14 CFR 1232
CODE OF FEDERAL REGULATIONS
Effective Date August 22, 1989
Responsible Office: UL
Subject: CARE AND USE OF ANIMALS IN THE CONDUCT OF NASA ACTIVITIES
SECTION
1232.100 Scope.
1232.101 Applicability.
1232.102 Policy.
1232.103 Definitions.
1232.104 Implementation procedures by non-NASA institutions.
1232.105 Implementation procedures by NASA field installations.
1232.106 Management authority and responsibility.
1232.107 Sanctions.
AUTHORITY: 42 U.S.C. Sec. 2451; Pub. L. 89-544, as amended; 7
U.S.C. Sec. 2131; 39 U.S.C. Sec. 3001; 9 CFR Subchapter A Parts
1, 2, 3, and 4; and Pub. L. 99-158, Sec. 495.
S 1232.100 Scope.
This rule establishes the policy, implementation procedures, and
management authority and responsibility for the care and use of
vertebrate animals (hereinafter referred to as "animal subjects")
in the conduct of NASA activities.
S 1232.101 Applicability.
This rule applies to NASA Headquarters and NASA field installations
and will be followed in all activities using animal subjects that
are supported by NASA, conducted in NASA facilities, aircraft,
or spacecraft, or which involve NASA to any degree. All activities
using animal subjects conducted under a contract, grant, cooperative
agreement, memorandum of understanding, or joint endeavor agreement
entered into by NASA and another Government agency, private entity,
non-Federal public entity, or foreign entity are included within
the scope of this rule.
S 1232.102 Policy.
(a) It is NASA policy to require its laboratories and the institutions
performing NASA-supported activities using animal subjects to
comply with the Animal Welfare Act of 1966 (Pub. L. 89-544), as
amended (Pub. L. 91-579, Pub. L. 94-279, and Pub. L. 99-198),
7 U.S.C. Sections 2131 et seq., and 39 U.S.C. Section 3001, and
with the regulations promulgated thereunder by the Secretary of
Agriculture (9 CFR Subchapter A Parts 1, 2, 3, and 4) pertaining
to the care, handling, and treatment of animal subjects held or
used for research, testing, teaching, or other activities supported
by the Federal government. Investigators shall follow the guidelines
described in the National Institutes of Health (NIH) Publication
No. 85-23 (Rev. 1985), "Guide for the Care and Use
of Laboratory Animals" (the Guide) or subsequent
revisions. Attention is called to the U.S. Government "Principles
for the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training" on pp. 81-83 of the Guide. In order
to implement these guidelines and principles, investigators will
comply with the revised Public Health Service (PHS) Policy on
Humane Care and Use of Laboratory Animals (hereinafter referred
to as PHS Policy) effective November 1, 1986.
(b) This rule authorizes NASA to have the same authority for NASA-supported
programs as that delegated to PHS by the PHS Policy, including
the functions and responsibilities of the Animal Care and Use
Committees (ACUC's).
(c) All research supported by NASA that involves activities using
animal subjects shall be conducted under protocols that conform
to this rule and that are reviewed and approved as prescribed
in this rule.
S 1232.103 Definitions.
The following definitions of terms comply with the PHS Policy
and apply to the conduct of all NASA activities related to the
care and use of animal subjects.
(a) "Activity" includes research, testing of hardware
for animal use, flight experimentation, and any other tasks involving
the use of animal subjects.
(b) "Animal" is any live vertebrate animal.
(c) "Animal Care and Use Committee" (ACUC) is the committee
established at each institution and NASA field installation involved
in research with animal subjects. It is responsible for evaluating
the care and use of animal subjects at the facility and for ensuring
that the care and use of animal subjects at the facility is in
compliance with this rule and PHS Policy.
(d) "Authorized NASA Official" is the Director, Life
Sciences Division, NASA Headquarters, or designee, who is the
NASA Administrator's representative and is responsible for all
NASA activities involving animal subjects. This individual is
responsible for implementation of the provisions of this rule
and for ensuring that agency programs involving animal subjects
comply fully with all applicable laws, regulations, and guidelines.
