Sample consent form

CCSU Human Studies Council APPROVAL FORM PRINCIPAL INVESTIGATOR: JENNIFER BOSSI

PHONE: 860-681-5940

IF CCSU STUDENT, PLEASE ENTER CCSU ID#: 30301488 INVESTIGATOR'S MAILING ADDRESS: 114 BRENTWOOD DR. CITY, STATE AND ZIP: BRISTOL, CT 06010 TITLE OF PRINCIPAL INVESTIGATOR: GRADUATE INTERN ATHLETIC TRAINER EMAIL: [email protected] ACADEMIC DEPARTMENT OF PRINCIPAL INVESTIGATOR: PHYSICAL EDUCATION AND HUMAN PERFORMANCE TITLE OF PROJECT: EFFECTS ON MENSTRUAL CYCLE PHASE ON EXERCISE PERFORMANCE IN FEMALE COLLEGIATE STUDENT-ATHLETES PROPOSED PROJECT START DATE: SEPTEMBER, 2011 IS THIS A CONTINUATION OF PREVIOUSLY APPROVED STUDY

Yes___ No_x__

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ A.

STUDENTS ONLY

1.

Please indicate (check) which of the following best describes your project:

____ Dissertation x____ Thesis ____ Special Project (graduate level capstone other than thesis or dissertation) ____ Class project: specify CCSU DEPT/CLASS:________________________ ____ Other undergraduate research project 2.

Who is your supervising professor? Dr. Kimberly Kostelis

3.

What is your professor’s academic department? Physical Education and Human Performance

4.

Student submissions cannot be reviewed until an email is received by the project’s supervising professor. Professors are asked to send an email to [email protected] indicating that they have reviewed and approved* the student’s proposal for submission to the HSC. * APPROVAL means that the supervising professor has reviewed all material to be submitted by the student researcher and has determined that the submission is 1) complete, 2) consistent with relevant ethical principles and procedures, 3) free of typographical and other errors, and 4) the quality of the material is deemed to be suitable for human studies review and distribution to potential participants

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ B.

FOR ALL RESEARCHERS:

1. Per Federal mandate, every researcher is required to complete an ethics educational component when submitting research proposals to the HSC. Version 2.2011

I have completed the NIH Human Subjects Tutorial* Yes_x__ No___ I have met this requirement through other means Yes___ No___ How? __________________ *Click here to access the NIH Human Subjects Tutorial or go to http://phrp.nihtraining.com/users/login.php 2.

Will your research be conducted in a school or other external agency?

Yes x___ No ___

If you answered 'Yes' to the question above, you must attach written "gatekeeper" approval with this application. (For example, if you are conducting a study in a school or other external agency, you must obtain written permission from the principal/superintendent of the school or the director of the agency. Letter should be on official letterhead. Gatekeeper must indicate familiarity with the goals and methods of the study and state permission/support for the project). SPONSORING AGENCY (if applicable): Central Connecticut State University Athletics

C. PLEASE COMPLETE ALL PARTS OF THIS FORM 1. SUMMARIZE YOUR PROPOSED RESEARCH: (OUTLINE OBJECTIVES AND METHODS)

(Do not exceed 150 words) See #2 on Checklist This study is designed to examine the effects of menstrual cycle phase on exercise performance among collegiate female student-athletes. Menstrual cycle phases will be estimated using self reported tracking of previous periods for three months (See attached p.9). Subjects will first complete a basic questionnaire assessing exercise and menstrual cycle history (See attached pp. 10-11). Subjects will then undergo 3 treadmill exercise to exhaustion tests (Bruce, 1974; See attached p. 12 ). The first test will be a practice trial to get subjects familiarized with the testing procedures. The second and third tests will be conducted during the midfollicular and midluteal phases of one menstrual cycle. Heart rate and blood lactate levels will be taken pre and post exercise, while respiratory exchange ratio, Rate of Perceived Exertion (Borg, 1984; See attached p. 13), and VO2 values will be recorded throughout and after the test. To measure blood lactate accumulation, blood samples will be collected from the tip of the finger at 3 and 30 minutes into recovery following exercises. 2. SUMMARIZE ALL INVOLVEMENT OF HUMANS IN THIS PROJECT: (WHO, HOW MANY, AGE, SEX, LENGTH OF INVOLVEMENT, FREQUENCY, ETC.) Subjects will be approximately 10 female student-athletes at Central Connecticut State University ages 1824 with regular menstrual cycles. They will be recruited from varsity athletic teams on a volunteer basis. All participants will be medically healthy and will not have taken any oral contraceptives in the past year. They will be involved in the study for a total of 4 months, with 3 months of self tracking their menstrual cycle for baseline data

