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1United States mandate for IRBs

Toggle United States mandate for IRBs subsection

1.1Exceptions

2International ethics review committees

3Naming and composition

4Convened and expedited reviews

5Pharmaceutical trials and good clinical practice

6Adapting IRB review to social science

7Adapting IRB review to big data research

8Relationship with citizen science

9Managing conflicts of interest

10See also

11References

12Further reading

13External links

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Institutional review board

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From Wikipedia, the free encyclopedia

Type of committee that applies research ethics

This article is about research ethical oversight in the United States. For a worldwide perspective, see Ethics committee.

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB reviews is to ensure that study participants are not harmed (or that harms are minimal and outweighed by research benefits). Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances. Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with national and international norms, regulations or codes.[1]

The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of people participating in a research study. A key goal of IRBs is to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects, and seeks to maximize the safety of subjects. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted.[2]

IRBs are most commonly used for studies in the fields of health and the social sciences, including anthropology, sociology, and psychology. Such studies may be clinical trials of new drugs or medical devices, studies of personal or social behavior, opinions or attitudes, or studies of how health care is delivered and might be improved. Many types of research that involves humans, such as research into which teaching methods are appropriate, unstructured research such as oral histories, journalistic research, research conducted by private individuals, and research that does not involve human subjects, are not typically required to have IRB approval.

United States mandate for IRBs[edit]

See also: Human subject research legislation in the United States

Formal review procedures for institutional human subject studies were originally developed in direct response to research abuses in the 20th century. Among the most notorious of these abuses were the experiments of Nazi physicians, which became a focus of the post-World War II Doctors' Trial, the Tuskegee Syphilis Study, a long-term project conducted between 1932 and 1972 by the U.S. Public Health Service, and numerous human radiation experiments conducted during the Cold War. Other controversial U.S. projects undertaken during this era include the Milgram obedience experiment, the Stanford prison experiment, and Project MKULTRA, a series of classified mind control studies organized by the CIA.

The result of these abuses was the National Research Act of 1974 and the development of the Belmont Report, which outlined the primary ethical principles in human subjects review; these include "respect for persons", "beneficence", and "justice". An IRB may only approve research for which the risks to subjects are balanced by potential benefits to society, and for which the selection of subjects presents a fair or just distribution of risks and benefits to eligible participants. A bona fide process for obtaining informed consent from participants is also generally needed. However, this requirement may be waived in certain circumstances – for example, when the risk of harm to participants is clearly minimal.

In the United States, IRBs are governed by Title 45 Code of Federal Regulations Part 46.[3] These regulations define the rules and responsibilities for institutional review, which is required for all research that receives support, directly or indirectly, from the United States federal government. Specifically, research on human subjects that is conducted by any institution must be reviewed by that institution's review board if it is not an exempt type and it also involves:

is conducted by the federal government,[4]

involves any type of federal funding (e.g., a research grant from the National Institutes of Health),[4][5] or

testing an FDA-regulated product.[4][5]

Additionally, the states of California or Maryland have more expansive rules for reviewing research that is conducted within those two states.[5] Many institutions that engage in substantial amounts of research, such as research universities and research hospitals, have their board reviews all research programs, even though it is not required, as a matter of their own internal policy.[4][5]

IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS). Additional requirements apply to IRBs that oversee clinical trials of drugs involved in new drug applications, or to studies that are supported by the United States Department of Defense. In the United States, the Food and Drug Administration (FDA) and the OHRP have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are "scientific", "ethical", and "regulatory". The equivalent body responsible for overseeing U.S. federally funded research using animals is the Institutional Animal Care and Use Committee (IACUC).

In addition to registering its IRB with the OHRP, an institution is also required to obtain and maintain a Federalwide Assurance or FWA, before undertaking federally funded human research.[6] This is an agreement in which the institution commits to abiding by the regulations governing human research. A secondary supplement to the FWA is required when institutions are undertaking research supported by the U.S. Department of Defense.[7] This DoD Addendum includes further compliance requirements for studies using military personnel, or when the human research involves populations in conflict zones, foreign prisoners, etc.[8]

Exceptions[edit]

U.S. regulations identify several research categories that are considered exempt from IRB oversight. These categories include:

Research in conventional educational settings, such as those involving the study of instructional strategies or effectiveness of various techniques, curricula, or classroom management methods. In the case of studies involving the use of educational tests, there are specific provisions in the exemption to ensure that subjects cannot be identified or exposed to risks or liabilities.[9]

Research involving the analysis of existing data and other materials, where the data is either already publicly available or will be analyzed such that individual subjects cannot be identified.[9]

Studies intended to assess the performance or effectiveness of public benefit or service programs, or to evaluate food taste, quality, or consumer acceptance.[9]

Generally, human research ethics guidelines require that decisions about exemption are made by an IRB representative, not by the investigators themselves.[10]

Additionally, research projects conducted outside of a federal government agency or government-funded institution, such as a citizen science project conducted by a private individual or a group of private individuals, are generally not required to be approved by any institutional review board, unless the project is funded by the US federal government.[4][5]

International ethics review committees[edit]

