research ethics committee (rec)

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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. Managing the Research Ethics Committees in England is one of the Health Research Authority’s core functions.

We have a duty to provide an efficient and robust ethics review service that maximises UK competitiveness for health research and maximises the return from investment in the UK, while protecting participants and researchers.

We have a dual mission to protect the  rights, safety, dignity and well-being of research participants  and to facilitate and promote ethical research that is of potential benefit to participants, science and society. 

The Research Ethics Service consists of: 

• Research Ethics Committees (RECs) across the UK reviewing health and social care research
• volunteer members and chairs that sit on NHS/HSC RECs

The Governance Arrangements for Research Ethics Committees (GAfREC) describe what is expected from RECs when reviewing research proposals.

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• Volume 26, Issue 2
• Research made simple: ethics committee approval
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• http://orcid.org/0000-0002-1112-4389 Ben Parkinson 1 ,
• http://orcid.org/0000-0003-4308-4219 David Barrett 2
• 1 Nursing , Glasgow Caledonian University , Glasgow , UK
• 2 Department of Health Sciences , University of York , York , UK
• Correspondence to Dr Ben Parkinson, Nursing, Glasgow Caledonian University, Glasgow G4 0BA, UK; ben.parkinson{at}gcu.ac.uk

https://doi.org/10.1136/ebnurs-2022-103643

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• Nursing Research

Nursing research often involves collection of data from human participants. Participants involved with research may be vulnerable, acutely unwell or even lack capacity to make decisions. Protecting the safety and well-being of all participants is a requirement and nurse researchers need to ensure the ethical principles of autonomy, non-maleficence, beneficence and justice are maintained throughout the research process. 1

To protect participants, research studies are subject to approval by research ethics committees (RECs)—sometimes called research ethics boards or institutional review boards. 1 Securing REC approval can be a complex process, requiring nurse researchers to demonstrate that the proposed study meets the necessary ethical and research governance requirements for research involving human participants. This paper will provide an overview of the role of RECs and offer guidance to nurse researchers applying for REC approval.

Research ethics committees

RECs came to prominence in the second half of the 20th century. The internationally recognised Declaration of Helsinki— first adopted in 1964, but amended several times since then—states all researchers need to secure REC approval before commencing research involving human participants, in order to safeguard the health and well-being of those involved. 2 RECs can be part of national research authorities (such as the National Office for Research Ethics Committees in Ireland), and/or sit within organisations such as hospitals and universities. Their role is to provide independent scrutiny of research and to determine whether proposed studies can be given ethical approval.

REC approval is a formal process that nurse researchers complete before commencing research involving human participants. An initial step is to establish whether the study needs REC approval. Usually, research involving human participants requires REC approval, but deciding whether a study is research can be difficult. The lines between research, audit and evaluation are blurred, so it is useful to think carefully about whether the study meets the criteria for research ( table 1 ). 3 Some tools exist to help make this decision, including the ‘Do I need REC review’ tool provided in by the Health Research Authority in the UK ( http://www.hra-decisiontools.org.uk/ethics/ ).

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Evaluation, audit, research

What do RECs consider when scrutinising research protocols?

RECs consider a wide range of issues related to research ethics and integrity. REC applications can be lengthy documents including a detailed protocol, participant information sheets, consent documents and data collection tools. There may be different criteria or templates used across different RECs and variation does exist in the process and outcomes of REC review. 4 Despite this variation though, there is some agreement about what is important and the areas that need addressed in their REC applications. 5

Scientific value: does the study ask important questions; is the proposed methodology appropriate; will the research produce useful findings?

Resources: are there adequate resources available for the research; is the research team sufficiently competent and experienced to complete the research?

Risk assessment: does the risk assessment show a favourable risk-benefit ratio for people involved in the study and wider community?

Independent review: has an independent review of the research happened? What patient and public involvement has occurred?

Recruitment: will recruitment be fair, free from coercion, and are the risks and benefits of the research shared equally within society?

Consent: will participants provide informed voluntary consent, and will participants be able to withdraw their consent and remove themselves from the research should they wish to do so?

Privacy: does the study protect participants’ privacy and personal data?

Protection: does the research have adequate safety and welfare measures to ensure participants’ well-being?

Supporting documents: are research documents accessible enough for the intended audience, and do they provide enough information about the research, so participants can make an informed decision about participating?

What happens after the REC review?

Once the review process is complete, the REC will decide on the most appropriate outcome for the research. Though some different terminology may be used in different countries, REC decisions usually fall into one of the following: approved, approved with conditions, or revise and resubmit ( table 2 ). 6

REC decisions

What can help get an REC application approved?

Securing REC approval can be a lengthy and stressful process. Approval times vary between RECs, but some RECs can take several months to provide a decision on an application. 7 It is important that nurse researchers factor in the time taken to secure REC approval when planning research projects; even the most experienced researchers often need to revise their REC applications before being approved, and the process can take longer than expected. 6 This could have implications for funding or—in the case of student projects—for meeting academic deadlines. Taking simple steps before submitting the REC application can help minimise the chances of having to resubmit the REC application and can help expedite the research process.

Steps to take when applying for REC approval

Find out about the application process for the REC you will be using (eg, submission process, documents required, timelines involved). Some RECs use online submission systems, so it may be necessary to create an account and/or learn how to navigate the system.

All nurse researchers need to allow enough time for the REC review process and should assume they will need to revise the REC application because even experienced nurse researchers may have to revise their REC applications.

Involve stakeholders when designing the study and preparing an application for REC approval.

Consider the ethical principles of autonomy (respect of persons), non-maleficence, beneficence and justice when designing the research. 1

Complete a risk assessment and evaluate whether the potential benefits outweigh the possible risks associated with the research.

Write the research protocol using the structure recommended by the REC or an established framework such as the ‘Ethics Tool Kit’. 8

Ensure the participant-facing documents (such as information sheets) are comprehensive and that the language is accessible for the intended audience.

Get peer feedback on the application from an experienced researcher who is not involved in the study.

Use version control to manage the different versions of key documents.

Check all documents before submission to avoid unnecessary delays in the review process.

RECs are crucial in protecting the health, safety and well-being of research participants. In order to receive approval from these committees, nurse researchers need to ensure that their proposals are clear, comprehensive, informed by stakeholder input and focused on the well-being of those who will take part in their study.

• World Medical Association
• Twycross A ,
• Brandenburg C ,
• Thorning S ,
• Ruthenberg C
• Glasziou P ,
• Chalmers I , et al
• Wacholtz MC ,
• Barnes M , et al

Twitter @ParkinsonBen1, @barrett1972

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Provenance and peer review Commissioned; internally peer reviewed.

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What is a Research Ethics Committee?

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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 .

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Research Ethics Committees (REC)

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Table of contents

Last update: 15 July 2015

Introduction

The Research Ethics Committee ( REC ) evaluates the ethical acceptability of research before participants can be enrolled in a study. In addition, the REC will examine certain related financial and scientific aspects.

Authority, role and mandate of Research Ethics Committees

The setup, legal status and operation of RECs vary across countries. RECs are usually established by a government or an institutional authority (such as a hospital, research institution or university).

In some cases, RECs may be set up by private organisations, but these may need to be publicly accountable in some way (e.g. through accreditation). There is little evidence to suggest that the quality of ethics review conducted by private RECs varies from those established by a public institution or organisation.

RECs help to ensure the well-being, safety , and protection of persons who participate in research. To achieve this, an ethics review and favourable opinion must be sought before the research can begin and ongoing research will be continually monitored.

Independence of RECs and committee members

RECs must be independent from sponsors, funders, investigators , and from undue influence (e.g. political, institutional, professional or commercial). This ensures that the interest of research participants is paramount.

Achieving the independence of RECs is a challenge. It requires proper accountability (i.e. making sure the right people are responsible) and balanced membership (i.e. making sure the right mix of people is involved). REC members must be free from, or have properly managed and declared, conflicts of interest. REC members who have conflicts of interest may not be able to participate in decisions concerning a particular study protocol .

Composition and operational aspects

An REC is typically composed of members who together have the qualifications and experience to ensure proper review of the ethical, scientific, medical, and financial aspects of a study. In many countries, non-scientific members are required. Members should be appointed for a fixed term by the recognised authority according to an established procedure. The REC may choose to invite outside experts who are not members to advise on a project.

Properly constituted RECs and standard operating procedures (SOPs)

RECs need to ensure that their written procedures comply with national, local, and/or institutional requirements as well as to their own SOPs.

Guidelines and regulations for some countries specify that REC operating procedures should cover:

• How meetings will be conducted
• How applications to have proposals reviewed should be made
• How the REC will make its decisions at announced meetings, including the minimum quorum (i.e. the minimum number of people required to attend and vote in order to make a decision)
• Details of the process for ethics review
• A rule that no participant should be enrolled before the REC has issued its written favourable opinion of the study
• The investigator ’s duty to promptly report to the REC any substantial protocol amendments or safety issues, including serious and unexpected adverse events (AEs).

