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Controversy over genetically modified organisms: the governing laws and regulations. 转基因生物的争议:管理法律法规。
Pub Date : 2000-01-01 DOI: 10.1080/105294100753209174
K. L. Keatley
Genetically Modified Organisms (GMOs) are increasingly becoming a topic of controversy in the U.S. and abroad. The public is questioning their safety and wanting the products labeled as genetically modified. There are other concerns from some of the scientific world and some government officials and organizations such as the Food & Agricultural Organization (FAO) that question whether adequate research has been done to qualify GMOs as safe for long-term use. Of particular concern are the allergenic properties, a GMO may impart, possible transfer effects of antibiotic resistance (given that antibiotic resistant marker genes are used for many GMOs), the expression of previously unexpressed traits, and the drift of pollen from genetically modified crops. It has also been noted that the laws and regulations governing the biotechnology world are outdated, are not comprehensive, and span too many agencies. The primary agencies currently regulating biotechnology are the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).
转基因生物(GMOs)正日益成为美国国内外争议的话题。公众正在质疑它们的安全性,并希望这些产品贴上转基因的标签。一些科学界人士、一些政府官员和粮农组织(FAO)等组织也有其他担忧,他们质疑是否已经进行了充分的研究,以证明转基因生物长期使用是安全的。特别值得关注的是转基因生物可能带来的致敏特性、抗生素耐药性的可能转移效应(考虑到许多转基因生物都使用了抗生素抗性标记基因)、以前未表达的特性的表达以及转基因作物花粉的漂移。人们还注意到,管理生物技术世界的法律和法规已经过时,不全面,而且涉及太多的机构。目前管理生物技术的主要机构是美国农业部(USDA)、食品和药物管理局(FDA)和环境保护局(EPA)。
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引用次数: 3
Designation of a GLP facility by the Korean Ministry of Environment GLP authority: the case of the Center for Occupational Toxicology. 韩国环境部指定GLP设施:职业毒理学中心的案例。
Pub Date : 2000-01-01 DOI: 10.1080/105294100753209156
I. Yu, S. Maeng, J. Y. Lee, Y. M. Lee, H. K. Chung
In this report, the process of designating a GLP facility by the Korean Ministry of Environment (MOE) is described in detail using the case of the Center of Occupational Toxicology (COT). The COT, which had been prepared as a GLP facility, filed an application to the National Institute of Environmental Research (NIER) of the MOE. The GLP system of the COT was evaluated by a harmonized evaluation team that consisted of several authorities including the NIER, the National Institute of Agricultural Science and Technology (NIAST), and the National Institute of Toxicological Research (NITR). The evaluation was arranged for mutual acceptance of data among GLP authorities. The designation process, additional documents necessary for applying GLP facility, the process of test facility evaluation including reviewing the application and site inspection, and inspection results and submission of correction plans are explained by using the instance of the inspection process of the COT. COT was evaluated as a suitable GLP facility for acute oral and inhalation toxicity tests and the Ames test.
本报告以职业毒理学中心(COT)为例,详细介绍了韩国环境部(MOE)指定GLP设施的过程。作为GLP设施准备的COT向环境部国立环境研究所(NIER)提出了申请。COT的GLP系统由包括NIER、国家农业科学技术研究所(NIAST)和国家毒理学研究所(NITR)在内的几个权威机构组成的统一评估小组进行评估。评估安排在GLP主管部门之间相互接受数据。指定过程,申请GLP设施所需的额外文件,测试设施评估过程,包括审查申请和现场检查,以及检查结果和提交纠正计划,通过使用COT检查过程的实例来解释。COT被评价为适合急性口服和吸入毒性试验和Ames试验的GLP设施。
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引用次数: 1
The transformation of Lebanese firms from ISO 9000 certified to TQM. 黎巴嫩公司从iso9000认证到全面质量管理的转变。
Pub Date : 2000-01-01 DOI: 10.1080/105294100753209183
T. Mezher
Over the past decade, the most effective method of implementing a quality system has been ISO 9000 certification. Lebanese companies have recently followed the same path of adopting and improving their status in quality systems. The overwhelming belief is that ISO 9000 is, by itself, not enough. It is a first stepping-stone in the road to business excellence, but ISO 9000 does not guarantee an improvement in the product or service being offered. All indications are that Total Quality Management (TQM) is the method for improving quality as a whole. This improvement is, of course, entirely reliant on the proper implementation and understanding of the scope and underlying objectives. The relatively new adoption of TQM as an effective tool in the struggle to achieve substantial improvements in quality is made clear in the results of a survey that are presented in this article. Recommendations as how to make the transition between ISO 9000 and TQM are made, and a discussion is provided of the need for organizational change, both internal and external, within companies in the Lebanese market. The aim of this work is to present a clear representation of what is actually occurring within the Lebanese domestic market with regards to the understanding the TQM philosophy.