Main article: Ethics committee

Numerous other countries have equivalent regulations or guidelines governing human subject studies and the ethics committees that oversee them. However, the organizational responsibilities and the scope of the oversight purview can differ substantially from one nation to another, especially in the domain of non-medical research. The United States Department of Health and Human Services maintains a comprehensive compilation of regulations and guidelines in other countries, as well as related standards from a number of international and regional organizations.[11]

Naming and composition[edit]

Although "IRB" is a generic term used in the United States by the FDA and HHS, each institution that establishes such a board may use whatever name it chooses. Many simply capitalize the term "Institutional Review Board" as the proper name of their instance. Regardless of the name chosen, the IRB is subject to the US FDA's IRB regulations when studies of FDA-regulated products are reviewed and approved. At one time, such a committee was named the "Committee for the Protection of Human Subjects".

Originally, IRBs were simply committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical problems. Today, some of these reviews are conducted by for-profit organizations known as independent or commercial IRBs. Anyone, including private individuals, can pay a commercial IRB for review.[4] The responsibilities of these IRBs are identical to those based at academic or medical institutions, and within the US, they are governed by the same US federal regulations.

While its composition varies, it often includes a balance of academia and non-academia members. This serves to provide a greater scope of understanding which helps ensure ethics in research. In the US, regulations set out the board's membership and composition requirements, with provisions for diversity in experience, expertise, and institutional affiliation. For example, the minimum number of members is five, at least one scientist, and at least one non-scientist. The guidance strongly suggests that the IRB contain both men and women, but there is no regulatory requirement for gender balance in the IRB's membership. The full requirements are set out in 21 CFR 56.107.[12]

As IRBs are normally staffed with employees, who have to be paid, there are costs to operating them. In 2001, the cost of operating an IRB typically ranged from about $75,000 to $770,000 ($124,000 to $1,273,000, after accounting for inflation) per year, depending on the volume of research reviewed.[13]

Convened and expedited reviews[edit]

Unless a research proposal is determined to be exempt (see below), the IRB undertakes its work either in a convened meeting (a "full" review) or by using an expedited review procedure.[14] When a full review is required, a majority of the IRB members must be present at the meeting, at least one of whom has primary concern for the nonscientific aspects of the research.[14] The research can be approved if a majority of those present are in favor.[14]

An expedited review may be carried out if the research involves no more than minimal risk to subjects, or where minor changes are being made to previously approved research.[15] The regulations provide a list of research categories that may be reviewed in this manner.[15] An expedited review is carried out by the IRB chair, or by their designee(s) from the board membership. In the US, research activity cannot be disapproved by expedited review.[15]

Pharmaceutical trials and good clinical practice[edit]

The International Conference on Harmonisation sets out guidelines for registration of pharmaceuticals in multiple countries. It defines Good Clinical Practice (GCP), which is an agreed quality standard that governments can transpose into regulations for clinical trials involving human subjects.[16]

Here is a summary of several key regulatory guidelines for oversight of clinical trials:

Safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension.

Obtain trial protocol(s)/amendment(s), written Informed Consent Form(s) (ICFs) and consent form updates the investigator proposes for use in the trial, subject recruitment procedures (e.g., advertisements), written information to be provided to subjects, investigator's brochure, available safety information, information about payments and compensation available to subjects, the investigator's current curriculum vitae and/or other documentation evidencing qualifications, and any other documents the IRB may need to fulfill its responsibilities.

Review both the amount and method of payment to subjects to assure neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject. Information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, should be set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified.

Ensure that the proposed trial is reviewed within a reasonable time and document opinions and decisions in writing, clearly identifying the trial, the documents reviewed and recorded dates for approvals, required modifications prior to approval, disapproval of a proposed trial, or termination/suspension of any prior approval. Continuing review of ongoing trials is required at intervals appropriate to the degree of risk to human subjects, but at least once per year.

The reviewers may also request that more information be given to subjects when, in their judgment, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects. When a non-therapeutic trial is to be carried out with the consent of the subject's legally acceptable representative, reviewers should determine that the proposed protocol and/or other document(s) adequately address relevant ethical concerns and meets applicable regulatory requirements for such trials. Where the protocol indicates prior consent of the trial subject or the subject's legally acceptable representative is not possible, the review should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e., in emergency situations).

Adapting IRB review to social science[edit]

While the Belmont principles and U.S. federal regulations were formulated with biomedical and social-behavioral research in mind, the enforcement of the regulations, the examples used in typical presentations regarding the history of the regulatory requirements, and the extensiveness of written guidance have been predominantly focused on biomedical research.

Numerous complaints by investigators about the fit between the federal regulations and its IRB review requirements as they relate to social science research have been received.[17] Broad complaints range from the legitimacy of IRB review, the applicability of the concepts of risk as it pertains to social science (e.g., possibly unneeded, over-burdensome requirements), and the requirements for the documentation of participants' informed consent (i.e., consent forms).[18] Researchers have tried to determine under what instances participants are more likely to read informed consent forms, and ways to improve their efficacy in the social sciences.[19] Social scientists have criticized biomedical IRBs for failing to adequately understand their research methods (such as ethnography). For this reason, some large research institutions have set up multiple specialized IRBs, and may have one committee that exclusively oversees social science research.

