Procedural
Requirements
Effective Date: February 09, 2022
Expiration Date: February 09, 2027
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NASA Procedural Requirements |
NPR 8910.1D Effective Date: February 09, 2022 Expiration Date: February 09, 2027 |
| | TOC | Preface | Chapter1 | Chapter2 | Chapter3 | Chapter4 | AppendixA | AppendixB | AppendixC | ALL | |
2.1.1 The CHMO has appointed the Director, Medical Policy and Ethics as the Flight IACUC IO.
2.1.2 The CHMO is responsible for appointing the Chief Veterinary Officer (CVO).
2.1.3 The Flight IACUC IO, in addition to responsibilities detailed in Section 2.6, is responsible for:
a. Appointing the Flight Attending Veterinarian (AV).
b. Establishing the Flight IACUC, with charter.
c. Coordinating appointments of Center personnel to the Flight IACUC with concurrence of the respective Center Director.
2.1.4 The Office of Research Assurance ensures compliance with all applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines. The Office of Research Assurance is responsible for:
a. 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.
b. Assessing each IACUC’s semi-annual Program Review and Facilities Inspection report and OLAW, AAALAC, and USDA reports for all facilities operated or leased by NASA, and APRB reports and submitting a summary to the IO.
c. Establishing and maintaining mechanisms to obtain timely information and notify the CVO, IACUCs, Center Directors, IOs, and Program Managers of reports of unanticipated adverse events or noncompliance with any applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines received from non-NASA institutions where animal research is supported by NASA.
d. Reviewing all corrective actions required by IACUCs, IOs, and CVO to determine if further actions are warranted and/or, at their discretion, initiating investigations of unanticipated adverse events or noncompliance with NASA policy.
2.2.1 The CVO is responsible for:
a. Coordinating the Agency’s veterinary and animal care and use activities.
b. Advising the Office of Research Assurance, on any aspect of the Agency's and its international colleague’s animal care and use programs.
c. Designating a NASA representative for the COSPAR Panel on the Use and Care of Animals in Space-borne Research.
d. Serving as Chair of the APRB.
e. Assessing each IACUC’s semi-annual Program Review and Facilities Inspection report and OLAW, AAALAC, and USDA reports for all facilities operated or leased by NASA.
f. Ensuring an appropriate review is conducted for any NASA animal activity believed to be noncompliant with all applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines, and approved protocols.
g. Reviewing all corrective actions required by IACUCs and IOs, and recommending further actions, if warranted, and/or investigations of unanticipated adverse events or noncompliance with NASA policy to the Office of Research Assurance.
h. 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, the International Council for Laboratory Animal Science, and COSPAR.
i. Informing participating international entities and individuals regarding technical requirements in accordance with all applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines, and veterinary standards, including information regarding the requirements and constraints for animal research flight activities.
j. Reviewing and concurring with newly developed hardware, modified hardware, and established hardware to ensure they meet the health, husbandry, and housing requirements of the research animal prior to its use in the flight program.
k. Assessing the Vertebrate Animals and Higher Order Cephalopods Section (VACS) as part of the VACS Review process to discuss and advise on NASA specific requirements and unique aspects of animal care and use in a microgravity environment.
l. Maintaining the Memorandum of Understanding (MOU) Between Office of Laboratory Animal Welfare, Office of Extramural Research, Office of the Director, National Institutes of Health, and National Aeronautics and Space Administration
2.3.1 The AVs are responsible for:
a. Directing the animal care and use program to ensure the health and wellbeing of all animals used in ground and inflight research.
b. Serving as a designated member of the IACUC.
c. Consulting with PIs and Payload Developers during the planning stages of any proposed research activity with the potential for pain and distress.
d. Working with the respective IACUC Chair and IO to seek and maintain AAALAC accreditation and PHS Assurance and file the required USDA annual report.
2.3.2 The Flight AV is also responsible for:
a. The care of the research animals during all flight animal research activities.
b. Designating a Duty Veterinarian who has full authority in the absence of the Flight AV.
c. Advising PIs and Payload Developers on technical feasibility regarding the ability to complete proposed flight research to ensure animal welfare and achievement of scientific objectives.
