USE THIS SAMPLE FORM FOR ALL INDEPENDENT STUDIES WHICH USE HUMAN SUBJECTS. YOU CANNOT BEGIN TESTING OF ANY KIND UNTIL THIS FORM HAS BEEN APPROVED BY THE ADVISOR/SUPERVISOR.

INFORMED CONSENT DOCUMENT

Department of Exercise Science
University of Massachusetts, Amherst, MA

 

PROJECT TITLE: <YOUR PROJECT TITLE GOES HERE. BE SPECIFIC>

INVESTIGATOR: <YOUR NAME GOES HERE>

ADVISOR/SUPERVISOR: Dr. Frank I. Katch

Your written consent is required before you can participate in this study. Please read the following carefully and sign accordingly.

PURPOSE:

The purpose of my study attempts to <COMPLETE THE REST HERE>

PROCEDURES:

<REFER TO THE FOLLOWING EXAMPLE. SUBSTITUTE YOUR DETAILED PROCEDURES FOR THOSE BELOW. IF YOU HAPPEN TO USE AN IDENTICAL PROCEDURE, FEEL FREE TO COPY IT TO YOUR FORM>

1. Eating Attitudes Questionnaire (referred to as EAT): You will complete a 26-item questionnaire pertaining to your eating habits and attitudes towards food (about 10 minutes).

2. Physical Activity and Menstrual Cycle Questionnaire: You will complete an 11-item questionnaire pertaining to your regular physical activity habits. Three questions pertain to your menstrual cycle and oral contraceptive use will also be included (about 10 minutes).

3. Physical Activities Log: You will keep a record of your daily physical activity for eight consecutive days.

4. Dietary Recording: You will keep a detailed record of all food and beverages consumed for an eight-day period (I will conduct an instructive meeting to help demonstrate data recording procedures and to show how to estimate portion sizes. This meeting will last for approximately 30 minutes.).

5. Basal Body Temperature: You will record your oral temperature each morning for 10 consecutive days. I will provide disposable thermometers.

6. Body Composition: (total lab time required about 45 - 60 minutes).

A. Your height and weight will be measured (weight will be measured both at the beginning and end of the study).

B. Five fatfold measurements will be taken using a fatfold caliper. A caliper will measure the thickness of fat at the following sites: back of arm, back of shoulder, stomach, hip, and mid thigh. Fat thickness is measured by lightly grasping a fold of tissue at the site.

C. Twelve circumference (girth) measurements will be taken using a cloth tape measure around your shoulders, upper trunk above the chest, biceps, forearms, thighs, calves, abdomen, hips, knees, wrists, and ankles.

D. Your body composition (% body fat and lean body mass) will be determined through underwater weighing. While seated in a chair, you will be completely submerged in a warm tank of water (about the same as body temperature). Prior to submersion, you must exhale maximally and then hold your breath for approximately 5 seconds during submersion while I read the scale. This procedure will be repeated 10 times.

E. I will estimate your lung capacity using a device that measures how much air you can expel from your lungs. You will wear a nose piece to pinch your nose, then exhale as hard as you can into a tube. This procedure will be performed twice.

RISKS FROM LAB TESTING: <REFER TO THE FOLLOWING EXAMPLE. EXPLAIN ANY RISKS FROM YOUR PROCEDURES AS THE EXAMPLE DOES FOR UNDERWATER WEIGHING>

During underwater weighing, you may experience some discomfort while you remain submerged under water (some people feel a little pressure in their upper chest region). There is also the possibility that you may swallow some water if you open your mouth during water submersion. Since you are given adequate practice, discomfort and swallowing water usually never occur. There are no other apparent risks associated with taking any of the body composition measurements (height, weight, fatfolds, and girths).

RISKS FROM QUESTIONNAIRES: <REFER TO THE FOLLOWING EXAMPLE IF YOU ADMINISTER A QUSTIONNAIRE. SUBSTITUTE YOUR RESPONSE AS APPLICABLE>

None. After I complete my study, I will be happy to provide you with a summary of your test results for height, weight, body density, sum of the 5 fatfolds, girth measurements, nutritional intake (e.g., total calories consumed, grams of macro- and micronutrients), and total daily caloric expenditure. For your score on the EAT questionnaire, you should consult a health professional (e.g., Sports Nutritionist) for an interpretation.

BENEFITS:

1. You will participate in a carefully supervised scientific research study.
2. Your participation will contribute to the body of knowledge about nutrition
and fitness
<ADD ADDITIONAL INFORMATION APPROPRIATE TO YOUR TOPIC>.

FREEDOM AND CONSENT: Participation is completely voluntary. You are free to withdraw from the study at any time. No names will be used in reporting and/or publishing the results. The investigator has read and understands the General Guidelines on Rights and Welfare of Human Subjects at the University of Massachusetts. If you would like to read this document, please tell me now and I will provide a copy to you.

REQUEST FOR MORE INFORMATION: I will be happy to address any questions pertaining to test procedures, results, or any other aspects of the study. <YOUR NAME AND PHONE NUMBER HERE>

STATEMENT:

I, the undersigned, have read and understand this document and I voluntarily agree to participate in this study.

Before you sign, do you have any questions? If you do, please ask me now.

Subject Signature___________________________________ Today's Date____________

Local Address____________________________ Local Phone Number______________________

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