Columbia University Medical Center Information Sheet
Verbal Consent & HIPAA Authorization
Attach to Protocol: IRB AAAK 2357
Principal Investigator: Doctor Christina Tennyson, M.D.
IRB Protocol Title: Breastfeeding and Infant-Feeding Practices in Women with Celiac Disease
This research study aims to investigate how women with celiac disease feed their newborn infants as compared with healthy women and women with inflammatory bowel disease. The study will examine the effects of celiac disease on the success of breastfeeding, as well as gather information about the grains that women feed their babies and the time at which they introduce them in the diet. Information on health status, reproductive history, breastfeeding experience, and infant feeding practices will be obtained by questionnaire, which individuals will complete voluntarily and anonymously. Questionnaires will be completely untraceable to subjects, and researchers will have access only to data provided in questionnaires.
This research may collect information related to your medical history. Please note that the health information that may be used and disclosed includes only information that you provide during completion of the questionnaire. This may include medical information that may be considered sensitive.
The researchers may use and disclose the information you provide during this research with representatives of government agencies, review boards, and other persons who watch over the safety, effectiveness, and conduct of research. However, the information that you provide will be completely untraceable to you. It is not the intent or desire for this research study to identify subjects. There is no sponsor for this research study.
The use of information you provide will expire at the end of this research.
According to the rules governing research procedures at CUMC, by agreeing to participate in the study, you grant permission for anonymous information about you obtained during the study to be made available to:
• Christina Tennyson MD, Peter Green MD, Suzanne Lewis MD, Arun Swaminath MD, Amy Defelice MD, Suzanne Simpson RD, Benjamin Lebwohl MD MS, Maria Minaya, Ryan Demmer PhD MPH, Danielle Heller
• Authorities at CUMC including the Institutional Review Board (IRB) who independently review studies to assure adequate protection of research participants, as required by federal regulations
• The Federal Office of Human Research Protections (OHRP) and other government agencies that oversee the safety of human subjects.
Whom Do I call if I have questions or problems?
If you have any questions or concerns about this study, you may contact Dr. Christina Tennyson at (212) 342-4508 or Danielle Heller at (732) 718-3233. You may also email questions to firstname.lastname@example.org or
You do not have to participate in the research study. Your treatment at CUMC will not be affected by your decision to participate. If you have any questions about your rights as a research subject, you can contact the Institutional Review Board at 212-305-5883 or visit the website at http://www.cumc.columbia.edu/dept/irb/info.html.
A copy of this information sheet will be given to you.
If you are completing this form online, please print a copy of this sheet for your records.