Youth Assent Form

Approval Date: September 25, 2020 Approved
Consent Version No.:2
PI Name: Meaghan Moran
IRB No. 11186
OMB Control Number: 0910-NEW
Expiration Date: XX-XX-20XX

JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
ASSENT FORM
Study Title: How consumers use flavors to make inferences about Electronic Nicotine Delivery System (ENDS)

product qualities and intentions to use (Phase 2)
Principal Investigator: Meghan Moran, PhD
IRB No.: 11186
PI Version Date: April 23, 2020

Details About the Study
What is the purpose of this study?
Research allows us to collect information from people to help us answer questions about health. Through this
study, we would like to find out more about tobacco marketing.

Why we are asking you to participate?
We are working with SSRS, a survey research firm, to connect with participants for our online survey. You are
being asked to take part in this study because you have previously agreed to be contacted by SSRS about
chances to participate in research. We hope to include 2,500 young people like you in this study.

What will happen if you join this study?
If you join this study, you will be asked to complete an online survey. You may take this survey wherever you
like – on a computer, laptop, mobile device or other device with internet. The survey will ask you questions
about yourself and your experience with tobacco products. You will also be shown five different tobacco ads
and asked to tell us your perceptions of those ads. The survey should take about 20 minutes. You do not have
to answer any questions that you do not want to.

What are the risks or discomforts of the study?
We do not predict any significant risks to you if you take part in this study. You may become bored during the
survey, or may feel uncomfortable answering questions about yourself or your tobacco use. You do not need
to answer any questions that you do not wish to, and may stop participating at any time. The survey will not
collect any information that identifies you specifically.

What are the potential benefits to being in the study?
There is no direct benefit to you from taking part in the study. However, your participation in the study may
benefit young people in society by helping us better understand tobacco product use and tobacco marketing.

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AssentFormSigned_RCR5_21Dec2018

Approval Date: September 25, 2020 Approved
Consent Version No.:2
PI Name: Meaghan Moran
IRB No. 11186
OMB Control Number: 0910-NEW
Expiration Date: XX-XX-20XX

Will you be paid if you join this study?
You will receive 150 points for completing this survey. If you do not complete the survey, you will not receive
any points.

Ending study participation
You do not have to join this study. It is up to you. You can agree now and change your mind later. You may end
your participation at any time. If you wish to end your consent or leave the study, you can navigate away from
or close the survey webpage.

What Happens to Data Collected in the Study
Information from this study may be published in professional journals or presented at scientific conferences,
but your identifiable information will not be included in any report or presentation. All research staff are
committed to protecting your privacy.

What is a Certificate of Confidentiality?
This research is covered by a special protection (called a Certificate of Confidentiality) from FDA. This special
protection requires that researchers involved in this study protect your privacy. This means researchers
generally cannot provide your name, or any other information that could identify you, to anyone who is not
connected with the research. Researchers cannot share your information in court or during other legal
proceedings, unless you agree, even if there is a court order for the information. However, in other settings,
researchers may share study information that could identify you if:
• you agree to share information (for example, to get medical treatment);
• the study information is used for other scientific research that follows federal law;
• the FDA, which is paying for the study, needs information to check how their research money is being
spent; or
• a law requires sharing information (for example, when researchers must report to FDA, or if
researchers hear threats of harm to others or reports of child abuse).
The Certificate of Confidentiality does not prevent you from sharing any personal information or information
about your involvement in this study with others. For example, you can share that you are in this research
study or your history of tobacco use.
The Institutional Review Board (IRB) at Johns Hopkins School of Public Health has reviewed this research. An
IRB is a group of people who are responsible for making sure that the rights of participants in research are
protected. The IRB may review the records of your participation in this research to ensure that proper rules
were followed.

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AssentFormSigned_RCR5_21Dec2018

Approval Date: September 25, 2020 Approved
Consent Version No.:2
PI Name: Meaghan Moran
IRB No. 11186
OMB Control Number: 0910-NEW
Expiration Date: XX-XX-20XX

Study Contact and Questions
What is the Institutional Review Board (IRB) and how does it protect you?
This study has been reviewed by an Institutional Review Board (IRB), a group of people including scientists and
community people, that reviews human research studies. The IRB can help you if you have questions about
your rights as a research participant or if you have other questions, concerns or complaints about this research
study. You may contact the IRB at 410-955-3193 or jhsph.irboffice@jhu.edu.

What should you do if you have questions about the study, or are injured or ill as a result of
being in this study?
•

Call the principal investigator Dr. Meghan Moran, at 410-614-6872 if you have questions or complaints.

•

Call or contact the Johns Hopkins Bloomberg School of Public Health IRB Office if you have questions
about your rights as a study participant. Contact the IRB if you feel you have not been treated fairly or if
you have other concerns. The IRB contact information is:
Address:

Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe Street, Suite E1100, Baltimore, MD 21205
Telephone: 410-955-3193; Toll Free: 1-888-262-3242
E-mail:
jhsph.irboffice@jhu.edu

Agreeing To Participate
Completing this online survey and submitting it to us means that you have reviewed the information in this
form, you have had a chance to ask questions, and you agree to participate in this study. You may save or print
this information sheet if you wish.
Click ‘I agree to participate’ to continue on to the survey.
[link to survey – hyperlinked to phrase ‘I agree to participate’]

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to
average 2 minutes. Send comments regarding this burden estimate or any other aspects of this collection of information,
including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

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