In 2003, the US Office for Human Research Protections (OHRP), in conjunction with the Oral History Association and American Historical Association, issued a formal statement that taking oral histories, unstructured interviews (as if for a piece of journalism), collecting anecdotes, and similar free speech activities often do not constitute "human subject research" as defined in the regulations and were never intended to be covered by clinical research rules.[20]

Other US federal agencies supporting social science have attempted to provide guidance in this area, especially the National Science Foundation. In general, the NSF guidelines assure IRBs that the regulations have some flexibility and rely on the common sense of the IRB to focus on limiting harm, maximizing informed consent, and limiting bureaucratic limitations of valid research.[21]

Adapting IRB review to big data research[edit]

Aspects of big data research pose formidable challenges for research ethics and thus show potential for wider applicability of formal review processes.[22][23][24] One theme is data breaches, but another with high difficulty is potentially dangerous predictive analytics with unintended consequences, via false-positives or new ways to invade privacy. A 2016 article on the hope to expand ethics reviews of such research included an example of a data breach in which a big data researcher leaked 70,000 OkCupid profiles with usernames and sexual orientation data.[23] It also gave an example of potential privacy invasion and government repression in which machine learning was used to build automated gaydar, labeling strangers as "probably gay" based on their facial photographs.[23] Analogies with phrenology[22] and Nazis identifying people as "probably part-Jewish" based on facial features have been made to show what can go wrong with research whose authors may have failed to adequately think through the risks of harm. Such challenges broach familiar themes, such as mistaken identity, pre-crime, and persecution, in new applications.

Relationship with citizen science[edit]

Generally speaking, citizen science, whether conducted by a single private individual or a group of individuals, is not required to follow the IRB process.[4] This is true even if some of the individuals involved are professional researchers or are also employed at institutions that normally review all research conducted by the institution.[4]

However, many academic journals require proof of IRB approval for all human-subject research, even when it is not legally required, which means that citizen scientists may be unable to publish scientific papers describing their findings.[4] Citizen scientists who expect to need IRB approval for publication or to comply with the terms of a research grant can pay a commercial IRB company.[4] In the US, a standard initial review often costs a few thousand dollars; a review to determine that the project is less expensive.[25]

The IRB-based approach to ethics assumes that human-subject research is conducted by an institution employing researchers, and that the institution and researchers have far more power and knowledge than the participants. The researchers and the participants are seen as distinct groups, and the concern is to prevent the researchers from exploiting the participants as a means to an end. This leads to IRBs issuing requirements such as having researchers explain the research project and obtain informed consent. However, this model does not always fit citizen science projects, especially when the participants are themselves the experts and researchers.[4] In such cases, a requirement to explain the project means participants would absurdly be informing themselves of their own plans. In a citizen science project, the boundaries between the researcher and the participant are blurred.[26] Similarly, many institutionally-driven research programs are limiting or prohibiting the return of results to individuals, especially for genetic or medical studies, for fear that some participants could be harmed if they misunderstand the results.[4] In this restrictive model, the participant never finds out their test results, or they can only find out their test results if the researchers carefully explain the results to them. But in a citizen science project, learning the results is a highly desired reason for participating, and, since the researchers are themselves participants, it would be impossible to prevent them from obtaining the results.

Managing conflicts of interest[edit]

While the IRB approval and oversight process is designed to protect the rights and welfare of the research subjects, it has been the subject of criticism, by bioethicists and others, for conflicts of interest resulting in lax oversight.[27][28] In 2005, the for-profit Western Institutional Review Board claimed to conduct the majority of reviews for new drug submissions to the FDA.[29] In a 2006 study of 575 IRB members at university medical centers, over one-third reported industry financial ties, and over one-third admitted they "rarely or never" disclosed conflicts of interest to other board members.[30]

In 2009 the US Government Accountability Office (GAO) set up a series of undercover tests to determine whether the IRB system was vulnerable to unethical manipulation. In one test, a fake product "Adhesiabloc" was submitted to a number of IRBs for approval for human tests. The product, company, and CVs of the supposed researchers were all fictitious and documents were forged by the GAO. The product was deliberately formulated to match some "significant risk" criteria of the FDA and was described by GAO as a "gel that would be poured into a patient's stomach after surgery to collect the bits and pieces left over from an operation." Despite this, one IRB approved the device for human testing. Other IRBs to whom the device was submitted rejected the application, one of them saying it was "the riskiest thing I've ever seen on this board". However, none of the IRBs approached detected that the company and product were fake. The GAO also set up a fake IRB and obtained requests for approval from companies. They succeeded in getting assurance approval from the HHS for their fake IRB. At the time, the US HHS has only three staff to deal with 300 IRB registrations and 300 assurance applications per month. HHS stated that it would not be worthwhile to carry out additional evaluation even if they had the staff to do it.[31][32][33][34][35]