(e) "Field Installation Director" is the Director of
a NASA Field Installation, or designee, who is the institutional
official responsible for the care and use of animal subjects in
research conducted at that field installation and for ensuring
compliance with this rule at that field installation.
(f) "Investigator" is any person who uses or proposes
to use live animal subjects in NASA-supported activities, e.g.,
receives funds, salaries, or support under a grant, award, agreement,
contract, or direct employment by NASA, or the use of any NASA
facilities, aircraft, or spacecraft for the purpose of carrying
out research, tests, or experiments using animal subjects.
(g) "PHS Assurance" is a document prepared by an awardee
institution assuring its compliance with PHS Policy.
(h) "Research or Flight Program Manager" is the NASA
Headquarters manager of each program in which NASA has a manifest
interest.
(i) "Supported" pertains
to activities either funded in part or in whole by NASA or an
approved activity that is not funded by NASA but that utilizes
NASA facilities, including spacecraft and aircraft.
(j) "Veterinarian" is the NASA attending veterinarian,
a person who has graduated from a veterinary school accredited
by the American Veterinary Medical Association's Council on Education
or has a certificate issued by the American Veterinary Medical
Association's Education Commission for Foreign Veterinary Graduates,
has received training and/or experience in the care and management
of the species being attended, and who has direct or delegated
authority and responsibility for activities involving animal subjects
at the NASA field installation.
S 1232.104 Implementation procedures by non-NASA institutions.
(a) Proposal Information. No animal subjects may be utilized unless
a proposal justifying and describing their use is submitted to
NASA for approval. The required proposal information is outlined
in the PHS Policy (IV.D.l.a.-e.).
(b) Proposal Approval by the Institutional ACUC. Before a proposal
for research involving the use of animal subjects will be considered
for NASA support, the NASA Headquarters Research or Flight Program
Manager must receive a statement that the research has been reviewed
in accordance with the PHS Policy (IV.C.) and approved by the
appropriate ACUC at the participating institution.
(c) Proposal Approval for Flight Experiments. In addition to the
institution's ACUC review, activities involving animal subjects
to be flown on NASA spacecraft will be subject to review and approval
by the Ames Research Center (ARC) ACUC. The ARC ACUC will submit
each evaluation report to the ARC Director who will transmit the
report with his/her recommendation to the Authorized NASA Official,
NASA Headquarters. Animal activities to be flown onboard NASA
manned spacecraft may also be subject to review by the Human Research
Policy and Procedures Committee (HRPPC) at the Johnson Space Center
(JSC). Animal activities utilizing the facilities of any NASA
field installation are also subject to approval of that field
installation's ACUC [S1232.105 (d)].
(d) Institutions with PHS Assurance on File. The institution,
by an approved or provisionally acceptable Assurance on file at
the NIH Office for Protection from Research Risks (OPRR), Department
of Health and Human Services (HHS), assures NASA that it will
comply with the PHS Policy. The Assurance file number must be
included in the research proposal submitted to NASA.
(e) Institutions with No PHS Assurance on File. Proposals from
institutions without an approved Assurance on file with the NIH
OPRR will first be peer-reviewed for scientific merit. If the
proposed research is deemed worthy of support, NASA will arrange
for a special Assurance to be negotiated by the Director, Life
Sciences Division, NASA Headquarters. The arrangements for a special
Assurance review by NIH should be undertaken in consultation with
the NASA representative to the Interagency Research Animal Committee
(IRAC) and will be handled on a case- by-case basis.
(f) Foreign institutions must comply with the PHS Policy (see
Section II of PHS Policy) and this rule before being supported
by NASA for any activities involving animal subjects.
S 1232.105 Implementation procedures by NASA field installations.
(a) Proposal Information. The information required for proposals
involving the use of animal subjects is identical to that described
in S1232.104 (a).
