ICH-GCP 9.2 Research Misconduct（2）
Part 4: Responding to Allegations of Research MisconductPart 5: Safeguards for Informants and Accused Persons
Part 6: Possible Penalties for Research Misconduct
Part 7: Summary of Key Points
Federal policy makes researchers and research institutions primarily responsible for reporting and investigating alleged research misconduct. Research institutions’ expected tasks in dealing with such allegations are spelled out in 42 CFR Part 50 Subpart A .
联邦政策规定研究人员和研究机构 主要负责报告和调查被指控的研究不当行为 。研究机构处理此类指控的预期任务在42 CFR第50部分A子部分中有详细说明。
Generally, the response to an allegation of research misconduct has three stages.
一般来说，对研究不当行为指控的回应分为三个阶段。
The inquiry assesses the facts of the allegation and the need for an investigation. An inquiry must be completed within 60 calendar days of its start, unless circumstances clearly require a longer time.
初步调查评估了 指控的事实和调查的必要性 。初步调查必须在开始后60个日历日内完成，除非情况明确要求更长的时间。
Those accused of misconduct must be informed of the allegation and of the inquiry. A written report of the inquiry must be prepared, summarizing the evidence reviewed and conclusions reached. The accused person(s) must be given a copy of the inquiry report.
必须将指控和调查 告知被指控行为不当的人 。必须 准备书面调查报告，总结审查的证据和得出的结论 。必须向被告提供一份调查报告的 副本 。
If the inquiry provides an adequate basis for an investigation, that investigation should begin within 30 days of completion of the inquiry. The decision to begin an investigation must be reported in writing to the Director, Office of Research Integrity (ORI), on or before the date the investigation begins.
如果调查为调查提供了充分的基础，则 （正式）调查应在（初步）调查完成后30天内开始 。开始调查的决定必须在 调查开始之日或之前以书面形式报告给研究诚信办公室（ORI）主任 。
The investigation normally will include:
Ⅰ、Examining all documents, including relevant research data, proposals, publications, correspondence, and records of telephone calls.
Ⅱ、Interviewing all informants and all those accused of misconduct as well as others who may have information about key aspects of the allegation.
Ⅲ、Preparing a report of the investigation’s findings and making the report available for comment by all informants and all those accused of misconduct.
Ⅳ、Submitting a final report to ORI, the PI, the sponsor, and NIH for NIH-funded or supported research.
正式调查通常包括：
1、 检查所有文件 ，包括 相关研究数据 、 提案 、 出版物 、 信函 和 电话记录 。
2、 采访所有举报人 、 所有被指控行为不端者 以及 可能掌握指控关键方面信息的其他人 。
3、准备一份 调查结果报告 ，并将该报告提供给所有举报人和所有被指控不当行为的人以 供评论 。
4、 向ORI、PI、赞助者和NIH提交最终报告 ，用于NIH资助或支持的研究。
In most cases, the investigation should be completed within 120 days of its start. If the institution decides it cannot complete the investigation within this time, it must submit to ORI a written request for an extension.
在大多数情况下，正式调查应在开始后120天内完成。如果机构决定无法在此时间内完成调查，则必须 向ORI提交书面延期请求 。
This request must explain the reason for the delay, report on the investigation’s progress so far, and estimate when the investigation will be completed and the final report submitted.
该请求必须解释延迟的原因， 报告到目前为止的调查进展 ， 并估计调查何时完成和提交最终报告 。
If the investigation concludes that the allegation has merit, the institution may impose suitable penalties. In addition, the ORI may impose penalties of its own on investigators or institutions.
如果调查结论认为该指控有根据，该机构可以施加适当的处罚 。 此外，ORI可对调查人员或机构施加自己的处罚。
Institutions must notify the Office of Research Integrity (ORI) immediately if certain circumstances are found during an inquiry or investigation into an allegation of research misconduct.
