 |
|
|
Introduction
The use of animals in research involves responsibility for stewardship
of the animals, to the scientific community and society as a whole.
Investigators, fellows, students, technicians and staff must be
aware that use of animals in research is a privilege governed by
public concerns, federal and local regulations, and Johns Hopkins
University policies. Failure to comply with the provisions of the
contract between the investigator, university and federal government
granting the privilege to use animals in research can lead to severe
sanctions for the investigator and the university. Such sanctions
include but are not limited to:
- Loss of privilege to use animals in research
- Loss of funding for animal research
- Principal Investigator being held personally responsible for
professional misconduct
- Criminal and civil penalties for the PI and/or Institution.
It is a violation of federal regulations to carry out studies in
animals without an approved protocol or to maintain animals after
expiration of a previously approved protocol.
[Return to top]
Principal Investigator Responsibilities
- Abiding by all approved protocol terms
- Training personnel involved in their projects
- Ensuring personnel involved in their projects are enrolled in
the Occupational Health program
- Providing a safe working environment
- Record keeping
[Return to top]
Resources Available to Investigators
Comparative Medicine has a wide variety available to investigators
at Johns Hopkins University including:
- Veterinary consultation
- Model selection and development, surgery, anesthesia and pathology
services.
- Research collaboration
- Seminars and lectures
- Reference library
- Books, journals, videos, slides and audio tapes
- Training materials
There are also a number of core
facilities that investigators can tap into including
[Return to top]
Johns Hopkins University Animal Welfare
Assurance
No activity involving animals may be conducted or supported by the
Public Health PHS until the institution conducting the activity
has filed a written Animal Welfare Assurance Statement of Compliance
with the Office
of Laboratory Animal Welfare (OLAW), National Institutes of
Health. Our assurance is applicable to all activities involving
live vertebrate animals by Johns Hopkins University faculty on staff
at any location.
The Johns Hopkins University’s assurance with OLAW stipulates our
commitment to quality care and use of animals. The assurances specifies
our institutional responsibilities which include defining lines
of responsibility and authority, monitoring animal care and use,
providing veterinary care, record keeping, appropriate environment
and housing of animals, personnel training, establishing an appropriate
occupational health and safety program. We use the Guide
for the Care and Use of Laboratory Animals (Guide) as a basis
for developing and implementing our institutional program for activities
involving animals.
Johns Hopkins University internal guidelines are set forth in
the document entitled Use
of Experimental Animals at the Johns Hopkins University. All
individuals working with animals at Johns Hopkins University should
be familiar with the handbook
Use of Experimental Animals at Johns Hopkins University. This
handbook describes the laboratory animal program within Johns Hopkins
University, provides a list of contacts, dosages of commonly used
drugs including anesthetics, analgesics and tranquilizers and a
list of useful publications.
The Institutional Animal Care and use Committee (IACUC) monitors
our animal use program as mandated by the PHS Policy and Animal
Welfare Act (AWA).
Individuals should be aware of their individual and collective
responsibilities for compliance with laws and regulations pertaining
to animal care and use.
[Return to top]
Ethical treatment of animals
The following principles should be observed in the conduct of
humane animal based research: respect for life, societal benefit
and non-malfeasance. Moreover, preventing pain and distress results
in improved experimental results. Further, pain and distress can
drastically alter the physiologic state of animals. Animals in distress
are no longer able to adapt to changes in their environment or physiologic
condition, displaying unpredictable maladaptive or abnormal responses,
which represents an uncontrolled experimental variable. For these
reasons, it is critical that individuals working with animals are
knowledgeable in the appropriate animal handling, care and use procedures.
Continued concern by the public and scientific organizations over
humane care and use of animals has resulted in the creation of laws
requiring animals used in research, testing and teaching to be cared
for according to specific guidelines.
[Return to top]
Regulatory Framework for Animal Research
Public Concerns
Animal research activity is strongly influenced by public
opinion and is subject to public scrutiny though the Freedom of
Information Act. Laws and regulations governing use of animals
in research most often are passed in response to public outcry.
In 1966, a Dalmatian named Pepper disappeared from her backyard
in Pennsylvania and was subsequently tracked by the owners to
a New Year City Hospital where the dog had been used in a study
and euthanized. The subsequent investigation of the incident by
a U.S. Congressman and an article in Life magazine resulted in
a bill from the Senate Commerce Committee that was passed by the
Senate and signed into law by President Johnson on August 24,
1966 and became Public Law 89-544, the Animal Welfare Act (AWA)
of 1966.
Real and perceived abuse of animals can be a powerful force.
Several types of research have been shut down due to public pressure.
There are multiple organizations and individuals opposed to use
of animals in research. Johns Hopkins University maintains active
membership of pro-research organizations, which can provide you
with important information:
[Return to top]
Twenty-Eight Hour Law of 1873
The Twenty-eight hour law was the first federal law protecting
animals against cruel or abusive treatment. This law was intended
to insure that livestock being transported by railroad to market
would be rested and watered at least once every 28 hours during
their journey.
