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
1232.104 Implementation procedures by non-NASA institutions.
1232.105 Implementation procedures by NASA field installations.
1232.106 Management authority and responsibility.
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
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
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
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).
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.
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.
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.
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
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.
/s/ Daniel S. Goldin
National Aeronautics and Space Administration
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for the Ethical Care and Use of Animals
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.
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.
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