what is a research ethics committee

Subscribe to our Newsletter

Publications

Annual Conference

Research Ethics Support and Review

Code of Practice for Research

Checklist for Researchers

Checklist during COVID-19

Case Study Packs

Researcher Checklist of Ethics Applications

Concordat Self-Assessment Tool

What is a Research Ethics Committee?

Newsletter issues

Research ethics committees (RECs) are an important part of a healthy research culture. Their role is to consider the ethical implications of research. Traditionally this has focussed on the need to protect research participants (both human and animal), but in recent years their role in supporting researchers, and promoting research integrity more generally, has been increasingly recognised.

Two types of RECs

It is important to distinguish two types of research ethics committees. The first type is often set up to consider ethical issues that may be relevant to researchers working in specific areas. These might include the ethics of research into genetic modification, climate engineering, dual-use research (e.g., research with military applications), or research using potentially contentious methodologies such as “ human challenge ” trials (where participants are intentionally infected with diseases such as COVID). As these are difficult and complex areas, the main output is often in the form of guidance or position statements that can be applied by researchers, their institutions, funders, and ultimately policymakers. Consequently, these committees are convened at a fairly high level by organisations with an interest in the area of research being considered. They normally include scientific and legal experts alongside those with a specific interest in the topic under consideration (such as patient groups).

But the second, and far more common, type of research ethics committee is those set up by universities, research organisations, or health care providers (such as the NHS) to consider the ethical issues relating to individual, and often very specific, research projects. These Research Ethics Committees — abbreviated as RECs and referred to as Institutional Review Boards (IRBs) in the United States — provide a point-in-time review of a very detailed research protocol before the research is allowed to start. They aim to provide an opinion as to whether the research, if carried out in accordance with the detailed protocol, will meet accepted ethical norms. Exactly what these norms are, and how they can be addressed, is a complex question that may need to take into account guidance created by the first type of ethics committee described above. As such, although RECs still need to have suitably experienced individuals, it is more important that they are also suitably independent from the researcher (and their funder) to ensure they give an ethical opinion that is free from as many conflicts of interest as possible. Scientific or research expertise is important, but so is the voice of non-expert members. Quite often researchers will not be allowed to publish their work if they cannot prove it was reviewed by a REC before it started.

REC review supports research and researchers

REC review is criticised by researchers as being too lengthy, burdensome, or bureaucratic. This is often because it is confused with wider governance processes relating to issues such as data protection, health and safety, financial management, etc. While such issues are important, the fact that they are related to specific, often legally prescribed, arrangements means that they are governance issues that are the responsibility of the research institution (e.g., the university) to review and approve. The distinction between governance approvals , and ethics opinion , is extremely important if the aim is to create systems that provide robust, but proportionate, support to research and researchers. While in some contexts committees are expected to review both governance and ethics issues, there is an increasing recognition that governance is best handled separately by expert research officers, freeing RECs to consider the more complex ethical issues that may arise in any given research project.

Written by Dr Simon Kolstoe, UKRIO Trustee .

Research organisations and research ethics committees - ESRC

Our principles: research ethics committees.

All parties involved in research have an active role to play in creating and sustaining a culture of rigorous ethical reflection.

We acknowledge that RECs have many competing obligations, with duties to protect participants, researchers and research organisations which mean they are constantly working to achieve many goals; we encourage RECs to engage with researchers in all stages of a project’s research lifecycle.

The principles below should also be considered during any ongoing monitoring of ESRC-funded projects.

Research should aim to maximise benefit for individuals and society and minimise risk and harm

A REC review of a project should consider the ethical conduct of the research whilst also facilitating high quality ethical research; this includes high-impact activities and new forms of research, for example, co-production. The review should be proportionate to the potential benefits and level of risk of the proposed research. RECs should determine the degree of risk and potential harm that may be tolerable in relation to the potential benefits.

The rights and dignity of individuals and groups should be respected

The primary role of the REC review is to ensure that the research will respect the dignity, rights, welfare and, where possible, the autonomy of participants and all parties involved in and potentially affected by the research.

Wherever possible, participation should be voluntary and appropriately informed

The REC should consider the information provided by the researchers regarding consent and voluntary participation, and evaluate how researchers justify and mitigate risks associated with withholding information and the adequacy of any proposed debriefing.

Participants should, wherever possible, take part in research voluntarily and there should not be any coercion or inappropriate influence.

The REC should be confident that participants will be given sufficient information about the research to enable them to make an informed decision about their participation. REC members should also be aware that there may be instances where this is not practical or desirable (for example, for methodological reasons, or covert or crowd research).

Research should be conducted with integrity and transparency

RECs should ensure that they fulfil their role and responsibilities with integrity and record their decisions and feedback in a transparent way.

Lines of responsibility and accountability should be clearly defined

The remit and responsibilities of the RECs should be clear; RECs should be committed to training and development to enable them to fulfil their role. Where the REC feels that it does not have the expertise to review a proposal, it should seek the help of independent bodies or external members. The REC’s performance is subject to review by the research organisation.

The independence of research should be maintained, and where conflicts of interest cannot be avoided they should be made explicit

RECs should be able to conduct ethics review in a wholly independent and impartial manner without any conflicts of interest and with a focus clearly on the ethics of research proposals.

Independence can be achieved by a committee composed of members from a wide range of disciplines and includes external members, within a policy and governance structure that establishes the right of the REC to pass opinions free of influence.

Secondary RECs that comprise members from only one discipline or a small number of closely related disciplines may be regarded as too closely aligned with the interests of researchers.

Further information

Criteria for research ethics committee review

Conflicts of interest, complaints and appeals

Last updated: 15 October 2021

This is the website for UKRI: our seven research councils, Research England and Innovate UK. Let us know if you have feedback or would like to help improve our online products and services .

Ethics Committees: Procedures and Duties

First Online: 24 December 2016

Cite this chapter

David Koepsell 2

Part of the book series: SpringerBriefs in Ethics ((BRIEFSETHIC))

872 Accesses

1 Citations

Ethics Committees (also called Institutional Review Boards, or IRBs) are common fixtures with which researchers around the world are generally quite familiar. In much of the scientific world, they are mandated by laws and regulations and research involving human subjects is generally guided and overseen by such committees. The manners in which they operate vary around the world, although the basic standards they apply generally adhere to the Belmont principles described above. In this chapter, I provide an overview of good study design, ethical use of human and animal subjects in clinical trials, and discuss briefly the principles behind informed consent. As with other chapters, I also provide guidance and context according to the Mertonian norms, extending the argument that these may form the basis for ethics in science very generally.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Subscribe and save.

Get 10 units per month
Download Article/Chapter or Ebook
1 Unit = 1 Article or 1 Chapter
Cancel anytime
Available as PDF
Read on any device
Instant download
Own it forever
Available as EPUB and PDF
Compact, lightweight edition
Dispatched in 3 to 5 business days
Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Angell, Marcia. 1997. The ethics of clinical research in the Third World. New England Journal of Medicine 337: 847–848.

Article Google Scholar

Corrigan, Oonagh. 2003. Empty ethics: The problem with informed consent. Sociology of Health & Illness 25(7): 768–792.

Emanuel, Ezekiel J., David Wendler, and Christine Grady. 2000. What makes clinical research ethical? JAMA 283(20): 2701–2711.

Emanuel, Ezekiel J., et al. 2004. What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases 189(5): 930–937.

Goodyear-Smith, Felicity, et al. 2002. International variation in ethics committee requirements: Comparisons across five Westernised nations. BMC Medical Ethics 3(1): 2.

Google Scholar

Hellman, Samuel, and Deborah S. Hellman. 1991. Of mice but not men: problems of the randomized clinical trial. New England Journal of Medicine 324(22): 1585–1589.

Jonsen, Albert R., Mark Siegler, and William J. Winslade. 1982. Clinical ethics: A practical approach to ethical decisions in clinical medicine . New York: McGraw-Hill.

Keith-Spiegel, Patricia, Gerald P. Koocher, and Barbara Tabachnick. 2006. What scientists want from their research ethics committee. Journal of Empirical Research on Human Research Ethics 1(1): 67–81.

Manson, Neil C., and Onora O’Neill. 2007. Rethinking informed consent in bioethics . Cambridge: Cambridge University Press.

Book Google Scholar

McGee, Glenn, et al. 2002. Successes and failures of hospital ethics committees: A national survey of ethics committee chairs. Cambridge Quarterly of Healthcare Ethics 11(01): 87–93.

Miller, Franklin G., and Howard Brody. 2003. A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials. Hastings Center Report 33(3): 19–28.

O’Neill, Onora. 2003. Some limits of informed consent. Journal of Medical Ethics (29)1: 4–7.

Peto, Richard, et al. 1976. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. British Journal of Cancer 34(6): 585.

Ramcharan, Paul, and John R. Cutcliffe. 2001. Judging the ethics of qualitative research: Considering the ‘ethics as process’ model. Health & Social Care in the Community 9(6): 358–366.

Rosenberger, William F., and John M. Lachin. 2004. Randomization in clinical trials: Theory and practice . New York: Wiley.

Valdez-Martinez, Edith, et al. 2006. Descriptive ethics: a qualitative study of local research ethics committees in Mexico. Developing World Bioethics 6(2): 95–105.

Verástegui, Emma L. 2006. Consenting of the vulnerable: The informed consent procedure in advanced cancer patients in Mexico. BMC Medical Ethics 7(1): 13.