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and 1 month of exercise testing. They will have to report to the exercise physiology laboratory 3 times during the exercise testing portion. 3. INDICATE WHETHER ANY SUBJECT OF YOUR RESEARCH WILL BE SELECTED FROM THE FOLLOWING CATEGORIES: ( ) Minors ( ) Pregnant women ( ) Prisoners ( ) Addicts ( ) Parolees ( ) Fetuses ( ) Mental retardation or intellectual disability ( ) Mental disability or psychiatric illness ( ) Physically disabled ( x ) none of the above

4. CHECK ALL RISKS TO HUMANS INVOLVED IN YOUR PROJECT: (See #3C Checklist) ______ No risks ______ Deception x_____ Personal material (interviews, opinions, test scores) ______ Stress or emotional arousal ______ Loss of privacy x_____ Embarrassment, disappointment, or other disagreeable emotion x_____ Alteration of self-concept (e.g. through knowledge of test scores) x_____ Physical or psychological trauma or pain ______ Loss of legal rights x_____ Experimental diagnostic procedures ______ Side effects of medications x_____ Experimental treatment procedures ______ Contraction of disease ______ Worsening of illness BRIEFLY EXPLAIN ANY OF THE ABOVE YOU CHECKED Subjects will be asked to run on a treadmill until they cannot go any longer which may cause physical injury or psychological damage from embarrassment. In the blood lactate measurements, blood will be drawn to measure lactate levels post exercise which could lead to other medical risks. Lastly, subjects will be asked to reveal personal information about their menstrual cycle which can cause embarrassment for some participants.

5. INDICATE PROCEDURES TO PROTECT HUMAN PARTICIPANTS FROM RISKS (Check all that are appropriate) ______ Precautions in uses of stressors or emotional material (explain below) ______ When deception is used, subjects are fully informed of the nature of the research at a feasible time (explain below) x_____ Procedures to minimize changes in self-concept (explain below) _____ Data from protected sources x_____ Code numbers will be used x_____ Individual data submerged in results x_____ No unauthorized use of data x_____ Data confidentiality will be used ______ Debriefing on experimental purposes ______ Clinical trial (describe data monitoring below) x_____ Sterile equipment Version 2.2011

x_____ M.D. or other appropriately trained individual in attendance OTHER AND EXPLAINATIONS A registered nurse will be present to supervise blood lactate measurements. The finger prick used for this measurement will be conducted using a specific approved protocol (See attached p. 13). A certified athletic trainer will be present during all exercise tests in case of physical injury. Subjects will be self- monitoring their menstrual cycles and only researchers will be able to see this information. All participants will be tested individually when performing the VO2max test to exhaustion to reduce feelings of embarrassment or pressure from others. Results from individual tests will be used but will be grouped when analyzed.

6. INDICATE HOW YOU WILL OBTAIN INFORMED CONSENT (Click to see sample consent form). x______ Subject or parent/guardian reads information on consent form and signs. (Please attach a copy of the consent form used) ______ Subject receives ORAL briefing (from principle investigator or project personnel) and then gives ORAL consent. (Please attach copy of the text of briefing and consent) ______ Other (please explain)

7. BRIEFLY DESCRIBE THE SOCIAL AND SCIENTIFIC BENEFITS THAT WILL ACCRUE TO EACH HUMAN SUBJECT, OR TO HUMAN BEINGS IN GENERAL, AS A RESULT OF THE INDIVIDUAL’S PARTICIPATION IN THE PROJECT. Participants will learn how their bodies respond to exercise during different phases of their menstrual cycle. This study may also benefit participants by making them more aware of their fitness level through the VO 2max test.

* If applicable, please submit the following attachments: a. Consent document(s) (written and/or verbal text). (Click to see sample consent form). b. Copies of all questionnaires, surveys, tests and other relevant material used. c. Copy of gatekeeper letter. DRUG FREE CERTIFICATION: As a condition of approval of this research, I certify that I will not engage in the unlawful manufacturing, distribution, dispensing, possession or use of a controlled substance in conducting any activity associated with this research. (45 CFR 620, subpart F, Appendix C) Investigator check here to certify x___

Date

7/18/11_

SCIENTIFIC MISCONDUCT STATEMENT: I certify that I am aware that Central Connecticut State University does not tolerate scientific misconduct. The following PHS definition (NPRM) is accepted by the University: "'Misconduct' or 'misconduct in science' as used herein is defined as plagiarism, deception or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research; or (2) material failure to comply with federal requirements that uniquely relate to the conduct of research." Investigator check here to certify x___ Version 2.2011

