IRB Approval Letters

APPROVAL
November 20, 2018
James Nonnemaker
919-541-7064, x27064
jnonnemaker@rti.org
Dear James Nonnemaker:
On 11/20/2018, the IRB reviewed the following submission:
Type of Review:
Title:
Investigator:
IRB ID:
Funding Source:
Customer/Client Name:
Project/Proposal Number:
IND, IDE, or HDE:

Initial Study
Experimental Study of Cigarette Warning Labels
James Nonnemaker
STUDY00020375
FDA Ctr Tobacco Products
DHHS FDA OAGS
0212926.032
None

The IRB approved the protocol from 11/20/2018 to 11/19/2019. Before 11/19/2019 or
within 30 days of study close, whichever is earlier, you are to submit a completed
continuing review and required attachments to request continuing approval or closure.
You can submit a continuing review by navigating to the active study and clicking Create
Modification / CR.
If continuing review approval is not granted before the expiration date of 11/19/2019,
approval of this study expires on that date.
In conducting this protocol, you are required to follow the requirements listed in the
Investigator Manual (HRP-103), which can be found by navigating to the IRB Library
within the IRB system.
Sincerely,
The RTI Office of Research Protection

Page 1 of 1

APPROVAL
December 11, 2018
James Nonnemaker
919-541-7064, x27064
jnonnemaker@rti.org
Dear James Nonnemaker:
On 12/11/2018, the IRB reviewed the following submission:
Type of Review:
Title:
Investigator:
IRB ID:
Funding Source:
Customer/Client Name:
Project/Proposal Number:
IND, IDE, or HDE:

Modification
Experimental Study of Cigarette Warning Labels
James Nonnemaker
MOD00000470
FDA Ctr Tobacco Products
DHHS FDA OAGS
0212926.032
None

The IRB approved the modification from 12/11/2018 to 11/19/2019. Before 11/19/2019
or within 30 days of study close, whichever is earlier, you are to submit a completed
continuing review and required attachments to request continuing approval or closure.
You can submit a continuing review by navigating to the active study and clicking Create
Modification / CR.
If continuing review approval is not granted before the expiration date of 11/19/2019,
approval of this study expires on that date.
In conducting this protocol, you are required to follow the requirements listed in the
Investigator Manual (HRP-103), which can be found by navigating to the IRB Library
within the IRB system.
Sincerely,
The RTI Office of Research Protection

Page 1 of 1

IRB Chair Letter
IRB Chair Letter
Check here to enter IRB Chair LetterComment: MEMORANDUM
Department of Health and Human Services
Food and Drug Administration
Research Involving Human Subjects Committee
______________________________________________________________________________
DATE: November 15, 2018
FROM: Chair, Research Involving Human Subjects Committee
SUBJECT: RIHSC Study #18-061CTP
Study Title: ³Experimental Study of Cigarette Warning Labels´
Principal Investigator: James Nonnemaker, PhD; RTI International
FDA Sponsor: David Portnoy, PhD, MPH; CTP
TO: David Portnoy, PhD, MPH; CTP
Carolyn Dresler, MD, MPA; CTP Liaison to the RIHSC
You have submitted a request for RIHSC review for your study, entitled, ³Experimental Study of
Cigarette Warning Labels.´Your study proposes to compare effects of new graphic health
warnings (GHW) to the existing, text-only Surgeon General¶s (SG) warnings. The goal is to garner
a better understanding on consumers¶knowledge, beliefs, and perceptions about the harms of
cigarette smoking. Adolescent, young adult, and adult smokers and non-smokers as well as
adolescents who are susceptible to initiation of cigarette smoking will be randomly assigned. You
propose to compare survey responses to determine whether GHW or SG warnings result in a
change in understanding about the negative health consequences of cigarette smoking.
Below is a comment for your consideration. If you make changes to any to your study
documents in response to this comment, please submit the tracked-changed documents in
an amendment.
1. Consider if it is appropriate for RTI to answer questions about rights as a participant or if a
disinterested party, such as the RIHSC, should be the point of contact.
Because your study is no greater than minimal risk, it could be reviewed using the expedited
procedure outlined in 45 CFR 46.110.
The RIHSC determined your study satisfies the criteria outlined in 45 CFR 46.404 for research not
involving greater than minimal risk to children. Assent and parental permission will be obtained
prior to the start of the study.
Your study is APPROVED.
EFFECTIVE PERIOD OF APPROVAL:
This study has been approved November 15, 2018±November 14, 2019.
FDA IRB:
Research Involving Human Subjects Committee, FWA #00006196
Chair: Jeffrey DeGrasse, PhD
Office of the Commissioner
Food and Drug Administration
RESPONSIBILITIES:
The Principal Investigator is responsible for ensuring that the investigation is conducted according
to the investigational plan and applicable regulations and for protecting the rights, safety, and
welfare of subjects. The Principal Investigator is also responsible for complying with the following
requirements:
1. Promptly reporting to the RIHSC all changes in the research activity including any modifications
to the Study Protocol or Informed Consent. 45 CFR 46.103(b)(4)(iii) Changes in approved
research may not be initiated without RIHSC review and approval except when necessary to
eliminate apparent immediate hazards to the subjects. 45 CFR 46.103(b)(4)(iii)
2. Promptly reporting to the RIHSC all unanticipated problems involving risk to human subjects or
others. 45 CFR 46.103(b)(5)(i)
3. Providing periodic reports to the RIHSC, as required. 45 CFR 46.109(e)
PROGRESS OR FINAL REPORT:
If you wish to continue your study beyond November 14, 2019, you will need to submit a
continuing review application and all supporting documentation to the RIHSC no later than
September 15, 2019.
If your study is completed or terminated within the next year, please submit a FINAL REPORT to
the RIHSC Executive Director. This report should contain the following information, if applicable:
1. RIHSC FILE Number/Study Title/Study Investigator(s)/Institution where study is being/was
conducted.
2. Brief summary of the project status, including a description of all changes, amendments, or
supplements to the previously approved protocol and consent form.

