IRB Approval Letter

Division of Scholarly Integrity and
Research Compliance
Institutional Review Board
North End Center, Suite 4120 (MC 0497)
300 Turner Street NW
Blacksburg, Virginia 24061
540/231-3732
[email protected]
http://www.research.vt.edu/sirc/hrpp

MEMORANDUM
DATE:

March 16, 2020

TO:

Jeff Hickman, Richard J Hanowski

FROM:

Virginia Tech Institutional Review Board (FWA00000572, expires October 29,
2024)

PROTOCOL TITLE:

Evaluation of the North American Fatigue Management Program

IRB NUMBER:

17-1087

Effective March 14, 2020, the Virginia Tech Institution Review Board (IRB) approved the Amendment
request for the above-mentioned research protocol.
This approval provides permission to begin the human subject activities outlined in the IRB-approved
protocol and supporting documents.
Plans to deviate from the approved protocol and/or supporting documents must be submitted to the
IRB as an amendment request and approved by the IRB prior to the implementation of any changes,
regardless of how minor, except where necessary to eliminate apparent immediate hazards to the
subjects. Report within 5 business days to the IRB any injuries or other unanticipated or adverse
events involving risks or harms to human research subjects or others.
All investigators (listed above) are required to comply with the researcher requirements outlined at:
https://secure.research.vt.edu/external/irb/responsibilities.htm
(Please review responsibilities before beginning your research.)
PROTOCOL INFORMATION:
Approved As:
Expedited, under 45 CFR 46.110 category(ies) 4,5,7
Protocol Approval Date:
January 1, 2020
Protocol Expiration Date:
December 31, 2020
Continuing Review Due Date*:
December 10, 2020
*Date a Continuing Review application is due to the IRB office if human subject activities covered
under this protocol, including data analysis, are to continue beyond the Protocol Expiration Date.
ASSOCIATED FUNDING:
The table on the following page indicates whether grant proposals are related to this protocol, and
which of the listed proposals, if any, have been compared to this protocol, if required.

IRB Number 17-1087

page 2 of 2

Virginia Tech Institutional Review Board

SPECIAL INSTRUCTIONS:
*** The Virginia Tech IRB/HRPP has requested that research involving person-to-person contact or
gatherings of human research participants be paused as soon as possible. The duration of the pause
is unknown, but to reduce disruption to the extent possible, we will be reassessing daily. Although we
continue to issue approval notices, Virginia Tech guidance should be followed. Please visit https://
www.research.vt.edu/covid-19-updates-impacts.html for updates.
This amendment, submitted March 13, 2020, provides requested documentation from NIOSH
regarding a determination if they are engaged in the research.

Date*

11/07/2018

12/21/2017

OSP Number

Sponsor

Grant Comparison Conducted?

PIIG63X5

Centers for Disease Control &
Prevention (Title: North American
Fatigue Management Program
Effectiveness in Reducing Commercial
Truck Driver Fatigue)

Compared on 01/18/2018

National Institute for Occupational
Safety & Health

Compared on 01/01/2018

* Date this proposal number was compared, assessed as not requiring comparison, or comparison
information was revised.
If this protocol is to cover any other grant proposals, please contact the HRPP office ([email protected])
immediately.