| 1. |
GENERAL
Texas A&M University-Corpus Christi recognizes the scientific and ethical
responsibility for the humane care and use of animals [for a definition
of "animal" see NIH, PHS and USDA policy] involved in research
and education and enjoins all individuals involved to the highest standards
of care and consideration. The Institutional Animal Care and Use Committee
(IACUC), as an agent for the University's obligations for humane care and
use of animals, shall: |
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1.1 |
Assure all activities involving animals
meet the ethical and legal requirements for the humane care and use
of animals. |
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1.2 |
Maintain and promote an open and cooperative
relationship with investigators, faculty and the greater University
community. |
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1.3 |
Educate the University community concerning
the ethical and regulatory considerations for the humane care of
animals. |
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1.4 |
Review, at least every six (6) months,
the University's program and all animal facilities using USDA Regulations/Guide
as a basis. |
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1.5 |
Meet all federal requirements
as defined in the Animal Welfare Act, the Public Health Service
Policy on the
Humane Care & Use of Laboratory Animals and the Guide for the
Care and Use of Laboratory Animals. |
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1.6 |
This document may be amended by vote of
the IACUC to meet changes in federal policy. The IACUC may amend
other procedures in the document by vote of the committee. |
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| 2. |
COMMITTEE STRUCTURE |
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2.1 |
Membership: Members are appointed
by the Provost and Vice President for Academic Affairs in consultation
with the Chair of the Committee on Committees, Faculty Senate for
staggered two-year terms. Membership must include a veterinarian,
a community representative, a non-scientific representative from
the University, and two scientific members from the University representing
the wide diversity of activities utilizing animals on campus. The
Chair is elected for a one- year term by the IACUC. |
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2.2 |
Qualifications: Members will
possess a commitment to the ethical and scientifically sound conduct
of research, testing or teaching involving animals. A thorough review
of pertinent documents concerning appropriate animal care for research,
testing and teaching activities is mandatory prior to the first meeting. |
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2.3 |
Meetings: Matters concerning personnel,
security arrangements, conferences with attorney, or issues required
to be confidential by federal, state or local law may be held in
executive session. Meetings will be scheduled not less than twice
per year, with additional meetings called by the Chair as deemed
necessary. While the committee actively works to reach consensus
on issues presented for consideration, decisions will be based on
majority rule. To further evidence diversity of opinion, minority
opinions may be included in the minutes of all meetings as well as
the Semi-Annual Report. |
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| 3. |
GENERAL IACUC APPROVAL PROCEDURES |
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3.1 |
New and renewal protocol applications
are approved by the IACUC. Protocols that have been approved pending
receipt of clarifications not involving major changes may be approved
by the Chair plus one other IACUC member (preferably the Veterinarian)
with notification of the IACUC. Clarifications involving major changes
are returned to the full committee. The IACUC determines whether
a clarification should come back to the committee at the time it
grants approval pending clarification to the protocol. Regardless
of the nature of the requested changes (i.e., 'non-major' or 'major'),
such requested clarifications, responses to restrictions, or other
requested changes shall be incorporated into a revised protocol with
the revision(s) highlighted. |
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3.2 |
Annual Reviews of ongoing
protocols are conducted administratively by two (2) committee members
(one of which
should be the Veterinarian) with notification of the IACUC unless
full Committee review is either requested by an administrative reviewer
or is mandated by other such policy. (see 4.6. "Procedures for
Conducting a Continuing Annual Review of Protocols") |
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3.3 |
Amendments to protocols (either alone
or as part of an annual review) involving significant changes are
approved by the full committee. Amendments (either alone or as part
of an annual review) involving non-significant changes may be approved
by two (2) committee members, usually the Chair and the veterinarian,
with notification of the IACUC. Either reviewer may decide whether
or not an amendment requires full IACUC review. Amendments that may
be presented to the IACUC include a significant change in procedure(s),
addition of new procedures, a significant change in administrative
matters and/or the request for additional (greater than 10% of original
approval) animals. |
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3.4 |
The Chair and two (2)
Committee members may conduct an expedited protocol review on a "need" basis.
