ICH-GCP 9.1 Research Misconduct(1)

如题所述

第1个回答  2022-06-20
Part 1: Introduction

Part 2: Identifying Research Misconduct

Part 3: Investigating Allegations of Research Misconduct

Public concern about misconduct in research arose in the early 1980s after reports of serious misbehavior by researchers. In one case, a researcher republished dozens of articles under his name that had previously been published by others. In other cases, researchers falsified or made up research results. Instead of looking into these problems, research institutions sometimes ignored them or covered them up.

公众对科研不端行为的关注始于20世纪80年代初,此前有研究人员严重不当行为的报道。在一个案例中,一名研究人员以他的名义重新发表了几十篇以前由他人发表的文章。在其他情况下, 研究人员伪造或编造研究结果 。研究机构有时忽视或掩盖这些问题,而不是调查这些问题。

Eventually, Congress required federal agencies and research institutions to develop policies on research misconduct. The U.S. Public Health Service created regulations for dealing with research misconduct ( 42 CFR 50 Subpart A ). These policies generally have three goals:

最终,国会要求联邦机构和研究机构制定有关研究不当行为的政策。美国公共卫生署制定了处理研究不当行为的法规(42 CFR 50子部分A)。这些政策通常有三个目标:

Ⅰ、To define research misconduct.

Ⅱ、To establish procedures for reporting and investigating research misconduct.

Ⅲ、To protect both those who report alleged research misconduct and those accused of research misconduct.

1、 界定科研不端行为 。

2、 建立报告和调查研究不当行为的程序 。

3、 保护举报涉嫌科研不端行为的人员 和 被控科研不端行为的人员 。

This module discusses how federal policy defines research misconduct and provides a brief overview of the processes established by the U.S. Public Health Service (PHS) for responding to allegations of misconduct in PHS-supported research.

本模块讨论了 联邦政策如何定义研究不端行为 ,并简要概述了美国公共卫生服务局(PHS)为应对公共卫生服务局支持的研究中的不端行为指控而建立的程序。

Federal regulations define research misconduct as:

"... fabrication, falsification, plagiarism , or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research."

联邦法规将 研究不端行为 定义为:

“…… 捏造、伪造、剽窃或其他严重偏离科学界普遍接受的提议、进行或报告研究的做法 。”

Ⅰ、 Fabrication is making up data or results and recording or reporting them.

Ⅱ、 Falsification is changing research materials, equipment, or processes or altering or omitting data or results so that the research record does not accurately reflect the research findings.

Ⅲ、 Plagiarism is using another person’s ideas, processes, results, or words without giving appropriate credit.

1、 制作 是指制作数据或结果并记录或报告。

2、 伪造 是指改变研究材料、设备或过程,或改变或省略数据或结果,使研究记录不能准确反映研究结果。

3、 剽窃 是指使用他人的想法、过程、结果或话语而没有给予适当的信任。

Research misconduct does not include honest error or differences of opinion. In addition, the federal policy on research misconduct does not apply to authorship disputes unless they involve plagiarism.

研究不端行为不包括诚实的错误或意见分歧 。此外, 联邦科研不端行为政策不适用于著作权纠纷,除非涉及剽窃。

Research misconduct has a very specific meaning in federal regulations. Noncompliance with policies and procedures for the protection of human research subjects, although reportable to an Institutional Review Board (IRB), is not considered to be research misconduct under the federal definition.

研究不端行为在联邦法规中有非常具体的含义。 不遵守保护人类研究对象的政策和程序,尽管可向机构审查委员会(IRB)报告,但根据联邦定义,不被视为研究不当行为。

Federal policy on research misconduct applies to all federally funded research and all proposals submitted to federal agencies for research funding.

关于研究不当行为的联邦政策适用于所有联邦资助的研究以及向联邦机构提交的所有研究资助提案。

Many research institutions and universities apply the federal policy on research misconduct to all research, whether or not it is federally funded. In addition, many institutions have broadened the federal definition of research misconduct to include other improper practices. Researchers must be familiar with their institutional policies on research misconduct as well as with the federal policy.

许多研究机构和大学对所有研究都适用联邦关于研究不当行为的政策,无论其是否由联邦资助。此外, 许多机构扩大了联邦对研究不当行为的定义,将其他不当行为也包括在内 。研究人员必须熟悉其关于研究不当行为的机构政策以及联邦政策。

The Office of Research Integrity (ORI) in the Department of Health and Human Services is responsible for promoting research integrity within the U.S. Public Health Service. ORI oversees investigations of research misconduct allegations and makes final decisions on findings of research misconduct.

卫生与公共服务部的研究诚信办公室(ORI)负责促进美国公共卫生服务部门的研究诚信 。ORI监督对科研不端行为指控的调查,并对科研不端行为的调查结果做出最终决定。

Through its Rapid Response Technical Assistance Program, ORI provides technical assistance to any institution that is responding to an allegation of research misconduct. In addition, researchers may hold informal discussions with ORI about allegations of research misconduct or the handling of research misconduct cases.

ORI通过其 快速反应技术援助计划 ,向任何回应研究不当行为指控的机构提供 技术援助 。此外,研究人员可能与ORI就科研不端行为的指控或科研不端行为案件的处理进行 非正式讨论 。

Records maintained by ORI during the investigation of an allegation of research misconduct are exempt from disclosure under the Freedom of Information Act to the extent permitted by law and regulation.