(b) Proposal Approval by the NASA ACUC. Before a proposal for
research involving the use of animal subjects will be considered
for NASA support, the NASA Headquarters Research or Flight Program
Manager must receive a statement that the research has been reviewed
in accordance with the PHS Policy (IV.C.) and approved by the
ACUC at the appropriate field installation.
(c) Proposal Approval for Flight Experiments. In addition to the
Field Installation ACUC review, activities involving animal subjects
to be flown on NASA spacecraft will be subject to review and approval
by the ARC ACUC. The ARC ACUC will submit each evaluation report
to the ARC Director who will transmit the report with his/her
recommendation to the Authorized NASA Official, NASA Headquarters.
Animal activities to be flown onboard NASA manned spacecraft may
also be subject to review by the HRPPC at JSC.
(d) Approval for Use of Field Installation Facilities. The NASA
Field Installation ACUC will review and approve or disapprove
those parts of proposals that call for the use of their facilities
to conduct any activity involving animal subjects (e.g., Kennedy
Space Center or ARC Dryden facilities used to support experiments
using animal subjects). The ACUC will submit each evaluation report
to the Field Installation Director who will transmit the report
with his/her recommendation to the Authorized NASA Official, NASA
Headquarters.
(e) NASA Animal Care and Use Committees.
(3) The ACUC, through the Field Installation Director, shall
promptly provide the Authorized NASA Official with a full explanation
of the circumstances and actions taken with respect to:
(4) Reports filed under S1232.105 (h) of this rule shall include
any minority views filed by members of the ACUC.
(5) A copy of the U.S. Department of Agriculture (USDA) Annual
Report will be furnished to the Authorized NASA Official.
S 1232.106 Management authority and responsibility.
(a) Authorized NASA Official. The Authorized NASA Official is
the NASA Administrator's representative and is responsible for
all NASA activities involving animal subjects. This individual
is responsible for implementation of the provisions of this rule
and for ensuring that agency programs involving animal subjects
comply fully with all applicable laws, regulations, and guidelines.
(b) Field Installation Director. The Field Installation Director
is responsible for and has the authority to:
(c) NASA Field Installation(s) ACUC Responsibility. Each NASA
Field Installation ACUC is responsible to its Field Installation
Director for the activities described in S 1232.104 (c) and S
1232.105 (b) (c) (d) (e) and (h).
(d) Research or Flight Program Manager Responsibility. The Research
or Flight Program Manager is responsible for ascertaining the
presence of the required PHS Assurance file number for proposals
involving animal subjects received from non- NASA institutions,
and a statement of ACUC review and approval of all NASA and non-NASA
proposals involving animal subjects. No awards for activities
involving animal subjects can be made without this documentation
[see S1232.104 (b) and (d) and S 1232.105 (b)].
(e) NASA Veterinarian(s) Responsibility. NASA veterinarian(s)
have direct or delegated authority and responsibility for activities
involving animal subjects at their field installation. Such authority
and responsibilities shall include recommending approval or disapproval
of procedures involving animal subjects as a member of the ACUC,
continual monitoring of these activities, surveillance of the
health and condition of animal subjects, and reporting any observed
deviations from approved procedures involving animal subjects
to the Field Installation Director and the ACUC. In the case
of deviation from ACUC- approved practices or procedures, the
veterinarian shall have the authority to immediately halt such
procedures until they are reviewed and resolved by the ACUC.
In cases of a conflict concerning animal usage by an investigator
that cannot be resolved between him/her and the veterinarian,
the matter may be brought to the attention of the Field Installation
ACUC for review and recommendation for action as set forth in
this rule. Whereas the performance of the veterinarian's duties
can be delegated to other qualified individuals, the ultimate
responsibility rests with the veterinarian. This responsibility
extends not only to the Animal Care Facility (ACF), but also
to other locations where animal subjects are used. Other specific
areas of responsibility and authority vested in the veterinarian
are:
(f) NASA Representative to the Interagency Research Animal
Committee (IRAC). The NASA representative to the IRAC will obtain
information of all cases in which an institution's Assurance
has been revoked by the PHS. The NASA IRAC representative will
notify NASA ACUC's, Field Installation Directors, the Authorized
NASA Official, and all Headquarters Research and Flight Program
Managers so that they can determine which NASA awards involving
the use of animal subjects are affected and can take appropriate
sanctions.
