INSTITUTIONAL ANIMAL CARE AND USE PROGRAM
HANDBOOK of POLICIES & PROCEDURES
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Section 1: Introduction
1.0 Purpose and Scope of Manual
1.1 Institutional Policy
1.2 Program Lines of Authority and Responsibility
1.3 Office of Laboratory Animal Welfare (OLAW)
1.3.1 Animal Welfare Assurance
1.4 United States Department of Agriculture (USDA)
1.4.1 The Animal Welfare Act
1.5 Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC)
1.6 New York State Public Health Law (Article 5, Title 1, Section 504)
Section 2: Institutional Animal Care and Use Committee (IACUC)
2.0 Authority
2.1 Committee Composition
2.2 Conflict of Interest
2.3 Quorum Requirements
2.4 IACUC Responsibilities
2.4.1 Semi-Annual Program Reviews
2.4.2 Semi-Annual Facility Inspections
2.4.3 Reporting
2.4.4 Animal Care and Use Concerns
2.4.5 Program Recommendations
2.4.6 Protocol Review
2.4.7 Protocol Modification Review
2.5.8 Notification of review Outcomes
2.5.9 Monitoring of Approved Protocols
2.5.10 Suspension of Animal Activities
2.5.11 Congruency Review of Approved Protocols with Proposals
Section 3: When and How Principal Investigators Should Secure IACUC Approval
3.0 Activities Requiring IACUC Approval
3.1 Off-Campus Activities Requiring IACUC Approval
3.1.1 Clarkson University Personnel Working at Off-Campus Site with PHS-Approved IACUC
3.1.2 Non-Clarkson Personnel Working at Off-Campus Site with PHS-Approved IACUC
3.1.3 Clarkson Personnel Working at Off-Campus Site with No PHS-Approved IACUC
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3.2 Use of By-Products Such As Discarded Tissues or Carcasses
3.3 Use of Antibodies
3.3.1 Off-the-Shelf Antibodies
3.3.2 Custom Antibodies
3.4 Activities Involving the Study of Animals in their Natural Habitat
3.5 Procedures for Applying for IACUC Approval
3.6 IACUC Forms
3.7 Procurement of Vertebrate Animals
Section 4: Training and Instruction
4.0 CITI Program Training
4.1 IACUC Members
4.2 Student Training
4.3 Personal Qualifications and Protocol Specific Training
4.4 Orientation
4.5 Species and Technique Specific Training
4.6 Specialized Training Sessions
4.7 Consultations
4.8 Environmental Health and Safety Training
Section 5: Occupational Health and Safety Program
5.0 Administration and Management
5.1 Program Scope
5.2 Hazard Identification and Risk Assessment
5.3 Health Histories and Evaluations
5.4 Common Identified Hazards and Risks
5.5 Procedure in Place to Alleviate Hazards and Minimize Risks
5.6 Immunizations
5.7 Precautions taken During Pregnancy, Illness, or Decreases Immunocompetence
5.8 Provisions for Personnel Not Involved in Animal Care and/or Use
5.9 Availability and Procedures for Treatment in the Event of Bites, Scratches, Illness or Injury
5.10 Procedures/Program for Reporting and tracking Injuries and Illnesses
Section 6: Institutional Program Evaluation and Accreditation
6.0 Program and Facility Evaluations
6.1 Accreditation
Section 7: Record Keeping Requirements
7.0 Maintaining IACUC Records
7.1 Inspection
Section 8: Reporting Requirements
8.0 OLAW Annual Report
8.1 Non-Compliance, Serious Deviations, and Suspensions
8.2 Minority Views
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Section 1: Introduction
1.0
Purpose and Scope of Manual
It is the responsibility of Clarkson University to provide suitable orientation, appropriate materials,
adequate resources and training to enable research faculty and staff and IACUC members to carry out their
respective duties consistent with Clarkson’s Animal Welfare Assurance with the Office of Laboratory
Animal Welfare (OLAW).
Institutional policies and procedures need to be a part of the training and education program. Frequently,
researchers and IACUC members find it confusing to understand the differences between the federal
policies and requirements and institutional policies and procedures. The Institution is responsible for
informing researchers and IACUC members of their responsibilities, providing training relative to their
respective roles, and ensuring information to fulfill their duties is available.
1.1
Institutional Policy
Clarkson University recognizes its responsibility to ensure the humane and appropriate care and use of
all live vertebrate animals used or intended for use in research, research training, experimentation,
biological testing, or teaching. Therefore, the University has established and provides resources for an
Animal Care and Use Program and an Institutional Animal Care and Use Committee (IACUC) that
oversees the program, facilities, and procedures.
As a recipient of Public Health Service (PHS) funding (i.e. NIH or NSF), Clarkson maintains an
approved Animal Welfare Assurance (Assurance) with the Office of Laboratory Animal Welfare
(OLAW). The Division of Research (DOR) is responsible for maintaining Clarkson University’s
Assurance. As part of this Assurance Clarkson agrees to comply with the:
 PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy)
http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf;
 Guide for the Care and Use of Laboratory Animals (Guide)
http://www.nap.edu/openbook.php?record_id=5140;
 U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training http://grants.nih.gov/grants/olaw/olaw.htm
 Animal Welfare Act (as applicable) http://www.nal.usda.gov/awic/legislat/awa.htm; and
 Other Federal Statutes and regulations relating to animals (as applicable).
Vertebrate animal use must be approved in advance by the Institutional Animal Care and Use
Committee (IACUC), regardless of funding source or status. These Policies and Procedures are
applicable to all research, teaching, training, experimentation, biological testing, breeding, and related
activities, hereinafter referred to collectively as “activities,” involving vertebrate animals and
conducted at this institution, or at another institution when Clarkson University personnel are involved,
or when funding flows through Clarkson University.
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1.2
Program Lines of Authority and Responsibility
The lines of authority and responsibility for administering the program and ensuring compliance with
this Policy are as follows*:
University President
(Chief Executive Officer)
Provost
Director of Research
(Institutional Official)
Attending
Veterinarian
IACUC
Chair
IACUC
University Animal
Facility/Animal Care
Program
IACUC
Office
Research Compliance
Division of Research
*Heavy lines represent established lines of authority. Dotted lines represent communication and
cooperation between components. As indicated, there are open and direct lines of communication
between the IACUC and the Institutional Official (IO) and between the Veterinarian and the IO.
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1.3
Office of Laboratory Animal Welfare (OLAW) 1
The Office of Laboratory Animal Welfare (OLAW) is responsible for negotiating Animal Welfare
Assurances and implementing PHS Policy. While OLAW is located organizationally at the National
Institutes of Health (NIH) in Bethesda, Maryland, OLAW’s responsibility for laboratory animal
welfare extends beyond NIH to all PHS-supported activities involving animals. From time to time,
OLAW issues policy guidance, interpretation, or general notices regarding PHS Policy, and cosponsors animal welfare workshops that are held in different locations across the country.
1.3.1 Animal Welfare Assurance
Before the PHS may award a grant or contract that involves the use of animals, the recipient
institution and all performance sites involving or using animals must have on file with OLAW
an approved Animal Welfare Assurance. The Assurance is the cornerstone of a trust
relationship between the institution and the PHS. Included in the Assurance are:



The designation of the Institutional Official responsible for compliance;
A commitment that the institution will comply with the PHS Policy, with the Guide, and
with the AWA and the Animal Welfare Regulations; and
A description of the institution's program for animal care and use.
The PHS Policy applies to the use of live, vertebrate animals in any activity supported or
conducted by the Public Health Service (PHS).
Clarkson University has an Animal Welfare Assurance on file with OLAW. The Animal
Welfare Assurance number is A4536-01.
