Study Procedure
You first will be asked to complete a questionnaire that asks for information such as age, education, health history, and physical activity as well as some of your feelings and healthcare experiences. This information will remain anonymous. Your name or other identifying information will not be used on the questionnaire.You will fill out the questionnaire at your own pace at home before meeting with the nurse practitioner. Your completion of the questionnaire will be considered your consent to participate in that part of the study.
Next, you will meet with the nurse practitioner (NP). This meeting will take
place at one of 7 locations that is most
convenient for you. During this meeting, the NP will go over the steps in the
study and the consent form and answer any of your questions. You will sign the
consent form if you agree to participate in the remainder of the study. Your
blood pressure, heart rate, height, weight,temperature and waist and hip circumferencs
will be measured. Blood will be drawn from your arm in order to measure substances
in your blood that may show that you have health risks, such as a high blood
sugar. At the most, a total of 3 tablespoons of blood will be drawn. In order
to get accurate results from your blood work, you will need to fast before the
blood is drawn. This means you should not drink alcohol for 24 hours before
and should not have food or drinks except for water for 12 hours before the
blood is drawn. After the blood is drawn, you will be given a nutrition bar
and fruit juice. The NP will then interview you and ask questions about your
health knowledge. With your permission, the interview will be audiotaped. Your
name will not be mentioned during the interview, so there will be no way to
identify the audiotape as your conversation with the NP. If you do not wish
the interview to be audiotaped, the NP will write down your responses. You also
have the opportunity to have the tape erased immediately following the interview.
Otherwise, the tapes will be destroyed within three years after the study is
completed. The meeting, including drawing your blood, taking your measurements
and interviewing you, should take about 2 hours.
Some of your blood will be frozen and saved with just a code number. No commercial
tests are available at the present to identify some blood substances that may
be related to lupus, but it is expected that tests may become available in the
future that will provide us with useful information about lupus. By having the
stored blood, future research will be able to test theories about lupus. Eventually,
such knowledge may help us to develop measures aimed at the treatment of lupus.
Your stored blood sample will be linked to certain information about you, but
it will not be linked to your name or any other information that might identify
the sample as yours. You may choose not to have your blood sample frozen and
stored. The decision not to have your blood saved will not limit or in anyway
affect your eligibility to enroll in this research study.
When all laboratory results are available, they will be mailed to you. You may
call the study to discuss any questions or concerns you have about the results.
With your permission, a copy of your results will be mailed to your healthcare
provider if you so desire.
Duration of Participation
The duration of your participation
will be the time involved in completing the questionnaire at home, which should
take less than one hour, and the time spent in the meeting with the nurse practitioner,
which should not exceed 2 hours.
Confidentiality
Your privacy will be protected. Your name or other identifying information will
not be used. Instead, only a number will identify you. The only connection between
your participation in this study and the study itself will be this signed consent
form, but there will be no association between your identity and your laboratory
results, your physical measurements and the information you provide on questionnaires
or in the interview. Your identity will not be made a part of any published
findings resulting from this study. All results will be published as group data.
All personal or protected health information that we collect from you in this
study including audioptapes and transcriptions made from the tapes will be destroyed
within three years of the completion of the study.
The only persons who are authorized to use and/or disclose your health information
are the investigators, who are listed on page one of the Research Consent Form,
and the UCF Institutional Review Board. The persons who are authorized to receive
this information are any healthcare providers whom you have given written permission
for us to contact, the UCF Institutional Review Board or its designees, and
(as allowable by law) state and federal agencies as required for their research
oversight in connection with this research study. Your authorization will expire
after the study is completed.
Potential Risks
You may feel some discomfort when your blood is drawn. There is a small chance
the needle will cause bleeding, a bruise, or an infection. This is uncommon
with blood withdrawals performed by personnel trained in blood drawing techniques
using sterile. In this study, all blood will be drawn by a licensed nurse practitioner
or medical technologist, both of whom have extensive blood drawing experience.
This research study has been reviewed and approved by the UCF Institutional
Review Board. UCF does not automatically reimburse participants for medical
claims or other compensation. If complications arise, the principal investigator
will assist you in obtaining appropriate medical treatment but this study does
not provide financial assistance for additional medical care or other costs.
If you believe you have been injured or harmed while participating in this research
or if you have questions or concerns about the treatment of research participants,
you can contact the University of Central Florida, Office of Research &
Commercialization, 12201 Research Parkway, Suite 501, Orlando, FL 32826-3246.
The telephone number is (407) 823-2901. The email address is IRB@mail.ucf.edu.
Benefits to You or Others
By taking part in this study, you will receive a risk profile that includes
results from your blood work at no cost to you. You also may help us learn how
to help women with lupus in the future.