The need for such a review will be determined by and the review will
be initiated by the Chair upon request from an investigator or IACUC
member. Expedited review will be done through a convened subcommittee
and approvals will be limited in terms of approval duration, animal
numbers, and/or allowed procedures. Such expedited review shall be
followed by full Committee review at the next IACUC meeting. |
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3.5 |
Closures of protocols are carried out
by the Graduate Studies and Research Office with notification of
IACUC. Certifications of current protocol approval are carried out
by the Graduate Studies and Research Office with notification of
IACUC. Reporting to the federal government will be carried out by
the Graduate Studies and Research Office with notification of IACUC. |
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3.6 |
The transfer of animals from one approved
protocol to another approved protocol will require action by the
Veterinarian, one other member, and notification of the Committee. |
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| 4. |
PROCEDURES FOR PROCESSING ANIMAL USE PROTOCOLS
AND AMENDMENTS |
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4.1 |
Procedures for Reviewing New Protocols:
Prior to submission to the Graduate Studies and Research Office,
protocols must be screened by the Veterinarian. Outcomes of this
screening may be: |
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4.1.1 |
The Veterinarian approves
and signs the protocol and it may be forwarded to the Graduate Studies
and Research Office. |
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4.1.2 |
The Veterinarian does not approve and suggests the
PI rewrite the protocol. The Veterinarian will notify the PI and
indicate how the protocol should be modified. A modified protocol
can then be presented to the Veterinarian and, if approved, he/she
will sign the new protocol and it may then be submitted to the Graduate
Studies and Research Office. |
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4.2 |
Protocol Receipt and Initial Processing:
A protocol reviewed and approved by the Veterinarian may be submitted
to the Graduate Studies and Research Office. It will be date stamped
and assigned a protocol number. A file will be opened and the original
will become the file copy. Copies of the protocol will be distributed
to IACUC Chair for distribution to the IACUC members for review. |
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4.3 |
IACUC Review: At the next IACUC meeting,
the Chair will give the Committee a short synopsis of the protocol
and the protocol will be discussed. The committee will vote to approve,
approve pending clarifications, defer action pending required modifications,
or disapprove the protocol. In general, approval pending clarification
will be given if the committee considers the clarification is sufficiently
minor or straightforward so that the Chair and Veterinarian can certify
the clarifications are adequate. |
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4.4 |
Outcomes of IACUC Actions: |
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4.4.1 |
If the protocol is approved, the IACUC chair will
sign a notice of approval and forward it to the Graduate Studies
and Research Office. A copy of the approval and a letter will be
sent to the PI indicating the protocol may be initiated, e.g., animals
may be purchased if needed and research covered by the protocol may
begin pending availability of necessary resources. |
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4.4.2 |
If the protocol is approved pending clarification,
a request for clarifications will be sent to the PI and he/she will
be asked to respond by a prescribed time. A protocol will be considered
withdrawn if a response is not received within 10 working days. Upon
receipt of the clarifications the Chair and Veterinarian will review
the response and either certify that it is adequate and proceed as
in 4.4.1. or bring the response to the full committee. |
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4.4.3 |
Regardless of the nature of the changes or modifications
requested, clarifications, responses to restrictions, or other requested
changes shall be incorporated into a revised protocol with the revision(s)
highlighted. This revised document will be the protocol of record. |
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4.5 |
Procedures for Reviewing Amendments
to Active Protocols |
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Amendment Receipt and
Initial Processing: Amendments will be received by the Graduate
Studies and Research
Office. There they will be copied for the protocol file and sent
to a preliminary screener (usually the Veterinarian). The preliminary
screener will indicate whether he/she believes the amendment is minor,
not requiring committee action, or should be reviewed by the committee.
He/she will indicate this judgment on the amendment, sign it, and
return it to Graduate Studies and Research Office. The amendment
will then be sent to a second screener (usually the Chair) who will
indicate his/her judgment as to whether the amendment is minor or
requires full committee action. He/she will indicate this decision
on the original amendment, sign it, and return it to Graduate Studies
and Research Office. If both Screeners agree that the amendment is
minor and does not require committee action, the PI will be notified
that the amendment is approved and in force. If either Screener believes
the Committee needs to consider the amendment, it will be processed
as in 4.1. "Procedures for Reviewing New Protocols". |
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4.6 |
Procedures for Conducting a Continuing
Annual Review of Protocols |
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Information for Continuing
Review: One month before the anniversary of a protocol, a continuing
review questionnaire
will be sent to the PI. The PI will be asked for a timely response.
If a response is not obtained the protocol will be inactivated after
appropriate warning. Once information is received it will be reviewed
by a member of the IACUC and the Veterinarian specifically for changes
in the protocol or changes in regulations that require modification
of the protocol. If there are no changes or minor changes then the
protocol will be handled as a minor amendment (see 4.5. "Procedures
for Reviewing Amendments to Active Protocols"). If the Veterinarian
or IACUC member believes the committee should review the continuing
review information, the protocol will be handled as an amendment
would (see 4.5. "Procedures for Reviewing Amendments to Active
Protocols"). |
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| 5. |
FORMAT FOR SUBMITTED PROTOCOLS
Forms are available from the Graduate Studies and Research Office for research
activities, teaching activities and amendments. Call for renewal protocols
will be initiated by the Graduate Studies and Research Office and shall
utilize the same forms as were used in the initial review. Requests and
appropriate forms for continuing annual reviews will be sent from the Graduate
Studies and Research Office. |
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| 6. |
REPORTING THE MISTREATMENT
OF ANIMALS AND DEFICIENCIES IN THEIR CARE
It is the policy of Texas A&M University-Corpus Christi that
the care, use and treatment of University-owned laboratory animals
should be of high
quality and in compliance with all federal, state, and local regulations.