Ethical deliberation and decision-making

Ethical deliberation.

Ethical deliberation refers to careful consideration and discussion of research, and should take into account the principles and values of research ethics from relevant local and international guidelines. All documentation relevant to the review must be examined by the REC before the discussion, during which each member should contribute and provide their expertise and perspectives.

Reaching a decision

Ideally, the REC will reach an opinion that all members find ethically satisfactory (consensus). This decision is valid as long as it emerges from deliberations that are honest, fair, and factually well-informed and follow SOPs.

Making decisions by vote, as opposed to consensus, should be restricted to exceptional circumstances because voting gives priority to the number of people who hold a certain opinion but does not take into account the reasoning behind those opinions.

Dissenting and abstaining

If a decision is reached that is not accepted by all members, then the number of people who abstain (do not vote) or dissent (do not agree with the majority decision) should be recorded.

Due process

Due process implies that the REC will be impartial and will only make decisions at announced meetings with a quorum. Only members who participate in deliberations are able to take part in decisions; investigators and sponsors should have a fair opportunity to be heard (although they cannot participate in the deliberation and decision-making process).

A decision (favourable or negative opinion) should be communicated in writing to the applicant and to the relevant authorities. The REC must store, and be ready to make available, relevant records of its decisions and SOPs.

Follow-up of ongoing research

RECs re-evaluate approved research at regular intervals, the frequency of which is dependent on the individual REC . This is based on the level of risk the project poses to participants. As part of the continuing review process, the following examples may require follow-up by the REC :

• Any substantial protocol amendments that are likely to have a significant impact on the safety or physical or mental integrity of the participants, or the scientific value of the trial where applicable, accompanied by an updated risk - benefit assessment
• Unexpected AEs and serious AEs related to the conduct of the study or study product

The goal of continuing ethics review

The purpose of continued review is to ascertain if the research is being conducted in compliance with the approved protocol . If the risk - benefit ratio has changed, the participants should be informed of the change and then be asked to re-consent to participating in the research. They may also withdraw from the study.

REC decisions during continuing review

If anything is found to be unacceptable during the follow-up, favourable ethical opinion may be suspended or withdrawn until further information is provided and reviewed. The new information may need to be communicated to participants to enable an informed choice regarding continued involvement in the research. The REC can ask for protocol modifications or changes to the Informed Consent Form, which will require re-approval and subsequent re-consent or refusal from participants.

Accountability

RECs must demonstrate accountability towards researchers and the broader public and are immediately accountable to their constituting authority whether a government, institutional authority or private organisation. RECs must promote the transparency of its activities and decisions, including the official announcement of meetings.

Which research requires ethics evaluation?

All research that involves humans must be evaluated by a REC before any prospective participants are recruited . This also applies to research conducted with personal information (e.g. medical records), or with human tissue and genetic material. Research with human gametes (i.e. sperm or eggs), embryos, and foetal tissue also require prior ethics review in addition to other requirements (see section on particular cases below).

Certain research may qualify for exemption from ethics review, for example, when there is no foreseeable risk of harm or discomfort, and it involves no more than inconvenience to participants (negligible risk ). This is also the case for research that involves the use of existing collections of data or records that contain only non-identifiable data about people (e.g. public records, archives, or publications).

Particular cases

Clinical trials are a type of research that has additional requirements. For example, in Europe, sponsors of clinical trials for medicines must have approval from the National Competent Authority and a favourable opinion by the REC before a trial can start.

Research involving human reproductive material (e.g. stem cells , gametes, embryos) requires review by the national oversight committee in addition to the REC .

Ethical aspects

Research that is not scientifically sound is not ethically acceptable. This is because it will expose participants to the burden and potential harms of research without having the possibility of yielding benefits to the participants and/or to society. Thus, the REC must ensure that appropriate scientific evaluation has occurred. If research does not pass scientific evaluation, then it should be denied ethics opinion as well.

Levels of evaluation

RECs can adopt a proportionate approach to ethics evaluation: the greater the burden of research, the greater the scrutiny. An evaluation can be completed by the REC ’s full committee or by a sub-committee (expedited review). Expedited review is allowed by certain RECs for research that poses only minimal burden to participants (when the amount of harm expected in the research is less than that ordinarily encountered in daily life, or in routine medical, dental, or psychological exams).

SOPs for expedited reviews of research should specify:

• the nature of the applications;
• amendments and other considerations;
• the quorum requirements; and
• whether or not the opinion reached will need to be confirmed by the full committee.

Ethics review of international collaborative research

Internationally collaborative research, like any multi-centre trial, may require a number of ethics evaluations in the respective countries.

Regardless of where the research is conducted, the EU requires that it follows the principles of the Declaration of Helsinki 1 if the research is to be used for marketing authorisation in the EU .

Documents subject to ethics review

Owing to the differences between individual research projects and the evolution of ethics evaluation practices over time, it is difficult to establish a definitive list of documents that the REC needs in order to conduct a full evaluation. Therefore, the REC may ask to be provided with any document it considers important. 2

Disclosure to prospective participants

Prospective participants should be fully informed of all aspects of the study, including the aims and methods, sources of funding, and identification of the researchers and sponsors, the anticipated benefits and potential risks . Participants will receive an official invitation to take part in the research and will be informed of the right to abstain (withhold) from participation, or to withdraw consent at any time without reprisal. All measures that are taken to ensure the privacy of participants should be highlighted. The address of who to contact for information at any time should be provided, together with the reassurance that access to free treatment (and compensation, in the event of impairment, disability or handicap) will be available in case of injury from research procedures. Participants will also be informed of the type of reimbursement that they will receive for taking part in the research (where applicable).

Detailed guidance on the application format and documentation to be submitted in an application for an ethics committee opinion on the clinical trial on medicinal products for human use.

Further Resources

• European Commission (2006). Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use . Brussels: European Commission. Retrieved 12 July, 2021, from: https:// ec .europa. eu /health/sites/default/files/files/eudralex/vol-10/12_ ec _guideline_20060216_en.pdf

Articles References

• World Medical Association (2013). Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Retrieved 12 July, 2021, from: https://www. wma .net/policies-post/ wma -declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
• European Parliament and the Council (2009). DIRECTIVE 2001/20/ EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use . Retrieved 12 July, 2021 from: https:// ec .europa. eu /health/sites/default/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf

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• Term: National Competent Authority
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Encyclopedia of Global Bioethics pp 650–656 Cite as

Committees: Research Ethics Committees

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Research ethics committees have become a permanent fixture when it comes to ethics of research. They are essential part of quality control of research protocol, and their existence and work are thoroughly described in all important international documents dealing with research ethics issues. In this contribution history, development and different types of research ethics committees are discussed. The functions, structure, and locale of research ethics committees are also addressed. The global dimension of the work of research ethics committees is also discussed.

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Borovecki, A., ten Have, H., & Oreskovic, S. (2009). Ethics committees in Croatia: Studies in bioethics . Saarbrücken: VDM Verlag Dr. Müller.

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Huriet, C. (2009). Article 19: ethics committees. In H. A. M. J. ten Have & S. J. Michele (Eds.), The UNESCO universal declaration on bioethics and human rights background principles and application (pp. 265–270). Paris: UNESCO.

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ten Have, H. (2005). Establishing bioethics committees guide No. 1 (pp. 40–52). Paris: UNESCO.

Further Readings

Amdur, R., & Bankert, E. A. (2011). Institutional review board: Member handbook (3rd ed.). Sudbury, MA: Jones and Bartlett Publishers.

Emanuel, E. J., et al. (Eds.). (2008). The Oxford textbook of clinical research ethics (pp. 541–588). Oxford/New York: Oxford University Press.

Schrag, Z. M. (2010). Ethical imperialism. Institutional Review Boards and the Social Sciences, 1965–2009 . Baltimore: The Johns Hopkins University Press.

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Borovecki, A. (2016). Committees: Research Ethics Committees. In: ten Have, H. (eds) Encyclopedia of Global Bioethics. Springer, Cham. https://doi.org/10.1007/978-3-319-09483-0_104

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Research organisations and research ethics committees - ESRC

Criteria for research ethics committee review.

These principles should be considered in relation to the nature of the research outlined, the context in which it is undertaken and the accepted norms and standards set by professional societies, disciplinary bodies and research organisations (ROs).

Researchers, ROs and research ethics committees (RECs) must ensure all proposals that have been recommended for funding by ESRC are appropriately reviewed before the actual research commences.

Role of a REC

A REC should review the research proposal and make a proportionate judgement concerning whether there is an appropriate balance of risks and benefits of the research.

RECs should give due regard to the consequences of the research for those directly involved in and affected by it, and to the interests of those who do not take part in the research but who might benefit or suffer from its outcomes in the future.