1.4
United States Department of Agriculture (USDA)
In 1966, Congress passed the Laboratory Animal Welfare Act (PL 89-544) and the United States
Department of Agriculture (USDA) was named the responsible agency for the enforcement of the
Animal Welfare Act (AWA) to protect certain animals from inhumane treatment and neglect. Congress
passed the AWA in 1966 and strengthened the law through amendments in 1970, 1976, 1985, and
1990. The USDA's Animal and Plant Health Inspection Service (APHIS) administers the AWA, its
standards, and its regulations.
Currently, Clarkson University is not required to be registered with the USDA.
1.4.1 The Animal Welfare Act
The Animal Welfare Act (AWA) requires that minimum standards of care and treatment be
provided for certain animals bred for commercial sale, used in research, transported
commercially, or exhibited to the public. Individuals who operate facilities in these categories
must provide their animals with adequate care and treatment in the areas of housing, handling,
sanitation, nutrition, water, veterinary care, and protection from extreme weather and
temperatures.
1.4.1.1 Inclusions
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The AWA (Title 7, Chapter 54, Section 2132(g)) defines the term “animal” to mean any live
or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such
other warm-blooded animal that is being used, or is intended for use, for research, testing,
experimentation, or exhibition purposes, or as a pet. With respect to a dog, the term means all
dogs including those used for hunting, security, or breeding purposes. Animal shelters and
pounds are regulated if they sell dogs or cats to dealers.
1.4.1.2 Exemptions
The AWA (Title 7, Chapter 54, Section 2132(g)) excludes birds, rats of the genus Rattus,
and mice of the genus Mus, bred for use in research, horses not used for research
purposes, and other farm animals, such as, but not limited to livestock or poultry, used or
intended for use as food or fiber, or livestock or poultry, used or intended for use for
improving animal nutrition, breeding, management, or production efficiency, or for
improving the quality of food or fiber.
Retail pet shops are not covered under the Act unless the shop sells exotic or zoo animals
or sells animals to regulated businesses. Pets owned by private citizens are not regulated.
1.4 Research Facilities
Currently, Clarkson University is not considered a research facility by the AWA.
However, if the University were to become a research facility, USDA registration would
be required.
1.5
Association for Assessment and Accreditation of Laboratory Animal Care,
International (AAALAC)
The Association for Assessment and Accreditation of Laboratory Animal Care, International
(AAALAC) is a private, nonprofit organization that promotes the humane treatment of animals in
science through voluntary accreditation and assessment programs. Participating institutions receive an
independent, unbiased expert assessment, and those that meet or exceed applicable standards are
awarded accreditation.
Currently, Clarkson University is not accredited by AAALAC.
1.6
New York State Public Health Law (Article 5, Title 1, Section 504)
New York State law mandates the establishment of an institutional animal care committee which shall
be responsible for evaluating the care of all animals held for research, teaching, or other activities by
Clarkson University or by other resources under University auspices.
NYS DOH Animal Care & Use Certificate Number: AW ID Number A-249
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Section 2: Institutional Animal Care and Use Committee
2.0
Authority
As required by Clarkson’s Animal Welfare Assurance with the Office of Laboratory Animal Welfare
(OLAW) and policy, the University operates an IACUC that oversees the program, facilities, and
procedures to ensure the appropriate care and use of all live vertebrate animals used or intended for use
in research, research training, experimentation, biological testing, or teaching.
IACUC’s derive their authority from the law. The Health Research Extension Act (HREA) of 1985 and
the Animal Welfare Act mandate the existence of IACUC’s. The laws require the Chief Executive
Officer (CEO) of an organization to appoint the IACUC, whose responsibilities are delineated in the
law and federal policy and regulations. The Office of Laboratory Animal Welfare (OLAW) considers
the CEO to be the highest operating official of the organization. The President of Clarkson University
is the IACUC CEO and delegates the authority to appoint the IACUC Chair and members to the
Provost.
Once appointed, the IACUC reports to a senior administrator known as the Institutional Official (IO).
The Director of Research is the appointed IO at Clarkson University. The IO is given the
administrative and operational authority to commit institutional resources to ensure compliance with
the PHS Policy and other requirements.
The IACUC’s mandate to perform semiannual program evaluations as a means of overseeing the
animal care and use program puts the IACUC in an advisory role to the IO. In its semiannual reports
the IACUC advises the IO of the status of the Institution’s compliance, establishes plans and schedules
for correcting deficiencies necessary to either maintain or achieve compliance, and makes
recommendation to the IO regarding any aspect of the Institution’s animal program, facilities, or
personnel training.
The IACUC’s authority to review and approve protocols is independent of the IO, who may not
overrule an IACUC decision to withhold approval of a protocol. If the IACUC approves a protocol,
however, the Institution is not required or obligated to conduct the research activity. The Institution
may also subject protocols to additional institutional review (e.g., department head, Biosafety
committee, etc.).
Clarkson University has established an Institutional Animal Care and Use Committee, which is
qualified through the experience and expertise of its members to oversee the Institution’s animal
program, facilities, and procedures.
2.1
Committee Composition
In general, the IACUC is composed of regular voting members, alternate voting members, and nonvoting members. The IACUC may use, as necessary, non-voting members and consultants during
review discussions. Some IACUC members fulfill specific regulatory requirements (e.g., veterinarian
with program responsibility, an individual nonaffiliated with the Institution); others have unique roles
by virtue of their position (e.g., Chair, Veterinarian, etc.)
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Clarkson maintains an IACUC containing at least five voting members. One must be a qualified
veterinarian licensed to practice in New York State with experience in the care of laboratory animals,
one must be a community member not affiliated with the University, one must be a practicing scientist
experienced in research involving animals, and one must be a non-scientist. The Director of Research
is an ex officio non-voting member.
IACUC members shall be appointed for three-year terms to which they may be reappointed. When a
sitting member of the IACUC is appointed chair, he or she shall begin a new three-year term. Members
or the Chair of the IACUC may be removed before the end of a given term by the Provost if upon
review by the Provost, cause exists or lack of attendance occurs.
Once appointed, the IACUC reports to a senior administrator known as the Institutional Official (IO).
The Director of Research in the DOR is the appointed IO at Clarkson University. The IO is given the
administrative and operational authority to commit institutional resources to ensure compliance with
the PHS Policy and other requirements.
There are no specific prohibitions regarding individuals filling more than one role on the IACUC, but
OLAW strongly recommends against the same person serving multiple roles, because the
responsibilities and authorities vested in each of the positions are distinct and often require different
skills. Appointing one individual to more than one of these roles may circumvent intended checks and
balances. Also of importance is the perception of conflict of interest, which can lead to allegations of
improprieties from various sources.
Required categories of membership include:
Veterinarian - The PHS Policy and AWRs mandate the appointment of a veterinarian with direct or
delegated program responsibility to the IACUC. The IO may appoint more than one veterinarian to the
IACUC, but the veterinarian with direct or delegated program responsibility must be designated as
such. The veterinarian with program responsibility, e.g., Attending Veterinarian, must have training or
experience in laboratory animal care.
Chair - The Chair is a faculty member of the University with research experience.
Nonaffiliated - The nonaffiliated member(s) represent general community interests. Neither they, nor
their immediate family, have an affiliation with Clarkson University. These members have equal status
(e.g., voting) to every other committee member and are provided the opportunity to participate in all
aspects of IACUC functions.
Scientist - PHS Policy requires that the IACUC include a practicing scientist experienced in research
involving animals.
Nonscientist - PHS Policy requires that the IACUC include a member whose primary concerns are in a
nonscientific area. Examples include, but are not limited to, ethicist, lawyer, member of the clergy,
librarian, etc.
The Institution should consider persons with expertise in the disciplines involved in institutional
research and teaching programs for service on the IACUC. In addition to the required categories of
membership, it is suggested that individuals with expertise in specific areas pertinent to protocol
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review and program oversight be considered (e.g. statisticians, occupational health experts,
information resource specialists, animal health technicians, and scientific research staff).
