Informed Consent

INFORMED CONSENT

SOCIOSEXUALITY OF ROMANTIC COUPLES Part 1

 

Introduction

You are being asked to participate in a research study that is being done by researchers from Oakland University. This study is being done by Dr. Tara DeLecce (postdoctoral researcher), under the direction of supervising faculty member Dr. Virgil Zeigler-Hill, and alongside co-investigators Dr. Todd Shackelford (faculty member) and Dr. Lisa Welling (faculty member). The purpose of this Information Sheet is to let you know more about the study so you can decide whether to volunteer for the study or not.  Please read the form carefully. You may ask questions about why the research is being done, what you will be asked to do, the possible risks and benefits, your rights as a volunteer, and anything else about the research or this form that is not clear. You may talk with your friends and family about this research study before making your decision. When all your questions have been answered, you can decide if you want to be in this study. This process is called ‘informed consent.’ If you decide to participate, your participation will indicate that you have read this information sheet and that you understand what it says.

 

Why is this study being done?

The present study is designed to examine the sexual behavior of heterosexual couples, in order to determine if humans engage in sperm competition in a manner that is similar to other species. More specifically, we will be analyzing the semen produced from masturbation and from copulation. The results of this study will be used to guide future research regarding human sexual behavior.

 

Who can participate in this study?
We are recruiting sexually active, heterosexual couples who have been in a committed relationship for at least three months. Participants must be between the ages of 18 to 35 and couples must currently be using condoms during sexual intercourse. Students from Oakland University are eligible to participate, but participation is not limited to these students. Individuals who are currently receiving fertility treatment are not eligible to participate in this study. Additionally, women who are using or have used a method of hormonal contraception in the past 3 months, such as the birth control pill, patch, hormonal IUD, or ring (such as the NuvaRing), are not eligible to participate in this study. Couples who are using calendar-based “rhythm” methods of contraception (i.e., avoiding sexual intercourse during periods in which the woman is at greater conception risk) are excluded from participating.

 

Who is sponsoring this study?

None

 

Where is this study being done?

Oakland University campus in Rochester, MI.

 

What procedures are involved with this study?

Participation will consist of attending one 90-minute laboratory session and six 10-minute sessions, scheduled at your convenience over the course of 45 days. Both male and female participants will attend all 7 sessions.

 

Romantic couples will also be asked to provide a total of six semen samples: three from (the man’s) masturbation and three from (the couple’s) copulation. You will wear a condom when producing copulatory semen samples. You will not wear a condom when producing masturbatory semen samples. These samples will be at the beginning of each of the scheduled sessions. You and your partner are free to decide which of the 6 samples you submit will be masturbatory samples and which are copulatory. We ask that both male participants and female participants abstain from all sexual activity for at least 48 hours but no longer than 7 days before contributing each semen sample. You may contact researcher Tara DeLecce (copulationstudy@gmail.com) to reschedule your sessions without penalty.

 

Male participants will be asked to measure their own testicular volume using instructions and measurement tools (i.e., calipers) that we will provide. This measurement will be conducted by you in the privacy of your own home (or other location of your choosing). In addition, the majority of male participants will be asked to participate in the “scent responses” portion of this research. If you are asked to participate in the scent responses portion, you will be asked to smell natural scent stimuli (that we will provide) each of the three times that you provide a masturbatory semen sample. When you provide masturbatory samples, you will ejaculate directly into a jar that is provided for you and you will not wear a condom while masturbating. Remember that you will wear a condom when producing copulatory semen samples.

Female participants will be asked to keep track of their menstrual cycles. During the study, female participants will be provided with a “reminder card” to contact the researcher when she begins her next menstrual cycle (first day of bleeding). We will also contact female participants around the estimated next menstrual onset to remind them to email us to confirm whether they began their period on the expected date. You will be asked to report information regarding any use of hormone replacement therapy, fertility treatment, contraception, and pregnancy. Remember that you will wear a condom when producing copulatory semen samples.

Romantic couples will also provide saliva samples, face photos, and voice recordings, and complete questionnaires. We ask that participants abstain from all sexual activity (e.g., masturbation, copulation) for at least 48 hours but no longer than 7 days before contributing each semen sample. You may contact researcher Tara DeLecce (copulationstudy@gmail.com) to reschedule your sessions without penalty. The experimenters will take various anatomical measurements as described below.