RECs also need to balance the safety of researchers, especially where they are working in covert situations or conducting lone fieldwork, and the benefits of the research.

RECs should review research proposals in terms of their ethics probity which will include consideration of the design, outputs and proposed conduct of the research. These should be considered in terms of the ethics issues raised (for example, whether the method of recruitment proposed puts undue pressure on individuals to participate) and the way in which they are addressed.

The scholarly or scientific standards or merits of the research are not the primary responsibility of the REC – these should be evaluated by appropriate peer review. Where the REC needs greater understanding of the scientific or scholarly merit of a proposal in order to make a judgement about ethics issues, it should seek the advice of an independent researcher with experience and expertise in the research methods and paradigm described in the proposal.

The knowledge and expectations that members of RECs bring to the ethics review of research proposals are fundamental to the way they are reviewing. This is particularly clear in some forms of qualitative research where it may be impossible or undesirable to obtain signed consent from each respondent at the outset of the research.

Where more than one perspective or ethics principle applies to a specific case, clear ethics reasoning will be required and debate should be encouraged.

Good ethics review requires sensitivity to the context in which a research study will be conducted, and good ethics reasoning requires careful thought and consideration.

Working collaboratively with researchers will best engage them in achieving the highest ethics standards in their work. Ethics review should be seen as a valuable part of research design, execution and dissemination rather than a troublesome hurdle to jump.

REC decision

RECs may give a favourable opinion on the proposal as submitted, give a provisional approval subject to the researcher meeting specified conditions (which may require further review), or reject the proposal on ethics grounds.

RECs should record and make clear how they come to their decisions, including whether ‘lead reviewers’ are designated for a proposal and whether decisions can be made on the basis of a majority view.

The decision made for a proposal, and the grounds on which it was made, should be recorded and provided to the researchers, and a copy kept on file with the proposal for a specified minimum period consistent with the RO’s policy on information retention. This period should extend beyond the lifetime of the project.

Accountability of REC decisions should be ensured within RO governance structures, and opinions given by RECs should be open to scrutiny. Certain aspects of research may need to remain confidential; for example, intellectual property needs to be protected, as do research findings pre-publication.

There should be clarity in REC operating procedures to ensure that this balance between openness and protection is consistently maintained.

Where a proposal does not meet the expected ethics standards or changes are required, it is important for the REC to give clear feedback on what needs to be amended.

Where an ethics proposal of ESRC-funded research is rejected, the ESRC lead officer should be notified by the RO representative (which may be the principal investigator or the RO’s research support office).

Ongoing review

As part of RO governance, RECs should serve to maintain ethics standards throughout the research lifecycle of a project and effectively and rapidly support researchers in resolving ethics issues as they arise. Ongoing monitoring and support should be proportionate to the nature and degree of risk and harm encountered in the research.

Where a study design is emergent, the REC should agree, with the researchers, procedures for ongoing ethics review (for example through submission of staged ethics applications relating to different aspects of the work, or through a Project Advisory Group).

Procedures for reporting to the REC (or a designated sub-committee) any unforeseen events that might challenge the ethical conduct of the research or which might provide grounds for discontinuing the study should be formally agreed with the researchers.

Where a REC or a designated sub-committee considers that a monitoring report or ad hoc audit by the RO has raised significant concerns about the ethics in the conduct of the study, it should request a full and detailed account of the research to be submitted for full ethics review conducted by the responsible REC. The REC should review the implications of the issues with assistance from non-conflicting advisory bodies, independent experts and mentors if required.

Where a principal REC or designated sub-committee considers that a study is being conducted in a way which is not in accord with the conditions of its review or in a way which does not appropriately protect the rights, dignity and welfare of research participants, it should initially arrange a meeting of all those concerned with a view to resolving the difficulties. In an extreme situation, the REC may withdraw its favourable opinion, and recommend to the appropriate body in the RO that the research be suspended or discontinued. ESRC should be informed of this decision and reserves the right to recoup its grant funding in extreme cases of ethics and research misconduct, pending further investigation.

Last updated: 16 March 2023

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UCL Research Ethics

About the UCL Research Ethics Committee

To support our reforms, the Research Innovation and Global Engagement Committee (RIGEC) has approved a new governance structure for research ethics at UCL. Find out more below.

Research ethics is fundamental to UCL's mission as a world-class institution dedicated to the continued pursuit of original knowledge and scientific advancement to benefit humanity and the world of the future. Research ethics committees play a central role in ensuring that research meets the highest standards of academic rigour, transparency, accountability and ethics, to safeguard and empower participants

These high standards are essential for ensuring the highest quality research and maintaining the continued trust and confidence of the wider research community and the public.

What does the UCL REC do?

From spring 2024, the UCL Research Ethics Committee (UCL REC) will be established as a strategic committee with overarching responsibility for research ethics policy, guidance and processes at UCL. There will be 3 subcommittees, including 2 to review both high and low-risk applications* (from non-LREC areas):

• Life and Medical Sciences Research Ethics Committee (LMS REC) : Brain Sciences, Life Sciences, Population Health Sciences and Medical Science
• Humanities, Arts and Sciences Research Ethics Committee (HAS REC) : Arts and Humanities, Bartlett, Institue of Education, Laws, Social and Historical Sciences, Mathematical and Physical Sciences and Engineering Sciences
• The LREC Chairs Group: For the Chairs of the 24  Local Research Ethics Committees (LRECs) operating in faculties and departments, to facilitate the sharing of best practice and developing consistent approaches to emerging ethical issues.

Our 2 central reviewing committees will be multi-disciplinary with cross-UCL faculty representatives working in different fields and disciplines.

We are working with faculties on the membership of these committees. If you are enthusiastic about promoting ethical research practices and contributing to the advancement of knowledge at UCL, find out more about joining an ethics committee on our Become an ethics committee member  page.

* High-risk applications submitted for the March 2024 deadline will undergo review by the existing UCL REC. Low-risk applications will continue to be considered on a rolling basis with applications being reviewed in order of submission.

Constitution and membership

Terms of reference.

• To maintain strategic oversight of research ethics at UCL. 
• To develop and review institutional policy and processes on research ethics to ensure they remain fit for purpose and respond to evolving research and ethics.  
• To ensure that ethics policy and processes and are in line with the principles set out in the UCL Code of Conduct for Research, UCL’s commitments to equality, diversity, and inclusion, and best practice in governance. 
• To oversee the work of the reviewing subcommittees and to review and recommend any required changes to the research ethics governance structure. 
• To review and approve proposals for the establishment of new low-risk LREC Chairs Group.  
• To receive and discuss reports from reviewing committees on complex ethical issues, recommending approaches, approving and implementing UCL-wide guidance and commissioning expert guidance where required. 
• To monitor and audit practice through the receipt of annual reports and to conduct other audits as required. 
• To review and suggest improvements required to the research ethics IT system. 
• To ensure that appropriate training and advice is available for staff, supervisors and students on good practice in relation to the ethics of their research.  
• To develop, implement and review the system of appeals, complaints and adverse events or incidents reported regarding ethically approved research.
• To report on an annual basis to UCL Research, Innovation and Global Engagement Committee an overview of the effectiveness of current ethics policy, practices and procedures in that reporting year.

The UCL REC membership will comprise Chairs from the reviewing committees, LREC Chairs Group (representing LRECs) and a range of experts to inform and support the ongoing development of research ethics review policy and process.

Page last updated: March 2024

REC Forms & Templates

REC Reviewer Guidelines

REC Research Project Proposal Additional Investigators

REC Research Proposal Signature Page

REC Proposal Template

REC Proposal worksheet

REC Informed Consent Template

Recruitment Script Example

Records-based Research Application

Waiver of Informed Consent 

Directions for Readability Level

Parental Permission Template

Assent Form Template

Example Photo and Video Release Form

Addendum Request Form

Project completion report

Progress Report Template

REC CATEGORY LISTS

Research Ethics Committee

Universiti teknologi mara.

RESEARCH ETHICS COMMITTEE

The Research Ethics Committee of Universiti Teknologi MARA is registered with the Drug Control Authority, National Pharmaceutical Regulatory Agency until 18 August 2022.

• University's 2024 Common Read Book Teaches Happiness

'Build the Life You Want' co-author Arthur C. Brooks to speak at freshman convocation

OXFORD, Miss. – University of Mississippi campus leaders hope incoming students discover their passion, fuel their curiosity and, most of all, find happiness.

Happiness is the focus of the 2024 Common Reading Experience selection, "Build the Life You Want: The Art and Science of Getting Happier" (Penguin, 2023) by Arthur C. Brooks and Oprah Winfrey.

"For more than a decade, our Common Reading Experience has enriched our classrooms, sparked lively conversations, and strengthened our connections," Chancellor Glenn Boyce said. "I'm excited to see how this year's selection by Arthur C. Brooks and Oprah Winfrey will inspire our campus community to reflect on their aspirations and goals for pursuing a life filled with meaning, joy and success."

