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The University of Houston
IACUC Policy
Title: IACUC Protocol Review
In accord with the PHS Policy IV.C.1-3, the IACUC shall review and approve, require
modifications in (to secure approval), or withhold approval of PHS-conducted or
supported activities related to the care and use of animals.
Investigators are not permitted to begin any animal-related research or teaching, order
animals for research , or make changes to any research already approved until they
have received an approval letter from the IACUC. The IACUC meeting schedule and
submission deadlines can be found on the IACUC website.
I. Protocol Submission
IACUC protocols are to be completed by using the currently active application , which
can be found on the Division of Research IACUC website. Completed protocols are
submitted electronically to the IACUC coordinator and should contain all applicable
appendices and the signature page, signed by the Principal Investigator. Protocols
submitted prior to the submission deadline (usually 3-4 weeks prior to the meeting
date) are placed on the agenda for the next monthly IACUC meeting. In rare
circumstances, protocols received after the submission deadline may be included on
the meeting agenda if authorized by the IACUC chairperson.
II. Protocol Pre-Review
All protocols undergo a pre-review of essential components by the IACUC coordinator
and a veterinarian. The pre-review screening process includes, but is not limited to, a
review of the following:
•
Contact Information
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Verification of Personnel Training and Qualifications
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Animal Use Location
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Assurance Signature from Pl
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Rationale for the following:
o animal use
o species and strain (if applicable)
o numbers of animals used
•
Search for alternative methods
•
Assurance of non-duplication of research
•
Description of animal use
•
Description of survival surgeries, including:
o pre-operative planning
o minimization of contamination
o inter-operative monitoring
o post-operative procedures
o scientific justification for multiple survival surgeries on a single animal
•
Type
o
o
o
o
•
Hazardous Substance Approvals
•
Euthanasia according to the 2013 AVMA Guidelines
•
Completion of appendices for:
o Unrelieved pain and distress
o Tumors
o Physical Restraint
o Surgery
o Breeding
o Adjuvant/Antigen Administration
o Exemption from standards (departures from the Guide or AWA)
o Field Studies
of exogenous substance administered, including:
dosage
route
and frequency
scientific justification for the use of non-pharmaceutical grade substances
including consideration of grade , purity, sterility, acid-base balance ,
pyrogenicity, osmolality, stability, compatibility of components, expected
adverse reactions , storage and pharmacokinetics
During the pre-review process, communication from the IACUC veterinarian is
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initiated with the Investigator for any of the above areas that, due to lack of
information/clarity or procedures that may be replaced by less painful alternatives,
may justify a decision of "withhold approval" by the convened committee. In
response to the pre-review, an Investigator may agree to voluntarily revise the
protocol and submit it to a later meeting.
Ill. Reviewer Assignment
A preliminary meeting (IACUC leadership and staff) is convened 7-10 days before
the monthly full board meeting. A primary and secondary reviewer is assigned for
each protocol to be reviewed by the full IACUC Committee (see Section V below) by
the IACUC Chair or his/her designee. Protocols and all other meeting materials are
provided to members at least one week prior to the meeting.
IV. IACUC Review
The University of Houston IACUC generally convenes on a monthly basis to conduct
IACUC business. Except to provide information to the IACUC, no IACUC member who
has a conflicting interest is eligible to participate in the IACUC review or approval of a
protocol , nor may this member contribute to the constitution of a quorum . The IACUC
may invite consultants to assist in reviewing complex issues. Consultants may not
approve or withhold approval of an activity or vote with the IACUC unless they are also
members of the IACUC. Any use of telecommunications will be in accordance with
NIH Notice NOT-OD-06-052 of March 24th, 2006 , entitled Guidance on Use of
Telecommunications for IACUC Meetings under the PHS Policy on Humane Care and
Use of Laboratory Animals.
In order to approve proposed protocols or proposed significant changes in ongoing
protocols, the IACUC will conduct a review of those components related to the care and
use of animals and determine that the proposed protocols are in accordance with the
PHS Policy. In making this determination, the IACUC will confirm that the protocol will
be conducted in accordance with the Animal Welfare Act insofar as it applies to the
activity, and that the protocol is consistent with the Guide unless acceptable justification
for a departure is presented . Further, the IACUC shall determine that the protocol
conforms to the institution's PHS Assurance and meets the following requirements:
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a. The transportation , care , and use of animals should be in accordance with the
Animal Welfare Act (7 U.S.C. 2131 et seq.) and other applicable Federal laws,
guidelines, and policies.
b. Procedures with animals avoid or minimize discomfort, distress, and pain to the
animals, consistent with sound research design.
c. Procedures that may cause more than momentary or slight pain or distress to
the animals are performed with appropriate sedation, analgesia, or anesthesia,
unless the procedure is justified for scientific reasons in writing by the
investigator.
d. Animals that would otherwise experience severe or chronic pain or distress that
cannot be relieved are painlessly killed at the end of the procedure or, if
appropriate , during the procedure .
e. The living conditions of animals will be appropriate for their species and
contribute to their health and comfort.
f. The housing, feeding , and nonmedical care of the animals is directed by a
veterinarian or other scientist trained and experienced in the proper care,
handling, and use of the species being maintained or studied .
g. Medical care for animals is available and provided as necessary by a qualified
veterinarian.
h. Personnel conducting procedures on the species being maintained or studied
are appropriately qualified and trained in those procedures.
i.