如果在调查或调查研究不当行为指控时发现某些情况，各机构必须立即通知研究诚信办公室（ORI）。
Click to view Clinical Trial Network（CTN） related content
Every CTN member institution is expected to have an official responsible for investigating complaints of research misconduct, also referred to as the Research Integrity Officer (RIO). When an allegation of scientific misconduct is made in a CTN trial, the Research Integrity Officer of the research institution should be contacted immediately.
每个CTN成员机构都应有一名官员负责调查研究不当行为投诉，也称为研究诚信官（RIO） 。当在CTN审判中提出科学不端行为指控时，应立即联系研究机构的研究诚信官员。
The Research Integrity Officer should promptly assess whether the allegation falls under the federal definition of research misconduct and whether sufficient evidence exists to warrant an inquiry. He or she should alert the NIDA Center for the Clinical Trials Network office that an allegation of research misconduct has been made at one or more CTN sites. Within NIDA, responsibility for oversight of inquiries and investigations into research misconduct rests with the Office of Extramural Affairs.
研究诚信专员应立即 评估该指控是否属于联邦对研究不当行为的定义 ，以及 是否有足够证据支持调查 。他或她应通知NIDA临床试验中心网络办公室，有人指控一个或多个CTN站点存在研究不当行为。在NIDA内部，校外事务办公室负责监督对科研不端行为的调查和调查。
In addition, if NIDA is the sponsor of a study under an Investigational New Drug (IND), NIDA must promptly report to the FDA any information that any person involved in human subject trials committed research misconduct. If the FDA receives a complaint of alleged trial misconduct, the FDA will independently investigate, separate from the ORI investigation, and proceed with any necessary regulatory actions.
此外，如果NIDA是研究新药（IND）项下研究的赞助者， NIDA必须立即向FDA报告参与人体试验的任何人有研究不当行为的任何信息。 如果FDA收到指控试验不当行为的投诉，FDA将独立于ORI调查进行调查，并采取任何必要的监管措施。
An allegation of research misconduct can have a significant impact on the informant, the accused person(s), and the institution where the alleged misconduct took place. Procedures must be in place to ensure the security of original documents, computers, biological specimens, laboratory notebooks, research and financial records, and other relevant items that might be altered, lost, or destroyed.
对研究不当行为的指控可能会对举报人、被告人和涉嫌不当行为发生的机构产生重大影响 。必须制定程序，确保原始文件、计算机、生物标本、实验室笔记本、研究和财务记录以及其他可能被更改、丢失或销毁的相关物品的安全。
In addition, specific safeguards are necessary to assure the protection of all persons concerned with an allegation of research misconduct.
此外，有必要采取具体的保障措施，以确保与研究不当行为指控有关的所有人员得到保护。
A whistleblower (informant) is any member of a research institution, including a non-employee, who alleges that the institution or one of its members has engaged in, or has failed to respond adequately to an allegation of, research misconduct.
举报人（告密人）是指研究机构的任何成员 ， 包括声称该机构或其成员之一参与或未能对研究不当行为的指控作出充分回应的非雇员。
The role of the whistleblower is essential to the effort to protect the integrity of research. People who in good faith report apparent research misconduct must be able to do so in confidence and without fear of retaliation or payback.
举报人的作用对于保护研究的完整性至关重要。真诚地报告明显研究不当行为的人必须能够在不担心报复或回报的情况下秘密报告。
Federal policy requires institutions to offer informants the following safeguards:
Ⅰ、Protection of privacy to the extent possible. However, informants cannot remain anonymous.
Ⅱ、Protection against retaliation.
Ⅲ、Fair and objective procedures for examining and resolving research misconduct allegations.
Ⅳ、Diligence in protecting the positions and reputations of informants.
联邦政策要求机构向举报人提供以下保障：
1、尽可能 保护隐私 。 但是，告密者不能保持匿名 。
2、 防止报复 。
3、 审查和解决科研不端行为指控的公正客观程序 。
4、 努力保护举报人的地位和声誉 。
Neither research institutions nor individual researchers may penalize persons who, in good faith, report alleged research misconduct. Even if the allegations are not sustained, as long as they are made in good faith, informants must be protected because they play a vital role in professional self-regulation.
