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Responsible Conduct in Research Animal Subjects Education Module

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Responsible Conduct in Research
Animal Subjects Education Module
CopyrightВ©2002 Winona State University, P.O. Box 5838, Winona, Minnesota, 55987
Welcome to the WSU Animal Subjects Education Module
Introduction
– WSU encourages the review of this module by all WSU students,
faculty and staff engaging in research, research training,
experimentation, biological testing and related activities (including
classroom demonstrations and exhibits) involving live, vertebrate
animals on- or off-campus.
– If you have any questions about the module’s contents, contact the
Grants & Sponsored Projects (G&SP) Office at 5519 or
npeterson@winona.edu for more information.
Contents
Contents
–
–
–
–
Rationale for the Education Module
Institution-wide Application
Definitions -- Animals and Activities Covered
History
• Scientists’ Role
• Public Involvement
• Government Response
• U.S. Government Principles
– Federal Regulations
– Principle Investigator - General Responsibilities
Contents (Continued)
– IACUC
• Authority
• Members
• General Responsibilities
• Purpose of the Protocol Review
• Protocol Form
– Appeals
– Animal Subjects - Summary
– Additional Information
Rationale for the Education Module
– Regulations on the care and use of animals in research and
teaching are more complex than those covering human subjects.
There is a single “common rule” on protecting human subjects,
which is followed by 16 federal agencies. But for animal subjects,
HHS and the U.S. Department of Agriculture (USDA) have
extensive, at times, contradicting regulations.
– The regulations also require adherence to non-government issued
publications which undergo periodic revisions. Hence, the
regulations on protection of animal subjects are in a constant state
of flux.
Contents
Rationale for the Education Module (Continued)
– This Animal Subjects Education Module is designed to meet two
goals:
• To assist researchers in complying with the complex and
rapidly changing regulations on the care and use of animals.
• To provide evidence the institution has made information
about the regulations publicly available.
Contents
Institution-wide Application
– WSU’s past practice has been to apply all federal research-related
regulatory requirements to all research conducted under its
auspices, regardless of source of financial support, if any. The
HHS Office for the Protection of Research Risks has also gone on
record as saying all species must be treated uniformly institutionwide regardless of whether or not they are “regulated.”
• “Only when an institution can document that the animal care
and use program funded by a non-PHS source is entirely
separate and distinct, physically and programmatically, from
PHS-supported activities will OPRR consider its exclusion
from the Institutional Assurance. Unless there is such total
separation, OPRR cannot except the potential risks presented
to animals involved in PHS-funded research.”
Contents
Definitions - Animals and Activities Covered
– The HHS Public Health Service (PHS) defines animal as “any live,
vertebrate animal used or intended for use in research, research
training, experimentation, or biological testing or for related
purposes.” (Public Health Service Policy on Humane Care and
Use of Laboratory Animals, III. A.)
– The U.S. Department of Agriculture (USDA) defines animal as
“any live or dead dog, cat, nonhuman primate, guinea pig, hamster,
rabbit, or any other warm blooded animal, which is being used, or
is intended for use for research, teaching, testing, experimentation,
or exhibition purposes, or as a pet.” It defines wild animal as “any
animal which is now or historically has been found in the wild, or
in the wild state….includes, but is not limited to, animals such as:
deer, skunk, opossum, raccoon, mink, armadillo, coyote, squirrel,
fox, wolf.” (Title 9, Chapter I, Part 1, Sec. 1.1)
Contents
Definitions - Animals and Activities Covered
(Continued)
– The USDA regulations cover “research, testing, or teaching
procedures that involve the care and use of animals” and “any
school (except an elementary or secondary school), institution,
organization, or person that uses or intends to use live animals in
research, tests or experiments.” (Title 9, Chapter I, Part 1, Sec.