To protect your privacy, the researchers will not share information you provide in this study (e.g., your responses on questionnaires) with your romantic partner. However, note that both romantic partners will be informed of the female participant’s conception risk. That is, we will estimate the calendar dates during which the female participant is at greatest conception risk (e.g., using calendar-based methods), and we will provide this information to both romantic partners so that participants can make informed decisions—as a couple—about their sexual behaviors over the course of the study (e.g., whether to submit a copulatory semen sample or a masturbatory semen sample during sessions of greater conception risk).

If you and your partner successfully complete all phases of the study, then you and your partner will receive a total of $210 ($105 per person) after completing all sessions of the study. If you fail to schedule and attend the 6 required laboratory sessions within 45 days, then you and your partner will be excluded from the study.

If you agree to take part in this research study, both people in the couple will attend each of the following 7 sessions and be asked to participate in the following procedures:

 

Session 1 – 90 minutes*

·         Watch Orientation Video

·         Sign consent. Note: All participants will privately complete the consent form, in a room separate from their partner.

·         Complete various questionnaires concerning your sexual behavior (e.g., how long since the last time you had sex?), relationship satisfaction, and personality. Note: All participants will privately complete the questionnaires, in a room separate from their partner.

·         Physiological and anatomical measures are taken (e.g., height, weight, grip strength using a device called a dynamometer (a hand held device that you squeeze to see how strong your hand grip is), head circumference using a measuring tape, diameter of your wrists, elbows, ankles, biceps, length of your ears and fingers using a measuring tape, the circumference of your shoulders and your hips using a measuring tape).

·         Provide a saliva sample by spitting into a plastic pharmaceutical tube through a clean, disposable straw. We will use your saliva sample to measure your hormone levels.

·         The researchers will use a microphone to record your voice while you say aloud each vowel (“a”, “e”, “i”, “o”, and “u”).  The researchers will use a software program to measure the vocal pitch of your voice recordings.  Your voice recording will be rated by a third party panel (300 men and 300 women) that will be recruited from online sources. (Note: You may choose not to submit your voice recording, but you can still participate in all other aspects of the study. You will not be penalized if you choose not to submit your voice recording).

·         The researchers will also take a digital face photograph of you.  Your photo will be rated by a third party panel (300 men and 300 women) that will be recruited from online sources. (Note: You may choose not to submit your face photo, but you can still participate in all other aspects of the study. You will not be penalized if you choose not to submit your face photo. ).

·         The researcher will review the procedures regarding the production and transportation of semen. Male participants will receive a “Take-Home Kit” containing all the necessary materials (e.g., non-spermicidal condoms, vernier calipers for assessments of testes size, and scent stimuli (if applicable), and female participants will be provided with a “reminder card” to contact the researcher when she begins her next menstrual cycle).

·         If you are part of the sample that is provided scent stimuli, you will be provided with three scent bottles. You will sniff the scent bottle three times immediately before you begin masturbating and three additional sniffs while you are masturbating. You will dispose of the scent stimulus bottle after ejaculation.

·         Schedule Session 2.

·         Each member of the couple will be compensated $10 at the end of Session 1.

 

Prior to arriving to Sessions 2 through 7

·         Measure testicular volume at home using instructions and measurement tools (i.e., calipers) that we will provide. This measurement will be conducted by you in the privacy of your own home (or other location of your choosing).

·         Complete “At Home Questionnaire”

·         If you have been selected to participate in the scent responses portion of this research, you will smell natural scent stimuli immediately before and again during masturbation (but not before or during copulation).

·         Masturbate or have sex and collect semen.

·         Bring semen sample to 109A Pryale Hall within 60 minutes; send an e-mail to Tara DeLecce (copulationstudy@gmail.com) if can’t get to lab in 60 minutes.

 

*Men participating in the scent responses portion of this research*: You will smell the contents of one of the three bottles each time you provide a masturbatory semen sample. You will not smell the scent stimuli for copulatory semen samples. The first time you provide a masturbatory semen sample, you will smell the contents of the bottle marked with the letter A; for the second masturbatory session, you will smell the contents of bottle B; and for the third masturbatory session, you will smell the contents of bottle C. You will be asked that, on any given day you think you will provide a masturbatory semen sample, you remove the appropriate bottle from your freezer so that it can thaw for at least 15-30 minutes before you begin masturbating (and longer than that is fine). You will be asked to leave the bottle closed and in a safe place as it thaws. This will allow the contents of the bottle to warm to room temperature, thereby making the scents more detectable to you.