Methods of euthanasia used will be consistent with the current American
Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of
Animals unless a deviation is justified for scientific reasons in writing by the
investigator.
j.
Investigators and other personnel shall be appropriately qualified and
experienced for conducting procedures on living animals. Adequate
arrangements shall be made for their in-service training , including the proper
and humane care and use of laboratory animals .
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k. Where exceptions are required in relation to the provisions stated, the decisions
do not rest with the investigators directly concerned but are made by the
institutional animal care and use committee.
V. Review Types
The IACUC reviews animal activities by one of the following methods:
A. Full-Committee Review (FCR)
Full Committee Review is the default review for new protocols, annual renewals
of USDA covered species protocols, three-year de novo renewals of USDA and
non- USDA covered species, and significant changes to protocols. A quorum of
IACUC members is required for a fully convened meeting. Each protocol is
discussed and deliberated upon, with the discussion reflected in the IACUC
meeting minutes.
•
A quorum of eligible IACUC members is required for a fully convened meeting.
•
Members receive copies of the protocols to be reviewed at the meeting usually
one week prior to the meeting.
•
All IACUC members are encouraged to personally attend each meeting either in
person or via teleconference.
•
If a member cannot participate in the meeting, the member is encouraged to
review the protocol and send his/her written comments to the IACUC
Coordinator, who then provides the comments to committee members at the
IACUC meeting.
•
If it appears that quorum cannot be met with the regular appointed members, an
alternate member, also appointed by the 10, is designated to attend the meeting
in place of the absent member. All alternates are appointed to serve in a specific
capacity to ensure the membership is still properly constituted.
•
The assigned primary and secondary reviewers (or designee) present the
protocol for discussion at the IACUC meeting.
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•
Each protocol is discussed and deliberated upon, with the discussion reflected in
the IACUC meeting minutes.
•
A quorum must be present during full committee review of protocols in order to
vote to approve , require modifications in (to secure approval) , or withhold
approval. Protocols reviewed by the full committee must receive the approval
vote of a majority (>50%) of the quorum present in order to receive approval.
•
After discussion and deliberation of each protocol , the chairperson calls for a
vote by the Committee members present. Votes for the proposed outcome,
against the proposed outcome and abstentions are recorded in the meeting
minutes.
•
The possible outcomes of FCR are as follows:
•
•
•
Approval
**Modifications needed to secure approval
•
Withhold approval.
**Review of Required modifications Subsequent to FCR. When the IACUC
requires modifications to secure approval of a protocol , such modifications are
reviewed as follows:
a. FCR or Designated Member Review (DMR) following all applicable
procedures as delineated in the PHS Policy
OR
b. DMR if approved unanimously by all members at the meeting at which the
required modifications are developed I delineated AND if all current
IACUC members have previously approved , in advance and in writing,
(e .g. , documented and approved a policy) that the quorum of members
present at a convened meeting may decide by unanimous decision to use
DMR subsequent to FCR when modification is needed to secure
approval. However, any member of the IACUC may, at any time, request
to see the revised protocol and/or request FCR of the protocol.
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c. If DMR is used, the approval date is the date that the final revised protocol
is approved by the designated reviewer(s).
B. Designated Member Review (DMR)
•
The University of Houston Institutional Animal Care and Use Committee may
choose to review protocols using the Designated Member Review method.
•
Prior to the review, each IACUC member is provided with the proposed research
protocol and/or addendum to be reviewed.
•
Written descriptions of research activities/projects that involve the care and use
of animals are made available to all IACUC members; any member of the IACUC
may obtain , upon request, full committee review of those research projects.
•
If full-committee review (FCR) is not requested , at least one member of the
IACUC, designated by the chairperson and qualified to conduct the review, is
assigned to review those protocols and has the authority to approve , require
modifications in (to secure approval) or request full committee review of those
protocols.
•
If full committee review is requested , approval of those research projects may be
granted only after review at a convened meeting of a quorum of the IACUC and
with the approval vote of a majority of the quorum present.
•
Other IACUC members may provide the designated reviewer(s) with comments
and/or suggestions for the reviewer's consideration only.
•
After all required modifications are made, a final revised protocol , i.e ., an
identical document with all required modifications included , is submitted to all
designated reviewers for review and approval.
•
If multiple designated reviewers are used, their decisions must be unanimous; if
not, the protocol is referred for FCR.