Yank, Veronica, and Drummond Rennie. 2002. Reporting of informed consent and ethics committee approval in clinical trials. JAMA 287(21): 2835–2838.

Download references

Author information

Authors and affiliations.

Research and Strategic Initiatives at Comisión Nacional de Bioética (CONBIOETICA) Mexico, Universidad Autonoma Metropolitan – Xochimilco, Mexico City, Mexico

David Koepsell

You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

Copyright information

About this chapter

Koepsell, D. (2017). Ethics Committees: Procedures and Duties. In: Scientific Integrity and Research Ethics. SpringerBriefs in Ethics. Springer, Cham. https://doi.org/10.1007/978-3-319-51277-8_7

Download citation

DOI : https://doi.org/10.1007/978-3-319-51277-8_7

Published : 24 December 2016

Publisher Name : Springer, Cham

Print ISBN : 978-3-319-51276-1

Online ISBN : 978-3-319-51277-8

eBook Packages : Religion and Philosophy Philosophy and Religion (R0)

Share this chapter

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

Publish with us

Policies and ethics

Find a journal
Track your research

Fact sheets
Facts in pictures
Publications
Questions and answers
Tools and toolkits
HIV and AIDS
Hypertension
Mental disorders
Top 10 causes of death
All countries
Eastern Mediterranean
South-East Asia
Western Pacific
Data by country
Country presence
Country strengthening
Country cooperation strategies
News releases
Feature stories
Press conferences
Commentaries
Photo library
Afghanistan
Cholera
Coronavirus disease (COVID-19)
Greater Horn of Africa
Israel and occupied Palestinian territory
Disease Outbreak News
Situation reports
Weekly Epidemiological Record
Surveillance
Health emergency appeal
International Health Regulations
Independent Oversight and Advisory Committee
Classifications
Data collections
Global Health Estimates
Mortality Database
Sustainable Development Goals
Health Inequality Monitor
Global Progress
Data collection tools
Global Health Observatory
Insights and visualizations
COVID excess deaths
World Health Statistics
Partnerships
Committees and advisory groups
Collaborating centres
Technical teams
Organizational structure
Initiatives
General Programme of Work
WHO Academy
Investment in WHO
WHO Foundation
External audit
Financial statements
Internal audit and investigations
Programme Budget
Results reports
Governing bodies
World Health Assembly
Executive Board
Member States Portal
Activities /

Ensuring ethical standards and procedures for research with human beings

Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants. As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld. Discussion of the ethical principles of beneficence, justice and autonomy are central to ethical review.

WHO works with Member States and partners to promote ethical standards and appropriate systems of review for any course of research involving human subjects. Within WHO, the Research Ethics Review Committee (ERC) ensures that WHO only supports research of the highest ethical standards. The ERC reviews all research projects involving human participants supported either financially or technically by WHO. The ERC is guided in its work by the World Medical Association Declaration of Helsinki (1964), last updated in 2013, as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS 2016).

WHO releases AI ethics and governance guidance for large multi-modal models

Call for proposals: WHO project on ethical climate and health research

Call for applications: Ethical issues arising in research into health and climate change

Research Ethics Review Committee

lab digital health research south africa

Standards and operational guidance for ethics review of health-related research with...

WHO tool for benchmarking ethics oversight of health-related research involving human...

Related activities

Developing normative guidance to address ethical challenges in global health

Supporting countries to manage ethical issues during outbreaks and emergencies

Engaging the global community in health ethics

Building ethics capacity

Framing the ethics of public health surveillance

Login Alert

< Back to search results
Manual for Research Ethics Committees

Manual for Research Ethics Committees

Centre of medical law and ethics, king's college london.

Get access Buy a print copy Check if you have access via personal or institutional login Log in Register

This Book has been cited by the following publications. This list is generated based on data provided by Crossref .

Google Scholar
6th edition
Edited by Sue Eckstein , King's College London
Export citation
Buy a print copy

Book description

The sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy. Presented in a clear and authoritative form, it incorporates the key legal and ethical guidelines and specially written chapters on major topics in bioethics by leading academic authors and practitioners, pharmaceutical industry associations and professional bodies.

Review of the hardback:‘… a timely and important publication that should be an invaluable aid for applied psychologists, or anyone planning joint research with the NHS … any researcher or member of an ethics committee will find plenty of interest.’

Source: The Psychologist

Review of the hardback:‘… the guidelines are narrowly drawn to provide help for specific types of research; from work on radiation, gene transfer, or the use of genetic information to research in developing countries or with participants who cannot give informed consent … the biggest challenge to the individual researcher is finding help to work through ethical issues, and the resource compiled by Eckstein and her colleagues is a useful place to start.’

Source: The Lancet

Review of the hardback:‘Read it now, before your administrators do!’

Aa Reduce text
Aa Enlarge text

Refine List

Actions for selected content:.

View selected items
Save to my bookmarks
Export citations
Download PDF (zip)
Save to Kindle
Save to Dropbox
Save to Google Drive

Save content to

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to .

To save content items to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle .

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service .

Save Search

You can save your searches here and later view and run them again in "My saved searches".

Page 1 of 3

« Prev
Next »

Frontmatter pp i-iv

Get access Check if you have access via personal or institutional login Log in Register

Contents pp v-viii

Editorial board pp ix-x, acknowledgements pp xi-xii, list of contributors pp xiii-xvi, introduction pp xvii-xx.

By Sue Eckstein

Part I pp 1-2

1 - the ethics of clinical research pp 3-14.

By Calliope (bobbie) Farsides

2 - Research ethics committees and the law pp 15-17

By Ian Kennedy , Phil Bates

3 - The regulation of medical research: a historical overview pp 18-22

By Richard H. Nicholson

4 - The regulation of medical research in the UK pp 23-33

By Pamela Charnley Nickols

5 - Observational and epidemiological research pp 34-36

By Nick Dunn

6 - Social survey research pp 37-39

By Crispin Jenkinson

7 - Approaching qualitative research pp 40-48

By Alan Cribb

8 - Complementary and alternative medicine: challenges for research ethics committees pp 49-52

By Julie Stone

9 - The ethical review of student research in the context of the governance arrangements for research ethics committees pp 53-56

By Richard Ashcroft , Michael Parker

10 - The ethics of genetic research pp 57-59

By Ruth Chadwick

11 - Research or audit? pp 60-60

By Anthony Madden

12 - Randomised controlled trials pp 61-63

By Hazel Inskip , Richard W. Morris

13 - Determining the study size pp 64-66

14 - risk assessment for research participants pp 67-68.

By Kenneth Calman

15 - Absorbed radiation in patient and volunteer studies submitted to the ethical committee: a memorandum pp 69-71

By Keith Britton , Rosemary Foley

16 - A guide to the use of radioactive materials and radiological procedures for research purposes pp 72-74

By Niall Moore

17 - Indemnity in medical research pp 75-78

By Janet Jeffs , Richard Mayon-White

18 - The prevention and management of fraud and misconduct: the role of the LREC pp 79-82

By Jennifer Blunt , Frank Wells

19 - Understanding clinical trials: a model for providing information to potential participants pp 83-88

By Philippa Easterbrook , Joan Houghton

20 - The law relating to consent pp 89-95

By Andrew Grubb , Rosamund Scott , Penney Lewis , Phil Bates

21 - Writing information for potential research participants pp 96-99

By Elizabeth Mellor , David K. Raynor , Jonathan Silcock

22 - The law relating to confidentiality pp 100-102

By Andrew Grubb , Ian Kennedy , Sabine Michalowski

23 - Research involving vulnerable participants: some ethical issues pp 103-110

Altmetric attention score, full text views.

Full text views reflects the number of PDF downloads, PDFs sent to Google Drive, Dropbox and Kindle and HTML full text views for chapters in this book.

Book summary page views

Book summary views reflect the number of visits to the book and chapter landing pages.

* Views captured on Cambridge Core between #date#. This data will be updated every 24 hours.

Usage data cannot currently be displayed.

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

Knowledge Base

Methodology

Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on May 9, 2024.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

protect the rights of research participants
enhance research validity
maintain scientific or academic integrity

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Here's why students love Scribbr's proofreading services

Discover proofreading & editing

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.


Voluntary participation	Your participants are free to opt in or out of the study at any point in time.
Informed consent	Participants know the purpose, benefits, risks, and funding behind the study before they agree or decline to join.
Anonymity	You don’t know the identities of the participants. Personally identifiable data is not collected.
Confidentiality	You know who the participants are but you keep that information hidden from everyone else. You anonymize personally identifiable data so that it can’t be linked to other data by anyone else.
Potential for harm	Physical, social, psychological and all other types of harm are kept to an absolute minimum.
Results communication	You ensure your work is free of or research misconduct, and you accurately represent your results.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Receive feedback on language, structure, and formatting

Professional editors proofread and edit your paper by focusing on:

Academic style
Vague sentences
Style consistency

See an example

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

what the study is about
the risks and benefits of taking part
how long the study will take
your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
Social harm: Participation can involve social risks, public embarrassment, or stigma.
Physical harm: Pain or injury can result from the study procedures.
Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

Normal distribution
Measures of central tendency
Chi square tests
Confidence interval
Quartiles & Quantiles
Cluster sampling
Stratified sampling
Thematic analysis
Cohort study
Peer review
Ethnography

Research bias

Implicit bias
Cognitive bias
Conformity bias
Hawthorne effect
Availability heuristic
Attrition bias
Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the “Cite this Scribbr article” button to automatically add the citation to our free Citation Generator.

