Iowa State University-Department of Health and Human Performance
Des Moines University-Osteopathic Medical Center
AUTHORIZATION TO USE AND DISCLOSE
PROTECTED HEALTH INFORMATION FOR RESEARCH
Title of Study:
Exercise and Influenza Immunity: A Psychoneuroendocrine
Model
Principal Investigator:
Dr. Marian Kohut
During your participation in this research study, the researcher will collect information about you
and your health. This information is called Protected Health Information. The Privacy Rule of
the Health Insurance Portability and Accountability Act of 1996 (HIPAA) establishes the
conditions for using and disclosing Protected Health Information for research.
Iowa State University and Des Moines University-Osteopathic Medical Center have policies and
procedures to assure compliance with these laws and regulations through the Notice of Privacy
Practices.
If you sign this form, then you are authorizing certain persons to use and
disclose some of your health information for research.
1. What information about you can be used or disclosed in this research study?
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Your name, address, telephone number, date of birth, Social Security number and other
details about you.
Your health history and your family health history.
Information from procedures carried out to determine whether you can join the Study
such as: Treadmill maximal stress test, electrocardiogram(EKG), fitness tests which
measure flexibility, strength, endurance, and body composition. A preparticipation
physical examination if deemed necessary by a physician
Information obtained during the Study: Blood samples to examine the immunity response
at various times during the study. You may elect to have a blood analysis done also.
Exercise records including heart rate, duration, and type of exercise. Blood pressures,
psychosocial surveys, self reports of illness or injury, arthritic joint surveys, diet surveys.
Information in your medical record at the hospital or clinic which you frequent may be
necessary for your participation in the Study.
Your previous influenza vaccination history and your recent physical activity history
2. Who may use and disclose information about you?
The persons who may use your Protected Health Information include the researcher, Dr. Marian
Kohut, her research staff, the Iowa State University Institutional Review Board and its staff, the
Des Moines University Institutional Review Board and its staff and other people who need to see
the information to help the Study or make sure it is being done correctly. These persons may
disclose your Protected Health Information to staff of the entities listed in the next section.
3. Who may see your health information?
Your Protected Health Information may be disclosed to persons associated with the following
entities:
• Governmental agencies that have the right to see or review your health information, such
as the Office of Human Research Protections and the Food and Drug Administration.
• Other institutions that are participating in the Study such as McFarland Clinic in Ames,
IA.
• The sponsor of the Study. The name of the sponsor is The National Institute of Health.
4. Why will your information be used and disclosed?
Your information will be used and disclosed in order to carry out the research Study and to
evaluate the results of the Study.
Your information may be used to meet the reporting requirements of governmental agencies.
The results of this study may be published in research journals or presented at scientific or
medical meetings, but your identity will not be disclosed.
5. Can you decide not to authorize the use and disclosure of your Protected
Health Information?
Yes. You do not have to authorize the use or disclosure of your Protected Health Information.
However, if you do not give this authorization, then you cannot participate in the Study.
6. Can you revoke your authorization?
Yes. You may revoke your authorization to allow your Protected Health Information to be used
or disclosed at any time by sending a written notice to the researcher, Dr. Marian Kohut, or the
Des Moines University Institutional Review Board, or the Iowa State University Institutional
Review Board.
If you revoke your authorization, you will be withdrawn from the Study and no health
information about you will be gathered after that date. However, information gathered before
that date may be used or disclosed if it is needed for the Study or any follow-up for the Study.
7. Is your health information protected after it has been disclosed to others?
If your health information is disclosed to someone who is not required to follow the Privacy
Rule, then that information may no longer be protected, and it may be used or disclosed without
your permission.
8. Can you see your health information?
Yes. You may review and copy your health information after the Study ends, and at any time you
request during the study.
9. Does your authorization have an expiration date?
The authorization to use and disclose health information will continue until the end of the Study
and any necessary data analysis follow-up activities for the Study.
10. What happens to the data after the authorization expires?
Data will be stored for five years in a locked area. After that, it will be shredded.
I authorize the use and disclosure of my Protected Health Information as described in
this form.
Date:
Participant Signature:
Investigator or
Clinical Study
Coordinator
Signature:
Date: