Effective Date: January 30, 2019
Expiration Date: January 30, 2024
a. This directive establishes policy for the care and use of vertebrate animals and cephalopods, recognizing NASA's 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 nonmaleficence.
b. It is NASA's policy to:
(1) Comply with all applicable Federal laws, regulations, policies, and guidelines regarding the care and use of vertebrate animals and cephalods, including 9 CFR ch. 1 subch. A pts. 1-3, the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy), the Guide for the Care and Use of Laboratory Animals (The Guide), and the Policy and Guidelines for the Use and Care of Animals in Space-borne Research.
(2) Adhere to the NASA Principles for Ethical Care and Use of Animals (Appendix C).
a. This NPD is applicable to NASA Headquarters and NASA Centers, including Component Facilities and Technical and Service Support Centers. This language applies to the Jet Propulsion Laboratory (a Federally Funded Research and Development Center), other contractors, recipients of grants, cooperative agreements, or other agreements only to the extent specified or referenced in the applicable contracts, grants, or agreements.
b. This NPD is applicable to all activities involving animals funded or sponsored by NASA, conducted in or on NASA facilities, aircraft and spacecraft, and using NASA personnel or assets.
c. 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.
d. In this directive, all document citations are assumed to be the latest version unless otherwise noted.
a. The Animal Welfare Act of 1966, 7 U.S.C. § 2131 et seq.
b. The National Aeronautics and Space Act, 51 U.S.C. § 20113 (a).
c. Health Research Extension Act of 1985, Pub. L. 99-158, 99 Stat. 820 (1985).
a. Animal Welfare, 9 CFR ch. 1 subch. A pts. 1-3.
b. Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy), U.S. Department of Health and Human Services, Revised 2015.
c. Policy and Guidelines for the Use and Care of Animals in Space-borne Research, Committee on Space Research (COSPAR) Information Bulletin: Space Research Today, Number 169, August 2007.
d. Guide for the Care and Use of Laboratory Animals (The Guide), Eighth Edition, 2011, National Academy Press, Washington, DC.
e. NASA Principles for the Ethical Care and Use of Animals, Sundowner Report 1996.
a. The Chief Health and Medical Officer (CHMO), the Authorized NASA Official (ANO) for the care and use of animals, is responsible for:
(1) Delegating the duties of the ANO to an Office of the Chief Health and Medical Officer (OCHMO) senior-level official, as necessary.
(2) Ensuring all Agency programs and activities involving animals comply fully with applicable Federal laws, regulations, and guidelines.
(3) Serving as the Institutional Official (IO) for the Flight Institutional Animal Care and Use Committee (IACUC). The IO role may be delegated to a senior-level official with administrative and operational authority; however, the ANO retains the ultimate responsibility for ensuring compliance with this NASA policy and applicable Federal laws, regulations, and guidelines.
(4) Ensuring the Administrator, appropriate Mission Directorate Associate Administrators, Office of Safety and Mission Assurance, NASA General Counsel, and NASA Inspector General (when appropriate) are well-informed, through official channels, of significant actions, problems, or other matters of substance related to the exercise of this authority.
(5) Approving each Center Director's annual summary of research and IACUC activities for the preceding year.
(6) Appointing the NASA Chief Veterinarian.
(7) Appointing the NASA Flight Attending Veterinarian.
(8) Establishing the Flight IACUC, with charter, whose functions are to:
(a) Develop, oversee, and periodically evaluate the program of animal care and use for flight activities.
(b) Approve all animal activities conducted in NASA aircraft or spacecraft, or using NASA resources regardless of the source of funding.
(c) Ensure flight-related research conducted at another location is performed at facilities with programs of animal care and use that meet the requirements of this NPD and under approved IACUC protocols.
(9) Appointing, with concurrence from the Center Director of the appointee, the Flight IACUC members.
(10) Designating a NASA representative for the Committee on Space Research (COSPAR) Panel on the Use and Care of Animals in Space-borne Research.
