Att7.IRB Determination

CORRESPONDENCE LETTER-Not Human Research
Determination
NUMBER
HRP-513

Version Date
09/03/2019

PAGE
1 of 2

See HRP-001 for definitions of applicable key terms and acronyms.

Oak Ridge Sitewide Institutional Review Board (IRB#: IRB00000547)
April 1, 2021
Type of Review: Initial Study
Title of Study: Evaluation of Fire Department Implementation of
NIOSH Fire Fighter Fatality Investigation and
Prevention Program (FFFIPP) Recommendations.
Investigator: Erin Burr
Submission ID: ORAU000807
Funding Source: Name: National Institute for Occupational Safety and
Health (NIOSH)
IND, IDE or HDE: None
Documents Reviewed: • FFFIPP Survey Invitational Email 2021 02 18.docx,
Category: Recruitment Materials;
• FFFIPP Survey Invitational Email_Fire Department
2021 02 18.docx, Category: Recruitment Materials;
• FFFIPP Survey Invitational Email_Reminder 2021 02
18.docx, Category: Recruitment Materials;
• FFFIPP Survey Invitational Phone Script 2021 03
10_revised.docx, Category: Recruitment Materials;
• FFFIPP_IRB Application for Review_9Mar2021.pdf,
Category: IRB Protocol;
• NIOSH FF Eval Qnaire - final_company
officer_uploaded to IRB7.docx, Category: Materials
Accompanying Consent Form;
• NIOSH FF Eval Qnaire - final_fire chief_uploaded to
IRB7.docx, Category: Materials Accompanying
Consent Form;
• NIOSH FF Eval Qnaire - final_firefighter_uploaded to
IRB7.docx, Category: Materials Accompanying
Consent Form;
The IRB determined that the proposed activity is not research involving human subjects
as defined by DHHS and FDA regulations.
IRB review and approval by this organization is not required. This determination applies
only to the activities described in the IRB submission and does not apply should any
changes be made.
If changes are made and there are questions about whether activities are research
involving human in which the organization is engaged and IRB review is needed, please

CORRESPONDENCE LETTER-Not Human Research
Determination
NUMBER
HRP-513

Version Date
09/03/2019

PAGE
2 of 2

See HRP-001 for definitions of applicable key terms and acronyms.

submit a study modification to the IRB for a determination. You can create a
modification by clicking “Create Modification/CR” in the IRB Electronic System.
Sincerely,
Electronically Signed
Elizabeth Ellis, Chair
[email protected]
865-574-4359