无论是研究机构还是研究人员个人，都 不得处罚善意报告研究不当行为的人员 。 即使指控不成立，只要指控是善意的，举报人也必须受到保护 ，因为他们在 职业自律 中发挥着至关重要的作用。
Most allegations of research misconduct are not substantiated. Persons accused of research misconduct must be assured that the mere filing of allegations will not bring their research to a halt or be the basis for other disciplinary action without compelling reasons. Other safeguards for accused persons include:
大多数关于科研不端行为的指控都没有得到证实。 必须向被指控研究不端行为的人保证，如果没有令人信服的理由，仅仅提出指控不会使他们的研究停止或成为其他纪律处分的基础。对被告人的其他保障措施包括：
Ⅰ、Timely written notification of allegations made against them.
Ⅱ、A description of all allegations.
Ⅲ、Reasonable access to the data and other evidence supporting the allegations.
Ⅳ、The opportunity to respond to allegations, supporting evidence, and any proposed findings of research misconduct.
Ⅴ、Confidential treatment to the maximum extent possible.
1、 及时书面 通知对其提出的指控。
2、 所有指控的描述 。
3、 合理获取支持指控的数据和其他证据 。
4、 对指控、支持性证据和任何研究不端行为的建议调查结果作出回应的机会 。
5、尽可能 保密 处理。
The persons selected to investigate allegations of research misconduct must have appropriate expertise and no unresolved conflicts of interest.
被选定调查研究不当行为指控的人员必须具备适当的 专业知识 ，并且 没有未解决的利益冲突 。
Reasonable time limits must be set for the response to an allegation of research misconduct. Extensions of time may be allowed when necessary.
必须为对研究不当行为指控的回应 设定合理的时间限制 。必要时可允许延长时间。
To the extent possible, knowledge of the identities of both subjects and informants involved in research misconduct investigations should be closely held. However, the accused person is entitled to know the identity of the informant.
在可能的情况下，应密切了解参与研究不当行为调查的受试者和线人的身份。但是，被告有权知道举报人的身份。
Alleged misconduct in a clinical trial that could threaten the health or safety of trial participants must be reported immediately to the trial principal investigator, the federal agency sponsoring the trial (NIDA in the case of CTN studies), and the Office of Research Integrity (ORI). The name(s) of the accused person(s) should remain confidential, but steps must be taken to ensure the safety of trial participants.
临床试验中可能威胁试验参与者健康或安全的涉嫌不当行为必须立即报告给 试验首席研究员 、 赞助试验的联邦机构（ 就CTN研究而言为NIDA）和 研究诚信办公室 （ORI）。被告的姓名应保密，但必须采取措施确保审判参与者的安全。
Research institutions may penalize researchers who are found to have committed research misconduct by terminating their employment or by requiring supervision of future research activities.
研究机构可以通过 终止他们的工作 或 要求监督未来的研究活动 ，来惩罚那些被发现有研究不端行为的研究人员。
When a grantee institution upholds a finding of research misconduct by anyone working on a NIH-funded research project, the grantee must assess the effect of the finding on that person’s ability to continue working on the research project. In addition, the grantee must promptly obtain approval from the sponsor and NIH for any intended change of principal investigator or other key personnel involved in the research project.
当被资助机构支持任何在NIH资助的研究项目中工作的人的研究不端行为的发现时，被资助机构必须评估该发现对该人继续从事该研究项目的能力的影响。 此外，被资助人必须立即获得资助人和NIH的批准，以变更任何涉及研究项目的主要研究人员或其他关键人员。
The Office of Research Integrity (ORI) may also impose penalties for research misconduct. Penalties are determined by the severity of the misconduct. Factors that ORI may consider in choosing a penalty may include the degree to which the misconduct:
研究诚信办公室（ORI）也可能对研究不端行为施加处罚。处罚取决于不当行为的严重程度。在选择处罚时，ORI可能考虑的因素包括不当行为的程度：
Ⅰ、Was committed in a knowing, intentional, or reckless manner.
Ⅱ、Was an isolated event or part of a pattern.
