Adult Consent 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
ADULT INFORMED CONSENT
Principal Investigator: Meghan Moran, PhD
Study Title: How consumers use flavors to make inferences about Electronic Nicotine Delivery System (ENDS)
product qualities and intentions to use (Phase 2)
IRB No.: 11186
PI Version Date: September 9, 2020

Key Information About the Study
•

We are asking you to volunteer for a research study about tobacco marketing.

•
•

You do not have to join the study; it is your choice and there is no penalty for not joining.
This consent form explains the research study and your part in the study. Please read it carefully
and take as much time as you need.
You are a volunteer. You may choose not to take part at all, and if you join, you may quit at any
time. There will be no penalty if you decide to quit the study.

•

Details About the Study
Why is this research being done?
This study aims to understand perceptions of and response to tobacco marketing. Responding to this survey
request is voluntary; it is your choice. Completing this survey and submitting it to us means you consent to
participate in the study.

Why we are asking you to participate?
We are working with SSRS, a survey research firm, to recruit participants for our online survey. You are being
asked to participate because you have previously agreed to be on this online panel and be contacted by SSRS
with opportunities to participate in research. We hope to include 2,500 young adults 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 in the location
of your choosing, 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 report your perceptions of those ads. The survey should take about 20 minutes. You
do not have to answer any question you do not want to.

Page 1 of 4

RCR1_12Dec2018

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

What are the risks or discomforts of the study?
We do not anticipate any significant risk to participants. 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
question you do not wish to, and may stop participation 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 being in the study. Your participation in the study may contribute to
broader social, scientific and community benefits through helping us better understand tobacco product use
and tobacco marketing.

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.

Data Confidentiality
Protecting data against unauthorized disclosure
No personally identifiable information will be collected during the survey.

Protecting your privacy during data collection
You are able to take the survey in the location of your choosing. To fully protect your privacy, we recommend
you take the survey in a private setting (e.g., where you are alone or with people you feel comfortable sharing
the information in the survey with).

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.
Page 2 of 4

RCR1_12Dec2018

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

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.

What Happens to Data Collected in the Study
Authorized disclosure of research data
No personally identifiable information will be collected and stored. Your responses to the survey will be stored
in an electronic file and will be available to the principal investigator and study team members. Other
collaborators may access the data, upon request and approval granted by this study’s principal investigator.
We will use data from this study to publish reports related to the study’s findings.

Data sharing
The data we collect from you will help advance science and public health. Sharing of research data is often
done to increase what scientists can learn. The data you provide us might be shared: directly with other
researchers, funders, government agencies, publishers of papers; through government or other
databases/repositories.

Ending Consent
You may end your consent at any time. Information obtained and used before you end your consent will
continue to be used for research. If you wish to end your consent, you can navigate away from or close the
survey webpage.

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 [email protected].

Page 3 of 4

RCR1_12Dec2018

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

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:
[email protected]

Consent and 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 consent 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’]

WĂƉĞƌǁŽƌŬZĞĚƵĐƚŝŽŶĐƚ^ƚĂƚĞŵĞŶƚ͗dŚĞƉƵďůŝĐƌĞƉŽƌƚŝŶŐďƵƌĚĞŶĨŽƌƚŚŝƐĐŽůůĞĐƚŝŽŶŽĨŝŶĨŽƌŵĂƚŝŽŶŚĂƐďĞĞŶĞƐƚŝŵĂƚĞĚƚŽ
ĂǀĞƌĂŐĞϮŵŝŶƵƚĞƐ͘^ĞŶĚĐŽŵŵĞŶƚƐƌĞŐĂƌĚŝŶŐƚŚŝƐďƵƌĚĞŶĞƐƚŝŵĂƚĞŽƌĂŶLJŽƚŚĞƌĂƐƉĞĐƚƐŽĨƚŚŝƐĐŽůůĞĐƚŝŽŶŽĨŝŶĨŽƌŵĂƚŝŽŶ͕
ŝŶĐůƵĚŝŶŐƐƵŐŐĞƐƚŝŽŶƐĨŽƌƌĞĚƵĐŝŶŐďƵƌĚĞŶƚŽWZ^ƚĂĨĨΛĨĚĂ͘ŚŚƐ͘ŐŽǀ͘

Page 4 of 4

RCR1_12Dec2018