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.