Exempt Determination

EXEMPT DETERMINATION
DATE:

4 Apr 2019

TO:

Caitlin Krulikowski
Fors Marsh Group LLC

PROJECT:

Centers for Disease Control and Prevention (CDC), CDC Enhanced Message
Development and Testing to Prevent Excessive Alcohol Consumption Study –
Phase 1 (Pro00033279)
DOCUMENTATION REVIEWED:

Protocol Version:



Full Protocol (Not Dated)

Consent Form:



FOCUS GROUP PARTICIPANT CONSENT FORM (Not Dated)

Other Material:



Submitted As: "CDC
Group_Worksheets"

Alcohol

-

Message

Frame

Focus

Using the Department of Health and Human Services regulations found at 45 CFR 46.104(d)(2), the IRB
determined that your research project is exempt from IRB oversight. The IRB also completed the necessary
additional limited review considerations as set forth under the Revised Common Rule, 45 CFR 46.104(d). All
study related documents will be removed from our active files and archived.
Please be advised that as Advarra IRB is not overseeing the conduct of the study, specific IRB details
such as the IRB company name and contact information should be removed from the consent form and
all study materials, and study materials should not state that the study is "approved" by an IRB. Study
materials may include a general statement that the study was reviewed by an IRB, such as, "This study
has been reviewed by an institutional review board (IRB), which is a committee that has reviewed this
research study to help ensure that your rights and welfare as a research participant are protected and
that the research study is carried out in an ethical manner".
Note: You will still be able to access this study via the Advarra CIRBI Platform under the "Archived" tab on
your Dashboard for three years. After three years, the study will be removed from the system in accordance
with IRB regulations.
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 46.104(d)(2), you will resubmit revised
materials for IRB review.

Page 1 of 2

3. It is the responsibility of the investigator to ensure that the project meets the ethical standards of the
institution. Specifically, the research involves no more than minimal risk to participants, the selection
of subject is equitable, there are adequate provisions to maintain the confidentiality of any identifiable
data collected, and when there are interactions with research subjects, they will be informed that the
activity involves research, a description of the procedures, participation is voluntary, and the contact
information for the researcher.
The IRB will evaluate the new information and make a determination at that time regarding the research
project’s status.
This project is not subject to requirements for continuing review.
If you have any questions or concerns, please use the Contact IRB activity on your Advarra CIRBI Platform .
Thank you for selecting Advarra IRB to review your research project.

Page 2 of 2