Bhandari, P. (2024, May 09). Ethical Considerations in Research | Types & Examples. Scribbr. Retrieved July 1, 2024, from https://www.scribbr.com/methodology/research-ethics/

Is this article helpful?

Pritha Bhandari

Other students also liked, data collection | definition, methods & examples, what is self-plagiarism | definition & how to avoid it, how to avoid plagiarism | tips on citing sources, "i thought ai proofreading was useless but..".

I've been using Scribbr for years now and I know it's a service that won't disappoint. It does a good job spotting mistakes”

This site uses session cookies and persistent cookies to improve the content and structure of the site.

By clicking “ Accept All Cookies ”, you agree to the storing of cookies on this device to enhance site navigation and content, analyse site usage, and assist in our marketing efforts.

By clicking ' See cookie policy ' you can review and change your cookie preferences and enable the ones you agree to.

By dismissing this banner , you are rejecting all cookies and therefore we will not store any cookies on this device.

Research Ethics Committees overview

There are more than 80 NHS Research Ethics Committees across the UK. They exist to safeguard the rights, safety, dignity and well-being of research participants.

RECs consist of up to 15 members, a third of whom are 'lay' - their main professional interest is not in a research area, nor are they a registered healthcare professional.

RECs review research proposals and give an opinion about whether the research is ethical. They also look at issues such as the participant involvement in the research. The committees are entirely independent of research sponsors (the organisations responsible for the management and conduct of the research), funders and the researchers themselves. This enables them to put participants at the centre of their review.

Search Research Ethics Committees

Listings, contact information and meeting dates for Research Ethics Committees (RECs) within the UK Health Departments’ Research Ethics Service.

RECs review around 6,000 research applications across the UK covering a wide range of research. On average, they give an opinion in less than 40 days: well within the statutory timeline of 60 days.

If you are applying to one of the following types of Research Ethics Committee, you will need to click on the relevant link:

Ministry of Defence REC (MoDREC)
Higher Education Institution (HEI) REC

REC annual reports

The Department of Health Governance Arrangements for Research Ethics Committees requires that the Appointing Authority receive and adopt the Annual Reports for the Research Ethics Committees (RECs) .

Annual reports for the following periods are available:

April 2016 to March 2017
April 2015 to March 2016
April 2014 to March 2015
April 2013 to March 2014
April 2012 to March 2013
April 2011 to March 2012

Research ethics committees: A forum where scientists, editors, and policymakers can cooperate during pandemics

Francesco chirico.

1 Post-graduate School of Occupational Health, Università Cattolica del Sacro Cuore, Rome, Italy

2 Centro Sanitario Polifunzionale di Milano, Health Service Department, Italian State Police, Ministry of the Interior, Milan, Italy

Katrina A. Bramstedt

3 Department of Medicine, Khalifa University College of Medicine and Health Sciences, Abu Dhabi, UAE

During public health pandemics such as COVID-19, cooperative behaviors among scientists, journal editors, policy makers and research ethics committees, are essential to promote scientific integrity and societal trust in translational research and resultant public health decisions. This cooperation is possible by expanding the current way of working to include stakeholders beyond the research team via community events and special communication channels sponsored by research ethics committees. Research ethics committees with wider communication channels, increased transparency, and enhanced knowledge exchange have the potential to improve research design, performance, dissemination, and ultimately public benefit.

During the Coronavirus Disease 2019 (COVID-19) pandemic, a fast-track peer review of COVID-19 papers submitted to journals has replaced the traditional, more time-consuming peer review process, causing concern among stakeholders in scholarly publishing. 1 However, “quick publishing” 2 is a pandemic-related phenomenon that may produce low-quality literature and, subsequently, more retractions. 3 Sometimes, even retracted articles continue to be repeatedly cited by sloppy scholars. Additionally, predatory journals and researchers can leverage the pandemic as a tool to propel their own goals. 4 Predatory journals were a troublesome presence long-before the emergence of COVID-19; however, the fast pace and competitive pandemic research setting is a ripe arena making researchers an easy target by these unscrupulous journals that provide little or no peer review, rapid publishing, and open access. 5 COVID-19 is one of the biggest public health challenges the world has confronted, and rapid, high-quality research plays a key role in the fight against the virus. Identifying categories of people that should be prioritized for COVID-19 vaccination (including boosters), as well as lockdown and physical distancing policies, are examples of how decision-making relies on scientific findings. 6 , 7 When scientists and policymakers have different attitudes and goals, this can hamper collaboration; 8 however, by working together during pandemics such as COVID-19, scientific findings can be translated into beneficial policies and procedures for the health of society.

Worldwide, the role of research ethics committees (also known as institutional review boards) has been to review and approve human research proposals to ensure novel research questions, robust study design, and the protection of research participant safety and welfare. Committee structure is generally a mix of lay volunteers and professional scientists, sometimes with subspecialty committees (e.g. social science, medical). Ideally, research ethics committees should have a multidisciplinary membership that reaches beyond the science, and also includes ethicists and patients concerned with the contextual aspects of research that impact methodology, data privacy, and the application of the research across populations. 9 The Chair at the helm of these committees is expected to guide the review process to ensure timely and constructive feedback to researchers so that their research protocols are optimized before receiving approval for study launch.

To do their job effectively, research ethics committees need to understand the research they are reviewing. Part of achieving this is by way of assigning protocol reviews to topic specialists within the committee, as well as the use of external expert reviewers as needed. Additionally, the committees can receive input from the Principal Investigator directly, answering queries and providing clarifications. We propose that the input mechanism to research ethics committees be widened for additional purposes related to understanding research proposals, as well as stakeholder opinions, and community impact. If publishers interface with research ethics committees, they can potentially develop better understandings of jurisdictional approval/exemption requirements, thereby avoiding publication delays due to incorrect assumptions or lack of awareness. If policy makers interface with research ethics committees, they can potentially develop an understanding of research risks and benefits across communities—something that is especially important if their community is facing a public health threat and they are vulnerable (e.g. socioeconomically disadvantaged, special cultural values).

While there is a time for closed [private] sessions, research ethics committees should be open to dialog with all research stakeholders (not only scientists) to gain a fuller understanding of research applications and implications, risks and benefits, and strategies for risk mitigation, as well as optimized delivery of the research review process so as to ensure a timely study launch (reducing study delays). This view is consistent with that of the World Health Organization which states, “For a [committee] decision to be ethically legitimate, it must be made in an open and inclusive process that takes into account the views of all stakeholders. Thus, research ethics committees should be encouraged to include individuals from diverse professional and social backgrounds and, where appropriate, to solicit input proactively from the community.” 9

Johns Hopkins Medicine Institutional Review Board (a research ethics committee in USA) provides an annual Community Day during which the public is invited to dialog with them about research ethics, research protections, and the research review process. 10 Events like these are important because research ethics committees and research participants (patients/community members) can have differing views regarding priorities. 11 Also, community-based participatory research will benefit from direct interaction with research ethics committees because research has shown that often these committees are not prepared for this type of research with these key stakeholders who are in fact helping shape the research question, recruit participants, collect study data, and disseminate the study results back to their community. 12 Committee events such as these could also provide a mechanism for transparent mediation of power struggles between research stakeholders. Ideally, these external research ethics committee events should be more frequent than annual, especially during public health crises when the public is participating in vaccine and treatment clinical trials, and the pharmaceutical industry has a duality of priorities (i.e. producing safe and effective product and making profit for shareholders). Community Days and other stakeholder events can be held in virtual formats using teleconferencing technology when public health crises demand physical distancing.

In Iran, three main working groups have been set up to manage COVID-19 research, including (1) research on epidemiology and public health, (2) clinical research, and (3) basic science and virology research. 13 These committees are having an additional role in research monitoring, not just protocol review. Monitoring is usually a function performed by the research sponsor, but in this instance, the committees are potentially having additional impact in research quality by checking the conduct of research themselves. In the context of COVID-19 and vaccine research, decisions to pause or abort studies or pause distribution of emergency-authorized vaccines can have profound research and clinical implications. 14

Research ethics committees and associated data safety monitoring boards are the canaries in the mines who should be audible voices not bullied by sponsors or governments. Their advocacy for science and public safety as well as research integrity means viewing them in the research co-working space, as well as the regulatory/governance space. This lens shift allows for a change in tone in the research workplace, creating a culture which is more conducive to stakeholder collaboration and shared decision-making (rather than bullying). While various governance boards will ultimately render decisions, a shared decision-making approach from the lens of collaboration and co-working potentially fosters data sharing and dialog for public health benefit.

In situations of alleged research misconduct, research ethics committees should collaborate with journal editors and publishers to ensure that the investigative process is not delayed. Timely evidence sharing in tandem with fair and expert investigations will promote prompt retraction of research which has ethical and/or scientific misconduct, limiting its use and reuse. During these situations, it is vital that research ethics committee members are free from external pressures and are able to dialog without intimidation or conflict from research stakeholders. In the end, research outputs should be trusted scientific evidence for use by government policymakers, and health officers in their pursuit of public health and safety. 8

The time burdens and administrative strain of research ethics committees are well-known, thus the idea of more tasks may not be embraced. Widening the research ethics committee's current work area might at first seem burdensome, but with efficient planning and organization of events and communication channels, the broader benefits could prove worthwhile. It would be interesting to pilot an “enhanced” research ethics committee offering service lines for editors, community, and policy-makers.

