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.


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