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NASA Ball NASA
Procedural
Requirements
NPR 8910.1D
Effective Date: February 09, 2022
Expiration Date: February 09, 2027
COMPLIANCE IS MANDATORY FOR NASA EMPLOYEES
Printable Format (PDF)

Subject: Care and Use of Animals

Responsible Office: Office of the Chief Health & Medical Officer


| TOC | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | AppendixA | AppendixB | AppendixC | ALL |

Chapter 4. NASA Specific Requirements

4.1 Introduction

NASA’s mission to explore, use, and enable the development of space for human enterprise is unique. NASA’s program of animal care and use complies with all applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines. Some aspects of NASA’s program of animal care and use implementation are specific to spaceflight, and, therefore, justified departures must be reviewed and approved by the appropriate IACUC.

4.2 Veterinary Care, Compliance, and Response

4.2.1 Veterinary responsibilities and processes are defined in Federal, state, and local animal welfare laws and regulations, policies, and guidelines. NASA has some unique aspects that require additional definition of responsibilities and processes.

4.2.2 In addition to all applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines for veterinary care, compliance, and response the Flight AV, or in their absence, the designated Duty Veterinarian shall:

a. Coordinate veterinary support during flight.

Note: The Flight AV interfaces with the Center and institution AVs where work is being conducted pre-flight and interfaces with Center and institution AVs until animals are returned to the host institution or COR post-flight for data collection.

b. Assess and respond to all animal care and use issues arising inflight.

c. Be the sole point of contact for the Mission Control Center Flight Director, Payload Developer, Payload Investigator and others on the science team, and Payload Operations and Integration Center Payload Operations Directors for all inflight animal care and welfare issues.

d. Ensure the proper storage, use, and disposal of controlled substances inflight.

e. With sole authority, intervene in and/or terminate any animal activity to ensure animal health and welfare.

f. With sole authority, direct unplanned euthanasia of animals during inflight animal research. The CVO will be notified of an unplanned euthanasia decision.

4.3 IACUC Responsibilities and Processes

4.3.1 IACUC responsibilities and processes are defined in Federal, state, and local animal welfare laws and regulations, policies, and guidelines. NASA has unique aspects that require additional definition of responsibilities and processes.

4.3.2 The Flight IACUC and Ground IACUCs both have cognizance of the entire research study and work closely together to ensure all activities are reviewed. During flight research, the Ground IACUC and Flight IACUC will be in close coordination as the flight animals will be in space and the controls at the ground facility. The authority to act will reside with the IACUC in possession of the research animals.

4.3.2.1 The Ground IACUCs shall oversee all activities occurring at their institution and be authorized to act in the event of an adverse event, noncompliance, veterinary intervention or significant modification, until handover to another ground IACUC or, with respect to flight animals, handover at the launch pad when the transport facility is integrated into the vehicle.

4.3.2.2 The Flight IACUC shall oversee all activities occurring on the launch pad, during launch, on-orbit operations, through euthanasia or return, including health check and/or handover at the receiving institution, and be authorized to act in the event of an adverse event, noncompliance, veterinary intervention or significant modification.

4.3.2.3 In the event of an adverse event, noncompliance, veterinary intervention or significant modification, the authorized IACUC shall inform any other IACUC that reviewed and approved the research proposal.4.3.3 Protocols for animal activities may need to be modified inflight as research design and procedures are refined to satisfy operational constraints or experimental variation.

4.3.3.1 When this occurs, the Flight IACUC, by Full Committee Review, Designated Member Review or Veterinary Verification Consultation, shall review and approve significant modifications to animal care and use activity prior to implementation.

4.3.3.2 Likewise, if corresponding modifications to ground activities are necessary, the responsible Ground IACUC and/or the Flight IACUC shall review and approve significant modifications to animal care and use activity prior to implementation.

4.3.4 The Flight IACUC cannot conduct in person inspections of animal facilities in space, however, the Flight IACUC shall, to the greatest extent possible, conduct the required inspections of animal facilities in space.