1.1)
– The USDA definition of animal excludes birds, rats, mice and farm
animals. The HHS definition does not. It covers all vertebrates,
including birds, rats, mice, fish, reptiles, amphibians, etc. The PHS
Policy does not define wild animals, but refers to the Guide for the
Care and Use of Laboratory Animals (the Guide), which states
“the basic principles…apply to the use of animals living in natural
conditions.”
Contents
Definitions - Animals and Activities Covered
(Continued)
– Most institutions across the country faced with contradictions in
the regulations, adhere to the highest standards and the policy that
ensures compliance with all the regulations. In doing so, the
institution maintains its eligibility to apply for a variety of federal
grants.
– Hence, animals refers to all vertebrates, used on or off campus,
including wildlife. Activities involving animals are covered when
the animals are used in “research, research training,
experimentation, or biological testing or for related purposes”
(PHS) and/or “research, testing, or teaching procedures…in
research, tests or experiments.” (USDA)
– There are some exceptions.
Contents
Definitions - Animals and Activities Covered
(Continued)
– Off campus, if a field study is strictly observational (USDA
defined as “does not involve an invasive procedure, harm the
animals under study, or materially alter the behavior of the animals
under study”), it is not covered by the regulations.
– Similarly, on campus, if an animal is simply on exhibit for
observation, it is not covered. But if an animal is removed from its
housing/exhibit for instructional uses or its environment is
manipulated for research or teaching purposes, it is covered.
– Students, faculty and staff are urged to seek guidance from the
WSU IACUC (Institutional Animal Care and Use Committee
described later) as to whether or not an activity is regulated.
Contents
History - Scientists’ Role
– Development of standards for the institutional care and use of
animals was not a government-driven process. In 1946, five
veterinarians at Chicago-area research institutions began meetings
that would lead, in 1950, to the establishment of the Animal Care
Panel (ACP). [The ACP eventually was renamed the American
Association for Laboratory Animal Science (AALAS).]
– In the early years of ACPs existence, there were no federal
guidelines or regulations on the care and use of animals in research
and teaching.
Contents
History - Scientists’ Role (Continued)
– In 1962, ACP applied for a National Institutes of Health (NIH)
grant to develop national, professional standards, and in 1963,
published the first Guide for Laboratory Animal Facilities and
Care, forerunner of today’s Guide for the Care and Use of
Laboratory Animals. Adherence to the Guide was voluntary.
– In 1963, ACP also appointed its first Animal Facilities
Accreditation Board. That Board eventually became the
Association of Assessment and Accreditation of Laboratory Care
(AAALAC), the only accrediting agency for animal care programs
currently recognized by HHS.
Contents
History - Public Involvement
– At the same time the Guide was being developed by scientists in
ACP, Rachael Carson published Silent Spring (1962), a book
credited with focusing the public’s attention on environmental
issues and the welfare of animals in the wild.
– Four years later, a sensational article in the nationally-circulated
Life magazine focused public attention on the welfare of animals
used in research. The cover headline was “Concentration Camps
for Dogs.” A sub-heading read “Your Dog is in Cruel Danger.”
The article described conditions found at the site of a dealer who
supplied animals to researchers with, the report claimed, “no
questions asked.” It included a picture of a dog-owner re-united
with his pet -- the identification tag of a research facility clearly
visible on the dog’s collar.
Contents
History -- Government Response
– The public outcry over the Life magazine story spurred the U.S.
Congress to pass the 1966 Laboratory Animal Welfare Act (now
simply the Animal Welfare Act) and assigned the burden of its
implementation to the USDA. The Act covers far more than
research and teaching. It also contains licensing and regulatory
requirements for breeders, dealers and exhibitors.
– HHS’s National Institutes of Health (NIH) issued their first policy
requiring institutional assurances of appropriate animal care and
use in 1971, and PHS issued its Public Health Service Policy in
1973. The PHS Policy now applies to all departments and
agencies within HHS.
Contents
History -- Government Response (Continued)
– In 1985, the Health Research Extension Act (Public Law 99-158)
urged the USDA and PHS to coordinate further regulatory
development, required institutions to establish Institutional Animal
Care and Use Committees (IACUC) to oversee activities involving
animals, and established national principles for the care and use of
animals in research and teaching.