2.4.1 The NASA IACUC operates in accordance with Federal regulations, laws, and guidelines. The NASA IACUC Chair is responsible for overseeing the development, coordination, and implementation of research protocol reviews, program reviews, and facility inspections. In addition, the IACUC Chairs are responsible for:
a. Ensuring availability of all IACUC minutes to the IO and CVO.
b. Developing and submitting each IACUC’s semi-annual Program Review and Facility Inspection report to their IO and the CVO.
c. When applicable and in consultation with the IO and AV, submitting to the OLAW, the PHS Animal Welfare Assurance; committing the Center to the requirements of the PHS Policy in all Center activities involving animal use; and providing the approved assurance, the OLAW letter of approval, and any correspondence with OLAW to the CVO.
d. When applicable and in consultation with the IO and AV, seeking and maintaining AAALAC accreditation, approving the annual AAALAC reports and providing the AAALAC accreditation letter, the annual reports, and any correspondence with AAALAC to the CVO.
e. When applicable and in consultation with the IO and AV, ensuring the submission of the USDA Annual Report of the Research Facility, and providing the report, and any correspondence with USDA, to the CVO.
2.5.1 The Center Directors are responsible for:
a. Serving as the Center's IO. The IO’s duties may be delegated, in writing, to a senior level official with administrative and operational authority, however, Center Directors retain the ultimate responsibility for ensuring compliance with all applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines. See Section 2.6 for specific IO responsibilities.
b. Establishing a Center IACUC, with charter.
c. Ensuring Center personnel conducting animal research at any another research location are doing so under IACUC approved protocols.
d. Concurring on appointments of their Center’s personnel to the Flight IACUC.
2.6.1 The IOs are responsible for:
a. Establishing, supporting, and overseeing the functions of their IACUC consistent with all applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines.
b. Committing their organization to compliance with all applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines in all center activities involving animal care and use.
c. Ensuring adequate funding for their animal care and use program, AAALAC accreditation, IACUC functions, IACUC member training, and travel of APRB members to the annual meeting.
e. Appointing IACUC members, including the chair, with concurrence of the respective Center Director.
f. In consultation with the corresponding IACUC and the Office of Research Assurance, determining, administering, and reporting to the appropriate federal authorities, corrective actions associated with suspensions of animal activities, serious or continuing noncompliance or serious deviation from NASA policy or applicable Federal, state, and local animal welfare laws and regulations, policies, and guidelines.
g. In coordination with the IACUCs, submitting required reports to the OLAW, AAALAC and USDA.
2.7.1 The Program Managers who fund or sponsor animal research are responsible for:
a. Ensuring compliance with NASA Policy through verification of flight or ground IACUC protocol approval and completion of the VACS Review or other peer review.
b. Ensuring IACUC approval at the institution receiving NASA funding prior to initiating animal research.
c. Ensuring peer review and technical implementation feasibility assessments have been performed for planned flight experiments using animals, and the AV has been consulted on the assessment prior to selection of an experiment for flight.
d. Notifying the CVO of any reports of noncompliance or unanticipated adverse events with respect to their funded or sponsored animal research.
e. Ensuring this policy is incorporated into the governing contracts, grants, or agreements for activities involving the use of animals.
f. Ensuring all research performance sites hold a PHS Animal Welfare Assurance.
2.7.2 Payload Developers, via their funding mechanism, are responsible for:
a. Communicating Flight AV recommendations and directions to the onboard crew.
b. Obtaining concurrence from the Flight IACUC, Flight AV, and CVO for all Flight Rules, Operational Interface Procedures (OIP), and other operational documentation that have the potential to impact the health and welfare of animals.
c. Obtaining concurrence from the AV and IACUC overseeing the research for all science requirements documents that may impact animal health and welfare.
d. Obtaining concurrence from the AV for housing, facilities, and/or experiment unique equipment designs or changes prior to submittal to the IACUC for approval.
e. Informing the Flight AV of flight emergencies that may result in delayed or no interventions for animal welfare.
2.8.1 PIs, including civil service and non-civil service (i.e., contractors and grantees), via their governing contracts, grants and agreements, are responsible for:
a. Familiarizing themselves and complying with relevant Agency and Center/institution policies and procedures for the conduct of animal research.
b. Consulting with the relevant attending veterinarian during the planning phase of any proposed research activity with the potential for pain and distress.
c. Describing proposed use of animals in grant applications.
d. Obtaining IACUC approval prior to using animals and prior to implementing significant changes to the protocol.
e. Ensuring research is conducted according to the IACUC approved protocol.
f. Complying with institutional policies and procedures.
g. Addressing significant changes to the use of animals in progress reports.
h. Addressing changes in the care and use of animals that may be a potential change in scope, including changes in performance site.
i. Reporting to the IACUC any noncompliance or unanticipated adverse events that occur during the conduct of their research and how these issues have been addressed.
j. Implement corrective actions required by the IACUC to mitigate a noncompliance or unanticipated adverse events.
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