There is no requirement that any particular member or category of members be present at all IACUC
meetings. The institution, however, must have a properly constituted IACUC in order for the IACUC
to conduct valid official business.
Alternate members may be appointed to the IACUC as long as they are appointed by the Provost and
there is a specific one-to-one designation of IACUC members and alternates. An IACUC member and
his/her alternate may not count toward a quorum at the same time or act in an official member capacity
at the same time. Alternates should receive training identical to the training provided to regular IACUC
members.
The Clarkson University IACUC meets the compositional requirements set forth in section of
IV.A.3.b. of the PHS Policy.
2.2
Conflict of Interest
Both the AWRs and PHS Policy state that no IACUC member “may participate in the IACUC review
or approval of an activity in which that member has a conflicting interest, (e.g. is personally involved
in the activity) except to provide information requested by the IACUC.”
All investigators, IACUC members, and consultants as necessary, are required to disclose any conflicts
of interest according to Clarkson University’s Conflict of interest Policy
(http://www.clarkson.edu/finance/conflict_of_interest.html).
If the investigator submitting a protocol believes that an IACUC member has a potential conflict, the
investigator may request that the member be excluded. When a member has a conflict of interest, the
member should notify the IACUC Chair and may not participate in the IACUC review or approval
except to provide information. Members who have a conflict of interest may not be counted toward a
quorum and may not vote.
Other possible examples of conflict of interest include cases where:
• a member is involved in a potentially competing research program,
• access to funding or intellectual information may provide an unfair competitive advantage, or
• a member’s personal biases may interfere with his or her impartial judgment.
2.3
Quorum Requirements
Certain official IACUC actions require a quorum: full committee review of a research project (Policy
IV.C.2. and AWR §2.31(d)(2)) and suspension of an activity (Policy IV.C.6. and AWR §2.31(d)(6)).
“Quorum” is defined as a majority (>50%) of the voting members of the IACUC. Therefore, a protocol
is approved only if a quorum is present, and if more than 50% of the quorum votes in favor. PHS
Policy and AWRs require that in order to suspend an activity, the IACUC must review the matter at a
convened meeting of a quorum of the IACUC and the suspension must be approved by a majority vote
of the quorum present.
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For reasons other than conflict of interest, abstentions from voting do not alter the quorum or change
the number of votes required. For example: If an IACUC has 20 voting members, at least 11 members
must be present at a convened meeting to constitute a quorum and approval of a protocol would require
a minimum of six votes whether or not there were abstentions.
2.4
IACUC Responsibilities
2.4.1 Semi-Annual Program Review
The Institutional Animal Care and Use Committee (IACUC) will review at least once every six
months the institution's program for humane care and use of animals, using the “Guide” as a
basis for evaluation. The IACUC procedures for conducting semiannual program evaluations
are as follows:
The IACUC will meet once at least every six months to review the Institutional Program for
Humane Care and Use of Animals. The Committee uses the Guide and other applicable
resources, e.g., the PHS Policy, the Code of Federal Regulations (Animal Welfare), and
AVMA Guidelines on Euthanasia, as a basis for the review. To facilitate the evaluation, the
Committee will use a checklist based on the Sample OLAW Program and Facility Review
Checklist from the OLAW website. The evaluation will include, but not necessarily be limited
to, a review of the following:
a) IACUC Membership and Functions;
b) IACUC Records and Reporting Requirements;
c) Husbandry and Veterinary Care (all aspects);
d) Personnel Qualifications (Experience and Training);
e) Occupational Health and Safety; and
f) Disaster Planning.
In addition, the evaluation will include a review of the Institution’s PHS Assurance.
Subcommittees may be used to conduct all or part of the reviews. However, no member will be
involuntarily excluded from participating in any portion of the reviews.
Members of the committee complete the IACUC Semi-Annual Program Review form. This
form includes all items listed in the “Guide” and upon completion is reviewed by all members
of the Committee and signed by all IACUC members in attendance. If program deficiencies
are noted during the review, they will be categorized as significant or minor and the Committee
will develop a reasonable and specific plan and schedule for correcting each deficiency.
2.4.2 Semi-Annual Facility Inspection
The Institutional Animal Care and Use Committee (IACUC) will Inspect at least once every six
months all of the institution's animal facilities, including satellite facilities, using the “Guide”
as a basis for evaluation. The IACUC procedures for conducting semiannual facility
inspections are as follows:
At least once every six months at least two (2) members of the IACUC will visit all of the
institute’s facilities where animals are housed or used, i.e., holding areas, animal care support
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areas, storage areas, procedure areas, and laboratories where animal manipulations are
conducted. Equipment used for transporting of the animals is also inspected. The Committee
uses the Guide and other pertinent resources, e.g., the PHS Policy, the Code of Federal
Regulations (Animal Welfare) as a basis for the review.
Inspection of the Zebrafish Facility, will include evaluating the following:
a) Tank water flow/conditions;
b) Filter cleanliness (reverse osmosis system, particle filters, and carbon filters);
c) Tank labeling;
d) Conductivity, pH, and temperature;
e) Feeding;
f) Overall health;
g) UV light maintenance;
h) Drug Storage; and
i) Correction plans for deficiencies from the most recent inspection have been implemented.
To facilitate the inspection, members conducting the evaluation will complete a Facility
Review Checklist. Inspection results will be discussed with the Committee during a convened
IACUC meeting—generally at the meeting at which the Program Review is conducted. If
deficiencies are noted during the inspection, they will be categorized as significant or minor
and the Committee will develop a reasonable and specific plan and schedule for correcting each
deficiency. A significant deficiency is one that is or may be a threat to the health and safety of
the animals or personnel. No member will be involuntarily excluded from participating in any
portion of the inspections.
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2.4.3 Reporting
The Institutional Animal Care and Use Committee (IACUC) will prepare reports of the IACUC
evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to the Institutional
Official. The IACUC procedures for developing reports and submitting them to the Institutional
Official are as follows:
Once the results of the Program Review and Facility Inspection are discussed and the
Committee develops a reasonable and specific plan and schedule for correcting each deficiency
identified (III.D.1. & III.D.2.), an IACUC Semiannual Program & Facility Review Report will
be prepared by the Research Compliance Officer using the sample OLAW Report Form. The
IACUC Semiannual Program & Facility Review Report will detail the following:
a) Deficiency category (significant or minor);
b) Location (program review or facility/location);
c) Deficiency & plan for correction;
d) Responsible party;
e) Correction schedule and interim status; and
f) Date completed (date completed or pending).
Once the IACUC Semiannual Program & Facility Review Report is completed, a Report to the
Institutional Official is prepared using the sample OLAW Semiannual Report to the
Institutional Official format from the OLAW website. The reports will contain a description of
the nature and extent of the institution's adherence to the Guide and the PHS Policy, identify
specifically any departures from the provisions of the Guide and the PHS Policy, and state the
reasons for each departure. The reports will distinguish significant deficiencies from minor
deficiencies. If program or facility deficiencies are noted, the reports will contain a reasonable
and specific plan and schedule for correcting each deficiency. This will generally be
accomplished by including a copy of the IACUC Semiannual Program & Facility Review
Report form. If some or all of the institution's facilities are accredited by AAALAC
International the report will identify those facilities as such.
Note: Corrective actions for minor deficiencies will typically be completed prior to the
preparation of the Report to the Institutional Officer, identified as complete, and are always
verified at the next scheduled Program Review and/or Facility Review. Corrective actions for
significant deficiencies are corrected immediately.
Once the Report to the Institutional Official is prepared, it will be distributed to all IACUC
members, along with the meeting minutes, for review, revision, and approval by the
Committee. Approved and final reports will be signed by a majority of the IACUC members
and will include any minority opinions. If there are no minority opinions, the reports will
reflect such. Following completion of each evaluation, the completed report will be submitted
to the Institutional Official in a timely manner.