In conclusion, cooperation between scientists, editors and policymakers is essential to promote the scientific integrity of COVID-19 research and public trust. Working together does not erode stakeholder autonomy, rather it gives the autonomy of each a voice which needs to be heard, especially during the urgency of a pandemic. Research ethics committees need freedom to perform their tasks without pressure from researchers, politicians, policymakers, and funders. In the setting of a pandemic, there are many stakeholders, scientific unknowns, and time pressure. With a multiplicity of competing interests, the setting can easily be a ‘boxing ring’ of personalities and agendas; however, a collaborative forum for perspectives, debate, and ethically-driven solutions is possible. This shifts the sometimes impression of research ethics committees as a scientific bottleneck 15 to a cooperative working space. 13 Research ethics committees evolve from gatekeepers, to also a forum where all stakeholders come together to speak up for the benefit of science and society.

Declaration of conflicting interests: Prof Chirico is Co-Founder and Co- Editor in Chief of the Italy-based journal, Journal of Health and Social Sciences

Funding: The author(s) received no financial support for the research, authorship and/or publication of this article.

ORCID iD: Francesco Chirico https://orcid.org/0000-0002-8737-4368

Log in using your username and password

Search More Search for this keyword Advanced search
Latest content
Current issue
JME Commentaries
BMJ Journals

In a recent paper Edwards, Kirchin, and Huxtable have argued that research ethics committees (RECs) are often wrongfully paternalistic in their approach to medical research. They argue that it should be left to competent potential research subjects to make judgments about the acceptability of harms and benefits relating to research, and that this is not a legitimate role for any REC. They allow an exception to their overall antipaternalism, however, in that they think RECs should have the power to prohibit the use of financial inducements to recruit research subjects into trials. In this paper it is argued that these claims are unjustified and implausible. A sketch is provided of an alternative model of the role of the REC as an expert body making judgments about the acceptability of research proposals through a consensual weighing of different moral considerations.

REC, research ethics committee
research ethics committees
inducements
paternalism

https://doi.org/10.1136/jme.2004.010447

Statistics from Altmetric.com

Request permissions.

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

↵ i We deliberately refer to research subjects and not participants. This is because we believe that the term “subjects” actually gives a closer approximation to what it is like to be a patient involved in a research project. In addition, the term “participant” is unclear since, technically, medical researchers are also research participants.

↵ ii For an excellent discussion of different conceptions of exploitation and related ethical issues see Bodies for Sale: Ethics & Exploitation in the Human Body Trade by Wilkinson . 12

↵ iii A full treatment of the authority and legitimacy of RECs would of course take more space than is available here.

Read the full text or download the PDF:

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

Carl H Coleman 1 &
Marie-Charlotte Bouësseau 2

BMC Medical Ethics volume 9 , Article number: 6 ( 2008 ) Cite this article

22k Accesses

78 Citations

1 Altmetric

Metrics details

Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.

Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.

The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.

Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?

Peer Review reports

Many countries are investing significant resources in creating or strengthening "research ethics committees" (RECs) to review proposed research involving human participants, either within research institutions, as part of governmental agencies, or in the private sector. Implicit in these efforts is the assumption that REC review will result in research that better complies with applicable ethical principles. Yet, surprisingly little attention has been devoted to testing the empirical validity of this assumption. As a result, it is possible that countries are wasting scarce financial and human resources on processes that do not result in any real protections for research participants or their communities. In addition, without a system for evaluating RECs' actual impact, opportunities for remedying correctable problems with RECs are likely to be missed.

The importance of evaluating the effectiveness of RECs should be obvious. Yet, despite the emphasis on quality assessment in other areas of health care, "there has been near silence on the possibility of applying quality assessment techniques to ethics practices [ 1 ]." While the need for quality assessment in research ethics is beginning to receive greater attention [ 2 ], the focus has largely been on evaluating the quality of the deliberations that take place in RECs' meetings, as opposed to the impact of those deliberations on the research process itself.

Existing mechanisms for evaluating RECs are primarily limited to governmental or private auditing and accreditation programs. While both auditing and accreditation can make important contributions to the quality of research review systems, they are incapable of answering many critical questions about RECs' impact on research practices. Moreover, comprehensive auditing and accreditation programs require an investment of human and financial resources that is unfeasible for many low- and middle-income countries. In this article, we look beyond auditing and accreditation to consider other mechanisms for assessing and improving the quality of RECs' work.

While the focus of this article is RECs in low- and middle-income countries, the issues it addresses are relevant everywhere. In the United States, for example, an increasing chorus of critics has charged that the process of research ethics review imposes substantial costs for the research enterprise that exceed any benefits to research participants [ 3 , 4 ]. Determining whether the costs of ethics review are in fact justified requires a better understanding of the impact of ethics review on how research is actually performed.

The Increasing Role of REC Review

REC review is a cornerstone of international guidelines on research with human participants. For example, the Council for International Organizations of Medical Sciences (CIOMS) states that "all proposals to conduct research involving human subjects must be submitted for review and approval to one or more independent ethical and scientific review committees [ 5 ]." Similar obligations appear in guidelines issued by the International Conference on Harmonization (ICH) [ 6 ], the Council of Europe [ 7 ], and UNESCO [ 8 ]. These guidelines require RECs to ensure that the risks of proposed studies are reasonable in relation to the anticipated benefits, that the investigators have adequate plans for obtaining participants' informed consent, and that other ethical issues, such as confidentiality and equitable participant selection, have been adequately addressed.

However, these international guidelines are not legally binding in countries that have not chosen to adopt them. Thus, whether REC review is required for any particular study depends on the requirements of national laws and policies. In the United States and many other wealthy countries, review by an REC is mandatory for most research involving human participants [ 9 ]. By contrast, in many low-income countries, there are no laws requiring REC oversight, or laws that exist are incomplete or under-enforced [ 10 , 11 ]. When research is conducted in collaboration with foreign research sponsors, some type of ethics review may be required by the laws of the sponsor's country, but such laws do not always require review by local RECs. For example, while the United States Food and Drug Administration (FDA) has extensive regulations governing REC review for clinical trials conducted pursuant to an Investigational New Drug Application (IND), those regulations do not apply to foreign trials not conducted pursuant to an IND. Instead, the FDA will accept data from non-IND foreign trials as long as the trial "conforms to the ethical principles contained in the Declaration of Helsinki [ 12 ]," which contains only very general provisions on ethical review.

In recent years, however, many low and middle-income countries have begun to pay greater attention to developing or strengthening RECs. For example, at the 2004 Ministerial Summit on Health Research in Mexico City, health officials from 58 countries called for national governments to adopt regulations providing for the "ethical oversight" of research [ 13 ]. In many African countries, governments have enacted, or are in the process of enacting, legislation requiring REC review of research involving human participants [ 14 , 15 ]. Even without a governmental mandate, many research institutions in resource-poor countries have created RECs on their own initiative, sometimes in collaboration with other countries [ 11 ] or with non-governmental organizations [ 16 ].

One reason for this increasing interest in RECs is that research sponsors are conducting more of their studies in low and middle-income countries, both because it is less expensive [ 17 ] and because it has become increasingly difficult to find a sufficient number of qualified participants in the sponsors' home countries [ 18 ]. In addition, a few highly-publicized controversies have led to greater attention to the potential for exploitation in the context of international collaborative research. For example, a lawsuit currently pending against the foreign sponsors of a Nigerian study of an anti-meningitis drug alleges that children in the control group were not given adequate medications, that parents were not told that effective treatment for meningitis was readily available outside of the study, and that documents claiming that the study had been approved by a Nigerian ethics review process were forged [ 19 ]. Publicity about cases like this has given sponsors a greater incentive to support the development of local RECs.

Challenges for REC Review

For a country that lacks any research oversight system, creating a review process – any review process – is likely to have a positive impact. For example, requiring researchers to submit their protocols to RECs creates an incentive for researchers to actually have written protocols. Requiring them to document the informed consent process reduces the likelihood that individuals will be enrolled in studies without even being asked for consent. In other words, simply requiring prior approval to do research should help weed out the truly egregious cases of researcher misconduct.

Designing a system to evaluate the ethical acceptability of studies that pass this minimal screening function raises more challenging conceptual and practical difficulties. On the most basic level, the very concept of "ethics review" is inherently ambiguous, particularly in the critical area of risk-benefit assessment. Identifying the risks and potential benefits of research, and determining whether the balance between them is "reasonable," depend not only on scientific arguments but also on value judgments that usually have no clearly right or wrong resolution. In the absence of objective standards, RECs must rely on individuals' discretionary judgments, an approach that risks overemphasizing the personal values and biases of the individuals who happen to be serving on the committee [ 20 ]. In addition, the discretionary nature of risk-benefit assessment increases the potential for inconsistent decision-making, not only between different RECs but also within a single REC as it confronts similar issues from meeting to meeting. Of course, in a pluralistic society, absolute uniformity in ethical decision-making is neither realistic nor desirable. However, widespread inconsistency, particularly within a single REC, creates the impression that ethical standards are being applied in an arbitrary manner.