在过去的十年中,实施质量体系最有效的方法是iso9000认证。黎巴嫩公司最近也采取了同样的方式,采用和提高其在质量体系中的地位。压倒性的信念是,ISO 9000本身是不够的。它是通往卓越经营之路的第一块踏脚石,但iso9000并不能保证所提供的产品或服务的改进。所有迹象表明,全面质量管理(TQM)是提高整体质量的方法。当然,这种改进完全依赖于对范围和潜在目标的正确实现和理解。本文中介绍的一项调查结果清楚地表明,相对较新的采用TQM作为一种有效的工具来实现质量的实质性改进。就如何在ISO 9000和TQM之间进行过渡提出了建议,并讨论了黎巴嫩市场公司内部和外部组织变革的必要性。这项工作的目的是提出一个明确的代表什么是实际发生在黎巴嫩国内市场与理解全面质量管理理念。
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引用次数: 4
Is ICH exportable outside the European Union? 非物质ICH可以出口到欧盟以外吗?
Pub Date : 2000-01-01 DOI: 10.1080/105294100753209165
N. Dent
This article sets out to explore whether or not the International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) Guidelines are exportable outside the European Union (EU). It is not a question of whether the Guidelines per se are exportable but rather can studies outside the EU be performed to the same, or a better standard? It is well known that the ICH Guidelines are accepted worldwide in the countries where International Clinical Trials are carried out. Likewise with the signatories to the Step 5 document being the major players--the USA, Japan, and Europe--the guidelines are already enshrined in national legislation. The author therefore sets out to address whether clinical trials can be conducted to the ICH GCP standard outside Western Europe. The facts and opinions presented here are based on a 16 centre (of which eight of the centres were required to be audited by the Sponsor) clinical study that was carried out in both the Czech Republic and Poland for nonseasonal rhinitis. The recruitment of patients was required to take place in a short period of time and had strict inclusion and exclusion criteria. The overall concept of the study and the compliance with internationally accepted ICH GCPs was found to be of a very high standard. In addition, several other studies from totally different therapeutic areas, clearly show that the standard in non-EU countries is equally high and in most cases of a higher standard than is seen at the principal investigators sites within the EU. In what Western Europeans like to call "developing countries," an understanding of the international GCPs has already been grasped and extremely high quality clinical trials are being carried out. To demonstrate this, attention is drawn to a large head and neck cancer study that was part device and part pharmaceutical product and was conducted in conjunction with photodynamic therapy (PDT), carried out in several countries, but of note in India.
本文旨在探讨国际协调会议(ICH)良好临床实践(GCP)指南是否可出口到欧盟(EU)以外。问题不在于《指引》本身是否可输出,而在于欧盟以外的研究能否以相同或更好的标准进行?众所周知,ICH指南在开展国际临床试验的国家得到了世界范围内的认可。同样,第五步文件的签署国是主要参与者——美国、日本和欧洲——这些指导方针已经写入了国家立法。因此,作者着手解决西欧以外是否可以按照ICH GCP标准进行临床试验的问题。本文给出的事实和观点是基于在捷克共和国和波兰进行的16个中心(其中8个中心需要由主办方审核)的非季节性鼻炎临床研究。患者的招募需要在短时间内进行,并有严格的纳入和排除标准。研究的总体概念和对国际公认的ICH gcp的遵守情况达到了非常高的标准。此外,来自完全不同治疗领域的其他几项研究清楚地表明,非欧盟国家的标准同样高,在大多数情况下,比欧盟主要研究地点的标准更高。在西欧人喜欢称之为“发展中国家”的国家,已经掌握了国际gcp的理解,并且正在进行极高质量的临床试验。为了证明这一点,人们注意到一项大型头颈癌研究,该研究部分是设备,部分是药物产品,与光动力疗法(PDT)一起进行,在几个国家进行,但在印度值得注意。
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引用次数: 3
Validating existing data in the Environmental Technology Verification Program. 验证环境技术验证计划中的现有数据。
Pub Date : 1999-10-01 DOI: 10.1080/105294199750061317
S. Wasson
Establishing the credibility of existing data is an ongoing issue, particularly when the data sets are to be used for a secondary purpose, i.e., not the original reason for which they were collected. If the secondary purpose is similar to the primary purpose, the potential user may have little difficulty establishing credibility since the acceptance criteria for both purposes should be similar. If the secondary purpose is different, then data credibility may be more difficult to establish because the experiment generating the data may not have been conducted optimally for the secondary purpose and all of the necessary quality assurance data ("metadata") may not have been collected. In either case, a process will be required to determine the acceptability of the data. For this reason, at the time the U.S. Environmental Protection Agency (EPA) Environmental Technology Verification (ETV) program was established, similar certification and verification programs run by states or foreign countries routinely used existing data sets, for cost reasons, rather than generate new data by testing. The issue of whether existing data could be used in the ETV program immediately surfaced. In response, a policy and a process that addressed existing data were written and published in Appendix C of the ETV Quality and Management Plan (Hayes et al., 1998). This paper discusses how the ETV program determines the credibility of existing data used to verify the performance of environmental technologies.