请问IEC(独立伦理委员会)和IRB(机构审查委员会)的区别是什么？ - 知乎

请问IEC(独立伦理委员会)和IRB(机构审查委员会)的区别是什么？ - 知乎首页知乎知学堂发现等你来答切换模式登录/注册临床试验CRO临床药学CRA药物临床试验请问IEC(独立伦理委员会)和IRB(机构审查委员会)的区别是什么？IEC Independent Ethics Committee IRB Institutional Review Board 根据ICH GCP中对…显示全部关注者11被浏览71,593关注问题写回答邀请回答好问题 3添加评论分享4 个回答默认排序临床试验Note东南大学公共卫生硕士关注你的IRB英文不完全正确，应该是Institutional Review Board，而非independent。两者职能上没有区别（均为保护受试者权益，文件审阅等），区别的是不同地域的称呼不同，美国加拿大那边一般称IRB。IRB不是机构。编辑于 2019-04-03 22:22赞同 42 条评论分享收藏喜欢收起丢妈Elsa中国药科大学药物代谢动力学硕士关注你可以理解成，IEC是伦理，IRB是机构发布于 2019-03-24 13:34赞同3 条评论分享收藏喜欢收起

伦理委员会？机构审查委员会？他俩什么关系？ - 知乎

伦理委员会？机构审查委员会？他俩什么关系？ - 知乎首发于一线临床试验——经验分享切换模式写文章登录/注册伦理委员会？机构审查委员会？他俩什么关系？一线临研人复旦大学药学硕士伦理委员会（Ethical Committee，EC），是一个由医学、科学专业人员及非医学、非科学人员共同组成的独立体；可以为研究单位、地区、国家的或跨国的审查机构或委员会。EC的职责—对临床试验方案、研究者资格及获得并签署受试者知情同意书的方法和相关资料进行审批或提建议，以确认临床试验所涉及的受试者的权益、安全性和健康得到保护，并对此保护提供公众保证。伦理委员会（Ethical Committee，EC）=机构审查委员会（Institution Review Board，IRB）。二者没有本质不同，只是因为在不同国家，采取的称呼不同而已。其实是一回事。EC/IEC——欧盟的伦理委员会 vs. IRB——美国的伦理委员会编辑于 2021-01-26 07:32伦理临床试验赞同 61 条评论分享喜欢收藏申请转载文章被以下专栏收录一线临床试验——经

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中国教育部发布《高等学校预防与处理学术不端行为办法》

为有效预防和严肃查处高等学校发生的学术不端行为，维护学术诚信，促进教学科研和学术研究的健康发展，根据《中华人民共和国高等教育法》《中华人民共和国科学技术进步法》《中华人民共和国学位条例》等法律法规，教育部研究起草了《高等学校预防与处理学术不端行为办法》。该《办法》已由2016年6月发布，自2016年9月1日起开始实施。

《高等学校预防与处理学术不端行为办法》

中国七部门印发的《发表学术论文“五不准”》

为弘扬科学精神，加强科学道德和学风建设，抵制学术不端行为，端正学风，维护风清气正的良好学术生态环境，重申和明确科技工作者在发表学术论文过程中的科学道德行为规范，中国科协、教育部、科技部、卫生计生委、中科院、工程院和自然科学基金会共同研究制定了《发表学术论文“五不准”》。

发表学术论文“五不准”

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本“五不准”中所述“第三方”指除作者和期刊以外的任何机构和个人；“论文代写”指论文署名作者未亲自完成论文撰写而由他人代理的行为；“论文代投”指论文署名作者未亲自完成提交论文、回应评审意见等全过程而由他人代理的行为。

BMJ对研究的伦理审查

BMJ在伦理道德方面的政策是为了确保由BMJ发表的所有文章只报告符合道德标准的研究，并期望作者能够严格遵守世界医学协会（WMA）的《赫尔辛基宣言》。为了落实这一点，但凡涉及到人体受试者的投稿，哪怕作者将其定义为描述性研究，我们都会采取各种措施严格评价投稿所涉及的伦理层面的问题，包括调查、审计甚至辩论。

我们的伦理道德政策是在BMJ伦理委员会的帮助与建议下创建的，下面对其中的关键点逐一作出解释。

伦理审查声明

我们要求投稿至BMJ期刊的每篇研究文章都附带一份伦理审查声明，清晰说明该研究已经获得伦理审查批准（或者声明不需要伦理审查并交代原因）。声明中需写明伦理审查委员会（ethics committee，美国一般称为institutional review board）的名称、批准书的编号以及一份受试者事先已签署知情同意书的声明。

此外，我们十分欢迎研究人员和作者就如何考量和辩证研究的伦理道德基础给出更细致的解释。如果在稿件中没有合适的位置交代细节，可以在投稿信（covering letter）中进行解释，或者在投稿时已单独的补充文件上传。同时，我们鼓励作者为研究的受试者提供解释性文件。虽然在最后发表的文章中不一定为出现这些具体的解释性信息，但在文章的评审过程中，我们可能会为审稿人和编委会提供这些信息，这点非常重要。作为同行评审政策的一部分，我们已经要求审稿人对文章的伦理层面做出评价。