The law requires that all persons involved or in any way associated with
the use of animals in research know how to report deficiencies in animal
care and treatment. There are no restrictions on who can report an alleged
incident. Anyone who has knowledge of such a deficiency is obligated to
report it immediately. Under no circumstances will reporting such incidences
in good faith be detrimental to an individual's standing within the organization. |
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6.1 |
Definition: Allegations of animal mistreatment
and deficiencies in care include the wrongful or abusive physical
or psychological treatment of an animal and non-compliance with established
procedures, policies or protocols. |
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6.2 |
Procedures: Any person with knowledge
of deficiencies or with reasonable suspicions of deficiencies or
mistreatment involving University laboratory animals is obligated
to report them directly to the Chair of the IACUC, any member of
the IACUC, or the Graduate Studies and Research Office. |
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6.3 |
Reporting: There are no restrictions on
who can report an alleged incident. Timely reporting is essential
to protect the animals involved and to aid the investigation of the
allegations. Reports of suspected deficiencies should be made in
writing and should include, but need not be limited to, the nature
and the place of the occurrence, the person or persons alleged to
be delinquent, the date, the time, and any supporting facts. If a
person actually witnesses mistreatment or abuse, the witness will
immediately notify the Veterinarian, the IACUC Chair or the Graduate
Studies and Research Office so that the animal or animals involved
can be evaluated and receive medical treatment if necessary. The
person should then report the incident through channels as described
above. The IACUC will investigate allegations and report its findings
and recommendations to the Graduate Studies and Research Office in
a timely fashion. |
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6.4 |
Details of any reports or
allegations of deficiencies, findings or recommendations of the IACUC,
as well as administrative or legal actions taken by the committee
are considered privileged information and may be released only through
official channels, or as required by law. |
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6.5 |
Willful mistreatment or abuse of animals
may be grounds for suspension of all animal use activities or protocols
involved, or other disciplinary actions. Disciplinary action may
be appealed through existing procedures. |
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6.6 |
This policy will be distributed to all
personnel involved in any way in animal research at TAMU-CC. Personnel
will be required to sign a document indicating that they have received
and understand this information. Principal investigators will be
responsible to assure that all personnel involved in research activities
under their direction are aware of the above procedures. Instructions
for reporting allegations will be posted on bulletin boards in each
building where research animals are used. |
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6.7 |
Statutory authority
for this instruction is found in the 1985 Amendment to The Animal
Welfare Act Title 7,
United States Code, Section 2131-2156, PL-99-198. The act requires
that "...training for scientists, animal technicians, and other
personnel involved with animal care...shall include...methods whereby
deficiencies in animal care and treatment should be reported." |
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| 7. |
IACUC PROCEDURES FOR THE INVESTIGATION
OF A COMPLAINT
The IACUC Chair is responsible for the receipt and disposition of all complaints.
All allegations will remain confidential to the extent possible until proven
or disproved. The IACUC, however, will not formally investigate anonymous
complaints. When the complainant wishes to be openly identified, the IACUC
Chair will acknowledge receipt of the allegation to the complainant in
writing. The IACUC Chair will present all allegations to the IACUC during
its next meeting. The IACUC will then determine if the complaint has sufficient
substance to warrant a full investigation. The IACUC will determine the
procedures by which it will carry out an investigation. All persons involved
in the investigation will be informed in writing of the purpose of the
investigation and the manner in which it will be conducted. If there is
indication of serious noncompliance, the IACUC may suspend an activity
pending the outcome of a full investigation. The IACUC will examine all
pertinent documents, animals, procedures, and interview involved personnel
during its investigation. Persons against whom the complaint is made will
be given the opportunity to appear before the committee. The final results
of the investigation will be presented during a formal meeting of the IACUC
and all committee members will be given the opportunity to present minority
views. The IACUC will inform all parties involved, including the complainant,
of the committee's findings. The results will be forwarded to the Graduate
Studies and Research Office with appropriate recommendations. |
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7.1 |
If following an investigation of the alleged
incident the IACUC finds no evidence of animal mistreatment or noncompliance,
the report of the investigation will be forwarded to the Graduate
Studies and Research Office with the recommendation that no further
action be taken. |
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7.2 |
If allegations of animal mistreatment
are substantiated, the Provost will be advised of the committee's
findings and recommendations and take appropriate action after consulting
with the IACUC and reviewing the results of the IACUC investigation.
The Provost has the power to impose sanctions on an investigator
found responsible for mistreatment or noncompliance. The decision
of the Provost is final. |
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7.3 |
IACUC is empowered by USDA Regulation
and PHS policy to suspend a previously approved project pending review
by the Provost. In this case, and whenever IACUC suspends an activity
involving animals (for example when activities are suspended pending
the outcome of an investigation), the Graduate Studies and Research
Office must report the action with a full explanation to any Federal
funding agency involved in the project. |
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Contact for Interpretation: Associate Vice President for Research and
Scholarly Activity