建立现有数据的可信度是一个持续的问题,特别是当数据集将用于次要目的时,即不是收集数据的原始原因。如果次要目的与主要目的相似,则潜在用户建立信誉可能没有什么困难,因为这两个目的的接受标准应该相似。如果次要目的不同,则数据可信度可能更难建立,因为生成数据的实验可能没有为次要目的进行最佳化,并且可能没有收集到所有必要的质量保证数据(“元数据”)。在任何一种情况下,都需要一个流程来确定数据的可接受性。因此,在美国环境保护署(EPA)建立环境技术验证(ETV)计划时,出于成本原因,各州或外国运行的类似认证和验证计划通常使用现有数据集,而不是通过测试生成新数据。现有数据是否可以用于ETV计划的问题立即浮出水面。作为回应,ETV质量和管理计划的附录C中编写并发布了一项针对现有数据的政策和流程(Hayes et al., 1998)。本文讨论了ETV计划如何确定用于验证环境技术性能的现有数据的可信度。
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引用次数: 1
Quality science and quality assurance: observations of an environmental scientist. 质量科学与质量保证:一位环境科学家的观察。
Pub Date : 1999-10-01 DOI: 10.1080/105294199750061344
T. J. Hughes
The purpose of this manuscript is to examine the relationship between quality science (QS) and quality assurance (QA). Many research scientists definitely want to do QS, but are afraid or do not want to do QA because they are intimidated by the QA process or they do not appreciate the benefits of QA. Therefore, the relationship between QS and QA is examined in this manuscript by an environmental scientist who has conducted 30 years of research in university, contract and government laboratories. To start, QS is defined in this paper as data that are published in the peer-reviewed literature. The quality of the research data is assumed by the general scientific population to be directly proportional to the status of the journal. For example, it is highly prestigious to have an article published in Science. At the U.S. EPA, the procedure for sending a manuscript to a journal for publication is the responsibility of the senior author. The senior author of an EPA-sponsored manuscript is expected to have the manuscript reviewed by the coauthors (they should also review the data), then the manuscript must be reviewed by at least two other scientists, one of whom must be from outside the authors' division. After this review and approval by management, the manuscript is sent to a peer-reviewed journal, where it is reviewed by several anonymous scientists as determined by the journal. After the comments of the reviewers are addressed, the manuscript can either be accepted or rejected for publication by the journal. For the purpose of this manuscript, the definition of QA is defined as the guarantee from a review team that the entire study was adequately and correctly conducted and recorded according to the study protocol. Many scientists view QS and QA as separate entities. From the scientist's perspective, QA procedures are not applicable to research studies, and should be used only for studies that will be submitted to either the EPA or the FDA for regulatory approval (i.e., Good Laboratory Practice [GLP] studies). However, QA can be applied to both types of studies. A QA review will examine all aspects of the study including data files (notebooks, protocols), as well as equipment, sample storage, actual experimental organisms (animals or cells) and the management of all study records. The data from a QA-reviewed study are therefore more defensible in a court of law, and more reproducible due to more through, chronological records. Generally speaking, few coauthors of a scientific manuscript analyze the raw data in the laboratory notebooks or inspect the laboratory equipment. Furthermore, coauthors generally have not been in the laboratory where the research was conducted in order to observe quality control measures. These are the areas where a QA review is extremely beneficial. In summary, data in the peer-reviewed literature do not undergo the same type of review as do data that have undergone a QA review. QA reviews assist EPA scientists in conductin
