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
May 17, 2017
Chair, Research Involving Human Subjects Committee
SUBJECT: RIHSC Protocol #17-032CTP
Study Title: “Experimental Study on Warning Statements for Cigarette Graphic Health
Principal Investigator: James M. Nonnemaker, PhD, MSPH, BS; RTI International
FDA Sponsor: David B. Portnoy, PhD, MPH; CTP
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:
• Add a Paperwork Reduction Act Statement to the following study documents: Adult Study
Invitation Email, Parent or Guardian Permission for Youth Study Participation, Youth Assent for
Study Participation, Adult Consent for Study Participation, Screening Questionnaire,
Questionnaire (aka Instrument)
• Change wording from “After completing” to “If you complete,” the survey, on the Youth
Assent for Study Participation and the Adult Consent for Study Participation documents
• Change wording from “for your child’s participation” to “if your child completes the survey,”
regarding voluntary participation, on the Parent or Guardian Permission for Youth Participation
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 [email protected], or by phone at (301) 7969605.