Perinatal loss |
Consent preamble
You are invited to take part in a research study because you have self-identified as having experienced perinatal loss (miscarriage and/or stillbirth). The study is being conducted under the direction of Dr. Lesley Harris at the University of Louisville to understand how people make meaning of their loss(es) and what supports might be most helpful for individuals and the couples’ relationship. You will be asked to complete an online survey at the beginning of the study, one at the mid-point (two months later), and one at the end (two months after the mid-point survey). The surveys will take approximately 15 minutes each. You will also be asked to participate in at least one interview, which can be scheduled at your convenience, and will be recorded and transcribed via a secure video platform.
The risk of participating may include mild to moderate emotional distress at recounting your experience(s). A list of mental health providers in your area will be provided at the beginning of the interview. The information collected may not benefit you directly. The information learned in this study may be helpful to others. The information you provide will be used to create interventions to help others facing perinatal loss.
Your completed surveys will be stored online. Individuals from the research team, the Institutional Review Board (IRB), and the Human Subjects Protection Program Office (HSPPO) may inspect these records. In all other respects, however, the data will be held in confidence to the extent permitted by law. Should the data be published, your identity will not be disclosed.
Taking part in this study is voluntary. By answering survey questions, you agree to take part in this research study. You do not have to answer any questions that make you uncomfortable. You may choose to not take part in this study at all. If you decide to be in the study, you may stop taking part at any time. If you decide not to be in this study or if you stop taking part at any time, there is no penalty.
If you have any questions, concerns, or complaints about the research study, please contact: Dr. Lesley Harris at 502-852-8316. If you have any questions about your rights as a research participant, you may call the Human Subjects Protection Program Office at 502-852-5188. You can discuss any questions about your rights as a research participant, in private, with a member of the Institutional Review Board (IRB). You may also call this number if you have other questions about the research and you cannot reach research staff, or if you want to talk to someone else. The IRB is an independent committee made up of people from the University community, staff of the institutions, and people from the community not connected with these institutions. The IRB has reviewed this research study.
If you have concerns or complaints about the research or research staff and do not wish to give your name, you may call 1-877-852-1167. This is a 24-hour hotline answered by people who do not work at the University of Louisville.
The risk of participating may include mild to moderate emotional distress at recounting your experience(s). A list of mental health providers in your area will be provided at the beginning of the interview. The information collected may not benefit you directly. The information learned in this study may be helpful to others. The information you provide will be used to create interventions to help others facing perinatal loss.
Your completed surveys will be stored online. Individuals from the research team, the Institutional Review Board (IRB), and the Human Subjects Protection Program Office (HSPPO) may inspect these records. In all other respects, however, the data will be held in confidence to the extent permitted by law. Should the data be published, your identity will not be disclosed.
Taking part in this study is voluntary. By answering survey questions, you agree to take part in this research study. You do not have to answer any questions that make you uncomfortable. You may choose to not take part in this study at all. If you decide to be in the study, you may stop taking part at any time. If you decide not to be in this study or if you stop taking part at any time, there is no penalty.
If you have any questions, concerns, or complaints about the research study, please contact: Dr. Lesley Harris at 502-852-8316. If you have any questions about your rights as a research participant, you may call the Human Subjects Protection Program Office at 502-852-5188. You can discuss any questions about your rights as a research participant, in private, with a member of the Institutional Review Board (IRB). You may also call this number if you have other questions about the research and you cannot reach research staff, or if you want to talk to someone else. The IRB is an independent committee made up of people from the University community, staff of the institutions, and people from the community not connected with these institutions. The IRB has reviewed this research study.
If you have concerns or complaints about the research or research staff and do not wish to give your name, you may call 1-877-852-1167. This is a 24-hour hotline answered by people who do not work at the University of Louisville.