"Again, this year, the chancellor and provost have selected a wonderful book for UM's Common Reading Experience," said Stephen Monroe, co-chair of the Common Reading steering committee and chair of the Department of Writing and Rhetoric . "Their choice follows recommendations from our dedicated committee of faculty, staff, students and alumni.

"We are a community of readers, and next fall we will gather together around another great book."

Brooks, a Harvard leadership professor, partnered with Winfrey, the lauded talk show host, philanthropist and producer from Kosciusko, to write this year's selection,  which explains the science behind happiness and how to cultivate it .

"'Build the Life You Want' is an ideal book for our freshmen and incoming students and will provide foundational tools for them to build the life they want to have and to become the people they want to be," said Natasha Jeter, assistant vice chancellor for wellness and student success. "It's a very unique approach because it uses a scientific slant to learning how to construct a life of happiness and fulfillment."

The book tells readers to ask themselves, "What is standing between me and happiness?" and, after identifying the problem, teaches methods to pursue purpose and cultivate joy, Jeter said.

"This little book focuses on the art of being happy and, from that happiness, building a better life for oneself and others," she said.

Brooks is the author of 13 books, including four national bestsellers, and is a regular columnist for The Atlantic. He has published more than 60 peer-reviewed research papers and is a former president of the American Enterprise Institute think tank.

Every freshman and transfer student gets a copy of the book over the summer, and many first-year experience and writing courses will use it in class. Jeter said she hopes the selection will introduce first-year students to a college experience predicated on literature that fosters a love of reading.

"Every year, we are challenged with how to participate in a process that accurately reflects our campus' devotion to literature and to our students," she said. "We want to make a selection that is relevant and provocative and that will help our students as they join the campus.

"The foundation we're establishing here with our students will help them prepare for the rest of their lives."

Clara Turnage

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April 14, 2024

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Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States

Elina hemminki.

THL (National Institute for Health and Welfare), P.O. Box 30, 00271 Helsinki, Finland

The aim of this paper is to compare common features and variation in the work of research ethics committees (RECs) in Finland to three other countries – England, Canada, the United States of America (USA) – in the late 2000s.

Several approaches and data sources were used, including semi- or unstructured interviews of experts, documents, previous reports, presentations in meetings and observations. A theoretical framework was created and data from various sources synthesized.

In Finland, RECs were regulated by a medical research law, whereas in the other countries many related laws and rules guided RECs; drug trials had specific additional rules. In England and the USA, there was a REC control body. In all countries, members were voluntary and included lay-persons, and payment arrangements varied. Patient protection was the main ethics criteria, but other criteria (research advancement, availability of results, payments, detailed fulfilment of legislation) varied. In all countries, RECs had been given administrative duties. Variations by country included the mandate, practical arrangements, handling of multi-site research, explicitness of proportionate handlings, judging scientific quality, time-limits for decisions, following of projects, role in institute protection, handling conflicts of interests, handling of projects without informed consent, and quality assurance research. The division of work between REC members and secretariats varied in checking of formalities. In England, quality assurance of REC work was thorough, fairly thorough in the USA, and not performed in Finland.

Conclusions

The work of RECs in the four countries varied notably. Various deficiencies in the system require action, for which international comparison can provide useful insights.

Electronic supplementary material

The online version of this article (doi:10.1186/s12961-016-0078-3) contains supplementary material, which is available to authorized users.

Review by research ethics committees (RECs), also called research ethics boards or institutional review boards, has become the key in clinical research regulation [ 1 - 4 ]. In the European Union (EU), the 2001 Clinical Trial Directive, which required the establishment of ethics committees to review drug trials, was an important stimulus for the appearance of such bodies. As part of a larger study on clinical research regulation, the work of RECs in Finland was compared to three other countries: England, Canada, and the United States of America (USA) [ 4 ]. This paper aims to compare common features and variation in the work of RECs in the late 2000s, concentrating on the main REC system. The comparison of REC structures and the study context have been previously published [ 4 ], and are only briefly summarized below.

There is much previous literature on the work of RECs in individual countries and their specific aspects; anecdotal stories and expert views have also been published. Comparative data on decisions and the quality of REC work are scarce, but studies show that countries vary in terms of the structural features of their RECs [ 1 , 5 - 14 ].

In Finland, RECs are area-based and have a monopoly, handling all medical research (as defined by law) in their area. Only a small and regulated number of RECs deal with clinical research (21 (five since 2010) and a central committee); there are no private RECs. In England, since 2004, the number of RECs has been regulated, declining from around 200 in 2002 to around 80 in 2010 (69 in 2013). England’s few private RECs were amalgamated with the NHS system by 2013. In Canada, RECs are health facility (hospital)-based, substance-based, or private, can be freely established, and are numerous. Likewise, the USA has a large number of RECs (around 4,500), and several RECs can be located within one institute or hospital. Private committees play a bigger role, being large in size but small in number (around 30). All four countries have RECs other than those described above, which handle health research beyond the mandate of the main REC system.

The methods used herein have been described in detail in previous papers [ 4 , 15 , 16 ], and briefly summarized below. Several approaches and data sources were used. The key method applied consisted of semi-structured and unstructured interviews of experts. In addition, use was made of previous reports, documents, meeting presentations, informal discussions with experts and observations. Empirical data was systematically collected: in Finland in 2009–2011, in Canada in late 2010, in England in early 2011, and in the USA in late 2011. Some data was completed up to spring 2014 using web pages, publications and later interviews.

In Finland, 26 experts involved in research and health services were purposefully selected and interviewed, as were 22 chairpersons from 25 official medical RECs. In the other countries, interviewees were chosen based on previous knowledge of institutes important in this context, suggestions made by the interviewees, geographical proximity, and availability during data collection visits. The numbers of interviewed experts were: 21 in England, 13 in Canada (Ontario), and 24 in the USA. In spring 2014, a draft report was shown to two experts in Canada, England, and the USA and was modified based on their comments.

Most interviews were semi-structured, but some were unstructured and resembled normal discussions. The themes of the interviews and some pre-prepared questions were drawn up prior to each interview, but the actual interview and its focus varied in accordance with the expert’s position, experience and emergent information. Information and material from previous interviews were utilized in subsequent interviews. In Finland, the original questions and themes were chosen by previous literature and the project researchers’ knowledge and experience of research regulation; the questions were reformulated when new information from the interviews accumulated. In the other countries, the interviewees were approached with an open mind. Data collection was a learning process: the questions and items were first formulated by the Finnish experience and prior reading, and reformulated in subsequent interviews by new information.

The interviews lasted from 30 minutes to 3 hours. They were not tape-recorded, but notes were made and a summary of the interview was drawn up afterwards. In each country, documents were collected from the web pages of the institutions involved, or were handed over during the interviews. The relevant publications were sought from literature databases and from references given during the interviews.

For the analysis, a theoretical framework was created comprising the dimensions of REC structures and work. The analysis was material based (grounded theory). During data collection, preliminary classes of items were raised and noted. After the data were collected, empty tables, organized by dimension each containing many items, were created. The tables were initially filled, as recalled from the data collection. Then, country-specific interview notes and documents were iteratively read by one researcher; notes were made on various topics and dimensions using self-adhesive notes, and organized by topic/dimension and by country. The framework was modified and made more detailed during note making. Data from various sources was synthesized and the features of the systems were simplified and classified. If an item was an unequivocal fact and not found in the original country-specific notes, documents and web-pages were searched for it.

Different terms, varying between the interviewees and documents, were used in each country. Specific names and terms were changed into general ones [ 4 ]. Clinical research refers to research conducted on and with patients; clinical trial refers to research that evaluates interventions using experimental methods (not restricted to drugs).

A positive statement was issued by the THL ethics committee on the project as a whole (MERGO Ethical review and administrative governance of clinical research; June 17, 2010, amendment Jan 27, 2011). All interviews were voluntary; the interviewees understood the purpose of the interviews and were interviewed as experts. The documents used were public.

Legal and ethical basis

In Finland, the law-based RECs held a monopoly on reviewing all “medical research” (Table  1 ), but could review other types of research by choice. The definition of medical research was narrow: “research, in which the integrity of a human or her embryo or fetus is subject to intervention or the causes, symptoms, diagnostics, care, prevention or general features of diseases, (since 2010) and which aims to increase knowledge on health”, leaving out much health and healthcare research. Until 2008, in England, all research within the NHS, all research with NHS patients since then, and some specific types of research defined by various laws, were to be handled by NHS RECs. In Canada and the USA, RECs covered human research broadly, but different types of research projects were often handled by different RECs. The definition of human research was restricted to identifiable private information and living humans.

