Orau Irb

Oak Ridge Site-wide IRB (FWA #00005031)
March 10, 2017
Title of Study: Re-entry Messaging Following a Radiation
Emergency
Investigator: Kelli Bursey
Type of Review: Non-Committee Review
Exempt Category: (2) Tests, surveys, interviews, or observation, (1)
Educational settings
IRB Submission ID: ORAU000364
Funding: Centers for Disease Control and Prevention (CDC)
Documents Reviewed: • Scenario, Category: Other;
• Application for Initial Study, Category: IRB
Protocol;
• Attachment D Info Sheet Re-entry Messages
3.8.17.pdf, Category: Consent Form;
• Re-entry Messages, Category: Other;
• Moderator's Guide, Category: Other;
• Attachment E Re-entry Messages_ Protocol.docx,
Category: IRB Protocol;
Action: Approved
Approval Date: 3/9/2017
Expiration Date: 3/8/2018
Thank you for your submission of New Project materials for this research study. The Oak
Ridge Site-Wide IRB has determined this project is EXEMPT FROM IRB REVIEW
according to federal regulations as outlined in 10 CFR 745.101(b).
Annual follow-up is required on EXEMPT projects. Before the expiration date or
within 30 days of study closure, whichever is earlier, you are to submit a continuing
review with required explanations. You can submit a continuing review by navigating to
the active study and clicking Create Modification / CR.
This approval is based on an appropriate risk/benefit ratio and a study design wherein the
risks have been minimized. All research must be conducted in accordance with this
approved submission.

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Any revision to previously approved materials must be approved by this office prior to
initiation. Please use the appropriate revision forms for this procedure.
All unanticipated problems or adverse events must be reported to this office (see DOE
Order 443.1B). Please use the appropriate form for this procedure. All FDA and sponsor
reporting requirements should also be followed.
Report all NON-COMPLIANCE issues or COMPLAINTS regarding this study to this
office (see DOE Order 443.1B).
Please note that all research records must be retained for a minimum of three years after
the completion of the study.
Sincerely,
The Oak Ridge Site-wide IRB
ORSIRB@orau.org
865-574-4359

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