Welcome to My Survey

Thank you for participating in our survey. Your feedback is important. Please review the following informed consent. If you have any questions feel free to reach out via email or text message to the contact information provided below.


Contact:
Email: Tkuehne@saybrook.edu
Text: (508)-627-2229
Informed Consent for Study Participation

KEY INFORMATION FOR: DIFFERENCES IN IBS SYMPTOM SEVERITY AND FREQUENCY IN WOMEN USING THE HORMONAL IUD, ORAL CONTRACEPTIVES, THE DEPO-PROVERA SHOT, AND THE IMPLANT
Researchers at Saybrook University are asking you to choose whether or not to volunteer for a research study about differences in IBS symptom severity and frequency in women using hormonal contraceptives. This research is being completed as part of the requirements for a Ph.D. You are being asked to participate because you are 18-35 years old with a diagnosis of IBS, experiencing symptoms, using hormonal contraceptives, have not been diagnosed with Crohn’s disease or Ulcerative colitis, and are not pregnant or breastfeeding. This page is designed to give you key information to help you decide whether to participate. Detailed study information follows this page. Please ask questions. If you have questions later, the contact information for the research investigator in charge of the study is below.

WHAT IS THE STUDY ABOUT AND HOW LONG ARE YOU BEING ASKED TO PARTICIPATE?
The purpose of this study is to identify any differences between types of contraceptives on IBS symptom severity and/or frequency. For a complete description of the study, refer to the Detailed Consent that follows. By doing this study, we hope to learn how hormonal contraceptives affect IBS symptoms. Your participation in this research will last about 30 minutes during which you will fill in automated, online surveys.

WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
The benefits for this study would be adding to the literature regarding hormonal contraceptives and IBS symptoms for women. This may give participants and practitioners a better understanding when prescribing contraceptives and what may be triggering severity and frequency of symptoms. This could prove to be beneficial for the relief of symptoms. For a complete description of benefits and/or rewards, refer to the Detailed Consent.

WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY?
The greatest risk for this study is a possible breach of confidentiality. For a complete description of risks, refer to the Detailed Consent.

DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, benefits, or rights you would normally have if you chose not to volunteer or if you choose to withdraw from the study.

WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of this study is Tayla Kuehne and Dr. Jessica Weissman of the Integrative and Functional Nutrition program at Saybrook University. If you have questions, suggestions, or concerns regarding this study, or you want to withdraw from the study, please contact the PI at: Tkuehne@saybrook.edu or (508) 627-2229.

If you have any questions, suggestions or concerns about your rights as a volunteer in this research, or if you are harmed in this research, contact the Saybrook Institutional Review Board (IRB) Office at 626-316-5380 or irb@saybrook.edu.

DETAILED CONSENT:
FOR PARTICIPATION IN: DIFFERENCES IN IBS SYMPTOM SEVERITY AND FREQUENCY IN WOMEN USING THE HORMONAL IUD, ORAL CONTRACEPTIVES, THE DEPO-PROVERA SHOT, AND THE IMPLANT

ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY?
You may be excluded from the study if you are outside of the ages of 18-35, male, have not used the same contraceptive method for at least 6 months, do not have a diagnosis of IBS, do have a diagnosis of Crohn’s disease or Ulcerative colitis, are pregnant or breastfeeding, and experience dysmenorrhea or amenorrhea.
WHERE WILL THE STUDY TAKE PLACE AND WHAT IS THE TOTAL AMOUNT OF TIME INVOLVED?
The research procedures will be conducted at online using SurveyMonkey. You will need to complete the survey one time taking approximately 30 minutes.

WHAT WILL YOU BE ASKED TO DO?
The research activities include:
A survey which is expected to involve a series of questions pertaining to your IBS symptom history, your contraceptive use history, and basic demographic information and should take you about 30 minutes.

There will be no audio or visual images or recordings required.

This study includes two questionnaires that are already established regarding IBS symptom severity and frequency. The Birmingham IBS Symptom Questionnaire and the IBS- Severity Scoring System (IBS-SSS)

WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?
Participating in this study involves no expected risks or discomforts.
Even if there are no expected risks, you may experience a previously unknown risk or side effect.

WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY?
You will not get any personal benefit from taking part in this study.

IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES?
If you do not want to be in the study, there are no other choices except not to take part in the study.

WHAT WILL IT COST YOU TO PARTICIPATE?
There are no costs associated with taking part in this study.

WHO WILL SEE THE INFORMATION THAT YOU PROVIDE?
When we write about or share the results from the study, we will write about the combined information. The people who will have access to your information are myself and/or my dissertation chair. We will make every effort to prevent anyone who is not on the research team from knowing that you gave us information, or about the information you provide.

Some steps we will take to your identity confidential:
- We will not ask your name or any identifying information.
- The methods we will use to secure your information include encrypting and securing digital files within a password secured folder on my personal laptop which is also password and fingerprint secured.

We will make every effort to safeguard your data, but as with anything online, we cannot guarantee the security of data obtained via the Internet. Third-party applications used in this study may have Terms of Service and Privacy policies outside of my control or the control of Saybrook University. SurveyMonkey only uses information required by respondents if the respondent contacts them with questions or concerns. https://www.surveymonkey.com/mp/legal/privacy/?ut_source=legal&ut_source2=privacy-basics&ut_source3=inline - how-we-use-the-information-we-collect

CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY?
You can choose to leave the study at any time. You will not be treated differently if you decide to stop taking part in the study. If you choose to leave the study early, data collected until that point will remain in the study database and may not be removed.

WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY?
You will not receive any rewards or payment for taking part in the study.

WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS/SURVEYS?
Generally, tests/surveys done for research purposes are not meant to provide results that apply to you alone.

WHAT ELSE DO YOU NEED TO KNOW?
If you volunteer to take part in this study, you will be one of about 300 people to do so.
I am a Saybrook University doctoral student and I am being guided in this research by Dr. Jessica Weissman.

WILL YOUR INFORMATION BE USED FOR FUTURE RESEARCH?
Your information collected for this study will NOT be used or s

Question Title

* 1. Do you consent to participating in this one time survey?

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