2.4.4 Animal Care and Use Concerns
The Institutional Animal Care and Use Committee (IACUC) will review concerns involving the
care and use of animals at the institution. The IACUC procedures for reviewing concerns are
as follows:
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Notices are located in the animal facilities advising individuals how and where to report animal
welfare concerns and stating that any individual who, in good faith, reports an animal welfare
concern will be protected against reprisals.
Any individual may report concerns to the Institutional Officer, IACUC Chair, Institutional
Veterinarian, the Research Compliance Officer, or any member of the IACUC. Any individual,
who in good faith, reports an animal welfare concern, will be protected against reprisals.
Additionally, any individual may use the University privacy hotline to report a concern.
All reported concerns will be brought to the attention of the full Committee. If necessary the
IACUC will convene a meeting to discuss, investigate, and address any reported concern.
Reported concerns and all associated IACUC actions will be recorded in the IACUC meeting
minutes. The Committee will report such actions to the Institutional Officer and, as warranted,
to OLAW.
2.4.5 Program Recommendations
The Institutional Animal Care and Use Committee (IACUC) will make written
recommendations to the Institutional Officer regarding any aspect of the institution's animal
program, facilities, or personnel training. The procedures for making recommendations to the
Institutional Official are as follows:
Recommendations regarding any aspects of the institution’s animal program or facilities are
discussed and developed by the Committee. The Committee’s recommendations are included in
the IACUC Meeting minutes or a report of the IACUC’s evaluations or a separate letter. Such
documents are approved by the Committee and then submitted to the Institutional Officer.
2.4.6 Protocol Review
The Institutional Animal Care and Use Committee (IACUC) will, in accord with the PHS
Policy IV.C.1-3, review and approve, require modifications in (to secure approval), or withhold
approval of PHS-supported activities related to the care and use of animals. The IACUC
procedures for protocol review are as follows:
Prior to the review, each IACUC member will be provided with written descriptions of
activities (protocols) that involve the care and use of animals and any member of the IACUC
may obtain, upon request, full committee review of those protocols. 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, may be assigned to review those protocols and have the
authority to approve, require modifications in (to secure approval) or request full committee
review of those protocols. Other IACUC members may provide the designated reviewer with
comments and/or suggestions for the reviewer’s consideration only. That is, concurrence to use
the DMR method may not be conditioned. If multiple designated reviewers are used, their
decisions must be unanimous; if not, the protocol will be referred for FCR. If FCR is
requested, approval of those protocols 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.
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In instances where the IACUC uses the designated-member review (DMR) method the protocol
will be distributed to all IACUC members to allow all members the opportunity to call for
FCR; records of polling of members to obtain concurrence to use the DMR method, or
concurrence by silent assent after three (3) working days, and approval of protocols via DMR
are maintained and recorded in the minutes of the next convened IACUC meeting.
Required modifications Subsequent to FCR. When the IACUC requires modifications (to
secure approval), of a protocol, such modifications are reviewed as follows:
1. FCR or DMR following the procedures delineated above.
2. DMR if approved unanimously by all members at the meeting at which the required
modifications are developed and delineated AND if the entire current Committee has
previously approved, in advance and in writing, that the quorum of members present
at a convened meeting may decide by unanimous vote 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.
3. Minor modifications of an administrative nature, i.e., typographical or grammatical
errors, required signatures, etc. may be confirmed by IACUC administrative/support
personnel.
No member may participate in the IACUC review or approval of a protocol in which the
member has a conflicting interest (e.g., is personally involved in the project) except to provide
information requested by the IACUC; nor may a member who has a conflicting interest
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.
Note: Any use of telecommunications will be in accordance with NIH Notice NOT-OD-06052 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:
a. Procedures with animals will avoid or minimize discomfort, distress, and pain to the
animals, consistent with sound research design.
b. Procedures that may cause more than momentary or slight pain or distress to the
animals will be performed with appropriate sedation, analgesia, or anesthesia, unless
the procedure is justified for scientific reasons in writing by the investigator.
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c. Animals that would otherwise experience severe or chronic pain or distress that
cannot be relieved will be painlessly killed at the end of the procedure or, if
appropriate, during the procedure.
d. The living conditions of animals will be appropriate for their species and contribute
to their health and comfort. The housing, feeding, and nonmedical care of the
animals will be directed by a veterinarian or other scientist trained and experienced
in the proper care, handling, and use of the species being maintained or studied.
e. Medical care for animals will be available and provided as necessary by a qualified
veterinarian.
f. Personnel conducting procedures on the species being maintained or studied will be
appropriately qualified and trained in those procedures.
g. Methods of euthanasia used will be consistent with the current recommendations of
the American Veterinary Medical Association (AVMA) Guidelines on Euthanasia,
unless a deviation is justified for scientific reasons in writing by the investigator.
2.4.7 Protocol Modification Review
The Institutional Animal Care and Use Committee (IACUC) will review and approve, require
modifications in (to secure approval), or withhold approval of proposed significant changes
regarding the use of animals in ongoing activities as set forth in the PHS Policy IV.C.
Changes to an existing protocol are categorized as either significant or minor. The table below
is based on guidance from DHHS/Office of Laboratory Animal Welfare. Questions regarding
whether a formal amendment is required should be directed to the Division of Research. All
amendments must be approved before the changes are implemented. Amendments do not
extend approval period.
Review and approval of significant changes are handled in the same manner as new protocols.
See Paragraph III.D.6.above. Review of minor changes can be handled administratively by the
research Compliance Officer, IACUC Coordinator, or designee in the Division of Research.
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PROPOSED CHANGE
SIGNIFICANT CHANGE
Anesthetic or analgesic
agent change (addition or
subtraction)
Criteria for euthanasia
Euthanasia agent or method
Funding Source
Increase in approximate
number of animals to be
used
Objectives of study
Personnel Changes (PI or
co-PI)
Personnel Changes (other)
Procedures: Increase in
duration, frequency, or
number (including blood
collection)
Procedures: Increase in
invasiveness, pain or
distress
Changes in duration,
frequency, or number of
procedures performed on
an animal.
Species
Change from non-survival
to survival procedures
Title change
2.4.8 Notification of Review Outcome
MINOR CHANGE
X
X
X
X
X
X
X
X
X
X
X
X
X
X
The Institutional Animal Care and Use Committee (IACUC) will 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. The IACUC procedures to notify investigators and the
Institution of its decisions regarding protocol review are as follows:
Upon the conclusion of discussion of a protocol there will be a decision of one of the
following:
1) Approval,
2) Modifications Required (to secure approval), or
3) Approval Withheld [i.e., non-approval].
Principal Investigators are notified either by e-mail or letter from the IACUC Coordinator. The
Institutional Official is notified by receiving a copy of the PI’s notification letter and/or a copy
of the IACUC meeting minutes.
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2.4.9
Monitoring of Approved Protocols
The Institutional Animal Care and Use Committee (IACUC) will conduct annual review of
each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as
determined by the IACUC, including a complete review in accordance with the PHS Policy
IV.C.1-4 at least once every three years. The IACUC procedures for conducting continuing
reviews are as follows:
All ongoing activities are monitored continuously by the animal care and use staff (postapproval monitoring) and the associated protocols are reviewed by a member or members of
the IACUC at least annually. Annual protocol reviews are recorded in the IACUC meeting
minutes. The IACUC meeting minutes are reviewed and approved by the Committee.
As part of the process for the ongoing review of previously approved protocols the PIs are
required to submit a continuation form on an annual basis. This form will then be reviewed by
the IACUC to determine if there are any changes to the original protocol, how it is being
funded, as well as the activity on the project.
Protocols are approved for a maximum of 36 months. That is, all protocols expire no later than
the three-year anniversary of the date of initial IACUC approval. If activities are to continue
beyond the expiration date, a new protocol must be submitted, reviewed, and approved as
described in Paragraph III.D.6.