4.3.5 For Research Sponsored or Funded by NASA, Conducted in International Partner Facilities/Spacecraft, or Using International Partner Resources:

a. The NASA sponsored or funded PIs shall obtain a letter, prior to award initiation, from the International Partner IACUC or equivalent oversight body stating it has reviewed and approved the research to be conducted using International Partner spacecraft and/or resources and provide this letter to the CVO and, in the case of flight research, also the Flight IACUC.

b. The PI shall also obtain Flight IACUC approval for flight research

c. The CVO shall review the letter to ensure NASA’s interests for ground research.

4.4 Communication of Animal Health and Welfare

4.4.1 The health and welfare of research animals used during spaceflight are of the greatest importance to NASA for both ethical and scientific reasons. Health assessments can be conducted by trained and qualified individuals other than a veterinarian. Therefore, a mechanism for direct and frequent communication will be established to ensure timely and accurate information is conveyed to the responsible veterinarian concerning issues associated with animal health, behavior, and wellbeing, and that appropriate treatment or euthanasia is directed and administered.

4.4.2 Mission Control Center personnel shall provide realtime voice and video communication links for the Flight AV and crew to communicate to ensure animal health and welfare. Communication can be requested by either the Flight Attending Veterinarian or the crew.

4.4.3 Crewmembers may request a voice and/or video consultation with the Flight AV to discuss animal health and welfare should unexpected or critical conditions exist which warrant immediate action.

4.4.4 The Flight AV shall communicate, via the Payload Developer, or directly, when necessary, with the crew caring for research animals regarding the animals’ condition. The Flight AV may also consult with the Project Scientist, Project Manager, and PI whose research may be affected regarding the circumstances and impact of the decision.

4.5 Vertebrate Animals and Higher Order Cephalopods Section Review

4.5.1 For each grant application or contract proposal that uses animals in research, NASA requires that a VACS be submitted and reviewed. The VACS provides a justification for using animals and of the species to be used, describes animal procedures and the minimization of pain and distress, and indicates the method of euthanasia.

4.5.2 A peer review panel shall conduct a VACS Review in accordance with the process described in the OCHMO-551, Vertebrate Animals and Higher Order Cephalopods Review Process.

4.5.3 The Program Manager shall inform the CVO of the details and results of the VACS Review for proposals selected for funding.

4.5.4 When proposals have not completed a peer review process, lack a VACS, or there is insufficient information for an IACUC to determine if a research design is sound, the IACUC may:

a. Request the PI complete the VACS and submit it with their IACUC application.

b. Identify outside consultants to review the scientific design proposed.

4.6 Standard Housing Guidelines for ISS

4.6.1 Conducting animal research in space requires specialized housing that can support animal welfare in the unique environment of space (e.g., microgravity).

4.6.2 Federal, state, and local animal welfare laws and regulations, policies, and guidelines require that the AV oversee the program of animal care, including housing conditions.

4.6.3 The Flight AV shall develop OCHMO-550, Standard Housing Guidelines for the International Space Station, for the animal enclosure module for research rodents that complies, to the greatest extent possible, with the 9 CFR Ch. I, Subch. A, Pts. 1-3, the PHS Policy, and The Guide for research animals.

4.6.4 PIs sponsored or funded by NASA, conducting research in NASA funded or sponsored facilities or using NASA resources shall:

a. Comply with the OCHMO-550 to the greatest extent possible.

b. Request scientifically justified departures from the OCHMO-550 only when necessary.

4.6.5 The Flight IACUC shall review and approve departures from OCHMO-550, when sufficiently justified. Should the Flight IACUC not approve a departure, the PI and Payload Developer, may provide additional scientific justification and request, through the IO, the Flight IACUC reconsider their decision.

4.7 Photo Documentation Policy

4.7.1 NASA reviews and approves the collection and distribution of photo documentation of animal research at all of its facilities, including spacecraft and aircraft, to assure the collection is justified for scientific or operational purposes and supports animal health and welfare.