对伦理问题的评价

在稿件的评审过程中，对伦理问题的考量不只是看受试者有否提供知情同意书这么简单。当然，这是其中非常重要的一个方面。编辑需要判断研究的总体设计和每个环节的执行是否在道德上成立。以下是编辑通常考虑的一些问题：

• 某措施与现有常见的（普遍接受的、地区性的）临床实践有多大的不同？

• 对患者（或其他人）会施加什么样（额外）的负担？

• 对患者（或其他人）会构成什么样（额外）的风险？

• 对患者（或其他人）可能产生什么益处？

• 对社会（今后的患者）有什么潜在的益处？

即使作者已从所在机构相应的伦理审查委员会获得了审核批准，期刊编辑依然可能对该项研究的伦理考量存在疑虑。这种情况下，编辑可能会向作者索要更详细的信息，譬如：

• 作者如何辩证研究工作的伦理道德基础

• 要求作者提供相关伦理审查委员会的联系方式，以便于期刊直接从该委员会获取更多信息和解释

• 未经伦理审查委员会审核的研究，要求作者说明考量了哪些具体的伦理问题，是如何搭建的研究的伦理基础的。

编辑可能会邀请其他同事一同评估一篇文章的伦理因素、作者的解释以及相关伦理审查委员会对期刊所提出的有关伦理批准的问题所作出的回应。这一过程有可能在期刊编辑之间非正式地完成，也可能以更正式的方式通过向BMJ伦理委员会或者COPE咨询意见来实现。向BMJ伦理委员会或COPE提出的问题，都会被相关编辑编写成匿名的概要，不会披露文章和作者的真实信息。

期刊认为不符合伦理标准时采取的措施

我们认为期刊编辑有责任对不符合伦理道德的行为采取审计或调查，目的不是为了惩罚作者，而是避免不道德行为和保护患者。

当编辑认为某篇稿件背后的研究存在伦理问题，不管有没有伦理委员会和/或COPE的意见，她/他都可能寻求更多的意见或者直接建议调查或采取措施。即使文章由于其它科学或编辑原因肯定会被拒稿，编辑依然会对严重伦理问题进行必要的调查。

首先，编辑通常会联系研究所在机构的系/科室主任（head of department）表达期刊的顾虑，并建议开展机构内部调查。然后，编辑可能会致信研究的担保人或项目负责人（guarantor or principal investigator）所在的专业注册团体。比如，如果项目负责人是英国的一位医生，那么该专业注册团体就是英国医学总会（General Medical Council）。

特殊情况

罕见情况下，存在即使所报告的研究有一定伦理问题，期刊仍旧将文章发表的可能。一般导致这种情况发生的原因是由于各地区对于卫生保健与研究的资源和标准差异，所以在一种情景下完成的研究在另一种情景下未必会涉及到伦理标准。在决定是否发表这类文章时，我们会谨慎考虑研究的情景，并在发表文章对于社会的总体价值与对研究受试者潜在的伤害之间尽量平衡。

学术不端

学术不端的定义不尽相同。在BMJ，我们根据每一个个例来处理问题，但同时遵循出版伦理委员会（COPE）、世界医学编辑学会（WAME）和国际医学期刊编辑委员会（ICMJE）等专业团体的指南与规范。WAME在美国科研诚信办公室对学术不端的定义基础上稍作调整，给出了一个实用的概况，包括以下这些行为：

• 伪造数据：包括凭空捏造数据、欺骗性报告研究结果、隐匿冲突数据、蓄意隐瞒或扭曲数据

• 剽窃（抄袭）：将别人的语言表述、想法等占位己用，造成原创的效果，而不指出其真正来源

• 作者署名不当：功劳归属不当，比如排除某位作者（ghost author）、同一材料在多篇文章变相利用、将没有充分贡献的人士列为作者（guest author）、在未经所有作者同意的情况下递交投稿

• 盗用他人想法：学术活动的其中一个重要环节就是同事间想法的交流。学者在诸如审核基金申请和评审稿件的过程中均可获取到他人的创意。然而，对所获信息的不当利用便可构成欺诈。大规模盗用就属于学术不端行为。

• 违反普遍接受的研究行为规范：与提出或执行研究普遍接受的规范有严重偏差，不当操控实验以获得偏见的结果，欺骗性解读和分析数据或者对结果的不当报告

• 与影响研究的立法和监管要求严重不符：包括但不局限于对当地适用法规的严重的或重大的、重复的、蓄意的违反，涉及到以下几个方面：资金的使用、对动物的关怀、人体受试者、研究用药物、重组产品、新设备或放射性、生物或化学材料

• 与学术不端行为相关的不当行为：包括对学术不端行为的无事实依据的或故意地虚假指控，对已知的或疑似的学术不端行为不举报，对某个不端行为或指控隐藏信息以及对指控或调查中涉及到的人采取报复行为

包括BMJ期刊在内的许多期刊也把冗余出版（redundant publication）和重复出版（duplicate publication）、缺乏利益冲突声明和资金/赞助声明、其它不透明行为视为学术不端的一种。

应对学术不端指控

我们严格对待所有潜在的学术不端行为。如果编辑怀疑某篇投稿所描述的某些内容可能存在研究、出版或专业行为的学术不端行为，我们可能会在隐去关键身份信息的前提下与BMJ伦理委员讨论。

