IRB 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:
April 4, 2016
FROM:
Chair, Research Involving Human Subjects Committee
SUBJECT:
RIHSC Protocol #16-019CTP
Study Title: “Multicultural Youth Tobacco Prevention Campaign – Copy Testing
Wave 2”
Principal Investigator: Dana Wagner, PhD
FDA Sponsor: Matthew Walker, DrPH; CTP
TO:
Matthew Walker, DrPH; CTP
Cathy Backinger, PhD; CTP Liaison to the RIHSC
You have submitted a request for RIHSC review for your proposal entitled, “Multicultural Youth
Tobacco Prevention Campaign – Copy Testing Wave 2.” Your study proposes to assess how
creative concepts designed to prevent youth from using tobacco provide an understandable and
engaging message about the harms of tobacco use without potential unintended adverse or
counterproductive effects by surveying multicultural youth influenced by Hip Hop culture.
Because your protocol is no greater than minimal risk, it could be reviewed using the expedited
procedure outlined in 45 CFR 46.110.
Your protocol is APPROVED.
EFFECTIVE PERIOD OF APPROVAL:
This protocol has been approved April 4, 2016 – April 3, 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 April 3, 2017, you will need to submit
a continuing review application and all supporting documentation to the RIHSC no later than
February 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 RIHSC@fda.hhs.gov, or by phone at (301) 7969605.

Signed By:

IRB Chair