Responsible Office: Office of the Chief Health & Medical Officer
1. POLICY
a. NASA shall conduct activities involving vertebrate animals, recognizing
its responsibility for the stewardship of the animals and to the scientific
community and society, in adherence with the ethical principles of respect
for life, societal benefit, and non-maleficence.
b. All activities to which this NASA Policy Directive (NPD) applies shall
comply with all applicable Federal regulations and guidelines, the "Public
Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals"
(PHS Policy), the guidelines in the National Research Council's "Guide for
the Care and Use of Laboratory Animals," and the International Council for
Science, Committee on Space Research (COSPAR) Policy and Guidelines for the
Use and Care of Animals in Space-borne Research.
c. All NASA Centers and Component Facilities that conduct activities,
regardless of funding source, involving animals shall be covered at all
times by a current Animal Welfare Assurance (AWA) approved by the National
Institutes of Health, Office of Laboratory Animal Welfare (OLAW).
d. All NASA Centers and Component Facilities that conduct activities
involving animals shall actively seek to receive and maintain accreditation
by the Association for Assessment and Accreditation of Laboratory Animal
Care International (AAALAC International).
2. APPLICABILITY
This NPD applies to NASA Headquarters and NASA Centers, including Component
Facilities, and to all activities involving animals funded by or sponsored
by NASA or conducted in or on NASA facilities, aircraft, or spacecraft.
Such activities include those conducted under a cooperative agreement or
grant, contract, reimbursable agreement, or other arrangement or agreement,
entered into by NASA and another Government agency, private entity,
non-Federal public entity, or foreign entity.
3. AUTHORITY
a. 42 U.S.C. 2473(c)(1), Section 203(c)(1) of the National Aeronautics and
Space Act of 1958, as amended.
b. 7 U.S.C. 2131 et seq., the Animal Welfare Act of 1966, as amended.
4. APPLICABLE DOCUMENTS
a. 9 CFR Chapter I, Subchapter A, Animal Welfare, Parts 1, 2, 3, and 4,
U.S. Department of Agriculture (USDA).
b. 14 CFR Part 1232, Care and Use of Animals in the Conduct of NASA Activities.
c. NPR 1440.1, NASA Records Retention Schedules.
d. U.S. Department of Health and Human Services, Public Health Service
Policy on Humane Care and Use of Laboratory Animals (1986) and revisions.
e. United States Interagency Research Animal Committee, U.S. Government
Principles for the Utilization and Care of Vertebrate Animals Used in
Testing, Research, and Training (1985) and revisions.
f. National Research Council, Guide for the Care and Use of Laboratory
Animals (1996) and revisions.
g. Council for International Organizations of Medical Sciences,
International Guiding Principles for Biomedical Research Involving Animals
(1985) and revisions.
h. Policy and Guidelines for the Use and Care of Animals in Space-borne
Research, in COSPARs Information Bulletin: Space Research Today,
Number 169, August 2007.
5. RESPONSIBILITY
a. The NASA Chief Health and Medical Officer (CHMO) has overall
responsibility for this NPD, including the conduct of regular reviews of
the implementation of the policies described in this NPD and the associated
records, and is the Authorized NASA Official for the care and use of
animals. The CHMO may delegate duties of the Authorized NASA Official to a
senior individual in the office of the CHMO. The CHMO is also responsible
for the following:
(1) Appointing the NASA Chief Veterinarian, who shall be a NASA civil
service employee, a Federal Government employee detailed to NASA, or an
employee assigned to NASA under an Intergovernmental Personnel Act
provision and reporting to the CHMO.
(2) Designating a NASA representative for the Interagency Research Animal
Committee (IRAC).
(3) Designating a NASA representative for the COSPAR Panel on the Care and
Use of Animals in Space-borne research.
(4) Implementing the provisions of this NPD and ensuring that all agency
programs and activities involving animals comply fully with all applicable
laws, regulations, and guidelines.
(5) Establishing and maintaining mechanisms for obtaining timely
information from OLAW of all cases in which the assurance of an institution
involved in NASA research has been withdrawn by the PHS; and notifying NASA
Institutional Animal Care and Use Committees (IACUCs), Center Directors,
and Research and Flight Program Managers of such revocations so that they
can determine if NASA awards involving the use of animals are affected and
take appropriate actions. The Authorized NASA Official may designate a
representative for implementing these functions.
(6) Reviewing all sanctions imposed by Center Directors or IACUC's to
determine if further sanctions are warranted or, at his or her discretion,
initiating investigations of alleged noncompliance with this NPD, and
imposing sanctions when warranted.
(7) Ensuring that all records related to implementing the provisions of
this NPD shall be preserved and maintained in accordance with NPR 1441.1.
b. Center Directors shall:
(1) Sign the Center's Assurance, making a commitment on behalf of the
Center that the requirements of this NPD will be met. Center Directors may
delegate authority for the day-to-day management of their Center's Animal
Care and Use Program, but they retain the ultimate responsibility for
ensuring compliance with this NPD, the Animal Welfare Act (AWA), PHS
policy, and the Animal Care and Use Guide at their Centers. In addition,
only Center Directors may appoint personnel to the IACUC.
(2) Establish and supervise the functions of their Center's IACUC. This
responsibility may be accomplished through the use of another Center's
IACUC via a formal intercenter agreement.
(3) Sign and submit to OLAW the Animal Welfare Assurance, committing the
Center to the requirements of the PHS policy and this NPD in all Center
activities involving animal use, and provide copies of the approved
assurance, OLAW letter of approval, and any OLAW correspondence to the
Authorized NASA Official.
