You are invited to participate in a research study of women’s immune health. You were selected as a possible subject because you indicated interest in the study and are a healthy female. We ask that you read this form and ask any questions you may have before agreeing to be in the study.
The study is being conducted by Dr. Tierney Lorenz of the Department of Psychology at UNC Charlotte.
STUDY PURPOSE
The purpose of this study is to compare immunity in samples of saliva and vaginal fluid. We are also looking at whether or not sexual arousal influences women’s immune systems.
NUMBER OF PEOPLE TAKING PART IN THE STUDY
If you agree to participate, you will be one of up to 100 women who will be participating in this research.
PROCEDURES FOR THE STUDY
If you agree to be in the study, you will attend one laboratory session lasting approximately 2 hours.
Lab visits are scheduled for the second half of your menstrual cycle, and always in the afternoons. The lab is located in the Colvard building on UNCC campus (Colvard 4104).
After you indicate your consent to participate, you will provide a urine sample that will be tested for pregnancy and ovulation, as well as urinary tract infections. Your tests will be read in private by the researcher, and then destroyed.
We will measure your height, weight, and percent body fat using a floor scale. We will also place some disposable electrodes on your chest and leg. These electrodes will connect to an electrocardiograph (ECG), which will measure your heart rate and heart rate variability (a marker of how your nervous system interacts with your organs).
You will fill out some surveys about your physical and mental health, menstrual cycle, sexuality, contraceptive use, relationships, and health habits (physical activity, sleep patterns, and diet) over the last week.
You will give two saliva samples by spitting into a tube.
You will provide two samples of vaginal fluid. You will be left alone in a private room for these procedures. We will give you a tampon (with a plastic applicator) and tubes filled with sterile solution. You will be asked to insert the tampon yourself, as far inside your vagina as is comfortable (as you would normally apply a tampon). The tampon will stay inside your vagina for about 10 minutes while you complete other procedures (e.g., filling out surveys). After 10 minutes, you will remove the tampon and put it in the tube with sterile solution. You will do this two times, before and after watching a sexual film.
You will watch a 10-minute film that will include a 3-minute neutral film followed by a 7-minute explicit sexual film depicting a heterosexual couple engaging in foreplay and intercourse. We will give you a one-time use, disposable vibrator. You are not required to use the vibrator; however, we ask that you try to achieve the highest arousal you can. You will wear gloves during the film to avoid introducing any material to your vulva that might get picked up by one of the tampons.
You will be asked to use a vaginal photoplethysmograph while watching the video. The vaginal photoplethysmograph is a small, tampon-shaped device that you will insert into your vagina in the privacy of a locked room. This device is used to record the amount of blood flow to your vaginal tissues. Most women find that the device is relatively unnoticeable after placement. The Principal Investigator or her research assistant will explain to you how to insert and remove the device before leaving your room. You will not be observed at any time while using the device, and you may remove the device at any time.
Prior to the film, you will also connect the electropads to ECG wires. The ECG will collect information about your heart rate during the video. After the film is over, you will remove the photoplethysmograph and unhook the ECG wires, and then insert the second tampon.
RISKS OF TAKING PART IN THE STUDY
While in the study, the risks and/or possible discomforts are:
- There are no known risks associated with the use of the vaginal photoplethysmograph. The plethysmograph is disinfected after each use using Cidex Plus according to the manufacturer’s guidelines. Cidex Plus has been designated by the U. S. Food and Drug Administration as a “high level disinfectant” that is used regularly to disinfect medical devices. Cidex Plus is known to be highly effective against infectious agents such as the tuberculosis bacterium, herpes simplex virus (Type 1 and 2), and HIV. The probe is always handled using gloves, and kept in individually-sealed plastic bags when not in use.
- Answering questions about your sexuality may be embarrassing for some people. You are free to skip any question you do not wish to answer, and none of your answers will be connected to your name or identifying information in any way. If you are distressed after filling out the surveys, you are welcome to speak with the head researcher (Dr. Tierney Lorenz), who has a Ph.D. in Clinical Psychology, with special raining in counseling women in sexuality issues.
- It is possible that you may discover you are pregnant and/or have a urinary tract infection during the first lab session. If this happens we will remove you from the study, and you will be encouraged to follow-up with your own primary care physician.
