safety or effectiveness, or the Human Research Review Committee (HRRC) for
the purposes of oversight and subject safety and compliance with human research regulations.
6. Will my information be used in any other way? Your information used under this permission may be
subject to re-disclosure outside of the research study and be no longer protected under certain circumstances
such as required reporting of abuse or neglect, required reporting for law enforcement purposes, and for
health oversight activities and public health purposes.

1

HIPAA is the Health Insurance Portability and Accountability Act of 1996, a federal law related to privacy of health
information.
Version: XX/XX/XX
HRRC# XX-XXX

7. What if I change my mind after I give this permission? You can change your mind and withdraw this
permission at any time by sending a written notice to the Principal Investigator at the mailing address listed at
the top of this form to inform the researcher of your decision. If you withdraw this permission, the researcher
may only use and share your information that has already been collected for this study. No additional health
information about you will be collected by or given to the researcher for the purposes of this study.
8. What are the privacy protections for my PHI used in this research study? HIPAA regulations apply to
personal health information in the records of health care providers and other groups that share such
information. There are some differences in how these regulations apply to research, as opposed to regular
health care. One difference is that you may not be able to look at your own records that relate to this research
study. These records may include your medical record, which you may not be able to look at until the study
is over. The HIPAA privacy protections may no longer apply once your PHI has been shared with others who
may be involved in this research.
9. How long does this permission allow my PHI to be used? If you decide to be in this research study, your
permission to access and use your health information in this study may not expire, unless you revoke or
cancel it. Otherwise, we will use your information as long as it is needed for the duration of the study.

I am the research participant or the personal representative authorized to act on behalf of the participant. By
signing this form, I am giving permission for my personal health information to be used in research as described
above. I will be given a copy of this authorization form after I have signed it.

_________________________________ __________________________________ ____________
Name of Research Subject
Signature of Subject/Legal Representative Date
___________________________________________________
Describe authority of legal representative
_________________________________ ___________________________________
Name of Person Obtaining Authorization Signature

_____________
Date

Version: XX/XX/XX
HRRC# XX-XXX