4.7.2 Photo documentation involving research animals related to the requestor’s specific function and responsibility may be obtained by authorized individuals for purposes of scientific data collection, operational verification of hardware or procedures, education, training, public outreach purposes, and animal welfare.

4.7.3 In addition to SSP 50521, Return, Processing, Distribution and Archiving of Imagery Products from the International Space Station, the following applies specifically to animal research photo/video.

a. Approval to collect photo documentation.

(1) PIs shall obtain approval from the IACUC responsible for overseeing the research prior to collection of photo documentation by submitting requests using the Photo Documentation of Animal Activities Form that describes the photo documentation to be collected, the intended use of the photo documentation, and the potential release of the images.

(2) The IACUC and CVO may, if necessary, place conditions on the collection of photo documentation.

(3) PIs, Payload Developers, and members of their teams

(a) Shall not collect unofficial or personal photo documentation.

(b) Shall use NASA assets when collecting photo documentation.

b. Archival photo documentation.

Photo documentation from NASA missions will be archived in the Life Sciences Data Archive (LSDA) website, https://lsda.jsc.nasa.gov.

c Release of photo documentation.

(1) Principal Investigators shall request new uses of photo documentation not previously approved by the IACUC by submitting requests using the Photo Documentation of Animal Activities form.

(2) Requests to use photo documentation archived in the LSDA will comply with the LSDA process.

(3) The IACUC and CVO may require, as a condition of approval, an opportunity to review, prior to their release, images that will be used in publications or presentations or that will be provided to the media.

(4) Some intended uses of images (e.g., for media reports) may require additional approvals, but in no case can images be used that have not been approved for release by the Rodent Research Data Release Board and CVO, and in some situations with the approval of the Public Affairs Office.

(5) Release of unapproved images is prohibited.

4.8 Biospecimen Sharing Program

4.8.1 A Biospecimen Sharing Program (BSP) provides an opportunity for tissues not utilized by the PI from a primary investigation to be collected and made available to other investigators. In addition to increasing the scientific return from animals used in the primary study, tissue sharing may enable other scientific questions to be answered without using additional animals, or may help investigators to refine their studies and animal number estimates for future studies, thus meeting NASA’s goals to reduce, replace, and refine the use of animals in research. A BSP is particularly valuable when research is conducted in novel environments and/or facilities (e.g., spaceflight, radiation, environmental chambers, and centrifuges).

4.8.2 Program Managers may establish BSPs for funded research.

4.8.3 PIs shall comply with Program BSP requirements.

4.9 Flight Rules and Operational Documentation

4.9.1 Flight rules and operational documentation are developed for space missions to establish rules and procedures on how specific nominal and off-nominal conditions will be addressed in order to preserve the success of the mission and experiment as well as ensure the health and welfare of the animals being used.

4.9.2 Payload Developers shall consult with the CVO during the development, design and modification of flight rules, OIPs, and other operational documentation that have the potential to impact the health and welfare of animals on spacecraft.

4.9.3 Payload Developers shall obtain approval from the Flight IACUC, Flight AV, and CVO for all Flight Rules, OIPs, and other operational documentation that have the potential to impact the health and welfare of animals on spacecraft prior to submitting to the Payload Operations Integration personnel.

4.9.4 Payload Developers shall coordinate with the program science sponsor during the development, design and modification of flight rules, OIPs, and other operational documentation that have the potential to impact the animal research science return.

4.10 Science Requirements

4.10.1 Conducting research in space, and in some specialized ground facilities, requires principal investigators, project scientists, payload developers, and/or facility personnel to work together to successfully plan and implement research in unique and constrained environments that are typically very different than standard laboratory conditions. The planning process results in numerous products designed to assure appropriate resources are in place to complete the research, verify animal welfare and safety standards will be maintained, and document how the PI’s scientific objectives will be achieved, among others.

4.10.2 PIs and Payload Developers shall consult with and obtain concurrence from the Attending Veterinarian, who will notify the CVO, and IACUC overseeing the research to be conducted on any products (e.g., science requirement documents, flight rules, launch commit criteria, operations interface procedures, facility plans, and implementation schedules.) that may impact animal health and welfare.

