Developing Strategic Concepts Designed to Prevent AI/AN Youth Tobacco Use

FDA Center for Tobacco Products

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RESEARCHER NOTE:
CONSENT PROVIDED
DECLINED CONSENT
UNABLE TO REACH
(CANNOT PARTICIPATE)

PARENT / GUARDIAN PERMISSION VERBAL SCRIPT
TITLE OF INFORMATION COLLECTION: Developing strategic concepts designed to prevent
AI/AN youth tobacco use
Sponsor:

U.S. Food and Drug Administration
Center for Tobacco Products

Principal Investigator:

Dana Wagner, PhD

Email Address of Investigator:

[email protected]

Telephone:

619-231-7555 ext 331 (24 Hours)

Address:

Rescue Agency
2437 Morena Blvd
San Diego, CA 92110

Hello, is this [NAME OF PARENT/GUARDIAN]?
[NO] May I please speak to [NAME OF PARENT/GUARDIAN]?
[IF UNAVAILABLE, ASK FOR BETTER TIME TO CALL] Great, thank you. I will call back then.
[WHEN SPEAKING TO PARENT GUARDIAN, CONTINUE]
Hello, my name is __________ and I’m with Rescue, a health communications and research
company. I’m calling because we are conducting discussion groups in your area. Just to
confirm, are you [INSERT YOUTH FIRST NAME]’s parent or guardian?
[IF NO] Is [INSERT YOUTH FIRST NAME]’s parent or guardian available, or do you have their
contact information? [COLLECT APPROPRIATE INFORMATION AND CALL
PARENT/GUARDIAN; IF UNREACHABLE INDEFINITELY, MARK BOX ON 1 st PAGE]
[IF YES] We are interested in hearing your child’s thoughts and opinions about teen culture and
other information that may help prevent youth from using tobacco products. Please be assured
that this research does not involve sales of any kind. [INSERT FIRST NAME OF YOUTH]
expressed interest in taking part in the study, so we sent home a permission form. Did you
happen to read the form?

Dana Wagner, PhD

Advarra IRB Approved Version 23 May 2018

FDA Center for Tobacco Products

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[IF NO, SKIP TO NEXT PAGE AND FOLLOW INSTRUCTIONS STARTING AT “IF PARENT
DID NOT READ PERMISSION FORM”].
[IF YES] Ok, great. Do you have any questions about the study I can answer for you?
[YES] ANSWER QUESTIONS, REFER TO CONSENT ON NEXT PAGE OR
GIVE PHONE TO LEAD RESEARCHER IF UNSURE HOW TO ANSWER.
[NO] READ STATEMENT BELOW AND FILL IN BOX.
Ok. We’re trying to finalize our list of youth who have their [parent’s/guardian’s] permission to
take part. If you’d like, you can give your answer over the phone. Would you like to give
[INSERT NAME OF YOUTH] permission to participate in the discussion groups on [INSERT
DAY AND TIME]?
PARENTAL/GUARDIAN PERMISSION
 AGREES to child taking part in this study.
 DOES NOT AGREE to child taking part in this study.
Name of Youth: _________________________________________
Name of Parent/Guardian: ________________________________
Relation to Youth: _______________________________________
Phone # Confirmation: ___________________________________
Date: _____________ Time of Call: ___________AM/PM (Circle)
I certify that the nature and purpose, the potential benefits, and
possible risks associated with participating in this research have
been explained to the above-named parent/guardian.
Name of Researcher (Caller): _____________________________
Signature of Researcher (Caller): __________________________
Name of Witness: _______________________________________
Signature of Witness: ____________________________________

AFTER FILLING IN BOX, SKIP TO “ENDING CALL” PROCEDURE ON LAST PAGE.
[IF PARENT DID NOT READ PERMISSION FORM]