Rules regulating research ethics committees (RECs) and their work in clinical research, Finland compared to England, Canada (Ontario), and the USA, around 2010

a Regardless of place, a certain type of research, such as investigational drugs and devices, adults lacking capacity to consent, exposure to ionizing radiation.

b Tri-Council statements, tri-council policy statement: ethical conduct for research involving humans.

In each country, there were many rules and guidelines, which RECs should or could use to guide their work. These are described in simplified format in Table  1 and Additional file 1 . In Finland, RECs had been regulated since 1999 by a medical research law and its sub-laws, specifying REC mandates and tasks. In the other countries, RECs were less directly law based, but referred to by various laws. In England, RECs were specified by health ministry rules, including those of the REC control body (National Research Ethics Service (NRES); in 2012, it became part of the Health Research Authority). Although RECs were not legal bodies in general, they were in regard to drug and device trials and some special classes, such as research with persons lacking the capacity to consent and exposure to ionizing radiation, as stipulated in specific laws. In Canada, RECs were formalized by the requirements and guidelines of the main public funder, the Canadian Institutes of Health Research, part of the Tri-Council funding agency. In the USA, the research law (1974 National Research Act) mentioned the need for REC review and informed consent. REC tasks were expanded in government (federal) regulations (Common rule). The Common rule concerned all human research, but was adaptable to the research type and purpose.

In each country, laws on data confidentiality (privacy laws/freedom of information laws) existed and were integral to research regulation. Detailed information on these intricate regulations was not collected, and the role of the RECs overseeing them varied. Additional special laws governed drug trials in all of the countries [ 4 ].

Research ethics codes, such as the Declaration of Helsinki [ 1 ], were not central to discussions on the REC system or work. However, codes had had an impact on national guideline formulation.

REC members and processes

In Finland, expertise in research ethics, law, medicine, nursing sciences (since 2010) – and at least two lay-members – were required (Table  2 ). In England, a varied composition was required, with one third of the members being lay-persons. In Canada, the required expertise was defined as multidisciplinary and independent: at least five members, both men and women, of whom at least two were experts in the research area, one in ethics, one in the relevant law, and one community representative. In the USA, the regulations defined the minimum number of members (five), at least one of whom was to be unaffiliated with the institution. Membership should be diverse (by race, gender, cultural background, sensitivity to community issues), with at least one scientist and one non-scientist. In all countries, REC membership was voluntary.

Members and processes of research ethics committees (RECs), Finland compared to England, Canada (Ontario), and the USA, around 2010

a Private RECs different.

Payment arrangements varied by REC and country; furthermore, the employers of REC members decided on whether work could be done during working hours. In Finland, meeting costs were usually covered (Table  2 ). In some committees, the chairperson and the member presenting the application were paid a lump sum. In England, members and chairpersons were unpaid, but locum (cover for members during REC meetings) and travel costs could be covered. In Canada, REC chairpersons were usually paid, but members were not. Some REC chairs were professional and paid for their weekly time. In the USA, institutional members could count REC work as part of their share of outside funding. Private committee members were paid.

Multi-centre project handling

In Finland, the research law’s amendment in 2010 was explicit to only a single handling. The central REC was the primary address for multi-centre drug trials, but most applications were delegated to local RECs. In England, the EU clinical trials directive contributed to the creation of a system in which multi-centre projects were reviewed by one REC only. In Canada (Ontario), several proposals had been made to centralize REC work for multi-centre projects, but this had occurred in only a few areas, such as cancer trials. In the USA, multi-centre projects could be handled in three ways: in each local committee, one committee being chosen to review on behalf of all, or an outsider ethics committee being chosen to conduct a single review. Even though the problems associated with multi-handling were obvious, various factors favoured decentralized handling. They included close collaboration between RECs, the decision maker and the research contract office, liability issues and hospital insurers’ requirements.

Time-limits for decisions

In Finland and England, the EU clinical trials directive set limits on review times and tabling for drug trials (Table  2 ), but did not apply to other types of research. In Canada and the USA, there were no rules on how quickly a REC should make decisions or the number of times it could table an application. In all countries, researchers and sponsors expected rapid handling and clear reasons for tabling; anecdotal information suggested that many researchers were dissatisfied with these aspects.

Presence of researchers

In Finland, researchers were seldom present in REC meetings to answer questions, in England this was standard practice, but in Canada (Ontario) it was rare. No information was available for the USA.

Proportionate review (different handling based on assumed risk to study participants)

In Finland, proportionate review was not explicit (Table  2 ). In England, proportionate review was pushed by higher level research regulators. In Canada and the USA (the terms ‘expedited review’ and ‘fast tracking’ were used) proportionate review was explicit. The division into ordinary and expedited reviews was usually proposed by the researchers and preliminarily determined by the REC secretariat.

Checking formalities

In all countries, REC secretariats often helped researchers to prepare the application. However, in Finland, the secretariats were modest in size and technical capacity, reducing the help they could offer (Table  2 ). REC secretariats were mainly responsible for ensuring that the applications fulfilled the various detailed rules, but REC members also performed much of this work. Among REC members, a common complaint was that ethics are buried under technical details. In England, the REC control body (NRES) had successfully lightened the administrative burden, including the introduction of a standard electronic portal for applications. In Canada, technical assistants for paperwork were commonly organized into ethics and contract offices. Applications were constructed based on standard forms, but REC members and researchers still complained about spending too much time following rules. In the USA, the application forms were detailed and institutions had created various well-resourced offices to lessen the REC’s work.

Institutions’ regulatory costs associated with RECs were mentioned in expert interviews only in the USA, being considered an important risk management element. Regulatory costs for researchers, including monitoring costs, emerged as an issue in Canada and the USA. The requirements set by RECs and other research regulators could consume a large part of the budget. In Canada, one interviewee considered high costs an unfair inhibition on researchers with small budgets.

Patient protection

In all countries, the starting point for REC work was patient protection (safety), including voluntary participation (patient autonomy) and data protection (confidentiality) (Table  3 ). In the absence of specific criteria, the way in which patient protection was measured and balanced with other study aspects varied.

Tasks and items in clinical research projects covered by research ethics committees (RECs), Finland compared to England, Canada (Ontario), and the USA, around 2010

a Patients, doctors and other resources for research.

Research advancement

In Finland, the advancement of (good) research was a concealed task (Table  3 ), although some REC committees or individual members were aware of it. The benefits of research were usually narrowly defined in relation to the participants in the project under review. In other countries, particularly England, research advancement was more explicitly acknowledged and the benefits for future patients were considered.

Research prioritization

Was not considered a REC task in any of the countries (Table ​ (Table3). 3 ). Neither were RECs interested in competition for resources (availability of eligible patients and professionals) within an institute or population. This potentially favoured sponsors who could offer better terms to the institute or health professionals conducting research.

Responsibility towards researchers

The consequences of REC work for researchers or research funders, in terms of time or resources, were not a REC consideration. An exception was drug trials in Finland and England, for which the EU directive set time limits on decision making (Table  2 ). Researchers and sponsors had to pay the extra costs or delays resulting from REC requirements. This was particularly problematic in the case of academic funding, which could be small with tight time limits.

Unlike the other countries, RECs in Finland were to review the research plan but not follow the project (Table  3 ). Researchers or sponsors could voluntarily send amendments for review, which commercial sponsors often did. The European clinical trials directive required the follow-up of drug trials, but this was done by the drug authority. In the other countries, RECs had to follow the projects and annual reporting was customary.

In Finland, RECs did not inspect contracts between sponsors and institutions/researchers, other than the size of intended payments to physicians (Table  3 ). Research sites (e.g. hospitals) made contracts, giving no feedback to RECs. The same occurred in England, where contracts were made by healthcare trusts, with little cooperation between RECs and trusts. In Canada and the USA, contract offices acted separately from RECs, but informed each other of their evaluations and decisions.

Specific items

Scientific quality.

In all countries, the scientific quality of a project was considered an ethical prerequisite: quality is important in evaluating the risk-benefit ratio and poor quality research needlessly puts patients at risk. The role of RECs in this evaluation varied, and there could be parallel reviews, including those of funders (Table  3 ). In Finland, this evaluation was a REC task, whereas in England RECs had clearly been deemed unsuitable for this role. Instead, researchers or sponsors were asked to provide evidence of scientific quality for REC consideration. In Canada and the USA, reviewing scientific quality was often a REC task. Sometimes, a tension existed between established researchers and REC capabilities: established researchers resented RECs’ involvement in methodological questions. In the USA, the drug control authority thoroughly reviewed the scientific aspects of clinical trials involving new drugs and devices or their new indications.

Availability of results

In Finland, RECs did not cover the availability of results (publication) (Table  3 ), even when it was clear that the researchers had no control over publication. Registration of trials or other research was not required. However, many trials were registered in international registers due either to anticipated publication requirements or the trial being international. In England, the standard nationwide REC application form asked for a publication plan and trial registration. In Finland and England, drug trial registration in an EU register was required by an EU directive.