4.10.3 When signing and submitting the IACUC protocol, the PI is ensuring that they understand the details of the research design and that the scientific objectives are achievable.

4.11 Engineering Requirements

4.11.1 Developing hardware that can adequately perform through the rigors of launch and landing and in the space environment requires compliance with NASA engineering standards. Hardware being developed for use with animals requires additional consideration to assure animal care and welfare standards are met and maintained.

4.11.2 PHS and NASA policy require that the AV have the authority to implement the veterinary care program and to oversee the adequacy of all other aspects of animal care and use (e.g., animal husbandry, nutrition, sanitation practices, zoonosis control, and hazard containment).

4.11.3 Payload Developers who develop housing, facilities and/or experiment unique equipment that will be used for animal care and use (including specialized diets) shall consult with the appropriate AV:

a. Early in the development process to ensure animal welfare requirements and standards are met.

b. Prior to implementing changes to existing hardware (housing, facilities, and experiment unique equipment) and specialized diets.

c. For concurrence prior to submittal of plans to the IACUC for functional evaluation.

4.11.4 The AV shall keep the IACUC and CVO informed of development activities.

4.11.5 The AV and CVO shall approve changes to existing hardware or specialized diets before any use of animals is permitted in new or modified hardware.

4.11.6 Program Managers shall inform the CVO of pending hardware development.

4.12 Noncompliance, Adverse Events, and Corrective Actions

4.12.1 Federal, state, and local animal welfare laws and regulations, policies, and guidelines defines responsibilities and processes for noncompliance, adverse events, and corrective actions. In addition, OLAW and the Office of Research Assurance, per the NASA/OLAW MOU, will evaluate allegations of noncompliance with the PHS Policy in conjunction with the IACUC and IO. Spaceflight is unique in that the PI is likely unaware of unanticipated adverse events or noncompliance occurring inflight until notified by NASA. All actions will be in compliance with Federal, state, and local animal welfare laws and regulations, policies, and guidelines.

4.12.2 The AV, shall inform the CVO, IACUC and PI of any noncompliance or unanticipated adverse events.

Note: Research misconduct is governed by NPR 1080.1, Requirements for the conduct of NASA Research and Technology.

4.12.3 The authorized IACUC shall notify the other IACUCs that reviewed and approved the research proposal, IO, CVO, the Office of Research Assurance, and OLAW of noncompliance and any immediate actions taken, including suspension of the activity.

4.13 Emergency/Disaster Plan

4.13.1 Federal, state, and local animal welfare laws and regulations, policies, and guidelines require an emergency disaster plan that address possible situations that could be encountered. The Guide requires animal facilities to have a plan to address disasters and emergencies in animal facilities including failures of critical systems or any event that jeopardizes or negatively impacts animal care and use.

4.13.2 Inflight spacecraft-based research activities will be suspended during life threatening emergencies; preservation of human life takes precedent over animal care during life threatening emergency operations. In flight disasters may result in significantly delayed or no interventions for animal welfare.

4.13.3 Payload Developers shall inform the Flight AV, who will notify the CVO of life-threatening emergencies that impact animal care and use activities. If time permits plans for emergency euthanasia of all research animals on orbit will be initiated.

4.13.4 Payload Developers shall consult with the Flight AV, or in their absence, the Duty Veterinarian, during an emergency that effects on-orbit animals to develop a plan concerning animal health and welfare. Such plans will not increase risk to the crew.

4.14 Records Management

4.14.1 In accordance with NPD 1440.6, NASA Records Management, Animal Care and Use records retention requirements are documented in NRRS 1441.1, NASA Records Retention Schedules.

4.14.2 All personnel producing animal care and use records shall comply with NPD 1440.6, NASA Records Management and NRRS 1441.1, NASA Records Retention Schedules, to ensure proper maintenance, safeguarding, and disposition of animal care and use records.



| TOC | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | AppendixA | AppendixB | AppendixC | ALL |
 
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