 

*Sessions 2 through 7 –  15 to 30 minutes

·         Deliver semen sample to 109A Pryale Hall

·         Female and male participants complete questionnaires

o   During 2 of the 6 followup sessions, female participants will provide saliva samples to determine conception risk.

·         Each member of the couple will be compensated $10 at the end of Session 2.

·         Each member of the couple will be compensated $10 at the end of Session 3.

·         Each member of the couple will be compensated $12.50 at the end of Session 4.

·         Each member of the couple will be compensated $15 at the end of Session 5.

·         Each member of the couple will be compensated $17.50 at the end of Session 6.

·         Each member of the couple will be compensated $30 at the end of Session 7.

 

 

 

*For Sessions 2 through 7:

You will be asked to schedule your subsequent sessions within 30 days of the first laboratory session and deliver your samples to the laboratory. These other sessions will be the times when participants will bring semen samples to the laboratory, so these sessions should be scheduled at times that will allow participants to collect the samples in close proximity to the scheduled laboratory session (i.e., within 60 minutes). You will produce the samples at home (or another private place of your choosing) and do your best to transport these samples to our laboratory within one hour of ejaculation. If issues arise that prevent you and your partner from bringing your sample to the laboratory at the arranged time, you can simply reschedule your appointment by sending an e-mail to Tara DeLecce (copulationstudy@gmail.com). Again, we ask that participants abstain from all sexual activity for at least 48 hours but no longer than 7 days before contributing each semen sample.

 

After providing each sample, you will be asked to complete some basic information (e.g., how long has it been since you had sex with your partner?). During 2 of the 6 returning sessions, female participants will provide additional saliva samples to verify fertility. We anticipate that it will take you no more than 15 minutes to drop-off your samples, complete the questionnaire for each session, and if applicable, to provide a saliva sample. These estimated times do not include travel time to (or from) the laboratory or the time spent producing the ejaculates. If you successfully complete all phases of the study, then you will receive a total of $105 ($210 per couple). If you fail to schedule and attend the appropriate laboratory sessions within 45 days, then you will be excluded from the study.

 

What happens to the semen samples?

After you submit your semen samples to the laboratory, the researchers will assess your semen quality (e.g., sperm number, sperm concentration) using an automated semen analysis device. Additionally, the researchers may mix your semen with the semen from another man and investigate the interaction between the semen samples under a microscope. We will retain your semen for up to 72 hours to complete semen mixing procedures. Following these procedures, specimens and all disposable materials (e.g., fluorescent dyes, microscope slides, test tubes, pipettes) will be discarded immediately in the proper receptacle. Materials that come into contact with the specimen will be discarded in a clearly-marked red biohazard bag.

 

What happens to the saliva samples?

After you submit your saliva sample, we will analyze the hormonal profile of your saliva samples either (1) in 211A Pryale Hall or  (2) at a commercial laboratory at Johns Hopkins University. Saliva sample containers are labeled only with your participant ID (no identifying information). The commercial laboratory will not be given any identifying information pertaining to the participants or the study objectives. All saliva samples are discarded following analyses.

 

After collection of all data

Face photo and voice recording are rated by third party panelists.

Your face photo and voice recording will be retained for a third party panel (300 men and 300 women) to rate your face photo and voice recording on various dimensions (face: attractiveness, masculinity/femininity, maturity, symmetry, intelligence, aggressiveness, dominance, perceived age; voice: attractiveness, masculinity/femininity, maturity, intelligence, aggressiveness, dominance, perceived age). The third party panelists will be recruited from online sources (e.g., Facebook, the researchers’ personal websites), and all the ratings will be performed entirely online. There is a possibility that local community members or Oakland University students might participate in that study, and so some of those participants may recognize individuals depicted in the stimuli. However, it is important to note that participants of that online study will not know the conditions under which the face photos and voice recordings were obtained. Immediately after we finish data collection for Part 1, we will destroy any recruitment materials used for Part 1, including flyers, as well as information about Part 1 on the recruitment website (e.g., Consent Form for Part 1 that is displayed online). After we secure third party ratings, we will destroy all identifying information, including your name, face photo, and voice recording.

 

How long will participation in this study last?