Some RECs deal with the amorphous nature of risk-benefit assessment by spending most of their time on detail-oriented questions that appear more susceptible to objective resolution, such as parsing the wording of informed consent forms [ 21 ]. Unfortunately, while rewriting consent forms is undoubtedly important in some situations, when it becomes the primary focus of ethics review larger ethical questions can easily become lost. Indeed, some critics charge that an obsessive focus on rewriting consent forms can actually undermine the protection of research participants, as it may simply result in longer and more confusing forms that participants will be less likely to understand [ 22 ].

On a more practical level, the effectiveness of REC review is often hampered by insufficient financial and human resources [ 15 ]. These limitations make it difficult to create committees with sufficient expertise and diversity, to provide funding for staff support, and to provide training for committee members. Ensuring the independence of RECs can also be a significant challenge. For example, in institutional-based RECs, committee members may be asked to vote on proposals submitted by colleagues who are personal friends, or by senior members of their department who control decisions about promotion and tenure.

The problem of independence is particularly acute for RECs in low and middle-income countries. Because such countries may depend on the financial or other benefits associated with foreign-sponsored research, RECs may be under explicit or implicit pressure not to reject research protocols or to insist on changes that might lead sponsors to take their studies elsewhere [ 23 ]. Adding to these problems is the fact that, in many resource-poor countries, RECs must carry out their work in the absence of a well-developed regulatory structure or a culture of compliance with administrative and procedural requirements.

Existing Oversight Mechanisms for RECs

In many countries, REC oversight is the responsibility of national governmental agencies. In the United States, for example, the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) are responsible for overseeing most RECs in the country (where they are known as institutional review boards, or IRBs). These agencies conduct site visits of selected programs, either without cause or in response to a specific problem, and they also have less formal procedures for responding to individual complaints. OHRP's site visits include a review of 20–35 randomly-selected protocols and meeting minutes dating back one to four years [ 24 ].

Some countries require RECs to go through a formal process of governmental accreditation. For example, in New Zealand, the Health Research Council accredits research ethics committees. If a study proceeds without the approval of an accredited ethics committee, participants who suffer injuries may not be eligible for compensation from the country's no-fault compensation system [ 25 ]. Approval by an accredited committee is also necessary for researchers to obtain access to data held by the New Zealand Health Information Service database [ 26 ]. Accreditation usually involves a combination of self-assessment and external reviews, focusing on issues like committee membership, operating procedures, and the documentation of meetings [ 27 ].

There are also voluntary accreditation programs for RECs. The largest of these is run by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) [ 28 ]. Obtaining AAHRPP accreditation is an intensive process that usually takes 12–18 months, including both document reviews and a 2–4 day site visit during which dozens of persons involved in all aspects of the research program are individually interviewed. In order to be accredited, programs must demonstrate not only that they are in compliance with all applicable regulatory requirements, but also that they have developed guidelines for addressing certain issues not expressly covered by the regulations (e.g., standards governing the participation of decisionally incapacitated persons in research). While most of the programs that have received AAHRPP accreditation are located in the United States, AAHRPP has also accredited programs in Canada, Singapore, and South Korea.

In addition to AAHRPP, the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), a network of local and regional ethics organizations working with several United Nations organizations, has established a voluntary "recognition" program for RECs. The program offers recognition to RECs that demonstrate that they "(1) have a structure and composition appropriate to the amount and nature of research being conducted; (2) have appropriate management and operational procedures; (3) review protocols in a timely fashion according to established procedure; (4) adequately and effectively communicate decisions to investigators; and (5) have appropriate practices regarding documentation and archiving [ 29 ]." The SIDCER program includes educational components designed to support RECs' progress toward recognition. Committees from China, Philippines, South Korea, Thailand and Taiwan have already been recognized through this process.

Finally, some mechanisms also exist for evaluating the qualifications of individual REC members. For example, a non-profit organization in the United States called Public Responsibility in Medicine and Research (PRIMR) offers a certification program for IRB members and staff, which "evaluates and validates individuals' knowledge of ethical principles, historical events, regulatory requirements, and operational and functional issues relating to IRBs and other human subjects protection programs [ 30 ]." Persons who pass the certification test are authorized to include the acronym CIP ("certified IRB professional") in their professional titles.

All of these mechanisms can make important contributions to the quality of the ethics review process. Auditing and accreditation programs encourage RECs to develop standardized policies and procedures, which helps promote the consistent application of ethical principles. They also provide a means for checking whether RECs are actually adhering to the policies and procedures they claim to be following. Private accreditation programs have the added advantage of encouraging RECs to develop policies and procedures for issues that are insufficiently addressed at the regulatory level. Certification programs for REC members can complement the accreditation process by promoting a common base of knowledge about applicable ethical and regulatory principles. Moreover, both accreditation and certification are likely to enhance the status of RECs within their own institutions, which may make it easier for RECs to gain necessary institutional resources.

However, these mechanisms also have inherent limitations. Most significantly, they focus primarily on questions about RECs' structure and process, such as how committees are constituted, whether their standard operating procedures are complete, and whether the process of protocol review is adequately documented [ 31 ]. One danger with this focus is that it may exacerbate RECs' tendency to emphasize form over substance. A recent study of OHRP enforcement activities highlights this problem; it found that "the agency continues to nitpick consent forms, depends upon (and demands) extensive documentation of compliance activities, and finds the remedy for most problems to be 'more' – review of studies, internal monitoring procedures, education, forms." The result of this focus, the authors conclude, is "a culture of red tape rather than a culture of ethics [ 24 ]."

A larger concern with an exclusive focus on structure and process is that it is incapable of answering the bottom-line question: whether REC review actually protects the rights and interests of research participants and their communities. For example, the fact that an REC has documented that it has considered a protocol's risks and potential benefits does not mean that it has done a good job identifying or weighing these factors. Nor does it show that studies that are approved by the committee have more favorable risk-benefit profiles than those that are turned down. Similarly, the fact that an REC has concluded that a consent form contains all relevant information does not mean that prospective participants who read the form will actually understand or absorb the information, or that it will have any appreciable impact on their decision-making process. In short, all that auditing and accreditation programs tell us is whether RECs are carrying out the specific tasks that have been assigned to them. While this is certainly an important question, even an affirmative answer does not prove that an REC system "works."

Integrating Quality Assurance Principles into REC Assessment

Principles developed through decades of experience with quality assurance and improvement in other areas of health care can guide the development of effective oversight programs for RECs. The most basic of these principles is that, before the quality of any program or service can be evaluated, the relevant elements of quality must be identified with precision. Quality is a multifaceted concept, including factors like the technical competence with which an activity is performed, the impact of the activity on morbidity and mortality, and the activity's cost effectiveness. Choosing which of these goals to emphasize "requires a commitment to finding out what patients and the community need, want, and expect from the health service [ 32 ]."

Thus, the first step in developing a comprehensive quality assurance program for RECs should be to identify what prospective research participants and their communities hope to get out of the ethics review process. For example, is the concern that people are being misled into enrolling in studies in which they would have refused to participate had they known what they were getting into? If so, it would be useful to know whether REC review has an impact on the number of people who go through the informed consent process and then decide not to participate. Alternatively, the goal might be to increase the extent to which participants feel respected in the research process, regardless of whether they end up making different decisions about participating [ 33 ]. In that case, we should try to find out whether REC review actually affects participants' subjective experiences in studies or their attitudes about research. Both of these questions, of course, depend on first determining whether prospective participants understand the information that has been presented to them in the consent process. While some research related to this question has already been conducted [ 34 ], assessing participants' understanding has not yet been systematically integrated into the process of REC oversight.

Similar questions can be raised about the process of risk-benefit assessment. For example, is REC review considered important because of a concern that research is generally "too risky"? If so, we should look at whether adopting an REC process actually affects the riskiness of research – perhaps by investigating whether REC review has an impact on the incidence of adverse events. Or is the concern that, without RECs, research might not address the health needs of the local community? In that case, we might want to see whether studies approved by an REC are in fact consistent with the local community's needs.

These broad outcome-oriented questions will not always be easy to answer. Outcomes assessment is one of the trickiest areas of quality assurance; numerous confounding variables can undermine the validity of simple before-and-after comparisons. For example, in many health care programs, outcome measurements such as mortality rates can be useful indicators of the quality of services, but they may also reflect "differences in the resources available, the risk factors of the patient group, data accuracy, and chance alone [ 35 ]." Likewise, an increase in adverse events following the creation of an REC does not necessarily mean that the REC is a failure; it may instead reflect a shift towards studies related to more serious conditions, where the greater potential benefits justify a higher degree of risk. Developing methodologically sound measures of assessing REC outcomes is an area ripe for further research.

Another important dimension of quality assurance that existing oversight efforts do not incorporate is the basic question of whether RECs' guidance to researchers is actually being followed. For example, do researchers really utilize the informed consent processes described in their protocols, or do they simply hand prospective participants a consent form and ask them to sign it? RECs could adopt a variety of relatively simple methods to generate information relevant to this question, such as soliciting feedback from prospective participants through questionnaires or suggestion boxes. Or, borrowing a practice used in other health care settings, they could use actors to play the role of prospective research participants, in order to evaluate how people are treated when they go through the informed consent process [ 32 ]. While these measures would require some additional resources, they are far less expensive than many other methods of quality assurance – for example, going through an 18-month process of obtaining accreditation.