Animal Welfare Act
The AWA
(7 U.S.C. 2131 et. seq.) enacted in 1966 and amended
in 1970, 1976, 1985, and 1990, is the principal Federal statute
governing sale, handling, transport and use of animals. The United
States Department of Agriculture (USDA), Animal and Plant Health
Inspection Service (APHIS), Animal
Care branch implements the AWA. The regulations implementing
the AWA are published in the Code
of Federal Regulations, Title 9 Subchapter A, Parts 1, 2, and
3 and are summarized in the Animal
Care Factsheet. These regulations address standards for housing,
husbandry, sanitation, veterinary care, minimization of pain and
distress, consideration of alternatives to procedures causing
pain and distress, IACUC functions, record keeping, personnel
training, exercise for dogs and psychological well-being of primates.
The AWA applies to all species of warm blooded vertebrate animals
used for testing, research, or teaching, excluding horses not
used for research, farm animals used for agricultural research,
birds, rats of the genus Rattus and mice of the genus
Mus bred for research. Considerations are under way to
cover rats, mice and birds under the AWA.
Johns Hopkins University is registered with the USDA as a research
facility. We report annually to the USDA the status of our compliance
with the AWA and the number of animals used in testing, research
and teaching. USDA Animal Care Inspectors conduct unannounced
inspections to monitor compliance with the AWA regulations. Significant
or repeated violations of the AWA may result in fines or other
enforcement actions. Non-compliance with the AWA can lead to severe
criminal and civil penalties for the investigator and Johns Hopkins
University.
[Return to top]
Animal Facilities and Husbandry
Federal regulations require that our facilities and husbandry
practices promote animal wellbeing and protect the health and
safety of personnel. Facilities are inspected daily on a rotating
basis by the veterinary staff, every six months by the IACUC and
unannounced by USDA Animal Care Inspectors. Special emphasis is
paid to:
- Daily observation and care of animals, including weekends
and holidays.
- Husbandry including food, water, bedding, sanitation, waste
disposal and pest control.
- Animal identification, genetic monitoring and animal health
records.
- Physical and social environment of the animals.
- Facility location, components, construction, management and
operation.
Veterinary Care
To provide quality care our veterinary and animal care staff need
access to all animals for evaluation of their health and well
being. Veterinary care includes provision of appropriate animal
husbandry, nutrition, sanitation practices, zoonosis control,
hazard containment, animal procurement and transportation. We
have a preventive medicine program in place to ensure freedom
from and control of infectious disease. Our veterinarians provide
emergency weekend and holiday care to treat diseases and injuries.
Pre-surgical planning, post-surgical care and training consultations
are available (410-955-3273). Our statement of assurance animal
welfare compliance requires the practice of relief from pain and
timely euthanasia. All drugs must be stored and maintained appropriately.
Expired drugs must be clearly labeled, separated from in date
drugs and discarded.
Pain and distress
Painful procedure in animals means any procedure resulting
in pain in excess of that caused by injections or other minor
procedures. Any procedure that causes pain and or distress to
humans is assumed to do the same in animals. Animals exhibiting
signs of pain, discomfort, or distress such as decreased appetite
and/or activity level, adverse reactions to touching inoculated
areas, open sores or necrotic skin lesions, abscesses, lameness,
conjunctivitis, corneal edema, and photophobia are expected to
receive appropriate relief unless written scientific justification
is provided in the animal activity proposal and approved by the
IACUC.
[Return to top]
Public Health Service
Policy
The Health Research Extension Act of 1985 (Public
Law 99-185) directs the Secretary of Health and Human Services
to establish guidelines for proper care and treatment of animals
used in research, and for organization and operation of the IACUC.
These guidelines contained in the PHS
policy address appropriate use of tranquilizers, analgesics,
anesthetics, paralytics, euthanasia, pre-surgical and post-surgical
veterinary medical and nursing care for animals, training in methods
to limit animal and animal distress, record keeping and for an
Animal Welfare Assurance statement of compliance. Significant
problems with animal care must be reported to the OLAW. Failure
to correct violations can result in suspension or revocation of
research funding, suspension of research privileges, as well as
civil and criminal sanctions.
PHS policy applies to all live vertebrate animals and requires
compliance with the AWA, the United States Government Principles
for the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training, the Guide and the Report of the American
Veterinary Medical Association Panel on Euthanasia.
The United
States Government Principles for the Utilization and Care of Vertebrate
Animals in Testing, Research, and Teaching was developed by
the Interagency Research Animal Committee and adopted in 1985
by the White House Office of Science and Technology Policy. As
summarized in the Guide, these principles stipulating investigator
responsibilities, mandate:
Adherence to Federal laws in transport, care and use of animals
- Design and performance of experiments with relevance to human
or animal health, advancement of knowledge, or the good of the
society.
