Consent Form revision

OMB No. 3041-0136

Expiration Date: 01/31/2024

FOCUS GROUP
PARTICIPANT CONSENT FORM
Sponsor/Study Title:

The U.S. Consumer Product Safety Commission (CPSC) Refining
Sleep Messaging for Seated/Non-Sleep Infant Products Focus Group
Study

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

Dr. Miriam Colman
610-349-2116
Rachel Ingersoll

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 that will collect information about seated infant
products in which infants may fall asleep, but that are not intended by the manufacturer for sleep. 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 to discuss all the information if you wish.
Fors Marsh Group (FMG) is conducting this study on behalf of the U.S. Consumer Product Safety
Commission (CPSC). This information is being collected to improve CPSC’s understanding of consumers’
perceptions, comprehension, interpretation, and use of warning label information on seated infant
standards.
What do I need to know about this study?
If you agree to be a part of the research study, you will be asked to participate in a focus group, during
which you will discuss your thoughts and experiences related to seated infant 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 do not want to answer.
People from the project team (both from FMG and CPSC) will observe the session either in person or via
livestreaming. They will take notes and listen, but they will not 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 section below titled, “Who will see the results of
this project or my information?” 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 (PII) 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 benefit directly from participating in this
study, others may benefit because the findings of this study may be used to improve communication or
messaging around safe use of infant non-sleep products.
Are there alternatives to participating?
This research study is for research purposes only. The only alternative is not to 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 group will receive $90 via a TangoCard, which can be redeemed for an
incentive of their choice (e.g., gift card, Visa card). Participants will be paid at the end of 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
not to 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 only to
let people working on the project see your information. There is a small risk that others might find out
what you say, despite all 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 (e.g., 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 principal 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 that 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 of 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 act out of concern for you and concern for others.
All 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, such
as your age and race, but we will not collect any information that could identify you personally. After
3 years, all 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

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scientific conferences or might be 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 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.
 Yes, I agree to participate in this project. I have read, understand, and have had time to consider all
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 agree to participate in this project. I have read, understand, and have had time to consider all
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
Consent Discussion

Date

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