FDA RIHSC Approval

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:
August 15, 2016
FROM:
Chair, Research Involving Human Subjects Committee
SUBJECT:
RIHSC Protocol # 16-048CTP
Study Title: “Consumer Comprehension of Displays of Harmful and Potentially
Harmful
Constituents (HPHCs) in Tobacco Products”
Principal Investigator: Jonathan Blitstein, PhD; RTI
FDA Sponsor: Katherine Margolis, PhD; CTP
TO:
Katherine Margolis, PhD; CTP
Cathy Backinger, PhD; CTP Liaison to the RIHSC
You have submitted a request for RIHSC review of your protocol titled, “Consumer
Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco
Products." This study proposes to gather information on different ways of presenting harmful and
potentially harmful constituent information to adults and youth. You plan to conduct nationwide indepth interviews to collect information from the subject population. This will assist in informing
you on how the details of HPHC should be presented, communicated, and improve understanding
by the public.
Because your protocol is no greater than minimal risk, it 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 protocol is APPROVED.
EFFECTIVE PERIOD OF APPROVAL:
This protocol has been approved August 15, 2016 – August 14, 2017.
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 the approval date of August 14, 2017, you will need to
submit a continuing review application and all supporting documentation to the RIHSC no later
than June 1, 2017.
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

Note to file:
8-18-16 Amendment was filed in order for RPMS to make correction of date error made on the approval
letter.