2.4.10
Suspension of Animal Activities
The Institutional Animal Care and Use Committee (IACUC) will authorized to suspend an
activity involving animals as set forth in the PHS Policy IV.C.6. The IACUC procedures for
suspending an ongoing activity are as follows:
The IACUC may suspend an activity that it previously approved if it determines that the
activity is not being conducted in accordance with applicable provisions of the Animal Welfare
Act, the Guide, this Assurance, or the PHS Policy. The IACUC may suspend an activity only
after review at a convened meeting of a quorum of the IACUC and with the suspension vote of
a majority of the quorum present. If the IACUC suspends an activity involving animals, or any
other institutional intervention results in the temporary or permanent suspension of an activity
due to noncompliance with the Policy, Animal Welfare Act, the Guide, or this Assurance, the
Institutional Official in consultation with the IACUC shall review the reasons for suspension,
take appropriate corrective action, and report that action with a full explanation to OLAW.
2.5.11 Congruency Review of Approved Protocols with Sponsored Award Proposals
To ensure compliance with Public Health Services Policy (IV, D,2) and NIH Grants Policy
Statement (Part II, Terms and Conditions); the institution has the responsibility to conduct a
review of approved components of sponsored award proposals that are related to the care and
use of animals to ensure grant to protocol congruency. This is a requirement before the
sponsored award can be released for a funded grant or contract. This section establishes
procedures to ensure that the information in the animal care and use protocol reviewed and
approved by the IACUC is congruent with the information that is provided in a sponsored
award proposal submitted by Clarkson University.
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The ultimate responsibility for ensuring grant to protocol congruency rests with the Institutional
Official. The Institutional Official has delegated the authority to conduct the reviews to the
Attending Veterinarian, IACUC Chair, or Research Compliance personnel.
2.5.11.1
Procedures for the Conducting Congruence Reviews
Typically congruency reviews are conducted once an award is received from an agency,
but must be done prior to issuing the award for spending to the Principal
Investigator. Congruency reviews may also be requested during the proposal stage prior
to submission to the agency or prior to an agency issuing an award to Clarkson; doing
so may prevent delays once an award is received by Clarkson. If a congruency review
is conducted prior to Clarkson receiving an award, a congruency review does not need
to be conducted prior to spending on the award.
Research Compliance personnel will be notified by the post-award staff once an award
containing animal research has been received by Clarkson or by the pre-award staff or
Principal Investigator when a congruency review is warranted before receiving an
award.
The individual assigned to conduct the congruency review will obtain a copy of the
award proposal and complete the review utilizing the IACUC Proposal to Protocol
Congruency Form.
The following information in the Vertebrate Animal Section (VAS) of the contract or
grant and in the IACUC Protocol to Award Proposal Congruency ReviewForm will be
reviewed for congruence:
1) Proposed use of animals
2) Species, strains, ages, sex, and number of animals to be used
3) Justification for animal use and for the appropriateness of the species and numbers
4) Procedures designed to ensure that discomfort and injury to animals will be limited to
that which is unavoidable in the conduct of scientifically valuable research
5) Analgesia, anesthetic, and tranquilizing drugs to minimize discomfort and pain to
animals
6) Euthanasia method and reason for its selection
If there are any issues with congruency, the PI is notified that they are required to either
modify the protocol or submit an amendment to the granting agency for approval
consideration.
The results of the review will be will be maintained with the review form in the protocol
folder by the IACUC Office..
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2.5.11.2
Special Considerations
Special considerations or exceptions for certification by the institution concerning
grant/contract award requirements will include but may not be limited to:


Unrestricted grants/contracts may not require specific animal care and use
procedures to be described in the grant/contract.
Private funding agencies may have different criteria for animal care and use
procedures required to certify the compare.
2.5.11.3
Reference Documents
Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section
(VAS) in NIH Contract Proposals
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-049.html
NIH Grants Policy Statement (Part II, Terms and Conditions)
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
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Section 3: When and How Principal Investigators Should Secure
IACUC Approval
3.0
Activities Requiring IACUC Approval
Vertebrate animal use must be approved in advance by the Institutional Animal Care and Use
Committee (IACUC), regardless of funding source or status. These Policies and Procedures are
applicable to all research, teaching, training, experimentation, biological testing, breeding, and related
activities, hereinafter referred to collectively as “activities,” involving vertebrate animals and
conducted at this institution, or at another institution when Clarkson University personnel are involved,
or when funding flows through Clarkson University.
3.1
Off-Campus Activities Requiring IACUC Approval
3.1.1 Clarkson University Personnel Working at Off-Campus Site with PHS-Approved
IACUC
In cases where the Clarkson University faculty member or student is involved in work located
at an off-campus site with a PHS-approved IACUC, the Clarkson University IACUC may
accept an approval statement from that other IACUC, in lieu of performing a duplicate review.
However, the Clarkson University IACUC requires investigators to submit a:




IACUC Off-Campus Site Application Form;
Copy of the IACUC application from the other reviewing institution;
Copy of that institution’s approval letter, and if externally funded;
Copy of the funding proposal statement of work.
The Clarkson University IACUC must be allowed to assess whether or not an application
should be submitted to the Clarkson University IACUC under these circumstances.
3.1.2 Non-Clarkson Personnel Working at Off-Campus Site with PHS-Approved IACUC
In cases where all animal work is performed off-campus by non-Clarkson personnel and under
a PHS-approved IACUC protocol approval, and where there is institutional engagement due to
funding or other involvement, the Clarkson University faculty member shall provide for
Clarkson’s IACUC's consideration a:




IACUC Off-Campus Site Application Form;
Copy of the IACUC application from the other reviewing institution;
Copy of that institution’s approval letter, and if externally funded;
Copy of the funding proposal statement of work.
The Clarkson University IACUC must be allowed to assess whether or not an application
should be submitted to the Clarkson University IACUC under these circumstances. The
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substantive issues will not be raised. If the Clarkson member does have direct involvement
with the off-campus work, the current Clarkson University IACUC application process must be
followed.
If Clarkson University is the prime recipient of an award, Clarkson University is required to
verify IACUC approval when vertebrate research is involved. If all vertebrate research is to
take place at an off-campus site with PHS-Approved IACUC Clarkson can rely on that
institution’s IACUC approval process, as allowed by regulation, by completing an IACUC
Authorization Agreement.
3.1.3 Clarkson Personnel Working at Off-Campus Site with No PHS-Approved IACUC
In cases where all animal work is performed off-campus at an institution with no PHSapproved IACUC, the Clarkson University application process must be followed. In addition,
the Clarkson faculty member shall provide for Clarkson University IACUC's consideration a
copy of that institution's IACUC application and letter of approval, if any.
3.2
Use of By-Products Such As Discarded Tissues or Carcasses
There is no requirement for IACUC approval for use of whole animals that are dead at the time of
acquisition, or for use of cells, blood, serum, organs, tissues, eggs or any other part of animals that
were euthanized for another purpose or died spontaneously. IACUC review is necessary when
euthanasia or procedures on a live animal are initiated to obtain the needed materials. PIs are
encouraged to consult with the IACUC when determining if IACUC approval is necessary, since each
situation may be different.
Even though IACUC review is unnecessary:
1. Researchers should maintain sufficient records to document the source of these discarded
tissues or carcasses, and that their acquisition proper and can be tracked (i.e. IACUC approval
from other institutions or collaborators).
2. Approval from a university safety committee will be required if materials are obtained from
animals exposed to hazardous materials or agents. Consult Environmental Health & Safety for
guidance.
3. Disposal of such materials must be in accordance with University policy. Consult
Environmental Health & Safety for guidance.
4. Use of such materials may require a Materials Transfer Agreement to protect intellectual
property. For guidance, contact the Director of Research and Technology Transfer.
