RIHSC amendment

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 12, 2017

FROM:

Chair, Research Involving Human Subjects Committee

SUBJECT:

RIHSC Protocol #17-032CTP Amendment
Study Title: ³Experimental 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 an amendment to your proposal, entitled, ³Experimental Study on Warning
Statements for Cigarette Graphic Health Warnings,´for RIHSC review. 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.
Your amendment proposes to make minor edits to the ³Study Screener, Assent, and Consent´
document, in ³Section B: Post-Test Outcomes,´requested and already approved by the RTI IRB
(No new version or date has been added to the file):
• Change instruction to, ³Please tell us how much you agree«´from question, ³How
much do you agree«´
• Add to instruction to study team, ³Display as scrolling list.´
• Add an answer option, ³9. Prefer not to answer,´to all the questions in this section.
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 protocol is
approved until May 3, 2018.
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