RIHSC Approval letter 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:
June 12, 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 an amendment to your proposal, entitled, “Experimental 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 edits to the Appendix F, the questionnaire, on instances
referring to smoking and raising glucose:
• Changed “Warning: Smoking raises blood sugar, which can cause type 2 diabetes,” to
Warning: Smoking
causes type 2 diabetes, which raised blood sugar.” This change occurs on
page 2 and 9, in question B13_1.
• Eliminated question B13_2, a statement that smoking raises blood sugar and asked for
the level of agreement to that statement.
• Eliminated on question C1, the choice C1_17, which referred to blood sugar being
raised by smoking, page 11.
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