3.3
Activities Involving Antibodies
3.3.1 Off-the-Shelf Antibodies
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Off-the-shelf antibodies are defined as standard reagent antibodies are defined as standard
reagent antibodies produced by a commercial supplier that uses its own resources and offers
them for general sale, e.g., through a catalogue. For these antibodies, the supplier is not
required to file an Animal Welfare Assurance with the Office of Laboratory Animal Welfare
(OLAW), and the IACUC is not required to review and approve the project.
3.3.2 Custom Antibodies
Custom antibodies are produced by a supplier or contractor using antigens provided by or at the
request of an investigator. The following requirements apply to the purchase and use of
custom antibodies by Clarkson Principal Investigators (PIs):
1. Prior to ordering custom antibodies, PIs should complete and submit an IACUC Protocol
Form for Custom Antibodies to the IACUC for review and approval. The protocol should
also include verification of the suppliers approved Animal Welfare Assurance on file with
NIH-OLAW and written approval for the project form the supplier’s IACUC.
2. Prior to ordering custom antibodies, the supplier Animal Welfare Assurance and written
approval for the project must be verified by the IACUC Office.
3. When submitting a PHS Grant application that proposes the use of custom antibodies the PI
must ensure the face page lists:




3.4
“Yes” for vertebrate animal involvement
The approval date of the PI’s project with the supplier, or “pending’ if not yet approved.
Clarkson’s Animal Welfare Assurance Number A-4536-01.
Animal Vertebrate section of the application as required by the application instructions.
Activities Involving the Study of Animals in their Natural Habitat
All activities involving the study of vertebrate animals, including those studies conducted in animals’
natural habitats and without investigator intervention, must be presented for the IACUC’s review and
approval prior to being undertaken. Federal guidance is provided below.
3.5
Procedures for Applying for IACUC Approval
To conduct animal research in which Clarkson University is a participant, the following steps are
required for IACUC approval:
Step 1: Read and be familiar with the Clarkson University’s Institutional Animal Care and Use
Program Handbook of Policies and Procedures found on the Division of Research
webpage at http://www.clarkson.edu/dor/compliance/animal_subjects.html.
Step 2: When familiar with Clarkson's policy and procedures, take the CITI Program
Laboratory Animal Welfare Training Course found on the found on the Division of
Research webpage at http://www.clarkson.edu/dor/compliance/animal_subjects.html.
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Step2: After you have read Clarkson's policy procedures and have completed the training
above, prepare and submit the appropriate IACUC protocol form, as described in
Section 3.6, one week prior to scheduled meeting date to the IACUC Coordinator,
Rebecca Thatcher, at rthatche@clarkson.edu or iacuc@clarkson.edu.
Careful consideration should be given to the following requirements and procedures:
IACUC FORMS: Forms are described below in Section 3.6 and found on the Division of Research
webpage at http://www.clarkson.edu/dor/compliance/animal_subjects.html.
Note: Depending on the complexity of the project and specific circumstances, the
IACUC approval process can take several weeks. Principal Investigator are
encouraged to submit early and consult with the IACUC; especially with time sensitive
activities.
ATTACHMENTS:
FUNDING PROPOSAL/SOW: Copy of the funding proposal or final grant pages sent to the
funding agency should be attached. Federal regulations require the IACUC to compare the
protocol to the funding proposal Statement of Work or Project Description. Substantive
differences must be satisfactorily addressed prior to IACUC approval. It is prudent for
Principal Investigators to consider submitting separate protocols for each funding
agency/sponsor. This is particularly wise when PIs have numerous sponsors. Such separation
facilitates project accounting and, in case of a serious non-compliance problem, the PI may not
have to halt all of his research.
LICENSURES/ADDITIONAL APPROVALS/QUOTATIONS: Any applicable licensures,
permits, off-site IACUC approvals, or quotations should be attached with each application.
REQUIRED TRAINING: Everyone named on the protocol—including students, lab techs, Visiting
Scholars, visitors and volunteers—is required to complete the online CITI training course, “Working
with the IACUC” and the other CITI training modules appropriate for the planned work, as described
above. Please note that IACUC protocols will not be approved without valid training on file.
Note: Once approval is granted Principal Investigators are also responsible for completing an
IACUC Occupational Health & Safety Program Personnel Training and Orientation Form for
each individual involved in the research.
PRELIMINARY PROTOCOL SUBMISSION: Submit the protocol application and attachments to the
IACUC Coordinator, Rebecca Thatcher, at rthatche@clarkson.edu or iacuc@clarkson.edu.
INITIAL REVIEW PROCESS: The protocol application will be given a preliminary review by the
Division of Research. The Principal Investigator may be contacted for clarification or additional
information, and or returned to the Principal Investigator for modifications, if necessary. If none are
needed, the protocol will be prepared for distribution to the IACUC.
If modifications are required, the Principal Investigator should revise the protocol in accordance with
the IACUC’s determinations and then submit the revised protocol to the Division of Research via
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email to iacuc@clarkson.edu or to Rebecca Thatcher, IACUC Coordinator, at rthatche@clarkson.edu
for distribution to the committee.
COMMITTEE REVIEW: All protocols are distributed to the IACUC committee in the order in which
they are received. If a committee member calls for full committee review, the protocol will be placed
on the agenda for the next meeting, unless it was received without sufficient lead time. Generally,
protocols requiring full committee review should be submitted no later than one week prior to the
meeting. In cases where other institutional reviews or approvals are required (i.e., Institutional
Biosafety Committee, Material Transfer Agreement, Office of Technology Licensing, Radiation
Committee), those should can be sought in parallel.
DEPARTMENTAL SIGN OFF: Once approved by the IACUC the prepared application is to be
signed by the applicant’s department head or, in lieu of a written signature, department heads may send
an email to iacuc@clarkson.edu stating that they are aware of the proposed work and concur with its
submittal to the IACUC. Once a signed acknowledgment is recieed the PI will receive an IACUC
approval letter, along with a signed copy of the proposal.
3.6
IACUC Forms
IACUC Protocol Form for Use of Animals in Research
The protocol application form must be used for new proposals and for continuations after the third year
of a protocol.
IACUC Protocol Form for Use of Animals in Field Research
The protocol application form must be used for new proposals and for continuations after the third year
of a protocol involving field studies.
IACUC Annual Protocol Review/Protocol Termination Form
It is also used for annual review of previously approved protocols continuing into years two and three
or to inform the IACUC when a protocol is closing. The new protocol process must be followed when
an activity will continue beyond the third year.
IACUC Amendment Form
This form is used to seek IACUC approval of significant and minor modifications to previously
approved protocols. For a description of significant and minor modifications, see Section 2.4.7.
IACUC Off-Campus Site Application Form
This evaluation form is used for all Off-Campus Site activities requiring approval, as described in
Section 3.1.
IACUC Protocol Form for Custom Antibodies
This evaluation form is used for projects involving the use of custom antibodies.
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Animal Care and Use Personnel Training and Orientation Record
This form is completed for each individual engaging in animal research as identified by the Principal
Investigator.
IACUC Member Traning and Oreintation Checklist
This checklist is used when appointing new IACUC members.
All forms can be found on the Division of research website at
http://www.clarkson.edu/dor/compliance/animal_subjects.html.
IACUC Protocol Form for Use of Animals in Research
IACUC Protocol Form for Use of Animals in Field Research
IACUC Annual Protocol Review and Protocol Termination Form
IACUC Amendment Request Form
IACUC Off-Campus Site Application Form
IACUC Protocol Form for Custom Antibodies
Animal Care and Use Personnel Training and Orientation Record
3.7
Procurement of Vertebrate Animals
Animals must be purchased or otherwise acquired from an approved commercial supplier. No animals
may be purchased without an IACUC approved animal use protocol. Investigators with specific
requests for animals from non-approved sources must submit a justification for their use in the animal
use protocol submission, or via a modification form for already approved protocols. All requested
purchases of species must be placed in accordance with Clarkson University’s procurement procedures
and must correspond to a current IACUC approved protocol.
