Attachment D-1 Determination of Exempt Research

ATTACHMENT D-1: DETERMINATION NOTICE FOR EXEMPT RESEARCH

EXEMPT DETERMINATION
DATE:

3 Nov 2023

TO:

Glynis Donaldson

PROJECT:

US Department of Agriculture - USD2201, USDA CNPP Baseline Collection of
MyPlate Brand Health (Pro00074806)
DOCUMENTATION REVIEWED:

Protocol Version(s):



Protocol (Expiration Date 02/28/2026)

Consent Form(s):



Consent Form (Expiration Date 02/28/2026)

Other Material:



Questionnaire, ATTACHMENT A-1: USDA CNPP Brand Health
Survey 2023 Baseline (Expiration Date 02/28/2026)
Internet, ATTACHMENT B-2: Survey Invitation (Expiration Date
02/28/2026)
Internet, ATTACHMENT B-1: Survey Invitation (Expiration Date
02/28/2026)
APPENDIX C-1 CONFIDENTIALITY AGREEMENT (Expiration
Date 02/28/2026)





TRANSLATED DOCUMENTATION:
Documentation:




Spanish (US) Questionnaire, ATTACHMENT A-2: USDA CNPP
Brand Health Survey 2023 Baseline (Expiration Date 02/28/2026)
Spanish (US) Internet, ATTACHMENT B-2: Survey Invitation
(Expiration Date 02/28/2026)

The IRB acknowledges the above referenced translated documentation.
The translated document(s) referenced above are electronically available on your Advarra CIRBI Platform
workspace under the “IRB Issued Documents” tab.
Using the Department of Health and Human Services regulations found at 7 CFR 1c.104(d)(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.

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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.
Please be advised that as Advarra IRB is not overseeing the conduct of the study, study materials, documents and
reports should not state that the study is "approved" by an IRB. Also, if your study includes subject-facing materials
such as consent forms, recruitment materials, and other materials used by subjects in the study, the IRB company
name and contact information should not be referenced. Study materials, documents and reports 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."
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, or any aspect of the study, change such that the nature of the study
no longer meets the criteria found in 7 CFR 1c.104(d)(2), you will resubmit revised materials for IRB
review.
3. It is the responsibility of each investigator to ensure that the project meets the ethical standards of the
institution. Specifically, 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; of a description of the procedures; that
participation is voluntary; and of 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 wish to appeal the IRB’s determinations and/or imposed modifications, please submit supporting
documentation to address the IRB’s concerns by creating an Appeal Modification in CIRBI.
Compliance Statement/REB Attestation (Applicable for research conducted in Canada):
The IRB attests that this submission has been approved by an IRB whose membership complies with the
requirements defined in Health Canada regulations, ICH GCP guidelines, FDA regulations at 21 CFR part 56, and
HHS regulations at 45 CFR part 46. The IRB carries out its functions in accordance with FDA regulations at 21
CFR parts 50, 56, 312, and 812; HHS regulations at 45 CFR part 46, subparts A-E; good clinical practices; Health
Canada regulations; and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, as
appropriate to the research.
Advarra IRB is registered with OHRP and FDA under IRB#00000971.
If you have any questions or concerns, please use the Contact IRB activity on the Advarra CIRBITM Platform.

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Thank you for selecting Advarra IRB to review your research project.
Sincerely,

Luke Gelinas, PhD
Executive Board Chair

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