According to the Public Health Service (PHS) guidelines, protocols can only be approved
for a three (3) year period, after which the investigator is required to submit
a new protocol in order to continue the project. In order to comply with these
guidelines and the requirements of the Animal Welfare Regulations (AWR),
the IACUC will review all protocols annually through the use of an annual review
form and require a new protocol submission every three years. The IACUC Coordinator
will notify the investigator when annual protocol updates are needed and/or
when a protocol is approaching the expiration of its 3-year approval limit.
Investigators are advised that because NEOUCOM/COP is a state institution, all protocols, annual
reviews, modification requests, and related paperwork are considered public
documents. Hence, this paperwork is subject to the Ohio Open Records laws.
The Consortial Protocol, Participant Qualifications, Annual Review, Modification
Request, Add Personnel, and Hazardous Substance forms are available on the IACUC
website
in Microsoft Word (doc) or Rich Text Format (rtf) and can be sent as
email attachments. Contact either the IACUC Chairperson or the
IACUC Coordinator with any questions or concerns regarding the
submission of protocol paperwork.
1. Protocols
Protocols are to be submitted electronically as an email attachment
to the IACUC Coordinator. The PI should save an electronic copy
for their files. If revisions to the protocol are needed, they
will be made on this copy. The PI will receive an email message
confirming receipt of the protocol and the assigned protocol
number. Three primary reviewers will review the protocol.
The reviewers will submit written comments to the IACUC Coordinator,
who in turn transmits them to the PI.
The
PI will be asked to revise the protocol according to the reviewer comments
and to resubmit it electronically to the IACUC Coordinator. Responses
to the sub-committee concerns must be in either bold or italic font. The PI should keep a revised electronic copy for their files. All revised
protocols received by 5:00 p.m. Thursday will be included in the once weekly
distribution of protocols to all IACUC members the following day. The signature
pages of the revised document will then be emailed to the PI. The PI will
be asked to print the signature pages, obtain the necessary signatures, and
send them via campus mail to the IACUC Coordinator. The original signed Investigator
Assurance and Participant Qualification pages are needed for final IACUC approval.
IACUC
members have seven days to review the protocol and communicate any additional
concerns. Any IACUC member can request a full committee review of the protocol
by contacting the IACUC Coordinator. The review would then take place at
the next scheduled IACUC meeting.
If
no additional concerns are communicated regarding pain category “C” (no more
than momentary or slight pain or distress) and "D" (more than momentary or
slight pain or distress for which analgesia, anesthesia or tranquilization
is provided) protocols, the three primary reviewers sign the revised protocol
indicating final IACUC approval. However, pain category “E” (pain or distress
which are not relieved by analgesia, anesthesia, or tranquilization) protocols
must be presented at a convened IACUC meeting. The protocol must be approved
by a quorum of the IACUC.
The
PI and the Institutional Official (IO) are notified in writing of the IACUC's
decision regarding the approval status of the protocol. Approved protocols,
with the reviewers' comments attached, are then filed with the IACUC records.
2.
Annual Reviews
Annual Reviews will be emailed to the PI approximately 30 days
before the expiration dates of the 1st and 2nd anniversary of the
original protocol approval dates. The sections above the double
line will be completed for the PI. The PI is asked to check the
appropriate "Project Status" box, save the form, print it, sign it, and
return it to the IACUC Coordinator via campus mail by the "Submit by" date. Modification Request and Add Personnel
forms are to be submitted as needed with the Annual Review.
The
Annual Review form and the protocol are forwarded electronically to
each IACUC member during the weekly protocol distribution. IACUC
members have seven days to review the protocol and communicate any additional
concerns. Any IACUC member can request a full committee review of the Annual
Review by contacting the IACUC Coordinator. The review would then take place
at the next scheduled IACUC meeting. If no additional concerns are communicated,
the three primary reviewers sign the annual review indicating IACUC approval.
The PI and the
Institutional Official (IO) are notified in writing of the IACUC's decision
regarding the approval status. The approved Annual Review, with any reviewer
comments, is filed with the original protocol.
3. Modification Requests
Modification
Requests need to be submitted when a change or addition to the protocol is
proposed. These changes may include, but are not limited to, the species
used, numbers of animals needed, experimental and/or surgical procedures to
be performed, etc.
Changes
must be approved by the IACUC before they are implemented. Modification Requests
are to be submitted electronically to the IACUC Coordinator. The
PI should save an electronic copy for their files. If there are frequent
modifications to a protocol, the IACUC may require submission of a new protocol.
The
Modification Request and the protocol are forwarded
electronically to each IACUC member during the weekly protocol distribution. Any reviewer comments will be forwarded
to the PI via email. If revisions are indicated, the PI will be asked to
submit a revised form as an email attachment to the IACUC Coordinator. Revisions
are to be indicated with bold or italics font. The signature
page will be emailed to the PI. The PI will be asked to print, sign, and
send the original signature page to the IACUC Coordinator via campus mail.
IACUC
members have seven days to review the Modification Request and communicate
any additional concerns. Any IACUC member can request a full committee review
of the modification by contacting the IACUC Coordinator. The review would
then take place at the next scheduled IACUC meeting. If no additional concerns
are communicated, the three primary reviewers sign the Modification Request
indicating final IACUC approval.
The PI and the
Institutional Official (IO) are notified in writing of the IACUC's decision
regarding the approval status of the Modification Request. The approved
Modification Request, with any reviewer comments, is filed with the original protocol.
4. Add Personnel Form
The Add Personnel form is used to designate all new personnel (including
technical support, graduate students, student volunteers, etc.) who
will participate on the protocol. New personnel must participate in the IACUC-approved
“Introduction to Laboratory Animal Care” course and complete the
necessary occupational health requirements. The
course is provided as a web-based training experience The course overview is located on the CMU website. The Safety Office oversees the occupational health requirements.
Personnel must
indicate their training and/or experience with procedures relevant to those
described in the protocol. It is acceptable to include a statement that personnel
will be trained by the investigative staff in those procedures relevant to
the protocol. By signing the form, participants acknowledge that they have
read the protocol and agree to comply with it.
The completed form is forwarded to the IACUC Coordinator for
processing. The form is circulated among the three primary reviewers
for their review and signature. The approved Add Personnel form
is attached to the original protocol signature page. The PI and
the Institutional Official (IO) are notified in writing of the IACUC's
decision regarding the approval status of the Add Personnel form.
