Ilar Journal最新文献

Globalization of the biomedical research enterprise is occurring at an accelerating pace. Increasingly, scientific collaborations and contracts cross national borders. Assurance that the caliber of animal research and animal welfare are consistent among countries and that such animal use is done in a humane and conscientious manner is of significant concern to the scientific community, the general public, and other stakeholders. Bridging these international collaborations is a clear scientific imperative for statistical validity of the data and reproducibility of results to ensure the animal use is both meaningful and impactful. One way to mitigate the potential confounding effects that the welfare of the animals may have on the research data is to harmonize animal care and use practices and procedures worldwide. By harmonizing the care and use of animals, using high standards that are internationally accepted, research animal welfare and high-quality science will be achieved.

Increasing focus on issues of research reproducibility affords us the opportunity to review some of the key issues related in vivo research. First, we set out some key definitions, to guide the reader through the rest of the paper. Next we consider issues of epistemology, of how animal experiments lead to changes in our understanding of biomedicine and, potentially, to the development of new therapeutics. Here we consider the meaning of statistical significance; the importance of understanding whether findings have general truth; and the advances in knowledge which can result from 'failed' replication. Then, we consider weaknesses in the design, conduct and reporting of experiments, and review evidence for this from systematic reviews and from experimental studies addressing these issues. We consider the impact that these weaknesses have on the development of new treatments for human disease, and reflect on the response to these issues from the biomedical research community. Finally, we consider strategies for improvement including increased use of brief, pre-registered study protocols; pre-registration, open publication and open data; and the central importance of education in improving research performance.

The scientific enterprise satisfies the innate human urge to understand the world; these efforts have led to both improvements and dangers to society. The storied history of relationships between scientists and citizens suggests that the lines between these 2 sectors of society are often blurred. Here we discuss these relationships on the context of animal welfare. We briefly outline the history of animal welfare in research, and the entry of citizens into the discussion, leading to the Animal Welfare Act of 1966. The commitment of scientists to society, in this context, is the act of whistleblowing in research. As medical and life sciences technologies continue to expand at breathtaking rates, the landscape that both scientists and citizens must navigate increases in complexity. We discuss the responsibility of both the scientist and the citizen, as members of the voting public, in the face of the challenges of the future.

This issue of the ILAR Journal focuses on the topic of responsible science as it relates to animal research. We start with the concept of the scientist as a responsible citizen and then move through multiple phases of research including careful experimental planning, reporting, and incorporation of laboratory animal science. The work of the Institutional Animal Care and Use Committee (IACUC) or animal ethical/oversight body in reviewing both animal use and contributing to scientific excellence is explored. Additional topics include protection of animal handlers from multiple experimental hazards, use of agricultural animals and wildlife studies, regulatory ambiguities, and harmonization of animal research. Rounding out the issue is a discussion of how animal care and use programs can enhance animal welfare while mitigating regulatory burden, and our responsibility to clearly communicate the ethical use of animals in advancing biomedical research. A deeper understanding of these topics can assist scientists in simultaneously advancing their research and animal welfare.

Disaster preparedness for research facilities can be a daunting task. The purpose of this review is to introduce basic preparedness concepts and terminology so that facilities may begin to develop customized plans for their specific needs. Regulatory requirements are reviewed and an overview of the Incident Command System, National Preparedness System Planning Frameworks, and fundamental terms is provided. Important concepts for successful planning are then explored. Good planning involves fostering a culture of preparedness, resilience, and understanding the interactions and partnerships with other groups that are essential for core functions and incident response. Methods to gain institutional support and set up an advisory committee are examined in detail. Next, the steps to develop and carry out a plan are outlined. Risk assessments using an all hazards approach and tools such as risk indices and risk matrices are explained, and tips to design and test plans, train personnel, and evaluate improvement are discussed. Finally, special challenges unique to animal research facilities are considered along with ways to address them. Examples and information are drawn from a wide variety of organizations both to underscore themes common to all preparedness plans and to introduce new concepts that may be adapted for use in research institutions.

Institutional Animal Care and Use Committees (IACUCs) occasionally face regulatory requirements for which clear guidance may not be available. Either the regulating body has chosen not to provide such guidance or the guidance may be minimal or even ambiguous. Such guidance may be desirable when institutions have research needs, in which case IACUCs are left to their own interpretation to develop internal policies, procedures, and documents. Typically, this is approached by an IACUC working with partners in the laboratory animal community and may involve input from regulators who can provide context as well as parameters to consider. Over time, shared institutional experiences and documentation coalesce to create a general framework that provides a baseline for others to consider as templates for further policy elaboration or development. The strength of this approach relies on the ability to share freely, including having unobstructed access to such documents.