Examples 3-4m



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Example 1 of 3

The risks of blood sampling by venipuncture include: commonly, the
occurrence of discomfort and/or bruise at the site of the puncture;
occasionally, fainting; and less commonly, infection or the formation of
a small blood clot, or swelling of the vein and surrounding tissue, or
bleeding at the needle puncture site.

There are no direct benefits of being in the study, though some people
find satisfaction in contributing to scientific knowledge about health
problems and their medical consequences.

Example 2 of 3

The results of this laboratory study will not directly affect you or your
treatment plan. Doctors hope to use these results in the future to show
them which patients will respond the best to additional therapy following
surgery for colon cancer.

Example 3 of 3

One of the risks to subjects in this study is the possibility of being
identified as having hepatitis or AIDS and the consequence that we are
legally required to report such findings. Prior to participating in the
study you will first be asked questions that are asked of all blood
donors regarding your state of health. If you are healthy, you will be
asked to have 30 mL of blood (about 2 tablespoons or 1 oz.) drawn to
test for exposure to hepatitis and the AIDS virus (HIV). The results of
these tests will be coded for confidentially and only available to a blood
bank physician. If your initial blood tests are abnormal or you are
found to have either of the viruses that cause hepatitis or AIDS, you are
not eligible for this study and you will be notified of this. We will
suggest that a blood bank physician contact your personal physician
regarding further studies and the significance of any positive tests. We
must also notify the Minnesota Department of Health if you are found to
have hepatitis or AIDS.

There are several other minor risks to the study, including (1) bleeding
in the arm when needles are placed to draw blood samples, (2) loss of
blood in the machine, and (3) reaction to citrate, the drug used as an
anticoagulant during the procedure.