Focus Group Consent Form

171555
Human Research
Protections Program

Approved
Current Approval:
Do not use after

10/19/2017
10/18/2018

University of California, San Diego
and
Tulane University

Pages 3

Consent to Act as a Research Participant
Focus Group
Addressing the Rise of Congenital Syphilis:
Working toward Setting-specific Solutions among High-Risk Pregnant Women
Sponsor: March of Dimes (INSERT GRANT NUMBER) and Center for Disease Control & Prevention
University of California, San Diego Principal Investigator: Dr. Jennifer Wagman
Tulane University Principal Investigator: Dr. Emily Harville
INTRODUCTION: Hello, my name is __________. I work with the University of California. The University
of California, San Diego and Tulane University are working together on a project to understand the health
behaviors of pregnant women in Kern County, CA. I’d like to invite you to take part in this study. This consent
form contains information about the research project. To be sure that you understand your part in this research,
we are reading this form to you. Please ask us to explain anything you may not understand.
REASON FOR THE RESEARCH: You are being asked to take part in a project to understand pregnant
women’s goals about their health and how they think health services can be improved. We would like to learn
about women’s health behaviors, where they go for health information, and how they access services in Kern
County, CA. You were selected for this study either because you are a resident of Kern County, CA or you are a
health care provider in this area.
STUDY PROCEDURES: All interviews and focus groups will be conducted by research assistants from the
University of California, San Diego. As part of this study, we will conduct about 8 focus groups (4 in Kern
County, CA and 4 in Baton Rouge Parish, LA) and about 20 interviews with health care providers(10 in Kern
County, CA and 4 in Baton Rouge Parish, LA), and expect up to 100 people to participate in this research. You
are being asked to take part in a focus group. Focus groups will be conducted in a public library meeting room,
or an area conveniently located to you. The information will be gathered in the following ways:
Focus groups: These are groups of about 6-10 persons. We will conduct focus groups with pregnant women
who live in Kern County, CA. We want your thoughts on how we can improve health services to meet the needs
of women like you. A researcher will guide the group. The group will be tape recorded if everyone in the group
agrees. Focus group participants can contribute to conversation as much as they wish, but they do not have to
provide any personal information or information they don't want to tell the group. They will also be asked not to
give their real names or address to the group. The researcher will start by telling everyone that they should not
discuss details of what any individual said with anyone outside the group, to make sure that every person’s
privacy is respected. However, we cannot fully ensure that every person will keep what is said within the group
private. The focus groups last about one and half hours. Each focus group participant will be asked to take part
in one focus group.
CONFIDENTIALITY: Any information collected during focus groups will stay private and will be kept in
secure locked files. Tapes of the focus groups will be written down on paper, and the tapes will be erased after
this is completed. Names of participants are not written down on the paper transcripts, but are kept in separate
secure files. We will ask to record the focus groups so we can transcribe them at a later date, but if you do not
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171555
want to be recorded we will not record your focus group and you can still participate in the study. People in the
focus groups will be asked not to discuss anyone’s comments or responses with anyone outside the group.
RISKS FROM BEING IN THE STUDY: The risks due to being in the study are small. They include:
 Social consequences if what you say becomes known to others. These risks are minimal. We will keep
all information safe and private. We will not release any information connected to your name without
your consent.
 Some of the questions are personal and sensitive. Some questions may be hard to answer, and others
could make you embarrassed or upset. You will not be required to answer any question that you do not
want to answer. You can stop at any time during the focus group. Or, you can refuse to be in the study
altogether.
There may be some unforeseeable risks from being in the study that we are not yet aware of. If we do find new
risks associated with this study, we will communicate these to you.
COSTS: There is no cost to you for being in this study.
BENEFITS: There are no direct benefits to you for being in the study. Talking about your experiences may
help you. After the focus group has been completed, you may want to talk with someone about the things that
were discussed during the focus group. If so, please ask us and we can provide you with extra information
and/or refer you to someone else to talk to. Also, the information collected in these focus groups may help us
understand how to help pregnant women access health services.
IF YOU DECIDE NOT TO BE IN THE RESEARCH: You can decide not to be in this study. Your decision
will not affect the care you receive from any health care providers in the area.
COMPENSATION: You will be given a $25 gift card at the end of the focus group. This is for your time.
STAYING IN THE RESEARCH: We would like you to complete the focus group, but this is your choice and
you can leave the study at any time.
LEAVING THE RESEARCH STUDY: Your decision to take part is voluntary. You may decide not to take
part at all, or to leave even after the focus group has started. If you want to leave from the study, you can inform
study staff or call the Principal Investigators. This will not affect your access to any health services. The
alternative to participation in this study is to not participate. The Principal Investigator may terminate your
involvement in the study without your consent if it is deemed by the Principal Investigator to be in your best
interests.
WHO CAN YOU CALL IF YOU HAVE QUESTIONS: Dr. Jennifer Wagman and/or ________________
has explained this study to you and answered your questions. If you have other questions or research-related
problems, you may reach Dr. Jennifer Wagman at 858-534-9619.
YOUR RIGHTS AS A PARTICIPANT: If you have any questions about your rights as a participant you may
contact the Human Research Protection Program Office at the University of California, San Diego (Tel: 858246-4777) or Tulane University (Tel: 504-988-2665). If you are injured as a direct result of participation in this
research, the University of California will provide any medical care you need to treat those injuries. The
University of California will not provide any other form of compensation to you if you are injured. You may
call the Human Research Protections Program Office at 858-246-HRPP (858-246-4777) for more information
about this, to inquire about your rights as a research subject or to report research-related problems. If there is
any part of this consent that you do not understand, ask the investigator before signing.
Human Research

Protections Program
______________________________________________________________________________________________
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Approved
Current Approval:
Do not use after

10/19/2017
10/18/2018

171555
STATEMENT OF CONSENT for ADULT

This statement of consent is to acknowledge that you have been asked to take part in a focus group about
pregnant women’s goals regarding their health and how they think services can be improved so they can better
protect their health.

In signing this document you agree that the study representative has explained the significance of the research,
the duration of the project, the focus group in which you will take part, all of the methods to be used, and the
risks that you may take.

You have been given an opportunity to ask questions about this research project. All questions were answered
in a way that you understand. If you have other questions about this research, you can ask the study
representative or the principal investigator. If you have any questions concerning your rights as a participant in
this study, you can contact the Human Research Protection Program at the University of California, San Diego
or Tulane University.

In signing below you acknowledge that you understand that your participation is voluntary, that you can decline
to be in the study or leave the study at any time, and that if you decline to join the study or if you leave the
study, you will not lose any access to health benefits or services. You are signing your name to indicate your
consent to be in this study. You will be given a copy of the consent form.

SIGNATURE OF PARTICIPANT

DATE

PRINTED NAME OF PARTICIPANT

PERSON OBTAINING CONSENT

DATE

Human Research
Protections Program

Approved
Current Approval:
Do not use after

10/19/2017
10/18/2018

______________________________________________________________________________________________
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