PREVENTION CENTER STANDARD OPERATING PROCEDURES
Research Clinic
Model Consent Risk Statements
Protocol ID:
Protocol Date: 6/12/2012
Supersedes:
Page 1 of 3
DEXA SCANS
DEXA Scan
You will undergo an x-ray test that will measure your body composition and/or bone density.
This test will require you to lie on a table and remain still from 20 to 30 minutes. If you cannot do this, it may not be possible to perform the DEXA scan. Other parts of the test may require that you lift your legs or bend your knees. During this time a trained technician will maneuver the table arm to scan down your body. There are no tubes or confined spaces involved with this test. Many people fall asleep during the test.
DEXA Scan Risks
Your DEXA scan involves a small exposure to radiation. Although it can vary from person-toperson, your whole-body radiation exposure from each DEXA scan will be about 5 mrem. Your total exposure for the study will be about 2% of the average annual exposure a person in the
United States receives from natural background radiation. The risk of harm from this amount of radiation is low and no harmful health effects are expected; however, your risk of harmful effects may increase if you are exposed to more procedures that involve radiation.
ORAL GLUCOSE TOLERANCE TEST
Oral Glucose Tolerance Test (OGTT) Script:
“After we are done collecting the fasting blood samples we will ask you to drink a beverage sweetened with a large amount of glucose, a type of sugar. We will ask you to drink __ ounces of the beverage within __ minutes. We will draw blood from your IV approximately every 20 minutes for 3 hours to measure how your body responded to the sweetened beverage. The total amount of blood we will draw for your Oral Glucose
Tolerance test will be about ___ mL (about __ of a cup).”
There are possible risks and/or discomforts associated with the blood draws and IV placement, and the oral glucose tolerance tests. These risks include, but are not limited to:
Approximately 5% Risk:
(About 5 out of 100 people will experience each complication, about 95 out of 100 will not)
 discomfort, bleeding, or bruising where a blood draw needle is inserted
 tenderness and inflammation in the area where a blood draw needle is inserted
 nausea, vomiting or diarrhea after drinking the liquid for the oral glucose tolerance test
 shakiness, dizziness or cold sweats during the oral glucose tolerance test
Approximately 1% Risk:
(About 1 out of 100 people will experience each complication, about 99 out of 100 will not)
 several weeks of soreness in the area where the IV was placed
 infection where a blood draw needle is inserted
 hardening of the vein that was used to draw blood
 infection or discharge where a tissue sample is obtained
 fainting during a blood draw. If you experience any of the symptoms listed in the section above while you are at the Prevention Center, please tell the study staff

PREVENTION CENTER STANDARD OPERATING PROCEDURES
Research Clinic
Model Consent Risk Statements
Protocol ID:
Protocol Date: 6/12/2012
Supersedes:
Page 2 of 3 immediately. If you experience any of the symptoms listed above after your visit call
______________
If you have a medical emergency, go to the nearest emergency room or dial 911
PHLEBOTOMY
What is involved in the blood draw?
A blood sample totalling __ ml (approximately ___Tablespoons) will be drawn from your arm through a small needle using sterile equipment and technique. This blood sample may be stored or sent to a local lab for analysis.
What are the risks of a blood draw?
There are very few risks to you. If you agree to a blood draw, you may experience a little pain
(pinprick) and there might be some bruising or, rarely, an infection. Some people who have blood taken may feel lightheaded or temporarily lose consciousness (faint).
VACCINE ADMINISTRATION
The risk of having a vaccine is usually very low and the problems are not usually serious. There is a small pinprick of pain and some people may feel lightheaded or faint. After the injection there may be soreness or redness at the site, which may last a day or two. In addition, you may develop arm soreness. Rarely, some people also develop general body aches or fatigue.
These symptoms usually do not last longer than a day. If you notice that your problem lasts longer than a few days, please contact and inform clinic staff (Claudia Kumai, Physician
Assistant, (206) 667-2831).
There are benefits to having a vaccine. You will develop immunity to the disease that the vaccine has been developed to fight.
FAT BIOPSY
The procedure used may cause some discomfort and there is a small risk of bleeding at the site.
Local anesthetic is used to minimize pain or discomfort of the procedure. A bruise is normal, and typically will get better in 7-10 days. A small lump may form under your skin, and may last up to six weeks. There is also a small risk of infection. To minimize infection risk, sterile methods are used to clean the area and remove the fat tissue sample. You will also be asked to keep the area dry for 24 hours following the procedure. If you notice that the area where your sample was taken is red or there is discharge, please contact clinic staff immediately (Claudia
Kumai, Physician Assistant, (206) 667-2831).
There is a small risk of allergy to the local anesthetic. You may not be eligible to participate in the study if you have any history of allergic reaction to anesthesia.
There are no direct benefits. Participants may gain a sense of satisfaction from knowing that they are ‘part of the solution’ through their valuable contribution to cancer research.

PREVENTION CENTER STANDARD OPERATING PROCEDURES
Research Clinic
Model Consent Risk Statements
Protocol ID:
Protocol Date: 6/12/2012
Supersedes:
Page 3 of 3
OPTIONAL BREAST BIOPSIES
Local anesthetic is used to minimize any potential discomfort associated with biopsy procedures. There is a small risk of bleeding at the site. A bruise is normal and typically will get better in 7-10 days. A small lump may form under your skin, and last up to six weeks. There is also a small risk of infection. To minimize such risks, sterile equipment and supplies are used to clean the area and remove the breast tissue sample. Participants are also asked to keep the area dry for 24 hours following the procedure. If you notice that the area where your sample was taken is red or there is discharge, please contact study staff immediately (Claudia Kumai,
Physician Assistant, (206) 667-2831).
There is a small risk of allergic reaction to the local anesthetic. You may not be eligible to participate if you have any history of allergic reaction to medications used in anesthesia.
There are no direct benefits. Participants may gain a sense of satisfaction from knowing that they are ‘part of the solution’ through their valuable contribution to breast cancer research.
BIOELECTRICAL IMPEDANCE TEST (BIA)
This test is used to determine what percent of percentage of body fat. There is no known risk associated with this test.
The benefit to having this test done is that, after calculations from the data are obtained, you will be notified of your body fat percentage.
IV PLACEMENT FOR SERIAL BLOOD DRAWS
If the study you are participating in requires frequent, multiple blood samples, an intravenous catheter may be placed in your arm to avoid multiple needle sticks. A small needle attached to tubing is threaded into a vein in your arm. It will be left in your arm until your blood draws are completed. Risks to this procedure include a small amount of pain, but no more than a regular blood draw, possible bruising, possible infection (very small risk) and possible bleeding. Rarely, one could feel lightheaded or faint during this procedure. If this is the case, you will be asked to lie down during your IV placement.
The benefit of this procedure is that you will only need to experience one needle stick to have all your blood samples taken.