Date

7/18/11___

CENTRAL CONNECTICUT STATE UNIVERSITY Department of Physical Education and Human Performance 1615 Stanley Street New Britain, CT 06050 Jennifer Bossi Graduate Intern [email protected] 860-832-3086

Dr. Kimberly Kostelis Associate Professor [email protected] 860-832-2791

EFFECTS OF MENSTRUAL CYCLE PHASE ON EXERCISE PERFORMANCE AMONG FEMALE COLLEGIATE STUDENT-ATHLETES INFORMED CONSENT STATEMENT 1. Invitation to Participate and Description of the Project. You are being asked to participate in our study examining menstrual cycle phase and blood lactate levels during exercise. We are investigating this topic in order to further our understanding of how the menstrual cycle affects exercise. You were recruited for this study because you are a female varsity athlete at Central Connecticut University, have a regular menstrual cycle, and have not been on any type of birth control or other medication that would affect your menstrual cycle in the past year. Your participation in the research study is voluntary. Before agreeing to be part of this study, please read and/or listen to the following information carefully. Feel free to ask questions if you do not understand something. 2. Description of Procedure. If you participate in this study, you will be asked to report information on your menstrual cycle history and birth control use. You will then be asked to complete 3 VO2max tests to exhaustion on a treadmill, including a practice test, and tests during the follicular phase (6-9 days after menses) and luteal phase (6-9 days after ovulation) of your menstrual cycle. The phase of the menstrual cycle will be determined by using self reported tracking of the menstrual cycle each month for 3 months. Blood samples will be collected from the tip of the finger at before exercise and 3 minutes and 30 minutes into post exercise. VO2max, heart rate, respiratory exchange ratio, and Rate of Perceived Exertion values will also be taken throughout and after each test. 3. Risks and Inconveniences. Risks that may be presented in this study include chance of physical injury resulting from the VO2max test to exhaustion and chance of feeling sick resulting from drawing blood for blood lactate accumulation measurements. You will be asked to run on the treadmill with progressing speed and incline until you feel like you cannot go any longer. Injuries may include but are not limited to: muscle strains, shin splints, and fatigue. There are also cardiovascular risks from the exercise tests. An athletic trainer will be present at all times to treat any injury and/or medical condition that may occur. If you have any preexisting injuries Version 2.2011

and/or medical conditions, you should not participate in this study. Also, blood will be drawn to measure blood lactate accumulation pre and post exercise. Risks that may occur include but are not limited to: lightheadedness, headache, nausea, and fainting. An athletic trainer and registered nurse will be present to draw the blood safely and treat any condition they may occur. The blood will be drawn from a finger prick using a specific approved protocol. 4. Benefits. From this study, you will learn how your body responds to exercise during different phases of your menstrual cycle. Also, this study might also be beneficial by making you more physically fit through the VO2max test. 5. Financial (or other) considerations: There are no financial and/or other considerations to this study. 6. Confidentiality. Any and all information obtained from you during the study will be confidential. Your privacy will be protected at all times. You will not be identified individually in any way as a result of your participation in this research. The data collected however, may be used as part of publications and papers related to the effects of the menstrual cycle on exercise. 7. Voluntary Participation. Your participation in this study is entirely voluntary. You may refuse to participate in this research. Such refusal will not have any negative consequences for you. If you begin to participate in the research, you may at any time, for any reason, discontinue your participation without any negative consequences. 8. Other considerations and questions. Please feel free to ask any questions about anything that seems unclear to you and to consider this research and consent form carefully before you sign. Authorization: I have read or listened to the above information and I have decided that I will participate in the project described above. The researcher has explained the study to me and answered my questions. I know what will be asked of me. I understand that the purpose of the study is to determine the effects of menstrual cycle phase on exercise performance. If I don't participate, there will be no penalty or loss of rights. I can stop participating at any time, even after I have started. I agree to participate in the study. My signature below also indicates that I have received a copy of this consent form. Participant’s signature: ________________________________ Name (please print); _________________________________

Date: ________________

If you have further questions about this research project, please contact the principal investigator, Jennifer Bossi, at (860) 681-5940 or e-mail [email protected] or faculty supervisor , Dr. Kimberly Kostelis, at (860) 832-2791 or e-mail [email protected]. If you have questions about your rights as a research participant or if you have a research- related complaint please contact Dr. Bradley Waite, Chair, CCSU Human Studies Council at (860) 8323115, e-mail [email protected] or Kim DeMichele, Administrator, CCSU Human Studies Council at (860) 832-2366, email [email protected].