In Canada, checking on the availability and assumed publication of results was part of REC work. At least in the studied RECs, contract offices checked that no clause prevented publication, which would be grounds for rejecting the study. In the USA, registration of drug and device trials was required by law and presenting the outcomes in a public register had been proposed. For other types of research, registration was voluntary.

This covers two related aspects: the role that RECs had played (1) in ensuring that laws and other rules were followed and (2) in protecting institutes and researchers from liability (Table  3 ). In Finland, checking that the project abided by laws and other rules was a key task. RECs had a small role with regard to liability. In England, a REC could define a project as ethically sound even when it broke a law or other rule. However, permission would scarcely be forthcoming from the institute for such a project.

In Canada, the Tri-Council statement offered ambivalent advice on how RECs should take account of laws and rules, but each REC was required to have a person familiar with the relevant laws. In the RECs on which information was available, the assessment of ethics and legality were separated in the evaluation. Insurance companies’ requirements and other factors suggested that institutional liability was a consideration. In the USA, although the REC secretariat checked the legal requirements, RECs also devoted time to legal issues. RECs played a major role in protecting institutions. If approval of a study later turned out to be wrong, the entire institute’s research could be endangered. Investment in RECs was a key risk avoidance method within institutions.

Conflicts of interest (COI)

In Finland, COI between the researcher/institute and sponsor were not part of ethical judgments (Table  3 ), and no other body oversaw COI. Since the late 2000s, RECs had been advised to ask about payments to physicians in order to assess the temptation to lock patients into a research project, but no transparency was required towards research participants. COI within RECs were carefully observed, based on the legislation on civil servants. In England COI checking was an REC task, though no information was available on its thoroughness. In Canada and the USA, COIs and their disclosers were important; special offices or bodies took care of them and informed the RECs of their conclusions. In Canada, patient leaflets usually included a description of the financing source.

Quality assurance of REC work

Rec control body oversight.

In England and the USA, RECs were regulated and supported by a REC control body (Table  4 ). In Finland, one of the central REC’s (the National Committee on Medical Research Ethics) tasks was to provide local RECs with guidance and education and to give second opinions in the case of complaints, but it had no formal power over local RECs and had not taken a leadership role.

Features related to quality of research ethics committee (REC) work, Finland compared to England, Canada (Ontario), and the USA, around 2010

a Not in established academic research centres, elsewhere possible.

b Since 2010, before then accountability unclear.

c Hospital boards consisting of outside members.

In England, the NRES had been active in improving REC work, reducing REC numbers, and streamlining and standardizing procedures. It appointed, credited and audited local RECs and educated their members. REC secretariats were employees of the NRES. The NRES audited RECs through visits, document checking, statistical follow ups, and feedback from researchers. The NRES did not review applications. In case of a complaint, it referred the application to another local REC for a second review.

In the USA, the Office of Human Research Protection (OHRP) registered RECs and issued an “REC license” (a federalwide assurance) by application. It could perform or commission site visits to RECs or research sites. In the case of (suspected) misconduct in a study, the OHRP could overrule the REC decision and all approvals made by the REC. Researchers could complain to the OHRP, but the OHRP did not perform reviews itself. It was more distant than the NRES, having no day to day interaction with local RECs. It had small resources in relation to the number of RECs. The OHRP hosted a national committee (Secretary’s Advisory Committee on Human Subjects Research), which provided expert advice and recommendations on ethics and research regulation.

Formal quality assurance

Unlike the other countries, Finland had no formal quality assurance of RECs (Table  4 ). In England and the USA, quality assurance was performed by the REC control bodies. In addition, the drug authorities could inspect RECs that had handled drug or device trials. In the USA, it could sanction and even disqualify RECs. In the USA, voluntary accreditation of RECs, especially private ones, was common, performed by a private company and costly. In Canada, there were plans to establish an accreditation system, but by 2011 this was not in place for human RECs. However, hospitals were accredited, obliging them to demonstrate that ethics were being attended to. Private RECs were unregulated. The Canadian General Standard Committee (a federal agency) had begun introducing standards for RECs dealing with drug and device trials. The drug authority occasionally inspected RECs performing drug and trial reviews.

REC dismissal

In England, the NRES could suspend a REC (Table  4 ). In the USA, the OHRP could temporarily stop the work of a REC and in theory dismiss it. In Finland and Canada, questions regarding dismissal were not specifically asked, but there were no clear practices for this and, to the author’s knowledge, it had never occurred.

Researchers’ choice

In Finland, researchers could not choose the REC, which was determined by the professional location of the principal investigator (Table  4 ). In England, researchers could choose a REC within the NHS, which then had to handle the application, but the distance travelled for presenting plans and waiting lists for popular RECs regulated client numbers. Besides specific groups defined by law, RECs did not handle research outside the NHS. In Canada, research on patients cared for in a health facility receiving government funding had to be handled by the REC for that facility, unless an agreement existed with a central committee. In the USA, researchers in academic institutions had to use the REC assigned by the institute. Researchers outside academic institutes could choose the REC, but institutional RECs seldom reviewed external research projects.

Researcher’s appeal possibilities

In Finland, a positive statement was made rather than a decision (Table  4 ), although the statement was tantamount to a decision in regard to obtaining research permission. However, since this was not a decision in legal terms, researchers could not complain, but could only request the REC to consult the central REC for a second opinion. There was no right to appeal in the case of projects handled by the central REC itself. Researchers could re-submit to the same committee in the case of a negative decision.

In England, in the case of rejection, the researcher could discuss the issue with the REC, resubmit the application to the same or another committee, or appeal to the control body (NRES). In Canada, the researcher could discuss the issue with the REC. If no agreement was reached, the researcher could appeal to an institutional appeal committee. In the USA, the author had the impression that researchers or sponsors could negotiate with RECs but did not often appeal, although appeals could be made to the OHRP.

REC independence from research sites

In Finland, RECs were based in central hospitals. As most clinical research occurred there, RECs were only semi-independent from the research sites (Table  4 ). After 2010, the number of RECs was reduced and more projects were evaluated outside the responsible institution. In England, RECs were administratively independent from research sites. In Canada and the USA, RECs were mostly within the institute. Private RECs were independent of research sites.

Accountability

In Finland, the nomination of REC members and the accountability of RECs were unclear until 2010. Since then, REC members had been appointed by university hospital districts (Table  4 ). Although municipal administrators appointed REC members, such members had “state civil servant responsibility”. The central committee was appointed by the health ministry. In England, RECs were accountable to the control body (NRES). In Canada, RECs were appointed by and reported to the hospital board. In the USA, RECs were accountable to the hospital/institution in which they were located. However, REC operational procedures were specified when registering with the control body (OHRP). Private RECs were accountable to themselves only, but their operational procedures too were specified upon registration.

Transparency

In Finland, REC work was not transparent (Table  4 ). Member selection was not an open process, there were no public annual reports of REC work and the meeting notes were available only upon request based on good grounds (as judged by the REC itself). The style of meeting notes varied. Some even used codes for projects, without mentioning the research objectives or topic and using standard phrases when giving reasons for decisions. Application documents were secret.

In England, transparency was an accepted policy and REC positions were advertised. Much information on RECs and their work, including most accepted study protocols, were available from the NRES web pages. Further openness was planned, including information on rejected projects. In Canada, REC handling notes and project protocols were kept secret. This had been identified as a transparency problem, but not solved by 2011. In the USA, REC meeting minutes were not public in most states and there was no broad discussion on lack of transparency. There was a proposal that access to research protocols be required upon trial registration; this had not occurred by 2011.

Obligatory education of REC members

In England, NRES provided obligatory introductory training for new REC members and old members were offered voluntary continuing training. In the other countries, REC members were not required training in ethics or in work practices. In Canada and the USA, many self-driven training options were available. In Canada, the voluntary organization for REC members and staff (CAREC) functioned as a clearing house, as well as a training and networking organizer. In the USA, the principal investigators were required to take ethics courses.

Variability in decisions

Variability in REC work and decisions was not discussed in Finland (Table  4 ). In England, this had been an important argument for streamlining the ethics system and creating the REC control body. In Canada and the USA, the issue had been recognized as a problem, but not solved. In Canada, in response, the public funder had issued detailed criteria for use in evaluations. In the USA, the problem had led to a proposal to modify the Common Rule.

Dealing with exceptions

Informed consent exemption in trials.

In each country, the main mechanism for assuring voluntary participation was obtaining permission from participants fully informed of the trial (informed consent). In certain research designs, however, this did not work. In Finland, exemptions from informed consent (waivers) were not possible for medical intervention studies (Table  4 ); practices varied in the case of surveys and document-based studies. Researchers solved the problem of lack of exemptions by using apparent consent, changing the design, redefining the project as non-medical research or development work, or dropping it. In the other countries, RECs could grant exemptions to informed consent. In England, some interviewees stated that informed consent had become less problematic.