本文的目的是研究质量科学(QS)和质量保证(QA)之间的关系。许多研究科学家确实想做QA,但害怕或不想做QA,因为他们被QA过程吓倒了,或者他们没有意识到QA的好处。因此,一名环境科学家在大学、合同和政府实验室进行了30年的研究,在这份手稿中对QS和QA之间的关系进行了研究。首先,本文将QS定义为发表在同行评议文献中的数据。一般科学人群认为研究数据的质量与期刊的地位成正比。例如,在《科学》杂志上发表一篇文章是非常有声望的。在美国环境保护署,将稿件发送到期刊发表的程序是资深作者的责任。美国环境保护署资助的论文的资深作者应该由共同作者审查论文(他们也应该审查数据),然后论文必须由至少两名其他科学家审查,其中一名必须来自作者部门以外。经过管理层的审查和批准后,稿件被发送到同行评议期刊,由期刊确定的几位匿名科学家进行评议。在解决了审稿人的意见后,期刊可以接受或拒绝稿件发表。在本文中,QA的定义被定义为评审小组对整个研究按照研究方案充分、正确地进行和记录的保证。许多科学家认为QS和QA是两个独立的实体。从科学家的角度来看,QA程序不适用于研究性研究,而应仅用于将提交EPA或FDA进行监管批准的研究(即良好实验室规范[GLP]研究)。然而,QA可以应用于这两种类型的研究。QA审查将检查研究的所有方面,包括数据文件(笔记本、方案)、设备、样品存储、实际实验生物体(动物或细胞)和所有研究记录的管理。因此,qa审查研究的数据在法庭上更站得住脚,而且由于有更多完整的、按时间顺序记录,数据也更容易再现。一般来说,科学手稿的合著者很少分析实验室笔记本中的原始数据或检查实验室设备。此外,共同作者通常没有进入进行研究的实验室,以观察质量控制措施。在这些领域,QA审查是非常有益的。总之,同行评议文献中的数据与经过QA审查的数据不进行相同类型的审查。QA审查通过识别优秀的研究实践和需要解决的研究缺陷来帮助EPA科学家进行和改进他们的研究,从而产生更高质量的科学数据。在这位EPA科学家和QA经理看来,尽管QA审查确实需要科学家的努力,但与未经QA审查的同行评议研究的数据相比,来自研究的数据通过QA审查得到了加强。QA审查应该被视为整个研究过程的一部分——一个提高数据整体质量的部分。
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引用次数: 1
Never audit alone--the case for audit teams. 永远不要单独审计——审计团队就是这样。
Pub Date : 1999-10-01 DOI: 10.1080/105294199750061308
N. Adams
UNLABELLEDOn-site audits, conducted by technical and quality assurance (QA) experts at the data-gathering location, are the core of an effective QA program. However, inadequate resources for such audits are the bane of a QA program and, frequently, the proposed solution is to send only one auditor to the study site. There are several reasons why audits should be performed by more than one person: 1.SAFETYAudits of EPA projects frequently involve hazardous chemicals or other environmental hazards. They also often involve working after normal work hours in remote locations with dangerous equipment. It is unsafe to work alone under such conditions. 2. Skills: Many of EPA's projects are multidisciplinary, involving multiple measurements systems, several environmental media, and complex automated data collection and analysis systems. It is unlikely that one auditor would have the requisite skills to assess all of these operations. 3. Separateness: Two auditors can provide two (sometimes differing) perspectives on problems encountered during an audit. Two auditors can provide complementary expertise and work experience. Two auditors can provide twice the surveillance power. 4. Support: The operations that need to be assessed are sometimes in different parts of a site, requiring two auditing devices or considerable commuting time. Also, auditors are occasionally diverted by managers wishing to show their best efforts rather than the whole operation; if two auditors are on-site, one can interview managers while the other talks with technical staff. If there is a dispute, one auditor can support the other in verifying observations. 5. Savings: Although sending one auditor is perceived to be a cost-saving measure, it may be more economical to send two auditors. Time on site (lodging, food) is decreased, more of the project is assessed in one visit, less pre-audit training is required, and report preparation is accelerated. In summary, sending more than one auditor on a field audit is smarter, safer and more effective, and can be less expensive in the long run.
