RIHSC Approval Letter - Amend

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 Study #17-078CTP Amendment
Study Title: ³Qualitative Study on Consumer perceptions of Cigarettes Health
Warning Images´
Principal Investigator: Denise Dickinson, MPH; RTI International
FDA Sponsor: David Portnoy, PhD, MPH; CTP
TO:

David Portnoy, PhD, MPH; CTP
Cathy Backinger, PhD, MPH; CTP Liaison to the RIHSC

You have submitted an amendment to your study, entitled, ³Qualitative Study on Consumer
perceptions of Cigarettes Health Warning Images,´for RIHSC review. Your study proposes to
conduct a series of 20 focus groups with adults and youth (16 to 17 years old) to evaluate
consumer comprehension, perceptions, and reactions to cigarette graphic health warning images.
Your amendment proposes to make text changes to the study documents required by OMB. The
required phrasing changes relate to the concept of ³confidentiality,´and include:
• Adolescent Screener ±change two occurrences of ³confidential´to ³private,´in the
³Introduction´section
• Adult Screener ±change one occurrence of ³confidential´to ³private to the extent
allowable by law,´in the
introductory section
• Parental Permission Form, Adolescent Assent form, and Adult Consent Form ±remove
³confidentiality of,´in
the ³Risks/Discomforts´section
None of these documents have been re-dated or re-versioned; all have an OMB number and the
expiration date of 6-30-18.
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.
The RIHSC waives the requirement for documentation of informed consent for subject assent and
parental permission, under 45 CFR 46.116(d), before the subjects are screened for eligibility.
Your amendment is APPROVED.
Approval of this amendment does not alter your effective date of RIHSC approval. Your study is
approved until November 29, 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.