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:

October 23, 2018

FROM:

Chair, Research Involving Human Subjects Committee

SUBJECT:

RIHSC Study #18-038CTP
Study Title: ³Measuring Consumer Comprehension of Displays of Harmful and
Potentially Harmful Constituents (HPHCs) in Tobacco
Products: Pilot Cognitive
Testing and Experimental/Quantitative Study´
Principal Investigator: Jessica Pepper, PhD; RTI
FDA Sponsor: Katherine Margolis, PhD and Jennifer Bernat, PhD; CTP
TO:

Katherine Margolis, PhD; CTP
Carolyn Dresler, MD, MPA; CTP Liaison to the RIHSC

Your study submission, entitled, ³Measuring Consumer Comprehension of Displays of Harmful
and Potentially Harmful Constituents (HPHCs) in Tobacco Products: Pilot Cognitive Testing and
Experimental/Quantitative Study,´was reviewed by the Research Involving Human Subjects
Committee (RIHSC) Chair. This study proposes to test the effectiveness of sample formats to
communicate harmful and potentially harmful constituents in tobacco products information.
Results will be used to inform strategies to effectively communicate understandable and not
misleading information about HPHCs to the layperson.
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 Chair determined that your study was APPROVABLE with certain stipulations. These
were sent to you in a letter dated October 9, 2018. Your response, received October 19, 2018,
adequately addresses the RIHSC¶s concerns.
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 study is APPROVED.
EFFECTIVE PERIOD OF APPROVAL:
This study has been approved from October 23, 2018 to October 22, 2019.
FDA IRB:
Research Involving Human Subjects Committee
US Food and Drug Administration
FWA #00006196
Chair: Jeffrey DeGrasse, PhD
RESPONSIBILITIES:
The Principal Investigator is responsible for ensuring that the investigation is conducted according
to the approved protocol 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 protocol or parental permission or assent forms. [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 October 22, 2019, you will need to submit a
CONTINUING REVIEW APPLICATION FORM and applicable materials to the RIHSC no later
than August 15, 2019.
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

MEMORANDUM
Department of Health and Human Services
Food and Drug Administration
Research Involving Human Subjects Committee
____________________________________________________________________________________
DATE:

October 23, 2018

FROM:

Chair, Research Involving Human Subjects Committee

SUBJECT:

RIHSC Study #18-038CTP
Study Title: “Measuring Consumer Comprehension of Displays of Harmful and
Potentially Harmful Constituents (HPHCs) in Tobacco Products: Pilot Cognitive Testing
and Experimental/Quantitative Study”
Principal Investigator: Jessica Pepper, PhD; RTI
FDA Sponsor: Katherine Margolis, PhD and Jennifer Bernat, PhD; CTP

TO:

Katherine Margolis, PhD; CTP
Carolyn Dresler, MD, MPA; CTP Liaison to the RIHSC

Your study submission, entitled, “Measuring Consumer Comprehension of Displays of Harmful and
Potentially Harmful Constituents (HPHCs) in Tobacco Products: Pilot Cognitive Testing and
Experimental/Quantitative Study,” was reviewed by the Research Involving Human Subjects Committee
(RIHSC) Chair. This study proposes to test the effectiveness of sample formats to communicate harmful
and potentially harmful constituents in tobacco products information. Results will be used to inform
strategies to effectively communicate understandable and not misleading information about HPHCs to
the layperson.
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 Chair determined that your study was APPROVABLE with certain stipulations. These were
sent to you in a letter dated October 9, 2018. Your response, received October 19, 2018, adequately
addresses the RIHSC’s concerns.
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 study is APPROVED.
EFFECTIVE PERIOD OF APPROVAL:
This study has been approved from October 23, 2018 to October 22, 2019.
FDA IRB:
Research Involving Human Subjects Committee

RIHSC# 18-038CTP
US Food and Drug Administration
FWA #00006196
Chair: Jeffrey DeGrasse, PhD
RESPONSIBILITIES:
The Principal Investigator is responsible for ensuring that the investigation is conducted according to the
approved protocol 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 protocol or parental permission or assent forms. [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 October 22, 2019, you will need to submit a CONTINUING
REVIEW APPLICATION FORM and applicable materials to the RIHSC no later than August 15, 2019.
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.
2.
3.
4.
5.
6.
7.

RIHSC FILE Number/Study Title/Study Investigator(s)/Institution where study is being/was
conducted.
Brief summary of the project status, including a description of all changes, amendments, or
supplements to the previously approved protocol and consent form.
Number of subjects initially approved by the RIHSC for inclusion in the study and the number
actually entered into the study.
Number of subjects whose participation was completed as planned.
Number of subjects that dropped out of the study.
Summary of Adverse Events that can reasonably be attributed to the study.
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) 796-9605.