– The U.S. Government Principles for the Utilization and Care of
Vertebrate Animals Used in Testing, Research, and Training,
established in the Act, apply to all federal agencies developing
animal subject regulations and, in essence, represent a “common”
federal regulatory policy. The nine principles are:
–
Contents
U.S. Government Principles
– I. The transportation, care, and use of animals should be in
accordance with the Animal Welfare Act (7 U.S.C. 2131 et. seq.)
and other applicable Federal laws, guidelines, and policies.
– II. Procedures involving animals should be designed and
performed with due consideration of their relevance to human or
animal health, the advancement of knowledge, or the good of
society.
– III. The animals selected for a procedure should be of an
appropriate species and quality and the minimum number required
to obtain valid results. Methods such as mathematical models,
computer simulation, and in vitro biological systems should be
considered.
Contents
U.S. Government Principles (Continued)
– IV. Proper use of animals, including the avoidance or minimization
of discomfort, distress, and pain when consistent with sound
scientific practices, is imperative. Unless the contrary is
established, investigators should consider that procedures that
cause pain or distress in human beings may cause pain or distress
in other animals.
– V. Procedures with animals that may cause more than momentary
or slight pain or distress should be performed with appropriate
sedation, analgesia, or anesthesia. Surgical or other painful
procedures should not be performed on unanesthetized animals
paralyzed by chemical agents.
Contents
U.S. Government Principles (Continued)
– VI. Animals that would otherwise suffer severe or chronic pain or
distress that cannot be relieved should be painlessly killed at the
end of the procedure or, if appropriate, during the procedure.
– VII. The living conditions of animals should be appropriate for
their species and contribute to their health and comfort. Normally,
the housing, feeding, and care of all animals used for biomedical
purposes must 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. In any case, veterinary care
shall be provided as indicated.
Contents
U.S. Government Principles (Continued)
– VIII. Investigators and other personnel shall be appropriately
qualified and experienced for conducting procedures on living
animals. Adequate arrangements shall be made for their in-service
training, including the proper and humane care and use of
laboratory animals.
– IX. Where exceptions are required in relation to the provisions of
these Principles, the decisions should not rest with the investigators
directly concerned but should be made, with due regard to
Principle II, by an appropriate review group such as an institutional
animal care and use committee. Such exceptions should not be
made solely for the purposes of teaching or demonstration.
Contents
U.S. Government Principles (Continued)
– The first principle in the legislation includes a footnote indicating
that for guidance in implementing the principles, the reader should
refer to The Guide for the Care and Use of Laboratory Animals -the Guide originally developed by the ACP. Today, both USDA
and HHS refer the the Guide as an authoritative source for
complying with their regulations. The latest edition (1996) was
created by an ad hoc committee of scientists, veterinarians and
nonscientists and produced by the Institute of Laboratory Animal
Resources, National Research Council, National Academy of
Sciences.
– In summary, today’s federal regulations were created in response
to public demand, but rely largely on self-imposed standards
created by the scientists whose activities are regulated.
Contents
Federal Regulations
– The text of the federal regulations can be found at:
• U.S. Department of Health and Human Services - Office of
Laboratory Animal Welfare (OLAW) - Public Health Service
Policy on Humane Care & Use of Laboratory Animals
(including the Health Research Extension Act (Public Law 99158 & US Government Principles) http://grants.nih.gov/grants/olaw/references/phspol.htm#USGo
vPrinciples
• U.S. Department of Agriculture – Animal & Plant Health
Inspection Service - Animal Welfare Act (Public Law 89-544,
1966, as amended, (P. L. 91-579, P.L. 94-279, P.L. 99-198) 7
U.S.C. 2131 et. seq.) published in the Code of Federal
Regulations (CFR), Title 9, Chapter 1, Sub. A, Parts 1, 2 & 3) htpp://www.aphis.usda.gov/animal_welfare/downloads/awr/aw
r.pdf
Contents
Federal Regulations (Continued)
– Both PHS and USDA also require adherence to:
• Guide for the Care and Use of Laboratory Animals - National
Research Council - 1996
http://www.nap.edu/openbook.php?isbn=0309053773
• American Veterinary Medical Association (AVMA)
Guidelines on Euthanasia – 2007
http://www.avma.org/resources/euthanasia.pdf
– Under the PHS Policy, institutions may be self-regulating and
evaluated internally by their IACUCs or they may be evaluated
and accredited by AAALAC (http://www.aaalac.org).