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Section 4: Training and Instruction
4.0 CITI Program Training
Clarkson is a member of the Collaborative Institutional Training Initiative (CITI) at
https://www.citiprogram.org/aboutus.asp?language=english and offers training instruction to scientists,
animal technicians, and other personnel involved in animal care, treatment, or use. The CITI Lab
Animal Welfare course offers basic courses for Investigators, students, staff, and IACUC members,
including specialized species or model specific courses. Topics include, but not limited to:
Basic course for Investigators, students, staff
 Introduction to Working with the IACUC
 Working with the IACUC
 Federal Mandates
 The Veterinary Consultation
 Getting Started
 Alternatives
 Avoiding Unnecessary Duplication
 Personnel Training and Experience
 Occupational Health and Safety
 Using Hazardous and Toxic Agents in Animals
 Euthanasia
 Using Explosive Agents in the Animal Facility
 Making Changes after You Receive Approval
 Reporting Misuse, Mistreatment, or Non-Compliance
IACUC Member Course
 Introduction to Essentials for IACUC Members
 Responsibilities of the IACUC and IACUC Members
 The Members of the IACUC
 The IACUC, the CEO, and the Institutional Officer
 Authority of the IACUC
 Conducting IACUC Business–The Quorum
 Procedures for Reviewing Protocol Forms
 Outcomes of Animal Protocol Reviews
 The Types of Protocol Reviews
 Documenting IACUC Actions
 The IACUC Semi-Annual Evaluation
 Performing the Facility Inspection and the Program Review
 Identifying, Documenting, and Correcting Deficiencies
 Investigating Allegations of Improper Animal Care or Use
 Maintaining the Public Trust
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4.1 IACUC Members
IACUC members will be required to complete the IACUC Member Course and any applicable CITI
Program courses and will be provided orientation materials by the Research Compliance Officer,
Institutional Officer, IACUC Chair, or the Attending Veterinarian, as necessary. Refresher training is
required every three years. In rare cases, training programs or certifications outside the CITI Program
may be accepted if deemed equivalent to CITI Program requirements and appropriate by the IACUC
Chair, Institutional Officer, or Assistant Director for Research and Compliance.
Each member is provided with a copy of the following:
1) The PHS Policy for the Humane Care and Use of Laboratory Animals;
2) The National Research Council (NRC) Guide for the Care and Use of Laboratory Animals;
3) The ARENA/OLAW IACUC Guidebook;
4) The AVMA Guidelines on Euthanasia;
5) A copy of Clarkson University’s Animal Welfare Assurance.
6) IACUC Member Resource List
4.2 Student Training
Students will be required to complete any applicable CITI Program courses and receive any necessary
one-on-one training prior to engaging in animal research. Refresher training is required every three
years.
4.3 Personal Qualifications and Protocol Specific Training
All personnel performing procedures using animals must be identified in the Institutional Animal Care
and Use Protocol. A description of each individual’s qualifications, experience and/or training with
the specific animal species, model and procedures must be provided for IACUC review. Any person
needing additional protocol-specific training will be identified during the review process and such
required training will be a condition of approval of the protocol.
4.4 Orientation
All persons involved in animal care and use will be required to attend an orientation seminar given by
the IACUC Chair, Consulting Veterinarian, or other qualified individual(s), which covers the laws and
regulations covering laboratory animal care and use with an emphasis on the contents of the NRC
Guide and the 3R’s. The training includes training or instruction on research or testing methods that
minimize the numbers of animals required to obtain valid results and limit animal pain or distress as
well as other requirements, as applicable, that are delineated in 9 CFR, Part 2, Subpart C, Section
2.32(c).
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4.5 Species and Technique Specific Training
Individual researchers will provide species- and technique-specific training to students and other
personnel, on an as-needed basis. Specifically, Training for the specific species of zebrafish will be
provided by Zebrafish Facility Manager/Principal Investigator, including appropriate handling and care
instructions. Additional reference for handling and care of zebrafish will be provided in the Zebrafish
Handbook which is a standard manual detailing protocols related to this subject. Zebrafish will be
used solely for embryo production and there are no procedures that cause pain or distress to the
animals.
4.6 Specialized Training Sessions
Special training sessions will be arranged when requested by the IACUC Chair,
Attending Veterinarian, Institutional Officer, Research Compliance Officer, or researcher.
The Research Compliance Officer and Attending Veterinarian will offer specialized training during
IACUC meetings on various topics related to the care and use of animals in research, as needed.
Topics that may be covered include federal regulations and policies, Clarkson and IACUC policies and
procedures, animal handling techniques, and euthanasia techniques, and aseptic surgical techniques.
4.7 Consultations
The Attending Veterinarian is available for consultation with IACUC members, researchers, and
Clarkson staff via telephone, e-mail, or in person.
4.8 Environmental Health and Safety Training
Training will be available by the Institution’s Environmental Health and Safety Office on topics such
as Clarkson’s Chemical Hygiene Plan, Fire Safety, and Biosafety.
4.9 Training Documentation
Training documentation is maintained in the IACUC Office in the Division of Research; Signin/attendance logs for in-person training, IACUC meeting minutes, and CITI Program completion
reports.
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Section 5: Occupational Health and Safety Program
5.0
Administration and Management
The Environmental Health and Safety (EHS) Office is responsible for the overall management of the
Occupational Health and Safety Program for Personnel involved in the care and/or use of laboratory
animals.
5.1
Program Scope
The Occupational Health and Safety Program covers all personnel involved in animal care and/or use
of laboratory animals. The level of participation is dependent on the level of assessed risk.
5.2
Hazard Identification and Risk Assessment
The Occupational Health and Safety Program is based on hazard identification, risk assessment, and
the development of strategies to minimize identified hazards and risks. Hazard and risk assessment
begins with the Principal Investigator writing an IACUC protocol and continues during evaluation of
the protocol by the IACUC and during semiannual program reviews and facility inspections. Principal
Investigators also perform an occupational health risk assessment with new personnel that covers the
nature of exposure, any associated risks and hazards, procedures in place to alleviate those hazards and
minimize risks (see sections III.E.5. and III.E6.), and training requirements. During this assessment
personnel are informed that certain drugs and medical conditions may place them at increased risk.
Such drugs and conditions include but are not limited to steroid, allergies, cancer, chronic diseases,
pregnancy, surgical procedures, and deficiencies of the immune system. Principal Investigators consult
with the Environmental Health and Safety Manager on a case-by-case basis, as needed.
5.3
Health Histories and Evaluations
All personnel are recommended to undergo a complete physical examination by a personal physician
prior to being involved in animal care and/or use of laboratory animals. Personnel involved long-term
are encouraged to receive follow-up physical examinations on an annual basis. Personnel are
encouraged to discuss with their personal physician the occupational health risk assessment completed
with the Principal Investigator; specifically discussing the nature of exposure, common associated risks
and hazards, and procedures in place to alleviate those hazards and minimize risks, and ways to reduce
the risk associated with any existing medical conditions or medications that may place them at
increased risk.
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5.4
Common Identified Hazards and Risks
The most common identified risks and hazards for personnel involved in animal care and/or use of
laboratory animals include:
a. Zoonoses (i.e. Mycobacterium, Salmonella);
b. Animal bites and scratches;
c. Animal allergens (i.e. sensitivity to fish proteins, sea food allergy, hair, dander);
d. Chemical hazards;
e. Physical hazards (i.e. slips, trips, or falls);
f. Biological hazards, when applicable; and
g. Radioactive hazards, when applicable.
