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INFORMED
CONSENT FORM FOR PARTICIPATION IN S.T.E.P. Program
Purpose
of the program:
1.
You are invited to participate in a 12-week Program which will look at how
increasing your
exercise
may help you to better control your blood sugar, weight and cholesterol
levels.
2.Procedures
to be followed:
You
will be asked to visit the clinic at two (2) scheduled times: once in the
beginning and then again after about 12 weeks. During each visit, you will
be asked questions about your health, the medications you are taking, and
your diet. Your weight and height will be measured. Blood samples will be
collected using a fingerstick to measure your blood sugar (glycosylated
hemoglobin) and cholesterol levels. The questionnaire, measurements,
and blood tests will take about 20 minutes, and will be conducted by the
clinic staff
At
the first visit, you will be given a pedometer and shown how to use it..
You should wear it immediately and over the next 2 days to get your base
number of steps you take on a normal day of activities.
3.
Discomforts and risks:
You
may experience some possible hypoglycemia when you increase your exercise
routine, so discuss with your educator how to avoid hypoglycemia.
4.
Benefits:
Participation
in this program may help you better control your blood sugar and/or blood
cholesterol levels.. At the end of the program, you will be given your
laboratory results, and advised on their implications for your future
care.
5.
Alternative procedures that could be utilized:
You
can choose not to participate in this Program and continue to follow your
current regimen for controlling your blood sugar levels.
6.
Confidentiality:
Records
containing your name and test results will be kept confidential at the
clinical center and the test laboratory. Information and any results
collected during this program will be coded and used to evaluate the
benefits of the program. The information collected will not be sold,
shared or licensed to others. No individual identities will be used in any
reports or publications resulting from this program.
7.
Medical Care and Program Questions:
Standard
medical care is available during your participation in this program.. By
participating in this program you are not waiving any rights against the
health center for injury resulting from negligence. If you have any
questions about this program, your medical care, or if you feel you have
any side effects, you can call your program supervisor at the following
phone number:
Name
of Healthcare Professional: _____________________________________
Phone
Number to Call for Questions: ___________________________
8.
Participation and termination:
Participation
in this test is entirely voluntary. You are completely free to withdraw
from participating in this program at any time without penalty or loss of
benefits to which you are otherwise entitled. You will be informed of any
new information that may affect your willingness to participate. You may
be asked to leave the Program at any time if you do not follow the program
procedures or at the discretion of your healthcare provider.
9.
Consent to Participate
I
hereby consent to voluntarily participate in this program. I agree to
release the results of the blood glucose and cholesterol tests to my
physician and my program supervisor. I also understand the results of the
blood glucose and cholesterol tests will not be released to any other
individuals, outside of those involved with this program, without my
express consent in writing.
I
hereby release any and all claims I, or anyone claiming by or through me,
now have or may hereafter acquire against the program staff, and any other
person or organization connected in any way with the blood glucose and
cholesterol tests for any and all damages or injuries resulting from or
arising out of my participation in the blood glucose and cholesterol tests
or any services provided in connection with this screening.
All
components of this program may not be resold to any third person, and no
claim may be submitted to any third party insurance program, whether
public or private.
I
have read and understand the consent form and have had an opportunity to
discuss this Program with a member of the clinic staff. All my questions
regarding my rights as a research participant concerning this Program have
been answered to my satisfaction and I hereby willingly consent to
participate in this Program. A copy of this consent form has been given to
me.
Signature
of Participant
Date
Signature of Healthcare Prof Date
Participants
Address
Healthcare Professional Name and Title
Participants
City
State Zip
Healthcare Professional Affiliation/City/St/Zip
Participant’s
Date of Birth
Healthcare Professional Phone Number
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