Investigators and IACUCs: integrity in animal research

描述（由申请人提供）：美国国立卫生研究院总预算的1/3以上支持实验室动物研究，很明显，动物使用是现代医学研究的主要组成部分，正确使用动物涉及重要研究规范的实施。违反这些规范构成了对研究诚信的基本破坏。机构动物护理和使用委员会（IACUC）负责与研究人员合作，确保动物使用遵循美国公共卫生署制定的指南。考虑到IACUC在监督和执行关于在研究中正确使用动物的规范方面的重要性，令人惊讶的是，很少有研究描述这些重要的监管监督委员会的运作。这些缺失的信息对于理解和加强IACUC如何履行其关键职能，帮助确保基于动物的研究的完整性，以及他们与研究者的关系如何影响研究中动物使用规范的实施非常重要。拟议的研究将描述IACUC在评估动物研究提案时关注的关键问题，以及组织差异如何影响这些决定。我们还将描述IACUCs做出决策的互动过程，包括不同参与者的角色，使用的评审方法，成员在评审中使用的信息资源，以及IACUCs对不同类型的研究提案所做的更改。该研究还将讨论IACUC和研究者之间的关系，以及这对动物研究的合作自我调节的影响。 公共卫生相关性（由申请人提供）：超过1/3的NIH资金用于使用动物的项目，因此必须由IACUC审查。有效和高效地组织动物研究审查将促进动物研究并提高研究的完整性。由于这项研究对美国卫生系统及其患者的未来至关重要，因此收集的数据必须准确，快速有效。拟议的研究是研究路径的第一步，可以产生政策和行政建议，促进IACUCs的有效和高效运作，从而促进动物研究。

DESCRIPTION (provided by applicant): With over 1/3 of the total NIH budget supporting studies with laboratory animals, it is clear that animal use is a major component of modern medical research and the proper use of animals involves the implementation of important research norms. Violating those norms constitutes a basic breach of research integrity. Institutional Animal Care and Use Committees (IACUCs) are responsible for working with investigators to see that animal use follows the guidelines established by the U.S. Public Health Service. Given the importance of IACUCs in overseeing and enforcing norms about proper uses of animals in research, it is surprising that there has been little research describing the functioning of these important regulatory oversight committees. This missing information is important to understanding and enhancing how IACUCs carry out their key function of helping to assure the integrity of animal-based research and how their relationships with investigators affect the implementation of the norms about animal use in research. The proposed research will describe the key issues that IACUCs focus on when evaluating proposals for research on animals, and how organizational differences may affect those decisions. We will also characterize the interactive processes by which IACUCs make decisions including the roles of the different participants, the method of review used, the informational resources that members use in their reviews, and the requested changes that IACUCs make on different types of research proposals. The study will also address the relationship between the IACUC and the investigators and the impact this has on collaborative self-regulation of animal research. PUBLIC HEALTH RELEVANCE (provided by applicant): More than 1/3 of all NIH funding goes to projects that make use of animals and therefore must be reviewed by IACUCs. Efficient and effective organization of animal research reviews will both facilitate animal research and improve the integrity of that research. Because this research is important to the future of the American health system and its patients, it is important that the data collected be accurate and done quickly and efficiently. The proposed research is a first step in a research path that can produce policy and administrative recommendations that will facilitate effective and efficient functioning of IACUCs and thus animal research.