5.5
Procedure in Place to Alleviate Hazards and Minimize Risks
The minimum procedures required, as applicable, to alleviate identified hazards and minimize risks
include (see section III.E.5. for hazards and risks):
a. Training on proper animal handling techniques;
b. Following personal protective equipment (PPE) requirements;
c. Following personal hygiene requirements;
d. Washing hands after handling animals or related equipment;
e. Using disposable supplies whenever possible; and
f. Sanitizing lab work areas after animal work.
Personal protective equipment (PPE) and personal hygiene are stressed. Depending on the setting,
individuals working with animals are required to wear appropriate clothing and PPE, such as lab coats,
gloves, and protective glasses. Eating, drinking, and smoking in the animal facility or when handling
animals is prohibited. Individuals are instructed to wash hands with soap and warm water prior to
leaving animal facility or after handling animals. In the event that bites and scratches occur, they are
immediately washed with antiseptic soap and water. If bites or scratches are severe, medical attention
is sought immediately.
Training specific to the species and the technique is provided to each individual by the Principal
Investigator, along with an occupational health risk assessment, CITI Program on-line lab animal
welfare course, and orientation seminars, as described in section G. Occupational health risk
assessments may result in additional assigned training, such as general lab safety, biosafety, chemical
safety, and radiation safety, provided by the University Environmental Health and Safety Office.
Specific to the Zebrafish Facility, Clarkson has adopted Oregon State University’s occupational health
for animal handling and care and use of zebrafish guidelines. The basis for Oregon State University’s
expertise is due to a number of researchers working with zebrafish as well as the home of Zebrafish
International Resource Center (ZIRC). This center supplies the community with fish, probes, and
antibodies. Topics include, but not limited to: Potential Zoonotic Diseases, Mycobacterium,
Aeromonas spp, Other Bacteria and Protozoa, Allergic Reactions, and How to Protect Yourself.
Additional procedures and oversight are provided by Environmental Health & Safety in the
institutional policies and procedures, such as: Clarkson University Chemical Hygiene Plan, Personal
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Protective Equipment Program, Hazard Communication, Emergency Response, Fire Safety, Radiation
Safety, and Biosafety. All laboratories are provided with a copy of the Chemical Hygiene Plan, which
includes our written policies on the topics mentioned above. The EH&S Office works with all
Principal Investigators (PI) to ensure they are provided the appropriate training and they have the
ability to train their staff and students on the specific hazards in their Laboratory.
Clarkson University’s Environmental Health & Safety Program also has a laboratory audit program to
ensure procedures are properly carried out by all laboratory personnel. Staff perform audits twice per
academic year.
5.6
Immunizations
Personnel directly involved with animals are recommended to have a current tetanus vaccination
(within 10 years). Student workers are referred to the Student Health Center and employees are
referred to their personal physician. Other immunization recommendations are on a case-by-case-basis.
5.7
Precautions taken During Pregnancy, Illness, or Decreases
Immunocompetence
Discussion of the health risk associated with, illness, pregnancy, or compromised immune system (e.g.,
cancer, chemotherapy, radiation, steroid use, immunosuppressive drugs after organ transplant) takes
place during the occupational health risk assessment and training. Personnel are advised during
training that if they are planning to become pregnant, are pregnant, are ill, or have impaired
immunocompetence that they should consult their personal physician regarding such conditions and
how they might pertain to their working with laboratory animals. If warranted, any work restrictions
and/or accommodations are coordinated among the individual, his/her personal physician, human
resources, etc.
5.8
Provisions for Personnel Not Involved in Animal Care and/or Use
Personnel who are not involved in animal care and/or use but need to enter areas where animals are
housed or used are briefed on appropriate precautions and provided any appropriate PPE, prior to
entering for a limited amount of time. Custodial and maintenance personnel are trained in laboratory
safety to recognize and protect themselves against chemical, biological, and radiological hazards, as
necessary.
5.9
Procedures for Treatment in the Event of Bites, Scratches, Illness or Injury
In the event of bites, scratches, illness or injury basic first aid kits are readily available in all animal
care facilities and laboratories where animals are utilized and on-site during field studies. Students and
employees requiring medical attention are sent to the Student Health Center or to their personal
physician, respectively. If injury or illness is serious, or after business hours, individuals are sent to
the local hospital emergency room for treatment. For life threatening injuries, 911 is immediately
called.
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5.10 Procedures/Program for Reporting and tracking Injuries and Illnesses
All work related injuries and illnesses must be reported to the Animal Facility Manager and the Office
of Risk Management. The Office of Risk Management provides reporting of job-related illness and
injuries to the University, and maintains records for state and federal regulatory agencies. The Office
of Risk Management reviews all injury and illness reports and investigates accidents. Compiled report
data is used to devise methods and improve safety procedures, as needed. The data also enables us to
follow injury incidence patterns over time and to identify areas needing improvements.
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Section 6: Institutional Program Evaluation and Accreditation
6.0 Program and Facility Evaluations
All of this Institution's programs and facilities (including satellite facilities) for activities involving
animals have been evaluated by the IACUC within the past six months and will be re-evaluated by the
IACUC at least once every six months thereafter, in accord with the PHS Policy IV.B.1-2. Reports
have been and will continue to be prepared in accord with the PHS Policy IV.B.3. All IACUC
semiannual reports will include a description of the nature and extent of this Institution's adherence to
the “Guide.” Any departures from the “Guide” will be identified specifically and reasons for each
departure will be stated. Reports will distinguish significant deficiencies from minor deficiencies.
Where program or facility deficiencies are noted, reports will contain a reasonable and specific plan
and schedule for correcting each deficiency. Semiannual reports of the IACUC’s evaluations will be
submitted to the Institutional Official. Semiannual reports of IACUC evaluations will be maintained by
this Institution and made available to the OLAW upon request.
6.1 Accreditation
This Institution is Category Two (2)—not accredited by the Association for Assessment and
Accreditation of Laboratory Animal Care, International (AAALAC).
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Section 7: Record Keeping Requirements
7.0 Maintaining IACUC Records
This Institution will maintain for at least three years:
1. A copy of this Assurance and any modifications thereto, as approved by the PHS.
2. Minutes of IACUC meetings, including records of attendance, activities of the committee, and
committee deliberations.
3. Records of applications, proposals, and proposed significant changes in the care and use of
animals and whether IACUC approval was given or withheld.
4. Records of semiannual IACUC reports and recommendations (including minority views) as
forwarded to the Institutional Official, the Director of Research and Technology Transfer.
5. Records of accrediting body determinations.
Records that relate directly to applications, proposals, and proposed changes in ongoing activities
reviewed and approved by the IACUC for the duration of the activity and for an additional three years
after completion of the activity.
7.1 Inspection
All records shall be accessible for inspection and copying by authorized OLAW or other PHS
representatives at reasonable times and in a reasonable manner.
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Section 8: Reporting Requirements
8.0 OLAW Annual Report
This Institution’s reporting period is January 1 – December 31. The IACUC, through the Institutional
Official, will submit an annual report to OLAW on January 31 of each year. The report will include:


Any change in the accreditation status of the Institution (e.g. if the Institution obtains
accreditation by AAALAC or AAALAC accreditation is revoked), any change in the
description of the Institution's program for animal care and use as described in this Assurance,
or any change in the IACUC membership. If there are no changes to report, this Institution will
provide written notification that there are no changes.
Notification of the dates that the IACUC conducted its semiannual evaluations of the
Institution's program and facilities (including satellite facilities) and submitted the evaluations
to the Institutional Official, the Director of Research and Technology Transfer.
8.1 Non-Compliance, Serious Deviations, and Suspensions
The IACUC, through the Institutional Official, will promptly provide OLAW with a full explanation of
the circumstances and actions taken with respect to:



Any serious or continuing noncompliance with the PHS Policy.
Any serious deviations from the provisions of the “Guide.”
Any suspension of an activity by the IACUC.
8.2 Minority Views
All reports shall include any minority views filed by members of the IACUC.
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