Form Approved
OMB No. 0920-1154
Exp. Date: 1/31/2020
CONSENT FORM FOR
PARTICIPATION IN RESEARCH
“Messaging to Improve Patient-Provider Communication and Engagement on Risks of Alcohol Use During Pregnancy”:
American Institutes for Research/Eureka Facts
Introduction:
Hello, my name is ________ and I am a researcher with a company called EurekaFacts, a social science research company working on behalf of the Centers for Disease Control and Prevention (CDC). Thank you for agreeing to speak with me today and answer my questions.
The goal of this consent form is to explain the purpose of this research project and help you decide whether you would like to be a part of this project. This consent process also gives you the opportunity to clarify any questions that you might have regarding this project or about your participation in this project.
Before you participate today, you should understand the risks and benefits of participating to make an informed decision. This process is known as informed consent. This consent form provides you with detailed information on the study, Messaging to Improve Patient-Provider Communication and Engagement on Risks of Alcohol Use During Pregnancy, which will be discussed with you in detail. Once you understand the study, and familiarize yourself with the risks and benefits, you will be asked to sign this form if you decide to participate in the study.
What is the purpose of this research?
The goal of this study is to improve communication materials to help women like you think about alcohol, contraception (birth control), and pregnancy, and ultimately help women have healthy pregnancies. This study is being conducted by American Institutes for Research (AIR) in collaboration with EurekaFacts, LLC.
Why am I being asked?
You are invited to participate in a research study on behalf of the Centers for Disease Control and Prevention (CDC) because you are of reproductive age and likely to have experiences, knowledge, and attitudes regarding alcohol, contraception, and pregnancy. Additionally, we also want to understand your experiences in discussing these topics with your healthcare provider.
What is an In-Depth Interview?
In-depth interviews involve having a one-on-one interview with a person to learn his/her perspectives on a topic in detail. This interview process will involve conversation with trained staff and with someone like you to understand their perspectives on alcohol, contraception, and pregnancy.
What procedures are involved?
For the in-depth interview, I will be asking you a series of questions about thoughts, attitudes, and behaviors around alcohol use, contraception, and pregnancy. For each topic, I will ask you questions and then possibly follow up with additional questions to get more detail or to clarify something. I anticipate that our conversation should last around one hour today.
As a part of the research team, I am neutral on this topic. Therefore, as a neutral researcher, I am interested in getting your point of view to understand what you are hearing, thinking, and feeling about alcohol, contraception, and pregnancy and the kind of help and resources you are receiving to address these areas.
Please keep in mind that there are no ‘right’ or ‘wrong’ answers. We are interested in your perspective. If there are any questions that you don’t feel knowledgeable about or don’t feel comfortable answering, please just let me know.
Will I be reimbursed for my participation in this research?
In appreciation for your time, you will receive a compensation of $40 from EurekaFacts at the end of the interview.
What are the potential risks and discomforts?
No more than minimal risk is expected during any phase of this study. Some individuals might experience discomfort when talking about sensitive topics like alcohol use, contraception, and pregnancy. You may choose to refuse to answer any question and stop the interview at any time during the interview.
How do I benefit from participating in this research?
You may not benefit directly by participating in this interview. However, your responses will play a crucial role in the development of communication materials to help women like you think about alcohol, contraception, and pregnancy and ultimately help women have healthier pregnancies.
What about privacy and confidentiality?
Any data we collect will not be disclosed to anyone other than the researchers working on this project. Each person in the study will be assigned a unique identification code so her name will not be used in the process of research or publishing the results. The only instance when we would release information about you to anyone outside the project would be if we were required to do so by law, such as a subpoena or if we learned someone were in danger of harm.
Can I withdraw or be removed from the study?
Your participation in this study is voluntary. You may choose to refuse to answer any question and stop the interview at any time during the interview. You also have the right to withdraw from the study at any time without any penalty or questions asked and without any effect on your present or future relationship with us.
Person to Contact
This survey has been approved by AIR’s Institutional Review Board (IRB). If you have any questions, please contact Dr. Hanno Petras (Project Director) at [email protected] or at 202-403-5639 or Erin Morrison Wallace (IRB Chair) at [email protected] or at 202-403-5542.
Consent
By signing below, you are agreeing to participate in the research study. Be sure that any of your questions about the study have been answered to your satisfaction, and that you have a thorough understanding of the research.
Participant’s Signature: ____________________________________
Print Name: _________________________________________
Date: ______________________________
Interviewer’s Name: _______________
Date: ______________
To better capture your responses, I would like to like to audio record our conversation. Do I have your permission?
[ ] Agree
[ ] Decline
Participant’s Signature: __________________________________
Print Name: ___________________________________________
Date: _________________________________________________
Public reporting burden of this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-1154).
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