Contents
Federal Regulations (Continued)
– PHS Policy, the Animal Welfare Act and the Guide constantly
cross-reference each other. All three refer to following the
guidelines for euthanasia established in the most recent AVMA
Panel report.
– Both PHS and USDA require filing of assurances; providing
training for personnel; establishment of an IACUC with similar
review, inspection, reporting and recommending responsibilities;
and the authority to investigate concerns and suspend activities
involving animals.
– The Guide also calls for establishment of institutional policies,
occupational health and safety programs (PHS also calls for such
programs, but not USDA), and a disaster plan.
Contents
Principle Investigator (PI) - General
Responsibilities
– WSU faculty, students and staff engaged in research or teaching
activities with vertebrates must adhere to the four primary
regulations covering animal subjects care and use:
• Public Health Service Policy on Humane Care & Use of
Laboratory Animals (Administered by HHS)
• Animal Welfare Act (Administered by the USDA)
• Guide for the Care and Use of Laboratory Animals
• American Veterinary Medical Association (AVMA) Panel on
Euthanasia
– Deviations are allowed, however, if PIs can produce written
scientific justifications based on appropriate documentation, such
as citations of standards set forth in publications by professional
societies or articles in scientific journals.
Contents
PI - General Responsibilities (Continued)
PIs responsible for:
• Design and preparation of the research and/or teaching plan
• Submission of a Protocol for Animal Research and/or
Teaching Activities to the IACUC prior to securing animals or
initiating activities, including written justification for any
deviation from regulations and standards
• Oversight of the housing, feeding and non-medical care of the
animals
• Appropriate euthanasia and disposal of the animals
• Training of students using animals in research and teaching
• Reporting to the IACUC any changes in activities and/or any
data required by the IACUC for reporting purposes
Contents
Institutional Animal Care & Use Committee
(IACUC) - Authority
– The Institutional Animal Care and Use Committee (IACUC) is an
agent of the institution, authorized to act on its behalf.
– It reports to a designated Institutional Official who is legally
responsible for compliance with the federal regulations.
– One IACUC member is a veterinarian who provides guidance on
animal care and is responsible for directing a veterinary care
program, as dictated by the species being used, as well as
addressing possible problems in terms of animal health, behavior
and well-being. Medical care for the animals at an institution must
be available and provided by a qualified veterinarian.
Contents
IACUC - Authority
– Animals to be used in research or teaching may not be acquired
and housed on campus, nor research and teaching activities
involving animals initiated, prior to approval by the IACUC.
– Animal may only be housed in facilities that have been inspected
by the IACUC and must be housed under living conditions that
meet regulatory requirements.
– Reports of unauthorized animals housed on-campus or research or
teaching being conducted without IACUC approval will be
investigated. Unauthorized activities will be suspended until
proper approval is secured.
Contents
IACUC - Authority
– The IACUC is also authorized to investigate any concerns raised
by interested persons -- on or off-campus -- regarding the care and
use of animals in research or teaching activities. If warranted, the
IACUC may require previously approved research be
discontinued.
– Activities that have been reviewed and approved by an IACUC
may be reviewed and disapproved by officials of the institution.
However, those officials may not approve any project if it has been
disapproved by the IACUC.