(11) Establishing and maintaining mechanisms to obtain timely information and notify the NASA Chief Veterinarian, NASA IACUCs, Center Directors, IOs, and Program Managers of reports of noncompliance with NASA policy and applicable Federal laws, regulations, and guidelines received from non- NASA institutions where animal research is supported by NASA.
(12) Reviewing all sanctions imposed by IOs or IACUCs to determine if further actions are warranted and/or, at his discretion, initiating investigations of alleged noncompliance with NASA policy.
b. The NASA Chief Veterinarian is responsible for:
(1) Coordinating veterinary and animal activities across the Agency.
(2) Serving as Chair of the Animal Policy Review Board (APRB).
(3) Advising the CHMO on any aspect of the Agency's and its international partners' Animal Care and Use Programs.
(4) Ensuring an appropriate review is conducted for any NASA animal activity believed to be noncompliant with applicable Federal laws, regulations, and guidelines, standards, NASA policy, and approved protocols.
(5) Representing NASA in the external laboratory animal science community and associations, such as the American Association for Laboratory Animal Science, the American Society of Laboratory Animal Practitioners, and COSPAR.
(6) Maintaining coordination with the International Council for Laboratory Animal Science (ICLAS) and COSPAR.
(7) Informing participating international entities and individuals regarding technical requirements in accordance with applicable Federal laws, regulations, and guidelines, standards, and NASA policy, including information regarding the requirements and constraints for flight animal research activities.
c. The Attending Veterinarians are responsible for:
(1) Serving as members of the Center or Flight IACUC.
(2) Directing the animal care and use program to ensure the health and well-being of all vertebrate laboratory animals and cephalopods used at a Center or in flight.
(3) Advising programmatic research sponsors on technical implementation feasibility regarding the ability to complete proposed research in space to ensure animal welfare and achievement of scientific objectives.
d. The IACUC Chairs are responsible for:
(1) Overseeing the development, coordination, and implementation of protocol and program reviews and facility inspections for the IACUC in compliance with Federal laws, regulations, and guidelines.
(2) Overseeing the development and submission of required reports and documents to the IO, Office of Laboratory Animal Welfare (OLAW), United States Department of Agriculture (USDA), and International AAALAC, as appropriate.
e. The NASA Center Directors are responsible for:
(1) Serving as the Center's IO. The IO's duties may be delegated to a senior-level official with administrative and operational authority; however, Center Directors retain the ultimate responsibility for ensuring compliance with NASA policy and Federal laws, regulations, and guidelines.
(2) Establishing a Center IACUC, with charter concurred by the CHMO, whose functions are to:
(a) Develop, oversee, and periodically evaluate the program of animal care and use at the Center.
(b) Approve all animal activities conducted at their Center.
(c) Prepare program plans and annual reports as required to obtain and maintain International AAALAC accreditation, PHS Assurance, and USDA registration.
(d) Ensure Center personnel conducting animal research at another location are doing so under IACUC approved protocols.
(3) Concurring on CHMO appointments of their appointees to the Flight IACUC.
(4) Submitting an annual summary of research and IACUC activities for the preceding year to the ANO. This summary will include a review of compliance activities, initial and continuing education, and IACUC membership.
f. The Center Institutional Officials are responsible for:
(1) Establishing, supporting, and overseeing the functions of their Center's IACUC consistent with NASA policy. This responsibility may be accomplished through the use of another Center's IACUC via a formal intercenter agreement.
(2) When applicable, submitting to the OLAW the Animal Welfare Assurance, committing the Center to the requirements of the PHS Policy and NASA policy in all Center activities involving animal use, and providing the approved assurance, OLAW letter of approval, and any OLAW correspondence to the ANO.
(3) Applying for AAALAC International accreditation, approving the annual AAALAC International reports and providing the AAALAC International accreditation letter, the annual reports, and any correspondence from AAALAC International to the ANO.
(4) Ensuring funding for AAALAC International accreditation, their Center's IACUC function, training for IACUC members (Center and Flight) at their Centers, personnel on the Flight IACUC, and travel of APRB members to the annual meeting.
(5) When applicable, approving the annual report to the USDA and providing the report, and any comments from the USDA, to the ANO.