Emergency drug trials

In Finland, the EU clinical trials directive had been interpreted as requiring informed consent from patients before recruitment for emergency drug trials (Table  4 ). In England, although also an EU country, interpretation of the directive had changed over time and emergency drug trials were possible. This change was said to have been facilitated by lobbying by emergency care physicians. In Canada and the USA, exemptions to informed consent were used in emergency trials.

Quality assurance research

Research evaluating how well healthcare services or patient care works or should work (quality improvement research, quality assurance, audit, quality evaluation) was problematic for RECs in all countries (Table  4 ). In Finland, there had been no public discussion of the issue. RECs emphasized separating research from care; once the project had been defined as medical research, no distinction was made in its handling. In England, some advocated the exemption of quality assurance studies from the ethics approval requirement. This was part of a trend of focusing the NHS REC system on clinical patient level research and leaving health services and social sciences research outside their mandate. In Canada and the USA, practices varied – some RECs exempted such research, some had an expedited procedure with simpler requirements, and some treated them as normal research projects with full handling procedures.

Study strengths and weaknesses

Most data from the four countries was collected by one person with prior knowledge of the topic, enabling the consistent external examination of each system [ 4 ]. This also enabled information from one interview to be used in the next.

Weaknesses included the difficulties inherent in any country comparison, such as those resulting from varying healthcare systems and the same tasks being handled by different actors in different countries. Aspects covered varied between interviews. Due to limited resources, it was not possible to approach informants again to enquire about issues which had arisen after their interviews. The findings presented are simplifications and do not describe the many exceptions and nuances. Data confidentiality, data access, secrecy, and privacy issues were not systematically studied, although these are topical in research ethics.

Similar previous comparative studies were not found in order to compare the results. This may be due to the fact that this study was the first of its kind, or that previous studies have appeared in forms difficult to trace via literature searches. Previous literature was unsystematically searched from medical databases using various keywords and from the reference lists of related articles.

Comments on results

In Finland, RECs were regulated by a detailed medical research law and in case of drug trials, as in England, by a detailed EU law (directive). Detailed legislation can lead to conflicts between laws and ethics [ 2 ]: an important ethical question concerns the amount of discretion left to researchers. A check-box mentality may make them feel that they have lost responsibility for their own work. There is no one way of performing clinical research ethically; overly detailed advice will harm both research and ethics [ 17 ].

Furthermore, laws make the ethics system rigid, particularly supra-national laws. They are more difficult to change than rules in response to regulatory problems or changes in research. Broad-based legislation and detailed rules at lower level, as in the USA, may be a good compromise, allowing a more responsive system. Another legal issue concerns how much consideration RECs should give to the consequences of their decisions. In Finland, little consideration was given to this, but it was a very prominent issue in the USA: RECs have functioned as legal insurance for hospitals in regard to research.

In Finland, a key issue was that regulation was legally required for “medical” research only. This distinction from the rest of “health” research or other human research was largely artificial. In the other countries, the definitional problems were smaller, being more related to the location of the research. None of the countries had resolved how to distinguish research from other activities; the boundaries with research and public health interventions or quality assurance programs were unclear. Such problems are likely to become more prominent alongside new trends in evidence-based healthcare [ 2 ]. Such distinctions were especially difficult in Finland, whose research legislation did not allow exemptions to informed consent. Healthcare ethics should be considered as a whole rather than divided between research and healthcare practice [ 18 , 19 ].

In all countries, drug trials were subject to special regulation and additional reviews by drug control authorities. The special regulation system for drug trials could be questioned, but this had not been done. The 2001 EU clinical trials directive on drug research was very detailed. In 2017, it will be replaced by a new revised EU-regulation (No 536/2014 on clinical trials on medicinal products for human use), equally detailed, but improved in some respects. In the USA, drug trials aiming at drug licensing had their own regulation path, since most were handled in private RECs, with the drug authority (FDA) playing a key role. Furthermore, in the two EU countries studied, Finland and England, the directive changed some features of the overall research regulation system and rules. In general, the EU directive had been important in the creation and formulation of RECs in many European Union countries [ 1 , 7 ].

Regulation costs for researchers and institutions have been discussed in the USA [ 12 , 18 ]. Studies show that RECs imposed notable costs on host institutions [ 18 , 20 , 21 ]. However, the current study suggests that institutions did not consider REC costs too high, as RECs were an important part of risk management. In addition, there were costs for other actors, particularly researchers and sponsors.

It is not clear what constitutes the ethics to be guaranteed by RECs [ 6 , 22 - 24 ]. In addition to patient protection, the RECs in the four countries studied had other criteria of varying importance. One of them, scientific quality, can be problematic, as REC members are chosen to review participant protection and may not be the best persons to evaluate scientific quality, particularly that of studies using novel approaches. The English approach, requesting evidence of scientific value for the REC’s consideration, was a good compromise.

A lack of ethics criteria also meant that research motives were not considered. Availability of results is an ethical issue because, if the results are not publicly available, altruistic participation or the use of publicly collected information become private property.

Studies suggest that many academic researchers (i.e. those not working for commercial sponsors) were unhappy with RECs. Some have complained that RECs impede their research work rather than ensuring ethical conduct [ 25 - 31 ]. In this study, the quality of REC work was not directly measured, but structures or procedures for ensuring quality were studied. Finland had the least and England the most such structures. In England, researchers’ ability to choose their REC was a key issue. As RECs were not paid for their work, there was no incentive to “sell permissions”, which was also likely to be prevented by the close surveillance of the REC control body. In the USA “selling permissions” was a clear danger in the case of private RECs. Other important elements of quality assurance were transparency and appeal possibilities; these too were best organized in England. However, some appeal possibilities may be notional only, due to researchers’ fear of the negative consequences of appeals. Fearing the possible consequences, researchers seldom wish to protest openly or challenge RECs. In the case of drug trials, researchers may be afraid to challenge the control authorities for fear of repercussions when applying for a product license or another trial.

The general aim of RECs, to help preserve research ethics, is rarely questioned, but various aspects of REC activities have been widely criticized [ 16 , 24 , 26 , 32 - 38 ]. In all countries, a great deal of time was used by RECs and other actors to check various procedural formalities. Such efforts are unlikely to have made research more ethical. They may serve other purposes, but these were not clearly spelled out. Multi-location projects were increasingly common, but the REC system had been created at a time when they were less so.

This study provides no direct answers to the obvious question – why had the various identified problems not been solved. Power relations may be important: who gets to define what is right and wrong [ 39 ] and what should be done and by whom? RECs are a channel through which outsiders can participate in decision making in a research project. Furthermore, much clinical research is supported by influential technology players such as multinational drug firms, which may be influencing the content of ethics and administrative rules to protect them from competitors and academic investigators, and may also want uniform regulations and requirements for large markets. Those responsible for REC work may feel the need to resist commercial pressures and create various rules to assist in this.

This study lends support to the criticism that RECs may prevent research: the rules and procedures are many and costly, and likely to deter individual clinicians [ 40 ]. General observations suggest that RECs have improved the rights of people participating in research, but the balance struck between the rights of people and patients in general is questionable if relevant research has been prevented or the relevance of research design and content compromised. The rules and practices of RECs should be improved.

Certain features of REC work in individual countries could serve as a model for others. Streamlining of the ethics committee system in England, content advice on the handling of ethical issues in Canada, and the separation of drug trials for licensing from other drug research in the USA, are examples. In regard to structure, some Finnish features, such as area responsibility, lack of private RECs, and the relative lightness of REC work, were good [ 41 ].

Acknowledgements

The study was financially supported by a grant from the Academy of Finland (grant 28356). I thank the interviewees for their time and give especial thanks to those who commented on earlier versions of this article. I would like to thank Piret Veerus, Jorma Virtanen and Sandra Liede for the interviews they conducted.

Abbreviations

Additional file.

Laws, rules and guidelines, which RECs should or could use to guide their work. (PDF 79 kb)

Competing interests

The author declares that there are no competing interests.

Authors’ contributions

The author originated the idea, planned the analysis, collected the data, and prepared the draft and final manuscript.

• Victor Mukhin

Victor M. Mukhin was born in 1946 in the town of Orsk, Russia. In 1970 he graduated the Technological Institute in Leningrad. Victor M. Mukhin was directed to work to the scientific-industrial organization "Neorganika" (Elektrostal, Moscow region) where he is working during 47 years, at present as the head of the laboratory of carbon sorbents.     Victor M. Mukhin defended a Ph. D. thesis and a doctoral thesis at the Mendeleev University of Chemical Technology of Russia (in 1979 and 1997 accordingly). Professor of Mendeleev University of Chemical Technology of Russia. Scientific interests: production, investigation and application of active carbons, technological and ecological carbon-adsorptive processes, environmental protection, production of ecologically clean food.   