如果在与作者讨论后仍无法解答编辑的顾虑，我们会将该案例上报至相关权威机构。如果在文章的评审过程中，编辑被告知该稿件可能与另一篇文章存在问题（比如欺骗性数据），编辑可能会联系已发表文章所在的期刊。

读者在阅读已发表的文章时，如果发现疑似学术不端行为，请积极通知相关期刊编辑或BMJ的出版人。

BMJ的所有期刊都是COPE会员。研究和出版不端行为都可以以匿名方式向COPE报告。

有用的参考文献

研究伦理

• American Association of Medical Colleges (AAMC)

• Canadian guidelines on Ethical Conduct for Research Involving Humans

• NHS Research Ethics Committee

• Indian Council of Medical Research’s Ethical Guidelines for Biomedical Research on Human Subjects

• US Office of Research Integrity

• World Medical Association Declaration of Helsinki

出版伦理

• International Committee of Medical Journal Editors

• Committee on Publication Ethics (COPE)

• COPE - flow charts for handling misconduct（期刊编辑处理学术不端行为的流程图，对作者也有参考意义，有中文译版供下载）

• COPE – guidelines on when and how to retract published articles（关于撤稿的说明）

• World Association of Medical Editors (WAME)

有关伦理的网络资源

• Applied Ethics Resources on the web

• National Institutes of Health Bioethics Resources on the web

• Journal of Medical Ethics

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Beyond Criticism of Ethics Review Boards: Strategies for Engaging Research Communities and Enhancing Ethical Review Processes | Journal of Academic Ethics

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Journal of Academic Ethics

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Beyond Criticism of Ethics Review Boards: Strategies for Engaging Research Communities and Enhancing Ethical Review Processes

Published: 15 July 2021

Volume 20, pages 549–567, (2022)

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Andrew Hickey

ORCID: orcid.org/0000-0002-9862-64441, Samantha Davis1, Will Farmer1, Julianna Dawidowicz1, Clint Moloney1, Andrea Lamont-Mills1, Jess Carniel1, Yosheen Pillay1, David Akenson1, Annette Brömdal1, Richard Gehrmann1, Dean Mills1, Tracy Kolbe-Alexander1, Tanya Machin1, Suzanne Reich1, Kim Southey1, Lynda Crowley-Cyr1, Taiji Watanabe1, Josh Davenport1, Rohit Hirani1, Helena King1, Roshini Perera1, Lucy Williams1, Kurt Timmins1, Michael Thompson1, Douglas Eacersall1 & …Jacinta Maxwell1 Show authors

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AbstractA growing body of literature critical of ethics review boards has drawn attention to the processes used to determine the ethical merit of research. Citing criticism on the bureaucratic nature of ethics review processes, this literature provides a useful provocation for (re)considering how the ethics review might be enacted. Much of this criticism focuses on how ethics review boards deliberate, with particular attention given to the lack of transparency and opportunities for researcher recourse that characterise ethics review processes. Centered specifically on the conduct of ethics review boards convened within university settings, this paper draws on these inherent criticisms to consider the ways that ethics review boards might enact more communicative and deliberative practices. Outlining a set of principles against which ethics review boards might establish strategies for engaging with researchers and research communities, this paper draws attention to how Deliberative communication, Engagement with researchers and the Distribution of responsibility for the ethics review might be enacted in the day-to-day practice of the university human ethics review board. This paper develops these themes via a conceptual lens derived from Habermas’ (The theory of communicative action. Volume 1: Reason and the rationalization of society, 1984) articulation of ‘communicative action’ and Fraser’s (Social Text, 25(26), 56–80, 1990) consideration of ‘strong publics’ to cast consideration of the role that human ethics review boards might play in supporting university research cultures. Deliberative communication, Engagement with researchers and the Distribution of responsibility provide useful conceptual prompts for considering how ethics review boards might undertake their work.

