Att I_PA_XChesapeake IRB Exemption Determination

Attachment I: Project Announcement – Chesapeake IRB Exemption Determination

EXEMPT DETERMINATION
DATE:

28 Sep 2016

TO:

Sarah A. Evans, Ph.D.
Fors Marsh Group

PROTOCOL:

CDC, CDC Developing Effective Messages about Excessive Alcohol
Consumption: Formative Focus Groups with Adult Drinkers and Abstainers
(Pro00019145)
DOCUMENTATION REVIEWED:

Protocol Version:



Protocol (Not Dated)

Consent Form:



Informed Consent Form (Not Dated)

Recruitment Material:



ALCOHOL CONSUMPTION FOCUS GROUPS SCREENER (Not
Dated)

Other Material:



Worksheet, "PROFILE OF A TYPICAL EXCESSIVE DRINKER" (Not
Dated)
Worksheet, "PROBLEMS ASSOCIATED WITH EXCESSIVE
DRINKING" (Not Dated)
Alcohol Definitions, "WHAT IS CONSIDERED A "DRINK"?" (Not
Dated)
Discussion Guide (Not Dated)
Funding Document (Date of Order 09/01/2016)






Using the Department of Health and Human Services regulations found at 45 CFR 46.101(b)(2), the IRB
determined that your research project is exempt from IRB oversight. All study related documents will be
removed from our active files and archived.
The IRB granted this exemption with an understanding of the following:
1. The research project will only be conducted as submitted and presented to the IRB, without
additional change in design or scope.
2. Should the nature of the research project change, or any aspect of the study change such that the
nature of the study no longer meets the criteria found in 45 CFR 46.101(b), you will resubmit revised
materials for IRB review.

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Attachment I: Project Announcement – Chesapeake IRB Exemption Determination

The IRB will evaluate the new information and make a determination at that time regarding the research
project’s status.
If you have any questions or concerns, please use the Contact IRB activity on your CIRBI workspace.
Thank you for selecting Chesapeake IRB to review your research project.

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