Research Determination

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Memorandum
Date

April 15, 2024

From

Kitty J. Hendricks, BA, MA
IRB Reviewer, NIOSH Institutional Review Board

Subject

IRB Approval of New NIOSH Protocol 23-NIOSH-11, “Identification of Hazards and
Risk Factors for Demolition Robot Operators” (Expedited)

To

Hugo E. Camargo, PhD
Project Officer, NIOSH/DSR
The NIOSH IRB reviewed the new protocol 23-NIOSH-11, “Identification of Hazards and
Risk Factors for Demolition Robot Operators.” 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), category (6), (7). Continued review is not required for this
protocol since it is eligible for expedited review.
The IRB found the additional protections required by Subpart B are in place for pregnant
women, human fetuses and neonates involved in the research.
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.
The subjects must have attained the legal age for consent to procedures involved in the
research, under the applicable law of the jurisdiction(s) in which the research will be
conducted.
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 (513) 533-8591 or 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
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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
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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
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Page 4 of 6

Request for initial review by an IRB

7 Additional comments

8 Research partners
all

Partner

Partner

Partner 3

Partner

CDC Form 0.1255
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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