Finally, and most importantly, a "monitoring system is not an end in itself [ 36 ];" the information generated through an assessment process must be used to stimulate improvements in practice. Doing this requires a commitment to a process of continuous quality improvement, in which information from the assessment process is disseminated to key decision-makers and incorporated into practice. Thus, an REC might ask researchers involved in approved studies to report back about the most common questions asked by prospective participants during the informed consent process, and then use this information to change the way they evaluate informed consent forms in the future. Global or regional meetings of RECs, as well as online discussion forums, can provide valuable opportunities for sharing information and identifying and promoting best practices. In addition to disseminating information among REC members, it is important to share findings about REC practices with external audiences like administrative authorities and community leaders.

Low and middle-incomes countries are increasingly demonstrating their capacity to put into practice concrete mechanisms for enforcing ethical requirements. International cooperation has been a key factor in this progress. However, it is not clear whether these systems have led to substantial improvements in the way that research is actually conducted. It is time to look beyond the basic question of whether RECs are complying with existing standards to the larger question of whether compliance with these standards is having the desired results.

Wolf SM: Quality assessment of ethics in health care: the accountability revolution. American Journal of Law & Medicine. 1994, 20: 105-128. at 110.

Google Scholar

Taylor HA: Moving beyond compliance: measuring ethical quality to enhance the oversight of human subjects research. IRB: Ethics & Human Research. 2007, 29 (5): 9-14.

Hyman DA: Institutional review boards: is this the least worst we can do?. Northwestern University Law Review. 2007, 101: 749-773.

Mueller JH: Ignorance is neither bliss nor ethical. Northwestern University Law Review. 2007, 101: 809-836.

Council for International Organizations of Medical Sciences: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva. 2002

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Guideline for Good Clinical Practice. 1996, [ http://www.ich.org/LOB/media/MEDIA482.pdf ]

Council of Europe: Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. 2005, [ http://conventions.coe.int/treaty/en/treaties/html/195.htm ]

UNESCO: Universal Declaration on Bioethics and Human Rights, art. 19. 2005, [ http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html ]

Coleman CH, Menikoff JA, Goldner JA, Dubler NN: The Ethics and Regulation of Research with Human Subjects. 2005, Newark, NJ: Lexis

Hyder AA: Ethical review of health research: a perspective from developing country researchers. Journal of Medical Ethics. 2004, 30: 68-72. 10.1136/jme.2002.001933.

Article Google Scholar

Caniza MA: Establishment of ethical oversight of human research in El Salvador: lessons learned. The Lancet. 2006, 7: 1027-1033. 10.1016/S1470-2045(06)70977-9.

21 C.F.R. § 312.120. 2008

Ministerial Summit on Health Research: The Mexico Statement on Health Research. 2004, [ http://www.who.int/rpc/summit/agenda/en/mexico_statement_on_health_research.pdf ]

Networking for Ethics on Biomedical Research in Africa: NEBRA Final Report. 2006, [ http://www.trree.org/site/en_nebra.phtml ]

Kass NE, Adnan AH, Ademola A, Appiah-Poku J, Barsdorf N, Elsayed DE, Mokhachane M, Mupenda B, Ndebele P, Ndossi G, Sikateyo G, Tangwa G, Tindana P: The structure and function of research ethics committees in Africa: a case study. PLoS Medicine. 2007, 4 (1): e3-10.1371/journal.pmed.0040003.

African Malaria Trust Network. [ http://www.amanet-trust.org/ext/news/HREGrant.htm ]

Macklin R: Double Standards in Medical Research in Developing Countries. 2004, Cambridge University Press

Book Google Scholar

Research Notes – Clinical Trials: Efforts To Increase Participation Examined. American Health Line. June 22, 2006

Nwabueze RN: Ethical review of research involving human subjects in Nigeria: legal and policy issues. Indiana International and Comparative Law Review. 2003, 14: 87-116.

Coleman CH: Rationalizing risk assessment in human subject research. Arizona Law Review. 2004, 46: 1-51.

Beh HG: The role of institutional review boards in protecting human subjects: are we really ready to fix a broken system?. Law & Psychology Review. 2002, 26: 1-46.

Burris S, Moss K: U.S. health researchers review their ethics review boards: a qualitative study. Journal of Empirical Research on Human Research Ethics. 2006, 1 (2): 39-58. 10.1525/jer.2006.1.2.39.

Coleman CH, Bouësseau MC: Strengthening local review of research in Africa: is the IRB model relevant?. Bioethics Forum. 2006, [ http://www.bioethicsforum.org/ethics-review-of-medical-research-in-Africa.asp ]

Burris S, Welsh J: Regulatory paradox in the protection of human research subjects: a review of OHRP enforcement letters. Northwestern University Law Review. 2007, 101: 643-685.

New Zealand Injury Prevention, Rehabilitation, and Compensation Act, § 32(6). [ http://interim.legislation.govt.nz/libraries/contents/om_isapi.dll?clientID=858250283&infobase=pal_statutes.nfo&jump=a2001-049%2fs.32&softpage=DOC#JUMPDEST_a2001-049/s.32 ]

Health Research Council of New Zealand: Accredited Ethics Committees. 2005, [ http://www.hrc.govt.nz/root/Ethics/Ethics%20Overview/Accredited_Ethics_Committees.html ]

See, for example, National Patient Safety Agency (United Kingdom): Quality Assurance – Accreditation. [ http://www.nres.npsa.nhs.uk/recs/quality/accreditation.htm ]

Association for the Accreditation of Human Research Protection Programs, Inc. [ http://www.aahrpp.org/www.aspx ]

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR): SIDCER Recognition Programme. 2005, [ http://www.sidcer.org/new_web/main/SIDCER_RecPro.doc ]

Public Responsibility in Medicine and Research: Certification. 2007, [ http://www.primr.org/certification/certification.html ]

Emanuel EJ, Wood A, Fleischman A, Bowen A, Getz KA, Grady C, Levine C, Hammerschmidt DE, Faden R, Eckenwiler L, Muse CT, Sugarman J: Oversight of human participants research: identifying problems to evaluate reform proposals. Annals of Internal Medicine. 2004, 141: 282-291.

Quality Assurance Project: Quality assurance of health care in developing countries. at14., [ http://www.qaproject.org/pubs/PDFs/DEVCONT.pdf ]

Saver RS: Medical research and intangible harm. University of Cincinnati Law Review. 2006, 74: 941-1012.

Flory J, Emanuel E: Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004, 292: 1593-1601. 10.1001/jama.292.13.1593.

Brown RW: Why is quality assurance so difficult? A review of issues in quality assurance over the last decade. Internal Medicine Journal. 2002, 32: 331-337. 10.1046/j.1445-5994.2002.00240.x. at 332.

Quality Assurance Project: Monitoring the quality of primary care. at 3., [ http://www.qaproject.org/pubs/PDFs/hmngrfinal.pdf ]

Pre-publication history

The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1472-6939/9/6/prepub

Download references

Acknowledgements

Dr. Bouësseau is a staff member of the World Health Organization. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy or views of the World Health Organization.

Author information

Authors and affiliations.

Seton Hall Law School, Newark, New Jersey, USA

Carl H Coleman

Department of Ethics, Equity, Trade & Human Rights, World Health Organization, Geneva, Switzerland

Marie-Charlotte Bouësseau

You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Carl H Coleman .

Additional information

Competing interests.

The author(s) declare that they have no competing interests.

Authors' contributions

CHC and MCB jointly developed the ideas presented in this article. CHC wrote the first draft, and both authors jointly revised the draft. Both authors read and approved the final manuscript.

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and permissions

About this article

Cite this article.

Coleman, C.H., Bouësseau, MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics 9 , 6 (2008). https://doi.org/10.1186/1472-6939-9-6

Download citation

Received : 21 October 2007

Accepted : 28 March 2008

Published : 28 March 2008

DOI : https://doi.org/10.1186/1472-6939-9-6

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

Research Participant
Prospective Participant
Accreditation Program
Ethic Review Process
Research Ethic Committee Review

BMC Medical Ethics

ISSN: 1472-6939

General enquiries: [email protected]

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Publications
Account settings
My Bibliography
Collections
Citation manager

Save citation to file

Email citation, add to collections.

Create a new collection
Add to an existing collection

Add to My Bibliography

Your saved search, create a file for external citation management software, your rss feed.

Search in PubMed
Search in NLM Catalog
Add to Search

Role of the research ethics committee

Affiliation.

1 Academic Department of Neurosurgery, Addenbrooke's Hospital, Cambridge, UK. [email protected]
PMID: 10808899
DOI: 10.1054/nedt.1999.0349

Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive sufficient information, which can be easily understood, and ensuring that appropriate strategies are in place to protect participants from potential adverse consequences of the research. Secondly, the research ethics committee has an obligation to society which provides the resources for research and will ultimately be affected by the results. Thirdly, the research ethics committee has an obligation to the researcher. The research proposal should be treated with respect and consideration. The research ethics committee should strive to meet each of these obligations. All researchers should welcome the contribution made by research ethics committees to the research process because they help to ensure that research meets the high ethical and scientific standards expected by society.

PubMed Disclaimer

Publication types

Search in MeSH

Related information

Cited in Books

LinkOut - more resources

Full text sources.

Elsevier Science
Citation Manager

NCBI Literature Resources

MeSH PMC Bookshelf Disclaimer

The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Unauthorized use of these marks is strictly prohibited.

