Appendix E- IRB approval

DEPARTMENT OF HEALTH & HUMAN SERVICES
_______________________________________________________________________________________________________

Memorandum
Date

November 15, 2013

From

Chair, NIOSH IRB (HSRB)

Subject

Report of NIOSH IRB (HSRB) – Protocol No. HSRB 13-DSR-03XP “Taxi Driver Survey on
Motor Vehicle Safety and Workplace Violence” Approval of New Protocol

To

Cammie Chaumont Menendez, Ph.D.
Project Officer, AFEB, DSR
Through: /Chief, AFEB, DSR ____ ____
/Director, DSR ____ ____
General Comments and IRB Actions
I received your response (memo dated 11/7/2013) and found it is responsive to my 10/22/2013 report for
the subject protocol. Your protocol was reviewed using the expedited procedure in that it presents no more
than minimal risk and involves the use of interview, program evaluation, human factors, or quality
assurance methods (category #7) as provided for in 45CFR46.110. Your request for a waiver of
documentation of informed consent is granted per 45CFR46.117(c)(2) in “(2) That the research presents no
more than minimal risk of harm to subjects and involves no procedures for which written consent is
normally required outside of the research context.” This protocol is granted approval for one year (renewal
date 11/15/2014). The revised protocol and consent document will serve as the documents of record for
this study (dated 11/15/2013). However, if you make any substantive changes to the protocol, or if any
adverse reactions occur in any study participants, please notify me immediately. Protocol incidents need to
be reported to NIOSH IRB by phone or E-mail within 2 working days; and reported formally [send CDC
form 0.1254 + 0.1379] within 2 weeks.
If you choose to make changes to your approved protocol, the changes must be reviewed and approved
prior to implementation by submitting via hard copy CDC forms 0.1379 (signature page), 0.1252
(amendment request), 0.1370 (non CDC collaborator, if have), a clean copy of the revised protocol and a
highlighted copy (track changes or pen/ink) of the revised protocol (all changes highlighted). Electronic
submission of your amendment request may facilitate review, but it is not required. The general procedure
for requesting annual continuing review is to send 45-60 days prior to renewal date completed hard copy
forms CDC 0.1379 (signature page), 0.1251 (continuing review request), 0.1370 (non CDC collaborator, if
have ), a copy of your current consent form (if consenting or recruiting currently). An electronic
submission of your continuing review may facilitate review, but it is not required.

Protocol Issues – None.
Consent Form Issues – None.
Addenda Issues (Scripts, questionnaires, brochures, etc.) – None.

cc:
HSRB 13-DSR-03XP