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INTRODUCTIONAs a new mother in your first pregnancy, you are being invited to be part of a research study. Taking part in research is voluntary. Please take as much time as you need to make your decision. This form provides a summary of the information the researchers will discuss with you. If you decide to take part in this research, you will keep a signed and dated copy of this form. Be sure to ask any questions you have about the study. WHY IS THIS RESEARCH STUDY BEING DONE?Previous research has shown that infant sounds can provoke a range of emotional responses in caregivers. In this study, we are interested in assessing first-time pregnant women’s thoughts and feelings related to infant crying. WHAT IS INVOLVED IN THE STUDY?You are asked to provide us with approximately an hour and fifteen minutes of your time. You may schedule an appointment for your interview at a time that is convenient for you and at a location of your choice: Either BC Women’s Health Center or in your own home. At the start of your interview, you will be asked to complete a questionnaire with some demographic questions and questions about emotional experiences (e.g., sadness, anger). You will then be asked to watch a DVD about care-giving and afterwards you will listen to an audio-recording of crying of an infant. While listening to the recording, you will be asked to use a slider-type device to indicate how you are feeling. A research assistant will show you how to use this device. When you have finished listening to the crying, we will ask you to complete a final questionnaire. These questions ask you about feelings and thoughts you may have experienced while listening to the recording. ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY? The results of the study may help us to understand more about new mothers’ responses to infant crying. Study results will be made available at https://www.motherinfantwellness.ca under Some of the questions in the questionnaires ask about various emotional experiences people sometimes have (e.g. sadness, anger) and also involve specific questions about thoughts and feelings you may have experienced while listening to the infant crying recording. Some women might experience mild distress when responding to these questions. You may decline to answer any question you do not wish to answer. Signing this consent form in no way limits your legal rights against the investigators or anyone else. Your confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, research records and medical records identifying you may be inspected in the presence of the Investigators, Health Canada, and the UBC Research Ethics Boards for the purpose of monitoring the research. However, no records which identify you by name or initials will be allowed to leave the Investigators' offices. The information we collect is identified with a randomly generated numerical code only, and not by name. All identifying information is coded and stored separately in a locked filing cabinet.
Any publications of these data will only report the results from participants in group form, so that no single person’s data will be separated from the rest of the participants. Access to the data will be restricted to project team members. Your taking part in this study is your choice. There will be no penalty if you decide not to be in the study. If you decide not to be in the study, you will not lose any benefits you are otherwise owed. You are free to withdraw from this research study at any time. All you paper and electronic data collected will be destroyed upon withdrawal. If you have any questions about the research, please contact Dr. Ronald G. Barr, Principal Investigator Tel: 604-875-2000 ext. 3568. Any concerns about your treatment as a research subject can be referred to the Research Subject Information Line, Office of Research Services at the University of British Columbia Tel: (604) 822-8598. In appreciation for your time and effort, you will be given Starbucks gift card (a $5 value) and a DVD and booklet about caring for your infant. A summary of our research findings will also be available on the Mother-Infant Wellness website when the study is finished. I have had the opportunity to ask questions and to discuss this study with the research team, and my questions have been answered to my satisfaction. I understand that my participation in the above study is entirely voluntary, and that I may refuse to participate, or may withdraw from the study at any time without any consequences to my involvement with B.C.'s Children's & Women’s Hospital. I consent to participation in this study and in signing this document I am, in no way, limiting my legal rights against the investigators, or anyone else. [Please note that this is a read-only copy of
the consent form. We will request that you sign this consent in-person
when you come for your study session. Please feel free to contact us
if you have any questions.] |
Department
of University of
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