根据 《信息自由法》 ,在法律和法规允许的范围内, ORI在调查研究不当行为指控期间保存的记录可免于披露 。

Research misconduct destroys the integrity or honesty of the research record. This sets it apart from other improper activities that may occur in research settings (e.g., financial conflicts of interest, misuse of grant funds, violation of human subject protections, sexual harassment, and discrimination). Although these improper activities are taken very seriously, they are not considered research misconduct because they do not alter the integrity of the research record.

研究不端行为破坏了研究记录的完整性或诚实性 。这使其与研究环境中可能发生的其他不当活动(例如,财务利益冲突、滥用拨款、违反人体保护、性骚扰和歧视)区别开来。尽管这些不当行为受到了非常严肃的对待,但它们不被视为研究不当行为,因为它们不会改变研究记录的完整性。

The term fraud has often been used to describe dishonesty in research. However, this term is more aptly used to describe illegal, deceptive financial practices. Behavior that destroys the integrity of the research record through fabrication, falsification, or plagiarism is most aptly termed research misconduct.

欺诈一词经常被用来描述研究中的不诚实行为。然而,这个术语更适合用来描述非法的、欺骗性的金融行为。 通过捏造、伪造或剽窃破坏研究记录完整性的行为最恰当地称为研究不端行为。

Instructions: Based on the description below, choose whether the information is True or False.

说明: 根据下面的描述,选择信息是否正确。

All three of the elements below must be present for a finding of research misconduct to be made. Under federal policy, a finding of research misconduct requires that:

Ⅰ、There be a significant departure from accepted practices of the relevant research community; and

Ⅱ、The misconduct be committed intentionally, or knowingly, or recklessly; and

Ⅲ、The allegation be proven by a preponderance of the evidence.

Feedback: Is this information True or False? All three of the elements must be present for a finding of research misconduct to be made. Therefore, the correct response is True.

必须具备以下三个要素,才能发现研究不当行为。根据联邦政策, 研究不端行为的发现要求 :

1、 与相关研究团体的公认实践存在重大偏差 ;和

2、 故意、明知或罔顾后果的不当行为 ;和

3、 该指控应以大量证据予以证明 。

反馈:这些信息是真是假?必须具备所有三个要素,才能发现研究不当行为。因此,正确的回答是正确的。

Federal policy on research misconduct places the primary responsibility for reporting and investigating allegations of research misconduct with researchers and research institutions. This is consistent with the position, supported by most researchers, that research is a profession that should regulate its own conduct.

联邦关于研究不当行为的政策规定,研究人员和研究机构负有举报和调查研究不当行为指控的主要责任。这与得到大多数研究人员支持的观点是一致的,即 研究是一种应该规范自身行为的职业。

Research institutions that receive federal funding are expected to:

Ⅰ、Foster an environment that discourages all research misconduct.

Ⅱ、Use procedures for receiving and investigating reports of research misconduct.

Ⅲ、Inform scientific and administrative staff of the procedures for responding to allegations of research misconduct and of the importance of complying with these procedures.

Ⅳ、Take immediate, appropriate action when research misconduct is suspected or alleged to have occurred at the institution.

Ⅴ、Investigate and rule on suspicions or allegations of research misconduct.

Ⅵ、Report both the start of and the results of a formal investigation (not the initial inquiry) into an allegation of research misconduct to the Office of Office of Research Integrity.

Ⅶ、File an Annual Report on Possible Research Misconduct with the designated federal agency.

接受联邦资助的研究机构应:

1、培养一个不鼓励所有研究不端行为的 环境 。

2、使用 接收和调查研究不端行为报告的程序 。

3、 告知 科学和行政人员应对研究不当行为指控的 程序 以及 遵守这些程序的重要性 。

4、 当怀疑或指称研究机构发生不当行为时 , 立即采取适当行动 。

5、对科研不端行为的怀疑或指控进行 调查和裁决 。

6、向研究诚信办公室报告对研究不端行为指控的 正式调查 (而非初步调查) 的开始和结果 。

7、向指定的联邦机构提交关于可能的研究不当行为的 年度报告 。

Federal policy on research misconduct assumes that research is a self-regulating profession. To be successful, professional self-regulation relies on conscientious participation by all members of the profession. Individual researchers are expected to:

关于研究不当行为的联邦政策假定研究是一种自我调节的职 业。要取得成功,专业自律有赖于所有专业人员的认真参与。个人研究人员应:

Ⅰ、Maintain a high standard of integrity at all times in all of their research activities.

Ⅱ、Assume responsibility for their actions.

Ⅲ、Take misconduct or alleged misconduct seriously.

Ⅳ、Report apparent misconduct by other researchers.

Ⅴ、Keep confidential at all times information that is relevant to an investigation of alleged misconduct.

1、在所有研究活动中始终保持高标准的 诚信 。

2、 对自己的行为负责 。

3、 认真对待不当行为或被指控的不当行 为。

4、 报告其他研究人员的明显不当行为 。

5、始终对与涉嫌不当行为调查有关的 信息保密 。