IRB Approval

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

May 13, 2022

From

Kathleen MacMahon, DVM, MS
IRB Reviewer, NIOSH Institutional Review Board
Jennifer M. Lincoln, PhD, CSP
Co-Chair, NIOSH Institutional Review Board

Subject

IRB Approval of New NIOSH Protocol 22-NIOSH-01, “Evaluating an Intervention Designed to
Reduce Fatigue among Taxi Drivers” (Expedited)

To

Cammie Chaumont Menendez, PhD, MPH, MS
Project Officer, NIOSH/DSR
The NIOSH IRB reviewed the request for approval of new protocol 22-NIOSH-01, “Evaluating an
Intervention Designed to Reduce Fatigue among Taxi Drivers.” The IRB determined the study poses
minimal risk to subjects. The protocol was reviewed in accordance with the expedited review process
outlined in 45 CFR 46.110(b)(1), categories (4) and (7). This protocol has been approved by the IRB.
Continued review is not required for this protocol since it is eligible for expedited review. Please note that
the protocol does not include in-person interaction. Should the investigator seek to initiate any in-person
interaction with subjects, the investigator should contact the DLO Associate Director for Science for
COVID-19 requirements.
The IRB found the additional protections required by Subpart B are in place for pregnant women, human
fetuses and neonates involved in the research.
COLLABORATOR SITE RESTRICTION: NIOSH study activities may not begin with the following
collaborators/sites until documentation indicating current IRB approval or IRB Authorization
Agreement has been received by the NIOSH Human Research Protection Program (HRPP) and the PI
has been notified by the HRPP this restriction has been lifted and study activities may begin:
Washington State University (WSU)
Due to the funding and collection of identifiable, sensitive information the project is determined to be
covered by a Certificate of Confidentiality under section 301(d) of the Public Health Service Act.
This study is a clinical trial. Please post the consent form on Regulations.gov after the clinical trial is
closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by
the protocol. 45 C.F.R. 46.116(h).
If other institutions involved in this protocol are being awarded NIOSH funds through the CDC
Procurement and Grants Office (PGO), you are required to send a copy of this IRB approval to the CDC
PGO award specialist handling the award. You are also required to verify with the award specialist that the
awardee has provided PGO with the required documentation and has approval to begin or continue research
involving human subjects as described in this protocol.
Investigators are required to report incidents to the HRPP in accordance with CDC/NIOSH policy and
procedure. Any proposed changes to the protocol should be submitted as an amendment to the protocol for
NIOSH IRB approval before they are implemented.
If you have any questions, please contact the NIOSH Human Research Protection Program at (513)
533-8591 or by e-mail: NIOSH IRB Mailbox.

0.1255

Centers for Disease Control and Prevention

Request for Initial Review by an Institutional
Review Board
HRPO Guide:

Review Cycle

1 Protocol identifiers

2 Key CDC personnel

CDC Form 0.1255
Version 4. 20 - -

Page 1 of 6

Request for initial review by an IRB

3

-site contractors, fellows, and others appointed or retained to work at a CDC facility conducting activities
under the auspices of CDC.

4 Study

5 Regulation and policy
5.1

CDC Form 0.1255
Version
20 - -

Page 2 of 6

Request for initial review by an IRB

5.2 Additional Considerations

5.3

nformed consent

CDC Form 0.1255
Version . 20 - -

Page 3 of 6

Request for initial review by an IRB

5.

Other regulation and policy considerations

See HRPO Worksheet to Determine FDA Regulatory Coverage for guidance on whether or not FDA
regulations apply.

5.

Confidentiality protections

5.

Clinical Trial

6 Material submitted with this form

CDC Form 0.1255
Version . 20 - -

Page 4 of 6

Request for initial review by an IRB

7 Additional comments

8 Research partners
all

Partner

Partner

Not engaged in Human Subjects research.
DCMorris 5/13/2022

Partner 3

Engaged in Human Subjects research. Waiting
for signed IAA from WSU. DCMorris 5/13/2022

CDC Form 0.1255
Version . 20 - -

Not engaged in Human Subjects research.
DCMorris 5/13/2022

Partner

Not engaged in Human Subjects research.
DCMorris 5/13/2022

Page 5 of 6

Request for initial review by an IRB

9 Signatures
Procedures for Protection of Human
Research Participants

Signature

Date

Remarks

Procedures for Protection of Human Research Participants

Signature

Date

Remarks

Procedures for Protection of Human Research Participants

Signature

Date

Remarks