Dana Wagner, PhD

Advarra IRB Approved Version 23 May 2018

FDA Center for Tobacco Products

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Ok, that’s not a problem. We gave [INSERT YOUTH FIRST NAME] a permission form for you to
sign, but it may have been misplaced. Would you like me to read it to you over the phone, and
then you can decide whether to give [HIM/HER] permission to participate?
[IF NO, SKIP TO THE “ENDING CALL” SECTION ON THE LAST PAGE AND FOLLOW
INSTRUCTIONS FOR “IF PERMISSION NOT PROVIDED.”]
[IF YES]. Ok, it will take a few minutes for me to read the entire permission form, so please bear
with me. Feel free to stop me with any questions or if you need me to repeat anything.
READ ALOUD WORD FOR WORD.
The purpose of the research study your child has been invited to take part in is to learn about
teen culture and get opinions from teens to inform a tobacco prevention educational campaign.
Rescue Agency (Rescue) is a health communications and research company who is working
with G+G Advertising (G+G), an American Indian communications company. Together we are
working with the U.S. Food and Drug Administration’s Center for Tobacco Products to hold
discussion groups with youth ages 12 to 17. Information we get from youth participants will be
used to develop a campaign to reduce youth tobacco use.
[PROCEDURE]
Your child will be one of 168 youth participating in this project. Your child is invited to take part
in an in-person discussion group with no more than 12 youth. You can choose to let your child
take part in the discussion group or not, regardless of what others choose to do. Your child can
choose to leave the group at any time.
If your son or daughter is invited to take part, a researcher will contact them or you with the date
and time of the discussion group. The group will last 90 minutes. The group leaders will ask for
feedback about teen culture and existing advertisements. Your child and the other participants
will be asked to share their opinions. Responses your child provided to screening questions will
also be included in reports. However, your child’s name will never be used.
[PRIVACY]
Everything your child says during the discussion group can be heard by the other youth in the
group, the group leader, and other research team members. All participants will be asked to
respect the privacy of the others in the group. Everyone will be asked to not share anything said
during the group.
Group discussions may be audiotaped and transcribed. Your child can choose not to be
audiotaped at the start of the session. If your child says no, we will not record the group. We will
take written notes instead. The report will not link your child’s comments to him/her. No one
(including parents or guardians) outside of the group participants and researchers will know
what your child said during the discussions. Your child’s name will be used only during check-in.
Any audio files, transcripts or written notes resulting from a discussion group will be stored on a
password-protected computer and/or in locked cabinets that only the research team can access.
We will collect some personal information including gender, age, and race. However, we will not
keep any information that could identify your child, such as his/her full name. Your and your
child’s contact information will not be shared with others. You or your child will not be reDana Wagner, PhD

Advarra IRB Approved Version 23 May 2018

FDA Center for Tobacco Products

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contacted about this discussion group. The sponsor and Advarra IRB may have access to the
study data.
All data will be kept for three years after the project ends. It will be stored on a passwordprotected computer or in a locked cabinet. Three years after the discussion group ends, we will
destroy all of the data by securely shredding paper documents and permanently deleting
electronic records. All identifiable information (for example, contact information such as name
and phone number) will be destroyed after data collection for the project.
All information your child provides will be kept private to the extent allowed by law. This means
that we will not share information with anyone outside of the discussion group unless it is
necessary to protect your child, or if it is required by law (for example, abuse, neglect, self-harm,
etc.). Information your child shares about their tobacco-related attitudes, beliefs and behaviors
will not be shared with others. This includes parent(s)/guardian(s).
General information from this discussion group, including sample descriptions, may appear in
professional journals or at scientific conferences.
[BENEFITS]
This discussion group is not expected to directly benefit you or your child. Your child’s feedback
will help us decide what ideas, images, and messages may prevent youth tobacco use.
[ANTICIPATED RISKS]
We will take care to minimize the potential risks of participating in this discussion group.
However, as with all research, there is a chance that privacy could be compromised. For
example:
● Everyone will be asked not to discuss any information other participants shared during
the discussion group. However, other participants may not keep all information private.
● The research team will do their best to keep the confidentiality of information collected
during the discussion group. A breach may occur from an accident or as a result of
hacking.
● Teens will be reminded to not share any private information in the group. However, they
may accidentally share such information. This information will not be included in any
written notes and will be removed from the audio transcripts. Other discussion group
participants could still hear and react to the information.
Your child may want to discuss tobacco use or prevention with you. Your child may also have
questions or concerns about the images or ideas he/she sees during this discussion group.
Every youth who participates in this discussion group will get $25. You or another adult who
drives your child and any other teens to the group will also get $25. That amount will only be
given to an adult driving one or more children to the discussion group, it is not given to a child
who arrives by himself or herself, and the same amount is provided no matter how many
children are transported. If your child does not arrive on time to the discussion group location,
he/she may be disqualified. There is no cost for taking part in this discussion group.
[PARTICIPATION AND WITHDRAWAL]
Your child does not have to take part in this discussion group. Your child’s participation in this
discussion group is completely voluntary. You and your child can choose to take part in the
discussion group or not, regardless of what others choose to do. Your child may stop
Dana Wagner, PhD

