Consent Form

FOCUS GROUP
PARTICIPANT CONSENT FORM
Sponsor / Study Title:

The U.S. Consumer Product Safety Commission (CPSC) / “Warning
Label Comprehension and Interpretation by Consumers for Children’s
Sleep Environments”

Principal Investigator:
Telephone:
Additional Contact(s): Study Staff

Panne Burke
571-858-3757 (24 hours)
Lauren Angel

Address:

Fors Marsh Group
901 N. Glebe Rd Suite 1010
Arlington, VA 22203

What is the key information?
You are being asked to participate in a research study collecting information about infant sleeping
products. This form describes the purpose, procedures, benefits, risks, and precautions of the
information collection. It also describes your right to withdraw at any time. A member of the study staff
is available to read through this form with you and discuss all the information, if you wish.
Fors Marsh Group (FMG) is conducting this project on behalf of the U.S. Consumer Product Safety
Commission (CPSC). This information collection is being done to improve CPSC’s understanding of
consumers’ perceptions, comprehension, interpretation, and use of warning label information on sleep
products. The findings will help inform CPSC regarding future labeling standards.
What do I need to know about this study?
If you agree to be part of the research study, you will be asked to participate in a focus group where you
will discuss your thoughts and experiences related to infant sleep products and warning labels. The
focus group will last about 90 minutes and you will be audio and video-recorded while you respond to
questions, worksheets, and other simple written activities that have been designed to facilitate
discussion. You do not have to answer any questions that you don’t want to.
People from the project team (both from FMG and CPSC) will be observing the session either in-person
or via livestreaming. They will take notes and listen, but they won’t interact with the group. You will only
be talking to the moderator and a small group of other participants.
What are the potential risks of being in this study?
There are minimal risks associated with this project. There is a possible risk of breach of confidentiality.
This risk is minimized by protections described in the “Who will see the results of this project or my
information?” section below. Please help protect the privacy and confidentiality of others by not
discussing anything from this session outside of the group. If you share stories about others during the
group, please avoid using real names or other identifying information. The study staff will do its due
diligence to remove any personally identifying information from the transcripts of the session.

Does participating in this project provide any benefits?
This study is for research purposes only. Although you may not directly benefit from being in this study,
others may benefit because the findings of this study may be used to improve
communication/messaging around safe use of infant sleep products.
Are there alternatives to participating?
This research study is for research purposes only. The only alternative is to not participate in this study.
Will it cost me anything to participate in the project?
There are no costs to participate in the project, other than possible transportation costs to and from the
facility. Participants in the focus groups will receive $75 for their participation, you will be paid at the
end of your participation in this study.
Do I have to be in this project?
Your participation is voluntary, which means you can stop or withdraw at any time. You may choose to
not participate, or you may withdraw from the study for any reason without penalty or loss of benefits
to which you are otherwise entitled.
Your part in the research may stop at any time for any reason, such as if the sponsor decides to stop
the study.
Who will see the results of this project or my information?
Everything you say during the focus group will be heard by the study staff. We will be very careful to only
let people working on the project see your information. There is a small risk that others might find out
what you say, despite all of our best efforts. In the case of a breach of confidentiality, appropriate steps
will be taken to notify participants.
The focus group will be audio and video-recorded and transcribed. The session may also be
livestreamed to other members of the project team and/or members of the sponsoring agency so they
can observe remotely. You will be told at the start of the focus group whether it is being livestreamed.
By signing this form, you consent to being audio and video-recorded and livestreamed during the focus
group.
Your name and other personal information (for example, contact and demographic information) will not
be linked to your responses and will not be shared with the sponsoring agency or distributed for future
research studies. This means that no one outside of the project team will be able to link what you said
back to you. The Investigator, the sponsor or persons working on behalf of the sponsor, and under
certain circumstances, the Institutional Review Board (IRB) will be able to inspect and copy confidential
study-related records which identify you by name. This means that absolute confidentiality cannot be
guaranteed. Everything you share will be kept private to the extent allowed by law. This means that we
will not share anything you provide with anyone outside the project unless it is required to protect you,
or if required by law. However, if you show a direct threat of harm to yourself or others, we have the right
to take action out of concern for you and concern for others.
All of the information we collect, including anything you say in the focus group, information collected
during screening, and audio files will be stored on a password-protected computer and/or in locked
cabinets that only the project team can access. We will collect some personal information from you, like
your age and race, but we will not collect any information that could identify you personally. After three
years, all of the collected information will be destroyed by securely shredding documents or permanently
deleting electronic information. Results from this project might appear in professional journals or

2

scientific conferences or shared with other project teams. No individual participants will be identified or
linked to the results. We will not disclose your identity in any report or presentation.
Whom to contact about this study:
If you have questions, concerns or complaints about the study, please contact the Principal Investigator
at the telephone number listed on the first page of this consent document.
An institutional review board (IRB) is an independent committee established to help protect the rights
of research subjects. If you have any questions about your rights as a research subject, and/or concerns
or complaints regarding this research study, contact:
• By mail:
Study Subject Adviser
Advarra IRB
6940 Columbia Gateway Drive, Suite 110
Columbia, MD 21046
• or call toll free: 877-992-4724
• or by email: [email protected]
Please reference the following number when contacting the Study Subject Adviser: [

].

Statement of Consent
Please mark one box and sign below. By signing this form, you have not waived any of your legal rights.
 Ye s , I a gree to pa rticipa te in this proje ct. I ha ve rea d, unde rs ta nd, a nd ha d time to cons ide r a ll of the
information above. My questions have been answered, and I have no further questions. I will receive a
copy of this signed and dated consent document.
 No, I do not a gre e to pa rticipa te in this proje ct. I ha ve rea d, unde rs ta nd, a nd ha d time to cons ide r a ll
of the information above. My questions have been answered, and I have no further questions.
________________________________________
Subject’s Printed Name
________________________________________ ___________
Subject’s Signature
Date
________________________________________
Printed Name of the Person Conducting the
Consent Discussion
________________________________________ ___________
Signature of the Person Conducting the
Date
Consent Discussion

3