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NotesAn exception is found in Allen’s (2008) accounts. We draw on this example in the later sections of this paper and extend Allen’s considerations of the participatory model he proposes.These documents have led to the development of further codes and guidelines, including the United States National Commission for the Protection of Human Subjects’ (1989) Belmont Report: Principles of Ethical Research with Human Subjects. The historical context that defines current ethical review processes is summarised in the following:There has…been increased attention to ethical reflection about human research since the Second World War. The judgment of the Nuremberg military tribunal included ten principles about permissible medical experiments, since referred to as the Nuremberg Code. Discussion of these principles led the World Medical Assembly in 1964 to adopt what came to be known as the Helsinki Declaration, revised several times since then. The various international human rights instruments that have also emerged since the Second World War emphasise the importance of protecting human beings in many spheres of community life. During this period, written ethical guidelines have also been generated in many areas of research practice as an expression of professional responsibility. (Australian Government, 2007/2018, p. 3).As a summary of the guiding principles that frame the considerations of ethical conduct contained in these (and similar) documents, we offer the following typology as a summary of the key tenets common to contemporary guidelines. In general terms, most guidelines give attention to the following:- Research Design: how is the research defined? What merit does this research maintain and what value does it hold? How will the methodological fidelity of stated procedures be ensured?- Benefits and Risks: how are the inherent risks associated with the research weighed in terms of an intent toward nonmaleficence?- Participant Recruitment: how will participants be informed of the research and recruited into its conduct?- Research Conduct: how will the treatment of participants proceed as part of the research? How will participants be informed of developments in the research and its ongoing effects?- Presentation of Research Outcomes: how will findings from the research be developed and disseminated? How will the storage and ongoing use and interpretation of data proceed?The Australian Government National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007/2018) provides an indicative illustration of how these principles are articulated in contemporary codes and guidelines:The relationship between researchers and research participants is the ground on which human research is conducted… respect for human beings, research merit and integrity, justice, and beneficence help to shape that relationship as one of trust, mutual responsibility and ethical equality…The values of respect, research merit and integrity, justice, and beneficence have become prominent in the ethics of human research in the past six decades, and they provide a substantial and flexible framework for principles to guide the design, review and conduct of such research. (p. 9).We note that particular attention toward respect, merit, integrity, justice and beneficence frame these considerations. For instance, this sentiment is outlined in the National Health and Medical Research Council’s (2018) accompanying Australian Code of Responsible Conduct of Research, (2018). The code highlights that attention should be given to ensuring the following:• Respect for research participants, the wider community, animals and the environment.• Treat human participants and communities that are affected by the research with care and respect, giving appropriate consideration to the needs of minority groups or vulnerable people.• Ensure that respect underpins all decisions and actions related to the care and use of animals in research.• Minimise adverse effects of the research on the environment. (p. 5).As an indication of the minimum requirements for the constitution of a review board, the Australian Government National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007/2018) details the following membership requirements:The constitution of the ethics review board is an important aspect of the review process. A wide range of expertise and disciplinary knowledge is typically sought in the membership, with ‘pastoral’ and ‘lay’ membership also a feature of most review boards’ constitution. The Australian Government’s National Health and Medical Research Council’s (2007/2018) National Statement on Ethical Conduct in Human Research for example highlights that review board membership should include the following:Composition of Human Research Ethics Committees [HREC].5.1.29 The minimum membership of an HREC is eight. As far as possible:(a) there should be equal numbers of men and women; and.(b) at least one third of the members should be from outside the institution for which the HREC is reviewing research.5.1.30 This minimum membership is:(a) a chairperson, with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under this National Statement;(b) at least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work;(c) at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional;(d) at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion;(e) at least one lawyer, where possible one who is not engaged to advise the institution; and.(f) at least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend. 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Principles and Practice of Clinical Trials pp 1–22Cite as

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Principles and Practice of Clinical Trials

Living reference work entry

Institutional Review Boards and Ethics Committees

Keren R. Dunn3

Living reference work entry

First Online: 06 January 2022

140 Accesses

AbstractInstitutional review boards (IRBs) are committees established in accordance with US federal regulations to review and monitor clinical trials and other research with human subjects. IRBs evolved from a history of egregious ethical violations in research with human subjects and the ethics codes and declarations that ensued, and were first mandated by US law in 1974, with the passing of the National Research Act. IRBs help to ensure the protection of the rights and welfare of human subjects by applying the ethical principles of the Belmont Report, respect for persons, beneficence, and justice, in their review of research projects. They have the authority to approve, require modifications to, or disapprove proposed research. IRBs review plans to obtain and document informed consent from research participants and can waive the requirements for informed consent in certain circumstances. IRBs may exist within the institution where research is being conducted or institutions can rely on an external IRB with a written agreement. While the term IRB is unique to the USA, clinical trials internationally adhere to the ethical principles of the Declaration of Helsinki, which requires independent review by an ethics committee.KeywordsInstitutional review boardIRBEthics committeeBelmont ReportCommon RuleInformed consent

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Keren R. Dunn .Editor informationEditors and AffiliationsSamuel Oschin Comprehensive Cancer Insti, WEST HOLLYWOOD, CA, USASteven Piantadosi Bloomberg School of Public Health, Johns Hopkins Center for Clinical Trials Bloomberg School of Public Health, Baltimore, MD, USACurtis L. Meinert Section Editor informationCenter for Observational Research, Amgen Inc, South San Francisco, CA, USAWinifred Werther Ph.DThe Johns Hopkins Center for Clinical Trials and Evidence Synthesis, Johns Hopkins School of Public Health, Baltimore, MA, USACurtis L. MeinertBrigham and Women’s Hospital, Harvard Medical School, Boston, MA, USASteven PiantadosiRights and permissionsReprints and permissionsCopyright information© 2021 Springer Nature Switzerland AGAbout this entryCite this entryDunn, K.R. (2021). Institutional Review Boards and Ethics Committees.