Advarra IRB Approved Version 23 May 2018

FDA Center for Tobacco Products

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participating in this discussion group at any time if he/she wants to stop participating.
You can also withdraw your permission for your child to participate at any time by contacting the
principal investigator at the top of this document. No matter what decision you make, there will
be no penalty or loss of benefits to your child.
Your child does not have to answer any questions he/she does not want to. Your child will
receive $25 for his/her participation even if he/she chooses to leave the discussion group early
or chooses to not answer some questions. You or the adult who drives your child will still get
$25 for driving them.
You and your child can ask questions about this permission form or the discussion group
(before you decide to let your child start the discussion group, at any time during the group, or
after completion of the group).
The FDA does not encourage the use or sale of tobacco products. It is illegal in most states for
people younger than 18 years old to use tobacco, and it is illegal in all states for people under
18 to buy tobacco. Contact the staff listed on the first page of this form with any questions,
concerns or complaints.
This project has been reviewed by an Institutional Review Board (IRB). The IRB reviewed this
research study to help ensure that your child’s rights and welfare are protected and that this
discussion group is carried out in an ethical manner.
For questions about your child’s rights as a research participant, contact:
● By mail: Participant 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 Participant Adviser: Pro00024887.
Would you like to give [INSERT NAME OF YOUTH] permission to participate in the research
study on [INSERT DAY AND TIME]?

Dana Wagner, PhD

Advarra IRB Approved Version 23 May 2018

FDA Center for Tobacco Products

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PARENTAL/GUARDIAN PERMISSION
 AGREES to child taking part in this study.
 DOES NOT AGREE to child taking part in this study.
Name of Youth: _________________________________________
Name of Parent/Guardian: ________________________________
Relation to Youth: _______________________________________
Phone # Confirmation: ___________________________________
Date: _____________ Time of Call: ___________AM/PM (Circle)
I certify that the nature and purpose, the potential benefits, and
possible risks associated with participating in this research have
been explained to the above-named parent/guardian.
Name of Researcher (Caller): _____________________________
Signature of Researcher (Caller): __________________________
Name of Witness: _______________________________________
Signature of Witness: ____________________________________

Dana Wagner, PhD

Advarra IRB Approved Version 23 May 2018

FDA Center for Tobacco Products

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ENDING CALL
[IF PERMISSION IS NOT PROVIDED] Ok, well, thanks anyway for taking the time to talk to me.
Have a good morning/afternoon/evening.
[IF PERMISSION IS PROVIDED] Great, thank you. I can send you a copy of the permission
form so you’ll have it for your records. Would you like me to mail or email it to you?
[IF YES] GET ADDRESS OR EMAIL.
[IF NO] OFFER TO REPEAT ANY PART VERBALLY.
Please understand that what your [CHILD/SON/DAUGHTER/GRANDSON/
GRANDDAUGHTER, ETC] says is important to us. It is very important that [HE/SHE] arrive right
on time so that the group may begin on time. Please remind [HIM/HER] about the discussion
group on [DAY] at [TIME]. Before we end the call, do you have any questions for me?
ANSWER QUESTIONS OR WAIT FOR “NO”
Ok, great. Thank you so much for your time. Have a good morning/afternoon/evening.
UPDATE RESEARCHER NOTE ON FIRST PAGE.

Dana Wagner, PhD

Advarra IRB Approved Version 23 May 2018