由数据收集地点的技术和质量保证(QA)专家进行的现场审核是有效的QA程序的核心。然而,用于此类审核的资源不足是QA计划的祸根,通常,建议的解决方案是只派遣一名审核员到研究现场。审计应该由多人执行的原因有以下几点:1。EPA项目的安全审核经常涉及危险化学品或其他环境危害。他们还经常在正常工作时间之后在偏远地区使用危险设备工作。在这样的条件下单独工作是不安全的。2. 技能:EPA的许多项目是多学科的,涉及多种测量系统、几种环境介质和复杂的自动化数据收集和分析系统。一个审计员不太可能具备评估所有这些业务的必要技能。3.独立性:两个审核员可以对审计过程中遇到的问题提供两种(有时是不同的)观点。两名审核员可以提供互补的专业知识和工作经验。两名审计员可以提供两倍的监督权力。4. 支持:需要评估的操作有时在站点的不同部分,需要两个审计设备或相当长的通勤时间。此外,审计人员有时会被那些希望展示自己最大努力而不是整个业务的经理们所转移;如果有两名审核员在场,一名可以采访管理人员,另一名可以与技术人员交谈。如果有争议,一个审核员可以支持另一个审核员核实观察结果。5. 节省:虽然派遣一名审计员被认为是一种节省成本的措施,但派遣两名审计员可能更经济。减少了在现场(住宿、餐饮)的时间,增加了一次评估项目的数量,减少了审核前的培训,加快了报告的准备。总而言之,派遣多名审核员进行现场审核更明智、更安全、更有效,而且从长远来看成本更低。
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引用次数: 3
Quality assurance growing pains: a state perspective on implementing an organizational-wide quality system in environmental laboratories. 质量保证成长的烦恼:在环境实验室实施组织范围质量体系的状态视角。
Pub Date : 1999-10-01 DOI: 10.1080/105294199750061326
S. Siders
To implement an effective and efficient quality system in a network of established environmental testing laboratories requires a committed long-term effort that is potentially fraught with multiple obstacles. This presentation discusses one state's ongoing efforts at implementing such a system. First is the need to convince management of the rationale for a quality systems-based approach versus the traditional QA/QC program. Once development of a quality system has been sanctioned, a team-based approach utilizing project planning tools is a good way to approach the effort. Resources are assigned to the development of key quality system components, and generally a phased-deployment or roll-out works best. Once implementation is underway, assuring operational utilization and compliance with the quality system are vital steps in the process. Important to successful implementation is ongoing assessment and refinement of the quality system. Fundamental and key elements of the laboratory quality system are numerous and need to work in concert with each other. Quality system elements to be discussed in the presentation range from management and QA roles and functions to the typical documentation of laboratory policies and procedures. Numerous QA assessment tools and other vital quality system practices that play an important role in making a complete quality system are addressed. In addition, efforts must be undertaken to integrate the laboratory quality system with other management systems within the organization. The bottom line is that all environmental laboratories need a quality system more now than ever. Data users need it. Customers' expectations for data quality are high. USEPA policy and/or programs call for it. Additionally, good quality systems can benefit the organization in multiple ways and help avoid the "pay-me-now or pay-me-later" syndrome. In conclusion, all environmental testing laboratories (i.e., academic, private, commercial and especially governmental) need to invest in and implement a quality system based on a recognized standard (e.g., NELAC, ISO 17025, ANSI/ASQC E-4). The author recommends pursuing NELAP laboratory accreditation with a NELAP-recognized accrediting authority.
