Social Impact of COVID-19 in Pregnancy
What is the purpose of this research?
The purpose of this research is to understand the social impact of the current pandemic in pregnancy. We want to study the factors related to pregnancy and how these can be modified to improve health and wellbeing of pregnant women and their offspring. We will also ask questions to see if you would be interested in participating in future studies conducted by our team.
Participation is voluntary.
You are invited to take part in this research if you are pregnant and live in the United States. If you choose to participate, you may change your mind and leave the study at any time. Refusal to participate or stopping your participation will involve no penalty.
How many people will take part in this research?
About 50,000 pregnant women will participate in this study.
How long will I take part in this research?
We expect that it will take you about 10-15 minutes to complete the study survey.
What can I expect if I take part in this research? What are my responsibilities?
If you choose to participate, you will be responsible for answering some questions on a survey about you, sleep habits, moods, feelings and a brief medical history.
What are the risks and possible discomforts?
We do not expect anyone to be harmed by participation in study. However, you may feel uncomfortable to answer some personal questions. If you feel uncomfortable and would like to skip some questions or discontinue with the survey, please feel free to do so. There is a risk of breach of confidentiality. However, we will take appropriate steps to ensure that your information remains confidential.
Are there any benefits from being in this research study?
There is no direct benefit for participating in this study. However, we hope that through your participation, researchers can learn more about the factors that are related to pregnancy during pandemics.
What will I have to pay for if I participate in this research?
It will not cost you anything to participate in this research.
Can my participation in the research end early?
You may decide not to continue in the research at any time without it being held against you. The person in charge of the research can remove you from the research at any time without your approval for any reason.
If I take part in this study, how will my privacy be protected? What happens to the information you collect?
Data collected, including your identifiable information, will be seen by the researchers conducting this study. If research results will be published in a medical book or journal or used to teach others, there will be no identifying information included. In addition, all data collected about you will remain confidential. We will never publish any identifiable information about you. No one who codes or analyzes the data will know your name. Completed surveys will be stored securely for seven years after the end of the study before being deleted. Please be aware that if you change your mind after you have completed the questionnaire, the research team will not be able to take back any information that has already been used or shared with others.
Who can I contact if I have questions?
Drs. Bizu Gelaye and Elizabeth Levey of the principal investigators of this study. If you have questions about the study, you can reach them at (617) 432-1071.
This research has been reviewed by a Harvard Longwood Medical Area Institutional Review Board (IRB). If you wish to speak with someone from the IRB, please contact the Office of Human Research Administration (OHRA) at 617-432-2157 (or toll-free at 1-866-606-0573) or 90 Smith Street, Boston, Massachusetts 02120.
Statement of consent
I have read the information in this consent form including risks and possible benefits. I understand that I am free to withdraw at any time without penalty or loss of benefits to which I am otherwise entitled. If you give your consent to participate in the study, please complete the survey below.