Contents
IACUC - Members
– Both the USDA and PHS require the Chief Executive Officer to
appoint IACUC members with the experience and expertise
needed to oversee the institution’s animal program and inspect its
facilities and procedures. Hence, the overall membership must
have both scientific and regulatory expertise. (Specific
membership requirements appear on the next slide.)
– An IACUC may invite individuals with competence in special
scientific areas to assist them as needed. In recent years,
institutions have also designated individuals to act as compliance
facilitators for IACUCs (and other regulatory bodies) to provide
authoritative advice when there are questions on regulatory
requirements.
Contents
IACUC - Members (Continued)
– IACUCs, under PHS guidelines, must include:
• at least five members, including:
• one Doctor of Veterinary Medicine with program authority
• one practicing scientist experienced in research involving
animals
• one member whose primary concerns are in a nonscientific
area (for example, PHS suggests an ethicist, lawyer, clergy
member, etc.)
• and one individual who is not associated with the institution in
any way (nor may a member of his/her immediate family be so
affiliated)
Contents
IACUC - Members (Continued)
– According to PHS, an IACUC member may meet more than one of
the required categories, but the IACUC must still have at least 5
members.
– The USDA regulations require only 3 members, including a chair,
a veterinarian and an unaffiliated individual to represent
community interests.
– Most institutions follow the PHS five-member structure to assure
compliance with both PHS and USDA requirements. Some also
appoint alternates to ensure quorums are available on short notice.
Contents
IACUC - General Responsibilities
• review the institution’s animal care program every six months
• inspect all animal facilities (all study/activity areas) every six
months, reporting deficiencies to institutional officials and
federal agencies as required
• prepare reports for the Institutional Official and federal offices
and maintain written records of all meetings, proposals
reviewed, decisions concerning reviews, and reports from
investigators
Contents
IACUC - General Responsibilities (Continued)
• make recommendations to institutional officials concerning any
aspect of the animal care program
• review and investigate concerns involving the care and use of
animals in research or teaching and suspend or terminate
research that is not conducted in accord with federal
requirements
• review animal use protocols and/or modifications to previously
approved protocols, and approve, require modifications in or
withhold approval of all proposed activities involving animals
used in research or teaching, including the re-review of protocols
every 3 years (PHS) or annually (USDA)
Contents
IACUC - Purpose of the Protocol Review
– The IACUC’s paramount responsibility is animal care. It reviews
requests to use animals in research and teaching in that context.
When in doubt, it relies on the U.S. Government Principles for the
Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training.
– Reviews are conducted in accord with two general goals:
• Scientific reliance on live animals should be minimized.
• Pain, distress, and other harm to laboratory animals should be
reduced to the minimum necessary to obtain valid scientific
results.
Contents
IACUC - Purpose of the Protocol Review
(Continued)
– The academic quality of proposed research or teaching activities is
reviewed in the context of those two general goals. The research
plan, design and methodology are reviewed as they are related to
the protection of animal subjects -- that is, that the use of animals
is justified, that any pain and distress is justifiable and that the
animals will receive appropriate care.
– There are nine general criteria that IACUCs consider when
reviewing protocols:
Contents
IACUC - Purpose of the Protocol Review
(Continued)
•
•
•
•
Selection and justification of species
Living conditions of the animals
Justification for the use of animals
Application of the principles of replacement, reduction and
refinement
– Replacement - use of reasonably available alternative nonanimal models (mathematical models, computer
simulations, tissue cultures) if objectives can be achieved
– Reduction - use of the minimal numbers of animals
needed to produce scientifically valid results
– Refinement - use of procedures that produce the least
possible amount of pain, discomfort or distress
Contents
IACUC - Purpose of the Protocol Review
(Continued)
•
•
•
•
•
Treatment of pain and discomfort
Use of restraints
Euthanasia methods
Qualification of research personnel
Occupational health and safety
– A protocol may be reviewed by the Chair or a designated member
of the IACUC. However if any member of the committee requests
a full committee review, the IACUC must comply with the request.