•
The possible outcomes of DMR are as follows:
•
approval
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•
•
modifications needed to secure approval.
Records of protocols reviewed and approved via the designated-member review
method are maintained in the IACUC meeting minutes.
VI. Modifications to an Approved Protocol
•
The review and approval of significant changes will be handled by FCR or DMR in
the same manner as new protocols.
•
Examples of changes considered to be significant include , but are not limited to,
the following :
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
in the objectives of a study
from non-survival to survival surgery
resulting in greater discomfort or in a greater degree of invasiveness
in the housing and or use of animals in a location that is not part of the animal
program overseen by the IACUC
in the species
in Principal Investigator
that impact personnel safety
in anesthetic agent(s) or the use or withholding of analgesics
in the method of euthanasia
in the duration, frequency, or number of procedures performed on an animal
**in approximate number of animals used
**Review and approval of item k: changes of less than 10% in the approximate number
of animals used of mice of the genus Mus and rats of the genus Rattus that are bred
for use in research only may, at the discretion of the IACUC, be considered a minor
(not significant) change. This change will be evaluated by a reviewe r qualified to
assess the rationale for the original number of animals used, approved study
objectives , the rationale for the additional animals, and possible negative impacts on
animal welfare.
•
All approved changes will be documented in the associated protocol file.
VII. Continuing Review
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The IACUC conducts continuing review of each previously approved , ongoing
activity covered by the PHS policy at appropriate intervals as determined by the
IACUC, including a complete (de novo) review in accordance with IV.C.1-4 at least
once every three years. Protocols for USDA-covered species are reviewed by a
member or members of the IACUC at least annually. Ongoing reviews of non-USDA
covered species are conducted, however the interval may be more than 12 months.
No animal activities are allowed to continue beyond the expiration date unless a new
protocol (de novo) has been approved by the committee.
VIII. Memoranda of Understanding (MOU)
Memoranda of Understanding (MOUs) are utilized when some or all of the animal
research described in a funded proposal will occur at an institution other than the
Primary Institution. This inter-institutional agreement defines the collaborative activity
involving the animals and addresses each institution's responsibility for animal use.
The MOU also captures information regarding the collaborating institution's animal
protocol details, IACUC approval letter (if the collaborating institution is not AALAC
accredited and PHS assured , the full protocol is also required) , ownership of the
animals, accreditation and assurance information. Signatures from both the
collaborating investigator and the University of Houston investigator, as well as
signatures from the signatory officials of both institutions are required , providing
assurance that all institutional, state , and federal guidelines will be followed.
Prior to approving the collaborative research at UH, the IACUC must receive the
collaborating institution's IACUC approval letter specific to the project. If the
collaborating institution is not AAALAC-accredited , a copy of the complete IACUC
protocol is also required .
The IACUC reviews MOUs at fully convened IACUC meets as informational items,
and acknowledges their review with a memo once all required collaborating approval
letters have been submitted . The review and acknowledgment are documented in
the IACUC minutes.
IX. IACUC Review Outcomes and Investigator Notification
The IACUC must notify Investigators and the Institution in writing of its decision to
approve or withhold approval of those activities related to the care and use of
animals, or of modifications required to secure IACUC approval as set forth in the
PHS Policy IV.C.4.
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Investigators and the Institution are notified of IACUC decisions, generally within 5-7
business following the IACUC meeting, regarding protocol review as follows:
•
Approvals
Approval letters are sent to the Principal Investigators electronically, via e-mail ,
with an attached copy of the corresponding approved protocol.
•
Modifications Needed to Secure Approval (MNSA)
When modifications are required to secure an IACUC approval, the Investigator is
sent a letter electronically indicating the review outcome and detailing the
modifications needed in order to secure an IACUC approval.
Depending on the modifications or clarifications needed , the IACUC can either
request for the response to be reviewed administratively (for administrative
details) , or by designated member review. DMR reviewers are assigned by the
IACUC chair at the meeting , and the information (administrative and DMR) is noted
in the meeting minutes.
•
Withhold Approval
The IACUC may determine that the information provided in the protocol
submitted does not adequately address all of the requirements detailed in the
PHS Policy, The Guide for the Care and use of Laboratory Animals, and/or the
Animal Welfare Act (AWA). In instances such as this, the IACUC must withhold
the approval of the application . When this occurs, the committee provides the
Investigator with a detailed list of the findings that substantiate the determination.
When further clarification has been provided by the Investigator, the protocol is
placed on the agenda for the next full committee review. Designated Reviewers
cannot withhold approvals, only a fully convened IACUC meeting may withhold
the approval of a protocol. Higher institutional authority may not overrule an
IACUC decision to withhold approval of a proposal.
The 10 has access to all IACUC meeting minutes and meets regularly with the Director
of Research Compliance to discuss Committee decisions. The IACUC Chair has open
access to the 10 to discuss outcomes as necessary.
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