- Use of appropriate species, quality and number of animals.
- Avoidance or minimization of discomfort, distress and pain.
- Establishment of experimental endpoints and timely euthanasia.
- Appropriate living conditions promoting health and comfort
of animals.
- Animal husbandry directed by qualified and experienced persons.
- Performing procedures on living animals by qualified or experienced
people
- Oversight by an appropriate review group such as an IACUC
[Return to top]
The Institutional Animal Care
and Use Committee
Federal regulations mandate that the Chief Executive Officer appoint
an IACUC. The IACUC is mandated to provide guidance and oversee
the university’s animal care and use program and to maintain
compliance with applicable laws, regulations and policies. The
Institutional Official, the Vice Provost for
Research, legally commits that Johns Hopkins University meets
the requirements of the AWA and PHS policy.
The IACUC executes its oversight functions through semi-annual
evaluations of the animal care program, semi-annual inspections
of facilities, and by advising the university administration on
ways to improve the animal care program including animal facilities,
personnel training and occupational health and safety program.
The committee reviews all animal use proposals and animal welfare
concerns. In event of non-compliance with federal regulations
or university policies, the committee is authorized by federal
law to suspend animal activities. The committee reports all its
activities to the Institutional Official and relevant federal
agencies.
[Return to top]
Good Laboratory Practices
Act
The Good Laboratory Practices (GLP) Act (21 CFR, Animal Care,
Non-Clinical Studies and 40 CFR, Animal and other test systems,
Clinical Studies) are used by the Food and Drug Administration
and the Environmental Protection Agency. The main concern of these
regulations is reliability of research results. These regulations
require separation of species, isolation of individual projects,
storage areas for feed, bedding, supplies and equipment. Also
required are written standard operating procedures for housing,
feeding, handling and animal care. There should be appropriate
identification of animals. Environmental records for each room
are required. GLPs require establishment of a Quality Assurance
Unit to conduct internal audits.
Studies included in GLP regulations include:
- Safety studies in animals, Mean Lethal Dose (LD50)
- Short and long term safety studies
- In vitro tests related to product safety e.g. short-term mutagenicity
- Studies of safety of regulated products on target animals
- Acute toxicity studies on a final product formulation
- Studies of a test article that are completed in fourteen days
or less
[Return to top]
State and Local regulations
State and local regulations affect use of animals in research
by controlling access to unclaimed pound animals, animal cruelty,
licensing and/or regulation of research facilities, protection
of animal research facilities and use of animals in education.
The State of Maryland prohibits release of pound animals by in-state
pounds for research use. In Maryland research institutes subject
to Federal requirements such as AWA or PHS policy are exempt from
animal cruelty laws. There is specific statutory protection to
research facilities by the State of Maryland.
[Return to top]
Non-compliance with federal regulations
The PHS policy on Humane Care and Use of Laboratory Animals identifies
three areas of non-compliance that require prompt reporting to OLAW:
a. Serious or continuing non-compliance with PHS policy
- Failure to correct situations identified in previous semiannual
evaluations as significant deficiencies.
- Conducting animal-related activities without appropriate IACUC
review and approval.
- Failure of animal care and use personnel to adhere to inst
IACUC reviewed and approved institutional policies and procedures.
b. Serious deviation form the provisions of the Guide
- Conditions that jeopardize the health or well being of animals,
including accidents, natural disasters and mechanical failures
resulting in actual harm or death to animals.
- Shortcomings in programs of veterinary care, occupational
health or training, identified during semiannual program review
and not corrected within the institutionally determined time
frame.
c. Suspension of an activity by the IACUC
- An IACUC intervention that results in the temporary or permanent
interruption of an activity involving animals.
Reports to OLAW will be forwarded by OLAW to other applicable regulatory
and/or funding agencies. Species covered by AWA will need to be
reported to the USDA. Such actions may result in internal disciplinary
action by The Johns Hopkins University.
[Return to top]
Records
Records relating to animal activities must be current, legible and
comprehensive in order to demonstrate delivery of adequate care
and convey necessary information to all parties involved in animal
care. Records should include at least:
- Identity of the animal, species, sex, age, strain, source, protocol
number and principal investigator including contact information
on animal cage cards.
- Description of procedures or manipulations performed and relevant
dates.
- Descriptions of illness, injury, distress, and/or behavioral
abnormalities and resolution of the problem
- Dates, details and results of all medically-related observations,
examinations, tests, procedures, and treatments
All records shall be maintained for at least three years. In any
case records, shall be maintained for the duration of the activity
and for an additional three years after completion of the activity.
All records shall be accessible for inspection by authorized OLAW,
PHS or other Federal representatives. Records should be available
to veterinary staff to enable appropriate clinical decisions.
[Return to top]
Copyright 2001 | All Rights Reserved | The Johns
Hopkins University and Health System
720 Rutland Avenue, Baltimore, Maryland 21205 USA
|
|
