IRB Exemption

DATE:

December 4, 2017

TO:

Kristen Cincotta

FROM:

Janet D. Griffith, IRB Chair

SUBJET:

IRB Review Forms for 162691.0.001.20.002

Attached is the IRB Review Findings Form documenting that the IRB determined the project you
recently submitted to be exempt from IRB review because of the following reason.

☐

☐

☒

☐

☐

☐

☐

The study does not meet the Federal definition of research given in 45 CFR 46.
The research will be conducted in established or commonly accepted educational settings and
involve normal educational practices, such as: (i) research on regular and special education
instructional strategies, or (ii) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management methods. (45 CFR 46.101 (b)
(1))
The research will involve the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior,
AND: (i) all of the information obtained will be anonymous, and (ii) any disclosure of the
subjects' responses outside the research cannot place the subjects at risk of criminal or civil
liability or be damaging to the subjects' financial standing, employability, or reputation. (45
CFR 46.101 (b) (2))
The research will involve the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior of
human subjects who are elected or appointed public officials or candidates for public office. (45
CFR 46.101 (b) (3))
The research will involve the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, AND: (i) the data sources are publicly
available, or (ii) the information is recorded by the investigator in such a manner that subjects
cannot be identified, directly or through identifiers linked to the subjects. (45 CFR 46.101 (b)
(4))
The research is being conducted by or subject to the approval of department or agency heads,
and is designed to study, evaluate, or otherwise examine: (i) Public benefit or service
programs, (ii) procedures for obtaining benefits or services under those programs, (iii) possible
changes in or alternatives to those programs or procedures, or (iv) possible changes in
methods or levels of payment for benefits or services under those programs. (45 CFR 46.101
(b) (5))
The research is limited to food taste and food quality evaluation and consumer acceptance
involving: (i) wholesome foods without additives or (ii) the food contains food ingredients at or
below the level found to be safe, or agricultural chemical or environmental contaminant at or
below the level found to be safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency or the Food Safety and Inspection Service of the U.S.
Department of Agriculture. (45 CFR 46.101 (b) (6))

9300 Lee Highway • Fairfax, VA 22031 • 703-934-3000 • 703.934.3740 fax • icfi.com

Antibiotic Use Educational Awareness Message/Materials Assessment
December 4, 2017

Institutional Review Board Findings Form
ICF IRB FWA00002349 (exp. 09/25/2018)

Project Director(s): Kristen Cincotta
Project Title: Antibiotic Use Educational Awareness Message/Materials Assessment
ICF Project Number: 162691.0.001.20.002

Type of Review:
☒ New

☐ Modification

☐ Annual review

Findings of the Board:

☐ Project complies with all of the requirements of 45 CFR 46, “Protection of Human
Subjects”
☒ Project is exempt from IRB review (See IRB Exemption Form)
☐ Project does not comply with all of the requirements of 45 CFR 46
Project Approved Until: April 20, 2017
Next Annual Review Date: N/A

December 4, 2017
Chair, Institutional Review Board

Date

(Revised 07/30/2014)

If you have any questions regarding this finding, please email [email protected].

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