IRB approval

Appendix J: IRB Approval

IRB ID Number: 14215
Office of Research Protection

Institutional Review Board Notice of Approval
Federalwide Assurance No. 3331
Title of Study: Food Safety Consumer Research Project
RTI Project Number: 0215472.001.002
RTI Proposal Number (if no Project Number):
Project Leader: Sheri Cates
Project Team Member Contact (if different from Project Leader): Kathy Kosa
Source of Funding for this Study: USDA
Date Submitted to IRB: September 20, 2017
Level of Review (check one):
Full , IRB Meeting Date:
Expedited , category: 7: Behavioral - surveys, focus groups, etc.

Type of Review (check one):
Preliminary review (For DHHS grants where RTI is prime, the grant application/contract proposal and protocol
submitted to the IRB are in concordance (45 CFR 46.103(f)). Do not involve human subjects or data until
pretest or full study is approved.)
Amendment, describe:
Add study site(s):
Pretest/Pilot Test:
Renewal
Full Implementation
Study Closure
IRB Approval of Special Conditions (check all that apply to this review):
Waiver of Signed Informed Consent/Parental Permission
Waiver of elements of Informed Consent or requirement for Informed Consent/Parental Permission
Participation of Pregnant Women (Worksheet B submitted by project team)
Participation of Prisoners (Worksheet C submitted by project team)
Participation of Prisoners in DHHS-funded studies (OHRP acknowledgement required)
Participation of Minors (Worksheet D submitted by project team)
IRB Agreement of Nonsignificant Risk Device Study Determination
HIPAA Waiver of Authorization
Please note the following requirements:
• If unexpected problems or adverse events occur, the project team must notify the IRB.
• If there are changes in study procedures or protocol or any data collection materials (brochures, letters,
questionnaires, etc.) the project team must notify the IRB before they are implemented.
• The project team is required to apply for continuing review as long as the study is active, which includes
participation of human subjects or possession of human data or specimens.

Expiration Date of IRB Approval:
September 25, 2018
(No human subjects research can occur after this date without continuing review and approval.)

September 25, 2017
Signature - IRB Member or Chair

Date of IRB Approval

Juesta Caddell, PhD
Name - IRB Member or Chair (print or type)
Copy sent to project leader on: September 25, 2017
Entered into MIS
OHRP acknowledgement received for participation of prisoners in DHHS-funded studies on:

Office of Research Protection, Institutional Review Board
3040 Cornwallis Road, Research Triangle Park, NC 27709-2194, USA
Telephone: 919-316-3358 Fax: 919-316-3897 [email protected]
1

APPROVAL
June 1, 2020
Sheryl Cates
919-541-6810, x26810
[email protected]
Dear Sheryl Cates:
On 6/1/2020, the IRB reviewed the following submission:
Type of Review:
Title:
Investigator:
IRB ID:
Funding Source:
Customer/Client Name:
Project/Proposal Number:
IND, IDE, or HDE:

Continuing Review
Food Safety Consumer Research Project
Sheryl Cates
CR00000597 for 14215
USDA FSIS
USDA FSIS
0215472.001.002
None

The IRB approved continuing review from 6/1/2020 to 5/31/2021. Before 5/31/2021 or within
30 days of study close, whichever is earlier, you are to submit a completed continuing review
and required attachments to request continuing approval or closure. You can submit a continuing
review by navigating to the active study and clicking Create Modification / CR.
If continuing review approval is not granted before the expiration date of 5/31/2021, approval of
this study expires on that date.
In conducting this protocol, you are required to follow the requirements listed in the Investigator
Manual (HRP-103), which can be found by navigating to the IRB Library within the IRB system.
Sincerely,
The RTI Office of Research Protection

2