msulogo

GUIDELINES FOR DESCRIBING RISKS - BLOOD DRAWS
AT MONTANA STATE UNIVERSITY

(updated 2/5/10)

Montana Hall

I. Standard venipuncture risk
 
"Approximately ____________ (amount in teaspoons, tablespoons or ounces) of blood will be removed by putting a needle in your vein on ______ (number of) occasion(s). This is the standard medical method used to obtain blood for tests. There is momentary pain at the time the needle is inserted into the vein, but other discomfort should be minimal. In about 10% of the cases there is a small amount of bleeding under the skin which will produce a bruise. The risk of infection is less than 1 in 1,000."
 
II. Blood drawing through plastic catheters
 
"An intravenous needle/plastic catheter will be placed in your arm for the removal of blood samples/infusion of fluids. This will be left in for __________ (length of time). Approximately ___________________ (amount in teaspoons, ounces, etc.) of blood will be removed on _______________ (number of) occasion(s). You can expect to experience some pain at the moment the needle/needle containing the plastic catheter goes into your arm. In addition to this momentary pain, there will be the minor discomfort of having the needle/catheter taped to your skin. In about 10% of cases, a small amount of bleeding under the skin will produce a bruise (hematoma). The risk of temporary clotting of the vein is about 1%, while the risk of infection of hematoma or significant external blood loss is less than 1 in 1,000.
  
III.  Indwelling catheter risk
 
"The risks of a tube left in a vein for more than 24 hours include local infection with swelling, redness and pain, bleeding from the site where the tube is put in, and the collection of blood under the skin. Rarely there can be severe infection of the bloodstream or the heart valves, or the formation of a blood clot that could go to your lungs. Complications are extremely unlikely, but treatment could require hospitalization. Your catheter will be left in place for ________________ (length of time)."
  
IV. Arterial blood gas risks
 
"We will ask to measure your blood oxygen and carbon dioxide levels by withdrawing approximately _______________ (amount in teaspoons or ounces) of blood from an artery near the elbow or wrist. Because there may be more pain from inserting a needle in an artery than in a vein, you may receive a small amount of numbing medication injected beneath the skin. Occasionally (less than 10% of the time) a small amount of bleeding under the skin will produce a bruise. Rarely, persons feel faint with any needle insertion."
 
V. Finger stick risks
 
"Approximately _________ drops of blood will be removed by finger stick. This is a standard method used to obtain blood for routine hospital laboratory tests. You will experience pain when the lancet goes into your finger. Other than this momentary pain, the discomfort of finger stick should be minimal. However, in about 10% of the cases a small amount of bleeding under the skin will produce a bruise (hematoma). A small scar may persist for several weeks. The risk of local infection is less than 1 in 1,000."
  
VI. Heel stick risk
 
"Approximately ___________ drops of blood will be removed from your baby by heel stick. This is the standard method used to obtain blood from infants for routine hospital laboratory tests. Your baby will experience some pain when the lancet goes into his/her heel. Other than this momentary pain, the discomfort of heel stick should be minimal. However, in about 10% of cases a small amount of bleeding under the skin will produce a bruise (hematoma). A small scar may persist for several weeks. The risk of local infection in this procedure is less than 1 in 1,000."



ADDITIONAL GUIDELINES FOR DESCRIBING RISKS

Radioactive Drug and X-ray Risks:
 
A. Permitted limits are: 
   
1. Adults - whole body, legs, gonads, bone marrow 
            Single dose - 3 Rem 
            Annual dose - 5 Rem 
 
2. Adults - other organs 
            Single dose - 5 Rem 
            Annual dose - 15 Rem 
 
3. Children under 18 years of age - 10% of  adult dose 
 
B. Check with radiologist for each test, [e.g. One (1) chest x-ray or other frames = 0.05 Rads]
 
"The radiation that you will receive in this study is ____ (% or fraction) of the amount permitted by the Food and Drug Administration (FDA) for Radioactive Drug Research (per year or per study). The more radiation that you receive over the course of your life, the greater the risk of having cancerous tumors or of inducing changes in genes. The changes in genes possibly could cause abnormalities or disease in your future offspring.  The radiation in this study is not expected to greatly increase this risk, but the exact increase in such risks is not known.  Women who are or could be pregnant should receive no unnecessary radiation and should not participate in this study.
 
 "The test will be carried out on _____ (number) occasions.
 
 
Exercise Stress Test Risk:
A. "The exercise stress test is a standard clinical procedure which is routinely performed on many people every year for diagnosis and evaluation of their condition.  Adverse effects are very rare, but have occurred.  The mortality of this test is approximately 1 in 10,000 tests, and the incidence of serious complications including prolonged abnormality of heart rhythm or prolonged chest pain is approximately 4 in 10,000 tests."

Return to IRB Home Page