Effective Date: May 28, 2008
Expiration Date: January 31, 2019
Administrative corrections made to address 1400 compliance, update authorities and applicable documents and incorporates administrative changes based on new/revised regulations and statutory requirements, as well as deletion of language that is no longer necessary or mandated.
a. It is NASA's policy to 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. 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. It is NASA's policy for all NASA Centers and Component Facilities that conduct activities, regardless of funding source, involving animals will 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 willl actively seek to receive and maintain accreditation
by the Association for Assessment and Accreditation of Laboratory Animal
Care International (AAALAC International).
a. 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.
b. In this directive, all mandatory actions (i.e., requirements) are denoted by statements containing the term "shall." The terms "may" or "can" denote discretionary privilege or permission, "should" denotes a good practice and is recommended but not required, "will" denotes expected outcome, and "are/is" denotes descriptive material.
a. Health Research Extension Act of 1985, as amended, Pub. L. 99-158, 99 Stat. 820 (1985).
b. Animal Welfare, 9 CFR Chapter 1, Subchapter A, Parts 1, 2, 3, and 4.
c. Care and Use of Animals in the Conduct of NASA Activities, 14 CFR Part 1232.
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).
f. 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.
g. Council for International Organizations of Medical Sciences, International Guiding Principles for Biomedical Research Involving Animals (1985) and revisions.
h. NPR 1400.1. NASA Records Management.
i. Institutional Animal Care and Use Committee Guidebook, 2nd Edition, 2002, DHHS, NIH, Office of Laboratory Animal Welfare; Applied Research Ethics National Association.
j. Occupational Health and Safety in the Care and Use of Research Animals, 1997, National Academy of Sciences Institute for Laboratory Animal Research.
(1) 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.
(2) Appointing the NASA Chief Veterinarian, reporting to the CHMO.
(3) Designating a NASA representative for the Interagency Research Animal Committee (IRAC).
(4) Designating a NASA representative for the COSPAR Panel on the Care and Use of Animals in Space-borne research.
(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 will be preserved and maintained in accordance with NPR 1441.1.
(8) Designating a NASA representative for the Interagency Research Animal Committee (IRAC).
(9) Establishing and maintaining mechanisms to notify the NASA Chief Veterinarian, NASA IACUCs, Center Directors, IOs, and Research and Flight Program Managers of reports of noncompliance with the Animal Welfare Act (AWA), PHS, and this NPR that are received from non-NASA institutions where animal research is supported by NASA.
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) Serve as the Center's Institutional Official (IO) or delegating, in writing, an IO who meets the requirements of the PHS Policy and AWA to perform the following:
(a) Establish, support, 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.
(b) 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.
(c) 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.
(d) 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.
(e) 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.
(f) 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
A.1 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.
A.2 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.
A.3 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.
A.4 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.
A.5 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.
B2. U.S. Department of Health and Human Services, Public Health Service Policy on Human Care and Use of Laboratory Animals (1986) and revisions
B3. National Research Council, Guide for the Care and Use of Laboratory Animals (1996) and revisions.
B4. 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.