A quorum must be present at the review and a majority of those
present must vote to approve or disapprove the protocol. Common
practice at WSU is to conduct full reviews on all protocols.
Contents
IACUC - Protocol Form
– PHS and USDA require protocols include:
• a complete description of the proposed use of the animals
• a description of procedures that will be used to avoid or
minimize discomfort, distress and pain, consistent with sound
research design
• a description of procedures designed to assure that discomfort
and pain or injury to animals will be limited to that which is
unavoidable for the conduct of scientifically valuable research,
and that analgesic, anesthetic and tranquilizing drugs will be
used when appropriate to minimize discomfort and pain
Contents
IACUC - Protocol Form (Continued)
– The Guide summarizes the specific elements that should be
included in a standard protocol form to facilitate IACUC review
under both sets of regulations. Note, some elements may not be
applicable to all protocols. The elements are:
• Rationale and purpose of the proposed use of animals
• Justification of the species and number of animals requested.
Whenever possible, the number of animals requested should be
justified statistically
• Availability or appropriateness of the use of less-invasive
procedures, other species, isolated organ preparation, cell or
tissue culture, or computer simulation
Contents
IACUC - Protocol Form (Continued)
• Adequacy of training and experience of personnel in the
procedures used
• Unusual housing and husbandry requirements.
• Appropriate sedation, analgesia, and anesthesia
• Unnecessary duplication of experiments
• Conduct of multiple major operative procedures
• Criteria and process for timely intervention, removal of
animals from a study, or euthanasia if painful or stressful
outcomes are anticipated
• Postprocedure care
Contents
IACUC - Protocol Form (Continued)
• Method of euthanasia or disposition of animal (must be
consistent with the AVMA report unless a deviation is justified
for scientific reasons in writing by the investigator)
• Safety of working environment for personnel
– The WSU IACUC Protocol for Animal Research and/or Teaching
Activities form is designed to include all the elements
recommended in the Guide in order to provide the IACUC with
enough information to conduct the review in accord with the two
general goals and nine criteria.
Contents
IACUC - Appeals
– An individual whose protocol request is disapproved by the
IACUC may revise and resubmit the request and/or request a
meeting with the IACUC to discuss the protocol and provide
additional documentation in support of the protocol. (Note, the
IACUC is required to have on file written scientific justifications
for any deviations from the regulations.)
– As noted earlier, activities disapproved by the IACUC cannot be
approved by other institutional officials. However, those officials
may disapprove activities approved by the IACUC.
Contents
Animal Subjects - Summary
– The regulations covering animal subjects are extensive and
complicated. They specify animal facilities’ structural and
physical requirements. For mammals, the regulations dictate what
type and size of cage and what environmental conditions are
required. When there are contradictions, the Guide defaults to the
USDA and PHS regulations and PHS recommends following the
USDA regulations.
– Specific care standards are not established for “cold-blooded”
vertebrates, such as amphibians, snakes, fish, etc. Instead, PHS
recommends defaulting to standards set by professional societies.
Contents
Animal Subjects - Summary (Continued)
– The PI is ultimately responsible for the well-being of the animals
under his/her care, even if s/he delegates their day-to-day care to
others. The IACUC is responsible for monitoring the care and use
of animals on behalf of the institution.
– The PI is also responsible for adhering to all regulatory
requirements. As a monitoring body, the IACUC can assist the PI
by providing regulatory guidance and acting as a liaison to federal
agencies when questions arise.
– The institution is ultimately responsible for the adequacy of its
own “self-regulation” and accreditation.
Contents
Additional Information
– For additional information, students, faculty and staff are
encouraged to review an online tutorial on the Office of Laboratory
Animal Welfare (PHS) web site.
• http://grants.nih.gov/grants/olaw/tutorial/index.htm
– PIs are also encouraged to contact the WSU IACUC any time they
have any questions. Inquiries may be addressed to any member of
the IACUC or to the G&SP Office, npeterson@winona.edu, ext.
5519.
Contents
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