IRB approval

DEPARTMENT OF HEALTH & HUMAN SERVICES
________________________________________________________________________
____________________________________________________________________________________
_________________
_____________________________
_________________

Memorandum
Date

April 3, 2013

From

Chair, NIOSH IRB (HSRB)

Subject

Report of NIOSH IRB -- Protocol No. HSRB 13-OMSHR-02XP “Virtual Reality to Train and
Assess Emergency Responders” Approval of Protocol

To

Launa Mallett, Ph.D.
Project Officer, HFB, DMRO, OMSHR
Through: /Chief, HFB, DMRO, OMSHR ____ ____
/Director, DMRO, OMSHR ____ ____
General Comments and IRB Actions
I received your revised protocol (memo dated 3/23/2013) and find that it is responsive to the issues
raised in my 3/14/2013 report for the subject protocol. Your protocol was reviewed using the
expedited procedure in that it presents no more than minimal risk and involves a human factors
evaluation (category 7) as provided for in 45CFR46.110. Your request for a waiver of
documentation of informed consent is granted per 45CFR46.117 (c) (1) in “(1) that the only record
linking the subject and the research would be the consent document and the principal risk would
be potential harm resulting from a breach of confidentiality. Each subject will be asked whether
the subject wants documentation linking the subject with the research, and the subject's wishes will
govern. The revised protocol and consent document (dated 4/3/2013) are approved for one year
and will serve as the documents of record for this study (renewal date 4/3/2014). However, if you
make any substantive changes, or 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, Consent Form Issues, Addenda Issues – None.

cc:
HSRB 13-OMSHR-02XP