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

View all journals
Explore content
About the journal
Publish with us
Sign up for alerts
Published: 01 July 2024

Ethics committees promote responsible research in China

Guoyu Wang ORCID: orcid.org/0000-0002-4330-2629 1

Nature Human Behaviour ( 2024 ) Cite this article

Metrics details

Science, technology and society

Guoyu Wang leads and serves on Chinese ethics committees. She explains how research ethics have developed in China, and why ethics review promotes responsible innovation.

This is a preview of subscription content, access via your institution

Access options

Access Nature and 54 other Nature Portfolio journals

Get Nature+, our best-value online-access subscription

24,99 € / 30 days

cancel any time

Subscribe to this journal

Receive 12 digital issues and online access to articles

111,21 € per year

only 9,27 € per issue

Buy this article

Purchase on Springer Link
Instant access to full article PDF

Prices may be subject to local taxes which are calculated during checkout

Lei, R., Zhai, X., Zhu, W. & Qiu, R. Nature 569 , 184–186 (2019).

Article CAS PubMed Google Scholar

Mittelstraß, J. in Berichte und Abhandlungen vol. 2 (ed. Berlin-Brandenburgische Akademie der Wissenschaften) 215–235 (Akademie, 1996).

Qui, J. Nature https://doi.org/10.1038/nature.2012.11998 (2012).

Download references

Acknowledgements

This work was supported by the National Natural Science Foundation of China (grant no. L2224015).

Author information

Authors and affiliations.

School of Philosophy, Institute of Technology Ethics for Human Future, Fudan University, Shanghai, China

You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Guoyu Wang .

Ethics declarations

Competing interests.

The author declares no competing interests.

Rights and permissions

Reprints and permissions

About this article

Cite this article.

Wang, G. Ethics committees promote responsible research in China. Nat Hum Behav (2024). https://doi.org/10.1038/s41562-024-01917-5

Download citation

Published : 01 July 2024

DOI : https://doi.org/10.1038/s41562-024-01917-5

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

Quick links

Explore articles by subject
Guide to authors
Editorial policies

Find guidance
Our organisation
Core Practices
Find a member
Become a member
Work with us

Response to COPE editorial

Professor Dr Mingfang Lu, Executive President, AiScholar

My understanding of this issue is that while language is important, it should not be overemphasised. Even with the DEIA concept in mind, academic research itself is highly hierarchical, with top-tier research papers containing groundbreaking results accounting for less than 10% to even 1% of all published academic papers. These papers are primarily authored by a relatively small group of top-tier researchers from different generations, whether English-speaking or using English as an additional language. For these researchers, the impact of language is relatively minor, as it is simply the fundamental tool they need to master in order to communicate their discoveries in their scientific careers.

Furthermore, major international academic publishers, especially those associated with not-for-profit and well-established learned societies, have long recognised the importance of language accessibility. They have implemented language-friendly codes early on, understanding that good results should not be rejected from publishing due to language barriers. Initially, understandable writing and language are acceptable for submitted papers, and once accepted, editors work with the authors to improve the language and presentation for quality dissemination.

Journal editors and reviewers also provide free English language editing and proofreading support, even during the peer review stage. This support has been offered for several decades, even when the entire submission, peer review, and publication process was conducted in paper form, and language editing was done through handwritten marks. Additionally, there were not as many submissions back then as there are today.

Conference organisers have also implemented similar measures to support academic communications across languages.

The current global social and economic development has led to a significant increase in research funding and support, resulting in a substantial rise in the number of academic papers published each year. While technological advancements in academic publishing have made significant progress with electronic and online publishing, publishers have found themselves unable to continue offering free language editing support for such a large volume of submissions. As a result, they have had to either commercialise these services or collaborate with external providers for English language editing. This brings us to the topic of accessible language matter under discussion.

In less funded regions, the limited representation of academic publications is primarily affected by the scarcity of research facilities and positions, with the impact of language being relatively minor.

The influence of the English language on ESL/EAL [English as a Second Language/English as an Additional Language] researchers varies across different disciplines. Authors in fields such as medicine may require stronger support in writing language and presentation, as a significant portion of them are medical practitioners rather than trained researchers. This need for support may also apply to the fields of engineering, social sciences, and humanities.

However, the language factor, and perhaps cultural background as well, clearly influences underrepresented ESL/EAL researchers participating in the peer review process or serving as journal editorial board members or editors-in-chief. For those outside of traditional research networks, acting in these editorial roles requires a high level of proficiency in English language and cultural understanding.

While leading ESL/EAL researchers can usually manage language matters well, the majority of authors require English editing services and often have to pay for them. Experienced language editors not only edit the language but also provide suggestions for adjustments in logic and changes to the paper's structure, as well as checking punctuation and sensitive phrasing that may not be suitable for an academic work. Even minor mistakes, if identified in later editorial and peer review processes, can lead to the paper being considered underqualified or untrustworthy in its research, rather than just in language.

Technological advancements such as generative AI can now assist ESL/EAL authors in drafting research papers and in English language editing or translation across languages to a large extent. However, for the time being, experienced academic writing and language specialists are still needed to guarantee the language and writing quality of the finally submitted papers. Publishers, funders, science decision-makers, and research institutions all need to pay greater attention to promoting equal access to language in academic publishing.

Promoting the idea of diversity, equity, inclusivity, and accessibility holds essential value for all of humanity, even though the discussions are mostly at the industry level. In the future, this will transcend geographical and other limitations and benefit everyone on this planet.

An experienced publishing expert, ex-Editor-in-Chief and physicist, Dr Mingfang has a diverse academic profile and has driven various initiatives in the academic publishing industry in China and beyond. He worked with IOP Publishing for 16 years as its Editor-in-Chief -China, where he worked in collaboration with organisations such as NSFC, MOST, CAST, CAS, and top researchers in IOPCAS, Tsinghua University, and Peking University, etc. At AiScholar, Dr Lu is leading the team to support researchers in advancing their science goal with full publication and communications supporting services.

COPE editorial

This is a guest response to the COPE editorial Can we make English-language publishing more accessible?

House Committee on Ethics

Search form.

Committee Members
Committee Staff
Committee Events
Committee Jurisdiction
Committee History
Committee Advice
Committee Rules
Committee Jobs
Committee Statements
FAQs About Campaign Activity
FAQs About Gifts
FAQ About Casework
FAQs About Financial Disclosure
FAQs about Future Employment and Recusal
FAQs About Official Allowances
FAQs About Official and Outside Organizations
FAQs About Outside Employment
FAQs About Staff Rights and Duties
FAQs About Training
FAQs About Travel
Gifts Guidance
Gift Waivers
Gift Pink Sheets
Travel Guidance
Travel Regulations
Travel Forms
Travel Calculator
Travel Pink Sheets
Campaign Activity FAQs
Campaign Contributions and Contributors
Campaign Work by House Employees
General Prohibition Against Using Official Resources for Campaign or Political Purposes
Other Applicable Laws, Rules, and Standards of Conduct
Proper Use of Campaign Funds and Resources
Campaign Activity Pink Sheets
General Information About Financial Disclosure
Financial Disclosure Forms and Filing
Financial Disclosure Guidance
Periodic Transaction Report Calculator
Past Financial Disclosures
Retention of and Public Access to Reports
Specific Disclosure Requirements
Termination Reports
Common Financial Disclosure Mistakes
Financial Disclosure Pink Sheets
New Employee
Existing Employee
Senior Staff
Training Pink Sheets
Art Competition Form
Future Employment Forms
Forms for Members Practicing Medicine
STEM Competition
Solicitation Waiver
Teaching Forms
Legal Expense Fund Form
Outside Positions Forms
Committee Reports
General Advisories
Historical Documents
Press Releases
Summary of Activities

Statement of the Chairman and Ranking Member of the Committee on Ethics Regarding Representative Ronny Jackson

Pursuant to Committee Rule 7, the Chairman and Ranking Member of the Committee on Ethics (Committee) determined to release the following statement:

On March 25, 2024, the Committee received a referral from the Office of Congressional Ethics (OCE) regarding Representative Ronny Jackson. Pursuant to House Rule XI, clause 3(b)(8)(A), and Committee Rules 17A(b)(1)(A) and 17A(c)(1), the Chairman and Ranking Member jointly decided on May 9, 2024, to extend the Committee’s review of the matter. In order to gather additional information necessary to complete its review, the Committee will review the matter pursuant to Committee Rule 18(a). The Committee notes that the mere fact of conducting further review of a referral, and any mandatory disclosure of such further review, does not itself indicate that any violation has occurred, or reflect any judgment on behalf of the Committee.

In order to comply with Committee Rule 7 regarding confidentiality, out of fairness to all respondents, and to assure the integrity of its work, the Committee will refrain from making further public statements on this matter pending completion of its initial review.

Pursuant to Committee Rule 17A, the Committee hereby publishes OCE’s Report and Findings relating to allegations against Representative Jackson.