S 1232.107 Sanctions.
(a) Non-NASA Institutions. Principal investigators not employed
by NASA whose activities are supported by NASA but whose activities
using animal subjects are restricted to non-NASA facilities shall
be subject to the control of their institution's ACUC and responsible
institutional official. Notification of noncompliance with this
rule shall be made either as described in S 1232.106 (f) or by
the non-NASA institution to the Director of the NASA Field Installation
through which the activity has been supported and to the Authorized
NASA Official. Any continued noncompliance may be cause for termination
of funding or support.
(b) NASA Field Installations.
/s/Richard H. Truly
Administrator
National Aeronautics and Space Administration
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Directive: NPD 8910.1
Effective Date: March 23, 1998
Expiration Date: March 23, 2003
Responsible Office: UL / Life Sciences Division
Subject: Care and Use of Animals
1. POLICY
a. NASA will conduct activities involving vertebrate animals,
recognizing its responsibility for the stewardship of the animals
and to the scientific community and society and adhering to the
ethical principles of respect for life, societal benefit, and
non-maleficence.
b. All activities to which this NPD applies will comply with
the "Public Health Service (PHS) Policy on Humane Care and
Use of Laboratory Animals"(PHS Policy) and the guidelines
in the National Research Council's "Guide for the Care
and Use of Laboratory Animals" (the Guide).
c. All NASA Centers (including Component Facilities) conducting
activities, regardless of funding source, involving animals will,
at all times, be covered by a current Animal Welfare Assurance
(Assurance) approved by the Office for Protection from Research
Risks (OPRR), National Institutes of Health.
d. All NASA Centers (including Component Facilities) conducting
activities involving animals will 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, 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. Sec. 2473(c)(1), Sec. 203(c)(1) of the National
Aeronautics and Space Act of 1958, as amended.
b. 7 U.S.C. Sec. 2131 et seq., the Animal Welfare Act of 1966,
as amended.
4. REFERENCES
a. 14 CFR Part 1232, Care and Use of Animals in the conduct
of NASA Activities.
b. U.S. Department of Health and Human Services, Public Health
Service Policy on Humane Care and Use of Laboratory Animals
(1986).
c. National Research Council, Guide for the Care and Use of
Laboratory Animals (1996).
d. 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).
e. Council for International Organizations of Medical Sciences,
International Guiding Principles for Biomedical Research Involving
Animals (1985).
f. 9 CFR Subchapter A, Parts 1,2,3, and 4, U.S. Department of
Agriculture (USDA), Animal Welfare.
5. RESPONSIBILITY
a. The Associate Administrator for the Office of Life and Microgravity
Sciences and Applications (AA for Code U) has overall responsibility
for this NPD, including the designation of the authorized NASA
official.
b. The Director of the Life Sciences Division (Code UL) will
be the authorized NASA official responsible for the following:
c. Center Directors are responsible for the following:
6. DELEGATION OF AUTHORITY
None.
7. MEASUREMENTS
Adherence to this NPD will be measured through strict implementation
of requirements outlined herein and detailed in NASA NPG 8910.
In general terms, for all NASA-sponsored research involving animals,
the requirements will include accreditation and certifications,
review and approval by the appropriate IACUC's, and specified
monitoring.
8. CANCELLATION
None.
/s/ Daniel S. Goldin
Administrator
National Aeronautics and Space Administration
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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
(see list at end). 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 non-maleficence.
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 that 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
various 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. Non-maleficence
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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Last updated February 16, 2001