Postapproval Monitoring Practices at Biomedical Research Facilities

Davis, Jennifer Nerissa; Greer, William G.; Banks, Ron; Philips, Blythe H; Marx, James O.

doi:10.30802/aalas-jaalas-18-000132

Cited by 4 publications

(4 citation statements)

References 14 publications

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“…Additionally, AVs typically excel in written and oral communication, equipped to effectively convey information to individuals with diverse educational backgrounds or ethnicities. Thirdly, AVs, with their professional grounding, can articulate animal welfare concerns directly and concisely [ 6 ]. Given these advantages, the inclusion of full-time AVs could be deemed essential for larger animal facilities, ensuring the well-being of animals and contributing to the enhancement of PAM activities.…”

Section: Discussionmentioning

confidence: 99%

“…In addition to a review of the protocol, one of the most important functions of the committee is to have oversight of animal activities, once approved by the IACUC. This ongoing monitoring and reporting of animal research activities, referred to as post-approval monitoring (PAM), is required, as stated in the laws governing the care and use of animals in research, instruction, and testing activities [ 6 , 7 ]. PAM is a tool that the IACUC can use to ensure that the institution fulfills its regulatory obligation for animal program oversight [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

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A survey of the impact of COVID-19 on the management of animal experiments and laboratory animal facilities in Korea

AHN,

PARK,

IHM

et al. 2024

Exp. Anim.

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The pandemic has affected the lives of people all over the world. The effects of the pandemic on laboratory animal facilities and their operations through this unusual global event are poorly understood. Here, we have applied a methodological framework of qualitative approach including semi-structured interviews to investigate laboratory animal operations in Korea and how it has shaped the on-going management and laboratory operations of such facilities. A total of fifty-two individuals, including members and administrators of the Institutional Animal Care and Use Committee (IACUC), researchers, and animal facility managers and staff, were surveyed through purposeful sampling. Survey questions explored how the pandemic impacted the IACUC and the functioning of animal facilities, and what steps to take in preparation of a future pandemic-like crisis. Our survey found evidence of an increase in animal experiments in Korea during the pandemic that correlated with increases in research funding during that period, such as for vaccine development. Also, operational challenges due to pandemic-related health issues in personnel were resolved through overtime, rather than by reducing facility operations. Moreover, a refinement of post-approval monitoring (PAM) practices was also discussed by respondents.Taken together, our study offers insights into animal facility operations during the pandemic and outlines recommendations for safeguarding operations in such future scenarios.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A survey of the impact of COVID-19 on the management of animal experiments and laboratory animal facilities in Korea

AHN,

PARK,

IHM

et al. 2024

Exp. Anim.

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“…it ensures compliance with the approved animal care strategies and identifies potential problems. 21 Based on Directive 2010/63/EU , on the protection of animals used for scientific purposes, the benefits of an effective inspection and enforcement programme can be reflected in optimal levels of noise, lighting, water quality, dust, ventilation and temperature being ensured within the facility. 22 Following a PAM inspection, the establishment is given feedback that facilitates the improvement of resource distribution/allocation, and is also reassured that appropriate standards are being met during their practices.…”

Section: Key Requirements For a Good Culture Of Carementioning

confidence: 99%

The Capability Maturity Model as a Measure of Culture of Care in Laboratory Animal Science

Amarasekara

Rathnadiwakara

Ratnayake³

et al. 2022

Altern Lab Anim

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Culture of care in Laboratory Animal Science (LAS) refers to a commitment toward improving animal welfare, scientific quality, staff wellbeing, and transparency for all stakeholders, ensuring that the animals and personnel involved are treated with compassion and respect. A strong culture of care can be established by the proactive implementation of the Three Rs, sharing best practices, caring for and respecting animals and colleagues, empowering staff, taking responsibility for our actions, and having a caring leadership. Culture of care, when established, should be evaluated continuously, in order to foster its progress and persistence. Even though several tools for assessing the culture of care within an institution have been proposed, an ultimate standard for measuring the concept is lacking. Here, we review the culture of care concept and propose the ‘Capability Maturity Model’ as a means of quantifying culture of care in the laboratory animal setting.

