Attachment P: IRB Exempt Letter

Attachment P: IRB Exempt Letter

EXEMPT DETERMINATION
DATE:

21 Dec 2018

TO:

Gerad O'Shea, MA
Applied Curiosity Research

PROJECT:

Applied Curiosity Research, Feeding Toddlers Resource Development
(Pro00031483)
DOCUMENTATION REVIEWED:

Protocol Version:

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Research Protocol: Feeding Toddlers Resource Development (Not Dated)

Consent Form:

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Online consent form for research participation (Not Dated)

Recruitment Material:

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Follow up Call to Screened Research Participants (Not Dated)
Follow up Email Instructions for Child Care Site Directors and Providers
(Not Dated)
Initial Call Script for Child Care Site Directors and Providers (Not Dated)
Initial Email for Child Care Site Directors (Not Dated)
Mailing Flyer for Child Care Site Directors (Not Dated)
Mailing flyer for Child Care Site Providers (Not Dated)
Screener for Research Participation (Not Dated)

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Research Introduction (Not Dated)
Guideline for In-depth Interviews (Not Dated)

Other Material:

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.
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. 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.

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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.
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.

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