Title : Active carbons as nanoporous materials for solving of environmental problems

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40 facts about elektrostal.

Written by Lanette Mayes

Modified & Updated: 02 Mar 2024

Reviewed by Jessica Corbett

Elektrostal is a vibrant city located in the Moscow Oblast region of Russia. With a rich history, stunning architecture, and a thriving community, Elektrostal is a city that has much to offer. Whether you are a history buff, nature enthusiast, or simply curious about different cultures, Elektrostal is sure to captivate you.

This article will provide you with 40 fascinating facts about Elektrostal, giving you a better understanding of why this city is worth exploring. From its origins as an industrial hub to its modern-day charm, we will delve into the various aspects that make Elektrostal a unique and must-visit destination.

So, join us as we uncover the hidden treasures of Elektrostal and discover what makes this city a true gem in the heart of Russia.

Key Takeaways:

• Elektrostal, known as the “Motor City of Russia,” is a vibrant and growing city with a rich industrial history, offering diverse cultural experiences and a strong commitment to environmental sustainability.
• With its convenient location near Moscow, Elektrostal provides a picturesque landscape, vibrant nightlife, and a range of recreational activities, making it an ideal destination for residents and visitors alike.

Known as the “Motor City of Russia.”

Elektrostal, a city located in the Moscow Oblast region of Russia, earned the nickname “Motor City” due to its significant involvement in the automotive industry.

Home to the Elektrostal Metallurgical Plant.

Elektrostal is renowned for its metallurgical plant, which has been producing high-quality steel and alloys since its establishment in 1916.

Boasts a rich industrial heritage.

Elektrostal has a long history of industrial development, contributing to the growth and progress of the region.

Founded in 1916.

The city of Elektrostal was founded in 1916 as a result of the construction of the Elektrostal Metallurgical Plant.

Located approximately 50 kilometers east of Moscow.

Elektrostal is situated in close proximity to the Russian capital, making it easily accessible for both residents and visitors.

Known for its vibrant cultural scene.

Elektrostal is home to several cultural institutions, including museums, theaters, and art galleries that showcase the city’s rich artistic heritage.

A popular destination for nature lovers.

Surrounded by picturesque landscapes and forests, Elektrostal offers ample opportunities for outdoor activities such as hiking, camping, and birdwatching.

Hosts the annual Elektrostal City Day celebrations.

Every year, Elektrostal organizes festive events and activities to celebrate its founding, bringing together residents and visitors in a spirit of unity and joy.

Has a population of approximately 160,000 people.

Elektrostal is home to a diverse and vibrant community of around 160,000 residents, contributing to its dynamic atmosphere.

Boasts excellent education facilities.

The city is known for its well-established educational institutions, providing quality education to students of all ages.

A center for scientific research and innovation.

Elektrostal serves as an important hub for scientific research, particularly in the fields of metallurgy, materials science, and engineering.

Surrounded by picturesque lakes.

The city is blessed with numerous beautiful lakes, offering scenic views and recreational opportunities for locals and visitors alike.

Well-connected transportation system.

Elektrostal benefits from an efficient transportation network, including highways, railways, and public transportation options, ensuring convenient travel within and beyond the city.

Famous for its traditional Russian cuisine.

Food enthusiasts can indulge in authentic Russian dishes at numerous restaurants and cafes scattered throughout Elektrostal.

Home to notable architectural landmarks.

Elektrostal boasts impressive architecture, including the Church of the Transfiguration of the Lord and the Elektrostal Palace of Culture.

Offers a wide range of recreational facilities.

Residents and visitors can enjoy various recreational activities, such as sports complexes, swimming pools, and fitness centers, enhancing the overall quality of life.

Provides a high standard of healthcare.

Elektrostal is equipped with modern medical facilities, ensuring residents have access to quality healthcare services.

Home to the Elektrostal History Museum.

The Elektrostal History Museum showcases the city’s fascinating past through exhibitions and displays.

A hub for sports enthusiasts.

Elektrostal is passionate about sports, with numerous stadiums, arenas, and sports clubs offering opportunities for athletes and spectators.

Celebrates diverse cultural festivals.

Throughout the year, Elektrostal hosts a variety of cultural festivals, celebrating different ethnicities, traditions, and art forms.

Electric power played a significant role in its early development.

Elektrostal owes its name and initial growth to the establishment of electric power stations and the utilization of electricity in the industrial sector.

Boasts a thriving economy.

The city’s strong industrial base, coupled with its strategic location near Moscow, has contributed to Elektrostal’s prosperous economic status.

Houses the Elektrostal Drama Theater.

The Elektrostal Drama Theater is a cultural centerpiece, attracting theater enthusiasts from far and wide.

Popular destination for winter sports.

Elektrostal’s proximity to ski resorts and winter sport facilities makes it a favorite destination for skiing, snowboarding, and other winter activities.

Promotes environmental sustainability.

Elektrostal prioritizes environmental protection and sustainability, implementing initiatives to reduce pollution and preserve natural resources.

Home to renowned educational institutions.

Elektrostal is known for its prestigious schools and universities, offering a wide range of academic programs to students.

Committed to cultural preservation.

The city values its cultural heritage and takes active steps to preserve and promote traditional customs, crafts, and arts.

Hosts an annual International Film Festival.

The Elektrostal International Film Festival attracts filmmakers and cinema enthusiasts from around the world, showcasing a diverse range of films.

Encourages entrepreneurship and innovation.

Elektrostal supports aspiring entrepreneurs and fosters a culture of innovation, providing opportunities for startups and business development.

Offers a range of housing options.

Elektrostal provides diverse housing options, including apartments, houses, and residential complexes, catering to different lifestyles and budgets.

Home to notable sports teams.

Elektrostal is proud of its sports legacy, with several successful sports teams competing at regional and national levels.

Boasts a vibrant nightlife scene.

Residents and visitors can enjoy a lively nightlife in Elektrostal, with numerous bars, clubs, and entertainment venues.

Promotes cultural exchange and international relations.

Elektrostal actively engages in international partnerships, cultural exchanges, and diplomatic collaborations to foster global connections.

Surrounded by beautiful nature reserves.

Nearby nature reserves, such as the Barybino Forest and Luchinskoye Lake, offer opportunities for nature enthusiasts to explore and appreciate the region’s biodiversity.

Commemorates historical events.

The city pays tribute to significant historical events through memorials, monuments, and exhibitions, ensuring the preservation of collective memory.

Promotes sports and youth development.

Elektrostal invests in sports infrastructure and programs to encourage youth participation, health, and physical fitness.

Hosts annual cultural and artistic festivals.

Throughout the year, Elektrostal celebrates its cultural diversity through festivals dedicated to music, dance, art, and theater.

Provides a picturesque landscape for photography enthusiasts.

The city’s scenic beauty, architectural landmarks, and natural surroundings make it a paradise for photographers.

Connects to Moscow via a direct train line.

The convenient train connection between Elektrostal and Moscow makes commuting between the two cities effortless.

A city with a bright future.

Elektrostal continues to grow and develop, aiming to become a model city in terms of infrastructure, sustainability, and quality of life for its residents.

In conclusion, Elektrostal is a fascinating city with a rich history and a vibrant present. From its origins as a center of steel production to its modern-day status as a hub for education and industry, Elektrostal has plenty to offer both residents and visitors. With its beautiful parks, cultural attractions, and proximity to Moscow, there is no shortage of things to see and do in this dynamic city. Whether you’re interested in exploring its historical landmarks, enjoying outdoor activities, or immersing yourself in the local culture, Elektrostal has something for everyone. So, next time you find yourself in the Moscow region, don’t miss the opportunity to discover the hidden gems of Elektrostal.

Q: What is the population of Elektrostal?

A: As of the latest data, the population of Elektrostal is approximately XXXX.

Q: How far is Elektrostal from Moscow?

A: Elektrostal is located approximately XX kilometers away from Moscow.

Q: Are there any famous landmarks in Elektrostal?

A: Yes, Elektrostal is home to several notable landmarks, including XXXX and XXXX.

Q: What industries are prominent in Elektrostal?

A: Elektrostal is known for its steel production industry and is also a center for engineering and manufacturing.

Q: Are there any universities or educational institutions in Elektrostal?

A: Yes, Elektrostal is home to XXXX University and several other educational institutions.

Q: What are some popular outdoor activities in Elektrostal?

A: Elektrostal offers several outdoor activities, such as hiking, cycling, and picnicking in its beautiful parks.

Q: Is Elektrostal well-connected in terms of transportation?

A: Yes, Elektrostal has good transportation links, including trains and buses, making it easily accessible from nearby cities.

Q: Are there any annual events or festivals in Elektrostal?

A: Yes, Elektrostal hosts various events and festivals throughout the year, including XXXX and XXXX.

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