Informed Consent For Confidential Survey
You are invited to participate in a research study titled: Socioeconomic and Other Influences in Nausea and Vomiting of Pregnancy and Hyperemesis Gravidarum.
This study is being conducted by medical students, Rachel McCann and Haley Shumway, under the direction of Ben Brooks, PhD, Assistant Director of the MSBS Program and Amanda Brooks, PhD, Director of Research and Scholarly Activity and Associate Professor of Molecular Biology at Rocky Vista University.
The purpose of this study is to investigate Hyperemesis Gravidarum and nausea/vomiting during pregnancy or “morning sickness” outcomes with consideration for the socioeconomic influences, race, age, support system, and pregnancy history. Dependent on your answers, we may ask for your help in upcoming studies targeting a gene that may be indicated in morning sickness. The results will be used to further understand what factors influence morning sickness and it’s outcomes.
Participation in this study is entirely voluntary at all times. You can choose not to participate at all or to leave the study at any point. If you decide not to participate, or to leave the study, there will be no penalty or loss of benefits to which you are entitled, or any effect on your relationship with the researcher(s), or any other negative consequences.
You are being asked to take part in this study because you are a mother who has been personally affected by morning sickness or know someone who has.
If you agree to participate, you will be asked to fill out one survey per living biological child about your pregnancy history along with symptoms as well as other factors such as socioeconomics, race, etc. This survey should take around 5 minutes to complete.
The survey will be collected via google forms. All of your responses to this survey will remain confidential by the investigators and will not be linked to you once de-identified. Only your email will be collected during the study. Dependent on your answers, we may contact you to participate in the next step of this research. You are free to withdraw from this study at any time. However, once you submit your completed survey, there will be no way to withdraw your responses from the study because the survey will be kept confidential.
Study data will be kept in digital format. This information/data will be stored and safeguarded in a restricted access folder on a password protected computer, and your survey responses will be identified only by the investigators listed above.
Any risks to you associated with this study are not expected to be greater than anything you encounter in everyday life. While you may not experience any direct benefits from participation, information collected in this study may benefit others in the future by helping to identify the various factors that contribute to morning sickness. More broadly, this research will help physicians and researchers continue to understand these diagnoses and how to better predict and treat them.
If you have any questions regarding the survey or this research project in general, please contact the principal investigator, Haley Shumway, at
haley.shumway@rvu.edu or her faculty mentor, Benjamin Brooks at
bbrooks@rvu.edu.
If you have any questions about your rights as a research participant, please contact the Rocky Vista University IRB Compliance Administrator at 720-874-2481 or
ldement@rvu.edu.
By completing and submitting this survey, you are indicating your consent to participate in this study.