The total time commitment will vary between participants based on a number of factors. However, we estimate that your participation should require approximately 2.5 hours in the laboratory (one 90-minute intake session, and six 10-minute follow-up sessions). This does not include the time spent traveling to (or from) the laboratory or the time spent producing semen samples. The researcher may stop your participation in this study at any time without your consent. For example, the researcher may stop your participation in this study if you fail to schedule and attend the appropriate laboratory sessions within 45 days. The Principal Investigator, Tara DeLecce, will contact you via email to inform you that you have been removed from the study.

 

How many people will be participating in this study?

100 heterosexual couples

 

What are the risks, side effects or discomforts that can be expected from participating in this study?

Participation in this study may be stressful for you because you will be asked to report your sexual behavior, and participants will be asked to provide semen samples to the researchers. Female participants may experience discomfort associated with answering questions regarding their menstrual cycle.

 

The current research asks participants to engage in sexual intercourse using condoms. Thus, there is a risk of pregnancy for participants. To ensure that the current research does not increase the risk of pregnancy over and above the risk you normally experience during typical sexual encounters with your partner, we ask that only participants who are already sexually active and who already use condoms during sexual intercourse participate in this study.

 

We ask participants to submit semen samples on days during which female participants are at peak fertility. Thus, we will NOT recruit participants who are using calendar-based methods of contraception (i.e., avoiding sexual intercourse on days during which conception risk is higher). These exclusion criteria are necessary to ensure that the procedures of this study do not expose participants to risk of pregnancy over and above what they normally experience in their normal sexual activities. Note that participants have leniency in whether they submit copulatory semen samples or masturbatory semen samples during each session. Participants may choose to submit masturbatory samples during days of higher conception risk to minimize the risk of pregnancy.

 

You may also experience physical discomfort/fatigue that is commonly associated with completing a survey. All participants have ample time to take breaks during the laboratory sessions, and are also free to skip any questions.

 

Male participants who are asked to participate in the scent responses portion of this research might perceive the smell of the natural scent stimuli as unpleasant. Although smelling the scent stimuli cannot cause you harm, participants who find the scent responses portion of the research unpleasant may choose not to continue that portion of the research and still remain in the study.

 

If you feel upset or distressed as a result of your participation in this study, you may want to consider contacting the Oakland University Graham Health Center (248-370-2341), the Oakland University School of Education and Human Services Counseling Services (248-370-2633), or Oakland Family Services in Rochester Hills (866-903-8955). It is important that you contact the Principal Investigator (Tara DeLecce, tdelecce@oakland.edu), the Faculty Advisor (Dr. Virgil Zeigler-Hill, zeiglerh@oakland.edu), and the Co-Investigators (Dr. Todd Shackelford, shackelf@oakland.edu; Dr. Lisa Welling, welling@oakland.edu) if you are upset by your participation in the present study.

 

What will be done to keep my information confidential?

Personal information regarding your participation in this study may be disclosed if required by law.  Also, your research records may be reviewed by the following groups:

 

·         Regulatory authorities involved in the oversight of research (Office for Human Research Protections or other federal, state, or international regulatory agencies)

·         Members or representatives of Oakland University Institutional Review Board (IRB) (in order to ensure that your rights as a research participant are being protected)

Every effort will be made to keep your study-related information confidential. All of your responses will be kept in the strictest of confidence and will not be available to anyone other than the researchers conducting the study, however a breach of confidentiality is a possible risk.  Breach of confidentiality means that it is possible that individuals not associated with this research may accidentally gain access to information that personally identifies participants. Appropriate safeguards are set in place to minimize a breach of confidentiality (e.g. researcher’s office is secure and computers and external storage devices are password protected); but no researcher can ever guarantee that this sort of breach will not occur.

The data you provide will be kept in a locked laboratory on campus in a password-protected computer. After recording your participation, your name will be replaced by a unique 3-digit identification number so that your name will not be directly linked with your responses. The master list linking your name with your 3-digit participant identification number will be kept in a locked laboratory on campus in a password-protected computer. This master list is necessary for us to keep track of the samples that you will provide during the study and to arrange your payment. The researchers supervising the study (Drs. Shackelford, Zeigler-Hill, and Welling) and the graduate students conducting the laboratory sessions will be the only individuals who will have access to this information. This master list will be destroyed when data collection is complete. After you receive payment for participation, we will destroy your identifying information, with the exception of your face photo and voice recording, which we will retain for use as stimuli for the third party panelists to rate. After we complete the part of the study in which third party panelists rate your face photo and voice recording, we will destroy all identifying information three years following data collection, including your face photo and voice recording.