Press Release

OCE Report and Findings

OCE Report and Findings Exhibits

IMAGES

Ethics and Integrity
Research: ethics committees, the risk of a "bureaucracy of virtue"?
DMMMSU Research Ethics Committee earns accreditation for high ethical standards
What do Research Ethics Committees review?
What can the history of research ethics teach us?
Asean Research Organization

VIDEO

Ethics Exchange: Paediatrics and Research with Children
Wits in 60 Seconds
#AΙ: Applications and Ethical Challenges
The importance of our Ethics Committee, and the history
82 Ethical Governance and IREC
Engaging with your HREC

COMMENTS

Ethics Committees: Structure, Roles, and Issues
An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty.
What is a Research Ethics Committee?
News. Research ethics committees (RECs) are an important part of a healthy research culture. Their role is to consider the ethical implications of research. Traditionally this has focussed on the need to protect research participants (both human and animal), but in recent years their role in supporting researchers, and promoting research ...
Standards and guidance for members of the research ethics committees
Standard 7. Ethical basis for decision-making in research ethics committees. The REC bases its decisions about research that it reviews on a coherent and consistent application of the ethical principles articulated in international guidance documents and human rights instruments, as well as any national laws or policies consistent with those principles.
Standards and guidance for entities that establish research ethics
The research ethics committee (REC) is constituted according to a charter or other document that establishes the manner in which members and the Chair will be appointed. The appointing entity ensures that the REC has a multidisciplinary and multisectoral membership, that its composition is gender balanced, that it reflects the social and cultural diversity of the communities from which ...
Research Ethics Service and Research Ethics Committees
The Health Research Authority and the Devolved Administrations provide a Research Ethics Service so that research proposals relating to their areas of responsibility can be reviewed by a Research Ethics Committee (REC). Research Ethics Committees protect the rights, safety, dignity and wellbeing of research participants.
Our principles: research ethics committees
RECs should be able to conduct ethics review in a wholly independent and impartial manner without any conflicts of interest and with a focus clearly on the ethics of research proposals. Independence can be achieved by a committee composed of members from a wide range of disciplines and includes external members, within a policy and governance ...
Committees: Research Ethics Committees
Research ethics committee is one of the three types of ethics committees that can be found. A research ethics committee is an independent, multidisciplinary body that performs the review of the research protocol. Throughout its development it was called differently, and these differences still remain in different countries in the world.
In Pursuit of Ethical and Inclusive Research: What Ethics Committees
Ethics committees have a big responsibility to keep people safe, but the experts who work on an ethics committee may not know a lot about disability. Stories and videos of people with disabilities participating in research can help the ethics committee to understand what is possible.
Ethics Committees: Procedures and Duties
Abstract. Ethics Committees (also called Institutional Review Boards, or IRBs) are common fixtures with which researchers around the world are generally quite familiar. In much of the scientific world, they are mandated by laws and regulations and research involving human subjects is generally guided and overseen by such committees.
Ensuring ethical standards and procedures for research with human beings
It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants. As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld. Discussion of the ethical principles of beneficence, justice and ...
The roles of research ethics committees: implications for membership
The purpose of a Research Ethics Committee in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants. And the Economic and Social Research Council's research ethics framework for social science research [3] states: A Research Ethics Committee (REC) is defined as a ...
Research ethics
Research ethics is a discipline within the study of applied ethics. Its scope ranges from general scientific integrity and misconduct to the treatment of human and animal subjects. The societal responsibilities science and research has are not traditionally included and less well defined. ... Today, research ethics committees, such as those of ...
Institutional review board
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 ...
The role of research ethics committees: Friend or foe in educational
Research ethics committees may be perceived as a friend; they have a legitimate and useful role to play by offering advice, providing a forum in which ethical principles and their application can be discussed and initiating discussion concerning problematic cases (Hammersley, 2009). In addition, ethics committees may assist in strengthening the ...
Manual for Research Ethics Committees
The sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy.
Ethical Considerations in Research
Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects. ... An IRB is a committee that checks whether your research aims and research design are ethically acceptable ...
Research Ethics Committees overview
Research Ethics Committees overview. Last updated on 4 Feb 2020. There are more than 80 NHS Research Ethics Committees across the UK. They exist to safeguard the rights, safety, dignity and well-being of research participants. RECs consist of up to 15 members, a third of whom are 'lay' - their main professional interest is not in a research ...
Research ethics committees: A forum where scientists, editors, and
Research ethics committees and associated data safety monitoring boards are the canaries in the mines who should be audible voices not bullied by sponsors or governments. Their advocacy for science and public safety as well as research integrity means viewing them in the research co-working space, as well as the regulatory/governance space. ...
What is the role of the research ethics committee? Paternalism
A research ethics committee might, for example, choose to prohibit researchers from injecting themselves with a new preventive vaccine for HIV because it is held that the risk of harm from the live vaccine's constituents was too great. 5 Edwards et al simply assert the primacy of respect for autonomy as a moral consideration, but nothing in ...
How do we know that research ethics committees are really working? The
The Increasing Role of REC Review. REC review is a cornerstone of international guidelines on research with human participants. For example, the Council for International Organizations of Medical Sciences (CIOMS) states that "all proposals to conduct research involving human subjects must be submitted for review and approval to one or more independent ethical and scientific review committees []."
Role of the research ethics committee
Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. ...
Ethics committee
A Comité de Protection des Personnes (CPP) in France. In the United States, an ethics committee is usually known as an institutional review board (IRB) or research ethics board (REB) and is dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US. Similarly in Canada, the committee is ...
(PDF) The role of research ethics committees: Friend or foe in
Background: The ethics committee has the responsibility to comply with the rules and guidelines regarding oversight of all human research activities, particularly when the research study involves ...
Ethics committees promote responsible research in China
Ethics committees in China began in the 1990s in hospital settings, and focused on physician virtues and physician-patient relationships. Since the turn of the century, the Chinese public and ...
Increasing research output brings new pressures for authors writing in
However, for the time being, experienced academic writing and language specialists are still needed to guarantee the language and writing quality of the finally submitted papers. Publishers, funders, science decision-makers, and research institutions all need to pay greater attention to promoting equal access to language in academic publishing.
2024 World Bronchiectasis Day Virtual Roundtable Event ...
Hosted by Bronchiectasis and NTM 360 of the COPD Foundation in honor of World Bronchiectasis Day, patients and a few of the world's leading physicians in...
Statement of the Chairman and Ranking Member of the Committee on Ethics
Pursuant to Committee Rule 7, the Chairman and Ranking Member of the Committee on Ethics (Committee) determined to release the following statement: On March 25, 2024, the Committee received a referral from the Office of Congressional Ethics (OCE) regarding Representative Ronny Jackson. Pursuant to House Rule XI, clause 3(b)(8)(A), and Committee Rules 17A(b)(1)(A) and 17A(c)(1), the Chairman ...

Publications

What is a Research Ethics Committee?

Two types of RECs

REC review supports research and researchers

Research organisations and research ethics committees - ESRC

Research should aim to maximise benefit for individuals and society and minimise risk and harm

The rights and dignity of individuals and groups should be respected

Wherever possible, participation should be voluntary and appropriately informed

Research should be conducted with integrity and transparency

Lines of responsibility and accountability should be clearly defined

The independence of research should be maintained, and where conflicts of interest cannot be avoided they should be made explicit

Further information

Ethics Committees: Procedures and Duties

Cite this chapter

Access this chapter

Author information

Rights and permissions

Copyright information

About this chapter

Download citation

Share this chapter

Standards and operational guidance for ethics review of health-related research with...

WHO tool for benchmarking ethics oversight of health-related research involving human...

Login Alert

Manual for Research Ethics Committees

This Book has been cited by the following publications. This list is generated based on data provided by Crossref .

Book description

Refine List

Save content to

Save Search

Frontmatter pp i-iv

Contents pp v-viii

Part I pp 1-2

2 - Research ethics committees and the law pp 15-17

3 - The regulation of medical research: a historical overview pp 18-22

4 - The regulation of medical research in the UK pp 23-33

5 - Observational and epidemiological research pp 34-36

6 - Social survey research pp 37-39

7 - Approaching qualitative research pp 40-48

8 - Complementary and alternative medicine: challenges for research ethics committees pp 49-52

9 - The ethical review of student research in the context of the governance arrangements for research ethics committees pp 53-56

10 - The ethics of genetic research pp 57-59

11 - Research or audit? pp 60-60

12 - Randomised controlled trials pp 61-63

13 - Determining the study size pp 64-66

15 - Absorbed radiation in patient and volunteer studies submitted to the ethical committee: a memorandum pp 69-71

16 - A guide to the use of radioactive materials and radiological procedures for research purposes pp 72-74

17 - Indemnity in medical research pp 75-78

18 - The prevention and management of fraud and misconduct: the role of the LREC pp 79-82

19 - Understanding clinical trials: a model for providing information to potential participants pp 83-88

20 - The law relating to consent pp 89-95

21 - Writing information for potential research participants pp 96-99

22 - The law relating to confidentiality pp 100-102

23 - Research involving vulnerable participants: some ethical issues pp 103-110

Book summary page views

Have a language expert improve your writing

Ethical Considerations in Research | Types & Examples

Table of contents

Here's why students love Scribbr's proofreading services

Receive feedback on language, structure, and formatting

Research misconduct

Cite this Scribbr article

Is this article helpful?

Pritha Bhandari

Research Ethics Committees overview

Search Research Ethics Committees

REC annual reports

Related links

Research ethics committees: A forum where scientists, editors, and policymakers can cooperate during pandemics

Katrina A. Bramstedt

Log in using your username and password

You are here

Statistics from Altmetric.com

Read the full text or download the PDF:

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

The Increasing Role of REC Review

Challenges for REC Review

Existing Oversight Mechanisms for RECs

Integrating Quality Assurance Principles into REC Assessment

Pre-publication history