UNIVERSITY OF WASHINGTON
AIDS CLINICAL TRIALS UNIT
AUTHORIZATION TO USE, CREATE AND SHARE HEALTH INFORMATION FOR RESEARCH FOR PROJECT ENTITLED, ___________
By law, researchers must protect the privacy of
health information about you. In this form the word “you” means both the person
who takes part in the research and the person who gives permission for another
person to be in the research.
Researchers may use, create, or share your health information for
research only if you let them. This form describes what researchers will
do with your information. Please read it carefully. If you agree with it,
please sign your name at the bottom. You will get a copy of this form after you
have signed it.
If you sign this form, information will be shared with the
people who conduct the research. In this form, all these people together are
called “researchers.” Their names will appear on the research consent form that
you sign.
The researchers will use the health information only for the
purposes named in this form.
1. What
“health information” includes
·
All
information about you that is collected during the research study. This might include the results of tests or
exams that become part of the study records; diaries and questionnaires that
you might be asked to fill out as part of the study and other records from the
study.
·
All
health information in your medical records that is needed for this research
study. These might include the results
of physical exams, blood tests, x-rays, diagnostic and medical procedures and your
medical history.
2. What the researchers may do
with health information
The researchers may use and create health information
about you for the study. They may also share your health information with
certain people and groups. These may include:
·
The sponsor
of the study, [sponsor’s name], and its representatives.
·
Government
agencies, review boards, and others who watch over the safety, effectiveness,
and conduct of the research.
·
Other
researchers when a review board approves the sharing of the health information.
·
Your
health insurer if they are paying for care provided as part of the research
study.
·
Others,
if the law requires.
3. Removing your name from health information
The researchers may remove your name (and other information
that could identify you) from your health information. No one would know the
information was yours.
If your name is removed, the information may be used, created, and shared by the
researchers and sponsor as the law allows. (This includes other research
purposes.) This form would no longer limit the way the researchers use, create,
and share the information.
4.
How the researchers protect health
information
The researchers [and sponsor] will follow the limits in this form. If
they publish the research, they will not identify you unless you allow it in
writing. These limitations continue even if you take back this permission.
5. After the researchers learn health
information
The limits in this form come from
a federal law called the Health Insurance Portability and Accountability Act.
This law applies to your doctors and other health care providers.
Once the researchers get your health information, this law may
no longer apply. But other privacy protections will still apply.
6. Storing your health information
Your health information may be added to a database or data repository. This
permission will end when the database or data repository is destroyed.
7. Please note
You do not
have to sign this permission (“authorization”) form. If you do not, you may not
be allowed to join the study. You may change your mind and take back your
permission at any time. To take back your permission, write to: Ann C. Collier,
MD, Professor of Medicine, University of Washington School of Medicine,
Director, AIDS Clinical Trials Unit, Harborview Medical Center, Box 359929, 325
9th Avenue, Seattle, WA
98104. If you do this, you may
no longer be allowed to be in the study. The researchers will keep any
information in the study record they already collected.
This form allows the researchers to access health information up to 90
days after you sign this form. If the
researchers need access more than 90 days after you sign this form they may ask
you to sign this form again. The UW
human subjects review board may give the researchers permission to access your
records without your written authorization after 90 days.
8. Your signature
I agree to the use, creation, and sharing of my health
information for purposes of this research study
Signature of research subject or subject’s legal Date
representative
Printed
name of research subject or subject’s Representative’s
relationship
legal representative to
subject
Last Update: 04/14/03