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MENSTRUAL CYCLE SELF-TRACKING SHEET Code Number: ______ Directions: Starting with this month, please circle the days that you have your period for the next 3 consecutive months.

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EXERCISE AND MENSTRUAL CYCLE HISTORY QUESTIONNAIRE Code Number: _____ Age: _____ Height : _____

Weight: _____

In Season Exercise History (Please circle your response.) 1. How many hours of exercise do you complete per day as part of your sport (practice, games, lift, etc)? 0-1 2-3 4-5 >5 2. How many days per week do you compete (practice and games)? 0-1 2-3 4-5 >5 3. How would you rate your average intensity of play (1 lowest; 5 highest)? 1 2 3 4 5 4. How many hours of exercise do you perform outside of your sport per week? 0-1 2-3 4-5 >5 Out of Season Exercise History (Non-competitive season. Please circle your response). 5. How many hours of exercise do you complete per day as part of your sport (practice, games, lift, etc)? 0-2 2-3 4-5 >5 6. How many days per week do you compete (practice and games)? 0-1 2-3 4-5 >5 7. How would you rate your average intensity of play (1 lowest; 5 highest)? 1 2 3 4 5 8. How many hours of exercise do you perform outside of your sport per week? 0-1 2-3 4-5 >5

Medical History: Please list any injury/ medical condition that you have sustained within the last 5 years that kept you from practice or play for more than one week. (Continue on back if necessary.) Injury: Length of time until return to activity. 1. 2. 3 Version 2.2011

Menstrual Cycle History (Please circle or write your response.) 1. Age you started your period: __________ 2. Your menstrual cycle is: Regular (comes consistently every month)

Irregular

3. Date of most recent menstrual period: __________ 4. Frequency of Menstrual Cycle: 35 days

5. Number of skipped/missed periods during that last 12 months: 0-1 2-3 4-5 6-7 8-9 6. PMS symptoms: (circle all that apply.) Cravings Cramps Headaches 7. Intensity of menstrual flow (on average): Very light Light Medium Heavy

Drowsiness

>10

Mood swings

Very Heavy

8. Longest period of time without menstruation (if applicable): 2 months 3 months 4 months

>4 months

9. Are you on birth control or any other medication that would affect your menstrual cycle? YES NO

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BRUCE VO2MAX TREADMILL TEST Stage 1

Time (min) 0

km/hr 2.74

Incline 10%

2 3 4

3 6 9

4.02 5.47 6.76

12% 14% 16%

5 6

12 15

8.05 8.85

18% 20%

7

18

9.65

22%

8 9

21 24

10.46 11.26

24% 26%

10

27

12.07

28%

(Bruce, 1994)

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BORG SCALE (RATE OF PRECIEVED EXERTION) 6

No exertion

7

Very Very Light

8 9

Very Light

10 11

Light

12 13

Somewhat Difficult

14 15

Difficult

16 17

Very Difficult

18 19

Very Very Difficult

20

Maximal Exertion

(Borg, 1982)

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Central Connecticut State University Athletic Training Protocol for Finger Stick Capillary Blood

Skill Level Indications Contraindications Procedure

Certified Athletic Trainer Unresponsive patients of unknown etiology, patients with suspected diabetic emergencies Cold, cyanotic, swollen, scarred, or rash covered finger

1. 2. 3. 4. 5. 6.

7. 8. 9. 10. 11. 12. 13. 14. Complications Remarks

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Apply powder free gloves. Patient should be seated or lying supine with arm in hyperextension. Turn patient’s hand upward. Massage patient’s hand and lower part of finger to increase blood flow. Scrub the patient’s 3rd or 4th finger of non-dominant hand with an alcohol pad and dry with gauze. Hold finger in an upward position, press lancet firmly just off the center of the finger pad on the palm-side surface of the finger with a sterile lancet making a puncture. Puncture should be made perpendicular to the ridges of the fingerprint. Apply slight pressure to start blood flow. Blot the first drop of blood on a gauze pad and discard pad in appropriate biohazard container. Keep the finger in a downward position and gently massage it to maintain blood flow. Avoid excessive pressure. Collect drop of blood on collection device. Provide patient with small gauze pad over the puncture site for a couple of minutes to stop bleeding. Apply a sterile bandage over the puncture site. Dispose of contaminated materials in designated biohazard containers.

NONE Normal blood glucose levels are from 60 to 110.

NIH CERTIFICATE

Certificate of Completion The National Institutes of Health (NIH) Office of Extramural Research certifies that Jennifer Bossi successfully completed the NIH Web-based training course “Protecting Human Research Participants”. Date of completion: 07/18/2011 Certification Number: 711213

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