INFORMED CONSENT DOCUMENT |
INFORMED CONSENT DOCUMENT
Project Title: Evaluation of sexual health associated with selective serotonin reuptake and selective norepinephrine reuptake inhibitor use
Principal Investigator: Amy Pearlman
Research Team Contact: Amy Pearlman, amy-pearlman@uiowa.edu, 319-353-8939
This consent form describes the research study to help you decide if you want to participate. This form provides important information about what you will be asked to do during the study, about the risks and benefits of the study, and about your rights as a research subject.
- If you have any questions about or do not understand something in this form, you should ask the research team for more information.
- You should discuss your participation with anyone you choose such as family or friends.
- Do not agree to participate in this study unless the research team has answered your questions and you decide that you want to be part of this study.
WHAT IS THE PURPOSE OF THIS STUDY?
This is a research study. We are inviting you to participate in this research study because you have been prescribed and have taken a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). SSRIs/SNRIs are used to treat depression and include: citalopram (Celexa), escitalopram (Lexapro), Fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), fluvoxamine (Luvo), venlafaxine (Effexor), desvenlafaxine (Pristiq), duloxetine (Cymbalta).
The purpose of this research study is to administer an online survey to patients with a history of SSRI use about post-selective serotonin reuptake inhibitor sexual dysfunction (PSSD) in order to obtain (1) details of SSRI use prior to PSSD symptoms and (2) information about potential treatment options that have helped these patients with their symptoms.
HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 5,000 people will take part in this study conducted by investigators at the University of Iowa. This survey will be a worldwide study and surveys will be posted on various online sites, including multiple PSSD support groups for this condition.
HOW LONG WILL I BE IN THIS STUDY?
If you agree to take part in this study, your involvement will be done upon survey completion. Completion of the survey will take approximately 20 minutes. There will be no further follow up, however please feel free to discuss the responses to the survey with your physician.
WHAT WILL HAPPEN DURING THIS STUDY?
You are invited to participate in this study after engaging with a web-based survey link posted on an online PSSD support group. Please review the entirety of this informed consent form. If you choose to participate, it will need to be electronically signed prior to starting the survey. Upon receiving your signature for consent, you will be redirected to an anonymous RedCap survey to complete. You should feel free to skip any questions you do not wish to answer in the survey. Upon completion, your direct participation is complete and there will be no further follow up.
If you would like to be contacted about future studies regarding PSSD, you may input your email when prompted in the survey. This is completely optional, and if you agree to take part in our current study you are not obligated to participate in one of our future studies. A separate Consent Document would be signed for future studies. We will only be keeping your email so that we may contact you in the future.
WHAT ARE THE RISKS OF THIS STUDY?
You may experience one or more of the risks indicated below from being in this study. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.
As some of these questions are asking personal questions regarding your sexual health, some questions may make you feel uncomfortable or embarrassed. There is a risk of loss of confidentiality of data. Measures in place to minimize this risk are indicated in the ‘What About Confidentiality’ section later in this document.
WHAT ARE THE BENEFITS OF THIS STUDY?
There is no direct benefit to you from being in this study.
We hope that, in the future, other people might benefit from this study as it may increase our knowledge and awareness of symptoms associated with SSRI/SNRI use, as well as potential therapeutic interventions.
WILL IT COST ME ANYTHING TO BE IN THIS STUDY?
You will not have any costs for being in this research study.
WILL I BE PAID FOR PARTICIPATING?
You will not be paid for being in this research study.
WHO IS FUNDING THIS STUDY?
The University and the research team are receiving no payments from other agencies, organizations, or companies to conduct this research study.
WILL YOU KEEP MY NAME ON FILE TO GIVE TO OTHERS?
We will keep information about you in a special kind of computer listing called a registry. A registry keeps information about you on file so that other researchers, not involved in this particular study, may contact you in the future about whether you are interested in being in different research studies. The registry will contain information such as your name, address, age, and selected medical information such as diagnosis and treatment. We will keep the information in this registry secure by storing your data on a password protected data platform. You may request that your personal information be removed from this file at any time by contacting Amy Pearlman at 319-353-8939.
WHAT ABOUT CONFIDENTIALITY?
We will keep your participation in this research study confidential to the extent permitted by law. However, it is possible that other people such as those indicated below may become aware of your participation in this study and may inspect and copy records pertaining to this research. Some of these records could contain information that personally identifies you.
- federal government regulatory agencies,
- auditing departments of the University of Iowa, and
- the University of Iowa Institutional Review Board (a committee that reviews and approves research studies)
To help protect your confidentiality, the surveys you complete will be encrypted on an online database. Data will be stored securely and confidentially on a password protected data platform. Only research team members with a secure login will have access to the data collected from this survey. If we write a report or article about this study or share the study data set with others, we will do so in such a way that you cannot be directly identified.
IS BEING IN THIS STUDY VOLUNTARY?
Taking part in this research study is completely voluntary. You may choose not to take part at all. If you decide to be in this study, you may stop participating at any time. If you decide not to be in this study, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you otherwise qualify.
WHAT IF I HAVE QUESTIONS?
We encourage you to ask questions. If you have any questions about the research study itself, please contact: Amy Pearlman at 319-353-8939. If you experience a research-related injury, please contact: Amy Pearlman at 319-353-8939.
If you have questions, concerns, or complaints about your rights as a research subject or about research related injury, please contact the Human Subjects Office, 105 Hardin Library for the Health Sciences, 600 Newton Rd, The University of Iowa, Iowa City, IA 52242-1098, (319) 335-6564, or e-mail irb@uiowa.edu. General information about being a research subject can be found by clicking “Info for Public” on the Human Subjects Office web site, http://hso.research.uiowa.edu/. To offer input about your experiences as a research subject or to speak to someone other than the research staff, call the Human Subjects Office at the number above.