RESEARCH SUBJECT INFORMATION AND CONSENT FORM
TITLE: Investigating Body Image, Mental Health, and Eating Behaviors in Women
VCU IRB NO.: HM20016491
If any information contained in this consent form is not clear, please ask study staff to explain any information that you do not fully understand. You may think about or discuss your participation with family or friends before deciding to be in this study.
PURPOSE OF THE STUDY
The purpose of this research study is to examine several factors that might influence body image in women. The factors include mental health and eating behaviors. Should you meet criteria and express interest, we will also be conducting a separate study on a writing intervention that may improve body image and creativity.
You are being asked to participate in this study because you are a woman (aged 18 or older).
DESCRIPTION OF THE STUDY AND YOUR INVOLVEMENT
If you decide to be in this research after reading this form, having all your questions answered, and understanding your involvement, you may begin the study.
The study will be completed on a computer at a time of your convenience. You will be asked to complete a set of surveys via RedCap that will take approximately an hour to complete. You will first complete a demographic questionnaire, which will ask you about your race/ethnicity, sexual orientation, gender, year in school, and self-reported height and weight. All responses are voluntary. You will complete questionnaires that ask about your emotions, and attitudes about eating and body image. The responses you provide will be kept confidential and secure. Approximately 700 participants will be involved in this study.
RISKS AND DISCOMFORTS
Possible risks of this study include feelings of discomfort or distress elicited by the questions. These risks are minimal and you do not have to answer any questions you do not want to answer, and you may end your participation at any time without penalty. For VCU students only: If you become upset, you can contact University Counseling Services at 804-828-6200 to schedule an appointment with a therapist. More information regarding VCU’s counseling services can be found here: https://students.vcu.edu/counseling/services/.
All participants (including VCU students) who need additional resources will receive a list of body image providers and resources.
Because this study involves transmission of data through the internet, there is a risk of breach of confidentiality.
BENEFITS TO YOU AND OTHERS
You are not expected to experience any direct personal benefits from your participation in this research. However, the information you and other participants provide may help us understand eating behaviors, mental health, and body image in college-aged women.
COMPENSATION
If you are enrolled in an applicable psychology course, you will receive 1 SONA credit for the study. If you choose to stop your participation after completing informed consent, you will receive .25 credits for your time. You will only receive full credit for completing the full study. Participants who are not enrolled in an applicable psychology course will not receive any form of compensation for the study.
COSTS
There are no costs for participating in this study other than the time you will spend filling out the questionnaires.
ALTERNATIVES
The alternative to participating in this study is to not participate. You may select another study in which to participate or consult your professor for an alternative to research participation in general.
CONFIDENTIALITY
If you choose to participate in this study, you will be assigned a study ID number, which will be used on all questionnaires. You will be asked to provide your name in order to grant SONA credit. RedCap allows the designation of fields as identifiers. The name field will be tagged as an identifier. RedCap allows you to export data without identifiers attached. Also, RedCap enables you to restrict who has access to identifiers. Once data collection is complete, data will be exported from RedCap to SPSS without identifiers. No user other than the primary researchers will have access to identifiers. The data are being collected only for research purposes. When data collection is finished, ID numbers will identify your data, not names. Access to all data will be limited to study personnel and access to identifying information will be limited to only the primary researcher.
This research involves the transmission of data over the internet. Although every reasonable effort has been taken to ensure the effective use of available technology, confidentiality during the actual Internet communication procedure cannot be guaranteed.
We will not tell anyone the answers you give us; however, information from the study may be looked at or copied for research or legal purposes by Virginia Commonwealth University.
What we find from this study may be presented at meetings or published in papers, but your name will not ever be used in these presentations or papers.
Should you qualify and express interest to participate in part two of the study, personal information about you might be shared with or copied by authorized representatives from the following organizations for the purposes of managing, monitoring and overseeing this study:
• The study Sponsor, representatives of the sponsor and other collaborating organizations
• Representatives of VCU and the VCU Health System
• Officials of the Department of Health and Human Services
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Website will include a summary of the results. You can search this Web site at anytime.
If you tell us that you may hurt yourself or someone else, the law says that we must let people in authority know.
VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is voluntary. You may decide to not participate in this study. Your decision not to take part will involve no penalty or loss of benefits to which you are otherwise entitled. If you do participate, you may freely withdraw from the study during active data collection. Your decision to withdraw will involve no penalty or loss of benefits to which you are otherwise entitled. If you would like the withdraw your data, please contact one of the researchers listed below.
Your participation in this study may be stopped at any time by the study staff without your consent. The reasons might include:
• the study staff thinks it necessary for your health or safety;
• you have not followed study instructions;
• administrative reasons require your withdrawal.
If you leave the study before the final survey is completed, you may not receive full credit for participation. However, you will receive .25 credits if you complete the consent form.
QUESTIONS
If you have any questions, complaints, or concerns about your participation in this research, contact:
Suzanne Mazzeo, Ph.D., Professor of Psychology (semazzeo@vcu.edu)
or
Alexandria Davies, M.S., Graduate Student (daviesae@mymail.vcu.edu)
The researcher/study staff named above is the best person(s) to call for questions about your participation in this study.
If you have any general questions about your rights as a participant in this or any other research, you may contact:
Office of Research
Virginia Commonwealth University
800 East Leigh Street, Suite 3000
Box 980568
Richmond, VA 23298
Telephone: (804) 827-2157
Contact this number for general questions, concerns or complaints about research. You may also call this number if you cannot reach the research team or if you wish to talk with someone else. General information about participation in research studies can also be found at http://www.research.vcu.edu/irb/volunteers.htm.
STATEMENT OF CONSENT
I have been provided with an opportunity to read this consent form carefully. All of the questions that I wish to raise concerning this study have been answered.