Ⅲ、Had a significant impact on the research record, research subjects, other researchers, institutions, or the public welfare.
1、以 明知 、 故意 或 不计后果 的方式进行。
2、是一个 孤立事件或模式 的一部分。
3、对 研究记录、研究对象、其他研究人员、机构 或 公益事业 有重大影响者。
The Office of Research Integrity (ORI) may impose a variety of penalties when a finding of research misconduct is upheld. These penalties may include:
研究诚信办公室（ORI）可能会在 维持研究不端行为的调查结果 时 施加各种处罚 。这些处罚可能包括：
Ⅰ、Correction of the research record.
Ⅱ、Letters of reprimand.
Ⅲ、Suspension or termination of a research grant.
Ⅳ、Suspension or debarment from receiving federal funds.
1、研究记录的 更正 。
2、 申斥信 。
3、 中止或终止研究资助 。
4、 暂停或禁止接受联邦资金 。
When administrative actions are imposed by ORI (or the FDA, who has their own bulletin boards for debarred and disqualified investigators), the names of the individuals will be made public.
当ORI（或FDA，他们有自己的公告栏供被禁止和被取消资格的调查人员使用）采取 行政行动 时，这些人的 姓名将被公布 。
If the ORI believes that research misconduct may have involved criminal or civil fraud, it will refer the matter promptly to an investigative body such as the Department of Justice or the Office of the Inspector General, Department of Health and Human Services.
如果调查机构认为研究不端行为 可能涉及刑事或民事欺诈 ，它将迅速将此事 提交司法部 或 卫生和公众服务部监察长办公室 等调查机构。
ICH GCP was put together and became operational after public outcry of research misconduct that had occurred over the years. Following the ICH GCP guideline assists in preventing fraud and misconduct. So research misconduct is also a form of non-compliance to ICH GCP
ICH GCP是在公众对多年来发生的研究不端行为提出强烈抗议后成立并开始运作的 。遵循ICH GCP指南有助于防止欺诈和不当行为。因此，研究不端行为也是不遵守ICH GCP的一种形式（？）。
Ⅰ、Federal policy defines research misconduct as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” This definition does not include honest error or differences of opinion or authorship disputes unless they involve plagiarism.
1、联邦政策将 研究不端行为 定义为“在提出、执行或审查研究或报告研究结果时捏造、伪造或剽窃。”该定义不包括诚实的错误、意见分歧或著作权争议，除非涉及剽窃。
Ⅱ、Federal policy on research misconduct applies to all federally funded research and all proposals submitted to federal agencies for research funding.
2、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 。
Ⅲ、The Office of Research Integrity (ORI) in the Department of Health and Human Services oversees investigations of research misconduct allegations and makes final determinations on findings of research misconduct within the U.S. Public Health Service.
3、卫生与公共服务部的研究诚信办公室（ORI） 负责监督对研究不当行为指控的调查 ，并 对美国公共卫生服务部门的研究不当行为调查结果做出最终决定 。
Ⅳ、Federal policy places the primary responsibility for reporting and investigating allegations of research misconduct with researchers and research institutions.
4、联邦政策将 报告和调查科研不端行为指控的主要责任 交给 研究人员和研究机构 。
Ⅴ、Generally, the response to an allegation of research misconduct has three stages:
i、Inquiry (to assess the facts of the allegation).
ii、Investigation (if the inquiry provides adequate basis for one).
iii、Adjudication (imposing of suitable penalties if the allegation is found to have merit).
5、一般而言，对研究不当行为指控的回应分为三个阶段：
（1） 初步调查 （评估指控的事实）。
（2） 正式调查 （如果调查提供了充分的依据）。
（3） 裁决 （如果发现指控有价值，则施加适当的处罚）。
Ⅵ、Penalties for research misconduct may include termination of employment, suspension or termination of a research grant, and suspension or debarment from receiving federal funds.
6、对研究不端行为的处罚可能包括 终止雇佣 、 暂停或终止研究资助 ，以及 暂停或禁止接受联邦资金 。
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