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“…A aprovação de projetos depende das decisões das CEUAs e esta revisão é parte do processo para obtenção dessa autorização. comissão a fim de garantir o comprometimento com o bem-estar dos animais, de forma que sua utilização seja favorável aos resultados da pesquisa, e que seu importante papel nas pesquisas seja motivador para que os envolvidos busquem adquirir habilidades cada vez mais refinadas, bem como ter ciência da importância do trabalho que está sendo realizado, considerando as premissas que justificam cada projeto específico com base em uma sólida formação científica, influenciando os resultados do trabalho de maneira positiva(MEDINA;ANDERSON, 2007).A responsabilidade da comissão não se esgota com a aprovação do protocolo de pesquisa, ao autorizar a realização do protocolo, torna-se corresponsável no que se refere aos aspectos éticos da pesquisa e é seu dever acompanhar e zelar pela realização da pesquisa da forma como foi aprovada, certificando-se de que a experimentação obedeça um padrão de tratamento digno dentro do mais amplo conceito de respeito a vida animal, incluindo certificar-se de que os animais utilizados na experimentação científica sejam submetidos à morte por meios humanitários, e em condições que envolvam o mínimo de sofrimento físico ou mental(DAVIS et al, 2019).conflitode interesse e conhecimento da legislação, assinatura do termo de confidencialidade) e do art. 6º, § § 3º e 4º, da RN nº 1 do CONCEA, os quais tratam do resguardo de sigilo, confidencialidade de suas ações e eventuais dolos."…”

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Mapeamento do modo de operação das comissões de ética no uso de animais no Brasil e as dificuldades encontradas

Borghesi,

Presgrave,

Silva

2024

Biol M Res & Tech

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Discussions about the use of the animal in experimentation have strongly contributed to the study of regulations capable of guaranteeing its use, when proven necessary, will guarantee the animal dignified treatment, ensuring its welfare. In the face of advances in science and technology, and at a time when rights and respect for animal life gained greater visibility, Law 11,794 / 2008 transformed animal welfare not only into an ethical and humanitarian issue, but also into a legal issue. The application of the law should not be impartial in relation to animal welfare and, in view of the requirements of the legislation regarding animal experimentation and in order to ensure that they are met within the established ethical standards, there was a need to create a ethics committee in the use of animals in every institution that carries out teaching and research activities involving animals, as an essential component for the evaluation, approval, control and surveillance of these activities. In view of the complexity required for its training, IACUC must be able to evaluate submitted protocols, as well as receive subsidies that enable adequate training to carry out this activity. The commission's responsibility does not end with the approval of the research protocol, when authorizing the realization of the protocol, it becomes co-responsible with regard to the ethical aspects of the research. The main objective of this work was to raise information regarding the operation of CEUAs in Brazil, so that we could answer the question of the effectiveness of this action as well as raise the difficulties encountered in the practice of the activities recommended in the legislation. The methodology used a questionnaire that was offered in an online format and through the executive secretariat of the CONCEA, forwarded to accredited institutions by the CIUCA.The results show that, despite Brazil having specific legislation that regulates animal experimentation, standardizing minimum necessary criteria is not yet a reality. By establishing a relationship between the content of the legislation and the way in which the commissions operate, we hope to a systematic uniformity that is capable of standardizing a minimum condition viable to provide a more efficient performance and aligned with ethical precepts.

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Postapproval Monitoring Practices at Biomedical Research Facilities

Cited by 4 publications

References 14 publications

A survey of the impact of COVID-19 on the management of animal experiments and laboratory animal facilities in Korea

A survey of the impact of COVID-19 on the management of animal experiments and laboratory animal facilities in Korea

The Capability Maturity Model as a Measure of Culture of Care in Laboratory Animal Science

Mapeamento do modo de operação das comissões de ética no uso de animais no Brasil e as dificuldades encontradas

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