 

The data will be used for professional presentations or publications in professional journals. No identifying information will be used in these publications; there will be no way to identify you as a participant in this study based on the information presented, unless you explicitly consent to the publication of your face photograph and/or voice recording. Your name will not be used. In other words, only group data will be presented or published to ensure your confidentiality. We will retain your semen samples for up to 72 hours after you submit them to the laboratory. During this 72 hour period, we will analyze the quality of your semen using an automated semen analysis machine, and also will conduct various semen mixing experiments (e.g., mixing together semen samples from two or more men). Following this 72 hour period, we will discard your semen sample.

 

Are there any known benefits from taking part in this study?

You will receive no direct benefit for participating in this study. However, you will learn about how psychologists conduct research. This research will help us better understand the sexual behavior of romantic couples, including semen production, which may have future applications (e.g., infertility treatments).

 

 

What are the alternatives to participation in this study?

You may choose not to participate in this study.

 

What are the costs of taking part in the study?

There is no cost to you for participating in this study.

 

What compensation is being provided for participation?

Each member of the couple will be paid a total of $105 ($210 per couple) for successfully completing all phases of the present study. The first session will last approximately 90 minutes, and each of the six follow-up sessions will last approximately 10 minutes. If you fail to schedule and attend the required laboratory sessions within 45 days, then you will be excluded from the study but you will be paid for the sessions that you complete. Each member of the couple will be compensated for completing the following sessions: Session 1: $10, Session 2: $10, Session 3: $10, Session 4: $12.50, Session 5: $15, Session 6: $17.50, Session 7: $30. Each couple will receive twice the allotted compensation amount (e.g., each participant will receive $10 for the first session, totaling $20 per couple). Oakland University students must report payments to the Office of Financial Aid at Oakland University.

 

What are your rights if you participate in this study?

Your participation in this research study is completely voluntary which means that you are free not to participate and you can choose to discontinue your participation at any time without penalty, or refuse to answer any questions that may be asked during the study. Your withdrawal from the research study will not affect your relationship with Oakland University or with any faculty or staff affiliated with Oakland University or the Psychology department. If you are a student or employee at Oakland University, your decision about participation will not affect your grades or employment status. If you agree to participate but later change your mind for any reason, you may withdraw from the study at any time. If you choose to withdraw from the study, then your partner will be removed from the study.

 

If you would like to stop participating in this study, you should contact the researcher Tara DeLecce (tdelecce@oakland.edu), who will provide instructions on how to withdraw from the study and any potential consequences for withdrawal.


Any new information that may affect your willingness to participate in the study will be provided to you as soon as possible.

 

What if I do not want to participate and decide I want to withdraw from the study?

Your participation in this research study is completely voluntary which means that you are free not to participate and you can choose to discontinue your participation at any time without penalty. Your withdrawal from the research study will not affect your relationship with Oakland University or with any faculty or staff affiliated with Oakland University. If you agree to participate but later change your mind for any reason, you may withdraw from the study at any time. If you choose to withdraw from the study, then your partner will be removed from the study.

What do you do if you have questions about the study?

For questions about the study you may contact the Principal Investigator, Tara DeLecce (tdelecce@oakland.edu), the faculty advisor: Dr. Virgil Zeigler-Hill (zeiglerh@oakland.edu), or the co-Investigators: Dr. Todd Shackelford (248-370-2285; shackelf@oakland.edu), Dr. Lisa Welling (welling@oakland.edu). For questions regarding your rights as a participant in human subjects research, you may contact the Oakland University Institutional Review Board, 248-370-2762.

 

After you have read this form in its entirety and understood the purpose and conditions of the study, please indicate below in which ways you consent for us to use your face photographs and voice recordings by initialing the boxes below.  If you decide not to consent to any of the photograph or voice recording portions of the study, you will not be penalized.  That is, you will still receive monetary compensation if you do not consent to all of the boxes below or decline to have your photograph and voice recording taken.

 

If you have questions, or if you choose to withdraw from the study, you can contact the following faculty members:

 

Dr. Todd Shackelford. 112 Pryale Hall. 248-370-2285. shackelf@oakland.edu

Dr. Virgil Zeigler-Hill. 212A Pryale Hall. 248-370-2676. zeiglerh@oakland.edu

 

Female participants who have questions, or who choose to withdraw from the study, can contact the following female faculty member:

 

Dr. Lisa Welling. 212 Pryale Hall. 248-370-2308. welling@oakland.edu