In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_65-1Download citation.RIS.ENW.BIBDOI: https://doi.org/10.1007/978-3-319-52677-5_65-1Received: 06 July 2021Accepted: 25 July 2021Published: 06 January 2022

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干货分享|到底什么是伦理声明？什么情况下需要提供伦理声明(附模板)？ - 知乎

干货分享|到底什么是伦理声明？什么情况下需要提供伦理声明(附模板)？ - 知乎首发于EA-ISET学术小贴士切换模式写文章登录/注册干货分享|到底什么是伦理声明？什么情况下需要提供伦理声明(附模板)？学术小贴士人生任何一条路都是打开新世界的机会有这么一项材料在投稿时很容易被作者忽视，即伦理声明（Ethical Statement）。如果作者在投稿时没有提供伦理声明，很容易被SCIE 期刊拒稿。现在，许多期刊的“Ethical Statement”是标准文本，在投稿过程中系统会显示，作者认真查阅后同意就可以了。有些期刊则需要伦理道德声明表，不同期刊有各自的道德声明格式，需要作者到期刊的网站上下载表格填写，有些期刊没有提供表单，以防万一，作者可以写信询问编辑是否需要递交伦理道德声明。Q: 什么情况下需要提供伦理声明？A: 如果研究涉及到人或者动物，如果是医学方向，涉及到病例报告等，作者一定要提供获得审批的道德审核单位或机构审查委员会名称以及核准编号。作者还要获得研究参与者的书面知情同意书，如果只有口头形式的知情同意，需要说明没有书面知情同意的原因。如果病例报告中有未成年人和残障人士，作者还要从监护人那里取得知情同意。要尊重患者的隐私权，任何能辨别出身份的信息，都不应该出现在影像、文字、照片的记录中，这些都需要进行声明。SAGE出版社旗下期刊的伦理声明政策译文：伦理声明Journal of Patient Experience请注意：如果您提交的是研究文章、病例报告或患者体验研究简报，必须遵守以下说明，即使在实验中没有使用动物或人类作为实验对象。如果您提交的是观点、特别关注、特写或给编辑的信，您可以不遵守这些说明。以下声明必须包含在稿件的结尾处，并列在各自的标题下。伦理批准，人权和动物权利声明，以及知情同意声明。当发表时，它们将显示如下。请注意：1. IRB的批准只针对人类研究，不包括使用动物对象的研究。2. 2. 使用动物对象的研究通常由机构动物护理和使用委员会（IACUC）批准。2. 使用动物对象的研究通常由机构动物护理和使用委员会（IACUC）批准，除非该研究是在另一个国家进行的，在这种情况下，它可能被称为完全不同的名称。在这种情况下，它可能被称为完全不同的东西伦理批准报告本病例的伦理批准来自*伦理委员会或机构审查委员会的名称（批准号/ID）。机构审查委员会（批准号/ID）*。或报道本系列病例的伦理批准是由*伦理委员会或机构审查委员会（批准号/ID）*获得的。或我们的机构在报告单个病例或系列病例时不需要伦理批准。或伦理批准不适用于此文章。2. 人权和动物权利声明本研究中的所有程序都是按照*伦理委员会或机构审查委员会（批准）的规定进行的。或机构审查委员会（批准号/ID）*批准的方案。或本文不包含任何涉及人类或动物的研究。3. 3. 知情同意的声明已获得患者的书面知情同意，他们的匿名信息将在本文中发表。或已从合法授权的代表处获得书面知情同意书，同意在本文中发表匿名的患者信息。在这篇文章中发表的患者信息。或获得患者的口头知情同意，在本文中发表他们的匿名信息。或从合法授权的代表那里获得口头知情同意，在本文中发表匿名的在这篇文章中发表的患者信息。或在本文中发表的患者信息没有获得知情同意，因为*原因*。或这篇文章中没有人类受试者，因此不适用知情同意。PLOS ONE期刊的伦理声明相关规定具体投稿时需要查看目标期刊的相关要求，按照作者指南的要求进行准备。以上就是今天EA-ISET协会给大家分享的内容了，祝科研顺利！欲了解更多科研热点及期刊信息可关注公众号“欧亚学术”~往期热点回顾：1.一手源刊|10月SCI/SSCI/EI刊源已更新, 新增多本TOP/CCF-B优质刊~2. 科研热点|2023申博倒计时！多个高校将迎一级学科博士点 (附名单)~3.【截稿专区】10月大批期刊即将截稿, 年前最后快刊, 1区SSCI仅28天录用~4.【重要通知】APC费用又双叒上涨啦！欲知详情，点击查看~5. 科研热点|发一篇SCI吃半年土？为何国际期刊版面费越来越贵？6.科研热点|2022下半年各省自然科学基金项目申报时间汇总~7.【新刊速递】这本2区SCI, 同领域被引次数排名第二，对国人友好~8. 10月第三周|8篇检索/2篇见刊/9篇录用(2区SCI仅24天录用)~9. 招募 | EA-ISET审稿专家招募令，期待志同道合的你！发布于 2022-10-24 10:15医学伦理伦理赞同 62 条评论分享喜欢收藏申请转载文章被以下专栏收录EA-ISET学术

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请问IEC(独立伦理委员会)和IRB(机构审查委员会)的区别是什么？ - 知乎

伦理委员会？机构审查委员会？他俩什么关系？ - 知乎

How to Set Up an Ethics Advisory Board

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