3. Number of subjects initially approved by the RIHSC for inclusion in the study and the number
actually entered into the study.
4. Number of subjects whose participation was completed as planned.
5. Number of subjects that dropped out of the study.
6. Summary of Adverse Events that can reasonably be attributed to the study.
7. List of abstracts or publications, and/or a brief description of any available study results.
If you have questions, or would like further information, please do not hesitate to contact the
RIHSC Program Management Staff by email at RIHSC@fda.hhs.gov, or by phone at (301) 7969605.

Signed By:

IRB Chair

IRB Chair Letter
IRB Chair Letter
Check here to enter IRB Chair LetterComment: MEMORANDUM
Department of Health and Human Services
Food and Drug Administration
Research Involving Human Subjects Committee
______________________________________________________________________________
DATE:
December 19, 2018
FROM:
Chair, Research Involving Human Subjects Committee
SUBJECT:
RIHSC Study #18-061CTP
Study Title: ³Experimental Study of Cigarette Warning Labels´
Principal Investigator: James Nonnemaker, PhD; RTI International
FDA Sponsor: David Portnoy, PhD, MPH; CTP
TO:
David Portnoy, PhD, MPH; CTP
Carolyn Dresler, MD, MPA; CTP Liaison to the RIHSC
You have submitted an amendment to your study, entitled, ³Experimental Study of Cigarette
Warning Labels,´for RIHSC review. This study proposes to garner a better understand on
consumers¶knowledge, beliefs, and perceptions about the harms of cigarette smoking.
Your amendment proposes to make updates to your study documents to include:
Protocol
Clarifying the consent process for each session; sections 10 and 11
Indicating that the study must be completed on a laptop or desktop; section 14
Consent/Assents/Parental Permission
Asking subjects to agree not to distribute copies of the study stimuli
Including separate assent documents for each session
Clarifying that Lifepoints are distributed to the parent¶s account
Changes to programming notes
Emails to adults and parents of youth
Updating the number of subjects from 9,760 to 10,000
Updating programming notes
Indicating that the study must be completed on a laptop or desktop
Surveys
Indicating that the study must be completed on a laptop or desktop
Making editorial changes and including directions to subjects
Updating programming notes
Clarifying that Lifepoints are distributed to the parent¶s account
Screener
Clarifying the consent process for each session; sections 10 and 11
Indicating that the study must be completed on a laptop or desktop; section 14
Updating programming notes
Because your proposed changes are minor and do not increase risk, your request could be
reviewed using the expedited procedure outlined in 45 CFR 46.110.
The RIHSC determined your study satisfies the criteria outlined in 45 CFR 46.404 for research not
involving greater than minimal risk to children. Assent and parental permission will be obtained
prior to the start of the study.
Your amendment is APPROVED.
Approval of this amendment does not alter your effective date of RIHSC approval. Your study is
approved until November 14, 2019.
If you have questions, or would like further information, please do not hesitate to contact the
RIHSC Program Management Staff by email at RIHSC@fda.hhs.gov, or by phone at (301) 7969605.

Signed By:

IRB Chair