(6) Determining and administering sanctions in cases of noncompliance with NASA policy in accordance with the applicable Federal laws, regulations and guidelines, and notifying appropriate funding officials, the NASA Chief Veterinarian, and the ANO.
g. The Program Managers who fund animal research are responsible for the following:
(1) Ensuring compliance with NASA Policy through verification of flight or ground IACUC protocol approval.
(2) Ensuring IACUC approval at the institution receiving NASA funding prior to conducting animal research.
(3) Ensuring peer review and technical implementation feasibility assessments have been performed for planned flight experiments using animals, and the Attending Veterinarian has been consulted on the assessment prior selection of an experiment for flight.
h. The NASA project officials (e.g., Project Managers) are responsible for ensuring this policy is incorporated into the governing agreement (e.g., contract, grant, cooperative agreement, reimbursable agreement, public- private partnership, other transaction or other arrangement) for activities involving the use of animals.
i. Principal Investigators are responsible for complying with Agency and Center policies and procedures for the conduct of animal research and are required to familiarize themselves with Agency and Center policies and procedures for the conduct of animal research.
NPD 8910.1B, Care and Use of Animals, dated May 28, 2008.
Animal Policy Review Board (APRB) - The board established by NASA to review the NASA animal care and use policy and procedures, including this NPD. The board is composed of the NASA Chief Veterinarian as Chair; Center veterinarians, Chairs of each IACUC, other representatives of each Center or Spaceflight Programs, a public affairs/legal/legislative representative, and other experts in animal care and use, as appointed by the ANO and defined in the charter.
Animal Welfare Assurance - The document submitted by an institution to the OLAW at the National Institutes of Health ensuring institutional compliance with the PHS Policy.
Attending Veterinarian - A person who 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 is experienced in laboratory animal science and medicine, or in the care of the species being used, and who has direct or delegated authority and responsibility for activities involving animals.
Authorized NASA Official (ANO) - The NASA Administrator's representative responsible for all NASA activities involving animals. This individual is responsible for implementation of the provisions of this NPD and for ensuring Agency programs involving animals comply fully with all applicable Federal laws, regulations, and guidelines.
Office of Laboratory Animal Welfare (OLAW) - The division of National Institutes of Health responsible for overseeing implementation and enforcement of the PHS Policy on Humane Care and Use of Laboratory Animals.
Principal Investigator - A civil servant or non-civil servant (e.g., contractors and parties to agreements) researcher who has overall responsibility for all aspects of the funded and/or sponsored research project. Responsibilities for non-civil servant researchers are implemented through a contract or agreement.
Program Manager - The person designated by NASA to manage each program in which NASA has a research or payload interest. Programs may consist of several projects.
ANO - Authorized NASA Official
APRB - Animal Policy Review Board
CHMO - Chief Health and Medical Officer
COSPAR - Committee on Space Research
IACUC - Institutional Animal Care and Use Committee
ICLAS - International Council for Laboratory Animal Science
IO - Institutional Official
PHS - Public Health Service
OCHMO - Office of the Chief Health and Medical Officer
OLAW - Office of Laboratory Animal Welfare
USDA - United States Department of Agriculture
C.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.
C.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.
C.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.
C.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.
C.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.
D.1 Care and Use of Animals in the Conduct of NASA Activities, 14 CFR pt. 1232.
D.2 U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, 85 Fed. Reg. 20864 (May 20, 1985).
D.3 NPR 1440.1, NASA Records Management Program Requirements.
D.4 Council for International Organizations of Medical Sciences, International Guiding Principles for Biomedical Research Involving Animals (1985) and revisions.
D.5 American Veterinary Medication Association Guidelines for the Euthanasia of Animals: 2013 Edition, ISBN 978-1-882691-21-0.
D.6 Institutional Animal Care and Use Committee Guidebook, 2nd Edition, 2002, DHHS, NIH, OLAW; Applied Research Ethics National Association.
D.7 Occupational Health and Safety in the Care and Use of Research Animals, 1997, National Academy of Sciences Institute for Laboratory Animal Research.