在已建立的环境测试实验室网络中实施有效和高效的质量体系需要承诺的长期努力,这可能充满多种障碍。本报告讨论了一个州在实施这种制度方面正在进行的努力。首先,需要说服管理层采用基于质量体系的方法,而不是传统的QA/QC程序。一旦质量系统的开发得到批准,利用项目计划工具的基于团队的方法是处理工作的好方法。资源分配给关键质量系统组件的开发,并且通常分阶段部署或推出工作最好。一旦实施开始,确保操作利用和符合质量体系是过程中的重要步骤。对质量体系的持续评估和改进是成功实施的重要因素。实验室质量体系的基本要素和关键要素数量众多,需要相互协调。在报告中讨论的质量体系要素范围从管理和QA角色和功能到实验室政策和程序的典型文件。许多QA评估工具和其他重要的质量体系实践在建立一个完整的质量体系中起着重要的作用。此外,必须努力将实验室质量体系与组织内的其他管理体系相结合。底线是,所有的环境实验室现在比以往任何时候都更需要一个质量体系。数据用户需要它。客户对数据质量的期望很高。美国环保署的政策和/或计划要求这样做。此外,良好的质量体系可以以多种方式使组织受益,并有助于避免“现在支付我或以后支付我”综合症。总之,所有的环境测试实验室(即学术的、私人的、商业的,尤其是政府的)都需要投资并实施基于公认标准的质量体系(例如,NELAC、ISO 17025、ANSI/ASQC E-4)。作者建议通过NELAP认可的认证机构进行NELAP实验室认证。
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引用次数: 0
Data quality objectives in environmental research planning. 环境研究规划中的数据质量目标。
Pub Date : 1999-10-01 DOI: 10.1080/105294199750061290
A. R. Batterman, S. Batterman, K. M. Jensen, F. W. Whiteman
This paper presents highlights of a Data Quality Objectives course relating the Environmental Protection Agency's (EPA) seven step research planning process to research efforts at the U.S. EPA National Health and Environmental Effects Research Laboratory, Mid-Continent Ecology Division, in Duluth, Minnesota. Introductory materials were derived from "Guidance for the Data Quality Objectives Process, EPA QA/G-4." Case studies illustrate decisions that were made during the systematic planning process and subsequent experimentation. This paper demonstrates how the Data Quality Objectives Process clearly links research goals and objectives with the final product. Application of the process to environmental research ensures that environmental research data are of known, credible, defensible and usable quality.
本文介绍了数据质量目标课程的重点内容,该课程涉及美国环境保护署(EPA)的七步研究规划过程,以及美国环境保护署国家健康与环境影响研究实验室(位于明尼苏达州德卢斯的中大陆生态学分部)的研究工作。介绍材料来源于“数据质量目标过程指南,EPA QA/G-4”。案例研究说明了在系统规划过程和随后的实验中做出的决定。本文演示了数据质量目标过程如何清晰地将研究目标与最终产品联系起来。将这一过程应用于环境研究,确保环境研究数据具有已知的、可信的、可辩护的和可用的质量。
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引用次数: 2
Research integrity: a government perspective. 研究诚信:政府视角。
Pub Date : 1999-03-01 DOI: 10.5840/PROFETHICS1999715
Linda S. Birnbaum, Brenda T. Culpepper
What is research integrity? At the United States Environmental Protection Agency (U.S. EPA) research integrity can be defined as conducting and fostering research to define, anticipate, and understand environmental problems; and generating sound, appropriate, credible, and effective solutions to those problems. Whether in government, academia, or industry, integrity is required at all stages of research--from data generation to data analysis. What constitutes research integrity? Simply put, Did we do the right thing? Did we do it the right way? Did we honestly document what we did? This is especially important if the research is used as a basis for public policy. The extensive and intensive use of the results of science in EPA's standard setting, regulatory, and enforcement responsibilities means that scientific misconduct can lead to costly and inappropriate actions through unnecessary expenditure or inadequate protection. The soundness, effectiveness, and credibility of EPA's regulations ultimately rest on the scientific and technical bases for these actions. Careful attention to research record keeping can help ensure data quality and integrity. The U.S. Environmental Protection Agency, its research requirements, and the work of the National Health and Environmental Effects Research Laboratory are discussed below.
什么是研究诚信?在美国环境保护署(U.S. EPA),研究诚信可以定义为开展和促进研究,以确定、预测和理解环境问题;并针对这些问题提出合理、适当、可信和有效的解决方案。无论是在政府、学术界还是工业界,从数据生成到数据分析的所有研究阶段都需要诚信。什么构成研究诚信?简单地说,我们做对了吗?我们做得对吗?我们是否诚实地记录了我们所做的?如果这项研究被用作公共政策的基础,这一点尤为重要。在环境保护署的标准制定、监管和执行职责中广泛和密集地使用科学成果意味着科学不当行为可能通过不必要的支出或不充分的保护导致代价高昂和不适当的行动。EPA法规的合理性、有效性和可信度最终取决于这些行动的科学和技术基础。仔细注意研究记录的保存有助于确保数据的质量和完整性。下面将讨论美国环境保护署及其研究要求,以及国家健康与环境影响研究实验室的工作。
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引用次数: 3
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Quality assurance
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