RIHSC Approval Letter

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:

November 30, 2017

FROM:

Chair, Research Involving Human Subjects Committee

SUBJECT:

RIHSC Study #17-078CTP
Study Title: “Qualitative 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 a request for RIHSC review for your study, entitled, “Qualitative Study on
Consumer perceptions of Cigarettes Health Warning Images.” 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.
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 study is APPROVED.
EFFECTIVE PERIOD OF APPROVAL:
This study has been approved November 30, 2017 to November 29, 2018.
Below is a comment for your consideration. If you make changes to your protocol and informed
consents in response to this comment, please submit those altered documents in an amendment.
Comment:
1. Certificate of Confidentiality (CoC)
A. Original Statement: Certification of Confidentiality (CoC), is not addressed in the protocol, and
there is no statement about it in the protocol and the consent documents.
B. Issue/Justification: The 21st Century Cures Act requires certificates of confidentiality for certain
human subject research.
C. Consideration: The statements need to be included in the protocol and informed consent
documents if you determine (after working through your Center) that a CoC is needed.
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 November 30, 2018, you will need to submit a
continuing review application and all supporting documentation to the RIHSC no later than
September 15, 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 [email protected], or by phone at (301) 7969605.

Signed By:

IRB Chair