We will test your saliva, and vaginal fluid samples for hormones and measures of how your immune system works. These will include tests for steroid hormones (e.g., estradiol), markers of inflammation (such as C-reactive protein), antibodies (such as immunoglobulin A), and well your blood is able to fight bacteria or viruses in a test tube. (If you would like more thorough information about analytes to be tested, please ask the experimenter now). We will not test your samples for your genes/DNA. Please note that we are not using tests that are used to diagnose health conditions. Also, your samples will be labeled with your study ID number and not your name. That means that we are not able to tell you anything about the results from the tests on your saliva or vaginal fluid.
BENEFITS OF TAKING PART IN THE STUDY
If you wish, at your lab session, you can be given personalized information about your body fat percentage, which is a measure of the ratio of fat and muscle in your body. You may also keep the vibrator that you used during the study.
The findings from this study could help women and their doctors make better decisions about how to protect themselves from getting sick, and help researchers studying how the body protects itself from sexually transmitted diseases.
ALTERNATIVES TO TAKING PART IN THE STUDY
You can choose not to participate in this study. If you are a Psychology student, you may complete an alternative assignment instead of participating in research studies. Please contact your professor for more details about completing this assignment.
CONFIDENTIALITY
We will make our best effort to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your data will be identified with only a code number, never your name or any other identifying information.
Thoroughly trained Undergraduate Research Assistants will be performing many components of the experiment. These individuals may be in your classes. Please visit the following link for information about your student researchers.
Your personal information may be disclosed if required by law. These circumstances include (but are not limited to) inspection of the study and study data by organizations that provide quality assurance and/or research participant protection such as the UNCC Institutional Review Board or its designees. As allowed by law, the study sponsor (the National Institute of Health) may need to access your medical and/or research records.
If the study research is published, you will not be personally identified in those reports. At most, a deidentified summary of the data from all participants will be reported.
After you finish the study, we will delete your name and contact information from our database. The only thing linking your data together is your study number. We will carefully examine all of your survey data to make sure nothing you entered could be used to identify you in any way. If for whatever reason you wish to withdraw your study data at a future date, you will need to provide your study number or we will not be able to identify your data. Your survey data will be kept in a password protected and encrypted computer file.
Your saliva and vaginal fluid samples will be kept frozen until analyzed, and then destroyed. The majority of tests on your saliva and vaginal fluid samples will be conducted within one year of your participation. However, a small part of your samples may be kept for up to 5 years as it is sometimes necessary to re-analyze samples to confirm findings using improved methods or to test for immune markers that had not been discovered at the time of the original analysis. No sample will be kept longer than 5 years.
COSTS
We do not anticipate the study procedures will incur any cost to you other than the cost of transportation to the lab for study sessions. If you are not an UNCC student and you drive to study appointments, you will have your parking validated in a UNCC parking lot. If you are an UNCC student, we cannot compensate your parking costs.
PAYMENT
In compensation for your time, you will receive up to $20 in Amazon.com gift cards OR 4 hours of credit towards your Psychology participation requirement.
If you withdraw from the study without completing, or if you are withdrawn from the study by the researchers (as described above), you will be entitled to compensation commensurate with your level of participation. That means that if you are a Psychology student participating for course credit and you are found ineligible to participate, you will be withdrawn from the study and be credited solely for the time spent completing the interview (0.5 credit hours).
If you do not attend the lab session you will not receive compensation.
COMPENSATION FOR INJURY
If you are hurt during this study, we will make sure you get the medical treatment you need for your injuries. However, the university will not pay for the medical treatment or repay you for those expenses.
CONTACTS FOR QUESTIONS OR PROBLEMS
For questions about the study or a research-related injury, contact the researcher Dr. Tierney Lorenz at 704-687-1323. You can also email the lab at unccwishlab@gmail.com at any time.
For questions about your rights as a research participant or to discuss problems, complaints or concerns about a research study, or to obtain information, or offer input about your experience as a research participant, contact the UNCC Research Compliance Office at 704-687-1871.
VOLUNTARY NATURE OF STUDY
You are a volunteer. The decision to participate in this study is completely up to you. If you decide to be in the study, you may stop at any time. You will not be treated any differently if you decide not to participate in the study or if you stop once you have started. Your decision whether or not to participate in this study will not affect your current or future relations with UNC Charlotte.
There are a few circumstances where the researchers may withdraw you from the study, even if you wish to participate further. These include:
- If you are sick on the day of your lab session.
- If you are found to be pregnant or to have a urinary tract infection on the day of your lab session.
- If you do not respond to our attempts to contact you for more than 2 weeks.
- If you are unwilling or unable to give saliva or vaginal fluid samples.
UNCC IRB Approval date: 11/3/2016
