RIHSC Approval letter

IRB Chair Letter
IRB Chair Letter
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MEMORANDUM
Department of Health and Human Services
Food and Drug Administration
Research Involving Human Subjects Committee
____________________________________________________________________________
DATE:
May 4, 2017
FROM:
Chair, Research Involving Human Subjects Committee
SUBJECT: RIHSC Protocol #17-032CTP
Study Title: “Experimental Study on Warning Statements for Cigarette Graphic Health
Warnings”
Principal Investigator: James M. Nonnemaker, PhD, MSPH, BS; RTI International
FDA Sponsor: David B. Portnoy, PhD, MPH; CTP
TO:
David B. Portnoy, PhD, MPH; CTP
Cathy Backinger, PhD, MPH; CTP Liaison to the RIHSC
You have submitted a request for RIHSC review for your proposal entitled, “Experimental Study
on Warning Statements for Cigarette Graphic Health Warnings.” Your study proposes to examine
consumer reactions to two different versions of textual warning statements that focus on negative
health consequences of cigarette use. The study aims to compare the effect of exposure to the 9
original statements in the Tobacco Control Act to revised versions of those statements.
Because your protocol 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 proposal is APPROVED.
EFFECTIVE PERIOD OF APPROVAL:
This study has been approved May 4, 2017 to May 3, 2018.
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 May 3, 2018, you will need to submit a continuing
review application and all supporting documentation to the RIHSC no later than March 21, 2018.
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