(4) Sign the application for AAALAC International Accreditation and the
annual AAALAC International reports and provide copies of the AAALAC
International Accreditation letter, the annual reports, and any
correspondence from AAALAC International to the Authorized NASA Official.
(5) When applicable, sign the annual report to the Department of
Agriculture (USDA) and providing copies of the report, and any comments
from USDA, to the Authorized NASA Official.
(6) Decide on and administer sanctions and take appropriate actions in
cases of noncompliance with this NPD in accordance with the AWA, PHS
policy, and applicable NASA regulations and notify appropriate funding
officials and the Authorized NASA Official.
(7) Provide the Authorized NASA Official with copies of all IACUC minutes
and reports.
c. The NASA IACUC's shall approve any animal use conducted at their Centers.
d. The NASA Chief Veterinarian shall:
(1) Coordinate veterinary and animal care activities on an Agency wide
basis. In accomplishing this responsibility, the NASA Chief Veterinarian is
specifically authorized to suspend any animal activity believed to be
noncompliant with applicable laws, regulations, this policy, and approved
protocols. Following suspension of any activity, the Chief Veterinarian
will initiate action, including IACUC re-review, to resolve the situation.
(2) Serve as Chair of the NASA Animal Policy Review Board (NAPRB),
composed of Center veterinarians; Chairs of each Center's IACUC; other
representatives of each Center as appointed by Center Directors; and a
public affairs specialist, a legal advisor, and others, as appointed by the
Authorized NASA Official.
(3) Advise the NASA CHMO on any aspect of the Agency's and its
international partners' Animal Care and Use Programs.
(4) Represent NASA in the external laboratory animal science community and
associations, such as the American Association for Laboratory Animal
Science, the American College of Laboratory Animal Medicine, and COSPAR.
(5) Maintain coordination with the International Council for Laboratory
Animal Science (ICLAS) and COSPAR.
(6) Participate in development, review, and approval of requirements for
all animal facilities and equipment for flight, as related to animal care
and use.
(7) Inform participating international entities and individuals regarding
technical requirements in accordance with U.S. laws, regulations,
guidelines, standards, and this NPD. This will include information
regarding the requirements and constraints for flight animal research
activities.
e. The NASA project officer (e.g., Contracting Officer Technical
Representative, Project Manager, Principal Investigator) shall ensure that
this policy is incorporated, as appropriate into the governing agreement
(e.g., contract, grant, cooperative agreement, reimbursable agreement, or
other arrangement).
6. DELEGATION OF AUTHORITY
None.
7. MEASUREMENTS/VERIFICATION
Adherence to this NPD will be measured through strict tracking of
requirements outlined herein and detailed in NASA NPR 8910.1A, Care and Use
of Animals Guidelines. In general terms, for all NASA-sponsored research
involving animals, the requirements will include verification of
accreditation and certifications, regular monitoring of research activities
and sanctions imposed, and corrective actions taken.
8. CANCELLATION
NPD 8910.1A, dated January 8, 2003.
/s/ Michael D. Griffin Administrator
ATTACHMENT A: (TEXT)
NASA Principles for the Ethical Care and Use of Animals
Introduction
A strong allegiance to the principles of bioethics is vital to any
discussion of responsible research practices. As reflected in the
considerations of the National Commission for the Protection of Human
Subjects, "scientific research has produced substantial social benefits
...[and] some troubling ethical questions" (The Belmont Report, 1979). The
Belmont Report identified the key fundamental principles underlying the
ethical evaluation of research involving human subjects. Similarly, the
principles governing the ethical evaluation of the use of animals in
research must be made equally explicit.
It is generally agreed that vertebrate animals warrant moral concern. The
following principles are offered to guide careful and considered discussion
of the ethical challenges that arise in the course of animal research, a
process that must balance risks, burdens, and benefits. NASA will abide by
these principles, as well as all applicable laws and policies that govern
the ethical use of animals. It is recognized that awareness of these
principles will not prevent conflicts. Rather, these principles are meant
to provide a framework within which challenges can be rationally addressed.
Basic Principles
The use of animals in research involves responsibility, not only for the
stewardship of the animals, but to the scientific community and society as
well. Stewardship is a universal responsibility that goes beyond the
immediate research needs to include acquisition, care and disposition of
the animals, while responsibility to the scientific community and society
requires an appropriate understanding of and sensitivity to scientific
needs and community attitudes toward the use of animals. Among the basic
principles generally accepted in our culture, three are particularly
relevant to the ethics of research using animals: respect for life,
societal benefit, and nonmaleficence.
1. Respect for Life
Living creatures deserve respect. This principle requires that animals used
in research should be of an appropriate species and health status, and the
research should involve the minimum number of animals required to obtain
valid scientific results. It also recognizes that the use of different
species may raise different ethical concerns. Selection of appropriate
species should consider cognitive capacity and other morally relevant
factors. Additionally, methods such as mathematical models, computer
simulation, and in vitro systems should be considered and used whenever
possible.
2. Societal Benefit
The advancement of biological knowledge and the improvements in the
protection of the health and well-being of both humans and other animals
provide strong justification for biomedical and behavioral research. This
principle entails that, in cases where animals are used, the assessment of
the overall ethical value of such use should include consideration of the
full range of potential societal goods, the populations affected, and the
burdens that are expected to be borne by the subjects of the research.
3. Nonmaleficence
Vertebrate animals are sentient. This principle entails that the
minimization of distress, pain, and suffering is a moral imperative. Unless
the contrary is established, investigators should consider that procedures
that cause pain or distress in humans may cause pain or distress in other
sentient animals.
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